PARIS – A new bioabsorbable sutureless device provides operators with a safe, simple, and dependable option for fully percutaneous closure of the large, 12-24 French femoral arteriotomies created for transcatheter aortic valve replacement or endovascular abdominal aortic aneurysm repair, Arne Schwindt, MD, reported at the annual congress of the European Association of Percutaneous Cardiovascular Interventions.
He presented the 12-month follow-up results of the FRONTIER II study of the Vivasure PerQseal device. The device recently received European marketing approval on the strength of FRONTIER II but remains investigational in the United States.
The PerQseal device is deployed in less than 1 minute at the end of the primary procedure and achieves immediate hemostasis. It’s a simple three-step deployment process with essentially no learning curve, as evidenced by the fact that in FRONTIER II, the technical success rate starting from no experience was 97%, explained Dr. Schwindt of St. Franziskus Hospital in Muenster, Germany.
The large femoral arteriotomies created for TAVR or endovascular abdominal aortic aneurysm repair have typically required surgical cut down and sutured repair with a 3- to 5-cm incision. Vascular complications have been common. Indeed, the literature shows this method entails on average a 14.7% rate of major vascular complications up to 3 months post procedure, so that was the bar set in FRONTIER II: In order for the PerQseal to be deemed noninferior to surgical cut down and sutured repair, the rate of major complications directly related to the novel device at 3 months follow-up could be no greater than 14.7%. The current Valve Academic Research Consortium (VARC) 2 definition of major complications was used.
In fact, the vascular complication rate proved to be zero. Moreover, at 12 months of follow-up, no cases of groin fibrosis or scarring had been observed, Dr. Schwindt reported.
FRONTIER II was a single-arm, prospective, multicenter European study of 58 patients who received the PerQseal device for 66 closures. They were evaluated at discharge and 1, 3, and 12 months post procedure by Doppler ultrasound, with uniformly unremarkable findings.
PerQseal features a synthetic low-profile implant with over-the-wire delivery. The implant is loaded into a sheath, released by pulling back on the sheath, then pulled up against the arteriotomy from the inside. Blood pressure molds the device to the arterial wall and seals it. The device is fully absorbed in 180 days.
Session co-chair Dr. Ted E. Feldman was favorably impressed.
“This is really terrific. It’s very nice to see we’re finally making progress with large-bore closure devices,” commented Dr. Feldman, professor of medicine at Northwestern University, Chicago.
Dr. Schwindt reported receiving a research grant from Vivasure, which sponsored the FRONTIER II study. In addition, he serves as a consultant to a half dozen medical device companies.