Mitral Bridge Implantation eliminates and prevents Early Recurrence of Mitral Regurgitation in Patients with Ischemic Mitral Regurgitation
Stepan Cerny1, Valavanur A. Subramanian2, Nirav Patel3, Miroslava Benesova1, Ivo Skalsky1, Katerina Mzourkova1.
1Na Homolce Hospital, Prague, Czech Republic, 2HRT – Heart Repair Technologies Inc, Morgan Hill, CA, USA, 3NSHS - Lenox Hill Hospital, New York, NY, USA.
OBJECTIVE: Indirect reduction of septolateral diameter (SLD) by circumferential cinching with ring annuloplasty (RA) results in high early recurrence of mitral regurgitation (MR) in patients with ischemic MR (IMR). A novel, dynamic, nitinol Mitral Bridge(MB) across the mitral annulus which achieves a non planar direct reduction of SLD with preservation of the leaflet curvature is currently under clinical CE Mark trial which includes 34 patients with Type I and III MR. This study examines the effect of this device in a subgroup of 8 patients with moderately severe (3+) and severe (4+) IMR.
METHODS: Implantation of MB as an exclusive mitral valve repair technique was done in all patients under cardio-pulmonary bypass with arrested heart. Concomitant procedures included coronary artery bypass (7), tricuspid valve repair (2) and CryoMAZE procedure (3). Implantation was rapid with 3 sutures at each midpoints of anterior and posterior mitral annulus. Serial clinical and echocardiographic follow up (F/U) was done at baseline, 1month, 3months and 6months. Mean age of patients was 67.5±5.52 years, mean left ventricular ejection fraction 44.4±10.4 %, mean left ventricular end diastolic diameter 55.37±7.55 mm.
RESULTS: All patients had freedom from MACE (death, myocardial infarction, stroke, reoperation and device related adverse events) at 6months F/U. Echocardiographic F/U showed a significant reduction of the mean grade of MR from 3.5±0.5 to 0.0±0.0 (p<0,0001), SLD from 39.5±2.7 mm to 29.1±2.1 mm (p<0,0001), increase in coaptation height from 4.0±1.3 mm to 7.9±1.1 mm (p<0,0001) and reduction in coaptation depth from 6.25±2.25 mm to 2.38±1.8 mm (p=0,004) at 6months F/U.
CONCLUSIONS: Mitral bridge implantation as the exclusive repair technique eliminates and prevents early recurrence in IMR at 6months F/U. This is achieved by direct SLD reduction, normalization of coaptation depth, increasing the coaptation height, preservation of leaflet curvature and annular function without any progressive annular dilatation. These encouraging results are in direct contrast to the results of RA in IMR patients and thus warrants further studies in a larger group of patients.
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