Trials Show Potential Benefits of Remote ICD Monitoring

Two clinical trials in France suggest that remote monitoring of implantable cardioverter defibrillators (ICDs) — which use electrical pulses to control irregular heartbeats — is a safe alternative to regular doctors’ office visits. Results of the trials were presented at a meeting of the European Society of Cardiology now underway in Paris.

ECOST trial

Salem Kacet of Centre Hospitalier Régional Universitaire in Lille, France reported on the ECOST clinical trial — funded by the German cardiovascular technology developer Biotronik — that tested daily, remote follow-up monitoring compared to clinic visits to follow-up on ICD recipients. In ECOST, 433 patients were followed for 27 months at 43 sites after having been randomized to remote monitoring (active group) or in-clinic follow-up (control group).

All patients received a first in-clinic ICD follow-up between one and three months after implanation. Patients in the active (test) group were seen in the clinic’s 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 visit. In the control group, the patients were followed in the ambulatory department at six month intervals.

The trial measured major adverse events affecting the health of the patients, including cardiac events and those related to the ICD. Also measured were the number of delivered shocks and battery longevity.

The findings show no difference in the rate of at least one major adverse event between the active (38.5%) and control (41.5%) groups.  The results also indicate in the active group, a 52 percent reduction of the number of patients with inappropriate shocks and a 72 percent reduction in the risk of hospitalizations related to inappropriate shocks, as well as longer battery life.

EVATEL trial

Philippe Mabo of Centre Hospitalier Universitaire in Rennes, France provided results of the EVATEL trial, funded by the French Ministry of Health. The EVATEL trial enrolled 1,501 patients at 30 sites in France between January 2008 and January 2010. They were each followed-up every three months for an overall period of one year.

Half of the randomized patients received conventional follow-up at the implant center (control group), the other half was followed remotely (remote group); 46 patients had to switch from the remote to control group because of incompatible telephone connections. The primary end-point of the trial was a clinical composite of adverse events: death from any cause, cardiovascular hospitalization, and ineffective or inappropriate therapy delivered by the device.

The findings show no difference in adverse events between the remote (30.2%) and control (28.5%) groups. Likewise there were no statistically significant differences between the two groups in time to occurrence of an adverse event and the one-year survival rate. The number of inappropriate therapies was lower in the remote group (4.7%) compared to the control group (7.5%).

Read more: Study Computes Cardiac Device Infection Mortality, Costs

Photo: Steve Winton/Flickr

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