Bruschi Dott. Giuseppe

Pubblicazioni su PubMed

• Eight-Year Outcomes of Patients With Reduced Left Ventricular Ejection Fraction Who Underwent Transcatheter Aortic Valve Replacement With a Self-Expanding Bioprosthesis.
  Am J Cardiol

  2024 Dec;232():57-64. doi: 10.1016/j.amjcard.2024.09.015.
  
  De Felice Francesco, Paolucci Luca, Musto Carmine, Nazzaro Marco Stefano, Chin Diana, Stio Rocco, Pennacchi Mauro, Adamo Marianna, Chizzola Giuliano, Massussi Mauro, Giannini Cristina, Angelillis Marco, De Carlo Marco, Gorla Riccardo, Bedogni Francesco, Bellini Barbara, Montorfano Matteo, Bruschi Giuseppe, Merlanti Bruno, Ferrara Erica, Poli Arnaldo, Regazzoli Damiano, Palmerini Tullio, Iadanza Alessandro, Nicolini Elisa, Toselli Marco, De Marco Federico, Gabrielli Domenico
  
  Abstract
  
  Data deriving from patients who underwent TAVR between 2007 and 2017 in 13 Italian centers were prospectively collected. Patients were stratified in those with normal LVEF and reduced LVEF. The latter was further classified according to ischemic or nonischemic etiology. The primary end point was a composite of all-cause death and rehospitalizations; the secondary end points were the isolated composers of the primary end point and cardiac death. Overall, 2,626 patients were included in the analysis: 68.1% with normal LVEF and 31.9% with reduced LVEF. At 8 years, reduced LVEF was significantly associated with the primary end point (adjusted hazard ratio 1.17, 95% confidence interval 1.06 to 1.29). Consistent findings were evident for the composite end point. No differences in these trends were found at the 30-day landmark analyses. Compared with nonischemic etiology, ischemic reduced LVEF was associated with an increased risk of cardiac death (adjusted hazard ratio 1.43, 95% confidence interval 1.02 to 2.02). In conclusion, patients with reduced LVEF who underwent TAVR are exposed to a progressively increased risk of death and rehospitalizations, even at very long-term follow-up.
  
  Copyright © 2024 Elsevier Inc. All rights reserved.
  
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• [Contemporary diagnosis and treatment of tricuspid regurgitation: from neglected valve to primetime].
  G Ital Cardiol (Rome)

  2024 Aug;25(8):576-589. doi: 10.1714/4309.42927.
  
  Montalto Claudio, Tognola Chiara, Ghidini Simone, Monticelli Massimiliano, Nava Stefano, Soriano Francesco, Munafò Andrea R, Tavoletta Pasquale, Bruschi Giuseppe, Esposito Giuseppe, Mangieri Antonio, Giannattasio Cristina, De Marco Federico, Oliva Fabrizio, Oreglia Jacopo A
  
  Abstract
  
  Tricuspid insufficiency has long been considered an entity with low prognostic importance and associated with symptoms and signs only secondarily to left heart pathology. Scientific research in recent years has debunked this myth, demonstrating a key role in determining symptoms and signs of right heart failure, even in advanced stages. In parallel, advances in transcatheter technologies have opened up treatment options even for patients with increased surgical risk, who were previously excluded from traditional surgical options, with increasingly convincing results in reducing symptoms and improving the quality of life of our patients. The contemporary challenge is to translate these messages into everyday clinical practice and to encourage the centralization of patients in centers that currently have the expertise for feasibility evaluation and subsequent treatment. In this Review, we will analyze the most recent evidence on the pathophysiology and diagnosis of tricuspid insufficiency, the latest recommendations from European guidelines, and we will try to illustrate the most common technologies for percutaneous treatment and the abundant evidence supporting them.
  
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• Use of cangrelor for complex percutaneous coronary intervention in the context of concomitant severe aortic stenosis: a case series.
  Eur Heart J Case Rep

  2024 May;8(5):ytae237. doi: ytae237.
  
  Soriano Francesco, Munafò Andrea R, Baydaroglu Nurcan, Nava Stefano, Bruschi Giuseppe, Esposito Giuseppe, Oreglia Jacopo A, Montalto Claudio
  
  Abstract
  
  BACKGROUND:
  There is a growing need for percutaneous coronary intervention (PCI) to be performed within the same transcatheter aortic valve implantation (TAVI) procedure. In such cases, cangrelor, a fast-acting intravenous P2Y12-inhibitor with a short offset, is potential clinical utility to minimize bleeding and vascular complications during large-bore arterial access (LBAA) as well as the thrombotic risk associated with concomitant PCI.
  
  CASE SUMMARY:
  We report two cases of TAVI with an indication to concomitant, high-risk PCI. In the first one, cangrelor was started only after LBAA was secured and TAVI completed, just before the initiation of complex PCI. In the second case, due to predicted complex coronary cannulation after TAVI, complex PCI was performed before TAVI and cangrelor started just after LBAA. In both cases, use of cangrelor (vs. pre-treatment with oral P2Y12-i) allowed for a tailored minimization of the risk of bleeding and vascular complications during LBAA while offering full platelet inhibition during a complex/high-risk PCI.
  
  DISCUSSION:
  In this case series, we illustrate a possible approach to the use of cangrelor for patients undergoing TAVI and complex/high-risk PCI. In such complex cases, thorough pre-procedural planning might include a cangrelor to minimize vascular, bleeding, and ischaemic complications.
  
  © The Author(s) 2024. Published by Oxford University Press on behalf of the European Society of Cardiology.
  
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• Clinical and Hemodynamic Outcomes of Balloon-Expandable Mitral Valve-in-Valve Positioning and Asymmetric Deployment: The VIVID Registry.
  JACC Cardiovasc Interv

  2023 Nov;16(21):2615-2627. doi: 10.1016/j.jcin.2023.08.047.
  
  Simonato Matheus, Whisenant Brian K, Unbehaun Axel, Kempfert Jörg, Ribeiro Henrique B, Kornowski Ran, Erlebach Magdalena, Bleiziffer Sabine, Windecker Stephan, Pilgrim Thomas, Tomii Daijiro, Guerrero Mayra, Ahmad Yousif, Forrest John K, Montorfano Matteo, Ancona Marco, Adam Matti, Wienemann Hendrik, Finkelstein Ariel, Villablanca Pedro, Codner Pablo, Hildick-Smith David, Ferrari Enrico, Petronio Anna Sonia, Shamekhi Jasmin, Presbitero Patrizia, Bruschi Giuseppe, Rudolph Tanja, Cerillo Alfredo, Attias David, Nejjari Mohammed, Abizaid Alexandre, Felippi de Sá Marchi Maurício, Horlick Eric, Wijeysundera Harindra, Andreas Martin, Thukkani Arun, Agrifoglio Marco, Iadanza Alessandro, Baer L Matthew, Nanna Michael G, Dvir Danny
  
  Abstract
  
  BACKGROUND:
  Mitral valve-in-valve (ViV) is associated with suboptimal hemodynamics and rare left ventricular outflow tract (LVOT) obstruction.
  
  OBJECTIVES:
  This study aimed to determine whether device position and asymmetry are associated with these outcomes.
  
  METHODS:
  Patients undergoing SAPIEN 3 (Edwards Lifesciences) mitral ViV included in the VIVID (Valve-in-Valve International Data) Registry were studied. Clinical endpoints are reported according to Mitral Valve Academic Research Consortium definitions. Residual mitral valve stenosis was defined as mean gradient ?5 mm Hg. Depth of implantation (percentage of transcatheter heart valve [THV] atrial to the bioprosthesis ring) and asymmetry (ratio of 2 measures of THV height) were evaluated.
  
  RESULTS:
  A total of 222 patients meeting the criteria for optimal core lab evaluation were studied (age 74 ± 11.6 years; 61.9% female; STS score = 8.3 ± 7.1). Mean asymmetry was 6.2% ± 4.4%. Mean depth of implantation was 19.0% ± 10.3% atrial. Residual stenosis was common (50%; mean gradient 5.0 ± 2.6 mm Hg). LVOT obstruction occurred in 7 cases (3.2%). Implantation depth was not a predictor of residual stenosis (OR: 1.19 [95% CI: 0.92-1.55]; P = 0.184), but more atrial implantation was protective against LVOT obstruction (0.7% vs 7.1%; P = 0.009; per 10% atrial, OR: 0.48 [95% CI: 0.24-0.98]; P = 0.044). Asymmetry was found to be an independent predictor of residual stenosis (per 10% increase, OR: 2.30 [95% CI: 1.10-4.82]; P = 0.027).
  
  CONCLUSIONS:
  Valve stenosis is common after mitral ViV. Asymmetry was associated with residual stenosis. Depth of implantation on its own was not associated with residual stenosis but was associated with LVOT obstruction. Technical considerations to reduce postdeployment THV asymmetry should be considered.
  
  Copyright © 2023 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• Impact of balloon post-dilation on valve durability and long-term clinical outcomes after self-expanding transcatheter aortic valve implantation.
  Catheter Cardiovasc Interv

  2024 Jan;103(1):209-218. doi: 10.1002/ccd.30907.
  
  Sanz Sánchez Jorge, Regazzoli Damiano, Barbanti Marco, Fiorina Claudia, Adamo Marianna, Angelillis Marco, De Carlo Marco, Bellini Barbara, Montorfano Matteo, Mangieri Antonio, Bruschi Giuseppe, Merlanti Bruno, Agnifili Mauro Luca, Testa Luca, Ferrara Erica, Musto Carmine, Colombo Antonio, Tamburino Corrado, Reimers Bernhard
  
  Abstract
  
  BACKGROUND:
  Balloon post-dilation (BPD) is a widely adopted strategy to optimize acute results of TAVI, with a positive impact on both paravalvular leak and mean gradients. On the other hand, the inflation of the balloon inside prosthetic leaflets may damage them increasing the risk of structural valve deterioration (SVD). Furthermore, the impact of BPD on long-term clinical outcomes and valve hemodynamics is yet unknown.
  
  AIMS:
  To evaluate the impact of BPD on valve durability and long-term clinical outcomes in patients undergoing self-expanding transcatheter valve implantation (TAVI).
  
  METHODS:
  Echocardiographic and clinical data from the ClinicalService (a nation-based data repository and medical care project) were analyzed. Patients were divided into two groups, those who underwent BPD after TAVI and those who did not. Coprimary endpoints were all-cause death and SVD. Cumulative incidence functions for SVD were estimated.
  
  RESULTS:
  Among 1835 patients included in the study, 417 (22.7%) underwent BPD and 1418 (77.3%) did not undergo BPD. No statistically significant differences at 6-year follow-up were found between groups in terms of all-cause mortality (HR: 1.05, 95% CI: 0.9-1.22; p?=?0.557) and SVD (2.1% vs. 1.4%, p?=?0.381). In addition, BPD did not predispose to higher risk of cardiovascular death, myocardial infarction, valve thrombosis, and endocarditis at 6-year follow-up.
  
  CONCLUSIONS:
  BPD following TAVI with a self-expanding prosthesis does not seem to be associated with an increased risk of adverse clinical outcomes or SVD at 6-year follow-up.
  
  © 2023 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.
  
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• Impact of Pacemaker Implantation After Transcatheter Aortic Valve Replacement on Long-Term Survival in Patients With Bicuspid Aortic Valve.
  Am J Cardiol

  2024 Jan;210():146-152. doi: 10.1016/j.amjcard.2023.10.018.
  
  De Felice Francesco, Paolucci Luca, Cesario Vincenzo, Musto Carmine, Nazzaro Marco Stefano, Chin Diana, Stio Rocco, Pennacchi Mauro, Gabrielli Domenico, Fiorina Claudia, Massussi Mauro, Angelillis Marco, Costa Giulia, Bruschi Giuseppe, Fineschi Massimo, Maffeo Diego, Barletta Marta, Regazzoli Damiano, Montorfano Matteo
  
  Abstract
  
  Limited data are available about the impact of permanent pacemaker (PPM) implantation on long-term survival in patients with a bicuspid aortic valve (BAV) and severe aortic stenosis (AS) treated with transcatheter aortic valve replacement (TAVR). We aimed to evaluate the long-term clinical outcomes of patients with BAV with AS who underwent periprocedural PPM implantation after TAVR with a self-expandable prosthesis. Data from patients with BAV and severe AS who underwent TAVR between April 2009 and January 2022 and followed in the framework of the One Hospital ClinicalService-CoreValve Project were collected. Patients were categorized in 2 groups according to PPM implantation after TAVR ("PPM" group) or not ("no PPM" group). The coprimary end points were all-cause death and a composite of cardiac mortality, rehospitalization because of cardiac causes, stroke, and myocardial infarction. Overall, 106 patients were considered (74 in the "no PPM" group and 32 in the "PPM" group). No statistically significant difference was found between the groups in terms of follow-up and baseline characteristics. Patients in the PPM group were more likely to show baseline conduction abnormalities (p = 0.023). Patients in the PPM group were more often treated with older generation prosthesis than those in the no PPM group (28.1% vs 5.4%, respectively, p = 0.013). At 2 years of follow-up, all-cause death in the no PPM and PPM groups occurred in 20.0% and 10.0% of patients, respectively (hazard ratio 0.37, 95% confidence interval 0.08 to 1.67). Similarly, no difference was evident for the composite end point between the 2 groups (no PPM vs PPM: 8 [14.6%] vs 6 [19.3%], hazard ratio 1.67, 95% CI 0.58 to 4.81). In conclusion, patients with severe AS and BAV treated with TAVR complicated by PPM implantation are not exposed to an increased risk of major adverse events at 2 years of follow-up.
  
  Copyright © 2023 Elsevier Inc. All rights reserved.
  
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• Outcomes of Patients With Very Severe Aortic Stenosis Treated With Transcatheter Aortic Valve Implantation.
  Am J Cardiol

  2023 Oct;205():241-248. doi: 10.1016/j.amjcard.2023.07.148.
  
  Angelillis Marco, Costa Giulia, Primerano Chiara, Giannini Cristina, Adamo Marianna, Chizzola Giuliano, Iadanza Alessandro, Fineschi Massimo, Barletta Marta, Bedogni Francesco, Ferrara Erica, Poli Arnaldo, De Felice Francesco, Bruschi Giuseppe, De Carlo Marco, Petronio Anna S
  
  Abstract
  
  Symptoms of aortic stenosis (AS) are not proportional to its severity and patients with very severe AS (VSAS) remain asymptomatic for a long time. The appropriate time for intervention in patients with VSAS and the effects of transcatheter aortic valve implantation (TAVI) on left ventricular hypertrophy (LVH) remain debated. Our aim was to compare the procedural and 30-day outcomes of TAVI between patients with VSAS and patients with severe AS (SAS) and the changes in LVH. We selected patients with an aortic peak velocity ?5 m/s (VSAS) and those with aortic peak velocity 4 to 5 m/s (SAS) treated with TAVI. Patients with reduced left ventricular ejection fraction (
  Copyright © 2023 Elsevier Inc. All rights reserved.
  
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• Natural history and clinical burden of moderate aortic stenosis: a systematic review and explorative meta-analysis.
  J Cardiovasc Med (Hagerstown)

  2023 Sep;24(9):659-665. doi: 10.2459/JCM.0000000000001490.
  
  Morelli Martina, Galasso Michele, Esposito Giuseppe, Soriano Francesco Stefano, Nava Stefano, Da Pozzo Caterina, Bossi Irene, Piccaluga Emanuela, Bruschi Giuseppe, Maloberti Alessandro, Oliva Fabrizio, Oreglia Jacopo Andrea, Giannattasio Cristina, Montalto Claudio
  
  Abstract
  
  AIMS:
  The mortality risk of patients with moderate aortic stenosis is not well known, but recent studies suggested that it might negatively affect prognosis. We aimed to assess the natural history and clinical burden of moderate aortic stenosis and to investigate the interaction of patients' baseline characteristics with prognosis.
  
  METHODS:
  Systematic research was conducted on PubMed. The inclusion criteria were inclusion of patients with moderate aortic stenosis; and report of the survival at 1-year follow-up (minimum). Incidence ratios related to all-cause mortality in patients and controls of each study were estimated and then pooled using a fixed effects model. All patients with mild aortic stenosis or without aortic stenosis were considered controls. Meta-regression analysis was performed to assess the impact of left ventricular ejection fraction and age on the prognosis of patients with moderate aortic stenosis.
  
  RESULTS:
  Fifteen studies and 11?596 patients with moderate aortic stenosis were included. All-cause mortality was significantly higher among patients with moderate aortic stenosis than in controls in all timeframes analysed (all P ?0.0001). Left ventricular ejection fraction and sex did not significantly impact on the prognosis of patients with moderate aortic stenosis ( P ?=?0.4584 and P ?=?0.5792), while increasing age showed a significant interaction with mortality (estimate = 0.0067; 95% confidence interval: 0.0007-0.0127; P ?=?0.0323).
  
  CONCLUSION:
  Moderate aortic stenosis is associated with reduced survival. Further studies are necessary to confirm the prognostic impact of this valvulopathy and the possible benefit of aortic valve replacement.
  
  Copyright © 2023 Italian Federation of Cardiology - I.F.C. All rights reserved.
  
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• Bi-Caval Valve Implantation to Palliate Symptoms in a Case of Massive Tricuspid Regurgitation.
  Cardiovasc Revasc Med

  2023 Aug;53S():S139-S143. doi: 10.1016/j.carrev.2023.01.014.
  
  Galasso Michele, Cartella Iside, Soriano Francesco, Nava Stefano, Tavoletta Pasquale, De Chiara Benedetta, Oliva Fabrizio, Bruschi Giuseppe, Oreglia Jacopo A, Giannattasio Cristina, Mangieri Antonio, Montalto Claudio
  
  Abstract
  
  Severe tricuspid regurgitation is associated with the occurrence of right failure and increased morbidity and mortality. Transcatheter heterotopic bi-caval valve implantation might offer symptom relief in these patients that are often at prohibitive surgical risk.
  
  Copyright © 2023 Elsevier Inc. All rights reserved.
  
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• Prognostic value of right ventricle to pulmonary artery coupling in transcatheter aortic valve implantation recipients.
  J Cardiovasc Med (Hagerstown)

  2022 Sep;23(9):615-622. doi: 10.2459/JCM.0000000000001336.
  
  Adamo Marianna, Maccagni Gloria, Fiorina Claudia, Giannini Cristina, Angelillis Marco, Costa Giulia, Trani Carlo, Burzotta Francesco, Bruschi Giuseppe, Merlanti Bruno, Poli Arnaldo, Ferrara Erica, Fineschi Massimo, Iadanza Alessandro, Chizzola Giuliano, Metra Marco
  
  Abstract
  
  AIMS:
  To investigate the impact of the right ventricle to pulmonary artery (RV-PA) coupling on the outcome of patients undergoing transcatheter aortic valve intervention (TAVI), and to describe changes in right ventricular function, pulmonary hypertension, and their ratio after TAVI.
  
  METHODS:
  Three hundred and seventy-seven patients from the Italian ClinicalService Project, who underwent TAVI between February 2011 and August 2020, were included. Tricuspid annular plane systolic excursion/pulmonary artery systolic pressure (TAPSE/PASP) ratio was retrospectively calculated as a surrogate of RV-PA coupling. The population was stratified according to TAPSE/PASP using a cut-off of 0.36?mm/mmHg derived from a receiving operating characteristic (ROC) curve. The primary end point was 6-month all-cause death.
  
  RESULTS:
  Compared with patients with a TAPSE/PASP ratio ?0.36?mm/mmHg (81%), those with TAPSE/PASP ratio
  CONCLUSIONS:
  A TAPSE/PASP ratio
  Copyright © 2022 Italian Federation of Cardiology - I.F.C. All rights reserved.
  
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• Predictors of early discharge after transcatheter aortic valve implantation: insight from the CoreValve ClinicalService.
  J Cardiovasc Med (Hagerstown)

  2022 Jul;23(7):454-462. doi: 10.2459/JCM.0000000000001318.
  
  Angelillis Marco, Costa Giulia, Giannini Cristina, Fiorina Claudia, Branca Luca, Tamburino Corrado, Barbanti Marco, Gorla Riccardo, Casenghi Matteo, Bruschi Giuseppe, Merlanti Bruno, Montorfano Matteo, Ferri Luca A, Poli Arnaldo, Regazzoli Damiano, De Felice Francesco, Maffeo Diego, Trani Carlo, Iadanza Alessandro, Petronio Anna S
  
  Abstract
  
  AIMS:
  The aim of this study was to minimize the procedure, and reduce the length of hospital stay (LoS) is the future objective for transcatheter aortic valve replacement (TAVI).Aims of the study are to identify procedural and electrocardiographical predictors of fast-track discharge in patients who underwent TAVI.
  
  METHODS:
  Patients treated with TAVI included in the One Hospital ClinicalService project were categorized according to the LoS. 'Fast-Track' population, with a postprocedural LoS less than or equal to 3?days, was compared with the 'Slow-Track' population with a postprocedural LoS greater than 3?days.
  
  RESULTS:
  One thousand five hundred and one patients were collected. Despite single baseline characteristics being almost similar between the two groups, Slow-Track group showed a higher surgical risk (P?0.001). Patients in the Slow-Track group were more frequently treated with general anaesthesia (P?=?0.002) and less frequently predilated (P?0.001) and received a lower amount of contrast media. No difference between Slow-Track and Fast-Track patients was observed at 30 days in death and in cardiovascular rehospitalization.In the multivariable analysis, STS score of at least 4% [odds ratio (OR): 1.64; P?=?0.01], general anaesthesia (OR: 2.80; P?=?0.03), predilation (OR: 0.45; P?001), NYHA 3-4 at baseline (OR: 1.65; P?=?0.01), AVB I/LBBB/RBBB onset (OR: 2.41; P?0.001) and in-hospital new PM (OR: 2.63; P?0.001) were independently associated with a higher probability of Slow-Track.
  
  CONCLUSION:
  Fast-Track patients were safely discharged home showing no difference in clinical outcomes after discharge up to 30?days compared with the Slow-Track group. The STS score, general anaesthesia, NYHA 3--4 at baseline, in-hospital onset of conduction disturbances and new PM implantation after TAVI turned out to be predictors of Slow-Track.
  
  Copyright © 2022 Italian Federation of Cardiology - I.F.C. All rights reserved.
  
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• Valve-in-Valve Implantation of Medtronic CoreValve Prosthesis in Patients With Failing Bioprosthetic Aortic Valves: Mid-term Outcomes From the Italian CoreValve Clinical Service Project.
  J Invasive Cardiol

  2022 Feb;34(2):E73-E79.
  
  Mangieri Antonio, Khokhar Arif A, Petronio Anna Sonia, Giannini Cristina, Angelillis Marco, Fiorina Claudia, Adamo Marianna, Curello Salvatore, Tamburino Corrado, Barbanti Marco, Bedogni Francesco, Testa Luca, Iadanza Alessandro, Fineschi Massimo, Bruschi Giuseppe, Poli Arnaldo, Montorfano Matteo, Maffeo Diego, Colombo Antonio
  
  Abstract
  
  OBJECTIVES:
  We evaluated the acute and two-year safety and efficacy of using the Corevalve, Evolut R, and Evolut PRO valves for treating failed surgical bioprosthesis from the Italian CoreValve Clinical Service Project.
  
  BACKGROUND:
  Valve-in-valve (ViV) TAVR is an emerging treatment option for failed surgical bioprosthesis. Choice of transcatheter valve is an important determinant of procedural and clinical outcomes, however, longer-term data are lacking.
  
  METHODS:
  The Clinical Service Project is a national clinical data repository evaluating the use of implantable devices across Italy. The present multi-center analysis includes consecutive patients who underwent ViV-TAVR with the Medtronic CoreValve series between October 2008 to June 2019. Evaluated endpoints included rates of overall mortality, cardiovascular mortality, myocardial infarction, and cerebrovascular accidents at 2-year follow-up. Procedural success, complications, and echocardiographic outcomes were reported according to VARC-2 criteria.
  
  RESULTS:
  A total of 139 patients (mean age, 80 ± 7 years; 47.5% male; mean STS score, 10.0 ± 9.7%) underwent ViV-TAVR with CoreValve (28.5%), Evolut R (68.6%), and Evolut Pro (2.9%) valves. Device success was achieved in 68% and acute coronary obstruction requiring PCI was observed in 4 patients (2.9%). Moderate PVL was observed in 3.7% and 2.8% of patients at 30-day and 2-year follow-up and moderate structural valve degeneration seen only 5 patients (3.6%). All-cause and cardiovascular mortality were 3.6% and 2.9% at 30 days, respectively, and 20.6% and 10.2% at 2-year follow-up.
  
  CONCLUSIONS:
  This real-world nationwide analysis demonstrates the acute and longer-term safety and efficacy of using the self-expanding Medtronic THV for ViV-TAVR.
  
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• Gender Differences after Transcatheter Aortic Valve Replacement (TAVR): Insights from the Italian Clinical Service Project.
  J Cardiovasc Dev Dis

  2021 Sep;8(9):. doi: 114.
  
  Denegri Andrea, Romano Michele, Petronio Anna Sonia, Angelillis Marco, Giannini Cristina, Fiorina Claudia, Branca Luca, Barbanti Marco, Costa Giuliano, Brambilla Nedy, Mantovani Valentina, Montorfano Matteo, Ferri Luca, Bruschi Giuseppe, Merlanti Bruno, Reimers Bernhard, Pivato Carlo, Poli Arnaldo, Musto Carmine, Fineschi Massimo, Maffeo Diego, Trani Carlo, Airoldi Flavio, Lettieri Corrado
  
  Abstract
  
  BACKGROUND:
  TAVR is a safe alternative to surgical aortic valve replacement (SAVR); however, sex-related differences are still debated. This research aimed to examine gender differences in a real-world transcatheter aortic valve replacement (TAVR) cohort.
  
  METHODS:
  All-comer aortic stenosis (AS) patients undergoing TAVR with a Medtronic valve across 19 Italian sites were prospectively included in the Italian Clinical Service Project (NCT01007474) between 2007 and 2019. The primary endpoint was 1-year mortality. We also investigated 3-year mortality, and ischemic and hemorrhagic endpoints, and we performed a propensity score matching to assemble patients with similar baseline characteristics.
  
  RESULTS:
  Out of 3821 patients, 2149 (56.2%) women were enrolled. Compared with men, women were older (83 ± 6 vs. 81 ± 6 years,
  CONCLUSION:
  Despite higher rates of peri-procedural complications, women presented better survival than men. This better adaptive response to TAVR may be driven by sex-specific factors.
  
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• Mechanical Hemolysis Complicating Transcatheter Interventions for Valvular Heart Disease: JACC State-of-the-Art Review.
  J Am Coll Cardiol

  2021 May;77(18):2323-2334. doi: 10.1016/j.jacc.2021.03.295.
  
  Cannata Aldo, Cantoni Silvia, Sciortino Antonio, Bruschi Giuseppe, Russo Claudio Francesco
  
  Abstract
  
  Mechanical intravascular hemolysis is frequently observed following procedures on heart valves and uncommonly observed in native valvular disease. In most cases, its severity is mild. Nevertheless, it can be clinically significant and even life threatening, requiring multiple blood transfusions and renal replacement therapy. This paper reviews the current knowledge on mechanical intravascular hemolysis in valvular disease, before and after correction, focusing on pathophysiology, approach to diagnosis, and impact of other hematological conditions on the resultant anemia. The importance of a multidisciplinary management is underscored. Laboratory data are provided about subclinical hemolysis that is commonly observed following the implantation of surgical and transcatheter valve prostheses and devices. Finally, clinical scenarios are reviewed and current medical and surgical treatments are discussed, including alternative options for inoperable patients.
  
  Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• Permanent Pacemaker Implantation Following Valve-in-Valve Transcatheter Aortic Valve Replacement: VIVID Registry.
  J Am Coll Cardiol

  2021 May;77(18):2263-2273. doi: 10.1016/j.jacc.2021.03.228.
  
  Alperi Alberto, Rodés-Cabau Josep, Simonato Matheus, Tchetche Didier, Charbonnier Gaetan, Ribeiro Henrique B, Latib Azeem, Montorfano Matteo, Barbanti Marco, Bleiziffer Sabine, Redfors Björn, Abdel-Wahab Mohamed, Allali Abdelhakim, Bruschi Giuseppe, Napodano Massimo, Agrifoglio Marco, Petronio Anna Sonia, Giannini Cristina, Chan Albert, Kornowski Ran, Pravda Nili Schamroth, Adam Matti, Iadanza Alessandro, Noble Stephane, Chatfield Andrew, Erlebach Magdalena, Kempfert Jörg, Ubben Timm, Wijeysundera Harindra, Seiffert Moritz, Pilgrim Thomas, Kim Won-Keun, Testa Luca, Hildick-Smith David, Nerla Roberto, Fiorina Claudia, Brinkmann Christina, Conzelmann Lars, Champagnac Didier, Saia Francesco, Nissen Henrik, Amrane Hafid, Whisenant Brian, Shamekhi Jasmin, Søndergaard Lars, Webb John G, Dvir Danny
  
  Abstract
  
  BACKGROUND:
  Permanent pacemaker implantation (PPI) remains one of the main drawbacks of transcatheter aortic valve replacement (TAVR), but scarce data exist on PPI after valve-in-valve (ViV) TAVR, particularly with the use of newer-generation transcatheter heart valves (THVs).
  
  OBJECTIVES:
  The goal of this study was to determine the incidence, factors associated with, and clinical impact of PPI in a large series of ViV-TAVR procedures.
  
  METHODS:
  Data were obtained from the multicenter VIVID Registry and included the main baseline and procedural characteristics, in-hospital and late (median follow-up: 13 months [interquartile range: 3 to 41 months]) outcomes analyzed according to the need of periprocedural PPI. All THVs except CoreValve, Cribier-Edwards, Sapien, and Sapien XT were considered to be new-generation THVs.
  
  RESULTS:
  A total of 1,987 patients without prior PPI undergoing ViV-TAVR from 2007 to 2020 were included. Of these, 128 patients (6.4%) had PPI after TAVR, with a significant decrease in the incidence of PPI with the use of new-generation THVs (4.7% vs. 7.4%; p = 0.017), mainly related to a reduced PPI rate with the Evolut R/Pro versus CoreValve (3.7% vs. 9.0%; p = 0.002). There were no significant differences in PPI rates between newer-generation balloon- and self-expanding THVs (6.1% vs. 3.9%; p = 0.18). In the multivariable analysis, older age (odds ratio [OR]: 1.05 for each increase of 1 year; 95% confidence interval [CI]: 1.02 to 1.07; p = 0.001), larger THV size (OR: 1.10; 95% CI: 1.01 to 1.20; p = 0.02), and previous right bundle branch block (OR: 2.04; 95% CI: 1.00 to 4.17; p = 0.05) were associated with an increased risk of PPI. There were no differences in 30-day mortality between the PPI (4.7%) and no-PPI (2.7%) groups (p = 0.19), but PPI patients exhibited a trend toward higher mortality risk at follow-up (hazard ratio: 1.39; 95% CI: 1.02 to 1.91; p = 0.04; p = 0.08 after adjusting for age differences between groups).
  
  CONCLUSIONS:
  In a contemporary large series of ViV-TAVR patients, the rate of periprocedural PPI was relatively low, and its incidence decreased with the use of new-generation THV systems. PPI following ViV-TAVR was associated with a trend toward increased mortality at follow-up.
  
  Copyright © 2021 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• Percutaneous RVAD with the Protek Duo for severe right ventricular primary graft dysfunction after heart transplant.
  J Heart Lung Transplant

  2021 Jul;40(7):580-583. doi: 10.1016/j.healun.2021.03.016.
  
  Carrozzini Massimiliano, Merlanti Bruno, Olivieri Guido Maria, Lanfranconi Marco, Bruschi Giuseppe, Mondino Michele, Russo Claudio Francesco
  
  Abstract
  
  Right ventricular primary graft dysfunction after heart transplant is a serious life-threatening condition. The severe form, refractory to maximal medical therapy, has traditionally required temporary mechanical support through veno-arterial extracorporeal membrane oxygenation or central right ventricular support. The Protek Duo is a dual lumen cannula recently introduced in the market, which allows for the institution of a percutaneous right ventricular support. We present the first promising case series of the use of this novel support in patients with right ventricular primary graft dysfunction after heart transplant.
  
  Copyright © 2021 International Society for Heart and Lung Transplantation. Published by Elsevier Inc. All rights reserved.
  
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• The effect of transcatheter aortic valve implantation approaches on mortality.
  Catheter Cardiovasc Interv

  2021 Jun;97(7):1462-1469. doi: 10.1002/ccd.29456.
  
  Nijenhuis Vincent J, Meyer Alexander, Brouwer Jorn, Mahmoodi Bakhtawar K, Unbehaun Axel, Spaziano Marco, Buzzatti Nicola, Stundl Anja, Jørgensen Troels H, Kooistra Nynke H M, Adamo Marianna, Saraf Smriti, Amrane Hafid, Bruschi Giuseppe, Zivelonghi Carlo, Swaans Martin J, Werner Nikos, Nickenig Georg, Hildick-Smith David, Stella Pieter R, Latib Azeem, Soendergaard Lars, Sinning Jan-Malte, Lefevre Thierry, Pasic Miralem, Kempfert Jorg, Ten Berg Jurrien M
  
  Abstract
  
  OBJECTIVES:
  We aimed to evaluate the effect of transcatheter aortic valve implantation (TAVI) approaches on mortality and identify effect modifiers and predictors for mortality.
  
  BACKGROUND:
  Alternative access routes to transfemoral (TF) TAVI include the surgical intra-thoracic direct-aortic (DA) and transapical (TA) approach. TA TAVI has been associated with a higher mortality rate. We hypothesized that this is related to effect modifiers, in particular the left ventricular ejection fraction (LVEF).
  
  METHODS:
  This multicentre study derived its data from prospective registries. To adjust for confounders, we used propensity-score based, stabilized inverse probability weighted Cox regression models.
  
  RESULTS:
  In total, 5,910 patients underwent TAVI via TF (N =?4,072), DA (N =?524), and TA (N =?1,314) access. Compared to TF, 30-day mortality was increased among DA (HR 1.87, 95%CI 1.26-2.78, p =?.002) and TA (HR 3.34, 95%CI 2.28-4.89, p .001) cases. Compared to TF, 5-year mortality was increased among TA cases (HR 1.50, 95%CI 1.24-1.83, p .001). None of the variables showed a significant interaction between the approaches and mortality. An impaired LVEF (?35%) increased mortality in all approaches.
  
  CONCLUSIONS:
  The surgical intra-thoracic TA and DA TAVI are both associated with a higher 30-day mortality than TF TAVI. TA TAVI is associated with a higher 5-year mortality than TF TAVI. The DA approach may therefore have some advantages over the TA approach when TF access is not feasible.
  
  © 2021 Wiley Periodicals LLC.
  
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• Long-term outcomes after transcatheter aortic valve replacement in nonagenarians: a multicenter age-based analysis.
  J Cardiovasc Med (Hagerstown)

  2021 Mar;22(3):204-211. doi: 10.2459/JCM.0000000000001119.
  
  Costa Giuliano, Valvo Roberto, Fiorina Claudia, Adamo Marianna, Giannini Cristina, Testa Luca, Bruschi Giuseppe, Poli Arnaldo, De Felice Francesco, Montorfano Matteo, Maffeo Diego, Iadanza Alessandro, Reimers Bernhard, Bedogni Francesco, Petronio Anna S, Tamburino Corrado, Barbanti Marco
  
  Abstract
  
  AIM:
  To assess the outcome of nonagenarians patients receiving transcatheter aortic valve replacement (TAVR).
  
  METHODS:
  We aimed to stratify the overall population from an Italian, multicenter, observational project including a total of 3792 consecutive patients who underwent TAVR with CoreValve and Evolut R/PRO devices between April 2009 and October 2018, into four groups according to their age class (?90 vs. 80-89 years vs. 70-79 vs.
  RESULTS:
  At 4 years, survival estimates showed no difference in terms of overall survival [Kaplan-Meier estimates (KM est.) 49.9 vs. 58.1% vs. 57.0 vs. 69.3%; Plogrank?=?0.28] among the four groups. After 2 years from the procedure, landmark analysis showed an age-based difference in overall survival (KM est. 63.8 vs. 75.0% vs. 75.1 vs. 88.7%; Plogrank?=?0.025) but no difference in terms of survival from cardiovascular death (KM est. 87.8 vs. 87.4% vs. 86.1 vs. 96.1%; Plogrank?=?0.43). Finally, age itself was not correlated with overall mortality at 4 years (hazard ratio 1.06, 95% confidence interval 0.86-1.30, P?=?0.591).
  
  CONCLUSION:
  TAVR with self-expanding CoreValve and Evolut prostheses was demonstrated to have good long-term outcomes, regardless of the patient's age. At 4 years, no difference in overall mortality was reported among age-based groups, while a higher overall mortality was reported in nonagenarians after 2 years from the procedure. TAVR showed good long-term outcomes even in nonagenarian patients, and it could be the therapy of choice for selected elderly patients.
  
  Copyright © 2020 Italian Federation of Cardiology - I.F.C. All rights reserved.
  
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• Transcatheter Mitral Valve Replacement After Surgical Repair or Replacement: Comprehensive Midterm Evaluation of Valve-in-Valve and Valve-in-Ring Implantation From the VIVID Registry.
  Circulation

  2021 Jan;143(2):104-116. doi: 10.1161/CIRCULATIONAHA.120.049088.
  
  Simonato Matheus, Whisenant Brian, Ribeiro Henrique Barbosa, Webb John G, Kornowski Ran, Guerrero Mayra, Wijeysundera Harindra, Søndergaard Lars, De Backer Ole, Villablanca Pedro, Rihal Charanjit, Eleid Mackram, Kempfert Jörg, Unbehaun Axel, Erlebach Magdalena, Casselman Filip, Adam Matti, Montorfano Matteo, Ancona Marco, Saia Francesco, Ubben Timm, Meincke Felix, Napodano Massimo, Codner Pablo, Schofer Joachim, Pelletier Marc, Cheung Anson, Shuvy Mony, Palma José Honório, Gaia Diego Felipe, Duncan Alison, Hildick-Smith David, Veulemans Verena, Sinning Jan-Malte, Arbel Yaron, Testa Luca, de Weger Arend, Eltchaninoff Helene, Hemery Thibault, Landes Uri, Tchetche Didier, Dumonteil Nicolas, Rodés-Cabau Josep, Kim Won-Keun, Spargias Konstantinos, Kourkoveli Panagiota, Ben-Yehuda Ori, Teles Rui Campante, Barbanti Marco, Fiorina Claudia, Thukkani Arun, Mackensen G Burkhard, Jones Noah, Presbitero Patrizia, Petronio Anna Sonia, Allali Abdelhakim, Champagnac Didier, Bleiziffer Sabine, Rudolph Tanja, Iadanza Alessandro, Salizzoni Stefano, Agrifoglio Marco, Nombela-Franco Luis, Bonaros Nikolaos, Kass Malek, Bruschi Giuseppe, Amabile Nicolas, Chhatriwalla Adnan, Messina Antonio, Hirji Sameer A, Andreas Martin, Welsh Robert, Schoels Wolfgang, Hellig Farrel, Windecker Stephan, Stortecky Stefan, Maisano Francesco, Stone Gregg W, Dvir Danny
  
  Abstract
  
  BACKGROUND:
  Mitral valve-in-valve (ViV) and valve-in-ring (ViR) are alternatives to surgical reoperation in patients with recurrent mitral valve failure after previous surgical valve repair or replacement. Our aim was to perform a large-scale analysis examining midterm outcomes after mitral ViV and ViR.
  
  METHODS:
  Patients undergoing mitral ViV and ViR were enrolled in the Valve-in-Valve International Data Registry. Cases were performed between March 2006 and March 2020. Clinical endpoints are reported according to the Mitral Valve Academic Research Consortium (MVARC) definitions. Significant residual mitral stenosis (MS) was defined as mean gradient ?10 mm?Hg and significant residual mitral regurgitation (MR) as ? moderate.
  
  RESULTS:
  A total of 1079 patients (857 ViV, 222 ViR; mean age 73.5±12.5 years; 40.8% male) from 90 centers were included. Median STS-PROM score 8.6%; median clinical follow-up 492 days (interquartile range, 76-996); median echocardiographic follow-up for patients that survived 1 year was 772.5 days (interquartile range, 510-1211.75). Four-year Kaplan-Meier survival rate was 62.5% in ViV versus 49.5% for ViR (
  CONCLUSIONS:
  Significant residual MS and/or MR were not infrequent after mitral ViV and ViR procedures and were both associated with a need for repeat valve replacement. Strategies to improve postprocedural hemodynamics in mitral ViV and ViR should be further explored.
  
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• Clinical Outcomes of the Portico Transcatheter Aortic Valve Delivered via Alternative Access: 30-Day and 1-Year Results of the Portico ALT Study.
  J Invasive Cardiol

  2020 Nov;32(11):405-411. doi: JIC20200810-3.
  
  van Wely Marleen, Bruschi Giuseppe, Bedogni Francesco, Thiele Holger, Jeger Raban V, van der Wulp Kees, Soendergaard Lars, Kempfert Joerg, Schlensak Christian, Linke Axel
  
  Abstract
  
  OBJECTIVE:
  The aim of this study was to report the 30-day and 1-year outcomes and performance from the Portico Alternative Access study to obtain CE approval of the alternative access delivery system.
  
  METHODS:
  The Portico Alternative Access study is a multicenter, prospective, non-randomized, investigational study (www.clinicaltrials.gov identifier, NCT03056573) describing 45 patients with severe symptomatic aortic valve stenosis (AS) treated with the self-expanding Portico device using subclavian/axillary access.
  
  RESULTS:
  Forty-five subjects (81.7 ± 5.9 years; 57.8% female; Society of Thoracic Surgeons score, 5.4 ± 4.7%) with severe, symptomatic AS had a Portico bioprosthetic aortic valve implantation attempt via axillary/subclavian access. Implantation was successful in 97.8% of subjects. At 30 days, the rate of major vascular complications at the subclavian/axillary access site was 4.4%. All-cause mortality was 2.2% at 30 days and 4.4% at 1 year.
  
  CONCLUSION:
  The Portico transcatheter aortic valve can be safely delivered by axillary or subclavian access with high implant success rate and low complication rates.
  
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• Interaction between severe chronic kidney disease and acute kidney injury in predicting mortality after transcatheter aortic valve implantation: Insights from the Italian Clinical Service Project.
  Catheter Cardiovasc Interv

  2020 Dec;96(7):1500-1508. doi: 10.1002/ccd.28927.
  
  Adamo Marianna, Provini Martino, Fiorina Claudia, Giannini Cristina, Angelillis Marco, Testa Luca, Barbanti Marco, Merlanti Bruno, Poli Arnaldo, Ferrara Erica, Latib Azeem, Reimers Bernhard, Maffeo Diego, Bruschi Giuseppe, Montorfano Matteo, Petronio Anna Sonia, Bedogni Francesco, Tamburino Corrado, Metra Marco, Curello Salvatore
  
  Abstract
  
  AIMS:
  We aim at exploring whether severe chronic kidney disease (CKD) may modify the impact of acute kidney injury (AKI) post-transcatheter aortic valve implantation (TAVI) on early, mid, and long-term mortality.
  
  METHODS AND RESULTS:
  The analysis included 2,733 TAVI patients from the Italian Clinical Service Project. The population was stratified in four groups according to the presence of baseline severe CKD and postprocedural AKI. All-cause mortality was the primary end point. Postprocedural AKI is associated with an increased risk of early and mid-term mortality after TAVI regardless of baseline severe CKD. Preprocedural severe CKD is associated with an increased risk of long-term mortality after TAVI regardless of postprocedural AKI. No interaction between preprocedural severe CKD and postprocedural AKI was observed in predicting mortality at both 30-day (CKD: hazard ratio [HR] =?2.65, 95% confidence interval [CI] =?1.15-6.12; no-CKD: HR = 3.83, 95% CI = 2.23-6.58; P =?.129) and 1-year (CKD: HR = 2.29, 95% CI = 1.37-3.82; no-CKD: HR = 2.47, 95% CI = 1.75-3.49; P =?.386). Preprocedural severe CKD is an independent predictor of postprocedural AKI (HR = 2.17, 95% CI = 1.56-3.03; p .001) as well as general anesthesia and access alternative to femoral. Among no-AKI patients, those with severe CKD at admission underwent kidney function recovery after TAVI (serum creatinine at baseline 2.24?±?1.57?mg/dL and at 48-hr 1.80?±?1.17?mg/dL; p =?.003).
  
  CONCLUSIONS:
  Preprocedural severe CKD did not modify the impact of postprocedural AKI in predicting early and mid-term mortality after TAVI. Closely monitoring of serum creatinine and strategies to prevent AKI post-TAVI are needed also in patients without severe CKD at admission.
  
  © 2020 Wiley Periodicals LLC.
  
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• Long-term outcomes after transcatheter aortic valve implantation in failed bioprosthetic valves.
  Eur Heart J

  2020 Aug;41(29):2731-2742. doi: 10.1093/eurheartj/ehaa544.
  
  Bleiziffer Sabine, Simonato Matheus, Webb John G, Rodés-Cabau Josep, Pibarot Philippe, Kornowski Ran, Windecker Stephan, Erlebach Magdalena, Duncan Alison, Seiffert Moritz, Unbehaun Axel, Frerker Christian, Conzelmann Lars, Wijeysundera Harindra, Kim Won-Keun, Montorfano Matteo, Latib Azeem, Tchetche Didier, Allali Abdelhakim, Abdel-Wahab Mohamed, Orvin Katia, Stortecky Stefan, Nissen Henrik, Holzamer Andreas, Urena Marina, Testa Luca, Agrifoglio Marco, Whisenant Brian, Sathananthan Janarthanan, Napodano Massimo, Landi Antonio, Fiorina Claudia, Zittermann Armin, Veulemans Verena, Sinning Jan-Malte, Saia Francesco, Brecker Stephen, Presbitero Patrizia, De Backer Ole, Søndergaard Lars, Bruschi Giuseppe, Franco Luis Nombela, Petronio Anna Sonia, Barbanti Marco, Cerillo Alfredo, Spargias Konstantinos, Schofer Joachim, Cohen Mauricio, Muñoz-Garcia Antonio, Finkelstein Ariel, Adam Matti, Serra Vicenç, Teles Rui Campante, Champagnac Didier, Iadanza Alessandro, Chodor Piotr, Eggebrecht Holger, Welsh Robert, Caixeta Adriano, Salizzoni Stefano, Dager Antonio, Auffret Vincent, Cheema Asim, Ubben Timm, Ancona Marco, Rudolph Tanja, Gummert Jan, Tseng Elaine, Noble Stephane, Bunc Matjaz, Roberts David, Kass Malek, Gupta Anuj, Leon Martin B, Dvir Danny
  
  Abstract
  
  AIMS:
  Due to bioprosthetic valve degeneration, aortic valve-in-valve (ViV) procedures are increasingly performed. There are no data on long-term outcomes after aortic ViV. Our aim was to perform a large-scale assessment of long-term survival and reintervention after aortic ViV.
  
  METHODS AND RESULTS:
  A total of 1006 aortic ViV procedures performed more than 5 years ago [mean age 77.7?±?9.7 years; 58.8% male; median STS-PROM score 7.3% (4.2-12.0)] were included in the analysis. Patients were treated with Medtronic self-expandable valves (CoreValve/Evolut, Medtronic Inc., Minneapolis, MN, USA) (n?=?523, 52.0%), Edwards balloon-expandable valves (EBEV, SAPIEN/SAPIEN XT/SAPIEN 3, Edwards Lifesciences, Irvine, CA, USA) (n?=?435, 43.2%), and other devices (n?=?48, 4.8%). Survival was lower at 8 years in patients with small-failed bioprostheses [internal diameter (ID) ? 20 mm] compared with those with large-failed bioprostheses (ID > 20 mm) (33.2% vs. 40.5%, P?=?0.01). Independent correlates for mortality included smaller-failed bioprosthetic valves [hazard ratio (HR) 1.07 (95% confidence interval (CI) 1.02-1.13)], age [HR 1.21 (95% CI 1.01-1.45)], and non-transfemoral access [HR 1.43 (95% CI 1.11-1.84)]. There were 40 reinterventions after ViV. Independent correlates for all-cause reintervention included pre-existing severe prosthesis-patient mismatch [subhazard ratio (SHR) 4.34 (95% CI 1.31-14.39)], device malposition [SHR 3.75 (95% CI 1.36-10.35)], EBEV [SHR 3.34 (95% CI 1.26-8.85)], and age [SHR 0.59 (95% CI 0.44-0.78)].
  
  CONCLUSIONS:
  The size of the original failed valve may influence long-term mortality, and the type of the transcatheter valve may influence the need for reintervention after aortic ViV.
  
  Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.
  
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• Long-term clinical outcome and performance of transcatheter aortic valve replacement with a self-expandable bioprosthesis.
  Eur Heart J

  2020 May;41(20):1876-1886. doi: 10.1093/eurheartj/ehz925.
  
  Testa Luca, Latib Azeem, Brambilla Nedy, De Marco Federico, Fiorina Claudia, Adamo Marianna, Giannini Cristina, Angelillis Marco, Barbanti Marco, Sgroi Carmelo, Poli Arnaldo, Ferrara Erica, Bruschi Giuseppe, Russo Claudio Francesco, Matteo Montorfano, De Felice Francesco, Musto Carmine, Curello Salvatore, Colombo Antonio, Tamburino Corrado, Petronio Anna Sonia, Bedogni Francesco
  
  Abstract
  
  AIMS:
  In the last decade, transcatheter aortic valve (TAV) replacement determined a paradigm shift in the treatment of patients with severe symptomatic aortic stenosis. Data on long-term TAV performance are still limited. We sought to evaluate the clinical and haemodynamic outcomes of the CoreValve self-expandable valve up to 8-year follow-up (FU).
  
  METHODS AND RESULTS:
  Nine hundred and ninety inoperable or high-risk patients were treated with the CoreValve TAV in eight Italian Centres from June 2007 to December 2011. The median FU was 4.4?years (interquartile range 1.4-6.7?years). Longest FU reached 11?years. A total of 728 died within 8-year FU (78.3% mortality from Kaplan-Meier curve analysis). A significant functional improvement was observed in the majority of patients and maintained over time, with 79.3% of surviving patients still classified New York Heart Association class ? II at 8?years. Echocardiographic data showed that the mean transprosthetic aortic gradient remained substantially unchanged (9?±?4?mmHg at discharge, 9?±?5?mmHg at 8?years, P?=?0.495). The rate of Grade 0/1 paravalvular leak was consistent during FU with no significant change from post-procedure to FU ?5?years in paired analysis (P?=?0.164). Structural valve deterioration (SVD) and late bioprosthetic valve failure (BVF) were defined according to a modification of the 2017 EAPCI/ESC/EACTS criteria. In cumulative incidence functions at 8?years, moderate and severe SVD were 3.0% [95% confidence interval (CI) 2.1-4.3%] and 1.6% (95% CI 0.6-3.9%), respectively, while late BVF was 2.5% (95% CI 1.2-5%).
  
  CONCLUSION:
  While TAVs are questioned about long-term performance and durability, the results of the present research provide reassuring 8-year evidence on the CoreValve first-generation self-expandable bioprosthesis.
  
  Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2020. For permissions, please email: journals.permissions@oup.com.
  
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• Outcome of Patients Undergoing Transcatheter Implantation of Aortic Valve With Previous Mitral Valve Prosthesis (OPTIMAL) Study.
  Can J Cardiol

  2019 Jul;35(7):866-874. doi: 10.1016/j.cjca.2019.03.028.
  
  Baldetti Luca, Giannini Francesco, Van Mieghem Nicolas, El Faquir Nahid, Tchétché Didier, De Biase Chiara, Petronio Anna Sonia, Giannini Cristina, Tarantini Giuseppe, Fraccaro Chiara, Finkelstein Ariel, Segev Amit, Barbash Israel, Bruschi Giuseppe, Tamburino Corrado, Barbanti Marco, Lim Scott, Kuntjoro Ivandito, Abdel-Wahab Mohamed, Colombo Antonio, Latib Azeem
  
  Abstract
  
  BACKGROUND:
  Transcatheter aortic valve replacement (TAVR) is the gold standard for severe valvular aortic stenosis in patients at high/prohibitive surgical risk. This procedure has also been used in patients with previous mitral valve (MV) prostheses, with contrasting outcomes reported. The aim of this study is to describe procedural and early outcomes of patients with previous MV prostheses undergoing TAVR.
  
  METHODS:
  This is a retrospective registry of 154 patients with previous MV prostheses who underwent TAVR across high-volume medical centres at a mean of 11.7 ± 8.4 years after mitral surgery.
  
  RESULTS:
  Mean mitroaortic distance at computed tomography was 9.7 ± 4.8 mm. Procedural success was achieved in 150 (97.4%) patients, with reduction of aortic gradients (42.6 ± 14.2 to 10.0 ± 7.0 mm Hg; P
  CONCLUSIONS:
  TAVR in patients with previous mitral prostheses appears to be safe and feasible, with good hemodynamic results at 30-day and at longer-term follow-up.
  
  Copyright © 2019 Canadian Cardiovascular Society. Published by Elsevier Inc. All rights reserved.
  
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• Incidence, Technical Safety, and Feasibility of Coronary Angiography and Intervention Following Self-expanding Transcatheter Aortic Valve Replacement.
  Cardiovasc Revasc Med

  2019 May;20(5):371-375. doi: 10.1016/j.carrev.2019.01.026.
  
  Tanaka Akihito, Jabbour Richard J, Testa Luca, Agnifili Mauro, Ettori Federica, Fiorina Claudia, Adamo Marianna, Bruschi Giuseppe, Giannini Cristina, Petronio Anna Sonia, Barbanti Marco, Tamburino Corrado, De Felice Francesco, Reimers Bernhard, Poli Arnaldo, Colombo Antonio, Latib Azeem
  
  Abstract
  
  BACKGROUND:
  Transcatheter aortic valve replacement (TAVR) is a well-established treatment option for severe aortic stenosis (AS). AS and coronary artery disease frequently coincide, and therefore some patients may require coronary angiography (CAG) and/or intervention (PCI) post-TAVR. Due to valve stent design, most self-expanding prostheses always cover the coronary ostium, and therefore may hinder future access. The objective of this research was to evaluate the incidence, safety and feasibility of CAG/PCI in patients with prior self-expanding TAVR valves.
  
