Reliability of implantable cardioverter defibrillator home monitoring in forecasting the need for regular office visits, and patient perspective: Japanese HOME-ICD study

Background: Remote monitoring (RM) technology has emerged as a potentially efficient method to manage patients with implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators (CRT-Ds). This study evaluated the reliability of daily RM in forecasting the need for regular in-hospital follow-ups (RFUs). Methods and Results: Two hundred and fifteen patients implanted with Biotronik Lumax devices (142 ICDs, 73 CRT-Ds) were enrolled. RFU was performed at 3, 6, 9, and 12 months after implantation. Immediately before an RFU, the physician forecasted the need for RFU based on RM data (pre-RFU assessment). A completed RFU session was classified as necessary if an action was undertaken potentially influencing patient safety, device therapy, or medication therapy (post-RFU assessment). Overall, 663 pairs of pre- and post-RFU assessments were compared. The number of pre-RFU assessments failing to predict the need for RFU was 38 (5.7%), fulfilling the study hypothesis of 5.0±4.0% (P<0.002; 95% confidence interval: 4.1-7.8%). Judged by an independent committee, the rate of false pre-RFU forecasts with high clinical relevance was 2 (0.3%). RM correctly forecasted non-necessity of 498 scheduled RFUs (75.1%). Patient acceptance of RM was evaluated using a targeted questionnaire. Of 182 interviewed patients, 172 (94.5%) felt security and comfort. Conclusions: RM-based forecasts appear sufficiently accurate to safely individualize RFU. Most patients have a positive attitude towards RM.