Deborah Cardiologists Investigate Revolutionary Heart Failure Treatments

Deborah Cardiologists Investigate Revolutionary Heart Failure Treatments

Deborah Heart and Lung Center is one of only three New Jersey hospitals - and one of 60 nationwide - participating in a phase four, randomized, FDA-approved clinical trial investigating the benefits of pacing devices for patients suffering from congestive heart failure (CHF). The trial, CPI/Guidant Corporation’s COMPANION Study, offers patients the first minimally invasive treatment option for symptoms of heart failure, where no such treatment previously existed.

Congestive heart failure is a very common condition which occurs gradually, beginning when the heart is weakened by conditions such as heart attack, prolonged high blood pressure, or an abnormal heart valve. Heart failure leaves the heart unable to pump enough blood to meet the metabolic needs of the body, resulting in symptoms such as shortness of breath, inefficient physical strength or stamina, fatigue and fluid retention. Patients suffering from CHF often complain of moderate to severe disruption of their daily lives, and dissatisfaction with their abilities to perform simple everyday activities.

Five million Americans are currently living with CHF, and an additional 500,000 are diagnosed each year. The condition is the leading cause of hospital visits for people over 65, and kills more than 250,000 of its victims each year, most within five years of diagnosis. Heart failure patients commonly die from two primary causes: progression of pump failure, or sudden cardiac death.

Many CHF symptoms are treatable with medications, or, in the most extreme cases, heart transplant. However, no treatment has been made available to correct pump failure and its associated symptoms, or to prevent sudden cardiac death. Until now, most heart failure patients were treated with medications and had to adjust to their limited condition, and many lived with the fear of possible sudden death.

Congestive heart failure patients at Deborah Heart and Lung Center now have a new option available to them: the Contak™ TR and Contak™ CD pacing devices, manufactured by CPI/Guidant Corp., Indianapolis, IN. These revolutionary devices, which are very similar to standard pacemakers and implantable cardioverter defibrillators (ICDs), are intended to provide therapy for the two most common causes of heart failure-related death: progressive pump failure and sudden cardiac death.

“A large population of congestive heart failure patients are at risk of pump failure or sudden cardiac death,” said Raffaele Corbisiero, MD, Director of Electrophysi-ology Laboratory Services at Deborah Heart and Lung Center. “Until now, there were no therapies available to effectively treat pump failure or prevent a sudden cardiac episode, leaving a large portion of patients to adjust to a much lower quality of life, or to live in fear of a fatal arrhythmia.”

The Contak TR, about the size of a silver dollar and only slightly thicker, works by emitting a mild electrical impulse to the patient’s heart. This impulse synchronizes the pumping contractions on the heart’s right and left sides, making each heartbeat more effective and increasing blood flow to the body. This increased blood flow can increase the patient’s strength, stamina and exercise tolerance, and thereby decrease or eliminate the shortness of breath, fatigue and fluid retention associated with pump failure. This therapy is called cardiac resynchronization therapy (CRT).

The Contak CD, comparable in size to a thin beeper or pager, provides the same resynchronization therapy as the Contak TR, yet with the addition of an ICD backup. In the event that the heart suddenly arrests or begins fatal arrhythmias, the ICD will shock the heart, causing it to resume normal beating rhythms. The Contak CD is the first CRT device to address both of the principle causes by which heart failure patients die.

According to Dr. Corbisiero, as many as 50 percent of congestive heart failure patients may benefit from this treatment. “Of the five million patients suffering from congestive heart failure, the risk of sudden death may be as high as 50 percent,” said Dr. Corbisiero. “We are pleased to be able to offer, through the COMPANION Study, this treatment to Deborah’s patients, as it has the potential make significant improvements in both their length and quality of life.”

Patients receiving the Contak TR or the Contak CD undergo implantation procedures very similar to standard pacemaker or ICD implantation. The minimally invasive procedure is performed in the Center’s Electrophysiology Laboratories, usually under sedation and with a local anesthetic. Typically, a small incision is made in the patient’s chest, near the left shoulder, where the device is placed under the skin. Like a pacemaker, a wire lead is threaded into the right atrium and another into the right ventricle. A third lead is threaded through the coronary sinus into the left ventricle, to resynchronize beating. The procedure can be completed in as little as two hours, and requires a single overnight stay at the Center.

All patients participating in the COMPANION Study will receive optimal medical therapy for their CHF symptoms, and, out of every five participating patients, two will receive the Contak TR and two will receive the Contak CD. All patients will see their doctor at least once every three months, and will receive individual attention and management of their heart failure condition. Patients will be evaluated in areas such as strength, stamina, exercise performance, quality of life, length and frequency of hospitalization, and survival. As many as 2,200 patients are expected to participate in the study nationwide; Deborah hopes to enroll at least two to three patients each month the study is active, though more are welcome.

Data from CPI/ Guidant’s preliminary studies of the Contak TR and Contak CD pacing devices showed that participating patients experienced 21 percent slowing of heart failure progression, increased quality of life and significant improvement in functional capacity. Most participants showed an increase in peak oxygen consumption, and, one year post-implant, 25 percent of participants experienced at least one life-threatening cardiac arrhythmia, which required defibrillation therapy. Positive changes in every clinical measurement studied, in preliminary trials, were observed in patients receiving resynchronization therapy, and investigators noted that patients with certain common types of more advanced heart failure (NYHA Class III or IV with left bundle branch block or nonspecific interventional conduction delay) received even greater benefit from the therapy.

The COMPANION Study will compare results of patients in all three patient groups, to determine which group experienced the most significant improvement in all of the trial’s clinical endpoints. The COMPANION Study is expected to lead to general FDA approval for both the Contak TR and Contak CD devices.

“I am pleased that Deborah Heart and Lung Center is participating in the COMPANION Study, as this research represents the cutting edge of treatments for congestive heart failure,” stressed Dr. Corbisiero. “Though pacing devices have not previously been used to treat patients suffering from heart failure, these devices seem to be a promising new addition to the arsenal of treatment options for this large patient population. By participating in the COMPANION Study, Deborah is able to offer this revolutionary treatment to its heart failure patients, which could significantly improve their overall quality of life.”

Raffaele Corbisiero, MD., Attending, Department of Cardiovascular Diseases

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