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Implantation of medical device to manage heart failure with thoracic fluid status monitoring procedure conducted in EP Lab at ECMC

BUFFALO, NEW YORK; January 11, 2005 - Erie County Medical Center (ECMC) implanted the region's (within Buffalo-Rochester area) first implantable medical device with automatic fluid status monitoring in the thoracic cavity (the chest area encompassing the lungs and heart).

Chee Kim, MD, Cardiology Electrophysiologist, Buffalo Medical Group (BMG) / ECMC Corporation, implanted the Medtronic InSync Sentry cardiac resynchronization therapy (CRT) defibrillator system in a 68 year-old woman on January 11, 2005, utilizing the advanced Electrophysiology (EP) Lab at ECMC to perform the procedure. The following day, the woman was evaluated and discharged.

The new implantable therapy is expected to provide a critical advantage in managing heart failure, since thoracic fluid accumulation is a primary indicator of worsening heart failure and often results in patient hospitalization. The U.S. Food and Drug Administration in November 2004 approved the InSync Sentry system.

Heart failure afflicts 5 million Americans and is the number one cause of hospital admissions, with most of these admissions due to fluid accumulation in the thorax. This fluid buildup often goes undetected until the patient is critically ill, and it is not unusual for patients to require hospitalization

or urgent treatment at an emergency room for severe respiratory distress. With approximately 1 million hospitalizations each year for heart failure at a cost of an estimated $40 billion annually, heart failure management is a tremendous cost burden to the country's health care system.

"We are excited to offer this advanced implantable device for many of our patients who have heart failure. In addition to providing important therapies to treat heart failure and fast heart rhythms, this is the first time we'll be able to have early notification about fluid accumulation in the lungs, which may signal future worsening of heart failure symptoms. This will allow us to alter patient medications and hopefully keep patients out of the hospital," said Dr. Kim.

Members of the ECMCC Electrophysiology Team who helped to make this procedure an overwhelming success include:

  • Chee Kim, MD, Cardiology Electrophysiologist, BMG / ECMC Corporation
  • Ed Backer, RN, ECMC Corporation
  • Kathy Dachauer, Special Procedures Technologist, ECMC Corporation
  • Sarah Krashefski, RN, ECMC Corporation
  • James Turner, RN, Director, Surgical Services, ECMC Corporation
  • Beverly Taibi, RN, Representative, Medtronic (device manufacturer)
  • George Karalus, Representative, Medtronic
  • Elizabeth Pellnat, Representative, Medtronic

The breakthrough feature that makes thoracic fluid measurement possible is called OptiVol Fluid Status Monitoring, which measures changes in impedance. Using very low electrical pulses that travel across the thoracic cavity, the system can measure the level of resistance to the electrical pulses, which indicates the level of fluid in the thorax. Since normal fluid levels may vary from patient to patient and fluid accumulation can be either slow or rapid, OptiVol's ability to measure fluid status trends over time can provide important insights in conjunction with ongoing monitoring of other patient symptoms.

InSync Sentry will provide vital patient information to physicians who implant CRT defibrillator systems and also to physicians who manage the ongoing care of heart failure patients. In the future, physicians will be able to access data gathered by the InSync Sentry system using the

Internet and through wireless transmissions that would not require direct patient interaction.

InSync Sentry is an ideal therapy option for the 400,000 Americans with heart failure who have dysynchronous beating in the heart's lower chambers and low blood output that places them at risk for sudden cardiac arrest.

CRT resynchronizes the contractions of the heart's lower chambers by sending tiny electrical impulses to the heart muscle, which can help the heart pump blood throughout the body more efficiently and reduce heart failure symptoms. The system's defibrillation capability offers 35 joules of delivered energy to treat a potentially lethal heart rhythm, which is important for heart failure patients who may require more energy to terminate life-threatening arrhythmias.

According to the American Heart Association, patients with heart failure are six to nine times more likely to suffer an episode of sudden cardiac arrest than the general population.

The Erie County Medical Center (ECMC) Corporation encompasses an advanced academic medical center with 550 inpatient beds and 156 skilled nursing home beds, on- and off-campus health centers, over 40 outpatient specialty care clinics, and the Erie County Home, a 586-bed skilled nursing facility. The medical center, ranked among the nation's 100 top hospitals for cardiac and intensive care, serves as the regional center for trauma, burn, rehabilitation, and a major teaching facility for the State University of New York at Buffalo. The ECMC Corporation is dedicated to being the medical center of choice through excellence in patient care and customer service.

NEWS CONTACT: Joe Cirillo at 716-898-4300

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1/11/2005

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