Usefulness of remote monitoring for the early detection of back-up mode in implantable cardioverter defibrillators.

BACKGROUND: Reversion of an implantable cardioverter defibrillator (ICD) to back-up mode degrades the operating capabilities of the device, puts patients at risk and requires rapid intervention by a manufacturer's technician. AIM: To illustrate the usefulness of remote monitoring of ICDs for the early detection of reversion to back-up mode. METHODS: In our centre, all patients implanted with an ICD, with or without resynchronisation, were offered remote monitoring as soon as the technology became available. Alerts triggered by the remote monitoring system were included prospectively in a register. During a mean follow-up of 5.7±1.3 years, a total of 1594 patients with an ICD (441 with resynchronisation function) followed with remote monitoring were included in the register. RESULTS: Among 15,874 alerts, only 10 were related to a reversion to back-up mode. Among those, seven reversions were caused by radiotherapy, two were fake events and one was caused by magnetic resonance imaging. Except for the two fake events, the eight other patients had an emergency admission for the resetting and reprogramming of their ICD. None of the reversion to back-up mode alerts was followed by a clinical alert (i.e. a shock alert) before the ICD problem was resolved. CONCLUSIONS: Reversion to back-up mode is a very rare event, accounting for 0.06% of total alerts; remote monitoring facilitates the early detection of this critical event to resolve the problem faster than the next scheduled follow-up. Remote monitoring can prevent serious damage to the patient and avoids systematic ambulatory control of the ICD after each radiotherapy session.

A report on the impact of remote monitoring in patients with S-ICD: Insights from a prospective registry.

INTRODUCTION: Several clinical studies have demonstrated that remote monitoring (RM) offers potential benefits in transvenous implantable cardioverter defibrillator (ICD). The potential interest of RM in subcutaneous-ICD (S-ICD) recipients has never been evaluated. The aim of this study was to evaluate the alert burden and its clinical relevance in a prospective cohort of S-ICD recipients. METHODS: We prospectively and consecutively enrolled all patients undergoing S-ICD implantation at Lille University Hospital from September 2015 to January 2017 and gave them a LATITUDE™ NXT RM system. The relevance of transmissions was assessed by the following ratio: number of transmissions leading to reaction or intervention per patient/number of transmissions per patient. RESULTS: From September 2015 to January 2017, 69 patients were enrolled with a mean follow-up of 415 ± 96.3 days. The mean age was 44.6 ± 15.6 years old, and 25% (n = 17) had ischemic cardiomyopathy. At the end of follow-up, 12% of the patients had events recorded by RM. These events were related to nine ICD shocks and eight untreated events. A total of 1,423 transmissions were collected. Most of these transmissions were patient-initiated without any event (77%, n = 1,096) or scheduled without any event (19%, n = 272). Only 3.2% ± 1.1 of the transmissions per patient led to reactions or interventions. CONCLUSION: On the basis of the current method of transmitting, S-ICD RM allowed detection of relevant events in 12% of patients but generated a high unactionable transmission burden. As a result of these findings, efforts should be made to optimize transmissions considering automatic transmissions and to focus on patient education.

[Telemonitoring by the nurse of patients equipped with an implantable heart device]. / Télésuivi par l'infirmière des patients porteurs d'un dispositif cardiaque implantable.

The nurse is at the heart of the caregiving relationship in the remote monitoring of patients with heart failure equipped with an implantable device. Her direct contact with the patient erases the distance imposed by telemonitoring and her close connection with the cardiologist-arrhythmia specialist ensures the patient follow-up is optimal. After her training in telemedicine, the nurse plays a key role in the telerhythmology activity.

Impact of remote monitoring on reducing the burden of inappropriate shocks related to implantable cardioverter-defibrillator lead fractures: insights from a French single-centre registry.

AIMS: Lead fractures in implantable cardioverter-defibrillator (ICD) patients may cause inappropriate shocks (ISs). An early diagnosis is essential to prevent adverse clinical events. Implantable cardioverter-defibrillator remote monitoring (RM) permits prompt detection of lead fracture. Limited data define the impact of RM on ISs specifically related to lead fracture. We sought to compare the number of ISs related to lead fracture in patients with vs. without RM follow-up. METHODS AND RESULTS: We checked the registry of our institution and collected, between July 2007 and June 2014, 115 cases of right ventricular lead fractures. All relevant data were documented from patients' files, device-interrogation printouts and electronic records, and remote transmissions databases when applicable. We assessed the ISs that were related to lead fracture. The first study endpoint was the number of ISs per shocked patient. Among the 82 patients with conventional follow-up (CFU) and the 33 patients with RM, a first IS occurred to 32.9% (n = 27) and 30.3% (n = 10, P = 0.83) of the patients, respectively. Shocked patients in the RM group underwent significantly fewer ISs with a mean of 6 ± 2 shocks per patient [median of 3.5 shocks (2-8)] than those in the CFU group with a mean of 18 ± 5 shocks per patient [median of 10 shocks (5-22), P = 0.03]. CONCLUSION: Remote monitoring helps to reduce the burden of ISs related to ICD lead fractures.