  METHODS:
  Among 2170 patients (age 82?±?6?years, 43% male) who underwent TAVR with Corevalve or Evolut prostheses, as part of the Italian CoreValve ClinicalService® framework (data from 13 Italian centers), the occurrence of CAG/PCI following TAVR and periprocedural characteristics were examined.
  
  RESULTS:
  During median follow-up of 379?days, 41 patients (1.9%) required CAG and/or PCI (total 46; 16 CAG, 14 PCI, 16 both PCI/CAG). 56.5% of the procedures were performed under emergency/urgency settings. Left system coronary angiography was successfully performed in most cases (28/32, 87.5%), while right coronary angiography was successful only in 50.0% (16/32). PCI procedures (20 for left system, 3 for right system, 4 for graft) were successfully performed in 93.3% (28/30) of the procedures. No CAG/PCI procedure-related complications including prosthesis dislodgment or coronary ostium dissection occurred.
  
  CONCLUSIONS:
  CAG and PCI procedures following CoreValve TAVR is safe and mostly feasible, although the success rate of selective right coronary angiography was relatively low when compared to the left system. Further investigations are required to explore this issue.
  
  Copyright © 2019. Published by Elsevier Inc.
  
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• Comparison of Early and Long-Term Outcomes After Transcatheter Aortic Valve Implantation in Patients with New York Heart Association Functional Class IV to those in Class III and Less.
  Am J Cardiol

  2018 Nov;122(10):1718-1726. doi: 10.1016/j.amjcard.2018.08.006.
  
  Adamo Marianna, Fiorina Claudia, Petronio Anna Sonia, Giannini Cristina, Tamburino Corrado, Barbanti Marco, Bedogni Francesco, Testa Luca, Colombo Antonio, Latib Azeem, Bruschi Giuseppe, Reimers Bernhard, Poli Arnaldo, Nazzaro Marco Stefano, Curello Salvatore, Ettori Federica
  
  Abstract
  
  Our aim was to investigate the impact of a baseline New York Heart Association (NYHA) class IV on clinical outcomes of a large real-world population who underwent transcatheter aortic valve implantation (TAVI). The primary end points were all-cause mortality, cardiovascular mortality, and re-hospitalization, evaluated at the longest available follow-up and by means of a 3-month landmark analysis. The secondary end points were: change in NYHA class, left ventricular ejection fraction, pulmonary pressure and mitral regurgitation. Out of 2,467 patients, 271 (11%) had a NYHA functional class IV at the admission. The latter had higher Society of Thoracic Surgeons (STS) score (9.2% vs 5.5%; p
  Copyright © 2018. Published by Elsevier Inc.
  
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• Evolut R implantation via the brachial artery.
  Eur J Cardiothorac Surg

  2018 Dec;54(6):1137-1139. doi: 10.1093/ejcts/ezy201.
  
  Bruschi Giuseppe, Merlanti Bruno, Colombo Paola, Russo Claudio F
  
  Abstract
  
  Transfemoral transcatheter aortic valve implantation is an established therapy to treat elderly patients affected by severe aortic stenosis, who are considered to be at high or extreme risk for surgical aortic valve replacement. The transfemoral approach is contraindicated in patients with severe peripheral artery disease, small vessel size or severe tortuosity. In these patients, other vascular access routes such as transapical, subclavian or direct-aortic access may be considered. We describe the first case of a Medtronic Evolut R (Medtronic, Minneapolis, MN, USA) implantation made through the brachial artery in a 75-year-old patient affected by severe aortic stenosis.
  
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• Prognostic Significance of Change in the Left Ventricular Ejection Fraction After Transcatheter Aortic Valve Implantation in Patients With Severe Aortic Stenosis and Left Ventricular Dysfunction.
  Am J Cardiol

  2017 Nov;120(9):1639-1647. doi: 10.1016/j.amjcard.2017.07.064.
  
  Angelillis Marco, Giannini Cristina, De Carlo Marco, Adamo Marianna, Nardi Matilde, Colombo Antonio, Chieffo Alaide, Bedogni Francesco, Brambilla Nedy, Tamburino Corrado, Barbanti Marco, Bruschi Giuseppe, Colombo Paola, Poli Arnaldo, Martina Paola, Violini Roberto, Presbitero Patrizia, Petronio Anna Sonia
  
  Abstract
  
  Patients with severe aortic stenosis and reduced left ventricular ejection fraction (LVEF) have a poor prognosis compared with patients with preserved LVEF. To evaluate the impact of early LVEF recovery in patients with baseline dysfunction on clinical outcomes after transcatheter aortic valve implantation (TAVI), we included all consecutive patients who underwent TAVI from the Italian ClinicalService registry with an LVEF of ?45% at baseline who had 1-month LVEF data. Patients who experienced a previous coronary artery bypass graft, a previous valve replacement, or a previous myocardial infarction were excluded from the analysis. Therefore, 131 patients with an improvement in LVEF of
  Copyright © 2017 Elsevier Inc. All rights reserved.
  
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• Transcathether aortic valve implantation with the new repositionable self-expandable Evolut R versus CoreValve system: A case-matched comparison.
  Int J Cardiol

  2017 Sep;243():126-131. doi: 10.1016/j.ijcard.2017.05.095.
  
  Giannini Cristina, De Carlo Marco, Tamburino Corrado, Ettori Federica, Latib Azeem M, Bedogni Francesco, Bruschi Giuseppe, Presbitero Patrizia, Poli Arnaldo, Fabbiocchi Franco, Violini Roberto, Trani Carlo, Giudice Pietro, Barbanti Marco, Adamo Marianna, Colombo Paola, Benincasa Susanna, Agnifili Mauro, Petronio A Sonia
  
  Abstract
  
  BACKGROUND:
  Despite promising results following transcatheter aortic valve implantation (TAVI), several relevant challenges still remain. To overcome these issues, new generation devices have been developed. The purpose of the present study was to determine whether TAVI with the new self-expanding repositionable Evolut R offers potential benefits compared to the preceding CoreValve, using propensity matching.
  
  METHODS:
  Between June 2007 and November 2015, 2148 consecutive patients undergoing TAVI either CoreValve (n=1846) or Evolut R (n=302) were prospectively included in the Italian TAVI ClinicalService® project. For the purpose of our analysis 211 patients treated with the Evolut R were matched to 211 patients treated with the CoreValve. An independent core laboratory reviewed all angiographic procedural data and an independent clinical events committee adjudicated all events.
  
  RESULTS:
  Patients treated with Evolut R experienced higher 1-year overall survival (log rank test p=0.045) and a significantly lower incidence of major vascular access complications, bleeding events and acute kidney injury compared to patients treated with the CoreValve. Recapture manoeuvres to optimize valve deployment were performed 44 times, allowing a less implantation depth for the Evolut R. As a consequence, the rate of more than mild paravalvular leak and new permanent pacemaker was lower in patients receiving the Evolut R.
  
  CONCLUSION:
  In this matched comparison of high surgical risk patients undergoing TAVI, the use of Evolut R was associated with a significant survival benefit at 1year compared with the CoreValve. This was driven by lower incidence of periprocedural complications and higher rates of correct anatomic positioning.
  
  Copyright © 2017 Elsevier B.V. All rights reserved.
  
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• Portico Sheathless Transcatheter Aortic Valve Implantation via Distal Axillary Artery.
  Ann Thorac Surg

  2017 Feb;103(2):e175-e177. doi: 10.1016/j.athoracsur.2016.07.065.
  
  Bruschi Giuseppe, Colombo Paola, Botta Luca, Nava Stefano, Merlanti Bruno, Belli Oriana, Musca Francesco, Soriano Francesco, Russo Claudio F, Oliva Fabrizio
  
  Abstract
  
  Transcatheter aortic valve implantation has been designed to treat older patients affected by severe aortic stenosis who are considered high-risk surgical candidates because of multiple comorbidities. The least invasive approach for transcatheter aortic valves implantation should be considered the transfemoral retrograde route, because it is minimally invasive and is feasible with local anesthesia and mild sedation. Despite significant technical improvements in recent years, the transfemoral approach is contraindicated in cases of severe peripheral artery disease. We describe the first case of a Portico transcatheter aortic valve implantation system (St. Jude Medical, Minneapolis, MN) made through the distal axillary artery in a 90-year-old patient affected by severe aortic stenosis.
  
  Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
  
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• Arterial Stiffness in Aortic Stenosis: Relationship with Severity and Echocardiographic Procedures Response.
  High Blood Press Cardiovasc Prev

  2017 Mar;24(1):19-27. doi: 10.1007/s40292-016-0176-x.
  
  Bruschi Giuseppe, Maloberti Alessandro, Sormani Paola, Colombo Giulia, Nava Stefano, Vallerio Paola, Casadei Francesca, Bruno Jolie, Moreo Antonella, Merlanti Bruno, Russo Claudio, Oliva Fabrizio, Klugmann Silvio, Giannattasio Cristina
  
  Abstract
  
  INTRODUCTION:
  Aortic stenosis (AS) is more than only a degenerative disease, it could be also an atherosclerotic-like process involving the valve instead of the vessels. Little is known about the relation of arterial stiffness and AS.
  
  AIM:
  We sought to determine wether pulse wave velocity (PWV), is related to AS severity and to the procedures response, both as surgical aortic-valve-replacement (AVR) and trascatheter-aortic-valve-implantation (TAVI).
  
  METHODS:
  30 patients with severe AS were treated (15 AVR, 15 TAVI). Before the procedures (t0) and after 1 week (t1) echocardiography and PWV were evaluated.
  
  RESULTS:
  On the whole population, subjects with higher PWV showed higher transvalvular pressure gradient at baseline (mean: 56.5 ± 15.1 vs 45.4 ± 9.5; peak: 93.3 ± 26.4 vs 73.3 ± 14.9, p = 0.02) and, a significantly greater response to the procedures (mean: -42.9 ± 17.2 vs -27.9 ± 10.1, peak: -68.7 ± 29.2 vs -42.8 ± 16.4, p = 0.02). When the two different procedures groups were separated, data were confirmed only in the TAVI subgroup.
  
  CONCLUSIONS:
  In patients undergoing procedures for AS, PWV is correlated with transvalvular gradient and, in TAVI subjects, is able to predict the echocardiographic response. Baseline evaluation of PWV in patients candidates to TAVI can help the selection of subjects, even if larger and longer studies are needed before definitive conclusion can be drawn.
  
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• A multicentre European registry to evaluate the Direct Flow Medical transcatheter aortic valve system for the treatment of patients with severe aortic stenosis.
  EuroIntervention

  2016 Dec;12(11):e1413-e1419. doi: 10.4244/EIJ-D-15-00511.
  
  Naber Christoph K, Pyxaras Stylianos A, Ince Hüseyin, Frambach Peter, Colombo Antonio, Butter Christian, Gatto Fernando, Hink Ulrich, Nickenig Georg, Bruschi Giuseppe, Brueren Guus, Tchétché Didier, Den Heijer Peter, Schillinger Wolfgang, Scholtz Smita, Van der Heyden Jan, Lefèvre Thierry, Gilard Martine, Kuck Karl-Heinz, Schofer Joachim, Divchev Dimitar, Baumgartner Helmut, Asch Federico, Wagner Daniel, Latib Azeem, De Marco Federico, Kische Stephan
  
  Abstract
  
  AIMS:
  Our aim was to assess the clinical outcomes of the Direct Flow Medical Transcatheter Aortic Valve System (DFM-TAVS), when used in routine clinical practice.
  
  METHODS AND RESULTS:
  This is a prospective, open-label, multicentre, post-market registry of patients treated with DFM-TAVS according to approved commercial indications. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events were adjudicated and classified according to VARC-2 criteria by an independent clinical events committee. The primary endpoint was freedom from all-cause mortality at 30 days post procedure. Secondary endpoints included procedural, early safety and efficacy endpoints at 30 days. Two hundred and fifty patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI) with the DFM-TAVS were enrolled in 21 European centres. The primary endpoint, freedom from all-cause mortality at 30 days, was met in 98% (245/250) of patients. Device success was 83.8%. Moderate or severe aortic regurgitation was reported in 3% of patients, and none/trace regurgitation in 73% of patients. Post-procedural permanent pacemaker implantation was performed in 30 patients (12.0%).
  
  CONCLUSIONS:
  The DFM-TAVS was associated with good short-term outcomes in this real-world registry. The low pacemaker and aortic regurgitation rates confirm the advantages of this next-generation transcatheter heart valve (THV).
  
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• Evolut R Implantation to Treat Severe Pure Aortic Regurgitation in a Patient With Mitral Bioprosthesis.
  Ann Thorac Surg

  2016 Dec;102(6):e521-e524. doi: 10.1016/j.athoracsur.2016.05.054.
  
  Bruschi Giuseppe, Colombo Paola, Nava Stefano, Musca Francesco, Merlanti Bruno, Belli Oriana, Soriano Francesco, Botta Luca, De Caria Danile, Giannattasio Cristina, Russo Claudio F
  
  Abstract
  
  Transcatheter aortic valves have been designed to treat high-risk surgical candidates affected by severe aortic stenosis, but little is known about the use of transcatheter valves in patients with severe pure aortic regurgitation. We describe the implantation of Medtronic CoreValve Evolut R (Medtronic, Minneapolis, MN) to treat an 82-year-old patient affected by severe pure aortic regurgitation who underwent prior mitral valve replacement with a biological valve protruding into the left ventricular outflow tract.
  
  Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
  
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• Acute and long-term (2-years) clinical outcomes of the CoreValve 31mm in large aortic annuli: A multicenter study.
  Int J Cardiol

  2017 Jan;227():543-549. doi: 10.1016/j.ijcard.2016.10.104.
  
  Attizzani Guilherme F, Ohno Yohei, Latib Azeem, Petronio Anna Sonia, Giannini Cristina, Ettori Federica, Curello Salvatore, Bedogni Francesco, Todaro Denise, Brambilla Nedy, Bruschi Giuseppe, Colombo Paola, Presbitero Patrizia, Fiorilli Rosario, Poli Arnaldo, Martina Paola, Colombo Antonio, Barbanti Marco, Tamburino Corrado
  
  Abstract
  
  INTRODUCTION:
  Little is known about the early and late performance of the 31mm CoreValve Revalving System (CRS, Medtronic Inc., Galway, Ireland). Our aim was to compare acute and long-term results of the 31mm CRS with other valve sizes.
  
  METHODS:
  Consecutive patients undergoing transcatheter aortic valve implantation (TAVI) with CRS in nine Italian centers were prospectively included and dichotomized according to prosthesis size in two different groups, as follows: 31mm and other valve sizes (i.e., 23, 26, and 29mm combined). End points were defined according to Valve Academic Research Consortium definitions. Propensity score matching was performed.
  
  RESULTS:
  In total, 2069 patients (n=169 [8%] in the 31mm group and n=1900 [92%] in the other valve sizes group) were included. After propensity matching, the implantation of the 31mm valve was associated with lower rates of procedural- (91.3% vs. 98.1%, p=0.030) and device-success (88.5% vs. 97.1%, p=0.016), longer procedural time (120 [80-180] min. vs. 90 [60-120] min., p
  CONCLUSIONS:
  The acute performance of the 31mm CRS was worse than other valve sizes but no negative impact was observed in long-term outcomes.
  
  Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.
  
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• One-Year Outcomes of Transcatheter Aortic Valve Implantation Using the Direct Aortic Approach.
  Ann Thorac Surg

  2017 May;103(5):1434-1440. doi: 10.1016/j.athoracsur.2016.08.080.
  
  Bruschi Giuseppe, Branny Marian, Schiltgen Molly, Ettori Federica, Marcheix Bertrand, Amrane Hafid, Bushnaq Hasan, Tan M Erwin S H, Trivedi Uday, Branny Piotr, Klugmann Silvio, Coletti Giuseppe, Dumonteil Nicolas, Porta Fabiano, Nordell Anna, Moat Neil
  
  Abstract
  
  BACKGROUND:
  The direct aortic (DA) approach allows for transcatheter aortic valve implantation (TAVI) in patients with difficult peripheral vascular anatomy. The CoreValve ADVANCE Direct Aortic (ADVANCE DA) study was performed to assess the outcomes of DA TAVI with the CoreValve System (Medtronic, Minneapolis, MN) in routine practice.
  
  METHODS:
  Patients were selected for the DA approach by local cardiac surgical teams, and TAVI was performed with patients under general anesthesia. Safety events were adjudicated according to the Valve Academic Research Consortium-2 definitions by an independent clinical events committee. All imaging data, including that from multislice computed tomography and follow-up echocardiography, were analyzed by an independent core laboratory.
  
  RESULTS:
  From September 2012 to February 2014, 100 patients were enrolled (52.0% male, age 81.9 ± 5.9 years, The Society of Thoracic Surgeons Score 5.9 ± 3.2%) at 9 centers in Europe. Peripheral vascular disease was present in 51.0% of patients, and 38.0% had diabetes. Of the 100 patients enrolled, 92 underwent TAVI. At 30 days after TAVI, 98.1% were free of moderate or severe paravalvular leak. At 1 year, 16 patients had died (Kaplan-Meier rate 17.9%), 1 (1.1%) patient had had a stroke, classified as nondisabling, and 15 (17.0%) patients had received a permanent pacemaker. Most patients experienced improved quality of life as measured by the Kansas City Cardiomyopathy Questionnaire overall summary score (mean change from baseline to 1 year, 39.6 ± 26.3; p 
  CONCLUSIONS:
  The DA approach provides a feasible alternative for patients with challenging anatomic features that may otherwise preclude use of the TAVI procedure.
  
  Copyright © 2017 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
  
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• Transaxillary versus transaortic approach for transcatheter aortic valve implantation with CoreValve Revalving System: insights from multicenter experience.
  J Cardiovasc Surg (Torino)

  2017 Oct;58(5):747-754. doi: 10.23736/S0021-9509.16.09566-5.
  
  Fiorina Claudia, Bruschi Giuseppe, Testa Luca, DE Carlo Marco, DE Marco Federico, Coletti Giuseppe, Bonardelli Stefano, Adamo Marianna, Curello Salvatore, Scioti Giovanni, Panisi Paolo, Bedogni Francesco, Petronio Anna Sonia, Ettori Federica
  
  Abstract
  
  BACKGROUND:
  About one-third of candidates for transcatheter aortic valve implantation (TAVI) suffer from severe peripheral artery disease, making the routine femoral approach difficult or impossible. The aim was to compare the transaxillary (TAx) and the transaortic (TAo) route for TAVI with Medtronic CoreValve Revalving System (CRS).
  
  METHODS:
  Out of 1049 consecutive TAVI with 18F CRS, 242 (23%) were treated in 4 high-volume Italian Centre through TAx (61%) and TAo (39%).
  
  RESULTS:
  The devices success was similar (P=0.16) with a trend to a lower incidence of significant paravalvular leak (6% vs. 14%, P=0.07) and a significant reduction of permanent pacemaker (PPM) implantation (13% vs. 34%, P=0.017) in the TAo. However, this route showed a higher incidence of acute kidney injury (P=0.016) and a longer hospital stay after the index procedure (days 10 [8-14] vs. 8 [7-12], P=0.001). By a multivariate analysis the vascular access is an independent predictor for a longer hospital stay (TAo route; OR=0.37, 95% CI: 0.18-0.75; P=0.006) and for PPM implantation (TAx route; OR=3.7, 95% CI: 1.2-10.8; P=0.017).
  
  CONCLUSIONS:
  Although the higher clinical risk profile of transaortic population, the TAo approach showed an equally high device success with similar 30-day safety and 1year efficacy, compared to TAx route. However, due to non-procedure-specific complications post-TAo TAVI, this route requires a specialized postoperative care and the treatment of patients in highly specialized and experienced centers.
  
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• A new access for transcatheter aortic valve implantation: Distal axillary artery.
  Int J Cardiol

  2016 Nov;223():810-812. doi: 10.1016/j.ijcard.2016.08.290.
  
  Bruschi Giuseppe, Colombo Paola, Merlanti Bruno, Nava Stefano, Belli Oriana, Musca Francesco, Soriano Francesco, Botta Luca, Calini Angelo, De Caria Daniele F, Oliva Fabrizio, Russo Claudio F
  
  
  
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• Age-Related Differences in 1- and 12-Month Outcomes in Patients Undergoing Transcatheter Aortic Valve Implantation (from a Large Multicenter Data Repository).
  Am J Cardiol

  2016 Oct;118(7):1024-30. doi: 10.1016/j.amjcard.2016.07.018.
  
  Attizzani Guilherme F, Ohno Yohei, Latib Azeem, Petronio Anna Sonia, Giannini Cristina, Ettori Federica, Fiorina Claudia, Bedogni Francesco, Brambilla Nedy, Bruschi Giuseppe, Colombo Paola, Presbitero Patrizia, Fiorilli Rosario, Poli Arnaldo, Barbanti Marco, Colombo Antonio, Tamburino Corrado
  
  Abstract
  
  Scarce data are available on the impact of age on transcatheter aortic valve implantation (TAVI) outcomes. We therefore, analyzed 1,845 consecutive patients from 9 Italian centers who underwent TAVI with the Corevalve Revalving System from September 2007 to March 2014; patients were dichotomized according to their age in the date of the procedure, as follows: 75 to 85 years old and >85 years old. End points were defined according to Valve Academic Research Consortium definitions. In-hospital, 30-day, and 1-year clinical and echocardiographic data were available for 100% of the patients included. Propensity matching was performed. Procedural success rates were high (>94%) and comparable between groups. Although worse baseline renal function was observed in the older group, the incidence of acute kidney injury after procedure was comparable (17.1% and 17.4%, respectively for the 75- to 85- and >85-year-old group, p = 0.877); importantly, >99% of acute kidney injury episodes in both groups were grades 1 and 2. Procedural complications rates were low without between-group differences. In-hospital death (3.7% and 4.6%, p = 0.379) and stroke/transient ischemic attack (1.9% and 1.9%, respectively, p = 0.960) were comparable. The 1-year death rates were 14.9% and 17.2% (p = 0.197) in the 75- to 85- and >85-year-old group, respectively. Cardiovascular death was observed in 7.8% and 7% (p = 0.542), while stroke/transient ischemic attack was demonstrated in 5.2% and 4.4% (p = 0.496), respectively. Results were sustained after propensity matching. In conclusion, advanced age did not negatively impact the outcomes of TAVI through 1-year after procedure.
  
  Copyright © 2016 Elsevier Inc. All rights reserved.
  
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• Direct Transaortic TEVAR: An Alternative Option for Selected Patients With Unsuitable Peripheral Access.
  Ann Thorac Surg

  2016 Aug;102(2):e117-9. doi: 10.1016/j.athoracsur.2016.01.010.
  
  Botta Luca, Bruschi Giuseppe, Fratto Pasquale, Margari Vito, Solcia Marco, Borgia Francesco, Rampoldi Antonio, Russo Claudio Francesco
  
  Abstract
  
  Thoracic endovascular aortic repair (TEVAR) is effectively executed in patients with arch or descending aortic diseases. Peripheral access sites are preferably used as standard gates for TEVAR. Feasibility of a peripheral approach might need an intraoperative evaluation and alternative routes should have been carefully assessed. In this article, we report 2 successful cases of direct transaortic TEVAR, where stent grafts were directly introduced into the native ascending aorta without external conduits. A satisfactory result and the absence of aortic-related complications were observed at 2 and 5 years' follow-up, respectively.
  
  Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
  
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• Early and mid-term outcomes of 1904 patients undergoing transcatheter balloon-expandable valve implantation in Italy: results from the Italian Transcatheter Balloon-Expandable Valve Implantation Registry (ITER).
  Eur J Cardiothorac Surg

  2016 Dec;50(6):1139-1148. doi: 10.1093/ejcts/ezw218.
  
  Salizzoni Stefano, D'Onofrio Augusto, Agrifoglio Marco, Colombo Antonio, Chieffo Alaide, Cioni Micaela, Besola Laura, Regesta Tommaso, Rapetto Filippo, Tarantini Giuseppe, Napodano Massimo, Gabbieri Davide, Saia Francesco, Tamburino Corrado, Ribichini Flavio, Cugola Diego, Aiello Marco, Sanna Francesco, Iadanza Alessandro, Pompei Esmeralda, Stefàno Pierluigi, Cappai Antioco, Minati Alessandro, Cassese Mauro, Martinelli Gian Luca, Agostinelli Andrea, Fiorilli Rosario, Casilli Francesco, Reale Maurizio, Bedogni Francesco, Petronio Anna Sonia, Mozzillo Rosa Alba, Bonmassari Roberto, Briguori Carlo, Liso Armando, Sardella Gennaro, Bruschi Giuseppe, Fiorina Claudia, Filippini Claudia, Moretti Claudio, D'Amico Maurizio, La Torre Michele, Conrotto Federico, Di Bartolomeo Roberto, Gerosa Gino, Rinaldi Mauro,
  
  Abstract
  
  OBJECTIVES:
  The aim of this multicentre study is to report the clinical experiences of all patients undergoing transcatheter aortic valve implantation (TAVI) with a balloon-expandable device in Italy.
  
  METHODS:
  The Italian Transcatheter balloon-Expandable valve Registry (ITER) is a real-world registry that includes patients who have undergone TAVI with the Sapien (Edwards Lifesciences, Irvine, CA, USA) bioprosthesis in Italy since it became available in clinical practice. From 2007 to 2012, 1904 patients were enrolled to undergo TAVI in 33 Italian centres. Outcomes were classified according to the updated Valve Academic Research Consortium (VARC-2) definitions. A multivariable analysis was performed to identify independent predictors of all-cause mortality.
  
  RESULTS:
  Mean age was 81.7 (SD:6.2) years, and 1147 (60.2%) patients were female. Mean Logistic EuroSCORE was 21.1% (SD:13.7). Transfemoral, transapical, transaortic and transaxillary TAVI was performed in 1252 (65.8%), 630 (33.1%), 18 (0.9%) and 4 (0.2%) patients, respectively. Operative mortality was 7.2% (137 patients). The VARC-2 outcomes were as follows: device success, 88.1%; disabling stroke, 1.0%; life-threatening and major bleeding 9.8 and 10.5%, respectively; major vascular complication, 9.7%; acute kidney injury, 8.2%; acute myocardial infarction ?72 h, 1.5%. Perioperative pacemaker implantation was necessary in 116 (6.1%) patients. At discharge, the mean transprosthetic gradient was 10.7 (SD:4.5) mmHg. Incidence of postoperative mild, moderate or severe paravalvular leak was, respectively, 32.1, 5.0 and 0.4%. A total of 444/1767 (25.1%) deaths after hospital discharge were reported: of these, 168 (37.8%) were classified as cardiac death. Preoperative independent predictors of all-cause mortality were male gender (HR: 1.395; 95% CI:1.052-1.849); overweight, BMI 25-30 kg/m (HR: 0.775; 95% CI: 0.616-0.974); serum creatinine level (every 1 mg/dl increase; HR: 1.314; 95% CI:1.167-1.480); haemoglobin level (every 1 g/dl increase; HR: 0.905; 95% CI:0.833-0.984); critical preoperative state (HR: 2.282; 95% CI: 1.384-3.761); neurological dysfunction (HR: 1.552; 95% CI:1.060-2.272); atrial fibrillation (HR: 1.556; 95% CI:1.213-1.995); pacemaker rhythm (HR: 1.948; 95% CI:1.310-2.896); NYHA Class III or IV (HR: 1.800; 95% CI:1.205-2.689 or HR: 2.331; 95% CI:1.392-3.903, respectively).
  
