Effectiveness and Cost Of ICD follow-up Schedule with Telecardiology - ECOST
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.
Daily remote monitoring would be safe (noninferior) and cost-effective as compared with office monitoring in patients undergoing ICD implantation.
- Adults over 18 years
- Primary or secondary prevention indication
- Biotronik ICD device with data transmission features
- Written informed consent
Number of enrollees: 433
Duration of follow-up: 24 months (mean)
Mean patient age: 62 years
Percentage female: 12
Ejection fraction: 35%
New York Heart Association (NYHA) class: I (29%), II (63%), III (8%)
- NYHA class IV
- Life expectancy <1 year
- Cardiac resynchronization therapy indication
- Major adverse events (all-cause mortality, MACE, device-related major adverse event)
- Rate of hospitalization
- Rate of inappropriate ICD therapies
- Cost-effectiveness analysis
- Number of ICD charges and impact on ICD battery longevity
- Quality of life (SF-36)
Following ICD implantation, all patients were seen in the clinic within 1-3 months. After this, patients were randomized to either daily remote monitoring or routine follow-up every 6 months. Remote monitoring patients were seen in the clinic in the event of an anomalous ICD function, or an event of clinical concern was reported by remote monitoring. An in-office visit was conducted in all patients annually. All ICD devices were from Biotronik, and its proprietary Home Monitoring System was utilized for remote monitoring.
A total of 433 patients were randomized, 212 to routine monitoring and 221 to remote monitoring. Baseline characteristics were fairly similar between the two arms. First implantation was in 85% of the patients, and about 53% of the patients underwent ICD implantation for primary prevention.
The primary endpoint of major adverse cardiac event (MACE)-free survival was similar between the remote and routine monitoring arms (38.5% vs. 41.5%, hazard ratio 0.91, 95% confidence interval 0.68-1.23, p for noninferiority < 0.05; p for superiority = 0.53). All-cause mortality was similar (~9% in both), as was MACE (26.7% vs. 29.7%, p > 0.05). Inappropriate shocks were less frequent in the remote monitoring arm (5% vs. 10.4%, p = 0.03), as were the number of hospitalizations (1.4% vs. 5.2%, p = 0.02). The total number of inappropriate shocks was numerically lower in the remote monitoring arm (28 vs. 283, p > 0.05). The total number of charged shocks was also lower in the remote monitoring arm (499 vs. 2081, p < 0.05). This was associated with a significant improvement in battery longevity (-0.07% vs. -0.18% per day, p = 0.02). The total number of delivered shocks was also lower (191 vs. 657, p < 0.01). Quality of life assessments by short form (SF)-36 were similar between the two arms.
The results of the current trial indicate that daily remote monitoring is noninferior to three monthly office visits for safety at 24 months, with a significant reduction in inappropriate and total ICD shocks. This was also associated with an increase in battery longevity. Cost-effectiveness analyses are awaited. These calculations will need to factor in the resources required for daily review of information from these devices for all patients being followed versus any improvements in ICD performance.
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, which was tested in this trial. The latter was also recently studied in the TRUST trial in the United States, where remote monitoring was done every 3 months rather than daily, as in this trial. 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.
Presented by Dr. Salem Kacet at the European Society of Cardiology Congress, Paris, France, August 2011.
Keywords: Telecommunications, Tachycardia, Ventricular, Quality of Life, Longevity, Informed Consent, Hospitalization, Defibrillators, Implantable, Primary Prevention
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