Tuesday, December 16, 2008

Remote Monitoring for ICD Patients

Implantable Cardioverter Defibrillators (ICD) can be an important and effective treatment for patients at risk for sudden cardiac death. To enable patients to have more continuous follow-up along with reduced complication rates, new devices such as home remote monitoring equipment geared to patients with ICD are now available.

Biotronik Home Monitoring an automatic wireless system used for patients with cardiac devices was used in a study with 1,443 patients to test if home remote monitoring would reduce the number of scheduled office visits in a prospective randomized trial. The data demonstrated that the home monitoring system reduced the number of office visits while maintaining patient safety, plus using the system led to earlier detection of arrhythmic events.

Eighty nine percent of remote monitoring alerts were managed remotely and required no follow-up office visits. About 30 percent of unscheduled office visits among patients in both the control and study groups required physician interaction and were considered actionable. However, unscheduled office visits triggered by the remote monitoring system nearly doubled the rate of treatment. More than 51 percent led to some action by the clinician and at the same time made better use of the clinician’s time.

In another ongoing clinical trial taking place in Germany, Charite University and Biotronik GmbH & Co. are currently recruiting participants to study remote monitoring after ICDs are implanted. The goal is to look at how effective remote monitoring does as compared to standard care in patients. All study participants will receive an ICD in the Biotronik Lumax family.

All of the patients in the study will have Ventricular Arrhythmias that need treatment. One group of the patients participating in this home monitoring experiment will not only receive a home monitoring device but will also receive an additional home monitoring device called the CardioMessengerII following the ICD implantation. Follow up appointments for this group will be done in outpatient clinics for the first month, for the first year, and for 24 months after the implantation.

Remote visits will be done for this group of patients for the third month, six month, and for 18 months after the ICD implantation. Doctors will be able to follow up on their patients with fewer in clinic consultations and hopefully the study will show that home monitoring results in more efficient and effective follow up along with cost savings.

The patients in the group that will receive standard care will also receive a home monitoring device but will have scheduled follow-up appointments at the outpatient clinics at 1,3,6,12,18, and 24 months.