  CONCLUSIONS:
  TAVI with a balloon-expandable device in the 'real world' shows good mid-term outcomes in terms of survival, technical success, valve-related adverse events and haemodynamic performance.
  
  © The Author 2016. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
  
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• Transcatheter Replacement of Failed Bioprosthetic Valves: Large Multicenter Assessment of the Effect of Implantation Depth on Hemodynamics After Aortic Valve-in-Valve.
  Circ Cardiovasc Interv

  2016 Jun;9(6):. doi: e003651.
  
  Simonato Matheus, Webb John, Kornowski Ran, Vahanian Alec, Frerker Christian, Nissen Henrik, Bleiziffer Sabine, Duncan Alison, Rodés-Cabau Josep, Attizzani Guilherme F, Horlick Eric, Latib Azeem, Bekeredjian Raffi, Barbanti Marco, Lefevre Thierry, Cerillo Alfredo, Hernández José María, Bruschi Giuseppe, Spargias Konstantinos, Iadanza Alessandro, Brecker Stephen, Palma José Honório, Finkelstein Ariel, Abdel-Wahab Mohamed, Lemos Pedro, Petronio Anna Sonia, Champagnac Didier, Sinning Jan-Malte, Salizzoni Stefano, Napodano Massimo, Fiorina Claudia, Marzocchi Antonio, Leon Martin, Dvir Danny
  
  Abstract
  
  BACKGROUND:
  Transcatheter valve implantation inside failed bioprosthetic surgical valves (valve-in-valve [ViV]) may offer an advantage over reoperation. Supra-annular transcatheter valve position may be advantageous in achieving better hemodynamics after ViV. Our objective was to define targets for implantation that would improve hemodynamics after ViV.
  
  METHODS AND RESULTS:
  Cases from the Valve-in-Valve International Data (VIVID) registry were analyzed using centralized core laboratory assessment blinded to clinical events. Multivariate analysis was performed to identify independent predictors of elevated postprocedural gradients (mean ?20 mm?Hg). Optimal implantation depths were defined by receiver operating characteristic curve. A total of 292 consecutive patients (age, 78.9±8.7 years; 60.3% male; 157 CoreValve Evolut and 135 Sapien XT) were evaluated. High implantation was associated with significantly lower rates of elevated gradients in comparison with low implantation (CoreValve Evolut, 15% versus 34.2%; P=0.03 and Sapien XT, 18.5% versus 43.5%; P=0.03, respectively). Optimal implantation depths were defined: CoreValve Evolut, 0 to 5 mm; Sapien XT, 0 to 2 mm (0-10% frame height); sensitivities, 91.3% and 88.5%, respectively. The strongest independent correlate for elevated gradients after ViV was device position (high: odds ratio, 0.22; confidence interval, 0.1-0.52; P=0.001), in addition to type of device used (CoreValve Evolut: odds ratio, 0.5; confidence interval, 0.28-0.88; P=0.02) and surgical valve mechanism of failure (stenosis/mixed baseline failure: odds ratio, 3.12; confidence interval, 1.51-6.45; P=0.002).
  
  CONCLUSIONS:
  High implantation inside failed bioprosthetic valves is a strong independent correlate of lower postprocedural gradients in both self- and balloon-expandable transcatheter valves. These clinical evaluations support specific implantation targets to optimize hemodynamics after ViV.
  
  © 2016 American Heart Association, Inc.
  
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• Direct Flow Implantation in a Patient With Mechanical Mitral Prostheses.
  Ann Thorac Surg

  2016 Feb;101(2):753-6. doi: 10.1016/j.athoracsur.2015.02.139.
  
  Bruschi Giuseppe, Barosi Alberto, Colombo Paola, Montorsi Emanuela, Nava Stefano, Soriano Francesco, Botta Luca, Fratto Pasquale, Klugmann Silvio, de Marco Federico
  
  Abstract
  
  We describe a case of Direct Flow (Direct Flow Medical Inc, Santa Rosa, CA) transcatheter aortic valve implantation in a patient with a mechanical valve in a mitral position.
  
  Copyright © 2016 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
  
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• Prospective Multicenter Evaluation of the Direct Flow Medical Transcatheter Aortic Valve System: 12-Month Outcomes of the Evaluation of the Direct Flow Medical Percutaneous Aortic Valve 18F System for the Treatment of Patients With Severe Aortic Stenosis (DISCOVER) Study.
  JACC Cardiovasc Interv

  2016 Jan;9(1):68-75. doi: 10.1016/j.jcin.2015.09.027.
  
  Lefèvre Thierry, Colombo Antonio, Tchétché Didier, Latib Azeem, Klugmann Silvio, Fajadet Jean, De Marco Federico, Maisano Francesco, Bruschi Giuseppe, Bijuklic Klaudija, Nava Stefano, Weissman Neil, Low Reginald, Thomas Martyn, Young Christopher, Redwood Simon, Mullen Michael, Yap John, Grube Eberhard, Nickenig Georg, Sinning Jan-Malte, Hauptmann Karl Eugen, Friedrich Ivar, Lauterbach Michael, Schmoeckel Michael, Davidson Charles, Schofer Joachim
  
  Abstract
  
  OBJECTIVES:
  The aim of this study was to assess the 1-year outcome after transcatheter aortic valve replacement (TAVR) of the Direct Flow Medical (DFM) valve in patients with severe symptomatic aortic stenosis who were contraindicated or high risk for surgery.
  
  BACKGROUND:
  The DFM transcatheter heart valve is a new-generation, nonmetallic aortic valve with a pressurized support structure and conformable double-ring annular sealing delivered through an 18-F sheath. The device allows repositioning, retrieval, and assessment of valve performance before permanent implantation.
  
  METHODS:
  A prospective multicenter European registry was set up to determine the safety and performance of the valve in 100 consecutive patients (10 centers). Echocardiographic and angiographic data were evaluated by an independent core laboratory, and adverse events were adjudicated by a clinical events committee using Valve Academic Research Consortium criteria.
  
  RESULTS:
  Patients were 83.1 ± 5.9 years of age and had a logistic EuroSCORE of 22.5 ± 11.3% and a Society of Thoracic Surgeons score of 9.7 ± 8.7%. Correct valve positioning was obtained in 99% of cases with a combined 30-day safety endpoint at 10%, including major stroke in 5.0%, major vascular complications in 2.0%, and death in 1%. At 12 months, 95% of patients were in New York Heart Association functional class I or II. Freedom from any death was 90%, and freedom from any death or major stroke was 85%. Echocardiography demonstrated none/trace to mild aortic regurgitation in 100% of patients and an unchanged mean aortic gradient of 12.2 ± 6.6 mm Hg and effective orifice area of 1.6 ± 0.4 cm(2).
  
  CONCLUSIONS:
  At 1 year, the DFM transcatheter heart valve had durable hemodynamics. This study demonstrates that the low rate of early complications and the low risk of significant aortic regurgitation translated into midterm clinical benefit.
  
  Copyright © 2016 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• Transfemoral Implantation of a Fully Repositionable and Retrievable Transcatheter Valve for Noncalcified Pure Aortic Regurgitation.
  JACC Cardiovasc Interv

  2015 Dec;8(14):1842-9. doi: 10.1016/j.jcin.2015.08.022.
  
  Schofer Joachim, Nietlispach Fabian, Bijuklic Klaudija, Colombo Antonio, Gatto Fernando, De Marco Federico, Mangieri Antonio, Hansen Lorenz, Bruschi Giuseppe, Ruparelia Neil, Rieß Friedrich-Christian, Maisano Franscesco, Latib Azeem
  
  Abstract
  
  OBJECTIVES:
  This study sought to evaluate the use of the Direct Flow Medical (DFM) transcatheter heart valve (Direct Flow Medical, Santa Rosa, California) for the treatment of noncalcific pure aortic regurgitation (AR).
  
  BACKGROUND:
  The treatment of noncalcific AR has remained a relative contraindication with transcatheter heart valves due to challenges in anchoring devices in the absence of calcium, concerns of valve embolization, and the high risk of significant residual paravalvular leak.
  
  METHODS:
  The study population consisted of patients treated for severe noncalcific pure AR with transfemoral implantation of a DFM transcatheter heart valve at 6 European centers. The primary endpoint was the composite endpoint of device success and the secondary endpoint was the composite early safety endpoint (according to the VARC-2 criteria).
  
  RESULTS:
  Eleven high-risk (STS score 8.84 ± 8.9, Logistic EuroSCORE 19.9 ± 7.1) patients (mean age 74.7 ± 12.9 years) were included. Device success was achieved in all patients. In 1 patient, the initial valve prosthesis was retrieved after pull-through, and a second valve was successfully deployed. The early safety endpoint was reached in 91% of the patients, with 1 patient requiring surgical aortic valve replacement secondary to downward dislocation of the prosthesis that was successfully managed with surgical aortic valve replacement. DFM implantation resulted in excellent hemodynamics with none or trivial paravalvular regurgitation in 9 patients and a transprosthetic gradient of 7.7 ± 5.1 mm Hg at 30-day follow up. All patients derived symptomatic benefit following the procedure, with 72% in New York Heart Association functional class I or II.
  
  CONCLUSIONS:
  This study reports the feasibility of treating severe noncalcific AR with the Direct Flow prosthesis via the transfemoral route.
  
  Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• First-in-man transcatheter mitral valve-in-ring implantation with a repositionable and retrievable aortic valve prosthesis.
  EuroIntervention

  2016 Feb;11(10):1148-52. doi: 10.4244/EIJY15M11_02.
  
  Latib Azeem, Ruparelia Neil, Bijuklic Klaudija, De Marco Federico, Gatto Fernando, Hansen Lorenz, Ozbek Cem, Greilach Peter, Bruschi Giuseppe, Rieß Friedrich-Christian, Alfieri Ottavio, Colombo Antonio, Schofer Joachim
  
  Abstract
  
  AIMS:
  Transcatheter interventions with balloon-expandable valves have been shown to be efficacious for the treatment of mitral annuloplasty failure but are limited by the fact that there is no opportunity for post-implantation adjustment. The aim of this study was to assess the safety and efficacy of the fully repositionable and retrievable Direct Flow Medical (DFM) valve for the treatment of mitral annuloplasty failure.
  
  METHODS AND RESULTS:
  Patients who underwent transcatheter mitral valve-in-ring (VIR) implantation of a DFM valve for failed mitral annuloplasty deemed high risk for redo surgery were included at four institutions. Eight patients underwent transcatheter mitral VIR procedures with implantation of the DFM valve. The DFM prosthesis was successfully positioned in all patients. Two patients required retrieval of the device due to a suboptimal result, and a further patient required repositioning of the valve with an ultimately successful implantation. During the 30-day follow-up period, two patients died for reasons unrelated to the valve implantation. The four patients with successful implantation had normal valve function associated with a significant improvement in their functional status.
  
  CONCLUSIONS:
  For the first time, we demonstrate the safety, efficacy and advantages of using the DFM prosthesis for the treatment of mitral annuloplasty failure.
  
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• Mitral valve endocarditis due to Abiotrophia defectiva in a 14th week pregnant woman.
  Interact Cardiovasc Thorac Surg

  2016 Jan;22(1):112-4. doi: 10.1093/icvts/ivv289.
  
  Botta Luca, Merati Roberto, Vignati Gabriele, Orcese Carlo Andrea, De Chiara Benedetta, Cannata Aldo, Bruschi Giuseppe, Fratto Pasquale
  
  Abstract
  
  Infective endocarditis during pregnancy carries a high mortality risk, both for the mother and for the foetus and requires a multidisciplinary team in the management of complicated cases. We report our experience with a 39-year old patient, affected by an acute active mitral endocarditis due to Abiotrophia defectiva at the 14th gestational week, strongly motivated to continue the pregnancy. Our patient successfully underwent mitral valve replacement with a normothermic high-flow cardiopulmonary bypass under continuous intraoperative foetal monitoring. Caesarean section occurred at the 38th gestational week. The delivery was uneventful and both the mother and child are doing well at the 16-month follow-up.
  
  © The Author 2015. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
  
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• CoreValve Evolut R implantation as valve-in-valve in an Edwards SAPIEN 3 to treat paravalvular regurgitation.
  EuroIntervention

  2015 Sep;11(5):e1. doi: 10.4244/EIJV11I5A116.
  
  Bruschi Giuseppe, Soriano Francesco, Musca Francesco, Nava Stefano, Einaudi Arturo, Garascia Andrea, Belli Oriana, Barosi Alberto, Fratto Pasquale, Colombo Paola, Russo Claudio Francesco, Gagliardone Maria Pia, Klugmann Silvio
  
  
  
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• The Choice Will Be Tailored TAVR Therapy: "The Talent Is in the Choices".
  J Am Coll Cardiol

  2015 Aug;66(7):801-803. doi: 10.1016/j.jacc.2015.06.1083.
  
  Bruschi Giuseppe, De Marco Federico
  
  
  
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• Letter by Frigerio et al Regarding Article, "Long-Term Outcomes of Inoperable Patients With Aortic Stenosis Randomly Assigned to Transcatheter Aortic Valve Replacement or Standard Therapy".
  Circulation

  2015 Aug;132(6):e117. doi: 10.1161/CIRCULATIONAHA.114.014377.
  
  Frigerio Maria, Bruschi Giuseppe, Klugmann Silvio
  
  
  
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• Direct Flow valve-in-valve implantation in a degenerated mitral bioprosthesis.
  EuroIntervention

  2016 Apr;11(13):1549-53. doi: 10.4244/EIJY15M07_05.
  
  Bruschi Giuseppe, Cannata Aldo, Barosi Alberto, Colombo Paola, Soriano Francesco, Nava Stefano, Montrasio Elisa, Botta Luca, Gagliardone Maria Pia, Klugmann Silvio, De Marco Federico
  
  Abstract
  
  AIMS:
  Mitral valve reoperations due to failing bioprostheses, in patients affected by multiple comorbidities, are associated with high morbidity and mortality. Transcatheter techniques may evolve as complementary approaches to surgery in these patients at high risk for surgery.
  
  METHODS AND RESULTS:
  We describe a case of Direct Flow 25 mm transcatheter valve implantation as valve-in-valve in a degenerated mitral bioprosthesis through a transapical approach in a 63-year-old man affected by dilated cardiomyopathy. The patient was affected by Carpentier-Edwards 29 mm severe regurgitation. The 25 mm Direct Flow bioprosthesis was advanced through the mitral bioprosthesis into the left atrium and then positioned using the three independent positioning wires. Transoesophageal echocardiography evidenced normal Direct Flow function with no paravalvular regurgitation and a low transmitral gradient of 4 mmHg.
  
  CONCLUSIONS:
  Our successful experience, characterised by a Heart Team approach and multidisciplinary patient care, demonstrated the technical feasibility and procedural safety of Direct Flow valve-in-valve mitral implantation.
  
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• 5-Year Outcomes After Transcatheter Aortic Valve Implantation With CoreValve Prosthesis.
  JACC Cardiovasc Interv

  2015 Jul;8(8):1084-1091. doi: 10.1016/j.jcin.2015.03.024.
  
  Barbanti Marco, Petronio Anna Sonia, Ettori Federica, Latib Azeem, Bedogni Francesco, De Marco Federico, Poli Arnaldo, Boschetti Carla, De Carlo Marco, Fiorina Claudia, Colombo Antonio, Brambilla Nedy, Bruschi Giuseppe, Martina Paola, Pandolfi Claudia, Giannini Cristina, Curello Salvatore, Sgroi Carmelo, Gulino Simona, Patanè Martina, Ohno Yohei, Tamburino Claudia, Attizzani Guilherme F, Immè Sebastiano, Gentili Alessandra, Tamburino Corrado
  
  Abstract
  
  OBJECTIVES:
  The purpose of this analysis was to assess 5-year outcomes of transcatheter aortic valve implantation (TAVI) using the current technology of the self-expanding CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota).
  
  BACKGROUND:
  There is a paucity of evidence on long-term durability of currently available transcatheter heart valves.
  
  METHODS:
  Starting in June 2007, all consecutive patients with severe aortic stenosis undergoing TAVI with the third-generation 18-F CoreValve device in 8 Italian centers were prospectively included in the ClinicalService Project. For the purposes of this study, we included only consecutive patients with 5-year follow-up data available (n = 353) treated from June 2007 to August 2009. All outcomes were reported according to VARC (Valve Academic Research Consortium)-1 criteria.
  
  RESULTS:
  All-cause mortality rates at 1, 2, 3, 4, and 5 years were 21%, 29%, 38%, 48%, and 55.0%, respectively. Cardiovascular mortality rates at 1, 2, 3, 4, and 5 years were 10%, 14%, 19%, 23%, and 28.0%, respectively. The overall neurological event rate at 5 years was 7.5%, of which more than two-thirds occurred early after the procedure. During follow-up, there were 241 rehospitalizations for cardiovascular reasons in 164 (46%) patients. Among all rehospitalizations, acute heart failure was the most frequently reported (42.7%), followed by requirement of permanent pacemaker implantation (17.4%). On echocardiography, mean transaortic gradients decreased from 55.6 ± 16.8 mm Hg (pre-TAVI) to 12.8 ± 10.9 mm Hg (5-year post-TAVI) (p
  CONCLUSIONS:
  TAVI with the currently adopted CoreValve generation was associated with sustained clinical outcomes up to 5-year follow-up, with a low rate (1.4%) of significant prosthetic valve degeneration. The procedure appears to be an adequate and lasting resolution of aortic stenosis in selected high-risk patients.
  
  Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• Transcatheter Aortic Valve Implantation Under Angiographic Guidance With and Without Adjunctive Transesophageal Echocardiography.
  Am J Cardiol

  2015 Aug;116(4):604-11. doi: 10.1016/j.amjcard.2015.05.024.
  
  Attizzani Guilherme F, Ohno Yohei, Latib Azeem, Petronio Anna Sonia, De Carlo Marco, Giannini Cristina, Ettori Federica, Curello Salvatore, Fiorina Claudia, Bedogni Francesco, Testa Luca, Bruschi Giuseppe, De Marco Federico, Presbitero Patrizia, Rossi Marco Luciano, Boschetti Carla, Picarelli Silvia, Poli Arnaldo, Barbanti Marco, Martina Paola, Colombo Antonio, Tamburino Corrado
  
  Abstract
  
  Although transcatheter aortic valve implantation (TAVI) is still currently guided by transesophageal echocardiography (TEE) in a considerable number of hospitals, exclusive angiographic (Angio) guidance seems a reasonable approach in this setting. To date, however, no studies have directly compared the outcomes of TAVI according to the imaging modality used for procedural guidance. We, therefore, used data from a large multicenter data repository to compare the outcomes of TAVI guided exclusively by Angio and ATEE. All consecutive patients with severe aortic stenosis who underwent TAVI with the CoreValve Revalving System (CRS) in 9 Italian centers from September 2007 to March 2014, dichotomized according to the imaging support used to guide the procedure (ATEE and Angio), were included. Thirty-day and 12-month clinical outcomes were evaluated. Propensity matching analysis was performed to adjust for baseline differences. A total of 625 patients were included (256 and 369 patients were included in the ATEE and Angio groups, respectively). Patients from the ATEE more frequently underwent TAVI under general anesthesia compared with Angio group (37.9% vs 22.8%, respectively, p
  Copyright © 2015 Elsevier Inc. All rights reserved.
  
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• Self-expandable CoreValve implantation without contrast media.
  Asian Cardiovasc Thorac Ann

  2016 Sep;24(7):696-8. doi: 10.1177/0218492315589867.
  
  Bruschi Giuseppe, Colombo Paola, De Marco Federico, Barosi Alberto, Mauri Silvia, Klugmann Silvio
  
  Abstract
  
  Transcatheter aortic valve implantation has been designed to treat high-risk surgical patients affected by severe aortic stenosis, many of whom are affected by chronic kidney disease. To perform transcatheter self-expandable valve implantation, multiple contrast injections are required to monitor the procedure, so these patients are at increased risk of acute kidney injury. We described self-expandable transcatheter aortic valve implantation without contrast media in an 80-year-old man affected by severe aortic stenosis and endstage chronic kidney disease.
  
  © The Author(s) 2015.
  
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• Treatment solution by Botta et al.
  Interact Cardiovasc Thorac Surg

  2015 Jun;20(6):869-70. doi: 10.1093/icvts/ivv056.
  
  Botta Luca, Cannata Aldo, Bruschi Giuseppe, Martinelli Luigi
  
  
  
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• [A simple but very complicated angioplasty: management of coronary artery perforation and dual antiplatelet therapy. A case report and literature review].
  G Ital Cardiol (Rome)

  2015 May;16(5):311-5. doi: 10.1714/1870.20436.
  
  Soriano Francesco, Oreglia Jacopo, Bossi Irene, Colombo Paola, Piccalò Giacomo, De Marco Federico, Bruschi Giuseppe, Klugmann Silvio
  
  Abstract
  
  Coronary artery perforation is a rare but potentially fatal complication. Therefore, it is crucial for interventional cardiologists to have knowledge of this condition and what management strategies are available, particularly in the case of procedures with a high level of complexity. Notwithstanding this, even simple procedures are not immune to serious complications, as described in this case report where coronary angioplasty was complicated by left anterior descending artery perforation with cardiac tamponade, giving rise to multiple complications of difficult management. The case presented here also provides the opportunity to investigate the optimal duration of dual antiplatelet therapy after implantation of drug-eluting stents, a topic much debated in recent years.
  
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• Pseudoaneurysm of the aortic isthmus involving a right aberrant subclavian artery long after multiple coarctation repairs.
  Interact Cardiovasc Thorac Surg

  2015 Jun;20(6):868-9. doi: 10.1093/icvts/ivv054.
  
  Botta Luca, Cannata Aldo, Bruschi Giuseppe, Martinelli Luigi
  
  
  
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• Direct aortic Direct Flow implantation via right anterior thoracotomy in a patient with patent bilateral mammary artery coronary grafts.
  Int J Cardiol

  2015 Apr;185():22-4. doi: 10.1016/j.ijcard.2015.03.083.
  
  Bruschi Giuseppe, Merlanti Bruno, Barosi Alberto, Colombo Paola, Fratto Pasquale, Nava Stefano, Soriano Francesco, Montrasio Elisa, Klugmann Silvio, de Marco Federico
  
  
  
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• Anaesthetic management of transcatheter aortic valve implantation: results from the Italian CoreValve registry.
  EuroIntervention

  2016 Jun;12(3):381-8. doi: 10.4244/EIJY15M03_05.
  
  Petronio A Sonia, Giannini Cristina, De Carlo Marco, Bedogni Francesco, Colombo Antonio, Tamburino Corrado, Klugmann Silvio, Poli Arnaldo, Guarracino Fabio, Barbanti Marco, Latib Azeem, Brambilla Nedy, Fiorina Claudia, Bruschi Giuseppe, Martina Paola, Ettori Federica
  
  Abstract
  
  AIMS:
  Transcatheter aortic valve implantation (TAVI) represents a valid therapeutic alternative for patients with severe aortic stenosis at high surgical risk. However, there is no general consensus regarding the role of anaesthesia in TAVI management. The goal of this clinical project was to assess the safety and non-inferiority of local anaesthesia (LA) versus general anaesthesia (GA) in a large cohort of patients undergoing TAVI.
  
  METHODS AND RESULTS:
  All 1,316 consecutive patients who underwent TAVI at seven high-volume Italian centres were enrolled. The anaesthetic regimen consisted of GA in 355 (26.9%) patients or LA in 961 (73.0%) patients. Baseline demographics were similar between the two groups except for a higher median logistic EuroSCORE (p=0.004) and peripheral artery disease (p
  CONCLUSIONS:
  Our study indicates that, in experienced centres which have gone beyond their initial learning curve with TAVI, the use of local anaesthesia in a selected patient population can be associated with good clinical outcomes. Nevertheless, as severe procedural complications are possible, an anaesthesiologist should always be present as part of the team.
  
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• Alternative transarterial access for CoreValve transcatheter aortic bioprosthesis implantation.
  Expert Rev Med Devices

  2015 May;12(3):279-86. doi: 10.1586/17434440.2015.1005605.
  
  Bruschi Giuseppe, De Marco Federico, Modine Thomas, Botta Luca, Colombo Paola, Mauri Silvia, Cannata Aldo, Fratto Pasquale, Klugmann Silvio
  
  Abstract
  
  Transcatheter aortic valve implantation (TAVI) is used to treat elderly patients with severe aortic stenosis who are considered extremely high-risk surgical candidates. The safety and effectiveness of TAVI have been demonstrated in numerous studies. The self-expanding CoreValve bioprosthesis (Medtronic Inc., Minneapolis, MN, USA) was the first transcatheter aortic valve to be granted the Conformité Européene (CE) mark in May 2007 for retrograde transfemoral implantation. However, TAVI patients are also often affected by severe iliofemoral arteriopathy. In these patients, the retrograde transfemoral approach carries a high risk of vascular injury, making this approach unusable. Alternative arterial access sites, such as the subclavian artery, the ascending aorta, and the carotid artery, have been used for retrograde implantation of the CoreValve bioprosthesis. In the present report, we present the procedural considerations, risks, and benefits of the different types of arterial access used to implant the CoreValve bioprosthesis.
  
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• Right anterior mini-thoracotomy direct aortic self-expanding trans-catheter aortic valve implantation: A single center experience.
  Int J Cardiol

  2015 Feb;181():437-42. doi: 10.1016/j.ijcard.2014.11.108.
  
  Bruschi Giuseppe, De Marco Federico, Botta Luca, Barosi Alberto, Colombo Paola, Mauri Silvia, Cannata Aldo, Morici Nuccia, Colombo Tiziano, Fratto Pasquale, Nonini Sandra, Soriano Francesco, Mondino Michele, Giannattasio Cristina, Klugmann Silvio
  
  Abstract
  
  OBJECTIVE:
  Transcatheter aortic valve implantation (TAVI) has been designed to treat elderly patients with severe aortic stenosis at high risk for surgery. These patients are also often affected by severe iliac-femoral arteriopathy, rendering the trans-femoral approach unusable. We report our experience with the direct-aortic approach to treat these patients.
  
  METHODS:
  From May 2008 to November 2013 two hundred and thirty-two patients (131 female, 56%) with severe symptomatic aortic stenosis and no reasonable surgical option due to excessive risk were evaluated for TAVI at our department. Of these patients, 202 were deemed eligible for TAVI. Of this group, 50 underwent CoreValve implantation by the direct aortic approach through a right anterior mini-thoracotmy (28 female, 56%), mean age 81.2±6.9. A combined team of cardiologists, cardiac surgeons with expertise in hybrid procedures, and anesthetists performed all the procedures.
  
  RESULTS:
  Twenty-eight (56%) patients were female and 11 (22%) were redo at TAVI. We used a 23-mm CoreValve Evolute in 3 patients (6%), and the most used valve size was the 29mm in 46% of patients. Mean hemodynamic trans-aortic gradient was less than 5mmHg. The paravalvular regurgitation was ? grade 1 in 46 patients as assessed by peri-procedural transesophageal echocardiography (TEE). Seven patients (7/43, 16%) required a permanent pacemaker implantation; 30-day mortality was 6% (3 patients). Seven patients (14.8%) died during follow-up. Actuarial survival at 2years is 84.7±5.3%.
  
  CONCLUSIONS:
  Transcatheter aortic valve implantation with the direct aortic approach is safe and feasible, offering a new attractive option to treat selected high-risk patients with severe aortic stenosis and peripheral vasculopathy, including those requiring a re-do procedure.
  
  Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.
  
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• Impact of balloon post-dilation on clinical outcomes after transcatheter aortic valve replacement with the self-expanding CoreValve prosthesis.
  JACC Cardiovasc Interv

  2014 Sep;7(9):1014-21. doi: 10.1016/j.jcin.2014.03.009.
  
  Barbanti Marco, Petronio Anna Sonia, Capodanno Davide, Ettori Federica, Colombo Antonio, Bedogni Francesco, De Marco Federico, De Carlo Marco, Fiorina Claudia, Latib Azeem, Testa Luca, Bruschi Giuseppe, Poli Arnaldo, Giannini Cristina, Curello Salvatore, Maffeo Diego, Sgroi Carmelo, Martina Paola, Gulino Simona, Patanè Martina, Ohno Yohei, Attizzani Guilherme F, Immè Sebastiano, Cannata Stefano, Gentili Alessandra, Rossi Agnese, Tamburino Corrado
  
  Abstract
  
  OBJECTIVES:
  The aim of this study was to assess the incidence and clinical impact of balloon post-dilation (BPD) after transcatheter aortic valve replacement (TAVR) with the CoreValve prosthesis (Medtronic Inc., Minneapolis, Minnesota).
  
  BACKGROUND:
  BPD is a widely adopted strategy to reduce the degree of paraprosthetic regurgitation in case of transcatheter heart valve underexpansion. However, controversies still remain regarding its real effectiveness and safety.
  
  METHODS:
  The ClinicalService (a nation-based data repository and medical care project) dataset was analyzed. All patients were dichotomized according to the need for BPD during the index procedure.
  
  RESULTS:
  Among 1,376 patients, BPD of the transcatheter heart valve was performed in 272 (19.8%). In 37% of cases, it was unsuccessful at reducing the paravalvular regurgitation to mild or less. No case of valve embolization, new intravalvular regurgitation, coronary occlusion, and aortic root injury occurred during BPD. There were no statistically significant differences between the 2 groups in the incidence of in-hospital all-cause and cardiovascular mortality, neurological events, myocardial infarction, bleeding, conversion to open-chest surgery, and the need for a permanent pacemaker. The need for BPD did not emerge as an independent risk factor for all-cause (adjusted hazard ratio [HR]: 1.33, 95% confidence interval [CI]: 0.81 to 2.19, p = 0.264) and cardiovascular (adjusted HR: 1.48, 95% CI: 0.74 to 2.97, p = 0.265) mortality at 1 year after the procedure. In addition, BPD did not predispose to higher odds of neurological events during 12 months after TAVR (HR: 0.92, 95% CI: 0.45 to 1.88, p = 0.815).
  
  CONCLUSIONS:
  This large study showed that BPD after TAVR was safe and not associated with increased rates of cerebrovascular events, mortality, myocardial infarction, and aortic root injury.
  
  Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• First case of trans-axillary direct flow implantation.
  Int J Cardiol

  2014 Dec;177(3):e176-8. doi: 10.1016/j.ijcard.2014.08.097.
  
  Bruschi Giuseppe, Botta Luca, Cannata Aldo, Colombo Paola, Barosi Alberto, Soriano Francesco, Bottiroli Maurizio, Nava Stefano, Klugmann Silvio, De Marco Federico
  
  
  
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• Mortality in the PARTNER trials: transfemoral is better.
  J Am Coll Cardiol

  2014 Jul;64(2):169-71. doi: 10.1016/j.jacc.2014.04.034.
  
  Bruschi Giuseppe, Morici Nuccia
  
  
  
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• Direct aortic transcatheter valve implantation in a porcelain aorta.
  Asian Cardiovasc Thorac Ann

  2014 Oct;22(8):968-71. doi: 10.1177/0218492313490409.
  
  Bruschi Giuseppe, Botta Luca, De Marco Federico, Colombo Paola, Klugmann Silvio, Martinelli Luigi
  
  Abstract
  
  Transcatheter aortic valve implantation has been designed to treat elderly patients with severe aortic stenosis at high risk for surgery, and is generally performed retrogradely with vascular access. However, in certain patients, this access is either not possible or deemed to carry a high risk of vascular injury. We report our experience of a direct aortic approach in a 78-year old man with severe aortic stenosis, excluded from standard aortic valve replacement due to a porcelain aorta, and affected by severe aortic, iliac-femoral, and subclavian arteriopathy, rendering the transfemoral or subclavian approach unemployable.
  
  © The Author(s) 2013 Reprints and permissions: sagepub.co.uk/journalsPermissions.nav.
  
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• Transcatheter valve implantation in a stenosed quadricuspid aortic valve.
  Asian Cardiovasc Thorac Ann

  2014 Jun;22(5):627. doi: 10.1177/0218492312475230.
  
  Bruschi Giuseppe, De Marco Federico, Klugmann Silvio
  
  
  
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• Transcatheter aortic valve implantation of the direct flow medical aortic valve with minimal or no contrast.
  Cardiovasc Revasc Med

  2014 Jun;15(4):252-7. doi: 10.1016/j.carrev.2014.03.003.
  
  Latib Azeem, Maisano Francesco, Colombo Antonio, Klugmann Silvio, Low Reginald, Smith Thomas, Davidson Charles, Harreld John H, Bruschi Giuseppe, DeMarco Federico
  
  Abstract
  
  The 18F Direct Flow Medical (DFM) THV has conformable sealing rings, which minimizes aortic regurgitation and permits full hemodynamic assessment of valve performance prior to permanent implantation. During the DISCOVER trial, three patients who were at risk for receiving contrast media, two due to severe CKD and one due to a recent hyperthyroid reaction to contrast, underwent DFM implantation under fluoroscopic and transesophageal guidance without aortography during either positioning or to confirm the final position. Valve positioning was based on the optimal angiographic projection as calculated by the pre-procedural multislice CT scan. Precise optimization of valve position was performed to minimize transvalve gradient and aortic regurgitation. Prior to final implantation, transvalve hemodynamics were assessed invasively and by TEE. The post-procedure mean gradients were 7, 10, 11mm Hg. The final AVA by echo was 1.70, 1.40 and 1.68cm(2). Total aortic regurgitation post-procedure was none or trace in all three patients. Total positioning and assessment of valve performance time was 4, 6, and 12minutes. Contrast was only used to confirm successful percutaneous closure of the femoral access site. The total contrast dose was 5, 8, 12cc. Baseline eGFR and creatinine was 28, 22, 74mL/min/1.73m(2) and 2.35, 2.98, and 1.03mg/dL, respectively. Renal function was unchanged post-procedure: eGFR=25, 35, and 96mL/min/1.73m(2) and creatinine=2.58, 1.99, and 1.03mg/dL, respectively. In conclusion, the DFM THV provides the ability to perform TAVI with minimal or no contrast. The precise and predictable implantation technique can be performed with fluoro and echo guidance.
  
  Copyright © 2014 Elsevier Inc. All rights reserved.
  
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• Transcatheter treatment of chronic mitral regurgitation with the MitraClip system: an Italian consensus statement.
  J Cardiovasc Med (Hagerstown)

  2014 Mar;15(3):173-88. doi: 10.2459/JCM.0000000000000004.
  
  Maisano Francesco, Alamanni Francesco, Alfieri Ottavio, Bartorelli Antonio, Bedogni Francesco, Bovenzi Francesco M, Bruschi Giuseppe, Colombo Antonio, Cremonesi Alberto, Denti Paolo, Ettori Federica, Klugmann Silvio, La Canna Giovanni, Martinelli Luigi, Menicanti Lorenzo, Metra Marco, Oliva Fabrizio, Padeletti Luigi, Parolari Alessandro, Santini Francesco, Senni Michele, Tamburino Corrado, Ussia Gian P, Romeo Francesco
  
  Abstract
  
  New percutaneous technologies are rapidly emerging for the treatment of structural heart disease including mitral valve disease. Preliminary data suggest a potential clinical benefit of percutaneous treatment of mitral regurgitation by the MitraClip procedure in selected patients. Until final data are available from randomized, controlled, multicenter clinical trials, there is an urgent need for a consensus among all the operators involved in the treatment of patients with mitral regurgitation, including clinical cardiologists, heart failure specialists, surgeons, interventional cardiologists, and imaging experts. In the absence of evidence-based guidelines, the heart-team approach is the most reliable method of making proper decisions. This study is the result of multidisciplinary consensus activity, and has the aim of helping physicians in the difficult task of making decisions for the treatment of patients with mitral regurgitation. It is the result of a joint effort of the major Italian Cardiology and Cardiac Surgery Societies, working together to find a proper balance between the points of view of the clinical cardiologist, the interventional cardiologist, and the cardiac surgeon.
  
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• Failed valve-in-valve transcatheter mitral valve implantation.
  Eur J Cardiothorac Surg

  2014 Apr;45(4):e127. doi: 10.1093/ejcts/ezt633.
  
  Bruschi Giuseppe, Botta Luca, Fratto Pasquale, Martinelli Luigi
  
  
  
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• Direct aortic transcatheter valve implantation via mini-thoracotomy using the Medtronic CoreValve.
  Multimed Man Cardiothorac Surg

  2013 ;2013():mmt015. doi: 10.1093/mmcts/mmt015.
  
  Bruschi Giuseppe, Botta Luca, De Marco Federico, Colombo Paola, Nonini Sandra, Klugmann Silvio, Martinelli Luigi
  
  Abstract
  
  Transcatheter aortic valve implantation using the Medtronic CoreValve is a well-established procedure. Although previously carried out only through the common femoral artery, today it is possible to perform the procedure through different arterial alternative access sites. A direct aortic approach through the ascending aorta could be carried out via a right anterior mini-thoracotomy in the second intercostal space. The pericardium is opened to expose the aorta. Two purse-string sutures are then placed on the ascending aorta and a standard retrograde CoreValve implantation is performed with the standard delivery system. Advantages, contraindications, surgical technique and results are discussed.
  
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• Redo mitral valve replacement through a right mini-thoracotomy with an unclamped aorta.
  Multimed Man Cardiothorac Surg

  2014 Aug;2014():. doi: mmu013.
  
  Botta Luca, Fratto Pasquale, Cannata Aldo, Bruschi Giuseppe, Merlanti Bruno, Brignani Christian, Bosi Mauro, Martinelli Luigi
  
  Abstract
  
  Redo cardiac surgery represents a clinical challenge due to a higher rate of perioperative morbidity and mortality. Mitral valve (MV) re operations can particularly be demanding in patients with patent coronary grafts, previous aortic valve replacement, calcified aorta or complications following a previous operation (abscesses, leaks or thrombosis). In this article we describe our technique to manage complex mitral reoperations using a minimally invasive approach, moderate hypothermia and avoiding aortic cross-clamping. Minimally invasive procedures with an unclamped aorta have the potential to combine the benefits of less invasive access and continuous myocardial perfusion. The advantage of a right mini-thoracotomy is the avoidance of sternal re-entry and limited dissection of adhesions, reducing the risk of cardiac structures or patent graft injury. Moderate hypothermia and continuous blood perfusion can guarantee adequate myocardial protection particularly in the case of patent grafts, decreasing the dangers of an incomplete or imperfect aortic clamping at mild hypothermia and potential lesions due to demanding clamp placing. Complex MV reoperations can be safely and effectively performed through a smaller right thoracotomy in the fourth intercostal space with an unclamped aorta.
  
  © The Author 2014. Published by Oxford University Press on behalf of the European Association for Cardio-Thoracic Surgery. All rights reserved.
  
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• Transcatheter aortic valve implantation in patients with severe aortic valve stenosis and large aortic annulus, using the self-expanding 31-mm Medtronic CoreValve prosthesis: first clinical experience.
  J Thorac Cardiovasc Surg

  2014 Aug;148(2):492-9.e1. doi: 10.1016/j.jtcvs.2013.09.059.
  
  Nijhoff Freek, Agostoni Pierfrancesco, Amrane Hafid, Latib Azeem, Testa Luca, Oreglia Jacopo A, De Marco Federico, Samim Mariam, Bedogni Francesco, Maisano Francesco, Bruschi Giuseppe, Colombo Antonio, Van Boven Ad J, Stella Pieter R
  
  Abstract
  
  OBJECTIVES:
  With the introduction of the 31-mm Medtronic CoreValve prosthesis, patients with large aortic annulus have become eligible for transcatheter aortic valve implantation. The aim of this study was to evaluate the feasibility, efficacy, and safety of transcatheter aortic valve implantation using the 31-mm Medtronic CoreValve in patients with severe aortic valve stenosis and large aortic annulus.
  
  METHODS:
  Five institutions in the Netherlands and Italy participated in a retrospective multicenter registry. Clinical, procedural, and imaging data of patients treated with the 31-mm Medtronic CoreValve were retrospectively collected in accordance with the Valve Academic Research Consortium-2 criteria.
  
  RESULTS:
  Between August 2011 and November 2012, 47 patients (44 men, mean age 77.6 ± 8.9 years) received the 31-mm Medtronic CoreValve prosthesis for severe aortic stenosis. Device success (correct positioning of a single valve with intended performance and no all-cause 30-day mortality) was achieved in 31 patients (66.0%). Reasons for failing the device success criteria were significant prosthetic aortic regurgitation in 3 patients (6.4%), second valve implantation in 10 patients (21.2%) (8 cases of malpositioning with high-grade aortic regurgitation, 1 acute valve dislocation, and 1 delayed valve dislocation), 1 of whom died intrahospital, and in-hospital mortality in a further 3 patients (6.4%). Peak and mean transaortic gradients decreased significantly (P 
  CONCLUSIONS:
  In this retrospective multicenter registry, transcatheter treatment of severe aortic valve stenosis with the 31-mm Medtronic CoreValve seemed to be challenging, even in experienced hands. If the prosthesis is properly implanted, it offers adequate valve hemodynamics and proper functioning.
  
  Copyright © 2014 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.
  
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• Minimally invasive approach for redo mitral valve surgery.
  J Thorac Dis

  2013 Nov;5 Suppl 6(Suppl 6):S686-93. doi: 10.3978/j.issn.2072-1439.2013.10.12.
  
  Botta Luca, Cannata Aldo, Bruschi Giuseppe, Fratto Pasquale, Taglieri Corrado, Russo Claudio Francesco, Martinelli Luigi
  
  Abstract
  
  Redo cardiac surgery represents a clinical challenge due to a higher rate of peri-operative morbidity and mortality. Mitral valve re-operations can be particularly demanding in patients with patent coronary artery bypass grafts, previous aortic valve replacement, calcified aorta or complications following a previous operation (abscesses, perivalvular leaks, or thrombosis). Risk of graft injuries, hemorrhage, the presence of dense adhesions and complex valve exposure can make redo valve operations challenging through a median sternotomy. In this review article we provide an overview of minimally invasive approaches for redo mitral valve surgery discussing indications, techniques, outcomes, concerns and controversies. Scientific literature about minimally invasive approach for redo mitral surgery was reviewed with a MEDLINE search strategy combining "mitral valve" with the following terms: 'minimally invasive', 'reoperation', and 'alternative approach'. The search was limited to the last ten years. A total of 168 papers were found using the reported search. From these, ten papers were identified to provide the best evidence on the subject. Mitral valve reoperations can be safely and effectively performed through a smaller right thoracotomy in the fourth intercostal space termed "mini" thoracotomy or "port access". The greatest potential benefit of a right mini-thoracotomy is the avoidance of sternal re-entry and limited dissection of adhesions, avoiding the risk of injury to cardiac structures or patent grafts. Good percentages of valve repair can be achieved. Mortality is low as well as major complications. Minimally invasive procedures with an unclamped aorta have the potential to combine the benefits of minimally invasive access and continuous myocardial perfusion. Less invasive trans-catheter techniques could be considered as the natural future evolution for management of structural heart disease and mitral reoperations. The safety and efficacy of these procedures has never been compared to open reoperations in a randomized trial, although published case series and comparisons to historical cohorts suggest that they are an effective and feasible alternative. Ongoing follow-up on current series will further define these procedures and provide valuable clinical outcome data.
  
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• Prospective multicenter evaluation of the direct flow medical transcatheter aortic valve.
  J Am Coll Cardiol

  2014 Mar;63(8):763-8. doi: 10.1016/j.jacc.2013.10.013.
  
  Schofer Joachim, Colombo Antonio, Klugmann Silvio, Fajadet Jean, DeMarco Federico, Tchétché Didier, Maisano Francesco, Bruschi Giuseppe, Latib Azeem, Bijuklic Klaudija, Weissman Neil, Low Reginald, Thomas Martyn, Young Christopher, Redwood Simon, Mullen Michael, Yap John, Grube Eberhard, Nickenig Georg, Sinning Jan-Malte, Hauptmann Karl Eugen, Friedrich Ivar, Lauterbach Michael, Schmoeckel Michael, Davidson Charles, Lefevre Thierry
  
  Abstract
  
  OBJECTIVES:
  The study sought a prospective multicenter nonrandomized evaluation of the Direct Flow Medical (DFM) system for the treatment of severe aortic stenosis.
  
  BACKGROUND:
  The DFM transcatheter aortic valve system is a nonmetallic design with a pressurized support structure that allows precise positioning, retrieval, and assessment of valve performance prior to permanent implantation.
  
  METHODS:
  One hundred high surgical risk patients with severe aortic stenosis were evaluated for the primary endpoint. There were 75 patients in the group evaluable for the secondary endpoints and 25 in the pre-specified roll-in training phase. Echocardiographic and angiographic data were evaluated by an independent core laboratory and adverse events adjudicated by clinical event committee and classified according to Valve Academic Research Consortium (VARC) criteria.
  
  RESULTS:
  There was 99% freedom from all cause mortality at 30 days (primary endpoint). VARC criteria defined 30 day combined freedom from patient safety event rate was 91% and overall device success was 93%. The post-implantation echocardiography results demonstrated mild or no aortic regurgitation in 99% (73 of 74) with a mean gradient of 12.6 ± 7.1 mm Hg (n = 72) and effective orifice area of 1.50 ± 0.56 cm(2) and New York Heart Association functional class was I or II in 92% of cases.
  
  CONCLUSIONS:
  The present study demonstrates the safety and efficacy of the DFM system in surgical high risk patients with severe aortic stenosis and complex anatomy aortic regurgitation was less than moderate in 99% of patients.
  
  Copyright © 2014 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
  
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• Transaortic access is the key to success.
  EuroIntervention

  2013 Sep;9 Suppl():S25-32. doi: 10.4244/EIJV9SSA6.
  
  Bapat Vinayak N, Bruschi Giuseppe
  
  Abstract
  
  Transcatheter aortic valve implantation (TAVI) using either the Edwards SAPIEN Valve or Medtronic CoreValve is a well-established procedure. Although initially carried out through transfemoral and transapcial approaches, alternative approaches have become popular and have been utilised to optimise the outcomes. The transaortic (TAo) approach can be used for both these devices and is carried out through the ascending aorta, which can be approached through a partial upper J-sternotomy, T-sternotomy or a right anterior thoracotomy. Due to its familiarity, this procedure is within the comfort zone of surgeons which reduces the learning curve as well as access site-related complications. There are also other potential advantages to the TAo approach, which make it versatile and less invasive. These advantages, indications, contraindications, surgical technique and results will be discussed in this paper. The ongoing ROUTE registry (SAPIEN multicentre European TAo registry), prospective CoreValve multicentre European registry and data from a pivotal trial for CoreValve in the United States will certainly provide robust data in confirming the various advantages seen in centres utilising this approach. Dedicated TAo delivery systems, which could also be used for the subclavian approach, are on the horizon for the newer devices which are currently implanted through other approaches.
  
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• [Treatment of advanced heart failure in women: heart transplantation and ventricular assist devices].
  G Ital Cardiol (Rome)

  2012 May;13(5 Suppl 1):35S-41S.
  
  Cipriani Manlio, Macera Francesca, Verde Alessandro, Bruschi Giuseppe, del Medico Marta, Oliva Fabrizio, Martinelli Luigi, Frigerio Maria
  
  Abstract
  
  Women candidates for heart transplantation are definitely less than men, just 20% of all patients transplanted; even in the INTERMACS registry they represent only 21% of all ventricular assist devices (VAD) implanted. The reasons for this big difference are discussed in this article. Why women are less frequently assessed for unconventional therapies? Are they sicker or just less regarded? Our experience and the literature show us clear epidemiological, clinical and treatment differences that could lead to a lower prevalence of end-stage disease in women of an age suitable for unconventional therapies. Once on the transplant list, women wait less than men for a heart transplant, because they present with more severe disease, have a lower body mass index and undergo less VAD implants. After transplantation women's survival is comparable to men's, although they usually complain of a lower quality of life. Females receive less often a VAD than men. The main reasons for this include presentation with advanced heart failure at an older age than men, worse outcomes related to small body surface area, and lower survival rates on VAD when implanted as bridge to heart transplantation.
  
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• Direct-aortic "evolute" self-expanding aortic bioprosthesis implantation.
  Int J Cardiol

  2013 Sep;167(6):e172-4. doi: 10.1016/j.ijcard.2013.04.155.
  
  Bruschi Giuseppe, De Marco Federico, Barosi Alberto, Botta Luca, Colombo Paola, Montorsi Emanuela, Klugmann Silvio, Martinelli Luigi
  
  
  
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• Postsurgical intrapericardial adhesions: mechanisms of formation and prevention.
  Ann Thorac Surg

  2013 May;95(5):1818-26. doi: 10.1016/j.athoracsur.2012.11.020.
  
  Cannata Aldo, Petrella Duccio, Russo Claudio Francesco, Bruschi Giuseppe, Fratto Pasquale, Gambacorta Marcello, Martinelli Luigi
  
  Abstract
  
  Postsurgical intrapericardial adhesions are still considered an unavoidable consequence of cardiothoracic operations. They increase the technical difficulty and the risk of reoperations. The pathogenesis of postsurgical adhesions is a multistep process, and the main key players are (1) loss of mesothelial cells, (2) accumulation of fibrin in areas devoid of mesothelial cells, (3) loss of normal pericardial fibrinolysis, and (4) local inflammation. Today, very promising methods to reduce adhesions are available for clinical use. This report reviews the process of formation of adhesions and the methods to prevent them, classified according to the mechanism of action.
  
  Copyright © 2013 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
  
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• Self-expandable transcatheter aortic valve implantation for aortic stenosis after mitral valve surgery.
  Interact Cardiovasc Thorac Surg

  2013 Jul;17(1):90-5. doi: 10.1093/icvts/ivt086.
  
  Bruschi Giuseppe, De Marco Federico, Barosi Alberto, Colombo Paola, Botta Luca, Nonini Sandra, Martinelli Luigi, Klugmann Silvio
  
  Abstract
  
  OBJECTIVES:
  Transcatheter aortic valve implantation has emerged as a valuable option to treat patients with symptomatic severe aortic stenosis, who are not being considered for surgery because of significant comorbidities. Concerns exist over treating patients who have previously undergone mitral valve surgery for possible interference between the percutaneous aortic valve and the mitral prosthesis or ring.
  
  METHODS:
  At our centre, from May 2008 to December 2012, 172 patients (76 male) with severe symptomatic aortic stenosis were eligible for transcatheter aortic valve implant. Nine patients, affected by severe aortic stenosis, had previously undergone mitral valve surgery (4 mono-leaflet, 3 bileaflet, 1 bioprosthesis, 1 mitral ring); they were considered high-risk surgical candidates following joint evaluation by cardiac surgeons and cardiologist and had undergone TAVI.
  
  RESULTS:
  Seven patients underwent standard femoral retrograde CoreValve(®) (Medtronic Inc., Minneapolis, USA) implantation, two patients underwent a direct aortic implantation through a mini-thoracotomy. All patients experienced immediate improvement of their haemodynamic status. No deformation of the nitinol tubing of the CoreValve, nor distortion or malfunction of the mechanical valve or mitral ring, occurred as assessed by echographical and fluoroscopic evaluation. No major postoperative complications occurred. In all patients , echocardiography indicated normal valve function during follow-up.
  
  CONCLUSIONS:
  Our experience confirms the feasibility of CoreValve implantation in patients with mechanical mitral valves or mitral annuloplasty ring.
  
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• Reply: To PMID 22633495.
  Ann Thorac Surg

  2013 Mar;95(3):1137-8. doi: 10.1016/j.athoracsur.2012.10.021.
  
  Bruschi Giuseppe, De Marco Federico
  
  
  
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• Giant true aneurysm of the right coronary artery button long after aortic root replacement.
  Eur J Cardiothorac Surg

  2013 May;43(5):e139-40. doi: 10.1093/ejcts/ezt057.
  
  Bruschi Giuseppe, Cannata Aldo, Botta Luca, Martinelli Luigi
  
  
  
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• Histological findings following use of CoSeal in a patient with a left ventricular assist device.
  Surg Innov

  2013 Dec;20(6):NP35-7. doi: 10.1177/1553350612443899.
  
  Cannata Aldo, Petrella Duccio, Gambacorta Marcello, Russo Claudio F, Bruschi Giuseppe, Martinelli Luigi
  
  Abstract
  
  Adhesions are a formidable challenge in patients undergoing reoperative cardiac surgery, particularly in those supported by an intracorporeal left ventricular assist device (LVAD) and undergoing heart transplantation. This report describes the pathological findings following the clinical use of a surgical sealant (CoSeal, Baxter Healthcare, Fremont, CA), in a patient who underwent LVAD implantation. On the treated surfaces, a minimal amount of adhesions were observed, whereas in untreated surfaces adhesions were present.
  
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• Time from adenosine di-phosphate receptor antagonist discontinuation to coronary bypass surgery in patients with acute coronary syndrome: meta-analysis and meta-regression.
  Int J Cardiol

  2013 Oct;168(3):1955-64. doi: 10.1016/j.ijcard.2012.12.087.
  
  Morici Nuccia, Moja Lorenzo, Rosato Valentina, Oreglia Jacopo Andrea, Sacco Alice, De Marco Federico, Bruschi Giuseppe, Klugmann Silvio, La Vecchia Carlo, Savonitto Stefano
  
  Abstract
  
  BACKGROUND:
  Adenosine di-phosphate receptor antagonists (ADPRAs) blunt hemostasis for several days after administration. This effect, aimed at preventing cardiac ischemic complications particularly in patients with acute coronary syndromes (ACS), may increase perioperative bleeding in the case of cardiac surgery. Practice Guidelines recommend withholding ADPRAs for at least 5days prior to surgery, though with a weak base of evidence. The purpose of this study was to systematically review observational and experimental studies of early or late preoperative discontinuation of ADPRAs prior to coronary artery bypass grafting (CABG) for patients with ACS.
  
  METHODS:
  MEDLINE, EMBASE, the Cochrane Library databases up to December 2011; and reference lists. Observational and experimental studies that compared early ADPRA discontinuation with late discontinuation, or no discontinuation, in patients with ACS undergoing CABG.
  
  RESULTS:
  There were 19 studies, including 14,046 participants, 395 deaths and 309 reoperations due to bleeding. ADPRA late discontinuation up to CABG was associated with an increased risk of postoperative mortality (OR 1.46, 95% confidence interval (CI) 1.10 to 1.93) and reoperations due to bleeding (OR 2.18; 95% CI 1.47 to 2.62). Between-study heterogeneity was low. Meta-analysis limited to high quality or prospective studies gave consistent results. In most instances, the 95% prediction intervals for summary risk estimates confirmed the risk across study groups.
  
