The Edwards MIRA heart valve prosthesis: a 2-year study.

BACKGROUND

The Edwards MIRA mechanical heart valve is designed to optimize hemodynamics, reduce thrombogenicity, and avoid mechanical failure with a special hinge mechanism. The purpose of the study was to investigate the clinical performance and postoperative hemodynamic results of the first European patients receiving Edwards MIRA mechanical heart valves.

METHODS

From March 1998 to March 1999 a total of 54 Edwards MIRA valves model numbers 3600 (aortic, n = 44) and 9600 (mitral, n = 10) were implanted in 52 (36 male, 16 female; mean age 61 +/- 10.1 years) consecutive patients undergoing mechanical valve replacement in a prospective study. Follow-up of the patients including physical examination, ECG, blood tests, and Doppler were performed prior to discharge, at 6 months, at 1 year, and at least 2 years postoperatively.

RESULTS

Through October 2001 a total of 172 follow-up examinations were completed (51 patients at discharge, 46 patients at 6 months, 43 patients at 12 months, 32 patients at 2 years or beyond). All patients were in NYHA class I and II at the 6-month and 2+-year follow-up. All the patients stated an improved quality of life. Hospital mortality was 1.9%. There were no complications related to anticoagulation. Mean international normalized ratio at 6 months was 3.2 (range 1.9 to 4.3); lactate dehydrogenase was slightly increased with 264 +/- 103 U/L on average (normal value 80 to 240 U/L). No signs of valvular dysfunction or paravalvular leakage were observed. Mean pressure gradients were related to valve diameter: after mitral valve replacement (size 27, 29, 31 mm: 4.8, 3.2, 2.1 mmHg); after aortic valve replacement (size 19, 21, 23, 25 mm: 12.1, 13.1, 9.3, 8.2 mmHg).

CONCLUSIONS

These preliminary data suggest good hemodynamic function and a low rate of valve-related complications of the Edwards-MIRA mechanical prosthesis.