PARIS — A vascular closure device without sutures or collagen plugs may be safer than traditional cut-down or suture-based closure devices, according to the FRONTIER II study.
At 12 months, there were no complications associated with the deployment of the Vivasure PerQseal closure device, which involves a synthetic implant that bioabsorbs within 180 days. Ultrasound and CT also showed no clinically-significant vascular changes over follow-up, nor were there any cases of stenosis or distal emboli.
Arne Schwindt, MD, of Germany’s St. Franziskus Hospital, reported a 97% rate of technical success as well. He emphasized the “low learning curve” involved in deployment, which he claimed takes less than a minute.
This device “offers a safe and dependable alternative to open surgical closure, suture-mediated or collagen plug devices for the percutaneous closure of large hole femoral arteriotomies,” Schwindt told the audience at the annual EuroPCR meeting.
“This looks really great. It’s nice to see we’re making progress with large bore closure devices,” said panelist Ted E. Feldman, MD, of Illinois’ Evanston Hospital.
FRONTIER II included 58 patients who underwent large bore femoral percutaneous access for transcatheter aortic valve replacement, endovascular aneurysm repair, or thoracic endovascular aortic repair. A total of 66 closures from eight European centers were analyzed by Schwindt’s group.
The PerQSeal is designed for large arteriotomies ranging from 12 to 24 French. Delivered over a wire, it is also fully absorbable by 6 months, leaving no scar in the arterial wall. Europe gave it the CE mark earlier this year.
When prompted by discussion panelist Ganesh Manoharan, MBBCh, MD, of Royal Victoria Hospital, Ireland, Schwindt said that exclusion criteria do exist for the PerQSeal. “Duplex scanning of the groin to see if the femoral artery is bigger than 7 mm is crucial,” he noted, or else the device won’t align properly. Similarly, patients should not have front wall calcification, the rough surface of which is not compatible with the device.
Following another question by the panel, Schwindt clarified that he had not encountered the need for subsequent re-access after vascular closure, but he recommended duplex-controlled punctures just in case.
Schwindt reported consulting for Avinger, Biotronik, Boston Scientific, Cordis, Johnson & Johnson, and Terumo.
Schwindt A “12-month results of a novel large access closure device: insights from the FRONTIER II study” EuroPCR 2016.