Clinical results of the Medtronic Mosaic porcine bioprosthesis up to 13 years.

ABSTRACT

BACKGROUND: The Mosaic bioprosthesis is a third-generation stented porcine bioprosthesis combining physiologic fixation and alpha-amino oleic acid (AOA) antimineralisation treatment to improve haemodynamic performance and durability. This single-centre study reports the clinical results, including haemodynamic performance, of the Mosaic bioprosthesis after implant in aortic or mitral position. METHODS: Between February 1994 and October 1999, 255 patients with aortic valve replacement (AVR; mean age 67 years, range 23-82 years) and 47 patients with mitral valve replacement (MVR; mean age 67 years, range 41-84 years) were enrolled in this prospective non-randomised clinical trial. Follow-up visits were performed 30 days and 6 months after implant and annually thereafter. The cumulative follow-up was 1976.2 patient-years (pt-yrs) after AVR (median 8.3 years, maximum 14.0 years) and 336.9 pt-yrs after mitral valve replacement (MVR) (median 8.2 years, maximum 13.3 years). RESULTS: After AVR, mean systolic gradient and effective orifice area at 4, 8 and 13 years follow-up were 13.3+/-5.6, 15.5+/-7.7 and 16.0+/-7.2 mmHg and 1.8+/-0.5, 1.8+/-0.5 and 1.7+/-0.4 cm(2). After MVR, respective data were 4.7+/-2.1, 4.3+/-1.2 and 5.0 mmHg (only one recording) and 2.2+/-0.7, 2.3+/-0.6 and 1.8 cm(2). Transvalvular regurgitation at 13-year follow-up was mild or less in both the AVR and MVR patients. Thirteen-year survival was 63.1+/-4.5% in the AVR group and 51.2+/-13.6% in the MVR group. Early mortality after AVR and MVR was 1.2% and 0.0%, respectively; late mortality was 3.2%pt-yr(-1) and 3.3%pt-yr(-1), including a valve-related/unexplained mortality of 1.1%pt-yr(-1) and 0.9%pt-yr(-1). Freedom from adverse events in the AVR and MVR group was permanent neurological event 97.4+/-1.2% and 96.0+/-3.9%; valvular thrombosis 97.8+/-1.1% and 100%; structural valve deterioration 84.8+/-7.8% and 93.8+/-6.1%; explant 73.3+/-7.3% and 89.3+/-6.5%. CONCLUSIONS: The Mosaic bioprosthesis demonstrates excellent clinical performance and safety after 13 years of follow-up. Continued follow-up will determine whether this new design will provide increased durability.