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THE JOURNAL OF CARDIOVASCULAR SURGERY
A Journal on Cardiac, Vascular and Thoracic Surgery
Indexed/Abstracted in: BIOSIS Previews, Current Contents/Clinical Medicine, EMBASE, PubMed/MEDLINE, Science Citation Index Expanded (SciSearch), Scopus
Impact Factor 1,632
ORIGINAL ARTICLES CARDIAC SECTION
The Journal of Cardiovascular Surgery 2003 February;44(1):25-30
Initial clinical and hemodynamic experience with Edwards MIRATM Mechanical Bileaflet Valve
De Feo M., Renzulli A., Onorati F., Della Corte A., Dialetto G., Covino F. E., Cotrufo M.
Department of Cardio-Thoracic Sciences, 2nd University of Naples, Naples, Italy
Aim. An enhanced bileaflet valve, the Edwards MIRA™ Mechanical Valve became available in 1998. Favorable hydrodynamic features and a redesigned sewing ring encouraged us to implant this device in indicated patients. Hemodynamics and clinical performance parameters were evaluated.
Methods. Between February 1998 and October 1999, 338 patients (171 males, 167 females) underwent native valve replacement with a MIRA™ prosthesis. Mean age 56.6±13.6 years, 320 patients were in NYHA class III/IV. Sixty-seven patients had echocardiographic examinations. Standard cardiopulmonary bypass was employed utilizing institutionally accepted implantation techniques. Aortic valve replacement was performed in 163 patients, mitral valve replacement in 134 patients, 35* double valve replacements and 1 triple valve replacement.
Results. Follow-up is 98% complete. Mean follow-up is 6.9±3.3 months (178.2 patient years). There were no operative deaths. Four early deaths were seen (1.18%). Late deaths reported in 12 patients. Linearized rate of late mortality was 6.7% per patient year (ppy). Overall actuarial survival at 13 months is 92.2%. Mean gradients and Effective Orifice Areas (EOA’s) are comparable to other bileaflet valves. Linearized rates for valve-related complications was 4.49% ppy. Only 5 transient thromboembolic events (TE = 2.81% ppy) and 3 non-structural valve dysfunction events (NSVD = 1.68%) were seen. No reports of bleeding events, prosthetic endocarditis, valve thrombosis or structural valve deterioration. One patient required mitral valve reoperation for perivalvular leak.
Conclusion. Short-term hemodynamic and clinical results are comparable to other bileaflet valves. The sewing ring is non-obstructive, compliant with smoother needle penetration. Early clinical results are encouraging, follow-up should be continued.