Remote follow-up of pacemakers in a selected population of debilitated elderly patients

Abstract

Aims

The majority of patients with pacemakers are very elderly, many being >85-years old. They often suffer from serious illnesses and have great difficulty in walking. The aim of our study was to compare remote pacemaker monitoring with in-home checks of pacemakers, in terms of applicability, efficacy, and cost in a selected population of debilitated elderly patients.

Methods and results

We selected 72 subjects (mean age 87 ± 8 years) among elderly debilitated patients with Medtronic pacemakers, compatible with the Carelink^® remote monitoring system (13 patients with DDD pacemaker; 59 patients with single-lead VDD pacemaker). Remote follow-up was compared with in-home checks performed by nurses in 326 patients in similar clinical conditions. A total of 190 transmissions were received by remote monitoring (mean transmissions per month: 7.0; mean per patient: 2.6; range 1–6) during 27 months of follow-up. In this period, seven pacemakers were replaced owing to battery exhaustion, after a mean of 6.7 years from implantation. The occurrence of atrial or ventricular high-rate episodes was reported in 98 transmissions (53%). Nineteen patients died (annual mortality: 11.7%). On comparing the costs borne by the hospital for in-home checks, both for medical personnel and transportation, the estimated average saving was €32 per year per patient.

Conclusion

Our study shows that the remote follow-up of pacemakers is a reliable, effective, and cost-saving procedure in elderly, debilitated patients. Moreover, remote controls provided an accurate and early diagnosis of arrhythmia occurrence.

Introduction

The majority of pacemaker patients are elderly people. In Italy, it is estimated that the mean age of patients with pacemakers is 76 years.¹ However, there is also a subpopulation of very elderly subjects (>85 years of age). These patients suffer from various co-morbidities and are often unable to walk or do so with extreme difficulty.

For these patients, travelling to the hospital for periodic pacemaker follow-up involves considerable physical and psychological disruption and long waiting times, and often requires transport by ambulance. The management of patients who need stretcher or wheelchair transport also constitutes a considerable organizational challenge for the centre. Moreover, these problems are associated with high costs for patients and their families and for the National Health System (NHS), both for transport itself and for the time required for the visit and waiting intervals.

To overcome the difficulties of transporting these patients, our department has organized a pacemaker in-home control service run by nurses. However, for logistical and organizational reasons, this has the disadvantage that only a limited number of daily controls can be performed.²

In recent years, many manufacturers have developed remote follow-up systems for pacemakers and implantable cardioverter defibrillators, which are capable of transmitting a complete set of data of the stimulator functions.^3–6 Various studies have demonstrated that these systems are reliable and that they can effectively replace ambulatory checks.⁷

On the other hand, not all of these systems use fully automatic data transmission; some require the direct intervention of the patient in the procedures of device interrogation and data transmission. Although these procedures are simple, older patients may have practical difficulties in instrument management and require the assistance of a caregiver.

The aim of our study was to compare the applicability and costs of a system for remote follow-up of pacemakers in a selected population of debilitated, very elderly patients with in-home checks performed by nurses.

Patients and methods

The study group for remote follow-up comprised consecutive subjects selected on the basis of the following inclusion criteria: severe limitation in walking; need for ambulance transport to hospital for pacemaker follow-up; implantation of pacemakers compatible with the Carelink^® remote monitoring system; availability of a telephone landline; life expectancy >6 months.

Seventy-two subjects (19 males, 53 females; mean age 87 ± 8 years; range 73–98) were finally included.

A group of 326 consecutive patients in a similar clinical condition served as a control population. These patients were implanted with devices not compatible with any system of remote follow-up and were therefore followed up by means of in-home checks performed by nurses.

Overall, about 2500 patients are referring to our pacemaker clinic. Therefore, those unable to reach the clinic and requiring a remote follow-up are about the 15% of our entire cohort.

Follow-up data were collected prospectively. The protocol was submitted and approved by our internal ethics review board; the patients signed an informed consent.

Clinical features of the patients are detailed in Table 1.

In-home controls

Nurses made home visits at various intervals, according to the estimated longevity of the patient's pacemaker. During each visit, the patient underwent standard electrocardiogram (ECG), with and without a magnet, by means of a portable electrocardiograph; data were saved on a solid memory (Prima ECG, ET medical devices, Vignate, Italy) so that the ECG could be transmitted trans-telephonically if consultation with the electrophysiologist was urgently needed. Moreover, the stimulation intervals (cycle length, atrial and ventricular pulse width, AV delay, with and without magnet) were acquired by a Miniclinic^TM pacemaker monitor (9513, Medtronic, Minneapolis, MN, USA).

