Quarterly vs. Yearly Clinical Follow-Up of Remotely Monitored Recipients of Prophylactic Implantable Cardioverter-Defibrillators: Results of the REFORM Trial
What is the effect of less frequent in-office follow-up intervals in primary prevention implantable cardioverter-defibrillator (ICD) patients under remote monitoring with automatic daily data transmissions from the implant memory?
The REFORM (Remote Follow-Up for ICD-Therapy in Patients Meeting MADIT II Criteria) study, conducted in 155 ICD recipients with MADIT II indications, compared the burden of scheduled and unscheduled ICD follow-up visits, quality of life (Short Form [SF]-36), and clinical outcomes in patients randomized to either 3- or 12-month follow-up intervals between 3 and 27 months after implantation.
Remote monitoring (Biotronik Home Monitoring) was used equally in all patients. In contrast to previous clinical studies, no calendar-based remote data checks were performed between scheduled in-office visits. Compared with the 3-month follow-up interval, the 12-month interval resulted in a minor increase in the number of unscheduled follow-ups (0.64 vs. 0.27 per patient-year; p = 0.03) and in a major reduction in the total number of in-office ICD follow-ups (1.60 vs. 3.85 per patient-year; p < 0.001). No significant difference was found in mortality, hospitalization rate, or hospitalization length during the 2-year observation period, but more patients were lost to follow-up in the 12-month group (10 vs. 3; p = 0.04). The SF-36 scores favored the 12-month intervals in the domains “social functioning” and “mental health.”
The authors concluded that in prophylactic ICD recipients under automatic daily remote monitoring, the extension of the 3-month in-office follow-up interval to 12 months appeared to safely reduce the ICD follow-up burden.
This study reported that in remotely monitored patients with primary prevention ICDs and no cardiac pacing indications, scheduling yearly instead of quarterly follow-up visits resulted in reduction of the total rate of follow-up visits by 58%, from 3.85 to 1.60 per patient-year. Furthermore, a favorable impact of longer follow-up interval on the patients’ quality of life was observed, while no impact on patient mortality, hospitalization rate, or other clinical outcomes was evident after the 2-year observation period. Overall, the data suggest that follow-up interval lengthening after ICD is feasible and that physicians can rely on remote monitoring information to decide on the necessity of an unscheduled in-office ICD follow-up.
Keywords: Defibrillators, Follow-Up Studies, Safety, Death, Quality of Life, Office Visits, Mental Health, Primary Prevention
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