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PATIENT SERVICES
Clinical Trials Focus on Controlling
Arrhythmias

Paul Maccaro, MD, Director of Electrophysiology

Since the early 1990s, Huntington Hospital's cardiologists have been involved in clinical research leading to the development of a treatment that has become the gold standard for patients in the throes of a heart attack. Their experience with these thrombolytic medications, also known as "clot-busters," contributed to the life-saving care received by countless Huntington patients.

Huntington cardiologists continue to contribute to medical knowledge by participating in research studies. Paul Maccaro, MD, Director of Electrophysiology, is overseeing three studies related to cardiac arrhythmia patients and those with congestive heart failure.

"Modern pacemakers have sophisticated information storage capabilities," said Dr. Maccaro. "Up until now, no one has collected this information, which can give us insight into the natural history of what happens to the heart after a pacemaker is implanted."

Dr. Maccaro is enthusiastic about participating in a clinical study that will attempt to collect and analyze the data that pacemakers record in patients with atrial fibrillation, the most common form of tachycardia, or rapid heartbeat. In atrial fibrillation, the upper chambers of the heart may beat up to 450 - 600 times per minute and the beats occur chaotically. A normal heart beats 60 - 100 times per minute.

"In its least severe form, it is a nuisance," said Dr. Maccaro about the condition. "However, since the atria is not contracting, blood can clot and cause a stroke in the worst case scenario."

Pacemakers implanted in patients with atrial fibrillation are akin to miniature computers that are programmed to recognize an episode of arrhythmia and record an electrogram, in essence an electrocardiogram taken from within the heart. Each pacemaker is equipped with a radiotransmitter which is typically used during routine checks of the device. In this study, the radiotransmitter will be used to download the information from electrograms, which will be electronically sent to the study site where it will be collated with information from thousands of other patients.

"Patients receiving new pace-makers are eligible to participate in this study," Dr. Maccaro explained. "The nice thing is that the data collection takes place during routine checkups. No additional hospital visits are required."

The sophisticated nature of implantable devices is making data collection a more objective process for another clinical trial that Dr. Maccaro is overseeing. This one is examining the potential benefits of a new anti-arrhythmic medication in patients with implanted defibrillators for ventricular tachycardia.

"Many of the current anti-arrhythmic drugs are potentially toxic, so we are constantly searching for new ones with less toxicity," Dr. Maccaro noted. This study will test the effectiveness of a new medication in reducing the number of episodes of arrhythmia in patients with implanted defibrillators. Recorded information on the incidence of arrhythmic episodes will be downloaded from the defibrillators in order to provide researchers with an unbiased account of the drug's impact.

Neither the physicians nor patients will know who is receiving the actual medication, who is receiving a standard medication, and who is receiving a placebo in this study.

"Ventricular tachycardia is a potentially life-threatening arrhythmia," Dr. Maccaro said. "In these patients, medication is the first line of defense, and the impantable defibrillator is like the EMS squad should the medication fail to control the arrhythmia."

Dr. Maccaro pointed out that no medication is 100% effective in eliminating arrhythmic episodes, however scientists are hoping that this study will prove that this new medication is as effective as currently available therapies, with fewer side effects.

Lastly, Huntington Hospital physicians are conducting a study of congestive heart failure, which affects large numbers of patients at the end of life, when the heart can no longer keep up with the demands of the body. Congestive heart failure typically occurs following a heart attack, or it may be associated with a structural problem such as a leaky valve, or a chronic problem such as hypertension.

Three hundred hospitals across the country are participating in this study, designed to evaluate the management of congestive heart failure by comparing treatment approaches at a variety of institutions.

"All types of healthcare institutions, including community hospitals like ourselves, university hospitals, and teaching centers will participate in this study," Dr. Maccaro explained. "We will be looking at patient charts and collecting data anonymously in order to accumulate information on how people with heart failure across the country are treated."

Dr. Maccaro expects the results to reveal differences in treatment approaches based on geography, but he says the study will also provide healthcare practitioners with an opportunity to benchmark patient outcomes.

"The primary objective is improved quality of care within every institution," he concluded.

For additional information on cardiac research at Huntington Hospital, call Dr. Maccaro at (631) 351-2798.

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MARCH 2002