No Safety Compromise With Remote ICD Monitoring

Reed Miller

August 29, 2011

August 29, 2011 (Paris, France) — Two studies from France presented at the European Society of Cardiology (ESC) 2011 Congress show that implantable cardioverter defibrillator (ICD) patients monitored remotely instead of relying on in-office visits suffer fewer inappropriate shocks without any significant difference in adverse events [1].

Dr Philippe Mabo

"ICD remote monitoring is a safe alternative to in-office follow-up, but no difference in major clinical events was demonstrated," explained Dr Philippe Mabo (University Hospital, Rennes, France), leader of the Evaluation of Tele Follow-up (EVATEL) study. However, he said, the widespread uptake of remote monitoring of ICDs is prevented by the lack of reimbursement for it in many places, including France. Mabo presented one-year results from the study during a hot-line session at the ESC meeting.

The EVATEL trial randomized 1501 patients with ICDs at 30 French centers to either conventional in-office follow-up visits at the implanting center every three months or remote transmission of data from the ICD to the implant center every three months. All brands of devices were used in the study, which was sponsored by the French government. The primary end point was major adverse events, including death, cardiovascular hospitalization, and ineffective or inappropriate device therapy.

The primary end point occurred in 210 patients in each group (p=0.7101); there was no significant difference in the time to first adverse event, and the survival rate was statistically similar in both groups (p=0.31). Fewer patients in the remotely monitored group experienced inappropriate or ineffective therapy from their ICD (4.7% vs 7.5%, p=0.03).

However, because 55 patients from the remote-monitoring group eventually crossed over to the control group and only one patient crossed over from the control group to the remote-monitoring group, the noninferiority of remote monitoring was demonstrated in the intention-to-treat analysis but not in the per-protocol analysis, Mabo said. In almost all of cases, the switch from the remote-monitoring group 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 have to switch to the control group because their medical condition required regular office visits.

Commenting on the study at the conference, Dr Angelo Auricchio (Fondazione Cardiocentro Tincino, Lugano, Switzerland) said, "The inconclusive result should not lead us to question the validity of device remote follow-up for ICDs, which is clearly supported by this result." EVATEL "has brought good news for us, and it's just confirming that we know from several other studies in the literature: the fact that the rate of inappropriate ICD therapy is significantly reduced with remote monitoring."

ECOST Shows Remote Monitoring Reduces Shocks and Saves Batteries

Dr Salem Kacet

During the same session as the EVATEL presentation, Dr Salem Kacet (Regional University Hospital, Lille, France) presented the results of the ECOST study, which randomized 433 patients at 43 centers to either daily remote monitoring with Biotronik's system or traditional in-office visits. All patients visited the clinic within three months of implantation, but the remote-monitoring patients were seen in the office only once a year, unless there was an anomalous ICD function or adverse event, while the control-group patients had in-office visits every six months. The trial ran for 27 months.

The remote-monitoring patients were about half as likely as the control patients to receive an inappropriate ICD shock. Eleven remotely monitored patients had a total of 28 inappropriate shocks vs 283 shocks in 22 patients in the control group (5% vs 10.4%, p=0.03). ECOST also showed that the 76% reduction in the number of charged shocks resulted in a significantly longer ICD battery life in the remotely monitored patients.

The remotely monitored patients were also about one-third as likely to require hospitalization (three vs 11 patients, p=0.02). There were 20 deaths in both groups.

Kacet said that ECOST showed a much bigger difference in the number of inappropriate shocks than EVATEL because the remotely monitored patients transmitted data daily, instead of every few months. "With the daily monitoring, it is possible to detect the different clinical events or device dysfunction and to treat this problem earlier than the next visit," he said.

"Remote monitoring might soon become the new standard of care for follow-up of ICD recipients," Kacet said. "In the past, we only had one randomized study of [remote monitoring], and that was TRUST," which showed that remote monitoring significantly reduced the need for in-office visits without leading to an increase in adverse events. "Now we have three trials, with EVATEL and ECOST, and I think that with these trials we can obtain reimbursement for remote monitoring, because it's very important if we want to expand remote monitoring," he said.

The discussant assigned to the ECOST presentation, Dr Jean-Claude Daubert (University of Rennes, France) said that ECOST and EVATEL results appear to be consistent and, combined, they support wider use of remote ICD monitoring, especially if the forthcoming cost-effectiveness analysis of the studies shows that remote monitoring saves money. "That will be the last piece of the puzzle of definitive validation of remote monitoring for ICD patients."

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