Midterm Durability and Hemodynamic Performance of a Third-Generation Bovine Pericardial Prosthetic Aortic Valve: The Leipzig Experience.

Background: The Trifecta valve (St. Jude Medical, St. Paul, MN) is a stented bovine pericardial bioprosthesis for aortic valve replacement (AVR). Implantation experience and midterm follow-up of this valve have not yet been reported from a large single-center cohort.

Methods: We retrospectively analyzed data from 918 patients (73.2 ± 6.5 years; logistic European System for Cardiac Operative Risk Evaluation [EuroSCORE], 13.2 ± 14.3) who underwent AVR. Analyses addressed implantation safety, short- and long-term survival, and hemodynamic valve performance.

Results: Concomitant procedures were performed in 54.9% of the patients. Low cardiac output syndrome, postoperative bleeding requiring transfusion or reoperation, and acute renal failure requiring temporary hemodialysis occurred at rates of 4.3%, 7.0%, and 11.7%, respectively. At discharge, 44 patients (4.8%) were identified with moderate prosthesis-patient mismatch (PPM) and none was identified with severe PPM. Mean follow-up was 2.7 ± 1.6 years (maximum, 7.4 years). Survival at 30 days was 88.7% and 92.0% for all patients and patients with isolated AVR, respectively; 5-year overall survival for these groups was 73.4% and 82.2%, respectively. Myocardial infarction (odds ratio [OR], 78; 95% confidence interval [CI], 20.8-294) and inotropic medication (OR, 6.8; 95% CI, 3.2-14.5) were the strongest independent predictors for long-term mortality. Five-year freedom from structural valve deterioration (SVD) was 97.9% ± 1.5%. Left ventricular ejection fraction (LVEF) after implantation was similar to baseline and was stable over time (range, 58.9%-62.3%). The mean gradient improved substantially (39.3 mm Hg at baseline versus 9.4 mm Hg at 6 months).

Conclusions: This large single-center cohort shows the easy and safe implantation, adequate hemodynamic performance, and satisfactory durability of the Trifecta valve at midterm follow-up.