Similar to the manner in which diabetes patients monitor their insulin levels to manager their disease, the investigational device continuously measures pressure in the heart’s left atrium to provide patients with an early notice, often before symptoms arise, that their heart failure is worsening.
Heart failure is a leading cause of death in the United States and the leading cause of hospital admissions among those who are over the age of 65. It is estimated that more than 5 million people in the U.S. suffer from the disease which occurs when the heart becomes weakened and is unable to pump blood sufficiently through the body.
Physicians typically use the symptoms of heart failure, such as fatigue or shortness of breath, to determine a patient’s status and treatment requirements. Changes in heart failure symptoms, however, can be difficult to gauge which often leads to critical delays in treatments that may help prevent further harm.
According to George Sokos, DO, a heart failure specialist at AGH, left atrial pressure (LAP) is considered the “gold standard” measurement of heart failure progression. Dr. Sokos said progression of heart failure over a period of days – referred to as acute decompensation – is frequently precipitated by elevated LAP.
High levels of LAP cause excess fluid to develop in the lungs (called pulmonary edema), a life threatening condition that often leads to a downward spiral of cardiac deterioration. Approximately 90% of patients admitted to hospitals for heart failure have pulmonary edema related to elevated LAP.
The LAPTOP-HF (Left Atrial Pressure Monitoring to Optimize Heart Failure Therapy) trial, sponsored by St. Jude Medical, is a pivotal, randomized, controlled, prospective, multi-center clinical investigation to evaluate the safety and effectiveness of the company’s implantable LAP HF management system. The system is being studied under an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA). Currently, there is no other means of obtaining LAP measurements outside the clinic or hospital setting.
The investigational LAP monitoring system includes the following components:
- A small, pacemaker-sized, stand-alone implantable LAP monitoring device, or a cardiac rhythm management (CRT/ICD) device with an integrated LAP monitoring device
- A lead, thin wire from the device to the heart, with an LAP sensor
- The Patient Advisor Module (PAM®), a portable, wireless, handheld device that is used by the patient to check LAP status and that, through the DynamicRx® feature, directs the patient to take specific medicines or make lifestyle adjustments based on the LAP measurement.
“Physician–directed, patient self-management has become a standard of care in diabetes management but it is an exciting, potential new approach to treating heart failure. Our hope is that this technology will enable physicians to better personalize and optimize heart failure management using daily, objective measures of a patient’s status. By providing patients and their physicians with daily feedback on left atrial pressure status, our ability to minimize complications associated with this disease and reduce hospitalizations could be greatly improved,” said Dr. Sokos, who is serving as AGH’s principle investigator in the LAPTOP-HF Trial.
The LAP management system is being studied in New York Heart Association’s (NYHA) Class III patients with a history of ischemic or non-ischemic cardiomyopathy for at least six months, and at least one HF hospitalization within the past 12 months. The trial is taking place at approximately 75 sites in the United States and additional sites outside the U.S. It will enroll approximately 700 patients in total, who will be monitored for several years.
Those interested in participating in the study at AGH, can call 412.359.3802.
For more information, contact:
The West Penn Allegheny Health System