Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: A post hoc analysis from the BRAVO-3 randomized trial.
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Power David, Schäfer Ulrich, Guedeney Paul, Claessen Bimmer E, Sartori Samantha, Sorrentino Sabato, Lefèvre Thierry, Kupatt Christian, Tchetche Didier, Dumonteil Nicolas, Webb John G, Colombo Antonio, Windecker Stephen, Ten Berg Jurriën M, Hildick-Smith David, Boekstegers Peter, Linke Axel, Tron Christophe, Van Belle Eric, Asgar Anita W, Jeger Raban, Sardella Gennaro, Hink Ulrich, Husser Oliver, Grube Eberhard, Lechthaler Ilknur, Wijngaard Peter, Anthopoulos Prodromos, Deliargyris Efthymios N, Bernstein Debra, Hengstenberg Christian, Mehran Roxana, Dangas George D
Аннотация
METHODS: The BRAVO-3 trial randomized 802 patients undergoing transfemoral TAVR. We stratified patients according to type of VCD used and examined the 30-day incidence of major or minor vascular complications, major bleeding (BARC ≥3b), AKI and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke).
RESULTS: A total of 746 (93%) patients were treated with either PS (n = 352, 47%) or PG (n = 394, 53%) VCD, without significant differences in successful deployment rate (PS 322 [91.2%] vs. PG 373 [94.2%] respectively, p = .20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (adjusted OR: 0.54; 95% CI: 0.37-0.80; p < .01). Rates of acute kidney injury were also lower with the PG device. There was no significant difference between bleeding, MACCE, and death.
CONCLUSIONS: Compared to PS, the PG VCD was associated with a lower rate of major or minor vascular complications and lower rates of AKI after transfemoral TAVR.