Prospective study of mitral valve repair with the CarboMedics AnnuloFlex annuloplasty system: effectiveness and safety after one year.

BACKGROUND AND AIM OF THE STUDY: The CarboMedics AnnuloFlex annuloplasty system includes a flexible ring that may be implanted as a complete or partial ring to correct mitral annular dilatation by reinforcement of the entire annulus, or only the posterior portion of the annulus. The study aim was to evaluate clinical and functional results during the first year in patients receiving this flexible annuloplasty system.

METHODS

Between February 2001 and August 2002, 69 patients (mean age 55 years; range: 27-81 years) underwent mitral valve repair that included implant of the AnnuloFlex annuloplasty ring. Mitral regurgitation (MR) was the predominant lesion, with 98.6% of patients exhibiting grade 3/4 insufficiency. Functional classification of valve pathology was normal leaflet motion (type I) in 4% of patients, leaflet prolapse (type II) in 93%, and restricted leaflet motion (type III) in 3%. Valve disease was degenerative in 90%, ischemic in 4%, infectious in 3%, and other in 3%.

RESULTS

There was one hospital death. Late follow up was obtained for 62 patients; cumulative follow up was 61 patient-years. One-year actuarial survival was 99%, freedom from thromboembolism was 94%, from endocarditis 98%, and from reoperation 98%. Echocardiographic evaluations performed at 3-6 months after repair (mean 4.7 months) showed MR to be grade 0/1+ in 90% of patients and grade 2+ in 8%. Mitral valve area was 3.4+/-1.7 cm2, within normal limits (mitral valve area > or =1.5 cm2) in 95% of patients. Average peak and mean pressure gradients were 5.9+/-3.0 and 2.8+/-1.7 mmHg, respectively. Left ventricular end-diastolic diameter decreased postoperatively, which may reflect successful correction of MR after mitral valve repair.

CONCLUSION

These early results show that the AnnuloFlex annuloplasty system is safe and effective when used with other techniques for repair of MR, and preserves mitral annular flexibility and function at one-year follow up.