Germán Armijo1, Gilbert H L Tang2, Nynke Kooistra3, Alfredo Nunes Ferreira-Neto4, Stefan Toggweiler5, Ignacio J Amat-Santos6, Lukas S Keller7, Marina Urena8, Hasan Ahmad9, Jose Tafur Soto10, Erika Muñoz-Garcia11, Ander Regueiro12, Geert E Leenders3, Gabriela Tirado-Conte1, Aditya Sengupta2, Angela McInerney1, Thomas Couture4, Oscar Cuevas Herreros7, Tania Rodriguez-Gabella6, Annapoorna Kini13, Mohammed Ahmed10, Syed Zaid9, Nieves Gonzalo1, Ivan J Nuñez-Gil1, Antonio J Muñoz-Garcia11, Pilar Jimenez-Quevedo1, Antonio Fernández-Ortiz1, Dominique Himbert8, Fabian Nietlispach14, Pieter Stella3, George D Dangas13, Javier Escaned1, Carlos Macaya1, Josep Rodés-Cabau4, Luis Nombela-Franco1. 1. Department of Cardiology, Cardiovascular Institute, Hospital Clínico San Carlos, Instituto de Investigación Sanitaria San Carlos, Madrid, Spain (G.A., G.T.-C., A.M., N.G., I.J.N.-G., P.J.-Q., A.F.-O., J.E., C.M., L.N.-F.). 2. Department of Cardiovascular Surgery, Mount Sinai Health System, New York, NY (G.H.L.T., A.S.). 3. Department of Cardiology, University Medical Center Utrecht, Utrecht University, the Netherlands (N.K., G.E.L., P.S.). 4. Department of Cardiology, Quebec Heart and Lung Institute, Laval University, Quebec City, Canada (A.N.F.-N., T.C., J.R.-C.). 5. Department of Cardiology, Heart Center Lucerne, Luzerner Kantonsspital, Switzerland (S.T.). 6. Department of Cardiology, Instituto de Ciencias del Corazón, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Hospital Clínico Universitario de Valladolid, Spain (I.J.A.-S., T.R.-G.). 7. Department of Cardiology, University Heart Centre Zurich, Switzerland (L.S.K., O.C.H.). 8. Department of Cardiology, Assistance publique-Hôpitaux de Paris, Bichat Hospital, France (M.U., D.H.). 9. Division of Cardiology, Westchester Medical Center, Valhalla, New York, NY (H.A., S.Z.). 10. Department of Cardiology, John Ochsner Heart and Vascular Institute, New Orleans, LA (J.T.S., M.A.). 11. Department of Cardiology, Hospital Clínico Universitario Virgen de la Victoria, Centro de Investigación Biomédica en Red de Enfermedades Cardiovasculares, Malaga, Spain (E.M.-G., A.J.M.-G.). 12. Department of Cardiology, Hospital Clinic de Barcelona, Institut Clinic Cardiovascular, IDIBAPS, Spain (A.R.). 13. Division of Cardiology, Mount Sinai Medical Center, New York, NY (A.K., G.D.D.). 14. Department of Cardiology, Universitz Hospital Zurich and Hirslanden Klinik Im Park, Zurich, Switzerland (F.N.).
Abstract
BACKGROUND: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm2 or perimeter ≥85 mm) and extra-large (≥683 mm2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement. METHODS: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported. RESULTS: Median aortic annulus area and perimeter were 617 mm2 (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm2 [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P=0.001), with a higher rate of significant paravalvular leak (P=0.004), second valve implantation (P=0.013), and valve embolization (P=0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group. CONCLUSIONS: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.
BACKGROUND: Currently, 2 third-generation transcatheter valves, 29-mm Sapien-3 and 34-mm Evolut-R (ER), are indicated for large sized aortic annuli. We analyzed short and 1-year performance of these valves in patients with large (area ≥575 mm2 or perimeter ≥85 mm) and extra-large (≥683 mm2 or ≥94.2 mm) aortic annuli undergoing transcatheter aortic valve replacement. METHODS: A total of 833 patients across 12 centers with symptomatic aortic stenosis and large aortic annuli underwent transcatheter aortic valve replacement with 29-mm Sapien-3 (n=640) or 34-mm ER (n=193). Clinical, anatomic, and procedural characteristics were collected, and Valve Academic Research Consortium-2 outcomes were reported. RESULTS: Median aortic annulus area and perimeter were 617 mm2 (591-657) and 89.1 mm (87.0-92.1), respectively (704 mm2 [689-743] and 96.0 mm [94.5-97.9] in the subgroup of 124 patients with extra-large annuli). Overall device success was 94.3% (Sapien-3, 95.8% and ER, 89.3%; P=0.001), with a higher rate of significant paravalvular leak (P=0.004), second valve implantation (P=0.013), and valve embolization (P=0.009) in the ER group. Thirty-day and 1-year mortality was 2.4% and 9.2%, respectively, without differences between groups. Valve hemodynamics were excellent (mean gradient, 8.8±3.6 mm Hg; 3.3% rate of moderate-severe paravalvular leak) in the extra-large annulus, without differences compared with the large annulus group. CONCLUSIONS: In patients with large and extra-large aortic annuli, transcatheter aortic valve replacement using 29-mm Sapien-3 and 34-mm ER is safe and feasible. Observed differences in clinical outcomes and hemodynamic performance may guide valve choice in this cohort of patients undergoing transcatheter aortic valve replacement.
Authors: Mauro Chiarito; Alessandro Spirito; Johny Nicolas; Alexandra Selberg; Giulio Stefanini; Antonio Colombo; Bernhard Reimers; Annapoorna Kini; Samin K Sharma; George D Dangas; Roxana Mehran Journal: J Clin Med Date: 2022-07-30 Impact factor: 4.964
Authors: Markus Mach; Philipp Szalkiewicz; Thomas Poschner; Waseem Hasan; Martin Andreas; Bernhard Winkler; Ena Hasimbegovic; Theresia Steinkellner; Andreas Strouhal; Christopher Adlbrecht; Georg Delle-Karth; Martin Grabenwöger Journal: Eur J Clin Invest Date: 2021-05-06 Impact factor: 4.686