Transcatheter Aortic Valve Replacement With Balloon- Versus Self-Expandable Bioprostheses for the Treatment of Bicuspid Aortic Valve Stenosis
Abstract
BACKGROUND: Differences between balloon- and self-expandable transcatheter heart valves (BE-THVs and SE-THVs, respectively) may influence the outcomes of transcatheter aortic valve replacement for bicuspid aortic valve (BAV) stenosis. METHODS: Consecutive patients undergoing transcatheter aortic valve replacement with BE-THV or SE-THV for computed tomography–diagnosed bicuspid aortic valve stenosis at 29 centers were included. The primary outcome was death or stroke. After propensity score matching in 10 data sets generated by multiple imputation, outcomes from transcatheter aortic valve replacement to 3-year follow-up were computed by multivariable binomial logistic mixed-effects models, multivariable linear mixed-effects models, or multivariable frailty models accounting for center-related influences and residual confounding effects (doubly robust adjustment). The results were replicated by inverse probability of treatment weighting and multivariable adjustment. RESULTS: A total of 1443 consecutive patients with bicuspid aortic valve stenosis undergoing BE-THV (n=860) or SE-THV (n=583) implantation were included. In-hospital and 30-day death or stroke did not significantly differ between BE-THV and SE-THV groups (5.1% versus 6.1%; hazard ratio after propensity score matching, 1.02 [95% CI, 0.51–2.02]). BE-THV implantation was associated with higher annulus rupture and mean transvalvular gradient compared with SE-THV implantation. In contrast, SE-THV implantation was associated with higher additional valve implantation and paravalvular regurgitation compared with BE-THV implantation. The results were consistent across the statistical methods used and between early- and new-generation THVs. At 30 days, pacemaker implantation was lower in the BE-THV group compared with the SE-THV group (11.9% versus 18.6%; hazard ratio after propensity score matching, 0.58 [95% CI, 0.36–0.93]). This result did not depend on the statistical method used. At 3 years, consistent with the 1- and 2-year analyses, death or stroke was not significantly different between the BE-THV and SE-THV groups (23.7% versus 26.2%; hazard ratio after propensity score matching, 0.99 [95% CI, 0.65–1.51]). Death or stroke across major clinical, anatomical, functional, and procedural conditions was consistent with the main analysis. After inverse probability of treatment weighting and multivariable adjustment, these conclusions remained unchanged. CONCLUSIONS: In patients undergoing transcatheter aortic valve replacement for bicuspid aortic valve stenosis, death or stroke does not significantly differ between those receiving a BE-THV and those receiving an SE-THV over a follow-up of 3 years. BE-THV is associated with higher transvalvular mean gradient and more frequent annulus rupture, whereas SE-THV is associated with more frequent moderate to severe aortic regurgitation, additional THV implantation, and permanent pacemaker implantation.
Article Details
Authors (62)
Daniele Giacoppo
Department of General Surgery and Medical-Surgical Specialties, University of Catania, Italy (D.G.).
Hector A. Alvarez-Covarrubias
Deutsches Herzzentrum München, Technisches Universität München, Germany (D.G., H.A.A.-C., E.X., J.M.M., J.Z., H.R., R.L., A.K., M.J., A.M.K., R.A.B.).
Erion Xhepa
Deutsches Herzzentrum München, Technisches Universität München, Germany (D.G., H.A.A.-C., E.X., J.M.M., J.Z., H.R., R.L., A.K., M.J., A.M.K., R.A.B.).
Yuji Matsuda
Stefano Cangemi
Department of Cardiovascular and Pulmonary Sciences Policlinico Universitario Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy (S.C., F.B.).
Jonathan M. Michel
Deutsches Herzzentrum München, Technisches Universität München, Germany (D.G., H.A.A.-C., E.X., J.M.M., J.Z., H.R., R.L., A.K., M.J., A.M.K., R.A.B.).
Anna Sannino
Johannes Ziegelmüller
Deutsches Herzzentrum München, Technisches Universität München, Germany (D.G., H.A.A.-C., E.X., J.M.M., J.Z., H.R., R.L., A.K., M.J., A.M.K., R.A.B.).
Enrico Criscione
Azienda Ospedaliero-Universitaria Policlinico Rodolico-San Marco, University of Catania, Italy (D.G., E.C., M.B., C.T., D.C.).
Motoki Fukutomi
The Heart Center, Rigshospitalet, University of Copenhagen, Denmark (M.F.).
Manuel Hein
Department of Cardiology and Angiology, Medical Center and Faculty of Medicine, University of Freiburg, Germany (M.H., P.R., F.-J.N.).
Romain Didier
Cardiology Department, CHU Brest, Brest, France
David Meier
Taishi Okuno
Department of Cardiology, Inselspital, University of Bern, Switzerland (T.O., S.W., T.P.).
Sebastian Ludwig
Marco Ancona
Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy (M.A., M.M.).
Dimitry Schewel
Cardiology, Marienkrankenhaus, Hamburg, Germany (D.S.).
Tommaso Fabris
Department of Cardiac, Thoracic, and Vascular Sciences, University of Padua, Italy (Y.M., T.F., G.T.).
Flavien Vincent
Cardiology, University Hospital Lille, France (F.V., E.V.B.).
Lisa Voigtländer
Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Germany (S.L., L.V., N.S.).
Francesca Ziviello
Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands (F.Z., N.M.V.M.).
Richard Tanner
Department of Cardiology, Mater Misericordiae University Hospital, Dublin, Ireland (R.T., I.C.).
Claudia Tamburino
Azienda Ospedaliero-Universitaria Policlinico Rodolico-San Marco, University of Catania, Italy (D.G., E.C., M.B., C.T., D.C.).
