CHOICE-CLOSURE Randomized Study Compares Plug-Based and Suture-Based Vascular Closure Devices After TAVR

November 5, 2021—The CHOICE-CLOSURE randomized trial comparing different closure device strategies after transcatheter aortic valve replacement (TAVR) found that a plug-based vascular closure technique had a shorter time to hemostasis but a higher rate of access-site or access-related vascular complications.

The findings were presented at TCT 2021, the 33rd annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held November 4-6 online and in Orlando, Florida. The study was published simultaneously by Professor Mohamed Abdel-Wahab, MD, online in Circulation.

The TCT press release noted that vascular complications after transfemoral TAVR 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, multicenter trial that randomized patients with severe symptomatic aortic stenosis and acceptable transfemoral vascular access to either the pure plug-based Manta VCD (Teleflex) technique or the primary suture-based ProGlide (Abbott) technique.

As reported in the TCT press release, between June 2020 and June 2021, 516 patients undergoing transfemoral TAVR were enrolled and randomized 1:1 at three German centers. The plug-based strategy was used in 258 patients and 258 patients received the suture-based vascular closure strategy.

The primary endpoint was the rate of access-site or access-related vascular complications according to the Valve Academic Research Consortium-2 definition during index hospitalization. The study found:

• The event rate for the plug-based technique was 19.4% versus 12.0% in the suture-based technique (risk ratio 1.61; 95% CI, 1.07-2.44; P = .029).

Secondary endpoints included device failure, time to hemostasis and access-site related bleeding at 30 days. The study found:

• Time to hemostasis was lower with the plug-based technique (80 seconds vs 240 seconds; P < .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 = .043).

Prof. Abdel-Wahab, who is Professor of Interventional Cardiology, Consultant Cardiology and Head of Department of Structural Heart Disease at the Heart Center Leipzig, University of Leipzig in Leipzig, Germany commented on the findings in the TCT press release.

“With the introduction of large-bore plug-based devices, operators now have an alternative to the classical suture-based technique,” stated Prof. Abdel-Wahab. “However, randomized 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 hemostasis, the plug-based technique did have a significantly higher rate of access-site or access-related vascular complications.”