Comparison of a Pure Plug-Based versus a Primary Suture-Based Vascular Closure Device Strategy for Transfemoral Transcatheter Aortic Valve Replacement: The CHOICE-CLOSURE Randomized Clinical Trial.

Background: Transcatheter aortic valve replacement (TAVR) is an established treatment option for patients with severe symptomatic aortic stenosis (AS), and is most commonly performed through the transfemoral access route. Percutaneous access site closure can be achieved using dedicated plug-based or suture-based vascular closure device (VCD) strategies, but randomized comparative studies are scarce. Methods: The CHOICE-CLOSURE (Randomized Comparison of CatHeter-based Strategies fOr Interventional ACcess SitE CLOSURE during Transfemoral Transcatheter Aortic Valve Implantation) trial is an investigator-initiated, multicenter study, in which patients undergoing transfemoral TAVR were randomly assigned to vascular access site closure using either a pure plug-based technique (MANTA, Teleflex, Wayne, Pennsylvania) with no additional VCDs or a primary suture-based technique (ProGlide, Abbott Vascular, Abbott Park, Illinois) potentially complemented by a small-plug. The primary endpoint consisted of access-site or access-related major and minor vascular complications during index hospitalization, defined according to the Valve Academic Research Consortium-2 criteria. Secondary endpoints included the rate of access-site or access-related bleeding, VCD failure, and time to hemostasis Results: A total of 516 patients were included and randomized. The mean age of the study population was 80.5±6.1 years, 55.4% were male, 7.6% of patients had peripheral vascular disease, and the mean Society of Thoracic Surgeons score was 4.1±2.9%. The primary endpoint occurred in 19.4% (50/258) of the pure plug-based group and 12.0% (31/258) of the primary suture-based group (relative risk [RR]: 1.61, 95% confidence interval [CI]: 1.07-2.44, p=0.029). Access-site or access-related bleeding occurred in 11.6% vs. 7.4% (RR: 1.58, 95%CI: 0.91-2.73, p=0.133) and device failure in 4.7% vs. 5.4% (RR: 0.86, 95%CI: 0.40-1.82, p=0.841) in the respective groups. Time to hemostasis was significantly shorter in the pure plug-based group (80 [32, 180] vs. 240 [174, 316] seconds, p<0.001). Conclusions: Among patients treated with transfemoral TAVR, a pure plug-based vascular closure technique using the MANTA VCD is associated with a higher rate of access-site or access-related vascular complications but a shorter time to hemostasis compared to a primary suture-based technique using the ProGlide VCD.