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Structural Valve Deterioration After Self-Expanding TAVR
Quick Takes
- In a post hoc analysis of data from two RCTs of self-expanding TAVR vs. bioprosthetic SAVR and two nonrandomized studies of patients undergoing self-expanding TAVR, there was a lower 5-year rate of structural valve deterioration (SVD) among patients undergoing self-expanding TAVR compared to SAVR, which was more pronounced among patients with a smaller (≤23 mm diameter) annulus.
- The development of SVD was associated with a twofold higher 5-year risk of all-cause mortality, cardiovascular mortality, and hospitalization for valve disease or worsening heart failure.
Study Questions:
What are the 5-year incidence, clinical outcomes, and predictors of hemodynamic structural valve deterioration (SVD) among patients undergoing self-expanding transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR)?
Methods:
In a post hoc analysis of pooled data from the CoreValve US High Risk Pivotal (n = 615) and SURTAVI (n = 1,484) randomized clinical trials (RCTs) supplemented by data from the CoreValve Extreme Risk Pivotal trial (n = 485) and CoreValve Continued Access Study (n = 2,178), patients with severe aortic valve stenosis at intermediate or increased risk of 30-day surgical mortality were identified. Data were collected from December 2010 to June 2016, and analyzed from December 2021 to October 2022. Patients were randomized to self-expanding TAVR or surgery in the RCTs or underwent self-expanding TAVR for clinical indications in the nonrandomized studies. The primary endpoint was the incidence of SVD through 5 years (from the RCTs). Factors associated with SVD and its association with clinical outcomes were evaluated for the pooled RCT and non-RCT population. SVD was defined as 1) an increase in mean gradient of ≥10 mm Hg from discharge or at 30 days to last echocardiography with a final mean gradient ≥20 mm Hg, or 2) new-onset moderate or severe intraprosthetic aortic regurgitation (AR) or an increase of ≥1 AR grade.
Results:
There were 4,762 included patients (2,605 [54.7%] male, mean age 82.1 ± 7.4 years), including 2,099 RCT patients (1,128 who underwent TAVR and 971 who underwent SAVR), and 2,663 non-RCT patients who underwent TAVR. Treating death as a competing risk, the cumulative incidence of SVD was lower in patients undergoing TAVR (2.20%) than SAVR (4.38%) (hazard ratio [HR], 0.46; 95% confidence interval [CI], 0.27-0.78; p = 0.004). The lower risk was most pronounced among patients with a smaller annulus (≤23 mm diameter; TAVR 1.32% vs. SAVR 5.84%, HR, 0.21; 95% CI, 0.06-0.73; p = 0.02). SVD was associated with increased 5-year all-cause mortality (HR, 2.03; 95% CI, 1.46-2.82; p < 0.001), cardiovascular mortality (HR, 1.86; 95% CI, 1.20-2.90; p = 0.006), and valve disease or worsening heart failure hospitalizations (HR, 2.17; 95% CI, 1.23-3.84; p = 0.008). From multivariate analysis, higher body surface area was a positive predictor of SVD; and male sex, older age, and a history of hypertension, percutaneous coronary intervention, or atrial fibrillation were negative predictors.
Conclusions:
This study found a lower 5-year rate of SVD among patients undergoing self-expanding TAVR compared to SAVR. The authors conclude that Doppler echocardiography was a valuable tool to detect SVD, which was associated with worse clinical outcomes.
Perspective:
Valve durability is an important factor in weighing the relative risks and benefits of TAVR among younger patients. This post hoc analysis of data from two RCTs of a self-expanding TAVR vs. bioprosthetic SAVR found a lower 5-year rate of SVD among patients undergoing self-expanding TAVR compared to SAVR, with the lower risk more pronounced among patients with a smaller (≤23 mm diameter) annulus. Using data from the two RCTs and two nonrandomized studies, the study found that the development of SVD was associated with approximately twofold higher 5-year risks of mortality and of hospitalization for valve disease or worsening heart failure. The current ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease considers echocardiography in the absence of a change in clinical status to be reasonable (class 2a) yearly after TAVR and at 5 and 10 years after bioprosthetic SAVR, but yearly only 10 years after bioprosthetic SAVR. However, the adverse outcomes associated with SVD in this study might argue for more frequent routine screening for evidence of SVD in asymptomatic patients after bioprosthetic SAVR.
Clinical Topics: Cardiac Surgery, Geriatric Cardiology, Heart Failure and Cardiomyopathies, Invasive Cardiovascular Angiography and Intervention, Noninvasive Imaging, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and Heart Failure, Cardiac Surgery and VHD, Acute Heart Failure, Interventions and Imaging, Interventions and Structural Heart Disease, Echocardiography/Ultrasound
Keywords: Aortic Valve Insufficiency, Aortic Valve Stenosis, Cardiac Surgical Procedures, Diagnostic Imaging, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Hemodynamics, Patient Discharge, Risk Assessment, Transcatheter Aortic Valve Replacement
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