Treatment of aortic stenosis with the JenaValve Trilogy transcatheter heart valve (THV) is safe and effective, according to the first results of commercial implants presented Tuesday at EuroPCR 2022 in Paris. Matti Adam, MD, of University Hospital Cologne, Germany, said in his presentation that TAVR has become the standard of care for high- and intermediate-risk patients with severe aortic stenosis and has proven safe and effective in low-risk patients. So, Adam asked in his presentation, “Why do we need another valve?” One unmet need as TAVR becomes the procedure of choice in younger, lower-risk patients is lifetime management, especially how to access the coronaries after TAVR, Adam said. Post-TAVR computed tomography has identified features of unfavorable coronary access in notable percentages of patients. Rates of mild or greater paravalvular leak range from about 20% to 30% at 30 days to 1 year, and thee have been shown to increase through 5 years. The JenvValve Trilogy THV was designed with locators that align the valve with the native cusps and provide limited protrusion into the left ventricular outflow tract and left ventricle. These locators “clip” onto the native leaflets, forming a seal and stable securement. The THV’s large open cells provide access to the low coronaries, Adam said, providing “coronary alignment by design.” The JenaValve was designed for both aortic regurgitation and aortic stenosis. It was available with a transapical delivery system, and 1,500 valves were commercially implanted from 2011 to 2016. The JenaValve Trilogy System is delivered via transfemoral access and is an improved TAVR system, Adam said, and it received the CE mark in 2021. Adam reported the first 73 commercial implants of the JenaValve Trilogy from six high-volume German centers. Of these patients, 45 were treated for aortic regurgitation and 28 for aortic stenosis. At baseline, the patients’ mean age was 78.4 ± 8.6 years, nearly half (48%) were female, 67.5% presented with New York Heart Association functional class III or IV heart failure, their mean EuroSCORE II was 5.9 ± 7.6, 22% had previous cardiac surgery, their mean body mass index was 27.07 ± 5.49 kg/m2, 21% had diabetes mellitus, and 53% had a left ventricular ejection fraction >50%. Patients with aortic stenosis had a mean annular perimeter of 75.3 ± 6 mm, significantly lower than that of patients with aortic regurgitation (79.3 ± 10.5 mm; p=0.003). Aortic-stenosis patients also had a significantly higher mean aortic valve gradient (42.5 ± 13 mmHg vs. 9.9 ± 7.8 mmHg; p<0.001), higher mean agitation score (3,107.3 ± 1,293.6 vs. 276.5 ± 342.4; p<0.001) and moderate-to-severe (0% vs. 20%) or severe aortic regurgitation (0% vs. 73%) than aortic-regurgitation patients. All TAVRs with the JenaValve Trilogy were done transfemorally. The valve sizes for aortic stenosis were 23 mm (39%), 25 mm (36%) and 27 mm (25%). About 75% of aortic-stenosis patients stayed 1 day in the intensive care unit, and their mean total hospital stay was 7.2 ± 3.5 days. None of these patients were converted to open surgery, none had a second valve implanted, none had major or life-threatening bleeding, none had vascular complications, and none needed a new pacemaker. There was one reported new stroke at follow-up and one patient died in the hospital. The mean aortic valve gradient at discharge was 6.4 ± 3 mmHg, and mean aortic valve area was 2.2 ± 0.4 cm2. Most patients had none or trace paravalvular regurgitation (86%), 14% had mild, and no patients had moderate or severe paravalvular regurgitation. In these 28 aortic-stenosis patients, Valve Academic Research Consortium (VARC)-3 technical success was 100%, device success was 96.4%, and performance as indicated was 100%. Whether the valves will continue to have coronary alignment will need to be the subject of larger studies, Adam said.