Novel Transvalvular Mitral Bridge As An Adjunct To Leaflet Repair For Mitral Valve Prolapse Without A Conventional Annuloplasty Ring
Stepan Cerny1, Valavanur A. Subramanian2, Miroslava Benesova1, Ivo Skalsky1.
1Na Homolce Hospital, Prague, Czech Republic, 2Heart Repair Technologies Inc, Morgan Hill, CA, USA.
BACKGROUND: Previously we reported that direct septo-lateral diameter [SLD] reduction of mitral annulus with implantation of a novel dynamic, nitinol transvalvular Mitral Bridge [MB] in patients with functional mitral regurgitation [FMR] prevented early recurrence of mitral regurgitation [MR] up to 4 years of follow up [F/U]. In this study we evaluate the feasibility, safety and performance of the MB as an exclusive adjunct to leaflet repair in the treatment of mitral valve P2 prolapse without the conventional annuloplasty ring in degenerative mitral regurgitation [DMR].
METHODS: This was a post-market prospective, observational, single center study to evaluate device safety and performance. Implantation of MB as an exclusive adjunct to mitral valve repair technique was done in 8 patients under cardio-pulmonary bypass with arrested heart. Implantation was rapid with 3 sutures at midpoints of anterior and posterior annulus. P2 prolapse of the mitral valve was repaired by simple traingular resection in all patients. Clinical and echocardiographic F/U was done at baseline, 1 month, 3 months, 6 months and 1 year. Baseline demographics were: Mean age 72.5±7.2 years, mean left ventricular ejection fraction [LVEF] 64.6±6.4 %, mean left ventricular end diastolic diameter [LVEDD] 55.1±4.5 mm. Mean effective regurgitant orifice [ERO] was 0.44±0.13 cm2 and regurgitant volume [RV] was 71.7±15.4 ml. Tricuspid regurgitation grade ≥ 3.0 was present in 6 patients, atrial fibrillation in 6 patients, ischemic heart disease in 1 patient and sever aortic regurgitation in 1 patient.RESULTS: All patients had freedom from MACE (death, myocardial infarction, mitral valve reoperation and device related adverse events) at 12 months F/U. Echocardiographic F/U at 12 months showed reduction of MR grade from 4.0±0.0 to 0.38±0.52 (p=0,031), 5/8 pts[62.5%] with 0+ MR, 3/8 pts [37.5% ]with ≤1+ MR, SLD reduction from 39.9±2.03 to 27.8±3.45 mm (p=0,031), increase in coaptation height from 4.67±2.5 to 9.00±0.93 mm (p=0,031). The intercommissural diameter [ICD], surrogate marker for annular dilatation, remained relatively unchanged [baseline 41.33±2.34 vs 40.63±0.76 mm].CONCLUSIONS: Transvalvular implantation of MB instead of ring annuloplasty as an adjunct to leaflet repair of P2 prolapse in DMR patients is safe and effective in elimination of MR. The results are stable at 12 months F/U of these patients. The simplicity of the technique and the effectiveness of the performance of MB may lead to wider adoption of mitral repair for DMR and MB may be a game changer in the therapy of DMR.
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