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Structural Valve Deterioration After Self-Expanding TAVI or Surgical Implantation
Quick Takes
- Transcatheter bioprosthesis was associated with a lower rate of structural valve deterioration (SVD) compared with surgery at 5 years in this post hoc pooled analysis.
- Patients who developed SVD had a 2-fold higher 5-year mortality and hospitalizations for valve disease or worsening heart failure, suggesting that serial Doppler echo is a useful tool to monitor patients after aortic valve replacement, regardless of the modality of valve replacement.
- Pending long-term 10-year follow-up data, valve durability using clinically relevant SVD criteria should be an important consideration for the selection of the first bioprosthetic valve in lower-risk patients with symptomatic severe aortic stenosis.
Study Questions:
What are the 5-year incidence, outcomes, and predictors of structural valve deterioration (SVD) after self-expanding transcatheter aortic valve implantation (TAVI), or surgical aortic valve implantation?
Methods:
The investigators conducted 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) and supplemented by the CoreValve Extreme Risk Pivotal trial (n = 485) and CoreValve Continued Access Study (n = 2,178). Patients with severe aortic valve stenosis deemed to be at intermediate or increased risk of 30-day surgical mortality were included. Patients were randomized to self-expanding TAVI or surgery in the RCTs or underwent self-expanding TAVI 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 of ≥20 mm Hg, or 2) new-onset moderate or severe intraprosthetic aortic regurgitation or an increase of ≥1 grade.
Results:
Of 4,762 included patients, 2,605 (54.7%) were male, and the mean (standard deviation) age was 82.1 (7.4) years. A total of 2,099 RCT patients, including 1,128 who received TAVI and 971 who received surgery, and 2,663 non-RCT patients who received TAVI were included. The cumulative incidence of SVD treating death as a competing risk was lower in patients undergoing TAVI than surgery (TAVI, 2.20%; surgery, 4.38%; hazard ratio [HR], 0.46; 95% confidence interval [CI], 0.27-0.78; p = 0.004). This lower risk was most pronounced in patients with smaller annuli (23 mm diameter or smaller; TAVI, 1.32%; surgery, 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). Predictors of SVD were developed from multivariate analysis.
Conclusions:
The authors reported a lower rate of SVD in patients undergoing self-expanding TAVI versus surgery at 5 years.
Perspective:
This pooled analysis found that transcatheter bioprosthesis was associated with a lower rate of SVD compared with surgery at 5 years. Of note, this lower risk of SVD was most pronounced in patients with smaller aortic annuli (23 mm or smaller diameter). Furthermore, patients who developed SVD had a 2-fold higher 5-year mortality and hospitalizations for valve disease or worsening heart failure, suggesting that serial Doppler transthoracic echocardiography is a valuable tool to monitor patients after aortic valve replacement, regardless of the modality of valve replacement or the definition used for SVD. Preprocedural predictors of SVD were a larger body surface area, while men, older patients, those with a history of hypertension, percutaneous coronary intervention, and atrial fibrillation had lower rates of SVD. Finally, pending longer-term 10-year follow-up data, valve durability using clinically relevant SVD criteria should be an important consideration for the selection of the first bioprosthetic valve in lower-risk patients with symptomatic severe aortic stenosis.
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, Echocardiography, Geriatrics, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis Implantation, Patient Discharge, Risk, Transcatheter Aortic Valve Replacement
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