Early Clinical Experience with the InSeal Vascular Closure Device

Background: The InSeal vascular closure device (VCD) was designed for closing large openings in an artery. It utilizes a self-expandable support structure covered with a resorbable membrane. The InSeal VCD system is designed for the closure of arterial puncture of 14-21Fr and is compatible with all TAVI systems.

Purpose: We aimed to report upon the results of InSeal closure among patients undergoing TAVI in two medical centers in Israel.

Study design: Thirty (N=30) patients undergoing transcatheter aortic valve implantation (TAVI) are planned to be enrolled in the study, the primary endpoints are as follow: 1. hemostasis within 15 minutes following vessel access site closure, 2. combined rate of closure-device related major adverse events.

Results: Interim results are reported on 14 consecutive patients with average age of 82.1 and target femoral artery diameter of 6.1mm to 9.9 mm. The InSeal VCD was successfully implanted in 12/14 (86%) of the patients. In one patient device was not implanted due to operator failure and in the other due to extreme spasm and/or failure to properly cover the arteriotomy site. The average time to hemostasis, as defined by protocol, was 2.4±3.9 minutes. There was no device related SAE in any of the patients. One patient developed a local hematoma that was resolved after a day with no intervention. In all other patients the treated groin was fully healed with no swelling or any other complications and Duplex exam 24 hours post procedure demonstrated vessel full patency. Eight of the patients reached the study end point of 1 month with no device or procedure related complications. A duplex exam, performed at this follow up, demonstrated full vessel patency.

Conclusions: The InSeal VSD device holds promise for arteriotomy site closure post femoral TAVI. The final report of the study is pending and will be reported.