ProGlide a potentially safer option than Prostar XL for vascular closure after TAVR
The ProGlide vascular closure device (VCD) shows a better safety profile than the Prostar XL VCD in terms of vascular complications and acute kidney injury (AKI) following transcatheter aortic valve replacement (TAVR), a post hoc analysis of the BRAVO-3* study finds.
“Patients undergoing TAVR are very frail and vulnerable to begin with, so significant blood loss, a kidney injury or spending extra days in the hospital may truly take a toll on their outcomes,” said lead author Dr David Power of Icahn School of Medicine at Mount Sinai in New York, New York, US.
“The results show that this device has the potential to serve as the safer, more effective option.”
Patients undergoing transfemoral TAVR in the original BRAVO-3 trial were randomized to receive bivalirudin or unfractionated heparin (UFH) for periprocedural anticoagulation. The current post hoc analysis stratified 746 patients (93 percent) from the initial population according to the type of VCD used. [Catheter Cardiovasc Interv 2019;93:1374-1381]
Compared with Prostar XL, patients treated with ProGlide were almost half as likely to have major or minor vascular complications** at 30 days (incidence, 15 percent vs 24 percent, adjusted odds ratio [OR], 0.54; p<0.01).
The incidence of AKI was also lower with ProGlide than Prostar XL (17 percent vs 25 percent, OR, 0.61; p=0.01). Similarly, the length of hospital stay was shorter in the ProGlide arm vs the Prostar XL arm (7.3 vs 9.2 days; p<0.001).
The success rates of VCD deployment were similar for both devices (94.7 percent vs 91.5 percent), but the procedure time was shorter with ProGlide (37.6 vs 42.9 minutes; p<0.003).
“Overall, ProGlide may be a simpler device to learn and apply than Prostar XL and appears to demonstrate a superior safety profile in terms of major or minor vascular complications and very low rates of device failure,” highlighted Power and co-authors.
The investigators believed that the inherent differences in the operation and design of the devices might have contributed to the differential safety profile. Prostar XL is typically angulated at 90o to the femoral artery and has a large lumen size, which entails “increased separation of the subcutaneous tissue around the femoral artery prior to deployment,” they explained.
“Previous studies have also noted increased learning curves associated with the Prostar XL device compared to ProGlide, which may further influence operator success and downstream vascular complications,” Power and co-authors pointed out.
No significant differences were seen in the risk of major or any bleeding defined by BARC*** criteria, MACCE#, and death. According to the authors, “This indicates that the majority of vascular complications within our study have mostly consisted of nonroutine postprocedural compression or nonroutine vascular interventions.”
Nonetheless, they acknowledged that this is a post hoc analysis of BRAVO-3 and thus, the study might not be sufficiently powered for the various outcomes. Also, follow-up was limited to 30 days and therefore do not reflect longer-term outcomes.