Dedicated Closure Device for Transcaval Access Closure: From Concept to First-in-Human Testing

Area of Science:

• Cardiovascular Interventions
• Medical Device Technology
• Vascular Access

Background:

• Transcaval access provides an alternative route for large-device delivery when transfemoral access is not feasible.
• Previous methods using off-label devices for aortocaval fistula closure had limitations, including persistent fistulae and bleeding complications.

Purpose of the Study:

• To evaluate the safety and exploratory effectiveness of a dedicated transcaval closure device (TCD).
• To assess the TCD's ability to achieve complete closure of the transcaval access tract and prevent complications.

Main Methods:

• Preclinical testing in swine followed by an early feasibility study in patients undergoing transcatheter aortic valve replacement (TAVR) ineligible for transfemoral access.
• Endpoints included technical, device, and procedural success, with in-hospital and 30-day clinical and imaging follow-up.

Main Results:

• The TCD demonstrated successful transcaval access, TAVR, and aortocaval fistula closure in all 12 subjects.
• 100% technical success was achieved, with 75% complete tract closure at catheterization lab exit, rising to 100% at 30 days.
• Zero major vascular or life-threatening/major bleeding complications related to the TCD or transcaval access were reported.

Conclusions:

• The dedicated TCD effectively closed transcaval access tracts, minimizing bleeding complications.
• This device has the potential to increase the use of transcaval techniques by mitigating concerns about bleeding.