Sami Alnasser1, Asim N Cheema2, Matheus Simonato1, Marco Barbanti1, Jeremy Edwards1, Ran Kornowski1, Eric Horlick1, Harindra C Wijeysundera1, Luca Testa1, Francesco Bedogni1, Hafid Amrane1, Thomas Walther1, Marc Pelletier1, Azeem Latib1, Jean-Claude Laborde1, David Hildick-Smith1, Won-Keun Kim1, Didier Tchetche1, Marco Agrifoglio1, Jan-Malte Sinning1, Ad J van Boven1, Joëlle Kefer1, Christian Frerker1, Nicolas M van Mieghem1, Axel Linke1, Stephen Worthley1, Anita Asgar1, Carmelo Sgroi1, Mina Aziz1, Haim D Danenberg1, Marino Labinaz1, Ganesh Manoharan1, Anson Cheung1, John G Webb1, Danny Dvir2. 1. From the St. Michael's Hospital, Toronto, Canada (S.A., A.N.C., J.E.); St. Paul's Hospital, Vancouver, Canada (M.S., M. Aziz, A.C., J.G.W., D.D.); Ferrarotto Hospital, University of Catania, Italy (M.B., C.S.); Rabin Medical Center, Tel Aviv, Israel (R.K.); Peter Munk Cardiac Center, Toronto, Canada (E.H.); Schulich Heart Centre, Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, Canada (H.C.W.); Department of Cardiology, IRCCS Pol. S. Donato, Milan, Italy (L.T., F.B.); Medisch Centrum Leeuwarden, Netherlands (H.A., A.J.v.B.); Kerckhoff-Klinik Bad Nauheim, Germany (T.W., W.-K.K.); New Brunswick Heart Center, Saint John, Canada (M.P.); San Raffaele Scientific Institute, Milan, Italy (A. Latib); St. George's Hospital, London, England (J.-C.L.); Sussex Cardiac Centre, Brighton, England (D.H.-S.); Clinique Pasteur, Toulouse, France (D.T.); Centro Cardiologico Monzino, Milan, Italy (M. Agrifoglio); Heart Center, University Hospital Bonn, Germany (J.-M.S.); University Clinics Saint Luc, Brussels, Belgium (J.K.); Asklepios Klinik St. Georg Hospital, Hamburg, Germany (C.F.); Erasmus University Medical Center, Rotterdam, Netherlands (N.M.v.M.); Heart Center, University of Leipzig, Germany (A. Linke); Royal Adelaide Hospital, Australia (S.W.); Montreal Heart Institute, Canada (A.A.); Hadassah Hebrew University Medical Center, Jerusalem, Israel (H.D.D.); Ottawa Heart Institute, Canada (M.L.); and Royal Victoria Hospital, Belfast, United Kingdom (G.M.). 2. From the St. Michael's Hospital, Toronto, Canada (S.A., A.N.C., J.E.); St. Paul's Hospital, Vancouver, Canada (M.S., M. Aziz, A.C., J.G.W., D.D.); Ferrarotto Hospital, University of Catania, Italy (M.B., C.S.); Rabin Medical Center, Tel Aviv, Israel (R.K.); Peter Munk Cardiac Center, Toronto, Canada (E.H.); Schulich Heart Centre, Division of Cardiology, Sunnybrook Health Sciences Centre, Toronto, Canada (H.C.W.); Department of Cardiology, IRCCS Pol. S. Donato, Milan, Italy (L.T., F.B.); Medisch Centrum Leeuwarden, Netherlands (H.A., A.J.v.B.); Kerckhoff-Klinik Bad Nauheim, Germany (T.W., W.-K.K.); New Brunswick Heart Center, Saint John, Canada (M.P.); San Raffaele Scientific Institute, Milan, Italy (A. Latib); St. George's Hospital, London, England (J.-C.L.); Sussex Cardiac Centre, Brighton, England (D.H.-S.); Clinique Pasteur, Toulouse, France (D.T.); Centro Cardiologico Monzino, Milan, Italy (M. Agrifoglio); Heart Center, University Hospital Bonn, Germany (J.-M.S.); University Clinics Saint Luc, Brussels, Belgium (J.K.); Asklepios Klinik St. Georg Hospital, Hamburg, Germany (C.F.); Erasmus University Medical Center, Rotterdam, Netherlands (N.M.v.M.); Heart Center, University of Leipzig, Germany (A. Linke); Royal Adelaide Hospital, Australia (S.W.); Montreal Heart Institute, Canada (A.A.); Hadassah Hebrew University Medical Center, Jerusalem, Israel (H.D.D.); Ottawa Heart Institute, Canada (M.L.); and Royal Victoria Hospital, Belfast, United Kingdom (G.M.). cheemaa@smh.ca danny.dvir@gmail.com.
