SAN FRANCISCO – Safety and efficacy outcomes were met in patients with severe, symptomatic aortic regurgitation (AR) who received the JenaValve Heart Valve System, a new study shows. Vinod H. Thourani, MD, of the Piedmont Heart Institute, Atlanta, presented these results during a late-breaking trial session Tuesday at Transcatheter Cardiovascular Therapeutics (TCT) 2023. Although the incidence is not known, the risk of AR increases with age. Surgical techniques and medical treatment are often used together in the management of patients with AR, but there are fewer options for high-risk patients who are not recommended for surgery. The rates of AR have slowly been gaining attention in recent decades, but treatment options have been lacking. “Aortic regurgitation is a different disease to aortic stenosis. The patients are different, the anatomy is different...therefore we need a different device,” said Bernard Prendergast, MD, of St Thomas’ Hospital and Cleveland Clinic London, during a news conference Tuesday. The ALIGN-AR study was a multicenter, non-blinded, single-arm trial that evaluated patients with symptomatic AR grade ≥3+ who were considered high risk for surgical aortic valve replacement. The safety and efficacy of the Trilogy valve was investigated in a 180 patients. “We are talking about a high-risk patient population that didn’t have surgical options, and what you’re seeing here is very excellent results,” said Kendra J. Grubb, MD, of the Emory School of Medicine, at the press conference. The Trilogy device aligns with the native cusps, then the three locators anchor to the leaflets to create a stable seal. The low coronaries can be accessed via large open cells, and the flared sealing ring fits around the annulus to deploy the device, Thourani explained. Follow-ups included clinical evaluation, echocardiography, functional assessments and quality-of-life assessments at 30 days, 6 months, 1 year, and annually up to 5 years post-procedure. The primary safety endpoint for this study was a composite of 30-day all-cause mortality, stroke, life-threatening/major bleeding, major vascular complications, acute kidney injury grade ≥2 or dialysis, valve intervention, new permanent pacemaker, or moderate or greater pulmonary vascular resistance. The primary efficacy endpoint was all-cause mortality at 1-year post-procedure. At 30 days, 26.7% of patients experienced a primary safety endpoint event, and this met was met the prespecified noninferiority criteria (40.5% prespecified margin; upper bound of the 97.5% confidence interval [CI]= 34.1%; p-noninferiority < 0.0001). At 1 year, 7.8% of patients had died. This also met prespecified noninferiority criteria for the primary efficacy endpoint (25% prespecified margin; upper bound of the 97.5% CI=12.3%; p-noninferiority < 0.0001). The rate of new pacemaker implantation decreased from 30% of the first group of patients to receive the valve to 14% in the last third of patients. None or trace paravalvular regurgitation was observed in 80.8% of patients, and mild paravalvular regurgitation was seen in 18.0%, at 30 days. By 1 year, this had improved to 92.2% with none/trace regurgitation and 7.8% with mild regurgitation. Moderate to severe paravalvular regurgitation was observed in 0.60% at 30 days, which improved to0% at 1 year. Rates of left ventricular (LV) remodeling also decreased over time. Overall, the 30-day performance goal safety outcome and 1-year efficacy goal were met for patients who received the Trilogy implant. Patients also reported improved quality of life and heart failure functional status through the 1-year follow-up. The study was sponsored by JenaValve Technology Inc. Image Caption: Vinod H. Thourani, MD, speaks during a news conference Tuesday at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. Image Credit: Jason Wermers/CRTonline.org