Medtronic (Minneapolis) this week reported the launch of a new clinical trial – billing it as a "landmark" event – for a new heart failure (HF) device that combines the capabilities of an implantable cardioverter defibrillator (ICD) with a new technology that continuously records pressure inside the heart and can alert physicians to potential heart-failure complications before they worsen.
Besides offering the life-saving potential of standard ICD therapy, the Chronicle ICD provides hemodynamic monitoring that provides broader and even more significant benefits, according to the company, by helping to slow the co-morbid complications of HF and the more frequent physician and hospital visits of HF.
The Chronicle ICD, features both the traditional ICD's ability to shock the heart and restore normal heart rhythm following a dangerously fast heartbeat and what Medtronic bills as "the first-ever real-time tracking" of pressure inside the heart, body temperature, patient activity and heart rate 24 hours a day.
The study seeks to determine the safety, efficacy and functionality of the Chronicle ICD when used in heart failure patients indicated for ICD therapy.
Patients implanted with a Chronicle ICD will transmit that information from home, using a standard phone line, to their physicians who view the recorded data from a secure Web site in their office. They then can, if necessary, make alterations in therapy changes to patients' medications or diet.
Overall, the trial is being billed by the company as part of a continuing effort to link the physician's hospital and the patient's home, or as one physician put it, "expand the walls of the cardiologist's office."
So said Eugene Chung, MD, of the Ohio Heart & Vascular Center and lead investigator for Christ Hospital (Cincinnati), site of the first implant in the Chronicle ICD study.
"By continuously recording pressure inside the heart, Chronicle ICD provides heart failure clinicians with a precise and early assessment of the patient's underlying congestion, allowing for immediate treatment changes based on the patient's most up-to-date data," Chung said.
"This is data previously only available through invasive testing in a cath lab or ICU. Neither the patient nor the doctor has to wait for the next office visit."
Tracy McNulty, spokesperson for Medtronic, told Diagnostics & Imaging Week that the trial "builds off of" the company's earlier Chronicle Offers Management to Patients with Advanced Signs and Symptoms of Heart Failure (COMPASS-HF) trial, which provided rather definitive evidence supporting the value of the Chronicle system.
At last year's annual scientific sessions of the American College of Cardiology (Bethesda, Maryland), investigators reported a very largely significant 41% reduction in the costs of treating HF patients implanted with the Chronicle.
Issuing and discussing those results, Robert Bourg, MD, director of the Division of Cardiovascular Disease at the University of Alabama at Birmingham, lauded the Chronicle system for offering "the potential to save a lot of money and [a lot] of morbidity."
At the time, Bourg noted that for COMPASS-HF, the Chronicle technology had been used in "stand alone" fashion, but he predicted that it would be combined with defibrillators and resynchronization devices and provide even more detailed information, with the new trial clearly bringing that prediction to hoped-for reality.
Once the new trial is complete, the enrolled patients will be followed for 12 months, McNulty said.
Given the just-commenced stage of the trial, she said it was much too early to predict the report of any trial results or a regulatory timeline for application or eventual device approval.
The Chronicle ICD, she noted, has the standard shock-providing features of an ICD, but then provides the added advantage of recording a range of hemodynamic data while the person is going about daily activities, perhaps providing even a better profile for therapeutic intervention than can be achieved in the physician's office or cath lab.
Philip Adamson, MD, director of The Heart Failure Institute at Oklahoma Heart Hospital (Oklahoma City), and the trial's principal investigator, said that the system "represents a fundamental change in the way heart device makers and cardiologists will address chronic diseases such as heart failure in the years to come. It's no longer enough to wait until patients develop symptoms of worsening heart failure – patients and physicians need technology like Chronicle ICD [with] the potential to provide an early and accurate indication of deterioration in heart failure status, thereby allowing clinicians to take appropriate preventive measures."
The blinded study, sponsored by Medtronic, is a prospective, randomized, multi-center clinical trial at up to 75 sites in the United States involving up to 850 patients with mild to moderate heart failure (NYHA Class II and III). Heart failure can lead to sudden cardiac arrest (SCA), an abrupt loss of heart function caused by a rapid, chaotic disturbance of the heart's natural rhythm that is almost always fatal without defibrillation.
More than five million Americans suffer from heart failure, and 550,000 new cases are diagnosed annually. The estimated direct and indirect cost of heart failure in 2004 was $25.8 billion, two thirds of which is due to hospitalization and home nursing care.
Every year more than 1 million hospitalizations occur due to acute heart failure exacerbation, and it is estimated that about half of these are attributed to about 200,000 patients who are admitted at least twice per year.
Steve Mahle, president of Medtronic Cardiac Rhythm Management, said, "The next generation of heart device technology will not only respond to heart rhythm anomalies when they occur but also provide clinicians with critical data and insight into the patient's underlying condition to improve the overall management of cardiac disease."