Structural valve deterioration tied to worse outcomes; favorable for TAVI versus surgery patients: JAMA

USA: In patients undergoing self-expanding TAVI (transcatheter aortic valve implantation) versus surgery, a recent JAMA Cardiology study showed a lower structural valve deterioration rate (SVD) rate at five years. Also, doppler echocardiography was shown to be a helpful tool for SVD detection, which was linked with worse clinical outcomes.

Considering the poor understanding of the frequency and clinical importance of structural valve deterioration in patients undergoing self-expanding TAVI or surgery, the researchers aimed to investigate the 5-year incidence, clinical outcomes, and predictors of hemodynamic SVD in this population.

Daniel O'Hair, Cardiovascular Service Line, Boulder Community Health, Boulder, Colorado and colleagues addressed the question, what are the 5-year outcomes, incidence and predictors of SVD following supra-annular, self-expanding transcatheter aortic valve implantation, or surgery from large-scale randomized clinical trials?

The researchers pooled data from the SURTAVI (n = 1484) and CoreValve US High-Risk Pivotal (n = 615) randomized clinical trials (RCTs) for the post hoc analysis. The data pooling was supplemented by the CoreValve Continued Access Study (n = 2178) and CoreValve Extreme Risk Pivotal trial (n = 485). The study included patients with severe aortic valve stenosis considered at intermediate or increased risk of 30-day surgical mortality. Data analysis was done from December 2021 to October 2022, and the collection was from December 2010 to June 2016.

Patients were randomized to surgery or self-expanding TAVI in the RCTs or underwent TAVI for clinical indications in nonrandomized studies.

SVD incidence through 5 years was assessed from the RCTs (primary endpoint). Factors linked with CVD and its association with clinical outcomes were investigated for the pooled RCT and non-RCT populations. SVD was described as (1) an increase in the mean gradient of 10 mm Hg or higher from discharge or at 30 days to the last echocardiography with a final mean gradient of 20 mm Hg or higher or (2) new-onset modest or severe intraprosthetic aortic regurgitation or a rise of 1 grade or more.

The authors reported the following findings:

• Of 4762 included patients, 54.7% were male, and the mean age was 82.1 years.
• The study included a total of 2099 RCT patients, comprising those who received TAVI (n=1128) and who received surgery (n=971) and non-RCT patients who received TAVI (n=2663).
• The cumulative incidence of SVD treating the death as a competing risk was lesser in patients undergoing TAVI versus surgery (TAVI, 2.20%; surgery, 4.38%; hazard ratio [HR], 0.46). This lower risk was most prominent in smaller annuli patients (23 mm diameter or smaller; TAVI, 1.32%; surgery, 5.84%; HR, 0.21).
• SVD was linked with increased 5-year all-cause mortality (HR, 2.03), cardiovascular mortality (HR, 1.86), and valve disease or worsening heart failure hospitalizations (HR, 2.17).
• SVD predictors were developed from multivariate analysis.

To conclude, structural valve deterioration is associated with worse outcomes, and self-expanding TAVI is associated with a lower rate of SVD compared to surgery.

Reference:

O'Hair D, Yakubov SJ, Grubb KJ, et al. Structural Valve Deterioration After Self-Expanding Transcatheter or Surgical Aortic Valve Implantation in Patients at Intermediate or High Risk. JAMA Cardiol. Published online December 14, 2022. doi:10.1001/jamacardio.2022.4627