Evaluation of the “Tele-follow-up” for the Follow-up of Implantable Defibrillators - EVATEL

Aug 29, 2011
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Author/Summarized by Author:
Dharam J. Kumbhani, MD, SM, FACC
Summary Reviewer:
Deepak L. Bhatt, MD, MPH, MBA, FACC
Trial Sponsor:
Rennes University Hospital, France. Grant from French Ministry for Health.
Date Presented:
01/01/2011
Date Updated:
08/29/2011
Original Posted Date:
08/29/2011
References

Description:

With an increasing number of indications, implantable cardioverter-defibrillator (ICD) implantation is one of the fastest growing procedures in cardiology today. Due to safety and technical reasons, routine follow-up with a device check is required every 3 months. This significantly increases costs and resource utilization. Remote monitoring is an appealing alternative, where information regarding devices and therapies delivered can be monitored remotely, without the need for routine follow-up office visits.

Hypothesis:

Remote monitoring would be noninferior to office monitoring in patients undergoing ICD implantation.

Study Design

  • Randomized
  • Parallel

Patient Populations:

  • Adults over 18 years
  • First implantation of a single- or dual-chamber ICD
  • Primary or secondary prevention indication
  • ICD device with data transmission features
  • Phone network compatible with remote transmission
  • Ability to correctly use the transmission system
  • Written informed consent

    Number of enrollees: 1,501
    Duration of follow-up: 1 year
    Mean patient age: 59.5 years
    Percentage female: 15%
    Ejection fraction: <35% (58%)
    New York Heart Association (NYHA) class: I (33%), II (53%), III (14%)

Exclusions:

  • NYHA class IV
  • Life expectancy <1 year
  • CRT indication

Primary Endpoints:

  • Combined clinical endpoint
  • Rate of major cardiovascular events occurring during the first year after ICD implantation
  • Death (all causes)
  • Hospitalization for a cardiovascular event
  • Ineffective therapy
  • Inappropriate therapy

Secondary Endpoints:

  • Time to first major adverse cardiac event
  • Time to all-cause death
  • Rate of cardiovascular hospitalization
  • Rate of ineffective or inappropriate ICD therapies
  • Cost-effectiveness analysis

Drug/Procedures Used:

Patients were randomized to either remote monitoring or routine follow-up every 3 months. In-office visit was conducted in all patients at 6 and 12 months.

Principal Findings:

A total of 1,501 patients were randomized, 750 to routine monitoring and 751 to remote monitoring. Baseline characteristics were fairly similar between the two arms. The majority of ICDs were either Biotronik (42%) or Medtronic (31%); other devices included St. Jude Medical (22%) and Boston-Guidant (5%). About two thirds were single-chamber devices. Crossover rates were relatively high in the remote monitoring arm (7.3%); the majority being due to telecommunication incompatibility (58.2%) or patient inability to correctly use remote monitoring (10.9%).

Of all the ICDs implanted, the main indication was primary prevention in about 65% of the patients; 12% had survived a ventricular fibrillation arrest. Atrial arrhythmias were noted in about 21% of the patients, and 21% had been hospitalized for congestive heart failure (CHF) in the preceding year.

The trial did not meet the noninferiority goal for the primary endpoint of death/cardiovascular hospitalization/ineffective or inappropriate therapy (28.4% vs. 28.9% for routine vs. remote monitoring, respectively; p for noninferiority = 0.01). Similar results were noted on per-protocol analysis (28.5% vs. 30.2%, p = 0.003). All-cause mortality was similar (p = 0.31). Inappropriate therapy was more frequent in the routine monitoring arm (7.5% vs. 4.7%, p = 0.033), while cardiovascular hospitalization was similar (20.6% vs. 24.7%, p = 0.063).

Interpretation:

The results of the current trial are inconclusive with respect to the noninferiority of remote monitoring, as compared with routine monitoring every 3 months in patients undergoing ICD implantation. Rates of clinical events at 1 year were similar between the two arms. The majority of crossovers to routine monitoring were due to telecommunication failures. Cost-effectiveness analyses are awaited. The value of this technology in patients with cardiac resynchronization therapy (CRT)-P/CRT-D is also awaited.

Remote monitoring has gained increased attention in the past few years, with a promise to streamline care for patients receiving ICD implantation. Studies indicate that of all patients undergoing routine follow-up visits, only about 10% result in a clinically actionable episode, such as programming changes. Currently, home/remote monitoring is available for most companies, each with a slightly different nuance to its functioning.

Medtronic has its CareLink Network, Guidant/Boston Scientific its Latitude Patient Management system, St. Jude Medical its Medical Housecall Plus system, and Biotronik its Home Monitoring System. The latter was recently studied in the TRUST trial in the United States, which similar to this trial, demonstrated comparable clinical events at 1 year between routine and remote monitoring. One interesting observation in that trial was that there was a large delay in clinician evaluation of first arrhythmic event in both routine and remote monitoring groups, with significant variation between centers (ranging from days to weeks). Similarly, despite not requiring routine clinic follow-up, there was a nonadherence rate of about 15% in the remote monitoring arm. These and other issues such as telecommunication failures will need to be addressed before remote monitoring can be routinely advocated for patients undergoing ICD implantation.

References:

Presented by Dr. Philippe Mabo at the European Society of Cardiology Congress, Paris, France, August 2011.

Keywords: Telecommunications, Follow-Up Studies, Secondary Prevention, Ventricular Fibrillation, Heart Failure, Informed Consent, Office Visits, Defibrillators, Implantable, Primary Prevention, Cardiac Resynchronization Therapy


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