The JenaValve Trilogy system provides a favorable survival rate and strong hemodynamic performance for patients at high risk for surgery with aortic regurgitation, findings from the ALIGN-AR Trial show. In Tuesday’s late-breaking trials presentation at Transcatheter Cardiovascular Therapeutics (TCT) 2024, Torsten P. Vahl, MD, of the New York-Presbyterian Hospital, revealed that cardiovascular mortality was relatively low, and the valve maintained function with minimal pressure buildup and regurgitation. Further insights pointed to improvements in patient symptoms and quality of life that were preserved through the two-year mark, supporting the Trilogy (JenaValve Technology) transcatheter heart valve (THV) system’s viability as a therapeutic option for this patient group. “Mortality was primarily noncardiac between one and two years in this population with numerous comorbidities,” said Dr. Vahl in a press conference on Tuesday. “Hemodynamic valve performance was favorable beyond one year with average effective orifice area (EOA) >2.5 cm2 and mean transvalvular gradient <5 mmHg and no cases of hemodynamic valve deterioration.” Sustained at two years Along with co-presenter Vinod H. Thourani, MD, of Emory University School of Medicine, Atlanta, the two physicians revealed that favorable left ventricular (LV) remodeling results observed by echocardiography at one year were sustained at two years. Similarly, the improvements in New York Heart Association (NYHA) functional class and Kansas City Cardiomyopathy Questionnaire Overall Summary Score (KCCQ-OS) — two quality of life measurements observed at one year — were preserved at the two-year follow-up. “The TRILOGY THV system provides the first dedicated TAVR option for symptomatic patients with ≥3+ aortic regurgitation (AR) who are at high risk for surgery and is well positioned to become the preferred therapy upon approval for this population,” said the presenters. Further two-year outcomes from the ALIGN AR Trial revealed an all-cause mortality of 15.4%, with a cardiovascular mortality rate noted at 7.4%. The researchers suggested that mortality from cardiovascular causes was about half of the total mortality rate, with most deaths being non-cardiac in nature. Hemodynamic valve performance, specifically the average EOA remained above 2.5 cm² at the two-year mark, indicating that the valve remained open adequately for good blood flow. The mean transvalvular gradient was also maintained below 5 mmHg, indicating minimal obstruction, while a low occurrence of paravalvular regurgitation was observed, suggesting effective valve sealing and functionality over time. ALIGN-AR single-arm study The study builds on previous research by the same team of investigators, which achieved the primary efficacy outcome of all-cause mortality at 12 months (7.8% vs. 25%.0, p<0.0001). The ALIGN-AR single-arm study, which used TAVR using the Trilogy THV, also achieved the 30-day performance goal for safety (26.7% vs 40.5%, p<0.0001). Further findings noted a new pacemaker rate of 24.0% at 30 days as well as significant improvement in left ventricular remodeling. The Trilogy THV’s performance was associated with improved quality of life (QoL) and heart failure symptoms at one year. Study design and methodology The multicenter, non-blinded, single-arm study enrolled 180 patients with ≥3+ symptomatic aortic regurgitation and high surgical risk. These patients were aged 75.5 ± 10.8 years of which 47.2% were female. The endpoints assessed included clinical outcomes, hemodynamic performance, echocardiography results and quality of life over two years. Image Caption: Torsten P. Vahl, MD, speaks during a news conference Tuesday at the Transcatheter Cardiovascular Therapeutics (TCT) conference in Washington, DC. Image Credit: Bailey G. Salimes/CRTonline.org