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Trial data shows cardiac devices with monitoring alerts help reduce heart failures

Medtronic : 01 September, 2008  (Company News)
New data presented at the European Society of Cardiology (ESC) Congress shows that Medtronic cardiac devices equipped with OptiVol Fluid Status Monitoring Alerts may give physicians advance warning of their heart failure patients’ worsening condition, thus reducing the rate of heart failure hospitalisations and clinically relevant events.
Two year follow‐up data, presented by Dr Maurizio Landolina of Italy, shows this may be as much as a 50 percent reduction. (OptiVol Alerts are currently investigational in the USA.)

“Heart failure is a progressive condition, frequently marked by worsening symptoms such as fluid build‐up in the chest cavity, which often must be addressed in hospital,” said Dr Landolina of Fondazione Policlinico S Matteo IRCCS, in Pavia, Italy. “Our research team concluded that devices with OptiVol may detect this decompensation in a broad population of heart failure patients. By allowing the chance for timely discovery and prompt intervention, the alerts could lead to a reduced number of events such as heart failure hospitalisations.”

OptiVol Fluid Status Monitoring is found only on Medtronic cardiac resynchronization therapy‐defibrillators (CRT‐Ds) and implantable cardioverter‐defibrillators (ICDs). The monitor uses low electrical pulses that travel across the thoracic cavity (the chest area encompassing the lungs and heart) to measure the level of resistance, indicating fluid in the chest a common symptom of heart failure. Since normal fluid levels 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 that are used in conjunction with ongoing monitoring of other patient symptoms.

Remote management of cardiac device patients with OptiVol who are on the Medtronic CareLink Network is further enhanced with the company’s wireless device offerings: the Concerto CRT-D, Virtuoso ICDs and Vision 3D devices. Physicians in Europe can pre‐program these devices’ CareAlerts signals, which are designed to give automatic notification to the physician via text message (SMS), email or a Medtronic CareLink Web site message when a patient’s individualized OptiVol threshold is crossed, without the physician having to see the patient in‐office for diagnosis.

Introduced in 2002, the Medtronic CareLink Network is the leading Internet‐based remote patient management system. Today, more than 275,000 patients at more than 2,500 clinics in 20 countries are followed remotely via the CareLink Network, saving patients time by eliminating in‐office visits, and allowing physicians to perform a complete analysis of all the device‐ and patient‐specific cardiac data stored within Medtronic patients’ ICDs, pacemakers and CRT devices.

The study was led by Dr Landolina and involved 532 patients at 34 Italian centres, the purpose of the study was to describe the use of intrathoracic impedance monitoring in clinical practice, and evaluate the clinical usefulness of the associated alert in reducing clinically relevant events and heart failure hospitalisations. There were 362 documented OptiVol events in 230 patients (43.2 percent of patients).

Clinical events (such as hospitalisation, heart failure deterioration without hospitalisation, pneumonia, and others) occurred within two weeks of 47 percent of the OptiVol events. Another 20 percent of the OptiVol events were judged reliable and the drug therapy was adjusted, despite the absence of overt signs of clinical deterioration.

A presentation earlier in the congress, “Remote Device Monitoring and Heart Failure Management of CRT‐ICD Patients,” on remote patient management for those who have Medtronic CRT‐Ds equipped with the OptiVol feature revealed that 70 percent of episodes evaluated using a Medtronic CareLink transmission of device and patient data were managed remotely without requiring additional in‐hospital visits by the patients.

“My experience with OptiVol and CareLink has given me options for the detection of heart failure events and treatment adjustments, with the potential to reduce both morbidity and the need for clinic or hospital visits,” said Dr Renato P Ricci of S Filippo Neri Hospital in Rome, who presented the earlier data.

Ref 1 - Rosamond W, et al. Heart disease and stroke statistics: 2007 update. Circulation. 2007; 115: e69e171
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