@article{aa513feceb64480986362d8d2e55aecb,
title = "Balloon Versus Self-Expandable Valve for the Treatment of Bicuspid Aortic Valve Stenosis: Insights from the BEAT International Collaborative Registrys: Circulation: Cardiovascular Interventions",
abstract = "Background: Large data comparing the performance of new-generation self-expandable versus balloon-expandable transcatheter heart valves in bicuspid aortic stenosis are lacking. We aim to compare the safety and performance of balloon-expandable and self-expandable transcatheter heart valves in the treatment of bicuspid aortic stenosis. Methods: The BEAT (balloon versus self-expandable valve for the treatment of bicuspid aortic valve stenosis) registry included 353 consecutive patients who underwent transcatheter aortic valve implantation using new-generation Evolut R/PRO or Sapien 3 valves in bicuspid aortic valve. Results: A total of 353 patients (n=242 [68.6%] treated with Sapien 3 and n=111 [68.6%] treated with Evolut R (n=70)/PRO [n=41]) were included. Mean age was 77.8±8.3 years and mean Society of Thoracic Surgeons Predicted Risk of Mortality was 4.4±3.3%. Valve Academic Research Consortium-2 device success was similar between Sapien 3 and Evolut R/PRO (85.6% versus 87.2%; P=0.68). In the Sapien 3 group, 4 patients experienced annular rupture whereas this complication did not occur in the Evolut R/PRO group. After propensity score matching, Valve Academic Research Consortium-2 device success was similar between both groups (Sapien 3=85.7% versus Evolut R/Pro=84.4%; P=0.821). Both in the overall and in the matched population, no differences in the rate of permanent pacemaker implant were observed. At 1-year follow-up, the rate of overall death and cardiovascular death were similar between the 2 groups. In the unmatched population, the 1-year echocardiographic follow-up demonstrated similar rate of moderate-to-severe paravalvular aortic regurgitation (Evolut R/PRO 10.5% versus Sapien 3 4.2%, P=0.077); however, after propensity matching, the rate of moderate-to-severe paravalvular leak became significantly higher among patients treated with self-expandable valves (9.3% versus 0%; P=0.043). Conclusions: Our study confirms the feasibility of both Sapien 3 and Evolut R/PRO implantation in bicuspid aortic valve anatomy; a higher rate of moderate-severe paravalvular aortic regurgitation was observed in the Evolut R/PRO group at 1-year follow-up in the matched cohort, although patients treated with balloon-expandable valve had a higher rate of annular rupture. {\textcopyright} 2020 Lippincott Williams and Wilkins. All rights reserved.",
keywords = "aortic valve, bicuspid valve, pacemaker, propensity score, surgeons, transcatheter aortic valve replacement, aged, annular rupture, aortic regurgitation, aortic valve stenosis, Article, bicuspid aortic valve, cardiovascular mortality, clinical outcome, cohort analysis, comparative effectiveness, conversion to open surgery, device safety, echocardiography, female, human, major clinical study, male, multidetector computed tomography, paravalvular leak, priority journal, transcatheter aortic valve implantation, valvular heart disease",
author = "A. Mangieri and D. Tchetch{\`e} and W.-K. Kim and M. Pagnesi and J.-M. Sinning and U. Landes and R. Kornowski and {De Backer}, O. and G. Nickenig and A. Ielasi and {De Biase}, C. and L. S{\o}ndergaard and {De Marco}, F. and M. Montorfano and M. Chiarito and D. Regazzoli and G. Stefanini and P. Presbitero and S. Toggweiler and C. Tamburino and S. Imm{\`e} and G. Tarantini and H. Sievert and U. Sch{\"a}fer and J. Kempfert and J. W{\"o}ehrle and F. Gallo and A. Laricchia and A. Latib and F. Giannini and A. Colombo",
