In patients with severe aortic stenosis (AS) undergoing transfemoral transcatheter aortic valve implantation (TAVI), periprocedural vascular complications are common and contribute significantly to the overall morbidity and mortality. These vascular complications are commonly related to the arterial access site of the TAVI procedure. As numerous plug-based and suture-based percutaneous vascular closure devices (VCDs) have been approved and available in the market, the real-world approach to vascular closure has been variable as these devices have been used interchangeably. Nonetheless, despite the abundance of these device closure techniques, randomized trials to compare techniques are lacking and remain an unmet need.
The CHOICE-CLOSURE trial (Randomized Comparison of Catheter-based Strategies for Interventional Access Site Closure During Transfemoral Transcatheter Aortic Valve Implantation) was an investigator-initiated, single-center, prospective, open-label randomized controlled trial that compared interventional access site closure using a plug-based strategy vs. suture-based strategy for during transfemoral TAVI. In the study, the investigators hypothesized that a relevant difference in the rate of peri-procedural complications of effectiveness of vascular closure would be present with either strategy vs. the other. Major exclusion criteria included, but were not limited to, vascular access site anatomy non-suitable for percutaneous vascular closure, prior history of vascular site complications, absence of computer tomographic data of the access site prior to the procedure, and known bleeding diathesis or significant unmanageable anemia.
Between June 2020 and July 2021, a total of 516 patients with severe AS undergoing transfemoral TAVI were randomly assigned in a 1 to 1 manner to have vascular access site closure using either a plug-based technique (MANTA, Teleflex Wayne PA) (n=258 patients) or a primary suture-based technique (ProGlide, Abbott Vascular, Abbott Park, IL) (n=258 patients). The primary outcome of the trial was the rate of in-hospital access-site or access-related vascular injury according to the Valve Academic Research Consortium-2 (VARC-2) definition through 7 days. Secondary outcomes included the rate of access-site or access-related vascular injury, as well as rate of VCD failure, and time to hemostasis.
The primary outcome occurred in 19.4% (50/258) of patients randomized to the plug-based technique, as compared with only 12.0% (31/258) in patients in the primary suture-based technique group (RR 1.61, 95% CI [1.07-2.44], p=0.029). There were no statistically significant differences in access-site or access related bleeding (11.6% vs. 7.4%, p=0.133) or device failure (4.7% vs. 5.4%, p=0.841). Time to hemostasis was significantly shorter with the plug-based technique (80 seconds vs. 240 seconds, p<0.001). Overall, the trial concluded that a pure plug-based vascular closure technique was associated with higher rates of access-site or access-related vascular complications, but shorter time to hemostasis, as compared with primary suture-based technique.
The results of the CHOICE-CLOSURE trial were presented by the principal investigator, Prof. Mohamed Abdel-Wahab, MD PhD (Leipzig Heart Center/University of Leipzig, Germany) on November 5th, 2021 at 11:40 AM EDT as a late-breaking clinical trial at TCT 2021 in Orlando, FL and published simultaneously in Circulation. The study was funded by Helios Kliniken GmbH; and Prof. Abdel-Wahab reported consulting fees/honoraria from Boston Scientific and Medtronic.