Device Detects Fluid Accumulation In Chest And Lungs

MIDHeFT Trial Published In Circulation, the Journal of the American Heart Association

This feasibility study demonstrated that the OptiVol Fluid Status Monitoring feature in an implantable medical device can successfully detect changes in fluid accumulation in the thoracic cavity (lungs and chest) by measuring changes in intrathoracic impedance. The OptiVol feature was shown to provide a warning of fluid accumulation in some patients an average of 15 days before heart failure symptoms appeared and 18 days before hospital admission.

This technology is now available in Medtronic's InSync Sentry(TM) cardiac resynchronization therapy (CRT) defibrillator system, the only FDA-approved implantable device that monitors fluid levels in the thoracic cavity, which may help reduce heart failure hospitalizations. In addition to tracking thoracic fluid levels, the device resynchronizes the beating of the heart's lower chambers and terminates life-threatening heart rhythms.

Until now, there was no device-based method for measuring heart-failure related fluid accumulation in the chest and lungs. Current alternative methods, including weight monitoring, are heavily dependent on patient compliance and not specific to pulmonary fluid buildup. This study demonstrated that Medtronic's OptiVol feature can detect early thoracic fluid build-up in many patients before they experience fluid-related heart failure symptoms. Better up-front management and diagnosis of worsening heart failure symptoms based on data retrieved using the OptiVol feature may prevent the need for hospitalizations and other emergency treatment.

Afflicting 5 million Americans, heart failure is the #1 cause of hospital admissions in the U.S., with most due to fluid accumulation in the thoracic cavity. It is estimated that heart failure is responsible for $40 billion in direct and indirect healthcare costs in the U.S. alone. The number of Americans with heart failure is expected to double in the next five years as the Boomer population ages. The U.S. Centers for Medicare and Medicaid Services estimates that complications brought on by this chronic syndrome cost the U.S. healthcare system more than any other illness.

SOURCE: Medtronic, Inc.