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31st Annual Meeting Abstracts: Comparison of Coapsys Annuloplasty and Traditional Mitral Repair in the Randomized Treatment of Functional Ischemic Mitral Regurgitation: Impact on the LV
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P8. Comparison of Coapsys™ Annuloplasty and Traditional Mitral Repair in the Randomized Treatment of Functional Ischemic Mitral Regurgitation: Impact on the LV
E. A. Grossi1, J. Woo2, D. M. Gangahar3, V. A. Subramanian4, N. Patel4, J. Wudel5, C. Schwartz1, A. Singh6, R. D. Davis7. 1New York University School of Medicine, New York, NY, 2Hospital of the University of Pennsylvania, Philadelphia, PA, 3University of Nebraska Medical Center, Omaha, NE, 4Lenox Hill Hospital, New York, NY, 5Nebraska Heart Institute, Lincoln, NE, 6Rhode Island Hospital, Providence, RI, 7Duke University School of Medicine, Durham, NC,
BACKGROUND: Functional ischemic mitral regurgitation (FIMR) is associated with both annular and ventricular distortion. Traditional mitral annuloplasty (MA) for FIMR acts primarily at the annular level, with variable impact upon the LV. The Coapsys device externally remodels both the annulus and ventricle to correct FIMR. We analyzed LV remodeling by each technique in a randomized study.
METHODS: The RESTOR-MV study randomizes patients with CAD and FIMR to either MA and CABG or Coapsys and CABG. The Coapsys device consists of two epicardial pads connected by a flexible chord. It was placed without CPB under echocardiographic guidance and sized to reduce annular dimension and improve leaflet coaptation. Traditional reduction MA was performed by annuloplasty device placement. Intraoperative end-diastolic long axis TEE views were analyzed pre & post procedure in 7 MA and 7 Coapsys patients. Short axis diameters were measured at the annulus and at three equidistant latitudes perpendicular to the long axis. Demographic and procedural data is presented below (mean+/-SD).
RESULTS: Both techniques reduced MR. Annular dimension was significantly reduced with both techniques, while short axis diameters and sphericity indices were significantly reduced only in the Coapsys patients.
* p<0.05 Pre vs Post; ‡p<0.01 Pre vs Post | MA | MA | MA | Coapsys | Coapsys | Coapsys | | Pre | Post | Change in Sphericity | Pre | Post | Change in Sphericity | | EF% | 37.9±7.0 | N/A | N/A | 37.4±8.5 | N/A | N/A | | Baseline MR(0-4) | 3.0±0.6 | N/A | N/A | 3.0±0.6 | N/A | N/A | | Intraop MR(0-4) | 2.86±0.7 | 0.5±0.7‡ | N/A | 2.64±0.9 | 05±0.7‡ | N/A | | Long Axis (cm) | 7.59±1.17 | 8.08±1.34 | N/A | 8.11±1.08 | 7.78±0.78 | N/A | | Annular Diameter (cm) | 3.45±0.39 | 2.34±0.37‡ | N/A | 3.40±0.27 | 2.85±0.34* | N/A | | Basal Diameter (cm) | 4.83±1.12 | 4.93±0.82 | -0.10±0.48 | 4.77±0.58 | 3.58±0.38‡ | -0.53±0.53* | | Mid Diameter (cm) | 4.84±0.81 | 5.01±0.70 | -0.08±0.48 | 4.88±0.55 | 3.57±0.43‡ | -0.58±0.44‡ | | Apical Diameter (cm) | 4.06±0.96 | 4.45±0.69 | 0.04±0.39 | 4.39±0.46 | 3.38±0.34‡ | -0.45±0.42‡ |
CONCLUSIONS: The Coapsys device and MA both acutely reduce FIMR and annular dimension. Coapsys provided significantly greater LV remodeling as compared to MA. Further evaluation will assess the long-term ventricular geometric stability of both techniques.
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