Medtronic Inc announced the European market release of the InSync Sentry cardiac resynchronization therapy defibrillator (CRT-D).
The InSync Sentry is the world's first CRT-D device with automatic fluid status monitoring, which can be programmed to alert patients and clinicians to changes in fluid accumulation in the lungs and thoracic cavity. When used with other standard clinical assessments, this indicator offers the potential for early warning of fluid accumulation and appropriate clinical response, a company release says.
"An implantable device that can automatically monitor a patient's fluid status and potentially provide an early warning of worsening symptoms is an incredibly significant advance in medical technology," said professor Cheuk-Man Yu, Prince of Wales Hospital in Hong Kong, the principal investigator evaluating the feasibility of using an implantable device to track patient fluid levels.
An exclusive new feature called OptiVol Fluid Status Monitoring measures changes in intra-thoracic impedance, which is an indication of a patient's changing fluid volume. Physicians set a threshold for each patient, and when the threshold is crossed, the patient and clinician are alerted, providing for the possibility of earlier clinical assessment.
A key challenge is that normal fluid levels may vary from patient to patient, and fluid accumulation can be either chronic and slow, or acute and rapid. OptiVol takes measurements over time to develop a trend. By monitoring vital physiologic functions on top of standard clinical practice, OptiVol provides clinicians with an additional source of information and important new insights into patient management.
"One of the major consequences of advanced heart failure is a significant worsening of symptoms that decrease the patient's quality of life," said Steve Mahle, president, Medtronic Cardiac Rhythm Management. "Many of these symptoms are due to fluid accumulation, and with InSync Sentry, physicians and patients can now monitor this condition more closely and get information earlier. This is a major benefit for patients and excellent news for the healthcare system," he stated.
InSync Sentry, the CRT-D system, offers a small size (40cc) with increased longevity and the ability to terminate most fast ventricular tachyarrhythmias painlessly without shocks. Clinical studies have shown that Medtronic's anti-tachycardia pacing (ATP) function can dramatically reduce the need for shocks to treat fast ventricular arrhythmias - a significant patient benefit - by as much as 77 per cent.
InSync Sentry offers 35 joules of delivered energy, which is important because studies have indicated that heart failure patients sometimes require more energy to terminate life-threatening arrhythmias, and their defibrillation thresholds may rise over time. Patients with heart failure also are six to nine times more likely to suffer an episode of sudden cardiac arrest than the general population.
In addition, the device maintains cardiac resynchronization therapy during changing patient conditions such as atrial fibrillation, a common co-morbidity that affects about one-third of all heart failure patients.
Heart failure is the number one cause of hospital admissions, and most of these admissions are due to fluid accumulation in the lungs, which is extremely challenging to manage and often goes undetected until the patient is critically ill. It is not unusual for these patients to require hospitalization or urgent treatment at an emergency room or critical care unit for severe respiratory distress. With hundreds of thousands of hospitalizations each year, this care pathway is a tremendous cost burden to the world's healthcare systems.
Approximately 22 million people worldwide have heart failure, including more than 3 million in France, Germany, Italy, Spain and the United Kingdom. Of these 3 million patients, approximately 450,000 have moderate to severe heart failure with ventricular dysynchrony and are candidates for cardiac resynchronization therapy, which helps the heart beat more efficiently. Heart failure is a progressive and debilitating condition that is responsible for more hospitalizations than all forms of cancer combined.