Antonio Mangieri1,2, Didier Tchetchè3, Won-Keun Kim4, Matteo Pagnesi2, Jean-Malte Sinning5, Uri Landes6, Ran Kornowski6, Ole De Backer7, Georg Nickenig5, Alfonso Ielasi8, Chiara De Biase3, Lars Søndergaard7, Federico De Marco9, Matteo Montorfano2, Mauro Chiarito10, Damiano Regazzoli10, Giulio Stefanini10, Patrizia Presbitero10, Stefan Toggweiler11, Corrado Tamburino12, Sebastiano Immè13, Giuseppe Tarantini14, Horst Sievert15,16, Ulrich Schäfer17, Jörg Kempfert18, Jochen Wöehrle19, Francesco Gallo1, Alessandra Laricchia1,20, Azeem Latib, Francesco Giannini1, Antonio Colombo1,21. 1. GVM Care and Research, Maria Cecilia Hospital, Cotignola, Ravenna, Italy (A.M., F.G., A.L., F.G., A.C.). 2. San Raffaele Scientific Institute, Milan, Italy (A.M., M.P., M.M.). 3. Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse (D.T., C.D.B.). 4. Kerckhoff Heart Center, Department of Cardiology, Bad Nauheim, Germany (W.-K.K.). 5. Cardiology Department, University Hospital Bonn, Germany (J.-M.S., G.N.). 6. Cardiology Department, Rabin Medical Center, Petah Tikva, Israel (U.L., R.K.). 7. The Heart Center-Rigshospitalet, Copenhagen, Denmark (O.D.B., L.S.). 8. Istituto clinic Sant'Ambrogio, Milan, Italy (A.I.). 9. Department of Cardiology, Istituto Clinico San Donato, Milan, Italy (F.D.M.). 10. Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy (M.C., D.R., G.S., P.P.). 11. Heart Center Lucerne, Luzerner Kantonsspital, Switzerland (S.T.). 12. Cardiology Division, CAST Policlinico Hospital, University of Catania, Italy (C.T.). 13. Centro cuore Morgagni, Catania, Italy (S.I.). 14. Interventional Cardiology unit, University of Padova, Italy (G.T.). 15. Cardiovascular Center Frankfurt, Germany (H.S.). 16. Anglia Ruskin University, Chelmsford, United Kingdom (H.S.). 17. UKE Hamburg, Germany (U.S.). 18. Deutsches Herzzentrum Berlin, Charité Universitätsmedizin, Germany (J.K.). 19. Ulm University, Germany (J.W.). 20. Department of Cardiology, Montefiore Medical Center, New York (A.L.). 21. Centro Cuore Columbus, GVM care and research, Milan, Italy (A.C.).
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.
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.
Authors: Tian-Yuan Xiong; Walid Ben Ali; Yuan Feng; Kentaro Hayashida; Hasan Jilaihawi; Azeem Latib; Michael Kang-Yin Lee; Martin B Leon; Raj R Makkar; Thomas Modine; Christoph Naber; Yong Peng; Nicolo Piazza; Michael J Reardon; Simon Redwood; Ashok Seth; Lars Sondergaard; Edgar Tay; Didier Tchetche; Wei-Hsian Yin; Mao Chen; Bernard Prendergast; Darren Mylotte Journal: Nat Rev Cardiol Date: 2022-06-20 Impact factor: 32.419
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