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Remote monitoring (RM) permits home interrogation of implantable cardioverter defibrillator (ICD) and provides an alternative option to frequent in-person visits.
The Italia-RM survey aimed to investigate the current practice of ICD follow-up in Italy and to evaluate the adoption and routine use of RM.
An ad hoc questionnaire on RM adoption and resource use during in-clinic and remote follow-up sessions was completed in 206 Italian implanting centers.
The frequency of routine in-clinic ICD visits was 2 per year in 158/206 (76.7%) centers, 3 per year in 37/206 (18.0%) centers, and 4 per year in 10/206 (4.9%) centers. Follow-up examinations were performed by a cardiologist in 203/206 (98.5%) centers, and by more than one health care worker in 184/206 (89.3%) centers. There were 137/206 (66.5%) responding centers that had already adopted an RM system, the proportion of ICD patients remotely monitored being 15% for single- and dual-chamber ICD and 20% for cardiac resynchronization therapy ICD. Remote ICD interrogations were scheduled every 3 months, and were performed by a cardiologist in 124/137 (90.5%) centers. After the adoption of RM, the mean time between in-clinic visits increased from 5 (SD 1) to 8 (SD 3) months (
In current clinical practice, in-clinic ICD follow-up visits consume a large amount of health care resources. The results of this survey show that RM has only partially been adopted in Italy and, although many centers have begun to implement RM in their clinical practice, the majority of their patients continue to be routinely followed-up by means of in-clinic visits.
Remote monitoring (RM) has been developed in order to handle the increasing number of patients with implantable cardiac devices, and who therefore require follow-up visits. Indeed, follow-up visits of implantable cardiac devices are the most frequent activities performed at arrhythmia services [
RM systems include a patient monitor that, using radiofrequency telemetry, allows data transmission without patient intervention. The patient’s information is sent to a secure network server via the telephone connection. The clinical staff can review device information on a secure Internet-accessible website. These systems provide full device interrogation, monitoring for arrhythmias, and surveillance of device performance from the patient’s home. Moreover, RM systems can alert the physician via phone or email, in the case of programmable parameters, about clinical or device issues. RM has many potential benefits, both for the patient and for the follow-up center. Indeed, it was shown to detect events more quickly and more frequently [
RM systems are currently available for almost all makes of implantable cardioverter defibrillator (ICD) and have been operational in Europe for about 10 years.
To date, only few and contradictory data were presented on the actual adoption of RM in routine clinical practice in Italy and Europe [
There were 206 Italian centers implanting ICDs that replied to an
A complete list of participating centers is reported in
The centers were asked to describe their practice of ICD follow-up. Specifically, they reported on the actions performed during routine device follow-up, the time required for follow-up examinations, the involvement of health care personnel, the interval between scheduled follow-up visits, and their use of RM. The complete list of survey questions is listed below.
Routine ICD follow-up:
Number of ICD patients in follow-up (single-, dual-chamber, CRT-D)
Number of routine in-clinic visits per year
Mean duration of in-clinic visits (single-, dual-chamber, CRT-D)
Number and type of health care personnel involved in in-clinic visits
Proportion of visits with ICD reprogramming
Clinical evaluation performed at the time of routine ICD follow-up
Presence of a structured heart failure management program in the center
Adoption and routine use of RM:
Number of ICD in remote follow-up (single-, dual-chamber, CRT-D)
Number of routine in-clinic visits per year in RM patients
Frequency of scheduled remote interrogations
Number and type of health care personnel involved in remote visits
Continuous data are expressed as means (standard deviations) or medians and interquartile ranges. Categorical data are expressed as percentages. Differences between mean data were compared by means of a
Volume of de novo implantations in the 432 Italian ICD implanting centers and the 206 Italia-RM survey centers in 2011 (published data from the national AIAC Registry).
The frequency of routine in-clinic visits was 2 per year in 158/206 (76.7%) centers, 3 per year in 37/206 (18.0%) centers and 4 per year in 10/206 (4.9%) centers.
Follow-up examinations were performed by a cardiologist in 203/206 (98.5%) centers and by more than one health care worker in 184/206 (89.3%). In 133/206 (64.6%) survey centers, the patient’s clinical status was not assessed during routine in-clinic follow-up, these visits being devoted exclusively to checking the ICD. In 75/206 (36.4%) centers, ICD patients were included in structured heart failure management programs. The reported duration of in-clinic follow-up visits was 15 (SD 7) minutes for single-chamber ICD, 16 (SD 8) minutes for dual-chamber ICD, and 20 (SD 9) minutes for cardiac resynchronization therapy ICD (CRT-D). Device reprogramming was required in (10%) (25th-75th percentile: 7-20) of visits.
