Dr. Zeynep Esra Güner

Name of the study: The ALIGN-AR Trial: Two-Year Outcomes of Transcatheter Aortic Valve Replacement with JenaValve TriologyTM in High Surgical Risk Patients with Moderate-to-Severe or Severe Native Aortic Regurgitation

Published in Congress: TCT 2024

Link: https://www.tctmd.com/news/align-ar-2-years-shows-promise-tavi-trilogy-aortic-regurgitation

Introduction:
Surgery is currently the only recommended intervention for patients with native aortic regurgitation. There is a significant need for transcatheter therapies to address the high risk of mortality and complications associated with surgical aortic valve replacement. Existing commercial transcatheter heart valves for pure aortic regurgitation face challenges due to unacceptable rates of embolization and paravalvular regurgitation. The Trilogy transcatheter heart valve (JenaValve Technology, Irvine, CA, USA) offers a potential treatment option for these patients.

Objective:
The aim of this study is to present the two-year outcomes of transfemoral transcatheter aortic valve implantation (TAVI) using the JenaValve Trilogy™ in high surgical risk patients with moderate-to-severe or severe native aortic regurgitation.

Methods:
The ALIGN-AR trial is a prospective, multicenter, single-arm study. The safety endpoint was defined as a composite of 30-day all-cause mortality, any stroke, major vascular complications, life-threatening or major bleeding, new pacemaker implantation, acute kidney injury, valve dysfunction, and any surgery or intervention related to the device.

Results:
At two years, the cardiac mortality rate remained below the study's prespecified performance goal of 25% at one year. Hemodynamic results were excellent, with very low rates of paravalvular leak and significant improvements in quality of life. The two-year results indicated that ALIGN-AR met its safety and efficacy goals when compared with historical datasets, demonstrating notable enhancements in quality of life.
All-cause mortality increased from 7.8% at one year to 15.4% at two years; however, only two additional cardiovascular deaths were recorded, raising the rate from 6.2% at one year to 7.4% at two years. This suggests that the majority of patients (11 out of 13) experienced non-cardiovascular deaths between the first and second years, attributed to a high rate of comorbidities.
The rate of non-disabling stroke remained consistent at 4.1% at both time points, while the incidence of disabling stroke rose from 1.7% at one year to 2.3% at two years. Notably, there were no patients requiring a new pacemaker or undergoing surgery/interventions related to the device between years one and two. Two new incidents of major/life-threatening bleeding and one myocardial infarction (MI) were reported.
In terms of hemodynamics, the mean gradient and valve effective orifice area were maintained from one to two years. Paravalvular regurgitation rates decreased from 8.2% in one year to 4.4% in two years. Patients consistently demonstrated good left ventricular remodeling and improvements in quality of life, as measured by NYHA functional class and KCCQ-OS, at both one and two years.

Conclusions:
Further follow-up from the ALIGN-AR trial supports the ongoing safety and efficacy of the Trilogy heart valve system (JenaValve) in treating patients with severe, symptomatic aortic regurgitation who are at high risk for surgical intervention.

Comment:
The JenaValve Trilogy™ is the first device approved for the treatment of aortic regurgitation using TAVI. The Trilogy device is equipped with locators that function like a paper clip to secure it to the native leaflets, providing stabilization and commissural alignment. This design offers advantages for use in aortic regurgitation, unlike devices used for aortic stenosis. The potential population eligible for this device is estimated to be larger than currently recognized. Contrary to the threshold values specified in current guidelines, as experience with the device increases, its applicability in older, high-risk patients with advanced aortic regurgitation may come into consideration even in the absence of significant left ventricular dilatation.