Only in those patients with a Biotronik pacemaker the in-home assessment was made by means of a portable programmer (ICS 3000, Biotronik, Berlin, Germany). The decision to limit the use of the programmer to Biotronik pacemakers was made because it is the only available instrument small enough to be carried easily.

The residual longevities of the pacemakers were estimated on the basis of the theoretical longevity and magnet period for all but the Biotronik devices, the longevity of which was estimated by the programmer.

Electrocardiograms and technical data were archived electronically and evaluated at the hospital by an electrophysiologist; a report was generated and sent to the patient's home by mail.

Remote follow-up

The remote monitoring service assessed in this study, called Medtronic CareLink^® Network (Medtronic), is a telemedicine system designed to assist clinicians in the management of patients with implantable cardiac devices, pacemakers, and defibrillators; it consists of two primary components, through which patients and clinicians interact: a patient monitor powered by batteries and plugged into a standard analogue telephone connection for use, and a lightweight wand to communicate with the implanted device; and an Internet-accessible website, where clinicians can monitor the condition of patients by securely viewing the physiological data transmitted.

To interrogate the pacemaker and transmit the data, the patient places the wand over the implanted device. The patient has to await completion of the interrogation and transmission sequences, the progress of which is indicated by a led display. The patient's information is sent to a secure network server via the telephone connection. It is not possible to remotely reprogramme the implanted device. Clinical staff can review device information on a secure website via the Internet. The data provided are equivalent to those which can be retrieved during an in-office visit: presenting rhythm, automatic device diagnostic data, and stored ECGs.

Once the data have been received at the centre, they are examined by an electrophysiologist, who prepares a final report and establishes the date when the subsequent transmission should be made. In the present study, transmissions were scheduled every 6 months when the expected longevity of the pacemaker was >18 months, otherwise after one-third of the minimum expected longevity.

The transmitter was delivered to the patient's home by a trained nurse and, on that occasion, the patient, his/her family members, and other caregivers were taught how to operate it. On the same occasion, the first transmission was made.

The settings for data collection in Medtronic devices were programmed as follows: for atrial high-rate episodes, when mode switch is programmed ‘On,’ the mode switch detection criteria are used, if mode switch is ‘Off,’ the rate/duration criteria was 180 b.p.m. for 5 s; for ventricular high-rate episodes, the rate/duration criteria was 180 b.p.m. for 5 s.

Cost analysis

To evaluate the economic impact of the in-home programme compared with remote follow-up by Carelink network, the costs from the points of view of hospital and NHS were considered for all the follow-up period.

The hospital costs included time spent by hospital staff for in-home visits and for remote follow-up. Further, for in-home visits, the costs sustained by hospital staff for going to and coming from patients' home were computed.

The costs sustained from NHS include the tariff paid for in-home visit and for remote follow-up. No other costs are sustained directly by NHS. The unit costs are described in Table 2.

Patients and society point of view were not considered because they do not sustain any cost either for in-home or remote follow-up.

Costs are expressed in Euro, based on year 2010.

Statistical analysis

Categorical variables are expressed as numbers and percentages. Continuous variables are expressed as mean ± SD. The χ² test for independence was used to measure differences between in-home and Carelink pacemaker checks for categorical variables. Differences between groups of single measures were analysed for variance; normal distribution was verified by the Kolmogorov–Smirnov test; homogeneity of variances was verified by Levene's test. Statistical significance was assumed with a level of P < 0.05.

STATISTICA software (StatSoft Inc. Tulsa, OK, USA) version 9.0 was used for the statistical analyses.

Results

In-home controls

During the 27 months of follow-up, 936 checks were performed by two nurses in the five districts of the Local Healthcare Service in the metropolitan area of Padua, Italy. Each nurse devoted ∼9 h per week to this programme. The average distance travelled by the nurses was 138 km per week.

The mean number of controls per month was 35 ± 10 (mean control per patient per year: 1.3). The number of assessments peaked in spring and autumn; the fewest visits occurred in August.

The maximum delay of an in-home visit, in relation to the planned date, was 16 days.