  CONCLUSIONS:
  ADPRA late discontinuation prior to CABG is associated with an increased risk of death and reoperations due to bleeding in patients with ACS. The confidence in the estimates of risk for late discontinuation is moderate to high.
  
  Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.
  
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• Heart transplantation: 25 years' single-centre experience.
  J Cardiovasc Med (Hagerstown)

  2013 Sep;14(9):637-47. doi: 10.2459/JCM.0b013e32835dbd74.
  
  Bruschi Giuseppe, Colombo Tiziano, Oliva Fabrizio, Botta Luca, Morici Nuccia, Cannata Aldo, Vittori Claudia, Turazza Fabio, Garascia Andrea, Pedrazzini Giovanna, Frigerio Maria, Martinelli Luigi
  
  Abstract
  
  OBJECTIVES:
  Heart transplantation (HTx) is still one of the most effective therapies for end-stage heart disease for patients with no other medical or surgical therapy. We report the results of our 25-year orthotropic HTx single-centre experience.
  
  METHODS:
  From November 1985, 905 orthotopic heart transplants have been performed at our centre. We exclude from the present analysis 13 patients who underwent re-transplantation and 14 pediatric cases (age at HTx
  RESULTS:
  The present study collected the data of 878 primary adult orthotopic HTx performed at our centre. Mean age at HTx was of 49.6?±?11.6 years. Mean donor age was 36.9?±?14.8 years. Hospital mortality was 11.6% (102 patients), early graft failure was the principal cause of death (58 patients) followed by infections (18 cases) and acute rejection (7 patients). Overall actuarial survival was 78.1% at 5 years and 63.8% and 47.5%, respectively, at 10 and 15 years from HTx. Mean survival was 10.74 years; 257 late deaths were reported (33.1%); main causes were neoplasm in 83 patients, and cardiac causes included coronary allograft vasculopathy in 78 patients. Freedom from any infection at 5, 10 and 15 years was 52.2, 44.1 and 40.1%, respectively. Freedom from rejection at 5 years was 36.2%, with 493 patients experiencing at last one episode of rejection, the majority occurring during the first 2 months after transplantation. The long-term survival of HTx recipients is limited in large part by the development of coronary artery vasculopathy and malignancies. In our experience freedom from coronary allograft vasculopathy at 10 years was 66.9%, and 85 patients underwent percutaneous coronary revascularization. In our study population, 44 patients experienced posttransplant lymphoproliferative disorder and 91 patients experienced a solid neoplasm, mean survival free from neoplasm was 12.23 years.
  
  CONCLUSION:
  Over the past four decades the field of HTx has evolved considerably, with improvements in surgical techniques and postoperative patients' care. A careful patient selection and treatment of candidates for transplantation as well as accurate clinical follow-up combined with real multidisciplinary teamwork that involved different heart failure specialists, allowed us to obtain our excellent long-term results.
  
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• CoreValve® transcatheter self-expandable aortic bioprosthesis.
  Expert Rev Med Devices

  2013 Jan;10(1):15-26. doi: 10.1586/erd.12.64.
  
  Bruschi Giuseppe, De Marco Federico, Martinelli Luigi, Klugmann Silvio
  
  Abstract
  
  Transcatheter aortic valve implantation has been designed to treat patients affected by severe symptomatic aortic stenosis considered extremely high risk for surgical aortic valve replacement. The CoreValve® (Medtronic Inc., MN, USA) is a multilevel self-expanding and fully radiopaque nitinol frame with a diamond cell configuration that holds a trileaflet porcine pericardial tissue valve and anchors the device in the native anatomy. CoreValve was the first percutaneous valve to be granted the CE mark for transfemoral implantation in May 2007 and the CoreValve US Pivotal Trial is actively underway. The CoreValve is available in four sizes (23, 26, 29 and 31?mm) to serve a broad range of patients' annulus from 18 to 29?mm. All the valves fit into an 18-Fr size catheter. Currently, more than 35,000 patients have been treated in more than 60 countries worldwide from the femoral artery, the axillary artery and, more recently, from a direct aortic approach, with excellent results up to 4-year follow-up.
  
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• Early giant pseudo-aneurysm originating from the right coronary ostium.
  Eur J Cardiothorac Surg

  2013 Apr;43(4):e102-3. doi: 10.1093/ejcts/ezs649.
  
  Botta Luca, Pelenghi Stefano, Bruschi Giuseppe, Martinelli Luigi
  
  
  
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• Transcatheter aortic valve implantation in patients with mitral prosthesis.
  J Am Coll Cardiol

  2012 Oct;60(18):1841-2. doi: 10.1016/j.jacc.2012.07.037.
  
  Barbanti Marco, Ussia Gian Paolo, Latib Azeem, De Marco Federico, Fiorina Claudia, Santoro Gennaro, Bedogni Francesco, Colombo Antonio, Bruschi Giuseppe, Ettori Federica, Agostini Cecilia, Brambilla Nedy, Petronio Anna Sonia, Tarantini Giuseppe, Napodano Massimo, De Carlo Marco, Confessore Pierpaolo, Tamburino Corrado
  
  
  
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• Direct aortic access for transcatheter self-expanding aortic bioprosthetic valves implantation.
  Ann Thorac Surg

  2012 Aug;94(2):497-503. doi: 10.1016/j.athoracsur.2012.04.021.
  
  Bruschi Giuseppe, de Marco Federico, Botta Luca, Cannata Aldo, Oreglia Jacopo, Colombo Paola, Barosi Alberto, Colombo Tiziano, Nonini Sandra, Paino Roberto, Klugmann Silvio, Martinelli Luigi
  
  Abstract
  
  BACKGROUND:
  Transcatheter aortic valve implantation (TAVI) has been designed to treat elderly patients with severe aortic stenosis at high risk for operation; however, these patients are also often affected by severe iliac-femoral arteriopathy that prohibits the transfemoral approach.
  
  METHODS:
  From May 2008 to January 2012, 400 patients were evaluated for TAVI at our center; of these, 141 patients (64 men; mean age 81.3±8 years) with severe symptomatic aortic stenosis and no reasonable surgical option due to excessive risk were eligible for CoreValve (137 patients; Medtronic Inc, MN) or Sapien (Edwards Lifesciences, CA) implantation. Twenty-five patients (all affected by severe peripheral vasculopathy, including five re-do procedures), with a mean The Society of Thoracic Surgeons mortality score 11%±6%, underwent CoreValve implantation directly from the ascending aorta through a right anterior minithoracotomy. This case series was reviewed to evaluate the clinical outcomes of these patients. A combined team of cardiologists, cardiac surgeons with expertise in hybrid procedures, and anesthetists performed all the procedures.
  
  RESULTS:
  In all patients after valve deployment, the mean aortic gradient immediately dropped to 5 mm Hg or less, and the angiographic grade aortic insufficiency was 1 or less in 22 patients. One patient was converted to the transfemoral approach due to an extremely fragile aortic wall, but the patient died of abdominal aorta aneurysm rupture on postoperative day 1. Procedural success was obtained in the remaining 24 patients. A left ventricle tear in 1 patient was successfully surgically treated. Four patients required a permanent pacemaker implantation. Thirty-day mortality was 8% (2 patients). All discharged patients improved their New York Heart Association functional class and functional capacity, and echocardiograms demonstrated good valve performance up to 2 years (mean valve gradient, 9 mm Hg). During follow-up, 1 patient died of cachexia and another of bone marrow aplasia.
  
  CONCLUSIONS:
  TAVI with the direct aortic approach is safe and feasible, offering a new attractive option to treat selected high-risk patients with severe aortic stenosis and peripheral vasculopathy, including those requiring a re-do procedure, and has emerged as a valuable alternative route to transapical access.
  
  Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
  
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• Direct transatrial transcatheter SAPIEN valve implantation through right minithoracotomy in a degenerated mitral bioprosthetic valve.
  Ann Thorac Surg

  2012 May;93(5):1708-10. doi: 10.1016/j.athoracsur.2011.08.084.
  
  Bruschi Giuseppe, Barosi Alberto, Colombo Paola, Botta Luca, Oreglia Jacopo, De Marco Federico, Paino Roberto, Klugmann Silvio, Martinelli Luigi
  
  Abstract
  
  Transcatheter valve implantation into failing surgical mitral bioprosthetic valves have been reported. This strategy avoids performing high-risk repeat cardiac surgery in elderly patients with multiple comorbidities. All these patients have been treated by a transapical approach. We report a case of failing bioprosthetic mitral valve in an 82-year-old woman successfully treated with a 29-mm Edwards SAPIEN balloon expandable bioprosthesis (Edwards Lifesciences, Irvine, CA) with direct left atrial approach through a right anterior thoracotomy. Our experience demonstrates the technical feasibility and safety of this approach. Therefore, mitral valve-in-surgical valve implantation may be a viable treatment alternative in carefully selected patients.
  
  Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
  
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• Percutaneous iatrogenic coronary fistula closure in heart transplant recipient.
  Asian Cardiovasc Thorac Ann

  2012 Apr;20(2):188-90. doi: 10.1177/0218492311421456.
  
  Bruschi Giuseppe, Oreglia Jacopo, Colombo Paola, De Marco Federico, Frigerio Maria, Martinelli Luigi, Klugmann Silvio
  
  Abstract
  
  A 61-year-old man with ischemic cardiomyopathy underwent orthotopic heart transplantation. On routine coronary angiography 1 year later, a huge fistula was seen between the left anterior descending coronary artery and the right ventricle. When the patient developed symptoms of ischemia 8 years later, the fistula was successfully closed percutaneously, using a covered stent.
  
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• Direct transaortic CoreValve implantation through right minithoracotomy in patients with patent coronary grafts.
  Ann Thorac Surg

  2012 Apr;93(4):1297-9. doi: 10.1016/j.athoracsur.2011.08.020.
  
  Bruschi Giuseppe, De Marco Federico, Botta Luca, Oreglia Jacopo, Colombo Paola, Paino Roberto, Klugmann Silvio, Martinelli Luigi
  
  Abstract
  
  Transcatheter aortic valve implantation has rapidly gained credibility as a valuable alternative to conventional aortic valve replacement in patients with severe aortic stenosis, who are otherwise left untreated owing to the perceived high risk of operative mortality. However, these patients are often also affected by severe iliofemoral arteriopathy, rendering the transfemoral approach unfeasible. Different alternative access routes have been used in these patients, such the transapical and the subclavian routes. We report our experience of direct aortic access through a right anterior minithoractomy to implant a self-expanding aortic valve bioprosthesis in two patients who had previously undergone coronary artery bypass graft surgery.
  
  Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
  
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• Does the cardioplegic solution have an effect on early outcomes following heart transplantation?
  Eur J Cardiothorac Surg

  2012 Apr;41(4):e48-52; discussion e52-3. doi: 10.1093/ejcts/ezr321.
  
  Cannata Aldo, Botta Luca, Colombo Tiziano, Russo Claudio F, Taglieri Corrado, Bruschi Giuseppe, Merlanti Bruno, Frigerio Maria, Martinelli Luigi
  
  Abstract
  
  OBJECTIVE:
  The choice of cardioplegic solution for myocardial preservation in heart transplantation (HT) remains debated. We analysed our experience with three different cardioplegic solutions in adult HT performed during past 5 years, in terms of non-immunological intraoperative biventricular graft failure (BVF) and in-hospital mortality.
  
  METHODS:
  A total of 133 patients underwent HT at our hospital from January 2006 to December 2010. Patients were divided into three groups, according to the solution adopted in the donor: HTK-Custodiol (n = 61), Celsior (n = 38) and St Thomas (n = 34). For each patient, solution was chosen according to surgeon's preference.
  
  RESULTS:
  Recipient and donor mean age was 48.2 ± 12.7 and 43.8 ± 13.6 years, respectively. Twenty-four patients (18.0%) were in Status 1 at the transplant. The mean ischaemic time was 187.9 ± 52.6 min. Intraoperative BVF was observed in 18 cases (13.5%). Patients with BVF, and their respective donors, were older than the other patients (patients: 53.3 vs 47.4 years, P = 0.06; donors: 49.4 vs 42.9 years, P 0.06), and experienced significantly higher in-hospital mortality (47.3 vs 7.8%, P = 0.0001). The combination of patients aged 60 years or older with donors aged 60 years or older carried a mortality of 66.6% (6 out of 9). The three groups of patients did not differ significantly in terms of preoperative and intraoperative features and outcomes, including biventricular graft failure and death. At multivariate analysis, predictors of in-hospital death were a combination of both a recipient and a donor aged ? 60 years (OR 27.9), intraoperative BVF (OR 14.8) and previous cardiac surgery (OR 13.0). Cardioplegic solution did not predict mortality.
  
  CONCLUSIONS:
  We did not observe a significant effect of the kind of cardioplegic solution on the early HT outcomes. The combination between both a recipient and a donor aged ? 60 years, reoperation and BVF are strong predictors of in-hospital death.
  
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• Twenty-five year outcomes of tricuspid valve replacement comparing mechanical and biologic prostheses.
  Ann Thorac Surg

  2012 Apr;93(4):1146-53. doi: 10.1016/j.athoracsur.2011.12.031.
  
  Garatti Andrea, Nano Giovanni, Bruschi Giuseppe, Canziani Alberto, Colombo Tiziano, Frigiola Alessandro, Martinelli Luigi, Menicanti Lorenzo
  
  Abstract
  
  BACKGROUND:
  Tricuspid valve replacement (TVR) has historically been associated with high mortality and morbidity, and current knowledge of long-term results of TVR is limited. This study reviewed our experience from a consecutive series at 2 institutions.
  
  METHODS:
  Ninety patients (65 women [72%]; mean age, 53.8 ± 14.2 years; mean body surface area, 1.6 ± 0.2 m(2)) underwent TVR between January 1980 and December 2005. The etiology was secondary to left-heart valve disease in 56 patients (62%), degenerative disease in 16 (18%), Ebstein anomaly in 7 (8%), and endocarditis in 11 (12%). Seventy patients (78%) were in New York Heart Association class III or IV. Sixty patients (67%) underwent redo procedures. TVR was with a mechanical valve in 46 patients (51%) and a biologic prosthesis in 44 (49%).
  
  RESULTS:
  The overall operative mortality was 17.7% (16 patients). During follow-up, 16 of the 74 survivors died. Kaplan-Meier survival at 5, 10, and 15 years was, respectively, 72%, 65%, and 63%. During follow-up, 16 patients (21.6%) underwent reoperation; among them, 8 with a mechanical valve underwent reoperation for tricuspid valve thrombosis and 6 with a biologic prosthesis for tricuspid valve deterioration. However, freedom from reoperation at 5 and 10 years was similar between mechanical (86% and 76%) and bioprostheses (97% and 83%). All 16 patients survived the reoperation.
  
  CONCLUSIONS:
  The present experience suggests that the type of implanted prosthesis in the tricuspid position does not affect early and long-term outcomes or the reoperation rate. Timely referral before end-stage cardiac impairment develops could determine further outcomes improvement.
  
  Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
  
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• How to remove the CoreValve aortic bioprosthesis in a case of surgical aortic valve replacement.
  Ann Thorac Surg

  2012 Jan;93(1):329-30. doi: 10.1016/j.athoracsur.2011.07.059.
  
  Bruschi Giuseppe, Oreglia Jacopo, De Marco Federico, Colombo Paola, Mondino Michele, Paino Roberto, Klugmann Silvio, Martinelli Luigi
  
  Abstract
  
  Transcatheter aortic valve implantation has been introduced as a treatment modality applied to high-risk surgery patients with severe symptomatic aortic stenosis, and it has been demonstrated to be an efficient and safe treatment option. Litzler and colleagues reported a case of a bailout of a transcatheter aortic valve implantation because of severe paravalvular leaks, using a 23-mm Edwards-SAPIEN Valve (Edwards Lifesciences, Irvine, CA), with conversion to conventional surgical aortic valve replacement. The authors reported an easy valve removal despite the impaction of the stent in the cusps of the native valve. Thyregod and colleagues reported a surgical valve replacement in a patient with a dysfunctional CoreValve self-expanding aortic valve bioprosthesis 4 months after implantation.
  
  Copyright © 2012 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
  
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• The role of the minimally invasive beating heart technique in reoperative valve surgery.
  J Card Surg

  2012 Jan;27(1):24-8. doi: 10.1111/j.1540-8191.2011.01358.x.
  
  Botta Luca, Cannata Aldo, Fratto Pasquale, Bruschi Giuseppe, Trunfio Salvatore, Maneggia Carla, Martinelli Luigi
  
  Abstract
  
  OBJECTIVE:
  We reviewed our experience to assess potential advantages of minimally invasive surgery without aortic clamping over conventional median sternotomy and cardioplegic arrest during reoperative valve surgery.
  
  METHODS:
  From August 2008 to August 2010, 22 reoperative valve procedures were performed through a minimally invasive approach without aortic cross-clamping [no-clamp group (NCG)]. Postoperative results were compared to a matched population in terms of sex, age, and type of surgery, and operated through median sternotomy with aortic cross-clamping and cardioplegic arrest [clamp group (CG)].
  
  RESULTS:
  We performed 17 mitral valve replacements (MVRs), one mitral valve repair, one MVR associated to a tricuspid plasty (TVP), and three isolated TVP in both groups. Cardiopulmonary bypass (CPB) time was 166 and 163 minutes in NCG and CG, respectively. Intra-aortic balloon pump was necessary in two (NCG) and three (CG) patients. Two patients died in both groups from multiorgan failure. Biochemical analysis showed no significant differences in perioperative lactate or creatine kinase-MB values.
  
  CONCLUSIONS:
  Redo valve surgery with an unclamped aorta is feasible, effective, and at least as safe as surgery using cardioplegic arrest. There was, however, no difference in biochemical or clinical outcomes from conventional surgery using aortic clamping and cardioplegic techniques.
  
  © 2011 Wiley Periodicals, Inc.
  
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• Transcatheter self-expandable aortic valve implantation after undersized mitral annuloplasty.
  Ann Thorac Surg

  2011 Nov;92(5):1881-3. doi: 10.1016/j.athoracsur.2011.04.045.
  
  Bruschi Giuseppe, De Marco Federico, Oreglia Jacopo, Colombo Paola, Barosi Alberto, Einaudi Arturo, Paino Roberto, Martinelli Luigi, Klugmann Silvio
  
  Abstract
  
  No data are available in the literature regarding the effectiveness and safety of transcatheter aortic valve implantation in patients who underwent previous mitral valve ring repair. Concerns exist related to the possible interference between the percutaneous aortic valve and the mitral annuloplasty ring. We report our experience with percutaneous aortic self-expandable valve implantation in a 76-year-old woman affected by severe aortic stenosis, previously operated on for "undersized" mitral annuloplasty repair of severe functional mitral regurgitation in dilated cardiomyopathy. No deformation of the nitinol tubing of the CoreValve device (CoreValve, Inc, Irvine, CA), neither distortion nor malfunction nor change of the conformation of the mitral ring occurred. No change in mitral function and regurgitation was evident at echocardiography monitoring, which was performed during the implant.
  
  Copyright © 2011 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
  
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• Influence of CoreValve ReValving System implantation on mitral valve function: an echocardiographic study in selected patients.
  Catheter Cardiovasc Interv

  2011 Oct;78(4):638-44. doi: 10.1002/ccd.23045.
  
  De Chiara Benedetta, Moreo Antonella, De Marco Federico, Musca Francesco, Oreglia Jacopo, Lobiati Elisabetta, Bruschi Giuseppe, Belli Oriana, Mauri Francesco, Klugmann Silvio
  
  Abstract
  
  OBJECTIVES:
  The purpose of this study is to verify whether transcatheter aortic valve implantation (TAVI) determined changes in mitral valve (MV) function, in terms of mitral regurgitation (MR) and stenosis.
  
  BACKGROUND:
  Little data is available regarding the effects of TAVI on global MV function, often derived from analysis primarily focused on clinical and aortic related outcomes.
  
  METHODS:
  From May 2008 to March 2010, 73 patients with severe symptomatic aortic stenosis underwent TAVI with the CoreValve ReValving System. The study population consisted of 58 patients (27 males, mean age 82 ± 7 years) who underwent transthoracic echocardiography at least ?1 month after implantation (mean follow-up 7.8 ± 5.4 months).
  
  RESULTS:
  In patients with a left ventricular dysfunction (ejection fraction, EF,
  CONCLUSIONS:
  In the majority of patients no significant changes occurred in the degree of MR in native valve, but we found that if the aortic valve was deeply implanted in the left ventricle outflow tract, a worsening in MR can be observed. A mitral stenosis development must be sought in patients with heavy calcifications of the anterior leaflet.
  
  Copyright © 2011 Wiley-Liss, Inc.
  
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• Orthotopic heart transplantation with donors greater than or equal to 60 years of age: a single-center experience.
  Eur J Cardiothorac Surg

  2011 Jul;40(1):e55-61. doi: 10.1016/j.ejcts.2011.02.013.
  
  Bruschi Giuseppe, Colombo Tiziano, Oliva Fabrizio, Morici Nuccia, Botta Luca, Cannata Aldo, Frigerio Maria, Martinelli Luigi
  
  Abstract
  
  OBJECTIVES:
  Heart transplantation is the best therapeutic option for patients suffering from end-stage heart failure, but donor organ availability still represents a major problem. This had led to a shift toward extended donor criteria. The aim of the present study is to analyze the short- and long-term results of heart transplantation in patients with donor age ? 60 years.
  
  METHODS:
  Since November 1985, 890 patients have been transplanted at our center. We consider, for the present study, only primary adult heart transplantations performed after 1990, totaling 761 patients, mean age at transplantation 49.8 years, and 616 patients being male (81%). We compare the short- and long-term results of patients transplanted with donors younger than 60 years or ? 60 years.
  
  RESULTS:
  Since 1990, at our center, 711 patients have been heart transplanted with a donor younger than 60 years, while 50 patients received a heart from a donor older than 60 years. No differences have been reported in the etiology of cardiomyopathy, previous surgery, or mean ischemic time. Patients transplanted with donors ? 60 years of age were significantly older compared to the younger donors' group. Donor cause of death was a cerebrovascular accident in 82% of donors ? 60 years versus 41% in younger donors. Patients' heart transplanted with donors ? 60 years had a higher incidence of acute graft failure with a hospital mortality of 32% (16 patients) significantly higher compared with 10.2% for the other group. No differences were noticed in the incidence of renal failure, acute rejection treated, coronary allograft vasculopathy, and neoplasm during long-term follow-up.
  
  CONCLUSIONS:
  It was possible to expand the cardiac donor pool by accepting allografts from donors ? 60 years of age in selected cases by performing a coronary angiogram. A meticulous donor evaluation and a careful risk assessment between the risk of death on the waiting list and probable increased hospital mortality are needed.
  
  Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.
  
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• Alternative approaches for trans-catheter self-expanding aortic bioprosthetic valves implantation: single-center experience.
  Eur J Cardiothorac Surg

  2011 Jun;39(6):e151-8. doi: 10.1016/j.ejcts.2011.01.014.
  
  Bruschi Giuseppe, De Marco Federico, Fratto Pasquale, Oreglia Jacopo, Colombo Paola, Botta Luca, Klugmann Silvio, Martinelli Luigi
  
  Abstract
  
  OBJECTIVE:
  Trans-catheter aortic valve implantation has emerged and rapidly gained credibility as a valuable alternative to treat patients with severe aortic stenosis and no surgical option; however, these patients are often affected also by severe iliac-femoral arteriopathy, rendering the transfemoral approach unemployable. From May 2008, 92 patients with severe, symptomatic aortic stenosis and no reasonable surgical option because of excessive risk underwent trans-catheter aortic valve implantation at our center. Eighty patients (34 male) with mean age 82 ± 8 years were eligible for CoreValve percutaneous femoral implantation. Twelve patients, mean age 81 ± 8 years, were excluded from percutaneous femoral CoreValve implantation because of iliac-femoral arteriopathy.
  
  METHODS:
  These 12 patients underwent trans-catheter aortic valve implantation through the left axillary artery in six cases, the other six directly from the ascending aorta through a right anterior mini-thoracotomy. Procedures were performed by a combined team of cardiologists, cardiac surgeons, and anesthetists.
  
  RESULTS:
  Procedural success was obtained in 11 cases; all these patients were discharged in asymptomatic status, with midterm good prosthesis performance. Three patients required the implantation of a permanent pacemaker. One patient needed a subclavian covered stent implantation to treat a post-implant artery dissection. One patient of the direct aortic access group was converted to the femoral approach due to an extremely fragile aortic wall, but died in the intensive care unit of abdominal aortic aneurysm rupture. All discharged patients improved their New York Heart Association (NYHA) functional class and functional capacity, and echocardiograms evidenced good valve performance at 2 years.
  
  CONCLUSIONS:
  Trans-catheter aortic valve implantation with surgical subclavian or direct aortic approach seems safe and feasible, offering a new attractive option to treat selected high-risk patients with severe aortic stenosis and peripheral vasculopathy, and has emerged as a valuable alternative route to trans-apical procedures.
  
  Copyright © 2011 European Association for Cardio-Thoracic Surgery. Published by Elsevier B.V. All rights reserved.
  
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• Transcatheter aortic valve implantation after heart transplantation.
  Ann Thorac Surg

  2010 Nov;90(5):e66-8. doi: 10.1016/j.athoracsur.2010.08.021.
  
  Bruschi Giuseppe, De Marco Federico, Oreglia Jacopo, Colombo Paola, Moreo Antonella, De Chiara Benedetta, Paino Roberto, Frigerio Maria, Martinelli Luigi, Klugmann Silvio
  
  Abstract
  
  Conventional cardiac surgical procedures after orthotopic heart transplantation are generally uncommon. We report the case of a 67-year-old man who had severe symptomatic aortic stenosis develop 9 years after heart transplantation. After joint evaluation of the cardiovascular team, transcatheter aortic valve implantation was preferred due to patient medical conditions. The CoreValve prosthesis (Medtronic, Minneapolis, MN) was inserted percutaneously into the femoral artery. At 4 months postoperatively, the patient is asymptomatic in New York Heart Association functional class II. This case report provides evidence that transcatheter aortic valve implantation is safe and suitable for selected patients with severe aortic stenosis and a history of heart transplantation that must improve allograft function.
  
  Copyright © 2010 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
  
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• Veno-arterial extracorporeal membrane oxygenation using Levitronix centrifugal pump as bridge to decision for refractory cardiogenic shock.
  J Thorac Cardiovasc Surg

  2010 Dec;140(6):1416-21. doi: 10.1016/j.jtcvs.2010.07.083.
  
  Russo Claudio F, Cannata Aldo, Lanfranconi Marco, Bruschi Giuseppe, Milazzo Filippo, Paino Roberto, Martinelli Luigi
  
  Abstract
  
  OBJECTIVES:
  Cardiogenic shock still carries a very high mortality. We adopted veno-arterial extracorporeal membrane oxygenation using the Levitronix centrifugal pump (Levitronix LLC, Waltham, Massachusetts) as a first-line treatment of cardiogenic shock in a "bridge to decision" strategy. This article provides our experience of this clinical approach.
  
  METHODS:
  Since 1988, 160 ventricular assist devices have been implanted at our hospital for heart failure. Since 2005, 15 consecutive patients have been treated with veno-arterial extracorporeal membrane oxygenation for refractory cardiogenic shock. Veno-arterial extracorporeal membrane oxygenation has been implanted either centrally or peripherally.
  
