The RAVI registry: prospective, multicenter study of radial access in embolization procedures - 30 days follow up.

Abstract

Background: There is a lack of registry studies about transradial access (TRA) outcomes. This prospective registry evaluated the TRA and procedure outcomes of visceral embolizations performed via TRA with 30-day follow-up.

Material & methods: Prospective, multicenter registry included uterine fibroids (UFE), prostate artery (PAE), liver tumors (LT), and other hypervascular tumors (OHT) embolization performed in six US hospitals. Between February 2020 and January 2022, 99 patients underwent one radial artery visceral intervention (RAVI); 70 had UFE (70.7%), 16 PAE (16.2%), 7 LT (7.1%), and 6 OHT (6.1%). The mean age was 50.1 (±11.1) years, and 74/99 (74.7%) were females. The primary safety endpoints included hand ischemia, stroke, and death. Procedural success was defined as completing the intended procedure via radial artery (RA) access. Technical success was defined as the successful delivery of HydroPearl™ microspheres and complete embolization of the target vessel.

Results: Procedural and technical successes were 100% and 97%, respectively. There was no stroke, hand ischemia, radial-to-femoral conversion, access-related serious adverse events, or clinically evident radial artery occlusion at 30 days. There were two deaths: one respiratory failure and one progression of liver disease. Minor RA-related adverse event included arterial spasm, hematoma, and post-procedure discomfort.

Conclusion: This prospective, multicenter, open-label registry confirmed the high safety profile and effectiveness of radial access in UFE, PAE, LT, and OHT embolization procedures without stroke, hand ischemia, or access-related serious adverse events at 30-day follow-up.