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Balloon-Expandable vs. Self-Expanding Valves for Transcatheter Bicuspid AS
Quick Takes
- Both current-generation balloon-expandable valves (BEVs) and self-expanding valves (SEVs) are effective for bicuspid aortic valve stenosis, showing a comparably high rate of technical success and similar midterm clinical efficacy.
- However, compared to SEVs, BEVs are associated with a lower incidence of new permanent pacemaker implant and moderate or greater paravalvular regurgitation but with a more frequent occurrence of severe patient-prosthesis mismatch, resulting in an overall higher rate of 30-day device success and early safety.
Study Questions:
What are the procedural and clinical outcomes of balloon-expandable valves (BEVs) and self-expanding valves (SEVs) in Sievers type 1 bicuspid aortic valve (BAV) stenosis?
Methods:
The investigators conducted the AD-HOC (Characteristics, Sizing, and Outcomes of Stenotic Raphe-Type Bicuspid Aortic Valves Treated With Transcatheter Device Implantation) registry, an observational registry enrolling patients with Sievers type 1 BAV stenosis undergoing transcatheter aortic valve replacement with current-generation BEVs and SEVs at 24 international centers. A 1:1 propensity-score matching analysis was performed to adjust for baseline imbalances. The primary endpoint was midterm major adverse events (MAEs), defined as a composite of all-cause death, neurologic events, or hospitalization for heart failure. Mid-term outcomes were reported as hazard ratios (HRs) and 95% confidence intervals (CIs) and were computed by mixed-effects Cox regression. Kaplan-Meier curves were reported for the incidence of MAEs at the last available follow-up.
Results:
Among 955 eligible patients, propensity-score matching resulted in 301 pairs. At a median follow-up of 1.3 years, BEVs and SEVs had a similar risk of MAEs (BEV vs. SEV: HR, 0.75; 95% CI, 0.49-1.16; p = 0.200). Technical success was similar (odds ratio [OR], 1.38; 95% CI, 0.63-3.04; p = 0.421). At 30 days, BEVs were associated with a lower risk of new permanent pacemaker implantation (PPI) (OR, 0.42; 95% CI, 0.24-0.72; p = 0.002) and moderate or greater paravalvular regurgitation (OR, 0.16; 95% CI, 0.05-0.48; p = 0.001) but a higher risk of severe patient-prosthesis mismatch (OR, 3.03; 95% CI, 1.02-8.95; p = 0.045).
Conclusions:
The authors report that compared to SEVs, BEVs were associated with less PPI and moderate or greater paravalvular regurgitation but with more severe patient-prosthesis mismatch.
Perspective:
This study reports that both current-generation BEVs and SEVs are effective for BAV stenosis, showing a comparably high rate of technical success and similar midterm clinical efficacy. However, compared to SEVs, BEVs are associated with a lower incidence of new PPI and moderate or greater paravalvular regurgitation but with a more frequent occurrence of severe patient-prosthesis mismatch, resulting in an overall higher rate of 30-day device success and early safety. Additional prospective, larger studies with long-term follow-up are indicated to validate these results.
Clinical Topics: Cardiac Surgery, Congenital Heart Disease and Pediatric Cardiology, Invasive Cardiovascular Angiography and Intervention, Valvular Heart Disease, Aortic Surgery, Cardiac Surgery and CHD and Pediatrics, Cardiac Surgery and VHD, Congenital Heart Disease, CHD and Pediatrics and Interventions, Interventions and Structural Heart Disease
Keywords: Aortic Valve Stenosis, Bicuspid Aortic Valve Disease, Transcatheter Aortic Valve Replacement
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