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BRAVO 3: Choice of vascular closure device in TAVR matters
LAS VEGAS — In a comparison of two vascular closure devices used in transfemoral transcatheter aortic valve replacement procedures, the Perclose ProGlide device was associated with lower rates of vascular complications and acute kidney injury compared with the Prostar XL device, according to new data from the BRAVO 3 trial.
In a post hoc analysis of BRAVO 3 presented at the Society for Cardiovascular Angiography and Interventions Scientific Sessions, David A. Power, MBBCh, internal medicine resident at Icahn School of Medicine at Mount Sinai, and colleagues evaluated 746 patients who were treated with the Perclose ProGlide device (Abbott Vascular; 53%) or the Prostar XL device (Abbott Vascular; 47%).
“Now that studies have been published expanding the indication for TAVR into lower-risk subgroups, and we expect to perform more TAVR procedures as a result, but it is still burdened by very high rates of vascular complications,” Power told Cardiology Today’s Intervention. “There have been previous nonrandomized trials comparing vascular closure devices, but we wanted to compare their impact on vascular and bleeding outcomes in a large randomized dataset.”
Outcomes of interest, all at 30 days, were major or minor vascular complications, major bleeding, acute kidney injury and MACCE, defined as death, MI or stroke.
Major vascular complications included blood transfusion of at least 4 U, unplanned interventions for closure or complications leading to death or end organ damage; minor vascular complications included blood transfusions of 2 U to 3 U or nonroutine compression; and major bleeding was defined as Bleeding Academic Research Consortium (BARC) grade 3b or higher.
The devices were successfully deployed in 94.2% of the ProGlide group and 91.2% of the Prostar XL group (P = .2), according to the researchers.
Major or minor vascular complications were lower in the ProGlide group compared with the Prostar XL group (15% vs. 24%; adjusted OR = 0.54; 95% CI, 0.37-0.8), Power and colleagues found.
Acute kidney injury was also lower in the ProGlide group (17% vs. 25%; aOR = 0.61; 95% CI, 0.4-0.9), but there were no differences between the groups in major bleeding, MACCE and mortality.
“It looks like there is a big difference between these devices, with the ProGlide coming out on top,” Power said in an interview.
Length of hospital stay was shorter in the ProGlide group (7.3 days vs. 9.2 days; P < .001), according to the researchers.
“These two devices are still commonly used, and this study may tip the balance toward use of the ProGlide device,” Power told Cardiology Today’s Intervention. “This post hoc analysis matches some prior data pointing to TAVR operators who are deciding between the two should be using the ProGlide device. Patients typically don’t get a choice in which device is used, but as we are moving toward more patient-centered care, it would be interesting to explore the concept of allowing patients to help choose a closure device, as it could impact their outcomes, especially in the more frail and elderly population.” – by Erik Swain
Reference:
Power DA, et al. Featured Clinical Research II. Presented at: Society for Cardiovascular Angiography and Interventions Scientific Sessions; May 19-22, 2019; Las Vegas.
Disclosure: Power reports no relevant financial disclosures.