Durability and Performance of 2,298 Trifecta Aortic Valve Prostheses: A Propensity-Matched Analysis

BACKGROUND Reports of early failure of the Trifecta externally wrapped, bovine pericardial aortic valve prosthesis raise concerns about its durability. We evaluated the hemodynamic performance and explant of Trifecta valves compared with the PERIMOUNT bovine pericardial prosthesis. METHODS From 10/2007 to 7/2017, 2,305 patients received a Trifecta bioprosthesis during aortic valve replacement at Cleveland Clinic. Trends in postoperative valve hemodynamics were assessed from 4,971 transthoracic echocardiograms and valve explant by systematic follow-up. To compare outcomes, 2,298 patients receiving a Trifecta valve were 1:1 propensity matched from 17,281 patients receiving a PERIMOUNT bioprosthesis. RESULTS Mean age at implantation was 69 years in both matched groups. Compared with PERIMOUNT valves, early transvalvular mean gradient of Trifecta valves was lower (11 vs 15 mmHg at 1 year, P<.0001); however, its longitudinal rate of rise was greater (P<.0001), resulting in 5-year mean gradients of 17 vs 16 mmHg, and more patients experienced severe aortic regurgitation (2.4% vs 0.81%, P<.0001). At 5 years, 35 Trifecta valves had been explanted, vs 14 PERIMOUNT valves; freedom from explant at 1, 3, and 5 years was 98.9%, 98.0%, and 95.9%, respectively, for the Trifecta group vs 99.3%, 99.0%, and 98.7% for the PERIMOUNT group (P<.0001). CONCLUSIONS Compared with an older-generation internally mounted bovine pericardial valve, the Trifecta externally wrapped bioprosthesis exhibits superior early hemodynamic performance, but a rapid increase in transvalvular gradient and more aortic regurgitation, with lower freedom from explant at 5 years. These findings raise concern regarding long-term Trifecta durability despite favorable early hemodynamics.