Abstract
BACKGROUND: Transcatheter valve-in-valve implantation is an established therapy for high-risk patients with failed surgical aortic bioprosthesis. There are limited data comparing outcomes of valve-in-valve implantation using different transcatheter heart valves (THV). METHODS AND RESULTS: Patients included in the Valve-in-Valve International Data registry (VIVID) and treated with self-expanding THV devices were analyzed using centralized core laboratory blinded to clinical events. St. Jude Medical Portico versus Medtronic CoreValve were compared in a 1:2 fashion after propensity score matching. A total of 162 patients, Portico- (n=54) and CoreValve- (n=108) based valve-in-valve procedures comprised the study population with no significant difference in baseline characteristics (age, 79±8.2 years; 60% women; mean STS [Society of Thoracic Surgery] score 8.1±5.5%). Postimplantation, CoreValve was associated with a larger effective orifice area (1.67 versus 1.31 cm2; P=0.001), lower mean gradient (14±7.5 versus 17±7.5 mm Hg; P=0.02), and lower core laboratory-adjudicated moderate-to-severe aortic insufficiency (4.2% versus 13.7%; P=0.04), compared with Portico. Procedural complications including THV malpositioning, second THV requirement, or coronary obstruction were not significantly different between the 2 groups. Survival and stroke rates at 30 days were similar, but overall mortality at 1 year was higher among patients treated with Portico compared with CoreValve (22.6% versus 9.1%; P=0.03). CONCLUSIONS: In this first matched comparison of THVs for valve-in-valve implantations, Portico and CoreValve demonstrated differences in postprocedural hemodynamics and long-term clinical outcomes. Although this could be related to THV design characteristics, the impact of other procedural factors cannot be excluded and require further evaluation.
BACKGROUND: Transcatheter valve-in-valve implantation is an established therapy for high-risk patients with failed surgical aortic bioprosthesis. There are limited data comparing outcomes of valve-in-valve implantation using different transcatheter heart valves (THV). METHODS AND RESULTS:Patients included in the Valve-in-Valve International Data registry (VIVID) and treated with self-expanding THV devices were analyzed using centralized core laboratory blinded to clinical events. St. Jude Medical Portico versus Medtronic CoreValve were compared in a 1:2 fashion after propensity score matching. A total of 162 patients, Portico- (n=54) and CoreValve- (n=108) based valve-in-valve procedures comprised the study population with no significant difference in baseline characteristics (age, 79±8.2 years; 60% women; mean STS [Society of Thoracic Surgery] score 8.1±5.5%). Postimplantation, CoreValve was associated with a larger effective orifice area (1.67 versus 1.31 cm2; P=0.001), lower mean gradient (14±7.5 versus 17±7.5 mm Hg; P=0.02), and lower core laboratory-adjudicated moderate-to-severe aortic insufficiency (4.2% versus 13.7%; P=0.04), compared with Portico. Procedural complications including THV malpositioning, second THV requirement, or coronary obstruction were not significantly different between the 2 groups. Survival and stroke rates at 30 days were similar, but overall mortality at 1 year was higher among patients treated with Portico compared with CoreValve (22.6% versus 9.1%; P=0.03). CONCLUSIONS: In this first matched comparison of THVs for valve-in-valve implantations, Portico and CoreValve demonstrated differences in postprocedural hemodynamics and long-term clinical outcomes. Although this could be related to THV design characteristics, the impact of other procedural factors cannot be excluded and require further evaluation.