Transvalvular Mitral Bridge Implantation Results In Persistent And Predictable Reduction Of Ischemic Mitral Regurgitation At 2 Years
Stepan Cerny1, Valavanur A. Subramanian2, Nirav Patel3, Miroslava Benesova1, Ivo Skalsky1, Katerina Mzourkova1.
1Na Homolce Hospital, Prague, Czech Republic, 2HRT - Repair Technologies Inc, Morgan Hill, CA, USA, 3Lenox Hill Hospital, New York, NY, 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 moderately severe[ ≥3+] and severe [≥4+] Ischemic Mitral Regurgitation [IMR] prevented early recurrence of Mitral Regurgitation [MR] at 6 months follow up [F/U]. This is the report of the clinical F/U at 2 years in this group of 8 patients to assess the long term durability of performance of Mitral Bridge.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 midpoints of anterior and posterior annulus. Clinical and echocardiographic F/U was done at baseline, 1 month, 3 months, 6 months, 1 year and 2 years. Baseline demographics were: Mean age 67.5±5.52 years, mean left ventricular ejection fraction [LVEF] 44.4±10.4 %, mean left ventricular end diastolic diameter [LVEDD] 55.37±7.55 mm and mean coaptation depth [CD] of 6.25± 2.25mm [5 pts. ≥ 7mm CD, range 7-9mm].RESULTS: All patients had freedom from MACE (death, myocardial infarction, mitral valve reoperation and device related adverse events) at 24 months F/U. Echocardiographic F/U at 24 months showed reduction of MR grade from 3.5±0.5 to 0.25±0.46 (p=0,031), 6/8 pts[85%] with 0 MR, 2/8 pts [25% ]with ≤ 1+ MR, SLD from 39.5±2.7 to 29.25±1.91 mm (p=0,031), increase in coaptation height from 4.0±1.3 to 8.00±1.07 mm (p=0,031) and reduction in CD from 6.25±2.25 to 3,00±1.41 mm (p=0,031). The intercommissural diameter [ICD], surrogate marker for annular dilatation, remained relatively unchanged [baseline 39.38±4.57 mm vs 36.88± 1.96].CONCLUSION: Mitral bridge implantation in IMR patients prevents not only early significant recurrence of MR but also maintains the freedom from significant recurrent MR at 2 years. 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 challenges the current wisdom of ring annuloplasty for IMR patients and may represent a paradigm shift in the treatment of these patients. Further studies are underway in a larger group of patients .
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