Cooper Adds Remote Data Transmission for Monitoring Heart Failure Patients

The 62-year-old female presented with worsening dyspnea upon mild exertion. Evaluated as NYHA Class III, the patient’s worsening heart failure had been unresponsive to medical therapy. Contemplating early retirement, she was presented with the option of biventricular pacer implantation. Six months post-procedure, the patient downloads information daily and transmits impedance data to her physician. She has returned to work and walks daily without distress.

Cardiac resynchronization therapy (CRT) has developed into one of the most effective treatments for patients who have maximized medical therapy in the treatment of their advanced heart failure. Measurable improvements in functional capacity and quality of life have been documented in clinical trials involving NYHA Class III and IV patients who have had biventricular devices implanted. However, the heart failure population continues to be burdened by repeat hospitalizations for decompensated heart failure. The toll is staggering both in dollars and quality of life, as in-patient days account for over 70% of heart failure management costs in the U.S.

To address this patient management issue, the Cooper Heart Institute has recently become the first center in the Delaware Valley, and one of only 100 hospitals in the U.S., to implant the Medtronic InSync Sentry™. This advanced heart failure management system features OptiVol™ Fluid Status Monitoring to track thoracic fluid status via measurements of intrathoracic impedance.

Intrathoracic Impedance
Impedance measurements have been discussed for decades as a means of tracking fluid accumulation in heart failure patients. Recent clinical studies, including the Medtronic Impedance Diagnostics in Heart Failure Patients (MIDHeFT) Trial, concluded that an inverse correlation exists between impedance and pulmonary capillary wedge pressure (PCWP). As fluid increases in the thoracic cavity the intrathoracic impedance decreases, and conversely, impedance increases as fluid level decreases. In the patients studied, intrathoracic impendance decreased in a significant number prior to their need for hospitalization.

“The OptiVol™ technology was developed and first tested by NASA over 30 years ago. Recently, the FDA approved its use in heart failure based on MIDHeFT data,” says John Andriulli, D.O., director of the Arrhythmia Device Program at the Cooper Heart Institute. “Comprehensive analysis of data collected provided the foundation for determining a reasonable threshold of detection for fluid accumulation in patients,” added Dr. Andriulli. “In addition, the system has the ability to set individual parameters for fluid accumulation levels for each patient.”

Intrathoracic impedance measurements are made using a vector from the right ventricle to the implanted biventricular pacing device. Multiple measurements are collected throughout the day and are averaged to calculate a daily impedance value. Variations in daily impedance values determine the fluid index and provide data for trends.

Remote Data Transmission
The physician is able to access the data remotely when the patient downloads and transmits the information from any analog phone line. “The clinical information is then transmitted to the physician via a secure web site for unprecendented access to the patient’s device data,” says Dr. Andriulli. “This access will allow for titration of medication prior to the patient exhibiting symptoms, thereby averting some hospitalizations for decompensated heart failure,” he added.

Echo Aids Selection Process
Experienced clinicians agree that the success of CRT is dependent on optimal patient selection. This selection is often aided by echocardiographic evidence of dyssynchrony. To determine the reliability of echocardiography as a predictor of response to CRT, a multi-center clinical trial is now underway at several advanced centers such as the Cooper Heart Institute. PROSPECT (Predictor of Responders to Cardiac Resynchronization Therapy) will identify echocardiographic predictors and determine if echocardiography criteria will provide prospective data to establish which patients will most likely benefit from CRT. The non-randomized, multi-center study will be under the direction of Dr. Andriulli at Cooper.

“Biventricular pacing is one of the most important advancement in the treatment of heart failure in the past decade,” says Joseph E. Parrillo, M.D., director of the Division of Cardiovascular Disease and Critical Care Medicine at Cooper University Hospital. “The addition of technology to monitor and transmit data adds an important new treatment dimension. It has the potential for decreasing inpatient days, while allowing physicians at advanced centers like Cooper unprecedented access to the physiologic parameters of their patients. We are pleased to be the first to offer this option in the Delaware Valley,” he added.

For more information about bi-ventricular pacing, remote monitoring, or to refer a patient, please call (856) 968-PUMP (7867).