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


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
MonashHEART, Monash Health, Melbourne, Victoria, Australia.
Sarah
S
Zaman
MonashHEART, Monash Health, Melbourne, Victoria, Australia.|Monash University, Melbourne, Victoria, Australia.
Robert
R
Gooley
MonashHEART, Monash Health, Melbourne, Victoria, Australia.
Victoria
V
Cheng
MonashHEART, Monash Health, Melbourne, Victoria, Australia.
Liam
L
McCormick
MonashHEART, Monash Health, Melbourne, Victoria, Australia.|Monash University, Melbourne, Victoria, Australia.
Ian T
IT
Meredith
D000368:Aged; D000369:Aged, 80 and over; D000792:Angiography; D001021:Aortic Valve / Q000000981:diagnostic imaging / Q000503:physiopathology; D001024:Aortic Valve Stenosis / Q000000981:diagnostic imaging / Q000503:physiopathology / Q000628:therapy*; D021721:Balloon Occlusion / Q000009:adverse effects / Q000295:instrumentation; D006328:Cardiac Catheterization / Q000009:adverse effects* / Q000379:methods; D016022:Case-Control Studies; D002406:Catheterization, Peripheral / Q000009:adverse effects* / Q000379:methods; D004867:Equipment Design; D017707:Erythrocyte Transfusion; D005260:Female; D005263:Femoral Artery / Q000000981:diagnostic imaging; D019918:Heart Valve Prosthesis Implantation / Q000009:adverse effects* / Q000379:methods; D006470:Hemorrhage / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D008297:Male; D011446:Prospective Studies; D011677:Punctures; D015641:Radiography, Interventional; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D062666:Vascular Access Devices
aortic valve disease; percutaneous intervention; peripheral intervention; vascular closure; vascular complications