Results from the largest randomised trial to date comparing different closure device strategies following transcatheter aortic valve implantation (TAVI) found that a plug-based vascular closure technique had a shorter time to haemostasis but a higher rate of access-site or access-related vascular complications.
Findings were presented by study author Mohamed Abdel-Wahab (University of Leipzig, Leipzig, Germany) during a late-breaking clinical trial session at the Transcatheter Cardiovascular Therapeutics annual meeting (TCT 2021, 4–6 November, Orlando USA and virtual) published simultaneously in Circulation.
TAVI is commonly used for elderly patients with severe aortic stenosis (AS), however vascular complications after transfemoral TAVI contribute significantly to morbidity and mortality and are commonly related to the arterial access site. Several approved percutaneous vascular closure device (VCD) strategies are available and are being used interchangeably in routine clinical practice.
The CHOICE-CLOSURE trial was an investigator-initiated, multicentre trial that randomised patients with severe symptomatic AS and acceptable transfemoral vascular access to either the pure plug-based Manta (Teleflex) closure technique or the primary suture-based ProGlide (Abbott) technique. Between June 2020 and June 2021, 516 patients undergoing transfemoral TAVI were enrolled and randomised 1:1 at three German centres.
The Manta, plug-based strategy was used in 258 patients and 258 patients received the suture-based, ProGlide, vascular closure strategy.
The primary endpoint was the rate of access-site or access-related vascular complications according to the Valve Academic Research Consortium (VARC)-2 definition during index hospitalisation. The event rate for the plug-based technique was 19.4% compared to 12% in the suture-based technique (RR 1.61, 95% CI 1.07‒2.44, p=0.029).
Secondary endpoints included device failure, time to haemostasis and access-site related bleeding at 30 days. Time to haemostasis was found to be lower with the plug-based technique (80 seconds vs. 240 seconds, p<0.001). The 30-day outcomes for access-site or access-related vascular complications, access-site or access-related bleeding and/or VCD failure was 19.8% for the plug-based group compared to 12.8% for the suture-based group (p=0.043).
“With the introduction of large-bore plug-based devices, operators now have an alternative to the classical suture-based technique,” said Abdel-Wahab. “However, randomised comparisons of these technique are scarce. Results from CHOICE-CLOSURE indicate that both techniques have infrequent severe complications, with low and comparable mortality and life-threatening bleeding rates. While associated with a shorter time to haemostasis, the plug-based technique did have a significantly higher rate of access-site or access-related vascular complications.”