Impact of routine crossover balloon occlusion technique on access-related vascular complications following transfemoral transcatheter aortic valve replacement.

Abstract

Objectives: To determine the impact of incorporating routine crossover balloon occlusion technique (CBOT) for vascular access closure following transcatheter aortic valve replacement (TAVR) on major access-site-related complications. Background(s): Vascular complications are associated with increased mortality following TAVR. The CBOT involves passage of a balloon catheter from the contralateral femoral artery to enable controlled closure of large-sheath access-sites. Method(s): Consecutive patients who underwent transfemoral TAVR as part of three clinical trials were prospectively recruited. Patients who had routine CBOT (CBOT group, n = 55) were compared to preceding patients who did not undergo CBOT (control group, n = 43). The primary endpoint was 30-day occurrence of access-site-related Valve Academic Research Consortium (VARC)-2 defined major vascular and/or bleeding complications. Result(s): CBOT was successfully performed in 96% with 2% occurrence of a minor CBOT-related complication. At 30-days access-site-related major vascular and/or bleeding occurred in 5.5% and 18.6% of the CBOT and control group, respectively (P = 0.042). This consisted of VARC-2 major vascular events in 3.6% and 16.3% (P = 0.036) and VARC-2 major/life-threatening bleeding events in 5.5% and 14.0% (P = 0.137) of the CBOT and control group, respectively. Transfusion of >=2 units of packed red blood cells were required in 10.9% and 30.2% of the CBOT and control group, respectively (P = 0.016). There was no significant difference in contrast load, procedure time, and kidney injury between the two groups. Conclusion(s): Routine CBOT for TAVR access-site closure has a high success rate and is associated with a significant reduction in VARC-2 major vascular and bleeding complications compared to TAVR performed without CBOT. © 2016 Wiley Periodicals, Inc.