Development of a Minimally Invasive Device Based Therapy Incorporating Simultaneous Adjustable Passive Support and Synchronous Active Assist Designed to Treat Congestive Heart Failure
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
