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

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

In: EUR HEART J, Vol. 36, No. 47, 14.12.2015, p. 3370-3379.

Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review

Harvard

Barbash, IM, Barbanti, M, Webb, J, Molina-Martin De Nicolas, J, Abramowitz, Y, Latib, A, Nguyen, C, Deuschl, F, Segev, A, Sideris, K, Buccheri, S, Simonato, M, Rosa, FD, Tamburino, C, Jilaihawi, H, Miyazaki, T, Himbert, D, Schofer, N, Guetta, V, Bleiziffer, S, Tchetche, D, Immè, S, Makkar, RR, Vahanian, A, Treede, H, Lange, R, Colombo, A & Dvir, D 2015, 'Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation', EUR HEART J, vol. 36, no. 47, pp. 3370-3379. https://doi.org/10.1093/eurheartj/ehv417

APA

Barbash, I. M., Barbanti, M., Webb, J., Molina-Martin De Nicolas, J., Abramowitz, Y., Latib, A., Nguyen, C., Deuschl, F., Segev, A., Sideris, K., Buccheri, S., Simonato, M., Rosa, F. D., Tamburino, C., Jilaihawi, H., Miyazaki, T., Himbert, D., Schofer, N., Guetta, V., ... Dvir, D. (2015). Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation. EUR HEART J, 36(47), 3370-3379. https://doi.org/10.1093/eurheartj/ehv417

Vancouver

Barbash IM, Barbanti M, Webb J, Molina-Martin De Nicolas J, Abramowitz Y, Latib A et al. Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation. EUR HEART J. 2015 Dec 14;36(47):3370-3379. https://doi.org/10.1093/eurheartj/ehv417

Bibtex

@article{ca1b4c3c87e6499281203ec8383d9751,
title = "Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation",
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 = "Acute Kidney Injury/etiology, Aged, Aged, 80 and over, Aortic Valve Stenosis/surgery, Cardiology/standards, Clinical Competence/standards, Constriction, Pathologic/etiology, Female, Femoral Artery, Humans, Learning Curve, Male, Myocardial Infarction/etiology, Postoperative Hemorrhage/etiology, Stroke/etiology, Transcatheter Aortic Valve Replacement/adverse effects, Vascular Closure Devices/adverse effects, Vascular Diseases/etiology",
author = "Barbash, {Israel M} and Marco Barbanti and John Webb and {Molina-Martin De Nicolas}, Javier and Yigal Abramowitz and Azeem Latib and Caroline Nguyen and Florian Deuschl and Amit Segev and Konstantinos Sideris and Sergio Buccheri and Matheus Simonato and Rosa, {Francesco Della} and Corrado Tamburino and Hasan Jilaihawi and Tadashi Miyazaki and Dominique Himbert and Niklas Schofer and Victor Guetta and Sabine Bleiziffer and Didier Tchetche and Sebastiano Imm{\`e} and Makkar, {Raj R} and Alec Vahanian and Hendrik Treede and R{\"u}diger Lange and Antonio Colombo and Danny Dvir",
note = "Published on behalf of the European Society of Cardiology. All rights reserved. {\textcopyright} The Author 2015. For permissions please email: journals.permissions@oup.com.",
year = "2015",
month = dec,
day = "14",
doi = "10.1093/eurheartj/ehv417",
language = "English",
volume = "36",
pages = "3370--3379",
journal = "EUR HEART J",
issn = "0195-668X",
publisher = "Oxford University Press",
number = "47",

}

RIS

TY - JOUR

T1 - Comparison of vascular closure devices for access site closure after transfemoral aortic valve implantation

AU - Barbash, Israel M

AU - Barbanti, Marco

AU - Webb, John

AU - Molina-Martin De Nicolas, Javier

AU - Abramowitz, Yigal

AU - Latib, Azeem

AU - Nguyen, Caroline

AU - Deuschl, Florian

AU - Segev, Amit

AU - Sideris, Konstantinos

AU - Buccheri, Sergio

AU - Simonato, Matheus

AU - Rosa, Francesco Della

AU - Tamburino, Corrado

AU - Jilaihawi, Hasan

AU - Miyazaki, Tadashi

AU - Himbert, Dominique

AU - Schofer, Niklas

AU - Guetta, Victor

AU - Bleiziffer, Sabine

AU - Tchetche, Didier

AU - Immè, Sebastiano

AU - Makkar, Raj R

AU - Vahanian, Alec

AU - Treede, Hendrik

AU - Lange, Rüdiger

AU - Colombo, Antonio

AU - Dvir, Danny

N1 - Published on behalf of the European Society of Cardiology. All rights reserved. © The Author 2015. For permissions please email: journals.permissions@oup.com.

PY - 2015/12/14

Y1 - 2015/12/14

N2 - 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.

AB - 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.

KW - Acute Kidney Injury/etiology

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve Stenosis/surgery

KW - Cardiology/standards

KW - Clinical Competence/standards

KW - Constriction, Pathologic/etiology

KW - Female

KW - Femoral Artery

KW - Humans

KW - Learning Curve

KW - Male

KW - Myocardial Infarction/etiology

KW - Postoperative Hemorrhage/etiology

KW - Stroke/etiology

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Vascular Closure Devices/adverse effects

KW - Vascular Diseases/etiology

U2 - 10.1093/eurheartj/ehv417

DO - 10.1093/eurheartj/ehv417

M3 - SCORING: Journal article

C2 - 26314688

VL - 36

SP - 3370

EP - 3379

JO - EUR HEART J

JF - EUR HEART J

SN - 0195-668X

IS - 47

ER -