There were 137/206 (66.5%) responding centers that had already adopted an RM system for remote ICD interrogation.
In centers currently using RM systems, the proportion of ICD patients remotely monitored was 15% (25th-75th percentile: 5-30) for single-chamber ICD, 15% (25th-75th percentile: 5-35) for dual-chamber ICD, and 20% (25th-75th percentile: 10-42) for CRT-D. Remote ICD interrogations were scheduled every 3 months (25th-75th percentile: 1-3), and were performed by a cardiologist in 124/137 (90.5%) centers (
Frequency of scheduled in-clinic follow-up visits in relation to ICD implantation volume.
Current RM utilization, stratified by ICD implantation volume.
The results of the Italia-RM survey confirm that, in current clinical practice, in-clinic ICD follow-up visits consume a large amount of health care resources. Internet-based RM is becoming a new standard for the follow-up of patients with active implantable cardiac devices [
A joint European Heart Rhythm Association (EHRA)-Eucomed survey [
In agreement with these findings, we ascertained that 184/206 (89.3%) of follow-up visits involved two staff members, and that a cardiologist attended 203/206 (98.5%) of examinations. By contrast, in the majority of survey centers, clinical evaluation by physicians was not performed at the time of routine device follow-up, although recommendations suggest that the clinical status of the patient should be reviewed during follow-up, as it may influence subsequent management [
Interestingly, it was recently demonstrated that patients who did not undergo clinical examination during device follow-up visits had a better attitude towards RM and were more appreciative of its timesaving advantage [
In 2010, an EHRA survey measured the use of RM in 61 European centers in 15 countries [
The Italia-RM nation-wide survey analyzed the practice of ICD follow-up and the current use of RM systems in a large number of implanting centers in Italy. The participating centers represent about half of the Italian implanting centers and performed 5534/8998 (61.50%) of all ICD implantation procedures in 2011. Moreover, the participating centers displayed wide variability in the volume of procedures and were well distributed throughout the country.
Our analysis showed that RM systems have so far been adopted by 137/206 (66.5%) of centers for remote ICD interrogation. In each center, the median proportion of patients remotely monitored ranged from 15% of single-chamber ICD to 20% of CRT-D. The more frequent use of RM in CRT-D may be explained by the need to monitor sicker patients with greater continuity. Nonetheless, a recent analysis of the actions taken during in-clinic follow-up examinations suggested that the lower incidence of visits eliciting clinical or device-related action in the single- or dual-chamber ICD population should encourage the use of RM in these patients [
In our survey, device reprogramming was reported to be necessary in 10% of visits. Similarly, Mascioli et al [
In general, RM may be timesaving for scheduled, nonactionable transmissions, while transmissions with clinically important findings and poor patient compliance have considerable workflow implications [
In accordance with recommendations [
The first reports on RM systems for the remote interrogation of ICD patients in Europe date back to around 10 years ago. Nonetheless, the results of the present survey show that it has only been partially adopted in Italy and that the majority of ICD patients continue to be followed-up by means of routine in-clinic visits.
Ostensibly, RM is more attractive for high-volume centers, where arrhythmia services may be overcrowded. Moreover, within each center, RM may be preferentially allocated to patients undergoing
Appropriate reimbursement by health care systems and insurance companies, which is currently lacking in Italy and other European countries, is critical to stimulating the widespread adoption of RM [
In conclusion, in-clinic ICD follow-up visits currently consume a large amount of health care resources. Internet-based RM has been developed as a cost-effective solution for the management of patients with implantable cardiac devices. However, we showed that RM has only partially been adopted in Italy and, although many centers have begun to implement RM in their clinical practice, the majority of their patients continue to be routinely followed up by means of in-clinic visits.
A complete list of participating centers.
Italian Society of Arrhythmology and Pacing
cardiac resynchronization therapy ICD
European Heart Rhythm Association
implantable cardioverter defibrillator
remote monitoring
The authors wish to thank Luca Stefanini (Boston Scientific Italy) for his valuable contribution to the manuscript finalization.
Francesco Accardi and Sergio Valsecchi are employees of Boston Scientific, Inc. Boston Scientific manufactures and sells implantable cardiac devices and RM systems.