Development of a Minimally Invasive Device Based Therapy Incorporating Simultaneous Adjustable Passive Support and Synchronous Active Assist Designed to Treat Congestive Heart Failure
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The technology described herein is a device based therapy targeting recovery of cardiac function in patients with congestive heart failure. This represents a shift in the present paradigm wherein available treatment options conservatively target inhibiting disease progression, e.g. non-adjustable cardiac support devices and/or alleviating symptoms, e.g. blood pumps for circulatory assist. Specifically, the innovation is a minimally invasive device incorporating adjustable passive cardiac support and synchronous active cardiac assist - device based technology designed to provide rehabilitative physical therapy for the heart muscle, mediating restorative remodeling processes to facilitate recovery of cardiac function. CHF affects more than 5.3 million people in the U.S. with 550,000 new cases diagnosed each year. For 300,000 Americans in end-stage failure, transplant is the preferred treatment; however, with less than 3,000 hearts available this treatment plan is epidemiologically trivial. The development of a therapeutic option targeting recovery of cardiac function would be a substantial advancement in the treatment of heart failure, and consequently a great benefit to the healthcare economy, biomedical science, and society as whole. Device performance was assessed in an acute implantation in an ovine model of acute heart failure (esmolol overdose). In the study it was confirmed that the device which was designed to be collapsible into a 1 1/2" diameter deployment tube and could be deployed using minimally invasive procedures. In examining pressure-volume loops, it was confirmed that the passive component of the device enabled a leftward shift in the enddiastolic pressure-volume relationship; important as disease typically shifts this relationship to the right. Further, it was verified that the active component of the device was capable of restoring stroke work lost in the esmolol induced failure model. Finally, the device did not invert the curvature of the heart, did not interfere with normal cardiac function, and remained in place through an intrinsic pneumatic attachment and thus did not require tethering to the myocardium. The versatile combination of support and assist provide the cardiologist with powerful therapeutic options to treat a wide variety of patient specific anomalies - with the primary target, rehabilitation of the heart and recovery of cardiac function and performance.
