November 13, 2000

BIRMINGHAM, AL — Thanks to a brand new monitoring device under clinical investigation, Dr. Robert Bourge was able to connect one patient’s Sunday shortness of breath to an almost-weekly Saturday night dinner date with his girlfriend.

But Bourge never once spent the weekend with his patient, who suffers from congestive heart failure. Instead, Bourge was able to monitor his patient’s activities — specifically, his heart activities — over the Internet.

Bourge, director of the division of cardiovascular disease at UAB (University of Alabama at Birmingham), will present the reasoning behind two clinical trials at the American Heart Association's 73rd annual Scientific Sessions on Wednesday, November 15 — including one trial that details the initial use of the new device.

The UAB cardiologist says a major key to managing the treatment of heart failure is to keep a close eye on the intracardiac pressures that build up on both sides of the heart when heart function is not normal. The pressures in the left and right side of the heart, and in the arteries to the lungs, become elevated when fluid builds up in the body. This leads to the release of hormones in the body that can actually make heart function worse in the long run, and also may worsen mortality in patients with heart disease. With the precise knowledge of these pressures, medications can be adjusted to keep those pressures within a normal range.

One of the most promising ways to monitor those pressures is the new device, The Chronicle implantable hemodynamic monitoring device. A study of the accuracy and safety of this device was launched in 10 medical centers in 1999, including UAB. The data from this device is being used to develop treatment strategies for patients with advanced heart failure. A large multicenter study will begin in 2001.

The Chronicle, a small implantable device, is part of a comprehensive patient management system being developed by Medtronic, Inc. The management system allows doctors to capture real-time data on the various physiological conditions of the heart, which is downloaded by the patient with a simple wave of a wand device over the chest area where the Chronicle is implanted. The wand contains a small computer device and is connected through the patient's phone line to transmit information to the physician over the Internet. The physicians caring for each patient then review the data, which are coded and encrypted to ensure Internet confidentiality.

“One of the biggest advantages of the Chronicle is its ability to continuously sense and collect unique and valuable information, such as the ventricular pressures, the heart rate and the physical activity of the patient,” Bourge said. “This is such a milestone because it allows us to continuously monitor the patient at home; and if their pressures go up we can intervene with adjustments in medication before hospitalization is necessary.

“As for the patient with shortness of breath every Sunday morning, his readout showed tremendous jumps in pressure in the wee hours of Sunday morning — indicating a build-up of fluid. We were able to determine that he and his girlfriend were eating Chinese food every Saturday night, which has a very high sodium content and caused the retention of fluid.”

The other study Bourge will discuss involves the use of an in-hospital monitoring device known as a pulmonary artery catheter. It is usually inserted into a vein in the neck and threaded into the heart and out into the artery to the lungs. It too allows for monitoring of ventricular pressures. A randomized trial, ESCAPE, or Evaluation Study of Congestive Heart Failure and Pulmonary Artery Catheterization Effectiveness, is being conducted at 16 centers across the country. The study will compare outcomes on patients who are dispensed therapy based on data collected by the catheter and outcomes on patients treated based on doctors’ bedside assessments.

“This is indeed a very exciting time in evaluating and treating patients with congestive heart failure,” Bourge said, “because not only do we have new drugs to treat these patients, but new diagnostic tools to aid in diagnosing and adjusting those treatments.”

Bourge added that heart failure is quickly rising in the United States and is now considered an epidemic. He said approximately 10 percent of the population over 70 in the United States now suffers from congestive heart failure. “As our population is saved from other disease by modern medicine, and as the baby-boomers age, the population with heart failure will continue to rapidly increase.” he said. “That’s why the new devices, technologies and medications are so important.”