Real-world data favor SAVR over TAVR when younger patients need aortic valve replacement
When patients between the ages of 65 and 80 present with severe aortic stenosis, a new real-world analysis out of Italy suggests surgery may be associated with a higher likelihood of long-term survival than transcatheter aortic valve replacement (TAVR).
The study, published in the Journal of Clinical Medicine, included data from more than 7,000 patients with severe symptomatic aortic stenosis who underwent aortic valve replacement. All patients were between the ages of 65 and 80 years old. Patients underwent treatment in either Lombardy or Puglia, two large regions in Italy. In Lombardy, 67% of patients underwent surgical aortic valve replacement (SAVR) and 33% underwent TAVR. In Puglia, meanwhile, 73% underwent SAVR and 27% underwent TAVR.
TAVR did become more common in both regions throughout the course of this study, researchers noted. The incidence of TAVR procedures increased by 19% in Lombardy and 25% in Puglia from 2018-2019 to 2020-2021.
The mean ages of the SAVR patients were 73.4 years old in Lombardy and 73.6 years old in Puglia. For TAVR, meanwhile, the mean ages were 76.3 in Lombardy and 76.5 in Puglia. TAVR patients also presented with more comorbidities. To help account for these differences, the group performed propensity score matching to focus on 786 matched pairs of patients from Lombardy and 321 matched pairs of patients from Puglia.
Patients were followed for two to five years. After 30 days, the all-cause mortality rates for the propensity-score-matched cohorts were slightly lower for TAVR. The rates were 1.3% for TAVR and 1.9% for SAVR in Lombardy, for example, and 2.2% for TAVR and 3.1% for SAVR in Puglia. However, starting at one year, the Kaplan-Meier curves started to diverge. By the end of the study, all-cause mortality was significantly higher for TAVR in both regions. In Lombardy, the rates were 24.6% after SAVR and 47.2% after TAVR. In Puglia, the rates were 18.1% after SAVR and 44.1% after Puglia.
“In our study, after propensity matching, the risk of death from 30 to 1825 post-procedural days was significantly higher in the TAVR group vs. the SAVR group in both Lombardy and Puglia,” wrote first author Marco Ranucci, MD, with Policlinico San Donato in Milan, Italy, and colleagues. “Our results may appear to be conflicting with the existing evidence from randomized control trials showing equivalent long-term outcomes of the two techniques, or even the superiority of TAVR.”
Ranucci et al. noted that SAVR has seen “great advances” in recent years that may help explain the strong performance of surgery in their real-world analysis. Also, they said it is possible that the randomized studies showing TAVR’s superiority were primarily performed at facilities where specialists have a “higher expertise in TAVR than in SAVR.”
The group noted that their research did have certain limitations. Patients were selected for inclusion using administrative codes, for example, which introduces the small risk of “miscoding.” Also, they were missing some baseline patient data, including a few risk scores commonly used to compare patients with another.
A big strength of their research, they added, was “the inclusion of all cardiac surgery institutions and patients in the two regions considered, thus minimizing the selection bias that is unavoidable in clinical trials.”
Ranucci and colleagues concluded with a warning to care teams that may be tempted to choose TAVR over SAVR in every patient over the age of 65.
“Caution should be applied in addressing patients < 80 years with TAVR unless SAVR is contraindicated,” they wrote.
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Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.