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

Catheter Cardiovasc Interv. 2019 Jun 1;93(7):1374-1381. doi: 10.1002/ccd.28295. Epub 2019 May 22.


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: BRAVO; TAVR; closure device; vascular complication.

Publication types

  • Multicenter Study

MeSH terms

  • Acute Kidney Injury / etiology
  • Acute Kidney Injury / prevention & control
  • Aged
  • Aged, 80 and over
  • Aortic Valve Stenosis / diagnostic imaging
  • Aortic Valve Stenosis / mortality
  • Aortic Valve Stenosis / surgery*
  • Canada
  • Equipment Design
  • Europe
  • Female
  • Hemorrhage / etiology
  • Hemorrhage / mortality
  • Hemorrhage / prevention & control*
  • Hemostatic Techniques / adverse effects
  • Hemostatic Techniques / instrumentation*
  • Hemostatic Techniques / mortality
  • Humans
  • Male
  • Randomized Controlled Trials as Topic
  • Risk Factors
  • Time Factors
  • Transcatheter Aortic Valve Replacement / adverse effects*
  • Transcatheter Aortic Valve Replacement / mortality
  • Treatment Outcome
  • Vascular Closure Devices*
  • Vascular Diseases / etiology
  • Vascular Diseases / mortality
  • Vascular Diseases / prevention & control*

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