ViV-TAVR Leads to Fewer Complications, but Increases Later Heart Failure Hospitalizations and Mortality

The adoption of valve-in-valve transcatheter aortic valve replacement (ViV-TAVR) is increasing as an alternative to redo surgical aortic valve replacement (SAVR) for deteriorated bioprosthetic valves, despite limited long-term data. According to new data just published in JAMA Cardiology, over a 2-year period, ViV-TAVR demonstrated fewer periprocedural complications and comparable all-cause mortality compared with redo SAVR.¹ However, ViV-TAVR was linked to higher rates of late mortality and heart failure (HF) hospitalizations.

These findings are based on a retrospective population-based cohort analysis of 1771 patients from California, New York, and New Jersey who underwent ViV-TAVR or redo SAVR between 2015 and 2020. About 37% of included patients were women and about 81% were White, with a mean (SD) age of 74.4 (11.3) years and a median (IQR) follow-up of 2.3 (1.1-4.0) years. Propensity matching resulted in 375 patient pairs after excluding those who had TAVR or redo SAVR within 5 years of initial surgery, infective endocarditis, or additional surgical procedures, as well as out-of-state residents.

From 2015 to 2020, the percentage of patients choosing ViV-TAVR over redo SAVR rose significantly, from 35.3% to 62.5%. According to the study, periprocedural mortality and stroke rates were similar between the 2 treatment groups, but the ViV-TAVR group experienced fewer complications such as major bleeding, acute kidney failure, and new pacemaker implantations.

Aortic valve surgery | Image credit: Damian – stock.adobe.com

While the 5-year mortality rate was higher for ViV-TAVR than redo SAVR (23.4% vs 13.3%), no mortality difference was seen up to 2 years. However, after 2 years, ViV-TAVR was linked to higher mortality and more hospitalizations for HF. The incidence of stroke, reoperation, major bleeding, and infective endocarditis over 5 years was similar between the treatment groups.

According to the authors, the reasoning behind these delayed increases in mortality and HF hospitalizations after ViV-TAVR—seen in this study and others—is unclear.

“However, we performed several sensitivity analyses and attempted to simulate clinical equipoise by adjusting for measured comorbidities and other factors that substantially affect the decision-making process and outcomes, such as prior surgical history, time interval from the initial SAVR, frailty scores, institutional case volumes, and history of endocarditis, factors that were not included or were incompletely accounted for in previous studies,” the authors said. “The falsification analysis showed that the propensity-matched groups had similar rates of several noncardiovascular morbidity end points, suggesting that the differences we observed between groups were not likely attributable to differences in underlying health risks.”

Additionally, the incidence of significant prosthesis-patient mismatch and residual obstruction to left ventricular outflow was higher after ViV-TAVR compared with redo SAVR, potentially explaining the differences observed in late outcomes, although this was not evaluated in the study.

Aortic valve surgery is a crucial treatment for aortic valve disease, where a surgeon repairs or replaces the valve connecting the heart to the aorta, enhancing heart function in those with narrowed or leaky valves.² This surgery can be performed through open-heart or minimally invasive techniques, managing blood flow from the heart's left ventricle to the aorta. Addressing issues like valve narrowing or leakage, aortic valve surgery reduces the risk of complications such as HF and cardiac arrest, and it can also correct congenital heart defects affecting valve function.

Over the past decade, TAVR has become the primary treatment for isolated, symptomatic severe aortic stenosis, proving to be a viable alternative to SAVR for patients aged 70 to 85 years across various surgical risks.¹ First used for a failed aortic valve bioprosthesis in 2007 and approved by the FDA for high-risk patients in 2015, TAVR cases reported to the STS-ACC TVT registry have since risen sharply. For managing a failed surgical aortic valve bioprosthesis, the transcatheter approach is often preferred over repeat open-heart surgery due to its lower procedural risks and quicker recovery. Single-arm registry reports and data from the current study have confirmed its safety and feasibility. However, according to the authors, the lack of extensive outcomes data for ViV-TAVR suggests caution, especially with its growing use in younger and lower-risk patients.

“Although outcomes with ViV-TAVR were equivalent or superior to redo SAVR in these registries, it is conceivable that the disparate results we report relate to the relatively younger age of the study cohort and longer follow-up time,” the study authors added. “Uncertainty would best be addressed by a rigorously conducted randomized clinical trial in younger patients with longer follow-up.”

References

1. Tran JH, Itagaki S, Zeng Q, et al. Transcatheter or surgical replacement for failed bioprosthetic aortic valves. JAMA Cardiol. Published online May 22, 2024. doi:10.1001/jamacardio.2024.1049
2. Aortic valve surgery. Cleveland Clinic. Updated August 23, 2023. Accessed May 21, 2024. https://my.clevelandclinic.org/health/treatments/16745-aortic-valve-surgery