Transcatheter aortic valve implantation (TAVI) using the JenaValve Trilogy system met its primary safety and efficacy endpoints in the first real-world test of the novel valve in high-risk patients with severe aortic regurgitation (AR).
Technical success, defined as a mean gradient less than 20 mm Hg and a greater than 1 grade reduction in AR, was achieved in all 45 consecutive patients treated at six German centers.
In terms of safety, there were no major adverse events (death, stroke, myocardial infarction, or cardiothoracic surgery) at discharge. Nine patients, however, needed a new pacemaker.
"AR patients ineligible or at high risk for surgery were previously without treatment options and now our results can give confidence to treat these patients with a lifesaving procedure," said Alexander Tamm, MD, during a hotline session at EuroPCR 2022 , held in Paris and online.
He noted that the JenaValve Trilogy (JenaValve Technology) is the only transcatheter heart valve in the world approved for the treatment of AR and aortic stenosis, earning CE Mark approval for both indications last year.
The JenaValve ALIGN-AR pivotal trialis ongoing in the United States, so patients with severe AR who are ineligible for surgery are currently treated with medical therapy, a left ventricular assist device, or off-label TAVI.
