CoreValve US Pivotal and SURTAVI Trials Show Rate of SVD Lower With TAVR Than With SAVR
Patients with severe aortic stenosis at intermediate- or high-surgical risk had significantly less structural valve deterioration (SVD) with TAVR compared with SAVR after five years, based on insights from the CoreValve US Pivotal and SURTAVI trials presented April 4 during ACC.22.
Researchers analyzed data from 1,128 patients who underwent TAVR and 971 patients who underwent SAVR as part of the CoreValve US Pivotal and SURTAVI trials. SVD was evaluated using Doppler echocardiography.
Results found that 2.57% of the patients treated with TAVR had SVD at five years, compared with 4.38% of those treated with SAVR. This difference in SVD was more profound in patients with smaller (≤23 mm) annuli (5.86% surgery vs. 1.39% TAVI; p=0.049), but a trend was also found in patients with larger (>23 mm) annuli (3.96% surgery vs. 2.48% TAVI; p=0.067). Patients in both groups who developed SVD were at about 50% greater risk of all-cause mortality or hospitalization for valve-related disease or worsening heart failure at five years, the researchers said.
In other findings, multivariate predictor analysis found a higher risk of developing SVD in patients with a higher body surface area, and a lower risk of SVD in men, older patients and those with prior PCI and atrial fibrillation.
With TAVR now approved by the U.S. Food and Drug Administration for use in patients of all ages and risk levels who need a replacement heart valve, "heart surgeons tend to worry that in younger, lower-risk patients, replacement valves inserted using TAVR may fail more quickly than surgically inserted valves," said Michael J. Reardon, MD, FACC, the study's senior author. "The results of this study suggest exactly the opposite – that at five years, the TAVR-inserted valve has less structural deterioration than the surgically inserted one."
According to Reardon, the study is the largest to assess SVD in patients who participated in randomized trials comparing TAVR and SAVR and the first to show less structural valve deterioration after five years among patients treated with TAVR compared with SAVR. Establishing durability of the valves over a longer period of time remains important. Patients in the two ongoing trials, SURTAVI for intermediate risk and Evolut for low risk, will each be followed for 10 years to help answer this question.
Keywords: ACC Annual Scientific Session, ACC22, Transcatheter Aortic Valve Replacement, Bioprosthesis, Incidence, Hemodynamics, Aortic Valve Stenosis, Heart Valve Prosthesis
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