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    • The CONNECT trial conducted by Crossley et al was

    2019-05-10

    The CONNECT trial conducted by Crossley et al. [22] was also a multicenter, prospective, randomized evaluation of wireless RM, which included 1997 patients implanted with ICDs or CRT-Ds. They were randomly assigned to the remote or in-office groups and followed up for 15 months. The median time from a clinical event to the clinical decision per patient was reduced from 22 days in the in-office group to 4.6 days in the remote group (P<0.001). Moreover, the health care utilization data revealed a decrease in the mean length of stay per cardiovascular hospitalization from 4.0 days in the in-office group to 3.3 days in the remote group (P=0.002). The Home Guide Registry [23] and the ECOST trials [24] also demonstrated the safety and usefulness of the automatic daily RM technology. In the Home Guide Registry trial, the workflow for RM was based on primary nursing, whereas in-person visits were scheduled once a year. In total, 1650 patients implanted with PPMs, ICDs, or CRT-Ds from 75 Italian sites were enrolled. During the 20±13 months follow-up, 2471 independently adjudicated events were collected in 838 patients (51%), of which 2033 (82%) were detected during RM sessions and 438 (18%) during in-person visits. Sixty were classified as false positive, with generalized estimating sensitivity and positive predictive value of 84.3% and 97.4%, respectively. Overall, 95% of asymptomatic and 73% of actionable events were detected during RM sessions, and the median reaction time was 3 days. The ECOST trial prospectively examined the long-term safety and effectiveness of RM of ICDs. A total of 433 patients were randomly assigned, at a 1:1 ratio, to RM (active) or control groups. During the 24.2 months-long follow-up, 38.5% of patients in the active and 41.5% in the control group experienced one or more major adverse event (MAE) (P<0.05 for non-inferiority). The overall number of shocks delivered was significantly lower in the active (n=193) than in the control (n=657) group (P<0.05), whereas the proportion of patients who acetylcholine inhibitors received inappropriate shocks was 52% lower in the active (n=11) than in the control (n=22) group (P<0.05). The majority of the existing reports on RM included patients with ICDs, whereas the reports focusing on PPMs are limited. The randomized, multicenter COMPAS trial was conducted in France to evaluate the benefits of automatic daily RM for patients implanted with PPMs [25]. In total, 538 patients were randomly assigned to RM follow-up (active group) vs. standard care (control group). Over a follow-up period of 18.3 months, 17.3% of the patients in the active and 19.1% in the control group experienced at least one MAE (P<0.01 for non-inferiority). Hospitalizations for atrial arrhythmias (6 vs. 18) and strokes (2 vs. 8) were fewer (P<0.05), and the number of interim ambulatory visits was 56% lower (P<0.001) in the active group. Changes in the pacemaker program or drug regimens were made during 62% of visits in the active vs. 29% in the control group (p<0.001). The quality of life remained unchanged in both groups. So far, clinical evidence from Japan supporting the efficacy of the RM technology has been limited. The HOME-ICD study reported by Watanabe et al. [18] evaluated the reliability of daily wireless RM in forecasting the need for regular in-hospital follow-ups (RFUs). Two-hundred fifteen patients implanted with ICDs or CRT-Ds were enrolled, and RFUs were 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 acetylcholine inhibitors session was classified as necessary if an action was undertaken (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%), including 2 actions with high clinical relevance (0.3%). Specifically, an additional prescription of warfarin for subclavian vein thrombosis in one case and activation of rate-adaptive pacing in another case were needed. Other actions were of non-critical character, including reprogramming to extend battery longevity, reprogramming to maintain safety margin for pacing. On the other hand, RM correctly forecasted that 498 scheduled RFUs (75.1%) were in fact not necessary. The patient acceptance of RM was also evaluated using a targeted questionnaire. Of 182 interviewed patients, 172 (94.5%) reported feelings of security and comfort. The authors concluded that RM-based forecasts appear to be sufficiently accurate to safely individualize RFU, and that most patients have a positive attitude towards RM. Many trials involving Japanese patients are currently ongoing, and the results are very much awaited.