Potential role of antitachycardia pacing alerts for the reduction of emergency presentations following shocks in patients with implantable cardioverter-defibrillators: implications for the implementation of remote monitoring.

AIMS: Despite increased use of remote monitoring (RM) to follow up implantable cardioverter-defibrillator (ICD) recipients, many patients still receive ICD shocks in the community and present to the emergency department. Our aim was to identify the best predictors of impending shock delivery that can be measured with an ICD and to identify the most appropriate activities to alert physicians to during RM follow-up. METHODS AND RESULTS: All patients presenting to our institution for ICD shock, from November 2011 to November 2014, were enrolled in this prospective study. Patient characteristics, investigation results, and details of electrical activities from ICD interrogation were recorded at presentation. Presentations were classified as potentially avoidable if activities from a list of set criteria were apparent more than 48 h before index shock. Univariate and multivariate analyses were then used to identify predictors of potentially avoidable shocks. In total, 109 emergency presentations were recorded in 90 patients (male: 85%; 57 ± 16 years; ischaemic cardiomyopathy: 49%; LVEF: 34 ± 13%; electrical storm: 40%), of which 26 (24%) were potentially avoidable. Antitachycardia pacing (ATP) episodes were the most important predictor of impending shock. Potentially avoidable shocks were preceded by more episodes of ATP than unavoidable shocks (13 [3-67] vs. 3 [0-10]; P < 0.001). Patients followed up with RM systems configured to generate alerts following ATP delivery experienced significantly less ICD shocks (24 vs. 16%, P < 0.01). CONCLUSION: Remote monitoring systems that generate alerts following ATP delivery could reduce emergency presentations for ICD shock by 24%, as ATP is a key predictor of impending shock delivery.

Validation of an Organizational Management Model of Remote Implantable Cardioverter-Defibrillator Monitoring Alerts.

BACKGROUND: Implantable cardioverter-defibrillators (ICDs) are a standard means of sudden cardiac death prevention. Compared with ambulatory visits, remote monitoring (RM) of ICD recipients has improved the quality of health care and spared its resources. Few studies have addressed the organization of RM. We optimized and validated our institutional model of RM organization for ICD recipients. METHODS AND RESULTS: This observational study of 562 ICD recipients compared 2 RM periods consisting of iterative, qualitative, and quantitative (1) device diagnostic evaluations by nurses and cardiologists; and (2) selected decisional trees. The main study end points were the professional interventions prompted by, and times allocated to, RM alerts. During the first period, 1134 alerts occurred in 427 patients (286 patient-year), of which 376 (33%) were submitted to cardiologists' reviews, compared with, 1522 alerts in 562 patients (458 patient-year), of which 273 (18%) were submitted to cardiologists' reviews during the second period (P<0.001). An intervention was prompted by 73 of 376 (19.4%) alerts in the first versus 77 of 273 (28.2%) in the second period (P=0.009). The mean time to manage an alert was 4 minutes 31 s in the first versus 2 minutes 10 s in the second period (P<0.001). The annual numbers of alert-related hospitalizations were 10.8 versus 8.1 per 100-patient-year (P=0.230), and annual numbers of alert-related visits were 9.8 and 6.1 per 100-patient-year (P=0.081), respectively. CONCLUSIONS: An optimized RM organization based on automated alerts and decisional trees enabled a focus on clinically relevant events and a decrease in the consumption of resources without compromising the quality of ICD recipients' care.

Remote monitoring of patients with implantable cardioverter-defibrillators: can results from large clinical trials be transposed to clinical practice?

BACKGROUND: Remote monitoring (RM) is increasingly used to follow up patients with implantable cardioverter-defibrillators (ICDs). Randomized control trials provide evidence for the benefit of this intervention, but data for RM in daily clinical practice with multiple-brands and unselected patients is lacking. AIMS: To assess the effect of RM on patient management and clinical outcome for recipients of ICDs in daily practice. METHODS: We reviewed ICD recipients followed up at our institution in 2009 with RM or with traditional hospital only (HO) follow-up. We looked at the effect of RM on the number of scheduled ambulatory follow-ups and urgent unscheduled consultations, the time between onset of asymptomatic events to clinical intervention and the clinical effectiveness of all consultations. We also evaluated the proportion of RM notifications representing clinically relevant situations. RESULTS: We included 355 patients retrospectively (RM: n=144, HO: n=211, 76.9% male, 60.3±15.2 years old, 50.1% with ICDs for primary prevention and mean left ventricular ejection fraction 35.5±14.5%). Average follow-up was 13.5 months. The RM group required less scheduled ambulatory follow-up consultations (1.8 vs. 2.1/patient/year; P<0.0001) and a far lower median time between the onset of asymptomatic events and clinical intervention (7 vs. 76 days; P=0.016). Of the 784 scheduled ambulatory follow-up consultations carried out, only 152 (19.4%) resulted in therapeutic intervention or ICD reprogramming. We also found that the vast majority of RM notifications (61.9%) were of no clinical relevance. CONCLUSION: RM allows early management of asymptomatic events and a reduction in scheduled ambulatory follow-up consultations in daily clinical practice, without compromising safety, endorsing RM as the new standard of care for ICD recipients.