Matched Comparison of Self Expanding Transcatheter Heart Valves for the Treatment of Failed Surgical Aortic Bioprosthesis: Insights from the Valve in Valve International Data (VIVID) Registry.
Sami M. Alnasser1, Asim Cheema1, Ran Kornowski2, Matheus Simonato3, Thomas Walther4, Azeem Latib5, Luca Testa6, JeanClaude Laborde7, David Hildick Smith8, Marco Barbanti9, WonKeun Kim10, Francesco Bedogni11, Hafid Amrane12, A. J. van Boven13, Marc Pelletier14, Josep RodesCabau15, Joelle Kefer16, Christian Frerker17, Nicolas M Van Mieghem18, Ganesh Manoharan19, Stephen G Worthley20, Anita W Asgar21, carmelo sgroi22, John Webb23, Danny Dvir24.
1University of Toronto, Toronto, ON, Canada, 2Rabin Medical Center, Tel Aviv, Israel, 3Escola Paulista de Medicina, Sao Paulo, Brazil, 4Kerckhhoff Heart Center, Bad Nauheim, Germany, 5Ospedale San Raffaele, Milan, Italy, 6Istituto Clinico S. Ambrogio, Milan, Italy, 7St.George hospital, London, Plumtree Nottingham, United Kingdom, 8Royal Sussex County Hospital, Brighton, United Kingdom, 9Ferrarotto Hospital, University of Catania, Catania, Italy, 10Kerckhoff Heart Center, Bad Nauheim, Germany, 11Istituto Clinico S Ambrogio, Milan, Italy, 12Medisch Centrum, Leeuwarden, Netherlands, 13Medisch Centrum Leeuwarden, Leeuwarden, Netherlands, 14New Brunswick Heart Center, Saint John, NB, Canada, 15Quebec Heart and Lung Institute, Laval, QC, Canada, 16Cliniques SaintLuc, Université catholique de Louvain, Brussels,, Belgium, 17Asclepios Clinic St. Georg, Hamburg, Germany, 18Erasmus MC, Rotterdam, Rotterdam, Netherlands, 19Royal Victoria Hospital, Belfast, United Kingdom, 20The University of Adelaide,, Adelaide, Australia, 21Montreal Heart Institute, Montreal, QC, Canada, 22FERRAROTTO'S HOSPITAL,, CATANIA, Italy, 23St Pauls Hospital, Vancouver, BC, Canada, 24St Paul's Hospital, Vancouver, BC, Canada.
OBJECTIVE: Portico® (St. Jude Medical) and CoreValve™ (Medtronic) are both nitinol based self-expanding transcatheter heart valves with unique features enabling device retrievability for Portico and supra annular valve position for CoreValve systems. In this study, we sought to investigate the effect of the different self-expanding valve design on hemodynamic and clinical performance when implanted for degenerated aortic valve bioprosthesis (valve in valve, ViV)
METHODS: Patients undergoing Portico implantation for degenerated aortic bioprosthesis were compared to those undergoing CoreValve implantation after matching for differences in age, gender, STS score, procedural access, bioprosthesis valve design and label size in a 1:2 fashion. Blinded core lab analysis of post-implantation imaging data was conducted independently. Outcomes were defined as per Valve Academic Research Consortium II (VARC¬II).
RESULTS: A total of 159 patients that underwent ViV using a self¬expanding device were included in the analysis (age 79±8yrs, 61.5% female). The group included 53 Portico implantations that were matched with 106 CoreValve patients having similar clinical and surgical valve characteristics. Baseline demographic and procedural characteristics, echocardiographic and clinical outcomes are detailed in the table. Clinical outcomes were comparable between the two groups; trend toward higher rate of major bleeding is noted among Portico group. Malpositioning, need for 2nd THV and coronary obstruction were higher among CoreValve but not statistically significant (4% vs. 9%, p=0.34). CoreValve is associated with larger effective orifice area (1.31 ± 0.47 vs 1.62 ± 0.55, p= 0.003), lower rate of patient prosthesis mismatch (77% vs. 55%, p=0.02), with comparable postoperative mean aortic gradient (17.2 ± 7.6 Vs. 15.5 ± 7.4, p=0.19). Rate of ≥ moderate aortic insufficiency was observed more frequently among Portico compared to CoreValve group (13.7% vs.4.2%, p=0.04).
CONCLUSIONS: Design differences between the studied self-expanding devices are associated with variable post implantation THV hemodynamics, observed more favorably in the CoreValve group. Further analyses of implantation data (operators experience, THV depth etc.) & longer term outcomes are planned to further understand the mechanism and significance of observed hemodynamic differences.
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