HomeCARE II: BIOTRONIK Launches Clinical Study Using Inovative Sensor Technology To Monitor Lung Fluid In Patients With Heart Failure

Main Category: Respiratory / Asthma
Also Included In: Medical Devices / Diagnostics;  Clinical Trials / Drug Trials
Article Date: 02 Aug 2008 - 6:00 PDT

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BIOTRONIK, the pioneer in remote monitoring technologies for patients with cardiac devices, announced today the launch of the HomeCARE II study. The first patient was enrolled at the University Hospital in Würzburg, Germany which marks the start of this important clinical program. As a pioneer in telecardiology, BIOTRONIK is setting the scientific direction for clinical investigation of remote monitoring of heart failure patients with cardiac devices.

HomeCARE II study will collect and evaluate long-term data from a new lung fluid sensor technology that is included on the BIOTRONIK Lumax 540 series implantable cardioverter defibrillator (ICD) and cardiac resynchronization therapy defibrillator (CRT-D) devices in order to further develop an optimized detection algorithm for the early diagnosis of worsening heart failure in this patient population. All 300 patients to be included in the HomeCARE II study will receive a Lumax 540 series ICD or CRT-D device that measures, multiple times during a day, the intrathoracic impedance (resistance) through the lung tissue in the area between device housing and right ventricular lead. In this way, an increase of lung fluid can be detected and therefore, predict an acute worsening of heart failure in these patients. Furthermore, the intrathoracic impedance measurements from the senor technology will be automatically transmitted to the investigating physicians via the internet-based, BIOTRONIK Home Monitoring® system which enables continuous remote monitoring of the patient's heart failure status. Timely therapeutic measures based on the lung fluid sensor data may reduce patients' risk of either heart failure decompensation or hospitalization.

Heart failure: acute decompensation leads to high rates of hospitalization

In the general population, heart failure is chiefly the end stage of hypertensive, coronary and valvular cardiovascular disease. It is a major and growing clinical problem in most developed countries due to the increasing aging population and improved survival of cardiac patients by modern therapy. Once clinically manifest, heart failure, despite recent innovations in therapy, carries an unacceptably high mortality rate. It is estimated to account for about 5% of overall hospital admissions and approximately 22 million patients are affected worldwide. Early detection of an increased risk of heart failure hospitalization or mortality is extremely important to patients and may provide opportunities to reduce health care costs in many countries.

New sensor technology: measures tissue resistance, detects increasing lung fluid

The monitoring of lung fluid status can help to avoid acute decompensation and hospitalization. Many heart failure patients have pulmonary congestion. The new sensor technology will continuously monitor lung fluid levels (intrathoracic impedance) in these patients. Within the study, all Lumax 540 ICD and CRT devices perform multiple measures of the intrathoracic impedance daily. If the impedance level drops, this indicates an increased conductivity and thereby an increased fluid level. "We will examine how this new data from the sensor, along with patient's clinical condition and hospitalization rates relate to each other in detail. It is our priority aim to extract a very reliable algorithm" stated Dr. Sebastian Maier, primary investigator of the HomeCARE II study from the University Hospital in Würzburg, Germany. "In a next step, we hope to further enhance and design the Heart Failure Monitor® in an even more significant way." Heart Failure Monitor®: prediction of cardiovascular risks

The Heart Failure Monitor which was developed by BIOTRONIK provides physicians with trend reports on different clinical predictors, including physical activity, heart rate variability, heart rate at rest and others, for early detection of changes in heart failure status which may allow for early intervention in order to avoid serious clinical events such as decompensation or rehospitalization. With the new integrated sensor, the Lumax 540 implants can monitor the lung fluid levels in addition. The Heart Failure Monitor will be enhanced by BIOTRONIK on the basis of all heart failure related long-term data from the HomeCARE II study.

Telecardiology: sensor technology data transmitted via mobile network

"With our latest and most technologically advanced cardiac device implant series, Lumax 540, we are taking another important step towards early detection of worsening heart failure and improved patient care", commented Marlou Janssen, Vice President, Global Marketing and Sales, Cardiac Rhythm Management, BIOTRONIK. "In the future, by measuring the intrathoracic impedance several times a day and transmitting it via our unique Home Monitoring technologies, physicians will be able to detect the onset of decompensation early and immediately intervene therapeutically." The modern GPRS-based technology, BIOTRONIK Home Monitoring® ensures continuous, fully automatic and wireless monitoring of therapeutic, diagnostic and technical data. Through a secured internet connection, the physician is able to monitor patients' clinical status from anywhere in the world. In case of important clinically relevant events, the physician is notified. Growing clinical experience and evidence is beginning to demonstrate that remote monitoring technologies enhance therapy safety while costs and time for cardiac device follow-ups decrease significantly.

About BIOTRONIK GmbH & Co. KG

As one of the worlds leading cardiovascular medical device companies, with several million implanted devices, BIOTRONIK is present in all world markets. Known for having its finger on the pulse of the medical community, BIOTRONIK helps to assess the challenges physicians face, and provides the best solutions, be they cardiac implants, minimal invasive devices or other products and services ranging from diagnosis to electrotherapy and vascular intervention or therapy management. Quality, innovation, and reliability define BIOTRONIK and its growing success, and deliver confidence and peace of mind to physicians and their patients worldwide.

BIOTRONIK GmbH & Co. KG