Novel TAVR system safe, effective for patients with severe aortic regurgitation
A novel system for transcatheter aortic valve replacement was safe and effective for a small cohort of patients with severe aortic regurgitation who were ineligible or at high risk for surgery, according to a real-world data analysis.
TAVR for patients with severe aortic regurgitation has been off-label and often presents procedural challenges and poorer outcomes, Alexander R. Tamm, MD, senior cardiologist and head of the TAVI program at the Heart Valve Center, at University Medical Center Mainz, Germany, said during a press conference at EuroPCR. If left untreated, severe aortic regurgitation has a mortality rate of greater than 10% per year, Tamm said.
The new TAVR system (Trilogy, JenaValve) features locators that align the heart valve with the native cusps of the valve, ensuring anatomically correct alignment. It received a CE mark in May 2021 for the treatment of aortic regurgitation and aortic stenosis and is not yet commercially available in the U.S.
“It is a completely new anchoring system, enabling anchoring in pure aortic regurgitation patients with noncalcified valves, totally different than in calcified arteries with aortic stenosis,” Tamm said.
Tamm and collogues analyzed data from 45 patients with severe aortic regurgitation from six German centers. The mean age of patients was 77 years and 40% were women; 29% had previous cardiac surgery and 58% had a left ventricular ejection fraction of less than 50%. The primary efficacy endpoint was technical success, defined by a mean gradient of less than 20 mm Hg and a reduction of aortic regurgitation by at least 1 grade. The combined primary safety endpoint was major adverse events, defined as death, MI, cardiothoracic surgery or stroke at discharge.
The Trilogy valve was implanted via transfemoral access with a success rate of 100%. Aortic regurgitation was reduced to mild or less for all patients, with 91% showing no or trace aortic regurgitation. There were no major adverse events reported and no in-hospital mortality. Mean aortic valve gradient at discharge was 4.04 mm Hg.
“These first real-world data confirm that transfemoral TAVI treatment of severe aortic regurgitation using the JenaValve Trilogy System is safe and effective for these patients who were ineligible or at high risk for [surgical aortic valve replacement] and previously without treatment options,” Tamm said. “Our results give confidence to TAVI as a lifesaving procedure for these patients.”
Tamm said more studies are needed to further prove safety and efficacy in larger cohorts and expanded patient populations.
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Tamm AR, et al. Late-Breaking Trials on TAVI. Presented at: EuroPCR; May 17-20, 2022; Paris (hybrid meeting).
