Matched Comparison of Self-Expanding Transcatheter Heart Valves for the Treatment of Failed Aortic Surgical Bioprosthesis: Insights From the Valve-in-Valve International Data Registry (VIVID).
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Alnasser Sami, Cheema Asim N, Simonato Matheus, Barbanti Marco, Edwards Jeremy, Kornowski Ran, Horlick Eric, Wijeysundera Harindra C, Testa Luca, Bedogni Francesco, Amrane Hafid, Walther Thomas, Pelletier Marc, Latib Azeem, Laborde Jean-Claude, Hildick-Smith David, Kim Won-Keun, Tchetche Didier, Agrifoglio Marco, Sinning Jan-Malte, van Boven Ad J, Kefer Joëlle, Frerker Christian, van Mieghem Nicolas M, Linke Axel, Worthley Stephen, Asgar Anita, Sgroi Carmelo, Aziz Mina, Danenberg Haim D, Labinaz Marino, Manoharan Ganesh, Cheung Anson, Webb John G, Dvir Danny, Valve-in-Valve International Data Registry Investigators
Аннотация
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.