Breakthrough for 10 million Indians suffering from heart failure
Fluid monitoring is a more accurate predictor of worsening heart failure compared to daily weight monitoring in heart failure patients with implantable devices, according to results released today from the FAST (Fluid Accumulation Status Trial) clinical trial.
FAST is a global, prospective, double-blinded study involving 156 heart patients implanted with ICD (implantable cardioverter-defibrillator) or CRT-D (cardiac resynchronization therapy-defibrillator) followed for an average of 18 months at 18 centers in the United States, Canada and Hong Kong. Heart failure events detected in this study were within 30 days of a fluid index threshold crossing or an acute weight gain.
According to Padmshree Dr. Balbir Singh, Senior Consultant, Electro-physiotherapy & Interventional Cardiology, Indraprastha Apollo Hospital, “This is indeed an important breakthrough because Indians are at a higher risk owing to higher incidence of diabetes and hypertension. Treatment for other heart conditions, particularly myocardial infarctions (heart attacks), has improved substantially which means that more patients survive the short-term events and hence the number of people who are at risk for developing heart failure subsequently is on the rise. Another cause of worry for India is the increasing life expectancy. We all know that the risk of heart failure increases dramatically with age. Approximately, heart failure affects 10 out 1000 people above the age of 65.”
Results showed that OptiVol® Fluid Status Monitoring, a feature available only in InSync Sentry™ (a CRT-D device by Medtronic, Inc., world’s leading medical technology company specializing in implantable and interventional therapies) which measures changes in fluid build up in the chest cavity, predicted 76 percent of future heart failure events as compared to only 23 percent detected by weight monitoring alone. In other words, fluid monitoring was three times more sensitive. These findings were presented as a late breaking clinical trial during the recent Annual Scientific Meeting of the Heart Failure Society of America (HFSA).
Thoracic fluid accumulation is a primary indicator of worsening heart failure. The InSync CRT-D by Medtronic is the world’s first implantable medical therapy offering automatic fluid status monitoring in the thoracic cavity - the chest area encompassing the lungs and heart. It uses low-level electrical pulses that travel across the thoracic cavity to measure the level of resistance, indicating fluid in the chest – a common sign of heart failure. OptiVol’s ability to measure fluid status trends over time can provide important insights that are used in conjunction with ongoing monitoring of other patient signs and symptoms. As fluid builds up in the lungs, OptiVol feature can be programmed to alert the patients and physicians, acting as an early warning, and allowing for appropriate clinical response.
Heart failure is the number one cause of hospital admissions, and most of these admissions are because of fluid overload. Often, this fluid build-up goes undetected and untreated until the patient becomes critically ill warranting his/her hospitalization. The CRT-D with automatic fluid status monitoring signals a new era in heart failure management, representing the convergence of sophisticated diagnostics and proven therapy in a single implantable device.
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A perfect combination of the “shock box” and the pacemaker
The four chambers of the heart contract in synchrony (people experience this as their heartbeat). However, in heart failure patients, the electrical impulses that coordinate the contractions of the heart’s chambers may be impaired. As a result, in up to 30 percent of people who have advanced heart failure, the two lower chambers, called ventricles, no longer contract simultaneously. In cardiac resynchronization therapy (CRT), a device is implanted in the upper chest in an attempt to resynchronize the contractions of the ventricles by sending tiny electrical impulses to the heart muscle. These pulses cannot be felt by the patient and do their work silently. CRT is also known as biventricular pacing. Three very thin insulated wires (leads), with tiny electrodes on their distal ends, are manoeuvred through veins from the device to the heart. The implantation procedure is typically done with local anaesthesia, so the patient remains conscious. A typical time, depending on physician experience and patient anatomy, is between 2-3 hours. Patients usually stay in the hospital overnight. The device is smaller than the palm of an adult hand.
Studies have shown that heart failure patients are at a higher risk for sudden cardiac arrest. Special CRT devices are available which can potentially stop life threatening ventricular fibrillation (very fast heart rates) by delivering an electrical shock (called defibrillation in medical terms) to the patient. A CRT-D device (wherein D stands for defibrillator) is a combination of a conventional Implantable Cardioverter Defibrillator (the “shock box”) and the pacemaker. It is also called as a “Combo” device.
Fluid monitoring emerges as the new standard of care for heart patients