HomeCARE II: BIOTRONIK Launches Clinical Study Using Innovative Sensor Technology to Monitor Lung Fluid in Patients with Heart F

BIOTRONIK announced the launch of the HomeCARE II study. The enrollment of the first patient at the University Hospital in Würzburg, Germany marks the start of this important clinical program. 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. 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. 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.” The Heart Failure Monitor, 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. 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. “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 cases of clinically important 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.