Device-based left ventricular geometry change for heart failure treatment: developmental work and current status.

Abstract

Device-based left ventricular (LV) geometry change is a new concept in the treatment of heart failure that reduces LV wall stress and improves cardiac function by reducing effective LV radius. Ventricular geometry change is achieved by placement of three Myosplint devices to bisect the LV and to create two smaller LV chambers. Since the first animal experiment in June 1997, the Myosplint has been tested extensively in a series of animal studies using a pacing-induced, canine dilated cardiomyopathy model. Device-based LV geometry change decreased LV wall stress, improved systolic function, and maintained diastolic function, resulting in an improvement in myocardial energetics. An acute human feasibility study during heart transplant surgery was started in July 1999. While awaiting the arrival of the donor heart, the Myosplint was implanted in the recipient LV in 5 patients. The device was easily applied on a beating heart without complications related to the device or the procedure in any of the patients. LV wall stress was significantly decreased after tightening of the device. Clinical safety studies with chronic Myosplint implantation were begun in Germany in June 2000 and in the United States in February 2001. There have been a total of 21 patients receiving the implant without evidence of bleeding, muscle tearing, severe arrhythmia, or thrombus formation associated with the implant. Device-based geometry change has been demonstrated to be practical, effective, and safe.