European heart journal · 2015
Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation.
Сравнительное исследованиеСтатьяМногоцентровое исследованиеНаблюдательное исследованиеНазвание и аннотация: Перевод в очереди
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Barbash Israel M, Barbanti Marco, Webb John, Molina-Martin De Nicolas Javier, Abramowitz Yigal, Latib Azeem, Nguyen Caroline, Deuschl Florian, Segev Amit, Sideris Konstantinos, Buccheri Sergio, Simonato Matheus, Rosa Francesco Della, Tamburino Corrado, Jilaihawi Hasan, Miyazaki Tadashi, Himbert Dominique, Schofer Niklas, Guetta Victor, Bleiziffer Sabine, Tchetche Didier, Immè Sebastiano, Makkar Raj R, Vahanian Alec, Treede Hendrik, Lange Rüdiger, Colombo Antonio, Dvir Danny
Аннотация
BACKGROUND: The majority of transcatheter aortic valve implantation (TAVI) procedures are currently performed by percutaneous transfemoral approach. The potential contribution of the type of vascular closure device to the incidence of vascular complications is not clear.
AIM: To compare the efficacy of a Prostar XL- vs. Perclose ProGlide-based vascular closure strategy.
METHODS: The ClOsure device iN TRansfemoral aOrtic vaLve implantation (CONTROL) multi-center study included 3138 consecutive percutaneous transfemoral TAVI patients, categorized according to vascular closure strategy: Prostar XL- (Prostar group) vs. Perclose ProGlide-based vascular closure strategy (ProGlide group). Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics.
RESULTS: Propensity matching identified 944 well-matched patients (472 patient pairs). Composite primary end point of major vascular complications or in-hospital mortality occurred more frequently in Prostar group when compared with ProGlide group (9.5 vs. 5.1%, P = 0.016), and was driven by higher rates of major vascular complication (7.4 vs. 1.9%, P < 0.001) in the Prostar group. However, in-hospital mortality was similar between groups (4.9 vs. 3.5%, P = 0.2). Femoral artery stenosis occurred less frequently in the Prostar group (3.4 vs. 0.5%, P = 0.004), but overall, Prostar use was associated with higher rates of major bleeding (16.7 vs. 3.2%, P < 0.001), acute kidney injury (17.6 vs. 4.4%, P < 0.001) and with longer hospital stay (median 6 vs. 5 days, P = 0.007).
CONCLUSIONS: Prostar XL-based vascular closure in transfemoral TAVI procedures is associated with higher major vascular complication rates when compared with ProGlide; however, in-hospital mortality is similar with both devices.
AIM: To compare the efficacy of a Prostar XL- vs. Perclose ProGlide-based vascular closure strategy.
METHODS: The ClOsure device iN TRansfemoral aOrtic vaLve implantation (CONTROL) multi-center study included 3138 consecutive percutaneous transfemoral TAVI patients, categorized according to vascular closure strategy: Prostar XL- (Prostar group) vs. Perclose ProGlide-based vascular closure strategy (ProGlide group). Propensity-score matching was used to assemble a cohort of patients with similar baseline characteristics.
RESULTS: Propensity matching identified 944 well-matched patients (472 patient pairs). Composite primary end point of major vascular complications or in-hospital mortality occurred more frequently in Prostar group when compared with ProGlide group (9.5 vs. 5.1%, P = 0.016), and was driven by higher rates of major vascular complication (7.4 vs. 1.9%, P < 0.001) in the Prostar group. However, in-hospital mortality was similar between groups (4.9 vs. 3.5%, P = 0.2). Femoral artery stenosis occurred less frequently in the Prostar group (3.4 vs. 0.5%, P = 0.004), but overall, Prostar use was associated with higher rates of major bleeding (16.7 vs. 3.2%, P < 0.001), acute kidney injury (17.6 vs. 4.4%, P < 0.001) and with longer hospital stay (median 6 vs. 5 days, P = 0.007).
CONCLUSIONS: Prostar XL-based vascular closure in transfemoral TAVI procedures is associated with higher major vascular complication rates when compared with ProGlide; however, in-hospital mortality is similar with both devices.