Mitral Valve Replacement with a Third Generation Porcine Valve: an Italian Multicentered Study

Abstract Background Postoperative outcomes of 3rd generation porcine bioprosthesis for mitral valve replacement (MVR) have been poorly addressed. The objective of this study was to perform an independent, retrospective, multicenter study on outcomes of patients undergoing MVR with Mosaic (Medtronic Inc., Minneapolis, MN) porcine bioposthesis. Methods From 1998 to 2011, 805 patients underwent MVR with Mosaic porcine valve in 11 cardiac centers. There were 465 female patients (58%) and overall mean age was 73.5±7 years. Associated procedures included CABG (201 patients, 24.9%), aortic valve replacement (152 patients, 18.9%), tricuspid annuloplasty (187 patients, 22.3%), and other cardiac procedures (116 patients, 14.4%). Results Median follow-up was 44 months (IQR range 16 – 63) with a cumulative duration of 2.769 patient-years. Early mortality for isolated elective MVR was 3.8% (12/313) and overall early mortality was 7.8% (n=63). Rate of late mortality was 3.4% per patient/year (95 late deaths). At 10 years, overall survival was 57.4% (95%CI 48.8%-67.5%) , and cumulative rates of cardiac- and valve-related death were 7.4% (95%CI 4.8%-10.1%) and 1.1% (95%CI 0.2%-1.9%). Ten year cumulative rates of thromboembolic and hemorrhagic events were 6.6% (95CI 1.4%-11.8%)% and 3.9% (95%CI 0.1%-8%) and 10 year cumulative incidence of prosthetic valve endocarditis was 3% (95%CI 1.2%-4.9%). Finally, 10-year cumulative incidence of SVD and reoperations were 5.8% (95% CI 0.2%-11.5%) and 4.8% (95%CI 0.7%-10.3%), respectively. Conclusions This independent, multicenter, retrospective study indicates that Mosaic porcine bioprosthesis for MVR provides satisfactory results in terms of early outcomes and long term outcomes up to 14 years from its implant.