Registry data point to ‘striking shift’ in treatment decisions after FDA approved low-risk TAVR
More low-risk patients under the age of 65 are being treated with transcatheter aortic valve replacement (TAVR) than ever before. According to a new analysis published in JACC, one key driver of that trend was when the U.S. Food and Drug Administration (FDA) approved TAVR for low-risk patients in 2019.[1]
The study’s authors emphasized that surgical aortic valve replacement (SAVR), not TAVR, is still recommended for patients younger than 65 years old. When the FDA expanded its indication for transcatheter treatment, however, it resulted in many patients who might be a more traditional candidate for SAVR being chosen or TAVR instead.
To learn more, the group evaluated data from more than 580,000 isolated TAVR procedures performed on adult patients being treated or severe aortic stenosis. Data came from the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy Registry. All patients were treated from 2012 to 2024, representing multiple years before and after the 2019 policy update.
Overall, 5% of TAVR patients were younger than 65 years old. The number of hospitals offering TAVR on younger patients increased from 161 in 2012, to 726 in 2024. The median STS predicted risk of mortality score decreased from 3% to 1.8%. While low-risk patients made up 2.7% of all TAVR procedures on a young patient in 2012, that increased all the way to 35.7% in 2024. Also, many more patients without severe heart failure were treated with TAVR as time went on.
“This national analysis demonstrates a striking shift in the characteristics of patients younger than 65 years undergoing TAVR after the 2019 indication expansion,” wrote senior author Natalia Egorova, PhD, MPH, a population health specialist with Icahn School of Medicine at Mount Sinai, and colleagues. “Case-mix evolved from primarily high-risk, comorbid patients to a growing segment of low-risk individuals with longer life expectancy and more frequent bicuspid valve anatomy.”
One key takeaway was the fact that these younger patients were associated with 30-day mortality, readmission, reintervention, stroke and endocarditis rates compared to older patients. On the other hand, adjusted data showed that the youngest patients treated with TAVR were linked to a greater one-year mortality risk than patients even slightly older.
“The risk-adjusted inverse age-mortality relationship in patients younger than 65 years reflects phenotypic heterogeneity: ‘very young’ patients often exhibit extreme-risk, noncalcific phenotypes, whereas those approaching 65 years resemble standard degenerative cases,” the authors explained. “This association likely reflects residual confounding from unmeasured noncardiac frailty or socioeconomic disadvantages. Thus, procedural improvements alone may be insufficient without refined patient selection and longer-term surveillance.”
Click here to read the full study in JACC, the flagship journal of the ACC.
Michael has more than 19 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.