TAVR: Balloon-Expandable or Self-Expanding Valves, Which Is the Answer?

Courtesy of Dr. Carlos Fava.

Transcatheter aortic valve replacement (TAVR) has shown benefit and is currently moving towards low-risk patients, as well as bicuspid aortic valves and (to a lower extent) aortic regurgitation.

However, we must ponder on which valve should be used on each patient: balloon-expandable (BE) or self-expanding (SE) valve? They represent different technologies with different stents, release methods, and leaflet characteristics, which translate into differences as regards functioning, hemodynamic profile, and complications.

The CHOICE trial randomized 241 high-risk patients with severe aortic stenosis to receive Edwards SAPIEN XT (121 patients) or CoreValve (120 patients).

Groups were similar: the mean age was 81 years, the Society of Thoracic Surgeons (STS) score was 6, and the EuroSCORElog was 14.

After 5 years of follow-up, there were no significant differences as regards cardiovascular mortality (31.6% for BE vs. 21.5% for SE; p = 0.12), all-cause mortality (53.4% vs. 47.6%; p = 0.38), stroke (17.5% vs. 16.5%; p = 0.73), and readmission due to heart failure (28.9% vs. 22.5%; p = 0.75), infarction, major bleeding, or vascular complications.

Read also: Should We Finalize TAVR with Atrial Pacing in Some Patients?

The need for pacemaker implantation was higher among patients with SE valve (40.4% vs. 25.4%; p = 0.01).

As regards the hemodynamic profile, SE patients had larger prosthetic aortic valve area (1.6 ± 0.5 cm2 vs. 1.9 ± 0.5 cm2; p = 0.02) and a lower gradient (12.2 ± 8.7 mm Hg vs. 6.9 ± 2.7 mm Hg; p = 0.001), without any differences in regurgitation. Clinical valve thrombosis and moderate to severe valve deterioration were higher among BE patients (7.3% vs. 0.8%; p = 0.006, and 6.6% vs. 0%; p = 0.0018). The rate of bioprosthetic valve failure was extremely low, without differences between valves (4.1% vs. 3.4%; p = 0.63).

Conclusion

After a five-year follow-up, patients in the CHOICE trial show that the clinical evolution after transfemoral transcatheter aortic valve replacement with early-generation balloon-expandable and with self-expanding valves is not statistically significantly different. The hemodynamic profile was significantly better with self-expanding valves. Structural valve deterioration was uncommon but occurred more frequent with balloon-expandable valves.

Courtesy of Dr. Carlos Fava.

Original Title: 5-Year Outcomes After TAVR With Balloon-Expandable Versus Self-Expanding Valves Results. From the CHOICE Randomized Clinical Trial.

Reference: Mohamed Abdel-Wahab, et al,. J Am Coll Cardiol Intv 2020;13:1071–82.

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