Transfemoral transcatheter aortic valve replacement (TAVR) with the JenaValve Trilogy transcatheter heart valve system is safe and effective for the treatment of severe aortic regurgitation, according to the first real-world data on this valve. Alexander R. Tamm, MD, of University Medical Center Mainz, Germany, presented these results Wednesday at EuroPCR 2022 in Paris. Results showing that the JenaValve Trilogy is safe and effective for the treatment of aortic stenosis were presented Tuesday. TAVR is widely accepted and performed to treat aortic stenosis. However, this is not the case for TAVR to treat aortic regurgitation, which has been off-label until recently and often presents procedural challenges and leads to poorer outcomes, Tamm said. The objective of this study was to examine early real-world data from the JenaValve Trilogy system, which received the CE mark in 2021 to treat both aortic stenosis and aortic regurgitation. The Trilogy features several unique locators, allowing the valve to “clip” onto the native leaflets and enabling anchoring in patients with pure aortic regurgitation with non-calcified valves. The study included a total of 45 consecutive patients with aortic regurgitation from six German centers. The valve was implanted via transfemoral access. The primary efficacy endpoint was technical success, with a mean gradient of <20 mmHg and reduction of aortic regurgitation grade by more than 1. The primary safety endpoint was major adverse events, a composite of death, myocardial infarction, cardiothoracic surgery or stroke, at discharge. At baseline, the patients had a mean age of 77 ± 9.52 years and mean EuroSCORE II of 7.09 ± 9. Technical success was achieved in all 45 patients, with none converted to open surgery. There was no major or life-threatening bleeding, one major vascular complication (2.2%), and nine new pacemakers (23%) were needed. At discharge, the patients’ mean aortic valve gradient was 4.04 ± 1.64 mmHg (an improvement from 9.85 ± 7.81 mmHg at baseline), and the mean aortic valve area was 2.62 ± 0.64 cm2 (an improvement from 2.07 ± 0.79 cm2 at baseline). At discharge, 91% of patients had none or trace paravalvular regurgitation was, and none had moderate or greater aortic regurgitation. All patients had presented with moderate-to-severe or severe aortic regurgitation, Tamm said.3 Tamm said that the data provide confidence that TAVR with the Trilogy valve can be a lifesaving procedure for patients with aortic regurgitation deemed ineligible or at high risk for surgical aortic valve replacement. He added that the Trilogy is the only transcatheter heart valve in the world approved to treat both aortic stenosis and aortic regurgitation. “This study demonstrated excellent clinical outcomes, meeting both the primary safety and efficacy endpoints with no major adverse events and no moderate or severe aortic regurgitation at discharge,” Tamm said.