Outcomes for the Commercial Use of Self-Expanding Prostheses in Transcatheter Aortic Valve Replacement: A Report From the STS/ACC TVT Registry.

OBJECTIVES

The authors sought to compare the outcomes of commercial transcatheter aortic valve replacement (TAVR) with the repositionable Evolut R platform to those observed with the CoreValve device in the Society of Thoracic Surgeons (STS)/American College of Cardiology (ACC) Transcatheter Valve Therapy (TVT) Registry.

BACKGROUND

TAVR continues to evolve, with rapid adoption of iterative changes for commercial practice. Insight into the outcomes of this adoption is needed.

METHODS

Patients in the TVT Registry who had TAVR using a 23-, 26-, or 29-mm self-expanding prosthesis were enrolled. Site-reported events for procedural, in-hospital, and 30-day outcomes were examined.

RESULTS

Between January 2014 and April 2016, 9,616 patients underwent TAVR with a self-expanding prosthesis with data entered in the TVT Registry. Compared with patients treated with CoreValve TAVR, those who received Evolut R TAVR had a lower STS-PROM score (8.0 ± 5.4% vs. 8.7 ± 5.3%; p < 0.001), more iliofemoral access (91.6% vs. 89.2%; p < 0.001), and more frequently had conscious sedation (27.4% vs. 12.7%; p < 0.001). With Evolut R TAVR, there was less need for a second prosthesis (2.2% vs. 4.5%; p < 0.001), less device migration (0.2% vs. 0.6%; p = 0.01), a lower incidence of moderate/severe paravalvular regurgitation (post-procedure, 4.4% vs. 6.2%; p < 0.001), and shorter median hospital stay (4.0 vs. 5.0 days; p < 0.001). Patients treated with Evolut R TAVR had greater device success (96.3% vs. 94.9%; p = 0.001). At 30 days, Evolut R patients had both lower mortality (3.7% vs. 5.3%; p < 0.001) and less need for a pacemaker (18.3% vs. 20.1%; p = 0.03).

CONCLUSIONS

Commercial adoption of the Evolut R platform is associated with significant improvements in acute outcomes for patients undergoing TAVR for aortic stenosis.