In patients with severe aortic regurgitation (AR), the purpose-built JenaValve Trilogy transcatheter heart valve (THV) system has better acute performance when used off-label compared with other THVs, a retrospective analysis shows. These data were reported by Luca Testa, MD, PhD, of IRCCS Pol. S. Donato, Milan, during a Late-Breaking Clinical Science session Monday at Cardiovascular Research Technologies (CRT) 2024 in Washington, D.C. Severe AR is often undertreated because of the risk of surgery, and the disease carries a high risk of mortality and morbidity. Mostly suboptimal results have come from the use of THVs for this patient population. The purpose-built THV (JenaValve Trilogy [JVT]) has shown promise but, so far, has not been compared to other THVs in treating severe AR. The investigators in this study examined the performance and outcomes of several new THVs used off-label (OL) and compared them with the purpose-built JVT in patients who could not undergo surgery due to severe AR of the native valve. This multicenter, international, retrospective registry had 18 centers collecting data. A bicuspid aortic valve excluded patients from the study. The primary endpoints of this study were technical and device success, mortality at 1 year and a composite of mortality and heart failure (HF) rehospitalization rate at 1 year. A total of 256 patients were enrolled in the study (OL-THV n=168, JVT n=88). The rates of oth technical (98% vs 81%, p<0.001) and device (95% vs 73%, p<0.001) success were higher in JVT versus OL-THV . These rates were driven by fewer incidences of THV embolization (1.1% vs 15%, p<0.001), need for a second valve (1.1% vs 11%, p=0.004) and moderate residual AR (1.1% vs 10%, p=0.007). Both groups had elevated pacemaker implantation rates (JVT=24% vs OL-THV=22%, p=0.7), and similar rates of 1-year mortality (hazard ratio [HR]=0.99) and composite endpoint (HR=1.5, p=0.355) at follow-up. Overall, the JVT THV system had better acute performance than the other OL-THVs in patients with severe AR, but no differences were observed in mortality or the composite endpoint at 1-year follow-up. Photo Credit: Bailey Salimes/CRTonline.org Photo Caption: Luca Testa, MD, PhD, presents a study evaluating the JenaValve Trilogy, a transcatheter valve dedicated to treating aortic regurgitation, on Monday at CRT 2024 in Washington, D.C.