Midterm, multicenter clinical and hemodynamic results for the Trifecta aortic pericardial valve

• Published in: The Journal of thoracic and cardiovascular surgery Vol. 153; no. 3; pp. 561 - 569.e2
• Main Authors: Goldman, Scott, MD, Cheung, Anson, MD, Bavaria, Joseph E., MD, Petracek, Michael R., MD, Groh, Mark A., MD, Schaff, Hartzell V., MD
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2017
• Subjects: Adult; Aged; Aged, 80 and over; Animals; Aortic Valve - diagnostic imaging; Aortic Valve - surgery; aortic valve replacement; Bioprosthesis; Cardiothoracic Surgery; Cattle; durability; Echocardiography; Female; Follow-Up Studies; gradient; Heart Valve Diseases - diagnosis; Heart Valve Diseases - physiopathology; Heart Valve Diseases - surgery; Heart Valve Prosthesis; Hemodynamics - physiology; Humans; Male; Middle Aged; Pericardium - transplantation; Prospective Studies; Prosthesis Design; Time Factors; Treatment Outcome; NYHA; SVD; New York Heart Association; aortic valve replacement; gradient; durability; transcatheter aortic valve replacement; structural valve deterioration; bioprosthesis; TAVR
• ISSN: 0022-5223; 1097-685X
• DOI: 10.1016/j.jtcvs.2016.09.089

Abstract Objective To evaluate the midterm hemodynamic performance and clinical outcomes of the Trifecta aortic pericardial valve. Methods In 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. Results Operations 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). Conclusion These 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.