Camille Yongue1, Diana C Lopez2, Edward G Soltesz3, Eric E Roselli3, Faisal G Bakaeen3, A Marc Gillinov4, Gösta B Pettersson4, Marie E Semple5, Jeevanantham Rajeswaran5, Michael Z Tong3, Wael Jaber6, Eugene H Blackstone7, Lars G Svensson3, Douglas R Johnston8. 1. Case Western Reserve University School of Medicine, Cleveland, Ohio. 2. Cleveland Clinic Lerner College of Medicine, Cleveland, Ohio. 3. Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Aorta Center, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. 4. Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. 5. Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio. 6. Department of Cardiovascular Medicine, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. 7. Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio. 8. Department of Thoracic and Cardiovascular Surgery, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio; Aorta Center, Heart, Vascular, and Thoracic Institute, Cleveland Clinic, Cleveland, Ohio. Electronic address: johnstd3@ccf.org.
Abstract
BACKGROUND: Reports of early failure of the Trifecta externally wrapped, bovine pericardial aortic valve prosthesis (Abbott Laboratories, Abbott Park, IL) raise concerns about its durability. This study evaluated the hemodynamic performance and explant of Trifecta valves compared with the PERIMOUNT bovine pericardial prosthesis (Edwards Lifesciences, Irvine, CA). METHODS: From October 2007 to July 2017, 2305 patients received a Trifecta bioprosthesis during aortic valve replacement at Cleveland Clinic. Trends in postoperative valve hemodynamics were assessed from 4971 transthoracic echocardiograms and valve explants by systemic follow-up. To compare outcomes, 2298 patients receiving a Trifecta valve were 1:1 propensity matched from 17,281 patients receiving a PERIMOUNT bioprosthesis. RESULTS: Mean age at implant was 69 years in both matched groups. Compared with PERIMOUNT valves, early transvalvular mean gradient of Trifecta valves was lower (11 vs 15 mm Hg at 1 year, P < .001); however, its longitudinal rate of rise was greater (P < .001), resulting in 5-year mean gradients of 17 vs 16 mm Hg, and more patients experienced severe aortic regurgitation (2.4% vs 0.81%; P < .001). 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 < .001). CONCLUSIONS: Compared with an older-generation internally mounted bovine pericardial valve, the Trifecta externally wrapped bioprosthesis exhibits superior early hemodynamic performance, but has 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.
BACKGROUND: Reports of early failure of the Trifecta externally wrapped, bovine pericardial aortic valve prosthesis (Abbott Laboratories, Abbott Park, IL) raise concerns about its durability. This study evaluated the hemodynamic performance and explant of Trifecta valves compared with the PERIMOUNT bovine pericardial prosthesis (Edwards Lifesciences, Irvine, CA). METHODS: From October 2007 to July 2017, 2305 patients received a Trifecta bioprosthesis during aortic valve replacement at Cleveland Clinic. Trends in postoperative valve hemodynamics were assessed from 4971 transthoracic echocardiograms and valve explants by systemic follow-up. To compare outcomes, 2298 patients receiving a Trifecta valve were 1:1 propensity matched from 17,281 patients receiving a PERIMOUNT bioprosthesis. RESULTS: Mean age at implant was 69 years in both matched groups. Compared with PERIMOUNT valves, early transvalvular mean gradient of Trifecta valves was lower (11 vs 15 mm Hg at 1 year, P < .001); however, its longitudinal rate of rise was greater (P < .001), resulting in 5-year mean gradients of 17 vs 16 mm Hg, and more patients experienced severe aortic regurgitation (2.4% vs 0.81%; P < .001). 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 < .001). CONCLUSIONS: Compared with an older-generation internally mounted bovine pericardial valve, the Trifecta externally wrapped bioprosthesis exhibits superior early hemodynamic performance, but has 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.
Authors: Robert J M Klautz; François Dagenais; Michael J Reardon; Rüdiger Lange; Michael G Moront; Louis Labrousse; Neil J Weissman; Vivek Rao; Himanshu J Patel; Fang Liu; Joseph F Sabik Journal: Eur J Cardiothorac Surg Date: 2022-08-03 Impact factor: 4.534