10News KGTV of San Diego is reporting that Scripps Clinic has implanted HeartPOD™, an experimental device for the management of congestive heart failure.
The Scripps Clinic explains about the device, designed to be implanted by a catheterization procedure:
HOMEOSTASIS I trial (Hemodynamically Guided Home Self-Therapy in Severe Heart Failure Patients) is expected to demonstrate for the first time in human trials whether daily optimization of drug therapy may improve clinical outcome in CHF by preventing both over- and under-treatment…
“This therapy could potentially change the landscape of how patients with Heart Failure (HF) are treated in the future,” says Dr. Paul Teirstein, surgeon and medical director for Interventional Cardiology at Scripps Clinic. “The information we gather from this study will provide us new insight into the dynamic cardiac changes that occur on a daily basis in our patients.
The HeartPOD™ System is a proprietary medical device consisting of a permanently implanted intracardiac sensor that allows the patient to directly monitor left atrial pressure, the intracardiac electrogram, and core body temperature. The implant’s readings are communicated with a hand-held computer called a Patient Advisory Module, or PAM. The information is used to adjust medications on a dose-by-dose basis according to the patient’s physician’s prescriptive instructions. This permits real-time adjustment and dosing of medication similar to the way diabetics adjust insulin dosage in response to home glucose monitoring. Left atrial pressure is believed to be a key measurement for predicting acute worsening of CHF that leads to lung congestion and the need for urgent hospitalization. The device is implanted by a minimally invasive cardiac catheterization procedure, similar to pacemaker insertion.
Savacor®, Inc, the device maker, has the following details about data management:
The handheld advisory module acquires the physiological signals from the implant by wireless transmission. The signals are analyzed and used to adjust treatment instructions which have already been provided by the patient’s physician and programmed into the module, creating what we call the ‘DynamicRx™.’ The treatment instructions from the HeartPOD™ module will enable the physician to optimize the patient’s medication dosage in response to the patient’s immediate physiological condition without the physician’s moment-to-moment intervention.