Long-term echocardiographic data, mechanisms of failure, and reintervention outcomes of the Epic valve in mitral position—a large observational cohort

OBJECTIVES: Long-term echocardiographic reports on mitral valve (MV) porcine xenograft bioprosthesis (Epic) are lacking, and postreintervention outcomes of failed Epic are unknown. We aimed to assess the mechanisms and independent predictors of Epic failures and to compare short- and mid-term outcomes according to reintervention type. METHODS: We included consecutive patients (n = 1397; mean age: 72 ± 8 years; 46% female; mean follow-up: 4.8 years) who received the Epic during mitral valve replacement (MVR) at our institution. Clinical, echocardiographic, reintervention, and outcomes data were retrieved from our prospective institution's database or government statistics. RESULTS: Gradients and effective orifice area of the Epic were stable over 5-years follow-up. A total of 70 (5%) patients had a MV reintervention at median follow-up of 3.0 (0.7-5.4) years due to prosthesis failure, by redo-MVR (n = 38; 54%), valve-in-valve (n = 19; 27%), paravalvular leak (PVL) closure (n = 12; 17%), or thrombectomy (n = 1). Mechanisms of failure were 27 (1.9%) structural valve deterioration (SVD; all leaflet tear); 16 (1.1%) non-SVD (15 PVL, 1 pannus); 24 (1.7%) endocarditis; and 4 (0.3%) thrombosis. Freedom from all-cause and SVD-related MV reintervention at 10 years are 88% and 92%, respectively. Independent predictors of reintervention were age, baseline atrial fibrillation, initial MV etiology, and moderate or greater PVL at discharge (all P ≤ .05). Comparison of redo-MVR and valve-in-valve revealed no significant difference in early outcomes or mid-term mortality (all P ≥ .16). CONCLUSIONS: The Epic Mitral valve has stable hemodynamics through 5 years and is associated with low incidence of SVD and reintervention, mostly due to endocarditis and leaflet tear without calcification. Reintervention type had no influence on early outcomes and mid-term mortality.