Postmarket JUPITER Registry Evaluates Second-Generation JenaValve to Treat Aortic Regurgitation
December 8, 2017—One-year outcomes from the postmarket JUPITER registry evaluating the safety and efficacy of transapical aortic valve implantation using the second-generation JenaValve transcatheter heart valve (JenaValve Technology GmbH) for aortic regurgitation were published by Miriam Silaschi, MD, et al online ahead of print in Catheterization and Cardiovascular Interventions (CCI).
According to the investigators, JenaValve is designed to overcome technical challenges seen in aortic regurgitation patients through a leaflet clipping mechanism.
The registry enrolled 30 patients with aortic regurgitation from 2012 to 2015. The mean patient age was 74.4 ± 9.3 years. Procedural success was 96.7% (29/30). One patient was converted to open surgery, and no annular ruptures or coronary ostia obstructions occurred.
In CCI, the investigators reported that mortality at 30 days was 10% (3/30). The combined safety endpoint was met in 13.3% (4/30). Paravalvular regurgitation was not present/trivial in 84.6% (22/26) and mild in 15.4% (4/26). The rate of permanent pacemaker implantation was 3.8% (1/26). The 1-year Kaplan-Meier survival rate was 79.9%, and the 1-year combined efficacy rate was 73.1% (19/30). No further strokes were observed during 1 year of follow-up.
This multicenter registry demonstrated satisfactory outcomes using the JenaValve device for predominant aortic regurgitation, with low rates of transcatheter heart valve embolization, residual aortic regurgitation, and permanent pacemaker implantation. The results using JenaValve for aortic regurgitation encourage its use for this indication, concluded the investigators in CCI.