Early clinical experience and echocardiographic results with a new semirigid mitral annuloplasty ring: the Sorin Memo 3D.

BACKGROUND

The Sorin Memo 3D (Sorin Biomedica Cardio S.r.L., Saluggia, Italy) is a new, complete semirigid annuloplasty ring. Clinical use, outcomes, and echocardiographic results are reported as an evaluation of its safety and efficacy in the treatment of mitral valve regurgitation (MVR).

METHODS

This device was assessed in 63 patients (63.5% men; mean age, 70.2 +/- 10.3 years) who underwent MVR operations between January 2007 and June 2008. Functional classification was normal leaflet motion (type I; 1.6%), leaflet prolapse (type II; 66.7%), and restricted leaflet motion (type III; 31.7%). Valve disease was degenerative (68.25%), ischemic (25.4%), and nonischemic dilated cardiomyopathy (6.35%).

RESULTS

Early mortality (< or = 30 days) was 3.3% (2 patients). Late mortality (11.2 +/- 5.1 months) was 4.9% (3 patients). No deaths were device-related. Thromboembolic stroke occurred in 3.3% and endocarditis in 1.6%. Freedom from reoperation was 98.4%. At 6 months, MVR was grade 0/1 in 93.7% and grade 2+ in 6.4%. Left end-diastolic ventricular diameters decreased significantly from 59.3 +/- 6.9 mm preoperatively to 50.6 +/- 12.2 mm at 6 months, pulmonary arterial pressure decreased from 44.8 +/- 7.1 mm Hg to 38.4 +/- 5.5 mm Hg, and left ventricular ejection fraction increased significantly from 0.469 +/- 0.129 to 0.582 +/- 0.106. New York Heart Association functional class was I in 81% and II in 13.8%.

CONCLUSIONS

Early results indicate the Sorin Memo 3D ring safely and effectively minimizes secondary MVR resulting from all causes and preserves mitral annular flexibility and function at follow-up.