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Observational Study
. 2015 Dec 14;36(47):3370-9.
doi: 10.1093/eurheartj/ehv417. Epub 2015 Aug 26.

Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation

Israel M Barbash  1 , Marco Barbanti  2 , John Webb  3 , Javier Molina-Martin De Nicolas  4 , Yigal Abramowitz  5 , Azeem Latib  6 , Caroline Nguyen  7 , Florian Deuschl  8 , Amit Segev  9 , Konstantinos Sideris  10 , Sergio Buccheri  2 , Matheus Simonato  3 , Francesco Della Rosa  4 , Corrado Tamburino  2 , Hasan Jilaihawi  5 , Tadashi Miyazaki  6 , Dominique Himbert  7 , Niklas Schofer  8 , Victor Guetta  9 , Sabine Bleiziffer  10 , Didier Tchetche  4 , Sebastiano Immè  2 , Raj R Makkar  5 , Alec Vahanian  7 , Hendrik Treede  8 , Rüdiger Lange  10 , Antonio Colombo  6 , Danny Dvir  3
Affiliations
Observational Study

Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation

Israel M Barbash et al. Eur Heart J. .

Abstract

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.

Keywords: Aortic stenosis; Transcatheter aortic valve replacement; Vascular closure device; Vascular complication.

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