Results from the MARVEL (Manta Registry for Vascular Large-Bore Closure) Prospective Registry demonstrate that the major vascular complication rate associated with the Manta large-bore closure device was 4%, which mimics results from the highly selected US IDE Safe MANTA trial.
These findings were presented Tuesday as a late-breaking trial by Dr. Nicolas M. Van Mieghem, MD, PhD, of Thoraxcenter, Erasmus University Medical Center, Rotterdam, Netherlands, at Cardiovascular Revascularization Technologies (CRT) 2020 in National Harbor, Maryland.
Vascular complications are commonly seen with large-bore access, and with the increased use of large-bore access in structural interventions, management of these complications is important. The MANTA (Teleflex, Wayne, Pennsylvania) is the first commercially available dedicated closure device for large-bore femoral arterial access site closure and can be used for transcatheter aortic valve replacement (TAVR), endovascular aneurysm repair (EVAR) and left ventricular assist devices (LVADs). The investigational device exemption pivotal trial in the U.S. demonstrated that the rate of major vascular complications with the MANTA device was 4.2%.
This prospective registry was a post-market, single-arm, observational study including 400 patients from 10 sites in the European Union and Canada. Operators were required to have performed more than 10 MANTA cases to participate in this study. The primary endpoint was 30-day follow-up through outpatient clinic visit with safety endpoints (major and minor vascular complications) and performance endpoint (time to hemostasis).
At 30 days, the primary safety endpoint for major vascular complications, as defined by Valve Academic Research Consortium (VARC)-2, was 4.0%, and minor vascular complication rate (VARC-2) was 5.8%. Time to hemostasis was 50 seconds. It was noted that severe vessel wall calcification and groin scarring are associated with Manta-associated major vascular complications.
Despite the increased experience by the operators in the study, these real-world results are promising for the Manta closure device for large-bore access, Van Mieghem said. Further research is needed to compare Manta with suture-based closure devices.
The MARVEL registry is sponsored by Essential Medical Inc.