Twenty-four pacemakers were replaced owing to battery exhaustion after a mean of 8.3 years (range 5.3–13.4 years) from implantation; only two of these patients displayed a significant presence of spontaneous rhythm. Six of the devices replaced had reached the ‘elective replacement indicator’ (ERI) at the time of replacement. The others had a predicted ERI within 4 months. No patients reached ‘End of Life’ indicator.

During follow-up, 61 patients died (8.3% annual mortality).

Two patients (incidence 0.6%) were called in for in-hospital evaluation to improve device function (new onset of atrial fibrillation in DDD/VDD); the problem was solved solely by reprogramming. No major malfunctions of devices or leads occurred (Table 3).

Remote follow-up

Remote follow-up provided a complete set of information, as is usually obtained by a programmer and two ECG strips: during spontaneous rhythm and magnet-induced asynchronous stimulation.

During 27 months of follow-up a total of 190 transmissions were received (mean transmissions per month: 7.0; mean per patient: 2.6). A considerable number of transmissions (98; 52%) contained notification of supraventricular and/or ventricular arrhythmic events (atrial high-rate episodes: 21, 21%; ventricular high-rate episodes: 45, 46%; atrial and ventricular high-rate episodes: 32, 33%).

In the case a significant arrhythmia was evidenced through remote follow-up, the event was communicated to patient's attending physician or referring cardiologist.

In follow-up period, seven pacemakers were replaced owing to battery exhaustion after a mean of 6.7 years from implantation, only one of which displayed a significant presence of spontaneous rhythm (>80% of spontaneous rhythm). Nineteen patients died (annual mortality 11.7%). No major malfunctions of devices or leads occurred (Table 3).

No patients refused remote checks. Only in one case the presence of the nurse at home was requested for transmissions. In three patients, transmissions failed owing to problems related to the telephone line. All three were residents in the same rest-home for the elderly, which had a radio-bridged connection to the phone line.

Cost analysis

The economic impact of the in-home programme was compared with that of remote follow-up from the hospital and NHS points of view.

With regard to the in-home pacemaker check-up, one nurse is engaged with the average time of 20 min for the visit and 1 h to go and to come from the patient's home. From the hospital point of view, computing also the time spent by physician to review patients data (10 min per patient per visit), the cost sustained for one visit is 31.12 € per patient. According to the regional ambulatory tariff, the NHS spends for each pacemaker check-up 25.65 € per patient (Table 4).

Considering the remote follow-up of pacemaker, one physician checks the transmissions received (cumulative time spent per patient per remote control by hospital staff: 14 min). The cost for the hospital is 5.04 € per transmission per patient. By the point of view of NHS, currently a specific tariff does not exist for remote control (Table 4). As consequence, comparing remote follow-up with in-home pacemaker control, the cumulative saving for hospital is €25.72 per patients per visit.

Carelink equipment was provided at no additional by Medtronic. The training of the patient and family took place during the last in-home visit performed by nurse.

In the cohort followed with remote follow-up no patient required to be assessed in the clinic. Therefore, no additional costs were considered in this regard.

Discussion

Our study aimed to assess the applicability of remote pacemaker follow-up in a specific population of very old people with walking difficulties and serious illnesses. The study revealed that the system is well accepted by patients and their families, and constitutes a reliable method of device follow-up. In addition, the use of this remote follow-up system has achieved a significant cost reduction, both for the NHS and for patients and their families.

The first aspect that we wanted to analyse was whether patients and their families were able to manage the transmission system, which, in the case of Medtronic Carelink^® for pacemakers, requires active intervention to start the process of pacemaker interrogation and data transmission. Requests for the assistance of trained nurses were minimal. Moreover, technical problems of communication were limited. Indeed, only in a very small number of cases did problems related to the phone line arise, and these were always due to the presence of a radio-bridged connection to the network.

The system provided detailed information on pacing function, and enabled battery longevity to be closely monitored. In very elderly and/or debilitated patients, the ability to precisely monitor residual battery life is particularly important. Indeed, as the time of elective replacement of the pacemaker approaches, in-home checks must be more frequent, owing to the limited accuracy of evaluating residual battery life on the basis of variations in magnet period alone. Moreover, postponing pacemaker replacement or reducing the number of replacements is strongly advisable in elderly patients, since replacement surgery, albeit not very traumatic, is not risk free, owing to co-morbidities, and concomitant medications, primarily antiplatelet or anticoagulant therapies.^8,9

In this study, important information was obtained from the diagnostic functions of the pacemaker, which enabled the patient's arrhythmic profile to be completely evaluated. Indeed, in a population of patients such as those in our study, the incidence of hyperkinetic arrhythmias, both supraventricular and ventricular, is higher.^10–12 The early accurate diagnosis of asymptomatic rhythm alterations, which would probably not be disclosed without the aid of pacemaker diagnostic systems, requires great effort and collaboration on the part of various health professionals. This diagnostic competence appears to be the most important distinguishing feature of remote control in comparison with home controls, when programmers are not utilized. To address the clinical problem of asymptomatic arrhythmias detected by remote follow-up, our procedures require that the attending physician or referring cardiologist must be informed of the event.

