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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Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: A post hoc analysis from the BRAVO-3 randomized trial. / 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.

in: CATHETER CARDIO INTE, Jahrgang 93, Nr. 7, 01.06.2019, S. 1374-1381.

Publikationen: SCORING: Beitrag in Fachzeitschrift/ZeitungSCORING: ZeitschriftenaufsatzForschungBegutachtung

Harvard

Power, D, Schäfer, U, Guedeney, P, Claessen, BE, Sartori, S, Sorrentino, S, Lefèvre, T, Kupatt, C, Tchetche, D, Dumonteil, N, Webb, JG, Colombo, A, Windecker, S, Ten Berg, JM, Hildick-Smith, D, Boekstegers, P, Linke, A, Tron, C, Van Belle, E, Asgar, AW, Jeger, R, Sardella, G, Hink, U, Husser, O, Grube, E, Lechthaler, I, Wijngaard, P, Anthopoulos, P, Deliargyris, EN, Bernstein, D, Hengstenberg, C, Mehran, R & Dangas, GD 2019, 'Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: A post hoc analysis from the BRAVO-3 randomized trial', CATHETER CARDIO INTE, Jg. 93, Nr. 7, S. 1374-1381. https://doi.org/10.1002/ccd.28295

APA

Power, D., Schäfer, U., Guedeney, P., Claessen, B. E., Sartori, S., Sorrentino, S., Lefèvre, T., Kupatt, C., Tchetche, D., Dumonteil, N., Webb, J. G., Colombo, A., Windecker, S., Ten Berg, J. M., Hildick-Smith, D., Boekstegers, P., Linke, A., Tron, C., Van Belle, E., ... Dangas, G. D. (2019). Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: A post hoc analysis from the BRAVO-3 randomized trial. CATHETER CARDIO INTE, 93(7), 1374-1381. https://doi.org/10.1002/ccd.28295

Vancouver

Bibtex

@article{a588fa722163496f8674394e20c9f192,
title = "Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: A post hoc analysis from the BRAVO-3 randomized trial",
abstract = "BACKGROUND/OBJECTIVE: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear.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.",
keywords = "Acute Kidney Injury/etiology, Aged, Aged, 80 and over, Aortic Valve Stenosis/diagnostic imaging, Canada, Equipment Design, Europe, Female, Hemorrhage/etiology, Hemostatic Techniques/adverse effects, Humans, Male, Randomized Controlled Trials as Topic, Risk Factors, Time Factors, Transcatheter Aortic Valve Replacement/adverse effects, Treatment Outcome, Vascular Closure Devices, Vascular Diseases/etiology",
author = "David Power and Ulrich Sch{\"a}fer and Paul Guedeney and Claessen, {Bimmer E} and Samantha Sartori and Sabato Sorrentino and Thierry Lef{\`e}vre and Christian Kupatt and Didier Tchetche and Nicolas Dumonteil and Webb, {John G} and Antonio Colombo and Stephen Windecker and {Ten Berg}, {Jurri{\"e}n M} and David Hildick-Smith and Peter Boekstegers and Axel Linke and Christophe Tron and {Van Belle}, Eric and Asgar, {Anita W} and Raban Jeger and Gennaro Sardella and Ulrich Hink and Oliver Husser and Eberhard Grube and Ilknur Lechthaler and Peter Wijngaard and Prodromos Anthopoulos and Deliargyris, {Efthymios N} and Debra Bernstein and Christian Hengstenberg and Roxana Mehran and Dangas, {George D}",
note = "{\textcopyright} 2019 Wiley Periodicals, Inc.",
year = "2019",
month = jun,
day = "1",
doi = "10.1002/ccd.28295",
language = "English",
volume = "93",
pages = "1374--1381",
journal = "CATHETER CARDIO INTE",
issn = "1522-1946",
publisher = "Wiley-Liss Inc.",
number = "7",

}

RIS

TY - JOUR

T1 - Impact of percutaneous closure device type on vascular and bleeding complications after TAVR: A post hoc analysis from the BRAVO-3 randomized trial

AU - Power, David

AU - Schäfer, Ulrich

AU - Guedeney, Paul

AU - Claessen, Bimmer E

AU - Sartori, Samantha

AU - Sorrentino, Sabato

AU - Lefèvre, Thierry

AU - Kupatt, Christian

AU - Tchetche, Didier

AU - Dumonteil, Nicolas

AU - Webb, John G

AU - Colombo, Antonio

AU - Windecker, Stephen

AU - Ten Berg, Jurriën M

AU - Hildick-Smith, David

AU - Boekstegers, Peter

AU - Linke, Axel

AU - Tron, Christophe

AU - Van Belle, Eric

AU - Asgar, Anita W

AU - Jeger, Raban

AU - Sardella, Gennaro

AU - Hink, Ulrich

AU - Husser, Oliver

AU - Grube, Eberhard

AU - Lechthaler, Ilknur

AU - Wijngaard, Peter

AU - Anthopoulos, Prodromos

AU - Deliargyris, Efthymios N

AU - Bernstein, Debra

AU - Hengstenberg, Christian

AU - Mehran, Roxana

AU - Dangas, George D

N1 - © 2019 Wiley Periodicals, Inc.

PY - 2019/6/1

Y1 - 2019/6/1

N2 - BACKGROUND/OBJECTIVE: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear.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.

AB - BACKGROUND/OBJECTIVE: Prostar XL (PS) and ProGlide (PG) are common vascular closure devices (VCD) used in TAVR via transfemoral vascular approach. The impact of these VCD on vascular and bleeding complications remains unclear.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.

KW - Acute Kidney Injury/etiology

KW - Aged

KW - Aged, 80 and over

KW - Aortic Valve Stenosis/diagnostic imaging

KW - Canada

KW - Equipment Design

KW - Europe

KW - Female

KW - Hemorrhage/etiology

KW - Hemostatic Techniques/adverse effects

KW - Humans

KW - Male

KW - Randomized Controlled Trials as Topic

KW - Risk Factors

KW - Time Factors

KW - Transcatheter Aortic Valve Replacement/adverse effects

KW - Treatment Outcome

KW - Vascular Closure Devices

KW - Vascular Diseases/etiology

U2 - 10.1002/ccd.28295

DO - 10.1002/ccd.28295

M3 - SCORING: Journal article

C2 - 31116908

VL - 93

SP - 1374

EP - 1381

JO - CATHETER CARDIO INTE

JF - CATHETER CARDIO INTE

SN - 1522-1946

IS - 7

ER -