Remote Healthcare

Efficacy of Remote Monitoring as a Function of CIED Type

Niraj Varma, MD, PhD
Cleveland Clinic 
Cleveland Ohio

Niraj Varma, MD, PhD
Cleveland Clinic 
Cleveland Ohio

Novel embedded technologies have created the ability for devices to monitor their own function, record arrhythmias and other physiological parameters, and to communicate this information to healthcare providers without active participation of the patient (Figure 1).1 Automatic wireless remote monitoring (RM) of this form, first developed in 2001, is preferred to conventional in-person follow-up since it offers not only convenience to patient and clinic alike, but also the capability of early detection and notification of changes in device or disease status. Recent recommendations indicate that RM should be employed to follow-up all CIED types.2 However, analysis of contemporary practice shows that a large proportion of RM-incapable devices are implanted.3,4 Even when devices are RM capable, then RM function is disabled.3-5 Several factors may influence the use of RM in practice, including availability and perceptions about the advantages of particular devices in specific sets of patients. 

The most comprehensive data for RM exists for patients with ICDs. Several large, prospective randomized trials have shown consistent effects (Figure 2). In the TRUST trial, RM reduced scheduled and unscheduled hospital evaluations by 50% without compromising safety (no increase in the incidence of death, strokes, or events requiring surgical interventions). In addition, RM also shortened the time to detection of arrhythmic events to a median of 1 day, compared to more than 30 days with quarterly conventional care. The CONNECT study showed the median time from clinical event to clinical decision per patient was reduced from 22 days in the in-office arm to 4.6 days in the remote arm (P<0.01).6 ECOST endorsed the safety of extended RM over a period of 24 months.7 The EVOLVO study showed that the rate of emergency department or urgent in-office visits was 35% less in the RM arm than the IPE arm.8 Furthermore, there was a 21% reduction in the rate of total healthcare visits for heart failure, arrhythmia, or ICD-related events. 

Regarding device function, the ECOST study9 evaluated ICD therapy events as a pre-specified secondary endpoint and reported a significant reduction in inappropriate therapy in patients assigned to the RM arm. Over 27 months, the incidence of inappropriate shocks was 5.0% in patients randomized to RM compared to 10.4% in the standard group (P=0.04). This was largely mediated by pre-emptive action taken on early notification of RM. Overall, 14.5% of shocks were inappropriate in the remote group compared to 43% in the control group (P<0.001). All causes of inappropriate shocks including supraventricular tachycardia, noise oversensing, lead dysfunction, and T-wave oversensing were lower for RM. System integrity issues were better reported by RM than conventional care.10

Patients with pacemakers are less likely to use automatic RM. Conventionally, these devices have been remotely interrogated (as opposed to monitored) with transtelephonic monitoring. However, this requires patient activation and coordination with the clinic, itself time consuming and vulnerable to missed appointments, and conveys very limited data (Figure 1). Early detection of asymptomatic events is not possible. In contrast, automatic RM offers several advantages. Thus, RM reduced the need for in-clinic assessments yet accelerated time to problem detection in the COMPAS trial.11 While issues with system integrity (e.g., lead failure) are less frequent with pacemakers than defibrillators, these need to be equally and carefully monitored (e.g., many patients are pacemaker dependent). Lead issues can be notified within 48 hours with RM. (These results contrast significantly with patient-activated transmissions with TTM. For instance, problem detection took a mean of >5.7 months in the PREFER trial.12) Similarly, automatic RM permitted early detection of clinically actionable arrhythmias such as atrial fibrillation (AF), permitting prompt intervention with anticoagulation, for example. Automatic RM was associated with reduced hospitalizations for AF and related strokes in the COMPAS trial (i.e., a direct effect on patient outcome). Prospective registry data support the benefits of RM on patient outcome (Figure 3). One mega-cohort analysis showed that survival in patients receiving RM-capable pacemakers correlated positively with intensity of RM usage.4 

There is great interest in using the early detection capabilities of RM for managing disease states. However, RM has had inconsistent effects in heart failure. Registries have indicated reduction in hospital readmission rates, but this has not been confirmed in recent randomized trials (IN-TIME13, OptiLink14, MORE-CARE15). However, IN-TIME showed reduced mortality in patients with ICDs and CRT-Ds randomized to RM. CONNECT showed reduced duration of hospital stay in patients with RM.6 Differences in results may be due to differences in patient characteristics, type of RM used (e.g., daily frequency vs weekly), and parameters followed.16,17 Registry data show improved survival with greater intensity of follow-up4 (Figure 3). One large randomized trial testing the use of a remotely monitored implantable pulmonary artery hemodynamic sensor (not linked to an implantable device) showed that pre-emptive intervention reduced HF hospitalization by 37%,18 and this extended to reducing 30-day readmissions.19 

AF occurs commonly across the spectrum of implantable devices. This arrhythmia may be well quantified and described by RM, as demonstrated by several observational20,21 and randomized trials in both pacemaker and ICD patients.6,11,22 Most RM mechanisms signal arrhythmia onset with a transmitted electrogram, which may be used to confirm the diagnosis. RM has a sensitivity of nearly 95% for true AF detection.23 Since as many as 90% of atrial fibrillation episodes are asymptomatic, alert notification has particular value for AF detection. Implantable loop recorders (ILRs) serve an important role in detecting infrequent arrhythmias and in the evaluation of syncope. However, storage capacity is limited and data are prone to be overwritten, erasing potentially important diagnostic data. RM-enabled ILRs overcome these limitations and facilitate early diagnosis by providing daily automatic as well as patient-activated transmissions. Although used to detect AF in patients with cryptogenic stroke, interventional strategies based upon the RM function of ILRs has yet to be evaluated.24 Although there was benefit of RM among pacemaker patients in the COMPAS trial, early intervention with anticoagulation has not shown improvement in stroke rates in ICD patients.25 However, among ICD/CRT-D patients, early AF detection may permit pre-emptive intervention to avoid inappropriate therapy, heart failure, and loss of CRT. 

Generally, CIED follow-up is erratic (e.g., only a small fraction of patients with ICDs were seen in person during the first year post implant26), likely reflecting the simple logistical hurdles of managing routine follow-up of a large patient volume. As discussed above, many trials have shown the superiority of RM for achieving the follow-up goals of patient adherence to structured follow-up protocols and improvement in device clinic efficiency,27 as well as the value of early detection. Therefore, the modest adoption of RM is surprising. Reluctance to use RM may reflect the organizational changes required in follow-up facilities to most effectively implement RM and handle the data communicated by remote monitoring.5 Significantly, RM prescription may depend on the patient. Patients at low risk (e.g., with a pacemaker) are thought not to gain benefit. At the other end of the spectrum, some patients are thought to be “too sick” to be managed remotely.3 In either case, data indicate otherwise: advantages of RM extend across the spectrum of CIEDs, from pacemakers to CRT-Ds, regarding follow-up efficiency and early detection of disturbances in system integrity and device function (Class 1A recommendation).2 In addition to clinical efficiencies, patient satisfaction with RM is high due to diverse aspects, including relationship with the healthcare provider, ease of use, psychological impact, reduced costs of travel, time off from work, and interruption of daily activities.28 In this author’s opinion, all patients receiving CIEDs should receive devices capable of automatic RM.

Disclosures: Dr. Varma has no conflicts of interest to report regarding the content herein. Outside the submitted work, he reports receiving grants and personal fees from Medtronic, St. Jude Medical, BIOTRONIK, and Sorin (LivaNova).    

References

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