  RESULTS:
  Mean age was 44.7 ± 20.0 years (2-78 years). There were 5 women. Veno-arterial extracorporeal membrane oxygenation was implanted peripherally in 8 cases (53.4%) and centrally in the remaining 7 (46.6%). Mean veno-arterial extracorporeal membrane oxygenation duration was 11.5 ± 8.1 days (range, 1-30). No patient experienced any neurologic event or vascular complication at the cannulation site. Twelve patients (80%) were weaned from veno-arterial extracorporeal membrane oxygenation or bridged to either a long-term left ventricular assist device or heart transplantation. Three patients died during veno-arterial extracorporeal membrane oxygenation support secondary to multi-organ failure. Seven patients (46.6%) were discharged from the hospital, with a 100% survival at follow-up. The survivors include 2 patients affected by fulminant myocarditis, who were bridged to recovery, and 5 patients who were bridged to heart transplantation. Survivors were younger than nonsurvivors (mean age, 28.5 vs 58.8 years, respectively).
  
  CONCLUSIONS:
  In our experience, the use of veno-arterial extracorporeal membrane oxygenation as bridge to decision has been effective to promptly restore adequate systemic perfusion, allowing further time to evaluate myocardial recovery or candidacy for ventricular assist device or heart transplantation. Younger patients, with no or mild end-organ injury, had the best outcomes. Peripheral cannulation decreases the surgical trauma and makes emergency implantation possible, even in the intensive care unit.
  
  Copyright © 2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.
  
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• The trans-subclavian retrograde approach for transcatheter aortic valve replacement: single-center experience.
  J Thorac Cardiovasc Surg

  2010 Oct;140(4):911-5, 915.e1-2. doi: 10.1016/j.jtcvs.2010.01.027.
  
  Bruschi Giuseppe, Fratto Pasquale, De Marco Federico, Oreglia Jacopo, Colombo Paola, Botta Luca, Cannata Aldo, Moreo Antonella, De Chiara Benedetta, Lullo Francesca, Paino Roberto, Martinelli Luigi, Klugmann Silvio
  
  Abstract
  
  OBJECTIVE:
  Aortic valve disease is the most common acquired valvular heart disease in adults. With the increasing elderly population, the proportion of patients with symptomatic aortic stenosis who are unsuitable for conventional surgery is increasing. Transcatheter aortic valve implantation has rapidly gained credibility as a valuable alternative to surgery to treat these patients; however, they often have severe iliac-femoral arteriopathy, which renders the transfemoral approach unusable. We report our experience with the trans-subclavian approach for transcatheter aortic valve implantation using the CoreValve (Medtronic CV Luxembourg S.a.r.l.) in 6 patients.
  
  METHODS:
  In May 2008 to September 2009, 6 patients (mean age of 82 ± 5 years), with symptomatic aortic stenosis and no reasonable surgical option because of excessive risk, were excluded from percutaneous femoral CoreValve implantation because of iliac-femoral arteriopathy. These patients underwent transcatheter aortic valve implantation via the axillary artery. Procedures were performed by a combined team of cardiologists, cardiac surgeons, and anesthetists in the catheterization laboratory. The CoreValve 18F delivery system was introduced via the left subclavian artery in 6 patients, 1 with a patent left internal thoracic to left anterior descending artery graft.
  
  RESULTS:
  Procedural success was obtained in all patients, and the mean aortic gradient decreased 5 mm Hg or less immediately after valve deployment. One patient required implantation of a permanent pacemaker. One patient required a subclavian covered stent implantation to treat a postimplant artery dissection associated with difficult surgical hemostasis. One patient was discharged in good condition but died of pneumonia 40 days after the procedure. All patients were asymptomatic on discharge, with good mid-term prosthesis performance.
  
  CONCLUSIONS:
  Transcatheter aortic valve implantation via a surgical subclavian approach seems safe and feasible, offering a new option to treat select, inoperable, and high-risk patients with severe aortic stenosis and peripheral vasculopathy.
  
  Copyright © 2010 The American Association for Thoracic Surgery. Published by Mosby, Inc. All rights reserved.
  
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• Percutaneous treatment of iatrogenic left-anterior descending artery to right ventricle fistula.
  Catheter Cardiovasc Interv

  2010 Dec;76(7):975-7. doi: 10.1002/ccd.22551.
  
  Oreglia Jacopo A, Bruschi Giuseppe, Klugmann Silvio
  
  Abstract
  
  Iatrogenic coronary fistula is a rare condition whose treatment strategy is not well established. We report the case of a 70-year-old patient who came to our attention with echocardiographic and scintigraphic signs of myocardial ischemia and who had undergone heart transplantation 10 years earlier. The coronary angiogram showed a coronary fistula connecting the left-anterior descending artery to the right ventricle via an enlarged septal branch. Because of the presence of myocardial ischemia, the patient was scheduled for percutaneous coronary intervention. The fistula was sealed with implant of two polytetrafluoroethylene (PTFE)-covered stents that excluded the septal branch. One-year follow-up showed persistence of the good result in terms of angiographic and clinical outcome.
  
  Copyright © 2010 Wiley-Liss, Inc.
  
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• Off-pump coronary revascularization in chronic dialysis-dependent patients: early outcomes at a single institution.
  J Cardiovasc Med (Hagerstown)

  2010 Jul;11(7):481-7.
  
  Bruschi Giuseppe, Colombo Tiziano, Botta Luca, Colombo Paola, Pelenghi Stefano, Trunfio Salvatore, Cannata Aldo, Merlanti Bruno, Paino Roberto, Klugmann Silvio, Martinelli Luigi
  
  Abstract
  
  INTRODUCTION:
  Atherosclerotic vascular disease is the leading cause of morbidity and mortality in patients with end-stage renal disease. Several authors reported that chronic dialytic patients have a high operative risk when submitted to coronary artery bypass grafting (CABG) on cardiopulmonary bypass (CPB) whereas little information exists about off-pump myocardial revascularization in these patients.
  
  MATERIAL AND METHODS:
  Between January 2000 and December 2008, 17 consecutive patients (12 men, mean age of 62.3 +/- 12.3 years) with end-stage renal failure maintained on chronic hemodialysis underwent isolated off-pump CABG at our center. To evaluate this approach we compared the outcomes of off-pump revascularization with those obtained in the same period in 23 patients (20 men, mean age of 64.0 +/- 9.7 years), with the same preoperative features, who underwent conventional CABG on the arrested heart using CPB.
  
  RESULTS:
  Off-pump revascularization in end-stage renal disease patients showed a satisfactory incidence of mortality and morbidity rates. When compared with conventional CPB CABG group, off-pump patients had a lower incidence of bleeding, transfusions, ventilation support time, length of inotropic support and perioperative myocardial infarction. Also ICU and hospital stay and incidence of new-onset atrial fibrillation were lower in off-pump CABG patients.
  
  CONCLUSION:
  In our experience, avoidance of CPB in end-stage renal disease patients was associated with an acceptable incidence of postoperative complications and of major adverse events. Off-pump CABG is a safe and effective method of myocardial revascularization in chronically dialyzed patients that should strongly be taken in consideration when planning the surgical strategy in this selected cohort of patients, although multicentric prospective randomized controlled trials are strongly recommended.
  
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• Direct aortic access through right minithoracotomy for implantation of self-expanding aortic bioprosthetic valves.
  J Thorac Cardiovasc Surg

  2010 Sep;140(3):715-7. doi: 10.1016/j.jtcvs.2010.02.030.
  
  Bruschi Giuseppe, De Marco Federico, Fratto Pasquale, Oreglia Jacopo, Colombo Paola, Paino Roberto, Klugmann Silvio, Martinelli Luigi
  
  
  
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• Beating heart mitral valve surgery: innovation or back to the past?
  J Card Surg

  2010 May;25(3):318; author reply 318-9. doi: 10.1111/j.1540-8191.2010.00998_1.x.
  
  Botta Luca, Cannata Aldo, Bruschi Giuseppe, Fratto Pasquale, Martinelli Luigi
  
  
  
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• Transcatheter aortic valve implantation by left subclavian access in the presence of a patent LIMA to LAD graft.
  Catheter Cardiovasc Interv

  2011 Feb;77(3):430-4. doi: 10.1002/ccd.22417.
  
  De Marco Federico, Bruschi Giuseppe, Klugmann Silvio
  
  Abstract
  
  We present a case of successful implantation of the Corevalve aortic bioprosthesis via the left subclavian artery in a patient with a patent internal mammary graft to the left anterior descending artery. This unusual choice of access, in the presence of adequate caliber femoral arteries, was justified by the presence of mobile thrombi in the abdominal aorta. The risk of thrombus dislodgement and subsequent major cholesterol embolization was deemed higher than the risk of coronary ischemia due to the large caliber sheath required for transcatheter aortic valve implantation. This case shows that presence of a LIMA to LAD graft is not an absolute contraindication for homolateral subclavian access and that the procedure is feasible and relatively safe provided that certain rules are followed.
  
  Copyright © 2009 Wiley-Liss, Inc.
  
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• Percutaneous implantation of CoreValve aortic prostheses in patients with a mechanical mitral valve.
  Ann Thorac Surg

  2009 Nov;88(5):e50-2. doi: 10.1016/j.athoracsur.2009.07.028.
  
  Bruschi Giuseppe, De Marco Federico, Oreglia Jacopo, Colombo Paola, Fratto Pasquale, Lullo Francesca, Paino Roberto, Frigerio Maria, Martinelli Luigi, Klugmann Silvio
  
  Abstract
  
  Concerns exist in the field of transcatheter aortic valve implantation regarding the treatment of patients with mechanical mitral valve for possible interference between the percutaneous aortic valve and the mechanical mitral prosthesis. We report our experience with percutaneous aortic valve implantation in 4 patients with severe aortic stenosis, previously operated on for mitral valve replacement with a mechanical prosthesis. All patients underwent uneventful percutaneous retrograde CoreValve implantation (CoreValve Inc, Irvine, CA). No deformation of the nitinol tubing of the prostheses (ie, neither distortion nor malfunction of the mechanical valve in the mitral position) occurred in any of the patients. All patients are alive and asymptomatic at a mean follow-up of 171 days.
  
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• Transcatheter aortic valve-in-valve implantation of a CoreValve in a degenerated aortic bioprosthesis.
  J Cardiovasc Med (Hagerstown)

  2010 Mar;11(3):182-5. doi: 10.2459/JCM.0b013e32832ffcb4.
  
  Bruschi Giuseppe, DeMarco Federico, Oreglia Jacopo, Colombo Paola, Fratto Pasquale, Lullo Francesca, Paino Roberto, Martinelli Luigi, Klugmann Silvio
  
  Abstract
  
  In recent years percutaneous aortic valve implantation has emerged as an alternative therapy to treat patients with symptomatic aortic stenosis considered to be high-risk surgical candidates. We report our experience of a percutaneous retrograde CoreValve implantation in a 77-year-old female with aortic bioprosthesis structural degeneration. The patient underwent aortic valve replacement for aortic stenosis in 1999 with the implantation of a 23 mm Carpentier-Edwards; her last echocardiography showed a severe bioprosthesis stenosis. After evaluation by cardiac surgeons and cardiologist, considering the high risk re-do surgical procedure (Logistic Euroscore 30%) and severe comorbidities (severe pulmonary hypertension, hepatocellular carcinoma and severe osteoporosis), a percutaneous aortic valve-in-valve replacement was preferred. A successful percutaneous 26 mm CoreValve prosthesis implantation was performed with the patient awake with local anesthesia and mild sedation. The patient was discharged after 10 days of hospitalization and she is in NYHA functional class I at follow-up. Our experience, characterized by a multidisciplinary approach, necessary to offer the safest conditions and care for patients, demonstrates the feasibility of a new, promising indication for the use of a transcatheter valve implantation: percutaneous treatment of a degenerated aortic bioprosthesis.
  
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• Percutaneous device closure of iatrogenic left ventricular wall pseudoaneurysm.
  Ann Thorac Surg

  2009 Oct;88(4):e31-3. doi: 10.1016/j.athoracsur.2009.07.032.
  
  Vignati Gabriele, Bruschi Giuseppe, Mauri Luigi, Annoni Giuseppe, Frigerio Maria, Martinelli Luigi, Klugmann Silvio
  
  Abstract
  
  A 67-year-old man with ischemic cardiomyopathy was transferred to our hospital in cardiogenic. During a video-assisted mini-thoracotomy for left ventricular epicardial lead implantation, a left ventricular free-wall rupture occurred and an emergency surgical repair was performed. Postoperatively patients experience left ventricular wall pseudoaneurysm. After stabilization of clinical conditions with aggressive medical treatment, we decided to attempt a minimally invasive procedure (ie, a transcatheter pseudoaneurysm closure). To date, few cases of device closure of left ventricle pseudoaneurysm are reported in the literature, usually secondary to myocardial infarction, and we believe this is the first case of left ventricle pseudoaneurysm after iatrogenic left ventricle laceration and surgical closure.
  
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• Use of CoSeal in a patient with a left ventricular assist device.
  Ann Thorac Surg

  2009 Jun;87(6):1956-8. doi: 10.1016/j.athoracsur.2008.10.042.
  
  Cannata Aldo, Taglieri Corrado, Russo Claudio F, Bruschi Giuseppe, Martinelli Luigi
  
  Abstract
  
  A 45-year-old man with end-stage idiopathic dilatated cardiomyopathy had previously undergone two left anterolateral thoracotomies for implantation and explantation of a left ventricular epicardial lead for biventricular pacing. Because of worsening heart failure and a predicted long delay to heart transplantation, a left-ventricular assist device was implanted, with application of CoSeal surgical sealant (Baxter Healthcare Corp, Fremont, CA) on the cardiac surface. At re-sternotomy for heart transplantation, surgical dissection of the left-ventricular assist device was greatly facilitated by the presence of avascular, very loose adhesions. CoSeal (Baxter Healthcare Corp) seems to be useful for the inhibition of adhesion formation after left-ventricular assist device implantation, although further clinical experience with this approach is required.
  
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• Technique to prevent inadvertent paramedian sternotomy.
  J Card Surg

  2009 ;24(3):290-1. doi: 10.1111/j.1540-8191.2009.00830.x.
  
  Cannata Aldo, Russo Claudio Francesco, Vitali Ettore, Bruschi Giuseppe
  
  Abstract
  
  Previous reports documented the relationship between inadvertent paramedian sternotomy and postoperative sternal instability and dehiscence.We describe a modification of the technique of median sternotomy in order to prevent inadvertent paramedian sternotomy and related wound complications.
  
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• Direct comparison of the short-term clinical performance of Z Guidant and Taxus stents.
  Int J Cardiol

  2010 Dec;145(3):e83-5. doi: 10.1016/j.ijcard.2008.12.161.
  
  Guildford Anna, Colombo Paola, Bruschi Giuseppe, Bonacina Edgardo, Klugmann Silvio, Santin Matteo
  
  Abstract
  
  The recent introduction of drug-eluting stents in angioplasty of atherosclerotic blood vessels has significantly reduced the risks of in-stent restenosis (ISR) [1]. Indeed, it is known that in conventional stents ISR takes place in over 20% of the cases and up to 60% when implanted in diabetic patients. Conversely, clinical trials have shown that drug-eluting stents have significantly reduced ISR. Among the drug-eluting stents available on the market, Taxus stents (Tax, Boston Scientific, USA) are among the most used devices [2]. Tax are stainless-steel stents coated with Translute, a poly(styrene-b-isobutylene-b-styrene) polymer (PSIBS) eluting Placlitaxel, an anti-mitotic drug. Clinical trials on this type of drug-eluting stents have shown an incidence of restenosis of approximately 4%. The majority of these trials were randomized studies where conventional stents and drug-eluting devices have been implanted in separate patients' cohorts. Such a randomized design, although fundamental to collect statistically-relevant data, does not allow a direct histological comparison of different stent types when implanted in the same patient and do not show the individual susceptibility to the host response especially at short-term implantation times. Here, an interesting case study is presented where two chrome-cobalt stents (Z Guidant, ZG, Guidant Corp.) and a Tax have been simultaneously implanted in the same patient in three separate coronary arteries, retrieved after only 8 weeks and histologically analysed.
  
  Copyright © 2009 Elsevier Ireland Ltd. All rights reserved.
  
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• Noncardiac surgical procedures in patient supported with long-term implantable left ventricular assist device.
  Am J Surg

  2009 Jun;197(6):710-4. doi: 10.1016/j.amjsurg.2008.05.009.
  
  Garatti Andrea, Bruschi Giuseppe, Colombo Tiziano, Russo Claudio, Milazzo Filippo, Catena Emanuele, Lanfranconi Marco, Vitali Ettore
  
  Abstract
  
  BACKGROUND:
  Left ventricular assist devices (LVADs) are increasingly used as bridges to transplantation or as destination therapy. As sicker and older patients are more frequently considered for mechanical support, general surgical problems are expected to increase in these patients.
  
  METHODS:
  Anesthesia records and clinical charts were reviewed for 11 recipients of LVADs undergoing 12 general surgical procedures between January 1988 and March 2007.
  
  RESULTS:
  Eight patients underwent major surgical procedures: 1 intracranial hematoma drainage, 1 right hemicolectomy with ileocolostomy, 1 splenectomy, 1 surgical repair of an iliac-femoral artery pseudoaneurysm, 2 cholecystectomies, 1 pyelolithotomy, and 1 coil embolization of a femoral side-branch disruption. Four patients underwent minor surgical procedures. The mean duration of LVAD support before surgery was 58.7 +/- 45.6 days. All patients survived the procedures.
  
  CONCLUSION:
  Noncardiac surgery in LVAD recipients is feasible, without significant morbidity or mortality. Intraoperative coagulation management has a key role in safely performing these procedures.
  
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• Mechanical circulatory support for patients with fulminant myocarditis: the role of echocardiography to address diagnosis, choice of device, management, and recovery.
  J Cardiothorac Vasc Anesth

  2009 Feb;23(1):87-94. doi: 10.1053/j.jvca.2008.03.008.
  
  Catena Emanuele, Paino Roberto, Milazzo Filippo, Colombo Tiziano, Marianeschi Stefano, Lanfranconi Marco, Aresta Francesca, Bruschi Giuseppe, Russo Claudio, Vitali Ettore
  
  
  
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• [Changes in patient survival and quality of life after heart transplantation].
  G Ital Cardiol (Rome)

  2008 Jul;9(7):461-71.
  
  Frigerio Maria, Oliva Fabrizio, Turazza Fabio M, Macera Francesca, Galvanin Silvia, Verde Alessandro, Bruschi Giuseppe, Pedrazzini Giovanna
  
  Abstract
  
  Heart transplantation was performed firstly in 1967, but it became a valuable option in the 1980s, due to the availability of cyclosporine and of the technique for rejection monitoring by means of serial endomyocardial biopsies. Post-transplant survival improved over the years, mainly due to a reduction in early mortality for infection or acute rejection. Expected 1-year and 5-year survivals are around 85% and 70%, respectively. During the past 20-30 years, better therapies for heart failure have been developed, leading to restriction of heart transplant candidacy to truly refractory heart failure. On the contrary, the criteria for donor acceptance have been liberalized, due to the discrepancy between heart transplant candidates and available organs. It must be kept in mind that renal and/or hepatic insufficiency that may be a consequence of heart failure, pulmonary hypertension, and donor age, all remain risk factors for mortality after transplantation. In order to maintain and possibly improve the results of heart transplantation, effective strategies to increase safely the donor pool are of utmost importance. Moreover, long-term post-transplant recipients present new challenges to research and clinical practice. Mechanical circulatory support devices represent a surgical bridge or an alternative to transplantation; their expansion is limited by costs, organizational burden, and by patient difficulties in accepting this therapy.
  
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• Ex-vivo characterization of three Björk-Shiley Delrin heart valves.
  J Heart Valve Dis

  2008 May;17(3):325-31.
  
  Farè Silvia, Brunella Maria F, Bruschi Giuseppe, Vitali Ettore
  
  Abstract
  
  BACKGROUND AND AIM OF THE STUDY:
  Björk-Shiley Delrin (BSD) tilting-disc mechanical valve occluders have demonstrated good performance, with superior patient survival and low incidence of obstruction phenomena compared to caged-ball valves. Unfortunately, the use of Delrin as the occluder material was problematic, and in 1971 this led to its replacement with a pyrolitic carbon-coated occluder. The study aim was to report and to determine the mechanism of wear on BSD valve discs. To achieve this, three BSD valves which had been in place for between 312 and 355 months were explanted and analyzed.
  
  METHODS:
  Optical microscopy and scanning electron microscopy were used to investigate material imperfections or damage to the housing and occluder components of the explanted valves.
  
  RESULTS:
  The valve discs showed more than one type of wear pattern. Notably, the wear pattern observed on the surface and edge of the disc did not affect correct in-vivo function of the valves, as indicated by their long implantation period. No cracks, fractures or perforations of the Delrin discs were observed, but clear imprints caused by the impact of the struts on the inlet and outlet disc surfaces were detected. The depth of the strut imprints was indicative of a hindered disc rotation. A reduction in the diameter of the Delrin disc (ca. 1.44 mm) was detected in valve #3.
  
  CONCLUSION:
  The results obtained for the three BSD valves were in agreement with data reported elsewhere, and showed good performance of this mechanical valve. Although the clinical follow up for these second-generation mechanical valves is extensive and supportive of their good clinical performance, they may in time fail due to wear of the polymer surface.
  
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• Long-term results of lung cancer after heart transplantation: single center 20-year experience.
  Lung Cancer

  2009 Jan;63(1):146-50. doi: 10.1016/j.lungcan.2008.04.018.
  
  Bruschi Giuseppe, Conforti Serena, Torre Massimo, Colombo Tiziano, Russo Claudio F, Pedrazzini Giovanna, Frigerio Maria, Ravini Mario
  
  Abstract
  
  OBJECTIVE:
  The present study analyses, long-term lung cancer survival rate in the Niguarda heart transplant population and the results of surgical treatments.
  
  METHODS:
  From November 1985 to December 2006, 786 heart transplants were performed in our Center; we underwent a retrospective review of patients developing primary lung cancer.
  
  RESULTS:
  Among 660 heart transplant recipients valuable in this study, 22 (3.3%) developed a primary lung cancer (20 male, 91%), their mean age at time of heart transplant was 54.5+/-5.2 years (range, 42-65). The mean time from transplantation to lung cancer diagnosis was 73.7+/-30 months. Eleven patients (50%) were in stage IIIB or higher at the time of presentation. The 5-year survival rate of the entire study population was 21.4%, with a median survival time (MST) of 10.1 months. Ten patients underwent surgical resection (9 lobectomies and 1 wedge resection) and demonstrated improved long-term survival with 5-year survival of 56% and MST 70.4 months, compared to patients who did not undergo any surgical procedure, all of whom died during follow-up, with 1-year survival of 33%.
  
  CONCLUSIONS:
  Long-term results following lung cancer surgery in heart transplant recipients are satisfactory when performed at the early stage of the disease. Preventive computed tomography screen should be considered as a routine method for early diagnosis in this group of high-risk patients.
  
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• [Percutaneous heart valves: clinical role].
  G Ital Cardiol (Rome)

  2008 Mar;9(3):155-66.
  
  Colombo Paola, Bruschi Giuseppe, Bossi Irene, Pirola Roberto, Klugmann Silvio
  
  Abstract
  
  Percutaneous valve therapy is said to be the last frontier in interventional cardiology. Over the past few years the work of decades has come to fruition. The first percutaneous implantation of a cardiac stent-valve in a human was reported by Bonhoeffer and colleagues in 2000. The first percutaneous aortic valve placement was performed by Cribier in 2002 using an antegrade approach in a patient with critical aortic stenosis. Attempts at percutaneous mitral valve repair are as varied as the pathophysiological mechanisms of mitral regurgitation. We are now embarking on a new era in the treatment of valvular heart disease with the introduction of percutaneous and minimally invasive devices and techniques to address valve dysfunction without conventional surgical repair/replacement. Pathology of all four cardiac valves has now been treated in early stage clinical feasibility (pilot) trials. There are at least 30 percutaneous valve programs currently being developed by 24 different companies. Two of the percutaneous aortic valve devices and five of the mitral valve devices are in various stages of clinical trials, ranging from feasibility to pivotal at the present time. Large-scale trials comparing percutaneous valve replacement and repair with surgery are just beginning. In this article we will look at the various technologies and advances in percutaneous valve replacement and repair, with an emphasis on those devices that are currently being utilized in the clinical realm.
  
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• Clinical outcome and bridge to transplant rate of left ventricular assist device recipient patients: comparison between continuous-flow and pulsatile-flow devices.
  Eur J Cardiothorac Surg

  2008 Aug;34(2):275-80; discussion 280. doi: 10.1016/j.ejcts.2008.02.019.
  
  Garatti Andrea, Bruschi Giuseppe, Colombo Tiziano, Russo Claudio, Lanfranconi Marco, Milazzo Filippo, Frigerio Maria, Vitali Ettore
  
  Abstract
  
  BACKGROUND:
  Long-term implantable continuous axial-flow pumps are increasingly used in bridging heart failure patients to heart transplant. Compared to pulsatile left ventricular assist devices (LVADs), they offer smaller dimensions, less surgical trauma and less thromboembolisms. However concerns still remain about the long-term effects of continuous-flow on patients' outcome. The aim of this study was to review our mechanical bridge to transplant experience to compare pre- and post-transplant outcomes between pulsatile and continuous-flow LVAD recipients.
  
  METHODS:
  Thirty-six patients with a continuous-flow device (Micromed DeBakey, Houston, TX or InCor Berlin Heart, Berlin, Germany--group A) were compared with 41 patients supported with a pulsatile device (Novacor, WorldHeart, Oakland, CA--group B).
  
  RESULTS:
  Mean age (48.6+/-12.4 vs 47.2+/-12.5) and LVAD duration (119.3+/-115.4 vs 128.3+/-198.3) were similar in the two groups. Group A recipients were smaller compared to group B (mean body surface area=1.77+/-0.18 vs 1.93+/-0.16; p
  CONCLUSIONS:
  In our experience, when compared to pulsatile LVAD, continuous-flow pumps are similarly effective in transplant rate and post-transplant outcome.
  
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• Thromboaspiration during acute myocardial infarction in a heart transplant patient.
  J Cardiovasc Med (Hagerstown)

  2008 Mar;9(3):293-5. doi: 10.2459/JCM.0b013e328216240a.
  
  Colombo Paola, Bruschi Giuseppe, Agozzino Manuela, Silva Pedro, Frigerio Maria, Vitali Ettore, Arbustini Eloisa, Klugmann Silvio
  
  Abstract
  
  Each year, an estimated 10% of heart transplant recipients develop coronary allograft vasculopathy, an aggressive form of coronary artery disease that limits survival after transplantation. The pathologic characteristics of coronary allograft vasculopathy are not uniform and both the clinical importance and pathophysiological significance of thrombosis and vasospasm in this setting are not completely understood. Mechanical reperfusion is a better alternative to systemic thrombolysis in patients with acute myocardial infarction and thrombus removal before standard percutaneous coronary intervention improves coronary epicardial flow. We report the case of a 38-year-old male admitted to the emergency room of our hospital with acute inferior myocardial infarction complicated by cardiogenic shock. He underwent heart transplant because of ischemic cardiomyopathy. Coronary angiography showed acute coronary thrombosis of the circumflex coronary artery. Percutaneous coronary intervention with thrombus extraction was successfully attempted. This case represents an unusual clinical presentation and treatment of cardiac allograft vasculopathy.
  
