Data from the PARTNER 3 Aortic Valve-in-Valve (AViV) registry demonstrates the long-term safety and effectiveness of transcatheter aortic valve replacement (TAVR) for failing bioprosthetic surgical valves in low- and intermediate-risk patients. The study, which builds upon earlier findings of no mortality and favorable hemodynamics at one year, uses the Kaplan-Meier estimate to calculate an all-cause death and stroke rate at five years of 14.7% from a cohort of 97 patients. Further findings presented by S. Chris Malaisrie, MD, Professor of Surgery at Northwestern Medicine, Chicago, revealed an all-cause mortality of 11.5% and stroke incidence at 5.4%. Reintervention occurred in 14.0% of patients, with 13 individuals undergoing a total of 14 reinterventions, including nine valve explants. Larger valve sizes "Larger valve sizes were associated with lower reintervention rates," Dr. Malaisrie said during Sunday's Late-Breaking Clinical Trials Structural and LAA session at Cardiovascular Research Technologies (CRT) 2025. "Hemodynamic improvements observed early in the study were largely sustained over time, with 94.2% of patients exhibiting none or trace aortic regurgitation at the five-year mark." Additionally, 96.7% of patients were classified as New York Heart Association Class I or II, indicating significant and lasting improvement in functional status and quality of life. The paper's investigators said that for low- and intermediate-risk patients with a failing surgical valve, AViV with the SAPIEN 3 transcatheter heart valve (THV) (Edwards Lifesciences) had favorable outcomes and was associated with high survival and low stroke rates. Improved AV hemodynamics The AViV with the SAPIEN 3 THV was also associated with sustained improvement in aortic valve hemodynamics, functional status, and quality-of-life through 5-year follow-up. Risk of reintervention may be associated with index surgical valve size, and further studies are needed to inform lifetime management strategies, the authors concluded. Despite the promise shown, Dr. Malaisrie outlined the study limitations that included the use of a single-arm registry model with no randomized comparator arm. In addition, the majority of enrolled patients were male. Also absent from the study were post-surgical mean gradients with lower echocardiogram follow-up rates at 5 years (67.1%), which Dr. Malaisrie said were partially due to COVID-19. “A 10-year follow-up will provide a better understanding of TAVR VIV durability,” he added. Study approach The prospective, single-arm, multicenter study enrolled 97 patients, all of whom underwent TAVR using the balloon-expandable SAPIEN 3 THV. The mean age of participants was 67.1 years, with 79.4% being male and an average Society of Thoracic Surgery score of 2.9%. The study aimed to assess the composite endpoint of all-cause death and stroke at five years, along with other measures such as valve durability and functional status. Image Credit: Bailey G. Salimes Image Caption: S. Chris Malaisrie, MD, presents his late-breaking clinical trial during a press conference at Cardiovascular Research Technologies (CRT) 2025 on Sunday.