Format

Send to

Choose Destination
Eur Heart J. 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.

Author information

1
Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sackler Faculty of Medicine, Tel Aviv University, Ramat Gan, Israel ibarbash@gmail.com.
2
Division of Cardiology, Ferrarotto Hospital, University of Catania, Catania, Italy.
3
Department of Cardiology, St Paul's Hospital, University of British Columbia, Vancouver, BC, Canada.
4
Groupe CardioVasculaire Interventionnel, Clinique Pasteur, Toulouse, France.
5
Cedars-Sinai Medical Center, Cedars-Sinai Heart Institute, Los Angeles, CA, USA.
6
Interventional Cardiology Unit, EMO-GVM Centro Cuore Columbus & San Raffaele Scientific Institute, Milan, Italy.
7
Department of Cardiology, Bichat-Claude-Bernard Hospital, Assistance Publique-Hôpitaux de Paris, Université Paris VII, Paris, France.
8
Department of Cardiovascular Surgery, University Heart Center, Hamburg, Germany.
9
Leviev Heart Center, Sheba Medical Center, Tel Hashomer, Sackler Faculty of Medicine, Tel Aviv University, Ramat Gan, Israel.
10
Clinic for Cardiovascular Surgery, German Heart Centre, Munich, Germany.

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

PMID:
26314688
DOI:
10.1093/eurheartj/ehv417
[Indexed for MEDLINE]

Supplemental Content

Full text links

Icon for Silverchair Information Systems
Loading ...
Support Center