LAS VEGAS – Comparison of two of the most commonly used vascular-access closure devices following transfemoral aortic valve replacement showed that Abbott’s ProGlide device led to significantly fewer vascular complications, especially minor complications; significantly less acute kidney injury; and may have also cut the average procedure duration and length of hospital stay, compared with the Prostar device sold by the same company, based on post hoc analysis of data collected from 746 patients.
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Dr. David A. Power
The analysis also revealed that overall access-site vascular complications occurred in 24% of these patients, who were treated from October 2012 to May 2015 at any of 31 sites in seven countries, David A. Power, MBBCh, said at the Society for Cardiovascular Angiography & Interventions annual scientific sessions.
Although the results came from a nonrandomized (but multivariate-adjusted) comparison of data collected from a trial designed to address a completely different question, the findings appeared to support where the field has moved in recent years, toward greater reliance on the ProGlide device over Prostar, said Dr. Power, a researcher at the Icahn School of Medicine at Mount Sinai, New York.
“The preponderance of data is moving away from using Prostar. ProGlide appears to be coming out on top,” he said during a press briefing. Many operators familiar with both devices seem more comfortable using the ProGlide. But Dr. Power also noted that newer methods have become available for closing a femoral artery puncture following a transvascular procedure with a large-bore catheter, such as new types of plugs and patches.
Dr. Timothy D. Henry
The nearly 25% rate of vascular complications seen in the study “shows we have a way to go” in limiting and dealing with these adverse events, commented Timothy D. Henry, MD, an interventional cardiologist at the Christ Hospital in Cincinnati. The number of vascular complications from large-bore catheters will likely increase now that lower-risk patients will start to routinely undergo transcatheter aortic valve replacement. Methods for optimizing femoral artery closure after catheter puncture “have not received as much attention as they should, so this is a nice and important study,” Dr. Henry said.
Dr. Power and associates used data collected from patients in the BRAVO-3 (Effect of Bivalirudin on Aortic Valve Intervention Outcomes) study, which was designed to compare two different anticoagulants during transcatheter aortic valve replacement procedures. The trial found no statistically significant difference in patient outcomes regardless of the anticoagulant used (J Am Coll Cardiol. 2015 Dec 27;66[25]:2860-8). Review of the patient data showed that 352 of the 802 patients enrolled in BRAVO-3 had their femoral-artery puncture closed with a ProGlide device and 394 had their wound closed with Prostar. These 746 total patients accounted for 93% of all BRAVO-3 patients, highlighting the reliance that the operators on these cases had for these two closure devices in recent practice. The choice of vascular-access closure device in each BRAVO-3 case was at the discretion of the operator for that case.
A multivariate-adjusted analysis that took into account baseline differences between patients treated with ProGlide and Prostar showed that the ProGlide-treated patients had a significant 46% reduced rate of major or minor vascular complications, driven primarily by a reduction in minor complications, Dr. Power reported. The ProGlide-treated patients also showed a statistically significant 39% relative reduction in acute kidney injury, compared with the Prostar patients, a cut Dr. Powers attributed to a reduced need for contrast to check for residual bleeding. The results also showed that the ProGlide-treated patients had an average hospital length of stay about 20% shorter than the Prostar patients, and the average procedure time for the ProGlide-treated patients was about 30% shorter than with Prostar closure.
Concurrently with his report at the meeting, the results also appeared in an article published online (Catheter Cardiovasc Interv. 2019 May 22. doi: 10.1002/ccd.28295).
BRAVO-3 received funding from the Medicines Company. Dr. Power had no disclosures.
SOURCE: Power DA et al. SCAI 2019, Abstract 5743.