Key Points:
- As transcatheter aortic valve replacement (TAVR) has experienced expanded indications into patients with low and intermediate surgical risk, conversations about valve durability have become increasingly important.
- Analysis of the pivotal CoreValve and SURTAVI trials demonstrated that TAVR was associated with less structural valve deterioration at 5 years than bioprosthetic SAVR.
- The analysis furthermore showed that structural valve deterioration was associated with higher risk of all cause mortality, including cardiovascular mortality and hospitalization for aortic valve disease.
As the indications for transcatheter aortic valve replacement have expanded to include low and intermediate surgical risk patients, a growing cohort of younger TAVR patients has emerged. Given the increased longevity of such patients, there has been a growing need to answer the question of durability for TAVR valves. Thus far, long-term data have not been analyzed in all-comers who underwent TAVR. Today, Dr. Michael Reardon (Houston Methodist, TX), sought to be the first to answer this question, at a late breaking clinical trials session during the 71st annual American College of Cardiology Scientific Sessions meeting.
In this retrospective analysis of the CoreValve Pivotal and SURTAVI trials, Dr. Reardon and colleagues analyzed data from 1,128 patients who underwent TAVR and 971 patients who underwent SAVR. To determine the prevalence of structural valve deterioration (SVD) at five years, patients were evaluated using Doppler estimations of velocity, gradient, and valve area. SVD was defined as an increase in mean gradient ≥ 10 mmHg from discharge or 30 day echo and mean gradient of ≥ 20 mmHg at the last available echo. New onset increase in intraprosthetic aortic valve insufficiency would also qualify as SVD.
At 5 years, deterioration was noted in 2.6% of the patients treated with TAVR and 4.4% of those treated with SAVR, a difference that reached statistical significance. In a pooled analysis of those with SVD, it was found that regardless of the type of valve implanted, deterioration was associated with an increase in all-cause mortality, cardiovascular mortality, hospitalization for aortic valve disease and worsening heart failure.
In a subgroup analysis, it was found that those with smaller annuli had a stark difference in SVD rates favoring TAVR (5.86% surgery vs. 1.39% TAVI; P=0.049( for those with annuli ≤23mm. A multivariate analysis showed that there was a higher risk of developing prosthetic failure in those with higher body surface area, women, and those with PCI and atrial fibrillation.
The authors concluded that the CoreValve/Evolut device (Medtronic) is the first and only transcatheter bioprosthesis to prove lower rates of SVD compared to surgery in randomized control trials. Unfortunately, this trial’s follow-up ended at 5 years. The ongoing trials, SURTAVI for intermediate risk and EVOLUT for low risk, will follow patients to 10 years. Long-term data would help inform clinicians of valve choice in very young patients undergoing aortic valve replacement, in whom multiple surgeries or procedures are indicated.