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Valve-in-Valve vs. Native Valve TAVR
Study Questions:
What is the safety and effectiveness of valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) compared to a benchmark of native valve TAVR?
Methods:
Patients who underwent ViV-TAVR (n = 1,150) were matched 1:2 (based on sex, high or extreme risk, hostile chest or porcelain aorta, 5-meter walk time, and Society of Thoracic Surgeons (STS) Predicted Risk of Mortality for reoperation) to patients undergoing native valve TAVR (n = 2,259). Baseline characteristics, procedural data, and in-hospital outcomes were obtained from the STS/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies (TVT) Registry. The 30-day and 1-year outcomes were obtained from linked Medicare administrative claims data.
Results:
Unadjusted analysis revealed lower 30-day mortality (2.9% vs. 4.8%; p < 0.001), stroke (1.7% vs. 3.0%; p = 0.003), and heart failure hospitalizations (2.4% vs. 4.6%; p < 0.001) in the ViV-TAVR compared with native valve TAVR group. Adjusted analysis revealed lower 30-day mortality (hazard ratio [HR], 0.503; 95% confidence interval [CI], 0.302-0.839; p = 0.008), lower 1-year mortality (HR, 0.653; 95% CI, 0.505-0.844; p = 0.001), and hospitalization for heart failure (HR, 0.685; 95% CI, 0.500-0.939; p = 0.019) in the ViV-TAVR group. Patients in the ViV-TAVR group had higher post-TAVR mean gradient (16 vs. 9 mm Hg; p < 0.001), but less moderate or severe aortic regurgitation (3.5% vs. 6.6%; p < 0.001). Post-TAVR gradients were highest after ViV TAVR in small surgical AVRs (SAVRs) and stenotic SAVRs.
Conclusions:
Comparison with the benchmark native valve TAVR shows ViV-TAVR to be a safe and effective procedure in patients with failed SAVR who are at high risk for repeat surgery.
Perspective:
This study used data from the STS/ACC TVT Registry to compare ViV TAVR to native valve TAVR. Procedural, 30-day, and 1-year outcomes were similar or better compared with native valve TAVR, with fewer procedural complications. Issues with valve malpositioning and coronary ostial obstruction reported with earlier global registry data presumably were reduced in this study due to patient selection and learning from those earlier experiences. Higher post-TAVR mean gradients associated with ViV-TAVR reinforce the importance of patient selection; weighing the risk of high gradients after TAVR among patients with a small bioprosthesis should be included in Heart Team decisions regarding ViV-TAVR versus re-do SAVR.
Keywords: Aortic Valve Insufficiency, Bioprosthesis, Cardiac Surgical Procedures, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Stroke, STS/ACC TVT Registry, Transcatheter Aortic Valve Replacement, Vascular Diseases
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