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

Abstract

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.

Real-World Experience With a Large Bore Vascular Closure Device During TAVI Procedure: Features and Predictors of Access-Site Vascular Complications

“…In our analysis focused on intermediate/low risk TAVR-treated patients, we confirmed a high arteriotomy closure success rate (98%) by the use of MANTA device, extending these results to patients also excluded in early studies as those with obesity, excessive calcifications, and/or tortuosity of the ileo-femoral artery ( 6 – 10 ). The rate of overall MANTA-access vascular complications (11%) was in line with previous observational registries and early trials and is definitely lower than in the largest randomized available experience mainly driven by a reduction of major events ( 8 – 12 , 25 ). Moreover, we found a lower rate of surgical repair and major or life threatening bleedings due to MANTA failure as compared to registries including patients with similar vessel size, SFAR ratio, and severity of calcification ( 12 , 23 , 26 ).…”

“…The rate of overall MANTA-access vascular complications (11%) was in line with previous observational registries and early trials and is definitely lower than in the largest randomized available experience mainly driven by a reduction of major events ( 8 – 12 , 25 ). Moreover, we found a lower rate of surgical repair and major or life threatening bleedings due to MANTA failure as compared to registries including patients with similar vessel size, SFAR ratio, and severity of calcification ( 12 , 23 , 26 ). The systematic performance of ileo-femoral angiography to visualize the site of the primary puncture before and to assess possible vascular complications after the vascular closure permitted to promptly treat and avoid major events ( 17 , 27 ).…”

“…In latest experiences, including more comers patients at intermediate to high surgical risk treated with TAVR and using 14F/18F MANTA VCD, the adverse vascular event rate was up to 14% (21)(22)(23)(24)(25). Moreover, comparative data with conventional suture-based devices have showed discordant results, highlighting a higher than anticipated rate of MANTA-access vascular events (up to 19%) in the early randomized studies (8)(9)(10)(11)(12).…”

“…Moreover, similar to previous analysis (11,12,25), only 18F MANTA was used for all patients due to cath lab availability. All definitions were complied with the Valve Academic Research Consortium-3 consensus document (VARC-3) for TAVR (13).…”

“…The MANTA VCD (Teleflex Inc., Pennsylvania, USA) is the first commercially available collagen-based technology dedicated for large bore arteriotomy closure approved by the United States Food and Drug Administration (FDA) (6,7). A reliable safety and efficacy have been well established in selected TAVR populations, but comparative studies with conventional suture-based devices have provided heterogenous results (8)(9)(10)(11)(12). Therefore, we sought to evaluate MANTA VCD performance for large bore arteriotomy closure in an unselected singlecenter TF-TAVR population, with a focus on access-site vascular complications rates and predictors.…”