A new completely flexible ring for mitral valve annuloplasty: the "Rama-Valvuloplasty-Ring". Five-year Pitié Salpétrière experience.

The aim of this study was to analyze the effects about the use of a new completely flexible ring for mitral valve anuloplasty, the "Rama-Valvuloplasty-ring", in 182 patients operated on in the Pitié-Salpétrière Hospital, Paris, France for mitral valve regurgitation (MVR). From January 1998 to December 2003, 182 patients with mitral regurgitation (MR) underwent mitral reconstructive surgery at our institution with the "Rama-Valvuloplasty-Ring". This group was made up of 117 men (64.3%) and 65 women (35.7%). The age ranged from 19 to 87 years (mean 62.51 +/- 8.2 years). The patients surviving the operation were the subject of a prospective follow-up. In the preoperative stage sinus rhythm was found in 71.97% (131) of patients and atrial fibrillation in the remaining 28.03% (51) of patients. The mean NYHA FC was 2.9 +/- 1.7 and subdivided as follows: 65 patients in FC I-II (35.72%), 104 patients in FC III (57.14%) and 13 patients in FC IV (7.14%). Most of the patients have shown, in the preoperative echocardiogram, grade II M.R. (46.15% N. 84) and grade III M.R. (29.12%, N.53); 24.72% of the patients (N. 45) had grade IV M.R. The mean E.F. was 42.8 +/- 9.7%. Left ventricular end diastolic diameter (LVEDD) was 57.7 +/- 9.7 mm. The causes of mitral valve insufficiency were degenerative disease in 141 patients (77.47%), post-ischemic disease in 21 patients (11.53%), rheumatic valvular disease in 11 patients (6.05%) and infectious endocarditis in 9 patients (4.95%). All the patients were operated using the Rama-Valvuloplasty-Ring. Ring sizes most commonly used were 30 mm and 32 mm, respectively in 92 patients (50.55%) and 41 patients (22.54%), followed by 28 mm (43 patients, 23.62%), 34 mm (5 patients, 2.74%), 36 mm (1 patient, 0.55%). The surgical tecnique was valve quadrangular resection in 103 patients (56.60%), triangular resection in 57 patients (31.32%) and no valve resection in 22 patients (12.08%). Among the above, 89 patients (48.90%) underwent an associated intervention as follows: 44 patients (24.18%) underwent coronary revascularization: 18 patients (9.89%) with single by-pass surgery, 21 patients (11.54%) with double by-pass, 5 patients with triple by-pass (2.75%); 42 patients (23.07) underwent aortic valve replacement (AVR); 3 patients (1.65%) underwent aortic repair. Early postoperative mortality was 2.19% (4 of 182 patients). Early postoperative echocardiographic control showed MR grade 0 in 142 patients (79.78%) and grade I in 36 (20.22%) with mean grade 0.4 +/- 0.12; no patients with grade III or IV. Therefore, there was no mitral annuloplasty failure requiring valve replacement (MVR). During the follow-up there were 12 late deaths (12 of 178 patients, 6.74%). Only one death was valve-related (thrombosis) whereas the other 11 ones were non cardiac-related deaths (subdural frontal haematoma, septic shock). Postoperative transthoracic echocardiogram data were available in 166 patients at 5 years: the presence of postoperative MR was evaluated and severity was graded as mild in 33 patients (19.88%), moderate in 18 patients (10.84%), severe in 3 (1.81%) patients. There was no MR in the other 112 patients (67.47%); LVEDD was 49.4 +/- 6.5 mm; EF was 51.8 +/- 4.3%. The mean NYHA FC was 0.8 +/- 0.4. Only one patient was reoperated on during the follow-up because of mitral annuloplasty failure with MVR. In conclusion, mid-term 5-years follow up is good for patients operated on with the new completely flexible Rama-Valvuloplasty-Ring for mitral annuloplasty. This study has also verified the advantage about the Rama-Valvuloplasty-Ring use in the preservation of native valve apparatus.