note = "Cited By :7 Export Date: 11 March 2021 Correspondence Address: Mangieri, A.; Gvm Care and Research, via della Corriera 1, Italy; email: antonio.mangieri@gmail.com Tradenames: Evolut PRO, Medtronic, United States; Evolut R/PRO, Medtronic, United States; Sapien 3, Edwards Lifesciences, United States Manufacturers: Edwards Lifesciences, United States; Medtronic, United States Funding details: Novartis Funding details: Sanofi Funding details: Pfizer Funding details: Bristol-Myers Squibb, BMS Funding details: Bundesministerium f{\"u}r Bildung und Forschung, BMBF Funding details: Bayer Funding details: European Commission, EC Funding details: AstraZeneca Funding details: Boston Scientific Corporation, BSC Funding details: Abbott Fund Funding details: Boehringer Ingelheim Funding details: Edwards Lifesciences Funding details: Medtronic Funding details: Deutsche Forschungsgemeinschaft, DFG Funding details: Daiichi Sankyo Company Funding text 1: Dr Mangieri has received a research grant (to the institution) from Boston Scientific and a and has served on medical advisory boards for Boston Scientific. Dr Kim received proctor fees from Symetis SA/Boston Scientific, St. Jude Medical/ Abbott, lecture honoraria from Edwards Lifesciences, Symetis SA/Boston, St. Jude Medical/Abbott. Dr Tchetche is proctor for Edwards LifeSciences, Medtron-ic and Boston Scientific. Dr De Biase has been supported by a research grant provided by the Cardiopath PhD program. Dr De Marco serves as proctor for Boston Scientific and Kardia. Dr Giannini serves as proctor for Neovasc. Dr Montor-fano serves as proctor for Edwards Lifescience, Abbott and Kardia. Dr Sch{\"a}fer is consultant and proctor for Edwards Lifesciences, Abbott Vascular, Biotronik, Jena Valve Technology, Medtronic, Inc, Symetis SA and Boston Scientific, received speaker honoraria and travel compensation from JenaValve Technology, Edwards Lifesciences, Abbott Vascular, Medtronic, Inc, Biotronik, Direct Flow Medical, Sy-metis SA and Boston Scientific. Dr Sinning has received speaker honoraria and research grants from Medtronic, Edwards Lifesciences, Abbott, and Boston Scientific. Dr De Backer is consultant for Abbott. Stefan Toggweiler is proctor and consultant for Boston Scientific, proctor and consultant for New Valve Technology, institutional research grant from Boston Scientific. Dr S{\o}ndergaard received institutional research grants and has been consultant for Abbott, Medtronic and Boston Scientific, Medtronic, and Symetis SA. Dr Sievert has received study honoraria, travel expenses, and consulting fees from 4tech Cardio, Abbott, Ablative Solutions, Ancora Heart, Bavaria Medizin Technologie GmbH, Bioventrix, Boston Scientific, Carag, Cardiac Dimensions, Celonova, Comed B.V., Contego, CVRx, Edwards Lifesciences, Endologix, Hemoteq, Lifetech, Maquet Getinge Group, Medtronic, Mitralign, Nuomao Medtech, Occlutech, pfm Medical, Recor, Renal Guard, Rox Medical, Terumo, Vascular Dynamics, and Vivasure Medical. Dr Nick-enig has received research funding from the Deutsche Forschungsgemeinschaft, the German Federal Ministry of Education and Research, the EU, Abbott, AGA Medical, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St Jude Medical; has received honoraria for lectures or advisory boards from Abbott, AGA Medical, AstraZeneca, Bayer, Berlin, Car-diovalve, Berlin Chemie, Biosensus, Biotronic, Bristol-Myers Squibb, Boehringer Ingelheim, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St Jude Medical; and has participated in clinical trials for Abbott, AGA Medical, AstraZeneca, Bayer, Berlin Chemie, Biosensus, Biotronic, Bristol-Myers Squibb, Boehringer Ingelheim, Cardiovalve, Daiichi Sankyo, Edwards Lifesciences, Medtronic, Novartis, Pfizer, Sanofi, and St Jude Medical. Dr Latib has served on advisory boards for Medtronic and Abbott; and has been a consultant to Edwards Lifesciences. The other authors report no conflicts.",
year = "2020",
doi = "10.1161/CIRCINTERVENTIONS.119.008714",
language = "English",
volume = "13",
journal = "Circ. Cardiovasc. Interventions",
issn = "1941-7640",
publisher = "Lippincott Williams and Wilkins",
number = "7",
}