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Heartpod Tested at Scripps Clinic

California's First In-Man Clinical Trial of the HeartPOD Implantable Heart Failure Therapy System Done at Scripps Clinic

Scripps Clinic is the second location in the United States to participate in the world’s first in-man feasibility trial designed to evaluate the preliminary safety, functionality and efficacy of the HeartPOD Implantable Heart Failure Therapy System. 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. The implant procedure will take place on October 25, 2005.

“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.

“Frequent hospitalization is an unfortunate and cumbersome reality for patients with CHF, and quality of life issues are costly and emotionally depleting,” said Dr. James Heywood, medical director for the Congestive Heart Failure Clinic at Scripps Clinic, “so we are hopeful that real-time monitoring will allow us to better treat our patients and to minimize complications, such as recurrent hospitalization, acute pulmonary edema and renal failure.”

Left atrial pressure is the measurement physicians have been waiting for because when it is too high, it is the proximate cause of water accumulating in the lungs, which is responsible for 90% of CHF hospitalizations and when it is too low, damage to the kidneys may occur, which carries a three to four-fold increase in mortality. HOMEOSTASIS I 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 has important implications for future trends in HF management, as preventing hospitalization is likely to be cost effective.

The impact of this can be significant when considering that in the U.S. alone, about 5 million patients suffer from CHF and almost one million are hospitalized annually. CHF carries a mortality rate similar to cancer and one in five patients with HF die within one year of diagnosis. The annual cost to the U.S. healthcare system is over $40 billion. The number of patients contracting CHF is expected to double within the next decade as baby boomers age and develop heart disease.