Results from the first commercial implants of the Trilogy transcatheter aortic valve implantation (TAVI) system (Jenavalve) for high-surgical risk patients with severe, symptomatic aortic stenosis (AS) or aortic regurgitation (AR) were reported at EuroPCR 2022 (17–20 May, Paris, France)
Matti Adam (University Hospital Cologne, Cologne, Germany) reported the first 28 commercial implants of the Trilogy system for AS across six high-volume German centres. In Adam’s series, all patients presented with severe AS. At baseline, 61% of the patients presented with New York Heart Association class III or IV heart failure (NYHA III/IV), and 29% had a left ventricular ejection fraction (LVEF) of less than or equal to 50%.
The outcomes were positive, achieving 100% technical success, zero conversions to open surgery, zero new permanent pacemakers, and one patient death, which was non-device related, Adam reported. Post-operatively, 86% of the patients had none or trace paravalvular regurgitation (PVL) and no incidence of moderate or greater PVL.
“The JenaValve Trilogy is specifically and uniquely designed with locators that align the valve with the native cusps providing excellent commissural alignment with easy access to the coronary arteries, and form a secure seal for minimal PVL,” said Adam. “Given the unique design, we are seeing very positive results in AS patients, as well as in the AR cohort.”
Alexander R Tamm (Johannes Gutenberg-Universität, Mainz, Germany) presented data on 45 AR patients from the same six German heart centres. In this series, all patients presented with moderate-severe or severe AR.
At baseline, 71% of the patients presented with NYHA III/IV, and 58% had an LVEF less than or equal to 50%. The outcomes of the AR series were also positive, with technical success achieved in all patients. There were no conversions to open surgery, stroke, or death. Post-operatively, 92% of the patients had none or trace PVL and nine patients required a new pacemaker.
Of the patients requiring a pacemaker, at least 33% of the patients had pre-existing conduction system abnormalities.
“Before Trilogy’s CE mark approval, TAVI for AR was performed off-label using devices designed for aortic stenosis—which posed procedural challenges with poorer outcomes,” said Tamm. “The Trilogy valve is a game-changer, which delivers solid anchoring and commissural alignment due to the locator technology while also limiting protrusion into the left ventricle. Additionally, the haemodynamics are the best in class.”