CHOICE-CLOSURE: Plug-Based vs. Suture-Based Closure Device Strategies Post-TAVR
Use of a plug-based vascular closure technique following transcatheter aortic valve replacement (TAVR) had comparable mortality and major bleeding rates compared with a suture-based closure technique, based on findings from CHOICE-CLOSURE presented Nov. 5 during TCT 2021 and simultaneously published in Circulation. Additionally, researchers noted the plug-based strategy had a shorter time to hemostasis, but a higher rate of access-site or access-related vascular complications.
The multicenter trial out of Germany randomized 516 patients with severe symptomatic aortic stenosis and undergoing transfemoral TAVR to either the pure plug-based MANTA VCD technique (n=258) or the primary suture-based ProGlide technique (n=258). 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.
Overall results found the event rate was 19.4% in the plug-based technique group compared with 12.0% in the suture-based technique group. In terms of secondary endpoints, time to hemostasis was lower with the plug-based technique (80 seconds vs. 240 seconds, p<0.001), while 30-day outcomes for access-site or access-related vascular complications, access-site or access-related bleeding and/or vascular closure device 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 Mohamed Abdel-Wahab, MD, PhD. “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.”
Clinical Topics: Invasive Cardiovascular Angiography and Intervention, Vascular Medicine, Interventions and Imaging, Interventions and Vascular Medicine, Angiography, Nuclear Imaging
Keywords: Transcatheter Cardiovascular Therapeutics, TCT21, Angiography, Aneurysm
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