By Werner Jung
Remote monitoring is the transmission of cardiovascular implantable electronic device (CIED) performance and patient data over a network from the patients’ home to their physician’s office. Data transfer can be automated or manual. Remote monitoring of cardiovascular implantable electronic devices involves the transmission of data regarding the status of the device, patient variables gathered by the device and sometimes additional disease-related data collected by the patient or caregiver (blood pressure and weight), over a network from the patient’s location via a central database to a hospital or physician’s office. Remote programming of devices, while technically feasible with existing systems, has not yet been implemented.
Patient acceptance and satisfaction
Safety and superiority concerning early detection of clinical events such as arrhythmia burden, implantable cardiac defibrillator therapies, and technical issues have been well documented for remote monitoring, whereas patient acceptance of this new principle has been less well documented and studies concerning patient acceptance have shown diverging results. One factor that might decrease patient compliance with remote monitoring is satisfaction. Although it has been assumed that patients would appreciate the convenience of remote follow-up, this has been questioned and might not be the case in all cultures, patient populations or at all times post-CIED implant. Published reports so far have dealt with ICD follow-ups, showing a high level of acceptance and satisfaction with remote monitoring over conventional in-office visits. A similar outcome was obtained by both the Finnish perspective study (Raatikainen et al, Europace 2008;10:1145–115), with the in-office visit needing a three-hour time consumption, and the CareLink Network study (Medtronic) (Marzegalli et al, PACE 2008; 31:1259-1264), where the preference for remote wireless monitoring peaked the level of 80% of patients. ICD recipient’s positive feedback on remote monitoring, as evaluated by a sophisticated poll (Ricci et al, Europace 2010;12:674-679), persisted in the long-term at a level of 96%.
In a pilot study of remote monitoring using the CareLink system versus standard in-office follow-up in patients implanted for a mean of 1.5 years at enrolment, health-related quality of life and patient satisfaction measures were worse at six months but the difference had disappeared by 12 months. It is possible that personal contact is important to satisfaction shortly after device implant and declines thereafter. Al-Khatib et al (J Cardiovasc Electrophysiol 2010;21:545-550) showed no difference in quality of life and patient satisfaction whereas Marzegalli found that 78% of the patients preferred remote follow-up to in-clinic visits. Ricci et al reported from a smaller population (119 patients with devices of which only 24 were ICD patients) and also found a high level of satisfaction, unrelated to age, gender, and type of device.
However, the vast majority of the evidence available to date indicates a high level of patient satisfaction with remote monitoring. Overall, 98% of the patients in the remote monitoring arm in the TRUST study from Biotronik (Varma et al, Circulation 2010;122:325-332) elected to continue this mode of follow-up after completion of the trial. Other studies reporting patient satisfaction in diverse populations with CareLink, Home Monitoring and Housecall II (the forerunner of Merlin.net, St Jude Medical) are universally positive, although each has used different methodologies. Physician satisfaction has also been high, where assessed. In a recent study (Petersen et al, J Interv Card Electrophysiol 2012;34:317–324), 95% of the patients were satisfied with the remote follow-up. Eighty-four per cent of the patients wished for a more detailed response and 21% wished for a faster reply after routine transmissions.
In a recent Italian survey (Gramegna et al, Europace 2012;14:345–350) of ICD outpatients, the inconvenience in attending scheduled in-hospital visits was assessed by a new questionnaire. Patients’ perceptions of in-hospital ICD visits were negatively affected by age and by travelling disadvantages. Individual factors seem to affect both opinions about in-office visits and expectations towards a possible remote follow-up. Thus, remote monitoring provides a tremendous convenience for patients and clinicians and reduces the cost of follow-up. Although the technology is not intended to replace direct patient contact completely, it can indeed release resources for other activities and help to maintain proactive patient care.
Remote monitoring platforms are marketed by all the major cardiovascular implantable electronic device manufacturers, including Medtronic (CareLink), St Jude Medical (Merlin.net), Boston Scientific (Latitude), Biotronik (Home Monitoring) and Sorin (SmartView). Traditional follow-up of CIEDs involves the intermittent download of largely non-actionable data. Remote monitoring represents a paradigm shift from episodic office-based follow-up to continuous monitoring of device performance and patient and disease state. This lessens device clinical burden and may also lead to cost savings, although data on economic impact are only beginning to emerge. Advantages include earlier detection of patient events such as arrhythmia onset and device therapy, programming issues such as therapies programmed off, and device integrity problems such as lead fracture and integrity, and possibly predict heart failure hospitalisations through integration of heart failure diagnostics and haemodynamic monitors. Remote monitoring platforms are also huge databases of patients and devices, offering unprecedented opportunities to investigate real-world outcomes. Remote monitoring is associated with patient and physician satisfaction. Data security appears to be robust. However, technical performance is not uniform across different proprietary technologies.
Remote monitoring reduces emergency department/urgent in-office visits and, in general, total healthcare use in patients with ICDs. Compared with standard follow-up through in-office visits and audible ICD alerts, remote monitoring results in increased efficiency for healthcare providers and improved quality of care for patients and in a high physician satisfaction and patient acceptance.
Werner Jung, Department of Cardiology, Academic Teaching Hospital of the University of Freiburg, Schwarzwald-Baar Klinikum, Villingen-Schwenningen, Germany