Why is this study important?
- In this analysis of 2099 randomized patients with severe aortic stenosis and intermediate or higher risk of 30-day surgical mortality, the 5-year rate of structural valve deterioration (SVD) was 4.38% in patients receiving surgery and 2.20% in patients receiving TAVI.
- The presence of Doppler-derived SVD conferred a two-fold increased risk of all-cause mortality and hospitalization for valve disease or heart failure.
What question was this study supposed to answer?
The long-term incidence of SVD in self-expanding, supra-annular transcatheter valves is not well-described and how it compares to the surgical valve replacement in a similar patient population is unknown. Additionally, how the presence of SVD impacts clinical outcomes.
This study was a post hoc analysis of pooled data from two randomized controlled trials (RCTs) and two non-randomized transcatheter valve studies; the primary endpoint was the incidence of SVD through 5 years (from the RCTs). Predictors of SVD and its association with clinical outcomes were also evaluated for the pooled RCT and non-RCT population.
Pooled data were obtained from the CoreValve US High Risk Pivotal (n = 615) and SURTAVI (n = 1484) RCTs; these were supplemented from the non-randomized CoreValve Extreme Risk Pivotal trial (n = 485) and CoreValve Continued Access Study (n = 2178). Those patients with severe, symptomatic aortic valve stenosis at intermediate or increased risk of 30-day surgical mortality were included.
What did the study show?
- Of 4762 included patients, 2605 (54.7%) were male, and the mean (SD) age was 82.1 (7.4) years.
- The cumulative incidence of SVD was lower in those patients receiving TAVR compared with surgical AVR (TAVI, 2.20%; surgery, 4.38%; hazard ratio [HR], 0.46; 95% CI, 0.27-0.78; P = .004).
- The difference was even more apparent in those patients with small annuli (23 mm diameter or smaller; TAVI, 1.32%; surgery, 5.84%; HR, 0.21; 95% CI, 0.06-0.73; P = .02).
- SVD was associated with increased 5-year all-cause mortality (HR, 2.03; 95% CI, 1.46-2.82; P < .001), cardiovascular mortality (HR, 1.86; 95% CI, 1.20-2.90; P = .006), and valve disease or worsening heart failure hospitalizations (HR, 2.17; 95% CI, 1.23-3.84; P = .008).
All editors: Jordan Safirstein, MD, FSCAI
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