Why is this study important?
This randomized study found higher rates of vascular complications after use of the MANTA large-bore vascular closure device than standard-of-care off-label use of suture-mediated vascular closure devices (VCD).
Should I change my practice because of these findings?
Perhaps. This study found higher rates of vascular complications with MANTA. Since the promise of fewer complications is the main reason to use this device, this study may lead you to change your practice.
What question was this study supposed to answer?
Suture-mediated VSD is used off-label for closing very large bore arterial access. MANTA was developed to supplant those devices and provide reliable hemostasis in these patients. The goal of the CHOICE-CLOSURE trial was to compare the safety and efficacy of the MANTA plug-based closure device to the current dominant strategy of the PreClose suture-mediated device for patients undergoing TAVR.
What did the study show?
516 patients undergoing TAVR at 3 German centers between June 2020 and June 2021 were randomized to plug-based vascular closure device (MANTA 18 Fr) or primary suture-mediated VCD (ProGlide) in a 1:1 open-label fashion. The primary endpoint was access site or access-related vascular complications according to VARC-2 definition. The MANTA-based technique was associated with a significantly higher event rate compared to the ProGlide technique (19.4% vs. 12.0%; relative risk 1.61, 95%CI 1.07-2.44, P = 0.02); this was driven primarily by the occurrence of pseudoaneurysms (6.2% vs. 1.2%, p = 0.005) and clinically significant access-site hematomas (15.5% vs. 7.4%, P = 0.006). Total access site-related vascular complications at 30 days were seen more commonly in the MANTA-based group (19.4% vs. 12.4%, P = 0.041). Time to hemostasis, measured in seconds, was significantly less in the MANTA group (80 vs. 240, P < 0.001) as was the presence of any residual stenosis (3.3 ± 6.9 vs. 8.9 ± 12.3, P < 0.001). Rate of vascular closure device failure was similar in both groups (4.7% vs. 5.4%, P = 0.84).
How good was the approach/methodology?
This study appears well-designed and administered. The study is of modest size, however, and was restricted to 2 German hospitals. Larger studies are needed to understand the true value of large plug-mediated closure in large-bore vascular access management.
All Editors: Jordan Safirstein, MD; Kirk M. Garratt, MD, MSCAI; and David A. Cox, MD, MSCAI
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