Abstract
BACKGROUND: The FlexNav delivery system (DS) features a hydrophilic coating, stability layer, and integrated sheath to facilitate valve deployment in vessel diameters ≥5.0 mm. METHODS: Data were pooled from 2 concurrent prospective, multicenter, premarket studies (PORTICO IDE [n = 147] and FlexNav EU CE Mark [n = 46]) to evaluate the safety and efficacy of the FlexNav DS to deliver the Portico valve in the Global FlexNav study. The primary end point was Valve Academic Research Consortium (VARC)-2 major vascular complication rate at 30 days. These outcomes were compared with those of the commercially available valve arm from the PORTICO IDE study. RESULTS: The Global FlexNav study enrolled 193 high- or extreme-risk subjects for sugery. The mean age was 84.8 years, and 59.6% were women, with a mean Society of Thoracic Surgeons score of 5.2%. At 1 year, the rate of all-cause mortality was 5.2%, disabling stroke 2.1%, and mild or less paravalvular leak 99.4%. The mean aortic gradient was maintained at 7.4 ± 4.3 mm Hg through 1 year. At 1 year, 96.8% of subjects were classified as New York Heart Association class I or II. A pacemaker was implanted in 15.4% of subjects at 30 days and 18.4% at 1 year. The results of the Portico valve in the Global FlexNav study are comparable with the results from the commercially available valve arm in the PORTICO IDE study. CONCLUSION: The FlexNav DS was shown to be safe for the delivery of the Portico valve, which demonstrated sustained treatment benefits at 1 year with low rates of all-cause mortality or disabling stroke, improved heart failure symptoms, and excellent valve performance.