In this study, we did not evaluate the clinical utility of remote follow-up in the management of arrhythmic events. However, follow-up visits performed by nurses, without the use of a programmer, do not provide information on the occurrence of arrhythmic events. Therefore, from this point of view, the superiority of remote follow-up is well evident.

Although the first home visits by the nurse are sometimes viewed with suspicion by the elderly, once patients become familiar with the staff, this type of control tends to maintain a more tangible relationship between the medical personnel of the referring center and the patient. In contrast, remote follow-up diminishes human contact with the referring cardiologist. Nevertheless, it seems that patients appreciate the feeling of almost continuous contact with the hospital, even if the data are transmitted at a distance of months.

Remote monitoring systems have been evaluated in various studies and have been shown to reliably replace conventional ambulatory checks.^3,5,6 On the other hand, recent trials seems to have focused more on defibrillation systems^7,13 rather than pacemakers.¹⁴ While the close surveillance of high-risk patients justifies the use of remote monitoring systems, their use in patients with pacemakers can have a greater impact, because of the higher number of patients involved. Moreover, when applied in specific populations, such as that of our study, such systems can yield particular benefits.

The in-home check of pacemakers is not generally expensive,² particularly if we consider that the costs for the patient and society, in terms of caregivers' time, are eliminated. On the other hand, even though home visits are certainly more patient friendly, there are significant limitations on the quantity and quality of the technical data obtained, in comparison with remote follow-up. Moreover, only a limited numbers of in-home checks can be performed per day.

Clearly, patient monitoring by means of remote follow-up systems is very cheap.¹⁵ In this regard, however, it should be pointed out that remote checks are not coded and recorded in Italy at present; the costs to the NHS are therefore difficult to quantify for the future.

We could probably hypothesize that the tariff for NHS will be the same currently applied for ambulatory check. In this case, the saving would be by the hospital point of view.

However, it is foreseeable that in the future, when remote follow-up is uniformly accepted and codified, the cost to the NHS will be particularly low.

On the other hand, a heterogeneous scenario, concerning economic rules, widespread in many European countries.¹⁶

In conclusion, our study shows that remote pacemaker follow-up is a reliable, effective, well-accepted, cost-saving procedure in elderly, debilitated patients. The more accurate diagnosis of asymptomatic arrhythmias provided by these checks is very useful from a clinical point of view, but, at the same time, requires a greater commitment in the management of this population.

While the availability of a dedicated system for remote follow-up may now be a selection criterion for the implantation of a specific pacemaker, in the future it will certainly be so.

On the other hand, it is well evident that remote monitoring with wireless transmission would be particularly suitable for elderly patients, for the complete automatism of the operations.

Finally, it must be considered that, as the use of remote follow-up systems increases, the amount of data arriving at the centre will also increase. This new approach to the management of patients therefore requires significant reorganization of the ‘pacemaker clinic’ in terms of personnel and roles. This will probably lead to the increased involvement of nurses with greater responsibilities and new expertise in patient management.

Although this reorganization of nurses' roles could raise costs, the increase would largely be offset by savings in the time spent by medical staff.

Limitations of the study

Some aspects of our study deserve further consideration. First of all, the analysis was conducted in a relatively small population. However, it is in line with the percentage of this subset of pacemaker patients in the common clinical practice.

Furthermore, no clinical outcome has been evaluated in the two study groups as a consequence of the small sample size. Nevertheless, it is worth considering that the outcome analysis was not the aim of the study which was focused on the practical and economic feasibility of remote monitoring.

Finally, the analysis of the cost associated with conventional in clinic pacemaker follow-up was not performed; however, the comparison with the remote monitoring strategy assessed in our study would have been inappropriate since in-clinic follow-up is not the standard of care for the population involved in our study.

Conflict of interest: F.B. and J.C. are employees of Medtronic Italia.

References