Healthcare Technology Featured Article

August 30, 2011

New Studies Confirm that Implantable Cardiac Devices Have Pros and Cons

It seemed too good to be true. Your heart condition could be monitored from home or on vacation or even while grocery-shopping for any irregular heartbeats on your implantable cardiac device (ICD), and alertyour health care provider if there's a problem. But two new studies presented in Paris at the European Society of Cardiology meeting have indicated that ICDs may be neither safe nor cost-effective.

An ICD is a small electronic device installed inside the chest to stop abnormally fast heart rhythms that could presage a heart attack, according to medicine net. com.

ICDs monitor the heart rhythm. According to the Web site, when the heart beats normally, the device remains inactive. But if the heart develops a life-threatening pattern, the ICD electronically "shocks" the heart back to its normal rhythm.

Salem Kacet presented the study, called ECOST (Effectiveness and Cost of ICD Follow-Up Schedule with Telecardiology) which followed 433 ICD randomly assigned to daily remote monitoring follow-up or in-office visits in 43 French centers, according to The trial found "a 52 percent reduction in the number of patients who had inappropriate shocks," according to the story, although three patients in the remote monitoring (RM) group "were hospitalized for a cause related to their inappropriate shocks, compared to 11 patients in the control group; 11, or 5 per cent of the patients in the RM group had inappropriate shocks versus 22 (10.4 percent) in the control group, and that the "reduction in inappropriate shocks would have a significant impact on battery longevity."

The findings of the second study. EVATEL (EVAluation of TELe follow-up) were less positive. In this study, according to the story at, 1501 patients were randomly assigned to the remote follow-up group, which transmitted information to the implant center every three months, or the control group, which had an in-office follow-up at the implant center every 3 months. According to the study, "no significant difference in the time to the first major cardiovascular event was observed (28.5 percent in the control group versus 30.2 percent in the RM group." However, the trial did not "meet the primary noninferiority endpoint, either in the intent-to-treat analysis or in the per-protocol analysis," according to the story.

According to the American Heart Assocation (AHA), almost 40 percent of American men between the ages of 40 and 59 have heart disease, while a little over 37 percent of women do due to increasing rates of obesity and diabetes.

AHA spokesperson Mariell Jessup said in an interview that "remote monitoring may improve outcomes and reduce inappropriate shocks, but that it cannot be recommended until its benefits are proven and it has been shown to be cost effective," according to the story.

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Deborah DiSesa Hirsch is an award-winning health and technology writer who has worked for newspapers, magazines and IBM in her 20-year career. To read more of her articles, please visit her columnist page.

Edited by Rich Steeves

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