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• Successful emergent surgical revascularization and retrieval of entrapped drug eluting stent.
  J Cardiovasc Med (Hagerstown)

  2008 Feb;9(2):182-3. doi: 10.2459/JCM.0b013e3281053ae3.
  
  Bruschi Giuseppe, Colombo Paola, Piccalò Giacomo, Trunfio Salvatore, Colombo Tiziano, Vitali Ettore
  
  Abstract
  
  We report the case of a 61-year-old man who was treated with percutaneous coronary intervention (PCI) for unstable angina. Seven days after the procedure, he voluntary suspended double anti-aggregant therapy and experienced acute coronary thrombotic occlusion. A repeat PCI procedure was undertaken but the stent and the balloon remained entrapped in the proximal left main-left anterior descending coronary artery. After ineffective attempt of stent removal using an Amplatz goose neck catheter, the patient that was hemodynamically stable underwent uneventful emergency coronary artery bypass grafting and removal of the damaged stent and Amplatz goose neck.
  
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• Small intestine capsule endoscopy in magnetic suspended axial left ventricular assist device patient.
  Interact Cardiovasc Thorac Surg

  2006 Feb;5(1):1-4.
  
  Garatti Andrea, Bruschi Giuseppe, Girelli Carlo, Vitali Ettore
  
  Abstract
  
  A 45-year-old male with dilatative cardiomyopathy was supported with an Incor (Berlin-Heart AG) axial flow magnetically levitated bearings pump. Due to constant anemization in late follow-up, gastrointestinal bleeding was suspected and a PillCamtrade mark Capsule Endoscopy (Given Imaging) was performed. No interference between the devices was detected and full small bowel visualization was achieved.
  
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• Long-term follow-up of simultaneous heart and kidney transplantation with single donor allografts: report of nine cases.
  Ann Thorac Surg

  2007 Aug;84(2):522-7.
  
  Bruschi Giuseppe, Busnach Ghil, Colombo Tiziano, Radaelli Loredana, Pedrazzini Giovanna, Garatti Andrea, Sansalone Cosimo V, Frigerio Maria, Vitali Ettore
  
  Abstract
  
  BACKGROUND:
  Combined heart-kidney transplantation is an accepted therapeutic option for patients with end-stage heart disease associated with severely impaired renal function. We report our single-institutional experience with this combined procedure and long-term follow-up.
  
  METHODS:
  Between April 1989 and August 2006, 9 patients underwent combined simultaneous heart-kidney transplantation at our center. Seven patients were male (mean age, 45.2 +/- 10.12 years); 7 patients were on dialysis at transplantation. Whenever possible, donors were selected on the basis of ABO identity, weight (ratio > or = 0.9), on-site or short-distance procurement, young age, low inotropic support, and normal renal function.
  
  RESULTS:
  Mean ischemic time was 132.2 +/- 57.0 minutes for the cardiac allograft and 6.0 +/- 1.0 hours for the kidney. Surgical procedure was uneventful in all patients. One patient died in the intensive care unit 41 days after transplantation. Three patients died during follow-up, 1 of lung neoplasm after 6 years, 1 of cerebral stroke after 34 months, and 1 of infection and multiorgan failure after 148 months. The mortality rates led to an overall actuarial survival of 88.9% +/- 10.4% at 1 year, 77.8% +/- 13.6% at 5 years, and 64.8% +/- 16.5% at 10 years. Seven patients lived beyond 5 years, 4 beyond 10 years, and the patient who has longest survival is patient no. 1, with 17 years of follow-up. One patient lost kidney function after 113 months.
  
  CONCLUSIONS:
  In selected patients, with coexisting end-stage cardiac and renal failure, combined heart-kidney transplantation with allograft from the same donor proved to have satisfactory short- and long-term results, with a low incidence of both cardiac and renal allograft rejection.
  
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• Mechanical circulatory support for cardiogenic shock complicating acute myocardial infarction: an experimental and clinical review.
  ASAIO J

  2007 ;53(3):278-87.
  
  Garatti Andrea, Russo Claudio, Lanfranconi Marco, Colombo Tiziano, Bruschi Giuseppe, Trunfio Salvatore, Milazzo Filippo, Catena Emanuele, Colombo Paola, Maria Frigerio, Vitali Ettore
  
  Abstract
  
  Cardiogenic shock (CS) occurs in 7% to 10% of cases after acute myocardial infarction and remains the most common cause of death in these patients. Despite aggressive treatment regimens such as fibrinolysis and percutaneous transluminal coronary angioplasty, mortality rates from CS remain extremely high. It has been shown that intra-aortic balloon pumping can result in initial hemodynamic stabilization. However, in the majority of studies, death was merely delayed. In recent years, efforts have been made to develop ventricular devices (LVAD) capable of providing complete short-term hemodynamic support. Seventeen major studies of LVAD support for CS complicating acute myocardial infarction are reported in the literature, with a mean weaning and survival rate of 58.5% and 40%, respectively. Patients considered in these studies are difficult to compare in terms of demographic and anatomic data, but taking these considerations into account, LVAD support seems to give no survival improvement in these patients compared with early reperfusion alone or associated with intra-aortic balloon pumping. Data emerging from experimental studies of acute myocardial infarction supported with LVAD are intriguing. In this review, we report the LVAD experience in the CS setting, starting from percutaneous extracorporeal support up to bridge therapy with implantable devices.
  
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• Effectiveness of hyperbaric oxygen therapy for hearing loss after cardiac surgery.
  Ann Thorac Surg

  2007 May;83(5):e9-10.
  
  Bruschi Giuseppe, Tarelli Giuseppe, Colombo Paola, Cavallazzi Giuseppe, Cannata Aldo, Garatti Andrea, Vitali Ettore
  
  Abstract
  
  Sudden sensorineural hearing loss is a rare complication after cardiac surgery with extracorporeal circulation. We report a case of a 60-year-old man who experienced severe sensorineural hearing loss after Bentall procedure and recovery of normal hearing after 20 days of hyperbaric oxygen therapy.
  
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• Left ventricular mechanical support with the Impella Recover left direct microaxial blood pump: a single-center experience.
  Artif Organs

  2006 Jul;30(7):523-8.
  
  Garatti Andrea, Colombo Tiziano, Russo Claudio, Lanfranconi Marco, Milazzo Filippo, Catena Emanuele, Bruschi Giuseppe, Frigerio Maria, Vitali Ettore
  
  Abstract
  
  The Impella Recover left direct (LD) is a new intravascular microaxial blood pump, intended as a short-term mechanical support especially in case of acutely reduced left ventricular function. From September 2002 to October 2004, Impella was used to support 12 patients: six patients were supported as bridge-to-heart transplant (HTx); three patients were treated for fulminant acute myocarditis, and three patients for postcardiotomy low-output syndrome. Mean support time was 8.8 +/- 2.3 days. Overall mortality was 50%. Four patients were successfully HTxed; two patients supported as bridge-to-HTx died on left ventricular assist device. Two patients with myocarditis died of septic shock; two patients in the group of postcardiotomy died of multiorgan failure. The latter two patients were slowly weaned from the device, and at 3-months follow-up showed good improvement of the left ventricular function. Our initial experience with Impella Recover LD as mechanical support for patients in cardiogenic shock of various etiology is promising, yielding a good survival in a population of particularly compromised patients.
  
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• An unusual cause of pulmonary edema: acute rupture of noncoronary sinus of valsalva aneurysm into the left atrium.
  J Am Soc Echocardiogr

  2006 Jul;19(7):938.e9-11.
  
  Moreo Antonella, De Chiara Benedetta, Bruschi Giuseppe, Tarelli Giuseppe, Parolini Marina, Mauri Francesco
  
  Abstract
  
  We present the case of a patient admitted to hospital with pulmonary edema and atrial fibrillation. The transthoracic echocardiogram showed noncoronary sinus of Valsalva aneurysm ruptured into the left atrium, with a turbulent flow directed toward the left atrium floor and the pulmonary vein, which explained the clinical presentation. Echocardiography played a crucial role in identification of the cause and correct therapeutic approach.
  
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• Bridge to transplantation with the MicroMed DeBakey ventricular assist device axial pump: a single centre report.
  J Cardiovasc Med (Hagerstown)

  2006 Feb;7(2):114-8.
  
  Bruschi Giuseppe, Ribera Elena, Lanfranconi Marco, Russo Claudio, Colombo Tiziano, Garatti Andrea, Oliva Fabrizio, Milazzo Filippo, Frigerio Maria, Vitali Ettore
  
  Abstract
  
  OBJECTIVE:
  Left ventricular assist devices (VADs) are an accepted therapy to bridge patients with end-stage heart failure to heart transplantation. The DeBakey VAD, a continuous axial flow pump weighing 93 g, has been introduced into clinical practice as a bridge to transplant.
  
  METHODS:
  Starting from April 2000,17 patients (12 males, five females, mean age 44.3 +/- 12.8 years; 11 dilated idiopathic cardiomyopathy, five ischaemic cardiomyopathy, one pulsatile device failure) with end-stage heart failure were implanted with a DeBakey VAD as a bridge to transplantation at our institution. Before implant, all patients suffered from severe heart failure (New York Heart Association functional class IV) despite optimal medical therapy and were put on the waiting list for heart transplantation. Mean cardiac index was 1.59 +/- 0.51 l/min/m2.
  
  RESULTS:
  Fourteen patients were successfully transplanted after 99 +/- 117 days of assistance (range 11-443 days). Two patients died during assistance of multiorgan failure, one patient is still on VAD. No patient needed additional right ventricular mechanical support. Left ventricular/left VAD thrombosis occurred in one patient who was successfully treated conservatively. No clinical elevation of plasma free haemoglobin was detected. Neither device, driveline, abdominal pocket infection nor device failure occurred.
  
  CONCLUSIONS:
  In our experience with the continuous axial flow DeBakey VAD, a high success rate was obtained associated with a low risk of complications. All the patients tolerated continuous blood flow for extended periods that makes this device a valuable alternative to pulsatile VADs as a bridge to transplantation.
  
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• [Mechanical assist devices in advanced heart failure. Indications and perspectives].
  G Ital Cardiol (Rome)

  2006 Feb;7(2):91-108.
  
  Colombo Tiziano, Russo Claudio, Lanfranconi Marco, Bruschi Giuseppe, Garatti Andrea, Milazzo Filippo, Catena Emanuele, Oliva Fabrizio, Turazza Fabio, Frigerio Maria, Vitali Ettore
  
  Abstract
  
  Congestive heart failure is recognized as a major public health issue and is the leading cause of death in western countries. Heart transplantation currently remains the gold standard option for end-stage heart failure patients. Heart transplantation is also one of the most limited therapies, not only with regard to the lack of donor hearts but also because of the surgical limitations inherent to the clinical aspects of this severely ill patient population. Mechanical circulatory support systems have been developed as effective adjuvant therapeutic options in these terminally ill patients. Over the past two decades, mechanical circulatory support devices have steadily evolved in the clinical management of end-stage heart failure, and have emerged as a standard of care for the treatment of acute and chronic heart failure refractory to conventional medical therapy. Future blood pumps should be smaller and totally implantable, as well as more efficient, biocompatible, and reliable.
  
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• Different clinical scenarios for circulatory mechanical support in acute and chronic heart failure.
  Am J Cardiol

  2005 Dec;96(12A):34L-41L.
  
  Vitali Ettore, Colombo Tiziano, Bruschi Giuseppe, Garatti Andrea, Russo Claudio, Lanfranconi Marco, Frigerio Maria
  
  Abstract
  
  Chronic heart failure (HF) is a leading cause of death in developed countries. Over the last 2 decades, mechanical circulatory support (MCS) devices have steadily evolved in the clinical management of end-stage HF and have emerged as a standard of care for the treatment of acute and chronic HF refractory to conventional medical therapy. Possible indications for using MCS are acute cardiogenic shock, as a bridge to transplantation, as a bridge to recovery, and more recently, as destination therapy in dilated cardiomyopathy, of either ischemic or idiopathic etiology. We reviewed the different clinical scenarios in which we think there are currently indications to implant different kinds of MCS systems.
  
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• Left ventricular support by axial flow pump: the echocardiographic approach to device malfunction.
  J Am Soc Echocardiogr

  2005 Dec;18(12):1422.
  
  Catena Emanuele, Milazzo Filippo, Montorsi Emanuela, Bruschi Giuseppe, Cannata Aldo, Russo Claudio, Barosi Alberto, Tarelli Giuseppe, Tartara Paolo, Paino Roberto, Vitali Ettore
  
  Abstract
  
  Axial flow pumps have gained increased acceptance in recent years as a bridge to heart transplantation and, more recently, as destination therapy. As left ventricular (LV) assist device dysfunction will be increasingly prevalent, the aim of our work was to introduce an echocardiographic management protocol as a guide to recognize the causes of pump failure. In this article we describe the echocardiographic approach to 5 episodes of malfunction of an axial flow pump (DeBakey, MicroMed Technology Inc, Houston, Tex) in 4 patients: 4 episodes caused by thrombosis of LV assist device and one caused by abnormal increase of systemic vascular resistance. In our experience, echocardiography played a pivotal role in clinical management of LV assist device failure. It allowed us to: assess patency and position of inflow and outflow cannulae; research the source of thromboembolic material; assess adequate LV filling and unloading; and optimize right ventricular function, volume replacement therapy, and pharmacologic support.
  
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• Interfacial biology of in-stent restenosis.
  Expert Rev Med Devices

  2005 Jul;2(4):429-43.
  
  Santin Matteo, Colombo Paola, Bruschi Giuseppe
  
  Abstract
  
  Percutaneous angioplasty is a nonsurgical method able to restore patency in atherosclerotic blood vessels through the expansion of a balloon. The clinical outcome of this technique has been significantly enhanced by the combined deployment of a stent. Although stents are successful in the majority of cases, a large percentage of patients (20-30%) still suffer a second vessel lumen reduction known as in-stent restenosis. In-stent restenosis is recognized to be caused by the mechanical and foreign body challenges elicited by the device. Drug-eluting stents have been recently made available to tackle restenosis, but their short clinical history and high costs may limit their future use. The present review links the most recent biologic findings related to in-stent restenosis to the devices' phyisico-chemical features in an attempt to demonstrate that a new generation of stents may be developed without the need of drug elution.
  
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• Surgical treatment of acute myocardial infarction.
  Ital Heart J

  2004 Jun;5 Suppl 6():92S-99S.
  
  Vitali Ettore, Colombo Tiziano, Garatti Andrea, Tarelli Giuseppe, Bruschi Giuseppe, Ribera Elena
  
  Abstract
  
  BACKGROUND:
  The role of surgical revascularization in the treatment of acute myocardial infarction (AMI) has changed considerably over the last 30 years along with improvement in intraoperative management and techniques of myocardial protection. The aim of this work was to analyze the long-term results of our experience of emergency myocardial surgical revascularization for AMI.
  
  METHODS:
  Between January 1986 and October 2003, 237 patients (85.3% males; mean age 59.6 +/- 9.6 years) underwent emergency coronary artery bypass graft for severe AMI. At admission 82 patients (34.6%) were in cardiogenic shock, while 124 patients (52.3%) presented major preoperative complications (acute pulmonary edema, mechanical ventilation, intra-aortic counterpulsation, cardiac arrest). Preoperative intra-aortic counterpulsation was performed in 125 patients (52.7%). The mean time interval between symptom onset and surgery was 9.4 hours. Three-vessel disease was detected in 107 patients (45%), with main left stenosis in 12.9%.
  
  RESULTS:
  There were overall 50 hospital deaths (21.1%). Amongst patients with major preoperative complications, mortality was 36.2% (45 cases out of 124); mortality for cardiogenic shock was 40.2% (33 patients out of 82). Survival of the first 140 patients undergoing operation and then discharged was 97.8% at 1 year and 79.6% at 5 years. The survival rate of the first 60 patients in cardiogenic shock operated on and then discharged is 98.8% at 1 year and 81.2% at 5 years. The ejection fraction in 102 echocardiographically controlled patients was 37.2 +/- 8.5% preoperatively and 44.0 +/- 10.1% at pre-discharge (p = 0.0001).
  
  CONCLUSIONS:
  Surgical revascularization for AMI, especially if complicated by cardiogenic shock, is a valid therapeutic option that carries a high periprocedural risk but that is balanced by a satisfactory late survival. A more precise patient's risk assessment at admission, improvement of surgical and myocardial protection techniques, extensive use of intra-aortic counterpulsation, and new circulatory support when needed, can improve outcomes and late survival.
  
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• [Comorbidity in surgical myocardial revascularization: risk factors or contraindications for surgery].
  Ital Heart J Suppl

  2004 May;5(5):376-81.
  
  Colombo Tiziano, Pelenghi Stefano, Bruschi Giuseppe, Tarelli Giuseppe, Montorsi Emanuela, Merli Mario, Vitali Ettore
  
  Abstract
  
  BACKGROUND:
  The worsening evolution of patients undergoing surgical myocardial revascularization makes it difficult the stratification of the preoperative mortality risk, a correct evaluation of results and the comparison of results of different centers. The aim of the study was to evaluate the prognostic weight of comorbidity in surgical myocardial revascularization.
  
  METHODS:
  We evaluated the characteristics of preoperative morbidity in 4999 patients who underwent surgical myocardial revascularization during four different periods (1979-1980, 1991-1992, 1994-1998, 1999-2002). We also evaluated the in-hospital results.
  
  RESULTS:
  By comparing the four different periods, an increase in older age, female sex, comorbidity, three-vessel disease, and severe left ventricular dysfunction was observed. Surgical mortality decreased to 2.3%. Multivariate analysis of the 1999-2002 period showed that only renal insufficiency was a risk factor for in-hospital mortality.
  
  CONCLUSIONS:
  Although the preoperative risk is higher, nowadays hospital mortality is reduced thanks to new cardiac-surgical techniques and approaches that increasing the capacity of controlling comorbidity in the pre-, intra- and postoperative course. For a correct decision-making process it is crucial to assess how much comorbidity may influence the long-term follow-up in these patients independently of surgical myocardial revascularization.
  
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• Unicuspid aortic valve.
  Asian Cardiovasc Thorac Ann

  2003 Dec;11(4):377.
  
  Bruschi Giuseppe, Santarone Mauro, Ribera Elena, Tarelli Giuseppe
  
  
  
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• First successful bridge to recovery with the Impella Recover 100 left ventricular assist device for fulminant acute myocarditis.
  Ital Heart J

  2003 Sep;4(9):642-5.
  
  Colombo Tiziano, Garatti Andrea, Bruschi Giuseppe, Lanfranconi Marco, Russo Claudio, Milazzo Filippo, Catena Emanuele, Frigerio Maria, Vitali Ettore
  
  Abstract
  
  A patient with septic and cardiogenic shock secondary to acute fulminant myocarditis was successfully treated by mechanical offloading of the left ventricle using the Impella Recover 100, a new implantable micro-axial blood pump designed for short-term circulatory support (for a maximum of 7 days). The possibility of implanting this device without using cardiopulmonary bypass allowed as to manage the septic shock, to reverse cardiac and hepatorenal failure and to wean the patient off treatment after 18 days of support. At 3 months the left and right ventricular function was satisfactory. The widespread application of this kind of support depends on the availability of an inexpensive "mini-invasive" blood pump, appropriate weaning protocols and emerging strategies to promote sustainable myocardial recovery.
  
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• Left ventricular assist devices as bridge to heart transplantation: The Niguarda Experience.
  J Card Surg

  2003 ;18(2):107-13.
  
  Vitali Ettore, Lanfranconi Marco, Bruschi Giuseppe, Russo Claudio, Colombo Tiziano, Ribera Elena
  
  Abstract
  
  BACKGROUND:
  Congestive heart failure is the leading cause of death in Western countries. Heart transplantation currently is the only accepted therapy for patients with end-stage heart failure, but the supply of donor hearts is inadequate, and different mechanical circulatory support systems have been investigated as bridges to heart transplant.
  
  METHODS:
  Since April 1992, 53 patients (47 men, 6 women, aged 12 to 61 years) received left ventricle mechanical circulatory support as bridge to heart transplant. The two principal devices used were: the Novacor LVAS in 31 patients and the DeBakey VAD in 11 patients.
  
  RESULTS:
  All patients survived the operation. Mean duration of LVAD support was 2.8 +/- 5.6 months. Thirty-seven patients (71.1%) underwent heart transplantation. Twelve major bleeding episodes occurred in nine patients (16.9%). Globally, major and minor neurologic events occurred in 13 patients (24.5%). Ten patients (19.9%) assisted with the Novacor Wearable LVAS device were discharged at home while waiting for heart transplant (HTx). The mean follow-up of the 34 discharged transplanted patients was 45.3 +/- 37 months. Actuarial survival of transplanted patients while on LVAD was 91.0 +/- 4.9% and 83.4 +/- 8.5% at 1 and 5 years, respectively. No differences in post-transplant long-term survival and rejection and allograft vasculopathy occurred between patients transplanted with or without LVAD implanted.
  
  CONCLUSIONS:
  LVAD therapy proved to be effective in bridging patients with end-stage heart failure to HTx. While on LVAD support, patients assisted with implantable wearable devices could be discharged at home, ameliorating their quality of life. The excellent survival rate after HTx is concomitant with a low incidence of rejection and cardiac allograft vasculopathy.
  
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• Surgical therapy in advanced heart failure.
  Am J Cardiol

  2003 May;91(9A):88F-94F.
  
  Vitali Ettore, Colombo Tiziano, Fratto Pasquale, Russo Claudio, Bruschi Giuseppe, Frigerio Maria
  
  Abstract
  
  Congestive heart failure (CHF) affects about 1% of adults in the United States and is a contributing factor in >250,000 deaths per year. In an increasingly elderly population, the surgical treatment of CHF made great progress during the past 3 decades, consuming enormous health care resources. Heart transplantation is still the most effective therapy for end-stage heart disease, with the 10-year survival rate after transplantation approaching 50%. Efforts to increase the supply of donor organs have failed to improve the shortage, underscoring the crucial need for alternatives to cardiac allotransplantation. Alternative surgical options to end-stage heart transplantation are rapidly evolving. Left ventricular assist devices have been used as a bridge to heart transplantation for patients who otherwise might die awaiting a new heart. There is also continued interest in the use of these devices either to bridge patients to full recovery or to destination therapy, without the need for heart replacement. Left ventricular reconstruction, including the Batista and Dor procedures, along with mitral valve repair, cardiomyoplasty, and extreme coronary artery bypass graft surgery, are now being increasingly performed as alternative options. The history, status, and personal experience of surgical treatment of end-stage heart disease are discussed.
  
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• Successful experience in bridging patients to heart transplantation with the MicroMed DeBakey ventricular assist device.
  Ann Thorac Surg

  2003 Apr;75(4):1200-4.
  
  Vitali Ettore, Lanfranconi Marco, Ribera Elena, Bruschi Giuseppe, Colombo Tiziano, Frigerio Maria, Russo Claudio
  
  Abstract
  
  BACKGROUND:
  Pulsatile left ventricular assist devices are used with increasing frequency to bridge patients with end-stage heart failure to heart transplantation (HTx). Implantation of pulsatile devices is a cumbersome surgical procedure that is associated with major complications, such as bleeding, thromboembolism, and infection. Recently, a continuous axial flow left ventricular assist device (DeBakey ventricular assist device) has been introduced with the goal of reducing the incidence of major complications.
  
  METHODS:
  We reviewed our experience with 11 patients who received a DeBakey ventricular assist device axial flow pump for bridge to HTx from April 2000 through November 2001.
  
  RESULTS:
  Two patients (18.2%) died of multiple-organ failure while on left ventricular assist device support. Bleeding requiring thoracotomy occurred in 2 patients (18.2%). One patient had a minor neurologic event, and one patient developed left ventricular assist device thrombosis, which was successfully treated without pump exchange. Renal failure developed in 1 patient and hepatic dysfunction in 2 patients. There were no instances of right heart failure. No device, pocket, or drive-line infections occurred. Nine patients (9 of 11, 81.8%) had HTx within 51 +/- 49 days (range, 11 to 141 days) after left ventricular assist device implant. One patient died 29 days after HTx because of acute rejection.
  
  CONCLUSIONS:
  The continuous axial flow DeBakey ventricular assist device had reliable features, including a high rate of bridge to HTx. This device had low complication and system failure rates. We consider the DeBakey ventricular assist device a favorable alternative to pulsatile heart assist devices as a bridge to HTx.
  
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• Aortic complications after bicuspid aortic valve replacement: long-term results.
  Ann Thorac Surg

  2002 Nov;74(5):S1773-6; discussion S1792-9.
  
  Russo Claudio F, Mazzetti Simone, Garatti Andrea, Ribera Elena, Milazzo Angela, Bruschi Giuseppe, Lanfranconi Marco, Colombo Tiziano, Vitali Ettore
  
  Abstract
  
  BACKGROUND:
  Bicuspid aortic valve (BAV) is a risk factor for aortic dissection and aneurysm. We studied patients with BAV and tricuspid aortic valve (TAV) to evaluate long-term changes in the ascending aorta after aortic valve replacement (AVR).
  
  PATIENTS AND METHODS:
  One hundred consecutive patients were allocated into two groups according to the presence of BAV (group A, 50 patients) or TAV (group B, 50 patients). Mean age was 51 +/- 12 years in group A, and 50 +/- years 12 in group B. No patients had hypertension or Marfan's syndrome. Until July 2001, mean follow-up was 234 +/- 47 months in group A and 241 +/- 43 months in group B.
  
  RESULTS:
  Five patients (10%, CL 5.7 to 13.9) in group A suffered late acute aortic dissection. Acute aortic dissection (5 vs 0, p = 0.0001) and sudden death (7 vs 0, p = 0.0001) occurred more frequently in patients with BAV. All survivors were assessed by echocardiogram. The mean diameter of the ascending aorta was 48.4 mm in group A and 36.8 mm in group B. Three patients in group A were operated on because of ascending aorta aneurysm more than 6 cm in diameter.
  
  CONCLUSIONS:
  As a result of our experience, we recommend a policy of prophylactic replacement of even a seemingly normal and definitely a mildly enlarged ascending aorta in cases of BAV at the moment of AVR, and consideration of a similar approach for any other cardiac surgical procedure in patients with BAV.
  
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• [Advanced heart failure: therapeutic options. Opinion of the surgeon cardiologist].
  Ital Heart J

  2002 Oct;3 Suppl 6():65S-70S.
  
  Bruschi Giuseppe, Colombo Tiziano, Garatti Andrea, Fratto Pasquale, Ribera Elena, Garascia Andrea, Oliva Fabrizio, Frigerio Maria, Vitali Ettore
  
  
  
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• Successful intraventricular thrombolysis during ventricular assist device support.
  Ann Thorac Surg

  2002 May;73(5):1628-9.
  
  Russo Claudio, De Biase Anna Maria, Bruschi Giuseppe, Agati Salvatore, Vitali Ettore
  
  Abstract
  
  Different types of mechanical ventricular assist devices are available for treating end stage congestive heart failure. Despite technical improvements, however, various complications are still reported for patients during mechanical support. We report our experience with intraventricular thrombolysis as a treatment for possible thrombosis of a continuous flow device that had been implanted as a bridge to heart transplantation. This approach has been demonstrated to be both effective and safe.
  
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