The novel Navitor aortic valve (Abbott Structural Heart) is an iterative, intra-annular, self-expanding transcatheter aortic valve. It features an active outer cuff designed to reduce paravalvular leak (PVL).
The PORTICO Next Generation (NG) study (NCT04011722) is a prospective, multi-center, international, single-arm study. A total of 26 clinical sites across Europe, Australia, and the United States participated between September 2019 and August 2022. The goal of the study was to examine safety and efficacy of the Navitor valve in patients with symptomatic, severe aortic stenosis that are at high or extreme risk of surgery. The primary safety endpoint was all-cause mortality (ACM) at 30 days. The primary effectiveness endpoint was moderate or greater paravalvular leak at 30 days. Follow-ups take place after 30 days, 12 months and annually at 2, 3, 4 and 5 years.
Researchers enrolled 260 patients with symptomatic, severe aortic stenosis deemed to be at high or extreme surgical risk. The mean age of the patients was 83.4 years, and 57.3% were female.
30-day results with Navitor aortic valve show low rate of adverse events
At 30 days follow-up, the rate of ACM was 1.9%, and no subjects had moderate or greater PVL. The rate of disabling stroke was 1.9%. Major vascular complications occurred in 4.2% of trial participants, and life-threatening bleeding in 3.8% of the patients. The rate of new permanent pacemaker implantation was 19.0%.
Researchers concluded that the Navitor valve is a safe and effective treatment for patients who have severe aortic stenosis and are at high or greater risk for surgery.
Author: Kelly Schoonderwoerd