Quarterly vs. yearly clinical follow-up of remotely monitored recipients of prophylactic implantable cardioverter-defibrillators: results of the REFORM trial

Abstract

AimsThe rapidly increasing number of patients with implantable cardioverter-defibrillators (ICD) places a large burden on follow-up providers. This study investigated the possibility of longer in-office follow-up intervals in primary prevention ICD patients under remote monitoring with automatic daily data transmissions from the implant memory.Methods and resultsConducted in 155 ICD recipients with MADIT II indications, the study compared the burden of scheduled and unscheduled ICD follow-up visits, quality of life (SF-36), and clinical outcomes in patients randomized to either 3- or 12-month follow-up intervals in the period 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 favoured the 12-month intervals in the domains ‘social functioning’ and ‘mental health’.ConclusionIn 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 during 27 months after implantation.ClinicalTrials.gov IdentifierNCT00401466 ().

Remote monitoring of patients with cardiac implantable electronic devices: a Southeast Asian, single-centre pilot study

“…Remote monitoring permits an earlier reaction to events requiring physician intervention in comparison to regular in-office device checks, with 98.6% of transmissions being reviewed within two working days in our cohort. (3,4,6,(14)(15)(16)(17)(18)(19)(20)(21) Early detection allows prompt management of arrhythmias, early management of device malfunction and device reprogramming to reduce inappropriate defibrillator shocks. (18,22,23) Compliance to remote monitoring was good, with an overall missed transmission rate of 11.8%.…”

“…(5,6) In addition, patient compliance to scheduled remote monitoring evaluation is superior compared to in-office checks. (5) Home monitoring is relatively new in Southeast Asia, (1,7) with pickup rates increasing over recent years.…”

Necessity of Face-to-Face Encounters With Recipients of Cardiovascular Implantable Electronic Devices With Remote Monitoring

“…7 Recently, the REFORM trial compared the burden of scheduled and unscheduled ICD follow-up visits, quality of life (QOL) by means of the SF-36 questionnaire, and clinical outcomes in patients randomized to either 3-or 12-month follow-up intervals. 8 The total rate of follow-up visits was reduced by 58% and there was a favorable impact on the patients' QOL because of a longer follow-up interval, although the 12-month follow-up interval resulted in a slight increase of in-office ICD follow-ups and more patients were lost to follow-up in the 12-month group. In addition, the REFORM trial found no difference in the morbidity and hospitalization rates between the 2 groups as did the TRUST 5 and COMPAS 6 trials, in which no difference was found in major adverse events between the conventional follow-up group and the Home Monitoring group.…”

Wpływ kardiowertera-defibrylatora na jakość życia — przegląd badań

“…W tym czasie QoL chorych objętych rutynowym schematem opieki kardiologicznej (planowe wizyty w poradni raz na 3 miesiące) pogorszyła się [62]. Natomiast Al-Khatib i wsp.…”