Hendrik Ruge
Deutsches Herzzentrum München, Technisches Universität München, Germany (D.G., H.A.A.-C., E.X., J.M.M., J.Z., H.R., R.L., A.K., M.J., A.M.K., R.A.B.).
Mattia Lunardi
Department of Cardiology, Galway University Hospitals, Ireland (M.L., D.M.).
Pablo Codner
Department of Cardiology, Rabin Medical Center, Tel-Aviv University, Israel (P.C., R.K.).
Marco Barbanti
Azienda Ospedaliero-Universitaria Policlinico Rodolico-San Marco, University of Catania, Italy (D.G., E.C., M.B., C.T., D.C.).
Fabian Nietlispach
Department of Cardiology, University Hospital Zurich, Switzerland (J.M.M., F.N., A.M.K.).
Holger Nef
Department of Cardiology, Justus Liebig University Giessen, Germany (H.N.).
Ivan Casserly
Cardiovascular Research Institute, Mater Private Hospital, Royal College of Surgeons in Ireland, Dublin, Ireland (D.G., I.C., M.S.S., R.A.B.).
Vasilis Babaliaros
Emory University, Atlanta
Didier Tchétché
Clinique Pasteur, Toulouse, France
Rüdiger Lange
Deutsches Herzzentrum München, Technisches Universität München, Germany (D.G., H.A.A.-C., E.X., J.M.M., J.Z., H.R., R.L., A.K., M.J., A.M.K., R.A.B.).
Martine Gilard
Cardiology Department, CHU Brest, Brest, France
Matteo Montorfano
Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy (M.A., M.M.).
Martin Landt
Segeberger Kliniken, Bad Segeberg, Germany
Paul Grayburn
Department of Cardiology, Baylor Research Institute, Plano, TX (A.S., P.G.).
Philipp Ruile
Department of Cardiology and Angiology, Medical Center and Faculty of Medicine, University of Freiburg, Germany (M.H., P.R., F.-J.N.).
Nicolas M. Van Mieghem
Department of Cardiology, Thoraxcenter, Erasmus University Medical Center, Rotterdam, the Netherlands
Francesco Bedogni
Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese, Milan
George Dangas
Corrado Tamburino
Azienda Ospedaliero-Universitaria Policlinico Rodolico-San Marco, University of Catania, Italy (D.G., E.C., M.B., C.T., D.C.).
Niklas Schofer
Department of Cardiovascular Surgery, University Heart and Vascular Center Hamburg, Germany (S.L., L.V., N.S.).
Francesco Burzotta
Department of Cardiovascular and Pulmonary Sciences Policlinico Universitario Gemelli, Università Cattolica del Sacro Cuore, Rome, Italy (S.C., F.B.).
Eric Van Belle
Department of Cardiology, Institut Cœur Poumon, Centre Hospitalier Universitaire Lille, Lille, France
Franz-Josef Neumann
Ran Kornowski
Department of Cardiology, Rabin Medical Center, Petah Tikva, Israel
Flavio Ribichini
Division of Cardiology, Department of Medicine, University of Verona, Italy (M.L., F.R.).
Darren Mylotte
From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (D.J.G., W.L.B., J.P., B.J.W.M.R., L.T., M.J.S., J.B., V.J.N., D.C.O., J.M.B.), the Department of Cardiology, Amsterdam UMC, Amsterdam (H.M.A., J.G.P.T., R.D.), the Department of Cardiology, University Medical Center Utrecht, Utrecht (H.M.A., M. Voskuil), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.J.P.R., V.J.N., N.R.), the Department of Cardiology, Maastricht University Medical Center (L.V., A.J.J.I., P.A.V., A.W.J.H.), and Cardiovascular Research Institute Maastricht (L.V., P.A.V., A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Leiden University Medical Center, Leiden (F.K., J.M.M.-C.), the Department of Cardiology, University Medical Center Groningen, Groningen (K.H.B., J.J.W.), the Department of Cardiology, Erasmus University Medical Center, Rotterdam (N.M.V.M.), the Department of Cardiology, Haga Hospital, the Hague (C.E.S.), the Department of Cardiology, Amphia Hospital, Breda (A.J.J.I...
Stephan Windecker
Gert Richardt
Lars Sondergaard
Abbott Structural Heart, Santa Clara, CA (L.S.).
John G. Webb
St. Paul’s Hospital, University of British Columbia, Vancouver, Canada
Giuseppe Tarantini
Interventional Cardiology Unit, Department of Cardiac, Thoracic, Vascular Sciences, and Public Health, University of Padua Medical School, Padua, Italy
Thomas Pilgrim
Roxana Mehran
Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, NY (R.M.).
Davide Capodanno
From the University of Florida College of Medicine, Jacksonville (D.J.A.); and Azienda Ospedaliero–Universitaria Policlinico “Gaspare Rodolico–San Marco,” University of Catania, Catania, Italy (D.C.).
Adnan Kastrati
Klinik für Herz- und Kreislauferkrankungen, TUM Klinikum Deutsches Herzzentrum, Technische Universität München, Munich
Michael Joner
Department of Cardiology, German Heart Center Munich, Technical University of Munich, Munich, Germany (M.J.).
Mark S. Spence
Cardiovascular Research Institute, Mater Private Hospital, Royal College of Surgeons in Ireland, Dublin, Ireland (D.G., I.C., M.S.S., R.A.B.).
Albert M. Kasel
Deutsches Herzzentrum München, Technisches Universität München, Germany (D.G., H.A.A.-C., E.X., J.M.M., J.Z., H.R., R.L., A.K., M.J., A.M.K., R.A.B.).
Robert A. Byrne
Department of Cardiology, Mater Private Network, Dublin