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TAVR vs. SAVR Outcomes in Lower-Risk Patients
Study Questions:
What are the outcomes of transcatheter aortic valve replacement (TAVR) in comparison to surgical aortic valve replacement (SAVR) among lower-risk populations with severe aortic stenosis?
Methods:
This study examined outcomes in 383 lower-risk patients from the CoreValve US Pivotal High-Risk Trial randomized to TAVR (n = 202) versus SAVR (n = 181); lower risk was defined as patients with a Society of Thoracic Surgeons Predicted Risk of Mortality (STS PROM) ≤7%.
Results:
The median STS PROM was 5.3% for both TAVR and SAVR subgroups. All-cause mortality at 2 years was lower with TAVR versus SAVR (15.0%; 95% confidence interval [CI], 8.9-10.0% vs. 26.3%; 95% CI, 19.7-33.0%; p = 0.01), with no difference in rate of stroke at 2 years (11.3% vs. 15.1%, p = 0.50). There was no change in quality of life by Kansas City Cardiomyopathy Questionnaire summary score between groups (20.0 vs. 18.6, p = 0.71). Patients with TAVR (vs. SAVR) had higher effective orifice areas (1.8 ± 0.5 vs. 1.5 ± 0.5 cm2, p < 0.001) and lower mean aortic valve gradients (8.6 ± 3.5 vs. 12.5 ± 6.8 mm Hg, p < 0.001), with lower rates of patient-prosthesis mismatch (8.1% vs. 25.6%, p < 0.001).
Conclusions:
Patients considered high risk, but with STS PROM scores ≤7% had improved survival and better valve hemodynamics with TAVR as compared to SAVR.
Perspective:
Despite all patients in this trial being considered high risk, the median STS PROM score was 7.1%, demonstrating a potentially lower-risk cohort in comparison to earlier trials. This study compared outcomes between TAVR and SAVR in this study cohort with an STS PROM ≤7%, and observes favorable findings in the TAVR group, with a large and significant reduction in 2-year mortality, a marked reduction in patient-prosthesis mismatch, and improved valve hemodynamics as compared to SAVR. While no significant “medical benefit” (defined by the Kansas City Cardiomyopathy Questionnaire score) was observed, the large reduction in mortality does suggest a favorable role for TAVR in this population. It is important to note that although these patients had lower-risk STS PROM scores, they were considered high risk by the screening committee, which may have been due to variables unmeasured by the STS PROM score. These results are best applied to patients with lower STS PROM scores who are still judged to be high surgical risk.
Keywords: Aortic Valve Stenosis, Cardiac Surgical Procedures, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Quality of Life, Risk, Stroke, Transcatheter Aortic Valve Replacement, Treatment Outcome
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