Vascular Closure Device Type Impacts Bleeding and Vascular Complications After TAVR: Results From the BRAVO 3 Randomized Trial

Background
ProGlide (PG) and Prostar XL (PS) are the leading vascular closure devices (VCDs) used in TAVR via transfemoral vascular approach. The impact of these VCDs on vascular and bleeding complications after TAVR 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), acute kidney injury (AKI) and major adverse cardiac and cerebrovascular events (MACCE; death, myocardial infarction or stroke). Major vascular events were defined as a blood transfusion ≥ 4 units, unplanned interventions for closure or complications leading to death or end organ damage; minor vascular complications included blood transfusions of 2-3 units or non-routine compression. Associations between device type and outcomes were assessed via multivariate logistical regression analysis.

Results
In total, 746 (93%) patients were treated with either PG (n= 394, 53%) or PS (n= 352, 47%) VCD, without significant differences in successful deployment rate (PG 94.2% vs PS 91.2%, p=0.20). PG was associated with a significantly lower incidence of major or minor vascular complications, compared to PS (PG 15% vs PS 24%; Adjusted OR: 0.54; 95% [CI 0.37 – 0.80]; p<0.01). Rates of AKI were lower with PG (PG 17% vs PS 25%, Adjusted OR 0.61 [0.40 - 0.90], p = 0.01). There was no significant differences between major bleeding, MACCE and death. PG was also associated with shorter length of hospital stay (PG 7.3 days [CI: 6.1–11.2] vs PS 9.2 days [CI: 6.8-14.2], p<0.001).

Conclusions
In this analysis of the BRAVO-3 randomized trial, the use of the PG VCD was associated with lower rates of vascular complications, lower rates of AKI and shorter hospitalizations after transfemoral TAVR, compared to PS.