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, MD, PhDb
a Department of Biomedical Engineering, Lerner Research Institute, Cleveland, Ohio
b Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio
Accepted for publication November 12, 2007.
* Address correspondence to Dr Fukamachi, Department of Biomedical Engineering, ND20, Cleveland Clinic, 9500 Euclid Ave, Cleveland, OH 44195 (Email: fukamak{at}ccf.org).
Purpose: This study evaluated the short-term feasibility of a novel epicardial device that treats functional mitral regurgitation by simultaneously changing the mitral and the left ventricular geometry.
Description: We implanted a prototype device that consists of 2 tissue anchors, a deflector, and a flexible tightening chord in 7 mongrel dogs with heart failure and functional mitral regurgitation induced by rapid ventricular pacing. Hemodynamic and echocardiographic data were obtained before and after device implantation.
Evaluation: The device acutely reduced the mitral regurgitation grade from 3.2 ± 0.3 to 0.9 ± 0.5 (p < 0.001). Left ventricular end-diastolic volume (79.6 ± 23.6 to 61.2 ± 16.9 mL; p = 0.004) and end-systolic volume (63.1 ± 17.3 to 49.2 ± 12.3 mL; p = 0.006) decreased substantially. End-systolic elastance significantly increased from 1.9 ± 1.0 to 2.6 ± 1.4 mm Hg/mL (p = 0.02). Device implantation did not alter coronary perfusion.
Conclusions: The epicardial device acutely reduced functional mitral regurgitation and improved left ventricular geometry. Further studies are required to demonstrate the long-term safety and efficacy of this concept.
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