Early Structural Valve Degeneration of Trifecta Bioprosthesis

Abstract

Background: Structural valve degeneration (SVD) is a major flaw of bioprostheses. An apparent increase in the SVD rate has been observed among patients who received the Trifecta bioprosthesis (Abbott Vascular, Santa Clara, CA).

Methods: This study retrospectively reviewed 1058 consecutive patients who underwent aortic valve placement with a stented bioprosthesis between January 2011 and December 2015. Patients were grouped into a Trifecta group (508 [48.0%] patients with Trifecta bioprostheses) and a non-Trifecta group (550 [52.0%] patients with other bioprostheses).

Results: Patients in the Trifecta group were older (69.7 years vs 64.6 years; P = .001), were more likely female (40.4% vs 28.0%; P = .001), more often had aortic stenosis (85.1% vs 77.1%; P = .001), and received smaller valves (23.0 mm vs 25.0 mm; P < .001) than patients in the non-Trifecta group. SVD occurred in 28 patients (Trifecta, n = 22; non-Trifecta, n = 6) within 7 years. Aortic regurgitation or mixed stenosis/regurgitation was observed as the mode of failure in more than 50% of the Trifecta group, whereas none in non-Trifecta group. The cumulative incidence of SVD was higher in the Trifecta group both in the entire cohort (13.3% vs 4.6%; P = .010) and in the younger cohort (age ≤ 65 years; 27.9% vs 6.9%; P = .004), with a notable increase between 5 and 7 years. Multivariable competing risks regression in the Trifecta group revealed younger age (hazard ratio, 0.56 per 10-point decrease; 95% confidence interval, 0.44 to 0.72; P < .001) to be the sole contributor to SVD.

Conclusions: The SVD rate of the Trifecta bioprosthesis has been greater than expected, compared with other bioprostheses, particularly in younger patients. In view of the large number of Trifecta bioprostheses implanted worldwide, further investigation involving other institutions is warranted.