A randomized study of remote follow-up of implantable cardioverter defibrillators: safety and efficacy report of the ECOST trial

Abstract

AimsThe ECOST trial examined prospectively the long-term safety and effectiveness of home monitoring (HM) of implantable cardioverter defibrillators (ICD).Methods and resultsThe trial's primary objective was to randomly compare the proportions of patients experiencing ≥1 major adverse event (MAE), including deaths from all causes, and cardiovascular, procedure-related, and device-related MAE associated with HM (active group) vs. ambulatory follow-ups (control group) in a sample of 433 patients. The 221 patients assigned to the active group were seen once a year, unless HM reported an ICD dysfunction or a clinical event requiring an ambulatory visit, while the 212 patients in the control group underwent ambulatory visits every 6 months. The characteristics of the study groups were similar. Over a follow-up of 24.2 months, 38.5% of patients in the active and 41.5% in the control group experienced ≥1 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) and the proportion of patients who received inappropriate shocks was 52% lower in the active (n = 11) than in the control (n = 22) group (P < 0.05). At the end of the follow-up, the battery longevity was longer in the active group because of a lower number of capacitor charges (499 vs. 2081).ConclusionOur observations indicate that long-term HM of ICD is at least as safe as standard ambulatory follow-ups with respect to a broad spectrum of MAE. It also lowered significantly the number of appropriate and inappropriate shocks delivered, and spared the device battery.Clinical trials registrationNCT00989417.

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%.…”

Economic impact of remote monitoring on ordinary follow-up of implantable cardioverter defibrillators as compared with conventional in-hospital visits. A single-center prospective and randomized study

“…Despite a cause-effect relationship that still needs to be definitively demonstrated, there is recent evidence that RM might be associated with a reduction of inappropriate ICD shocks [20]; emergency department or urgent in-office visits for heart failure, arrhythmias, or ICD-related events [21]; and even mortality [9]. Such potential clinical benefit might be explained by early detection of critical events: in the CON-NECT trial [11], the median time from clinical event to clinical decision per patient was reduced from 22 days in the control group to 4.6 days in RM group.…”

“…Moreover, these adverse events detected by RM are often silent [5] and, in the case of AF, occurred in about 30 % of the patients as new onset AF [23]. Such early diagnosis may reduce the rate of hospitalization and/or length of in-hospital stay [11], decrease the incidence of strokes [26,27], and reduce the number of inappropriate shocks causing early depletion of ICD therapy [20,22]. Such clinical benefit may result in an additional and even more important reduction of overall healthcare resource consumption, making RM economically attractive.…”

Ocena liczby i adekwatności interwencji, częstości programowania kardiowerterów-defi brylatorów oraz zmian farmakoterapii u pacjentów z kardiomiopatią rozstrzeniową w prewencji pierwotnej nagłego zgonu sercowego

“…Considering that the number of patients with implantable devices is increasing, there are attempts being made to include these patients in remote monitoring systems (RM). The most debatable issue concerning RM is safety issue, especially in the case of ICDs and CRT-D. Guédon--Moreau et al [23] in the ECOST trial confirmed the safety and effectiveness of RM of patients with ICDs. Moreover, patients controlled by RM had significantly lower incidence of NI and INAI and up to 72% less hospitalizations.…”