Not Shocking: French Studies Evaluate Remote Monitoring of ICDs Reply

Remote monitoring of ICDs can reduce inappropriate shocks, but the overall clinical benefit and cost effectiveness of the technology has not yet been demonstrated, according to two new studies presented in Paris at the European Society of Cardiology meeting.

Salem Kacet presented the ECOST (Effectiveness and Cost of ICD Follow-Up Schedule with Telecardiology) study in which 433  ICD patients were randomized to daily remote monitoring follow-up or in-office visits in 43 French centers. The trial found that remote monitoring was noninferior to in-office visits for the primary endpoint of cumulative survival free of major adverse events (HR 0.91, CI 0.68-1.23, p<0.05).

Kacet emphasized the secondary effectiveness endpoint, which found a 52% reduction in the number of patients who had inappropriate shocks.

  • Three patients in the remote monitoring group were hospitalized for a cause related to their inappropriate shocks, compared to 11 patients in the control group (p=0.02).
  • 11 (5%) patients in the RM group had inappropriate shocks versus 22 (10.4%) in the control group (p=0.03)

Kacet also noted that the reduction in inappropriate shocks would have a significant impact on battery longevity. He did not present the cost-effectiveness component of the study.

The results of the EVATEL (EVAluation of TELe follow-up) study, presented by Philippe Mabo, were less positive. 1501 patients were randomized to the remote follow-up group, consisting of a transmission to the implant center every 3 months, or the control group, consisting of an in-office follow-up at the implant center every 3 months. No significant difference in the time to the first major cardiovascular  event was observed (28.5% in the control group versus 30.2% in the RM group, p=ns). However, the trial failed to meet the primary noninferiority endpoint, either in the intent-to-treat analysis (p=0.0268) or  in the per-protcol analysis (p=0.0862).

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

Click here for the ECOST abstract and slides.

 

Click here for the EVATEL press release from the ESC.

Here are the 2 press releases issued by the ESC:

ECOST trial demonstrates for the first time that daily remote monitoring reduces inappropriate shocks and improves battery longevity for ICD patients 

Paris, France, 29 August: ECOST, a French prospective, multicenter, randomized clinical trial concludes that cardiac device management using a home monitoring system with daily telemetry in patients with an implantable cardioverter-defibrillator (ICD) is safe, reduces the number of inappropriate shocks, and improves battery longevity.

The results were presented during the ESC Congress 2011 on August 29, 2011, in Paris, France, by Professor Salem Kacet, CHRU Lille, France, in the Hot Line II and Meet the Trialist III sessions.

To prevent sudden cardiac death 600 ICDs per million population are implanted yearly in the United States and 189 per million in Europe. Information and Communication technology (ICT) applications for health, referred to as “e-health”, will significantly enhance the world healthcare systems during the ongoing decade in order to deliver high-quality patient care. The new device is a telemedicine technology which allows remote monitoring of patients with ICDs and pacemakers.

ECOST was designed to investigate whether daily remote monitoring follow-up is safe and effective compared to in clinic follow-up for ICD recipients.

A total of 433 patients were followed for 27 months in 43 centres after having been randomized to remote monitoring (active group) or in-clinic follow-up (control group). A first in-clinic ICD follow-up within 1 to 3 months after implantation was scheduled for all patients. Then, in the active group, patients were seen in the ambulatory department only once a year, unless an anomalous ICD function or an event of clinical concern was reported by remote monitoring and required an additional in-clinic visit. In the control group, the patients were followed in the ambulatory department at 6-month intervals.

Importantly, the ECOST trial is the first trial to show a 52% reduction of the number of patients with inappropriate shocks and a 72% reduction in the risk of hospitalizations related to inappropriate shocks, clearly underlining the effectiveness of home monitoring in ICD recipients. In addition, ECOST shows a 76% reduction in the number of charged shocks with a significant impact on ICD battery longevity.

ECOST has clinically proven with a non inferiority hypothesis that remote ICD monitoring is a safe alternative to conventional follow-up in terms of all cardiac and device related major adverse events and all cause deaths. These results are consistent with, and extend, previous findings by clearly demonstrating the safety of long-term remote ICD monitoring

Potential benefits of remote follow-up of ICD patients: the EVATEL trial 

Paris, France, 29 August: Results from the EVATEL (EVAluation of TELe follow-up) trial are the first in Europe to demonstrate potential safety and efficacy benefits from the remote follow-up of ICD patients. The trial was conducted in France, with the financial support of the French Ministry for Health and independent of any manufacturer grants.
ICDs (implantable cardioverter defibrillators) are devices routinely implanted in patients at risk of sudden cardiac death as a result of rhythm disturbances. The expending indications for ICDs are expected to have an impact on follow-up strategy, as the number of patients with ICDs is increasing rapidly.

“Currently,” explains investigator Dr Philippe Mabo form the University Hospital of Rennes, France, “regular in-clinic follow-up must be performed every three months, according to manufacturer guidelines. But there are two drawbacks to the in-clinic follow-up – they’re time-constrained for both the patient and the clinic,  and there’s no link between the time of the appointment and the clinical event or device malfunction. So there’s a clinical need to consider new follow-up strategy.”

In response, several manufacturers have developed new technologies which allow the remote transmission of information from the device and on its therapeutic effect. Critical data can be transmitted at any time on system integrity or unexpected events – for example, lead integrity, battery status or ineffectively delivered therapy. Data stored in the device are transmitted by phone from the patient’s home to the implant centre, with website access to the data.

“In this context,” said Dr Mabo, “remote device follow-up seems to be a promising technique for device follow-up. But the technology needed clinical validation in terms of safety, efficacy and cost-efficiency, which were the objectives of the EVATEL trial.”

The study included 1501 patients from 30 French centres enrolled between January 2008 and January 2010. They were each followed-up every three months for an overall period of one year. The last follow-up was performed in January 2011. The characteristics of the subjects were comparable to those of an ICD trial or registry, with a mean age of 59 years and the majority male (85%). Half the patient received conventional follow-up at the implant centre, the other half were followed remotely. The primary end-point of the trial was a clinical composite of death (all causes), cardiovascular hospitalisation, and ineffective or inappropriate therapy delivered by the device.

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 (p=0.71) and the one-year survival rate (p=0.31). The number of inappropriate therapies was lower in the remote group (4.7%) as compared to the control group (7.5%) (p=0.03).

Nevertheless, the non-inferiority hypothesis of the trial with a strict non-inferiority margin of 5% was not confirmed, as the event rate difference between the two groups was 1.7%, with a 95% confidence interval of -0.3 to 6.4.

Commenting on the results, Dr Mabo said: “The remote follow-up of patients implanted with an ICD seems to be a safe alternative to conventional in-office follow-up. 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.”

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