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J. Thorac. Cardiovasc. Surg. · Mar 2017
Multicenter Study Observational StudyMidterm, multicenter clinical and hemodynamic results for the Trifecta aortic pericardial valve.
- Scott Goldman, Anson Cheung, Joseph E Bavaria, Michael R Petracek, Mark A Groh, and Hartzell V Schaff.
- Lankenau Heart Group, Lankenau Hospital, Wynnewood, Pa. Electronic address: GoldmanS@mlhs.org.
- J. Thorac. Cardiovasc. Surg. 2017 Mar 1; 153 (3): 561-569.e2.
ObjectiveTo evaluate the midterm hemodynamic performance and clinical outcomes of the Trifecta aortic pericardial valve.MethodsIn a multicenter, prospective, nonrandomized, follow-up study, 710 patients underwent surgical implantation of a pericardial stented aortic prosthesis (Trifecta valve; St Jude Medical, St. Paul, Minn). The valve is constructed from bovine pericardium mounted externally onto a titanium stent. Subjects were followed on an annual basis over 6 years.ResultsOperations were performed from 2007 to 2009, and mean age was 72.4 ± 9.3 years; 471 of 710 (66.3%) were men. Preoperatively, 361 of 710 (50.8%) of patients were in New York Heart Association class III or IV, and at 6 years postoperatively, 92 of 96 (95.8%) were New York Heart Association class I or II. Six years postoperatively, average mean gradient across all valve sizes was 11.0 mm Hg, and the average effective orifice area index was 0.80 cm2/m2. The proportion of patients without moderate-to-severe valvular regurgitation at 6 years was 95.2% (80/84). Six years postoperatively, freedom from valve-related mortality, nonstructural dysfunction, and paravalvular leak were 98.3%, 98.6%, and 98.9%, respectively, and freedom from reoperation due to structural valve deterioration was 97.3% (95% confidence limits, 98.6-94.7).ConclusionThese midterm results demonstrate that the Trifecta valve is a safe and effective valve substitute with excellent hemodynamic performance and durability that is maintained through the 6-year follow-up period.Copyright © 2016 The American Association for Thoracic Surgery. Published by Elsevier Inc. All rights reserved.
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