Results of a new trial demonstrate the potential safety and efficacy benefits of the remote follow-up of patients with implantable cardioverter defibrillators (ICDs)

Researchers at the University Hospital of Rennes (France) and other institutions reported the results of the EVAluation of TELe follow-up (EVATEL) study, involving 1,501 patients (mean age of 59 years, 85% male) enrolled between January 2008 and January 2010 at 30 centers across France. All participants were followed every three months for an overall period of one year, with half the patient received conventional follow-up at the implant Center, while the other half was followed remotely. The primary end-point of the trial was a clinical composite of death (all causes), cardiovascular hospitalization, and ineffective or inappropriate therapy delivered by the device.

The results showed that the primary endpoint was validated in 28.5% of the control group and 30.2% of the remote group, thus indicating no difference in outcome between the groups. In addition, there were no statistically significant differences between the two groups in time to occurrence of the first primary endpoint and the one-year survival rate. The number of inappropriate therapies was lower in the remote group (4.7%) as compared to the control group (7.5%). The study was presented at the European Society of Cardiology (ESC) annual congress, held during August 2011 in Paris (France).

“The remote follow-up of patients implanted with an ICD seems to be a safe alternative to conventional in-office follow-up,” said lead author and study presenter Philippe Mabo, MD. “However, for the widespread uptake of this new strategy - at least in France - reimbursement from the healthcare system will be needed. We hope that it will be available soon in France.”

A limitation of the study was that 55 patients from the remote-monitoring group eventually crossed over to the control group, while only one patient crossed over from the control group to the remote-monitoring group. In almost all of cases, the switch to the control group was triggered by unexpected problems with the remote transmission system, or the patients' inability to use it. In only two cases did a patient in the remote-monitoring group need to switch to the control group due to their medical condition. As a result, the noninferiority of remote monitoring was demonstrated in the intention-to-treat analysis, but not in the per-protocol analysis.

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