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TAVR Outcomes With Balloon-Expandable vs. Self-Expanding Valves
Study Questions:
What are the device performance characteristics of a balloon-expandable (BE) transcatheter heart valve (THV) versus a self-expanding (SE) THV?
Methods:
The CHOICE (Randomized Comparison of Transcatheter Heart Valves in High Risk Patients With Severe Aortic Stenosis: Medtronic CoreValve Versus Edwards SAPIEN XT) trial is an investigator-initiated, multicenter trial in which 241 high-risk patients with severe symptomatic aortic stenosis and anatomy suitable for both a BE and SE THV were randomized to undergoing transfemoral-access transcatheter aortic valve replacement (TAVR) with either device at five German centers during 2012-2013. The primary endpoint was device success. Patients were followed up to 5 years, with assessment of clinical outcomes, echocardiographic evaluation of valve function, and THV durability.
Results:
After 5 years, there were no statistically significant differences between BE and SE valves in the cumulative incidence of death from any cause (53.4% vs. 47.6%, p = 0.38), death from cardiovascular causes (31.6% vs. 21.5%, p = 0.12), all strokes (17.5% vs. 16.5%, p = 0.73), and repeat hospitalization for heart failure (28.9% vs. 22.5%, p = 0.75). Patients who underwent SE TAVR had larger prosthetic valve area (1.6 ± 0.5 cm2 vs. 1.9 ± 0.5 cm2, p = 0.02) with a lower mean transprosthetic gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg, p = 0.001) at 5 years. No differences were observed in the rates of paravalvular regurgitation. Clinical valve thrombosis occurred in seven patients after BE TAVR (7.3%) and one patient after SE TAVR (0.8%, p = 0.06), and moderate or severe structural valve deterioration occurred in six patients after BE TAVR (6.6%) and in no patient after SE TAVR (0%, p = 0.02). The rate of bioprosthetic valve failure was low and not significantly different between both groups (4.1% vs. 3.4%, p = 0.63).
Conclusions:
Five-year follow-up of patients in the CHOICE trial revealed clinical outcomes after transfemoral TAVR with early generation BE and SE valves that were not statistically significantly different, albeit with limited statistical power. Forward flow hemodynamics were significantly better with the SE valve. Moderate or severe structural valve deterioration was uncommon but occurred more frequently with the BE valve.
Perspective:
Previous publication of the 1-year results of the CHOICE trial (J Am Coll Cardiol 2015;66:791-800) revealed no statistically significant differences in clinical outcomes after BE and SE TAVR, but higher gradients and lower valve area after BE than after SE TAVR, and a higher incidence of ≥ mild paravalvular aortic regurgitation (AR) after SE than after BE TAVR. Still limited by sample size and statistical power, the present study continues to show no statistically significant differences in clinical outcomes 5 years after TAVR with the two devices. The previous observation of hemodynamic differences persisted, whereas the difference in paravalvular AR did not (potentially due to actual regression, limitations in AR quantitation, or incomplete follow-up). This study suggests that clinical outcomes are similar following TAVR with a BE or a SE device. However, the study is limited in power, and also limited in that the devices used (albeit current at the time of intervention) now are no longer current generation, and results between BE and SE THVs may differ as the devices evolve.
Clinical Topics: Cardiac Surgery, 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, Heart Failure, Heart Valve Diseases, Heart Valve Prosthesis, Hemodynamics, Stroke, Thrombosis, Transcatheter Aortic Valve Replacement, Treatment Outcome
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