Final 5-Year Outcomes Following Aortic Valve Replacement With A Resilia (Tm) Tissue Bioprosthesis

OBJECTIVES: Long-term durability of bioprosthetic valves is predominantly limited by structural valve deterioration. RESILIA (TM) tissue has exhibited reduced calcification in pre-clinical and early clinical studies. This study evaluated the 5-year clinical and haemodynamic outcomes of an aortic valve with this tissue.METHODS: This was a prospective, non-randomized, single-arm study of 133 patients implanted with a RESILIA aortic bioprosthesis between July 2011 and February 2013 at 2 sites in Poland. Clinical outcomes and haemodynamic performance were assessed annually for 5 years post-implant. Safety events were adjudicated by a Clinical Events Committee and echocardiographic data were assessed by an independent core laboratory.RESULTS: Mean patient age was 65.3 +/- 13.5 years, with 34 patients (25.6%) <= 60. The mean follow-up was 4.2 +/- 1.5 years. Early (<= 30 days) and late (>30 days) all-cause mortality were 2.3% (N = 3) and 3.2%/late patients-years (N = 18) respectively. Early events included thromboembolism in 3 patients (2.3%). Late valve-related events included endocarditis in 1 patient, which led to explant, and valve thrombosis in another patient. There were no events of structural valve deterioration throughout the study. At 5 years, mean gradient was 14.8 +/- 7.6 mmHg and effective orifice area was 1.4 +/- 0.5 cm(2 ) a marked improvement over baseline values. All New York Heart Association class III patients and most class II patients at baseline had improved classifications at 5 years.CONCLUSIONS: The bioprosthesis with RESILIA tissue demonstrated a good safety profile with excellent haemodynamic performance over 5 years of follow-up. These encouraging outcomes warrant additional investigation of this novel tissue.