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, Vol. 93, No. 7, 01.06.2019, p. 1374-1381.Research output: SCORING: Contribution to journal › SCORING: Journal article › Research › peer-review
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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 -