BACKGROUND: Functional mitral regurgitation (AIR) plays a pivotal role in the pathophysiology of congestive heart failure, a major cause of cardiac morbidity and mortality. We have developed a mitral annular remodeling procedure through injection of a nonabsorbable substance into the peri-annular tissue of the posterior mitral annulus to reduce the mitral annular dimension in the septal-lateral axis. The purpose of this study is to describe a novel procedure for treatment of functional AIR and report its effects on the geometry of the mitral annulus and degree of AIR. METHODS: Seven preliminary studies were performed using an epicardial approach in a healthy dog model to establish the feasibility of this injection procedure. Unexpectedly, 2 of 7 healthy dogs had a functional AIR of grade 1 to 2+. In these 2 cases, the hemodynamic, angiographic, and echocardiographic assessments were conducted. RESULTS: A nonabsorbable substance injection was successfully performed on a beating heart without instability of hemodynamics or any evidence of myocardial ischemia in all 7 dogs. In the 2 dogs with a functional AIR, it was confirmed that the septal-lateral dimension decreased from 3.2 +/- 0.2 to 2.6 +/- 0.5 cm and the observed MR was reduced (AIR area from 1.2 +/-0.1 to 0 cm2) without any adverse effects on hemodynamics or coronary circulation (circumflex artery flow, 36.5 +/- 0.4 to 40.5 +/- 0.1 mL/min). CONCLUSION: Off-pump mitral annular remodeling through substance injection may be one procedural option for treatment of functional AIR.
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