PORTLink Study - Portuguese Research on Telemonitoring with

CareLink®

Baseline and Preliminary Data of the Pilot Phase

Milene Fernandes

, Mário Oliveira

, João Primo

, Hipólito Reis

and Paulo Nicola

Institute of Preventive Medicine, Faculty Medicine, University Lisbon, Av. Prof. Egas Moniz, 1649-028 Lisboa, Portugal

Hospital de Santa Marta, Centro Hospitalar Lisboa Central, Rua de Santa Marta nº 50, 1169-024 Lisboa, Portugal

Centro Hospitalar Vila Nova de Gaia / Espinho, Rua Conceição Fernandes, 4434-502 Vila Nova de Gaia, Portugal

Hospital do Porto, Centro Hospitalar do Porto, Largo Prof. Abel Salazar, 4099-001 Porto, Portugal

Keywords: Remote Monitoring, Implantable Cardioverter Defibrillator.

Abstract: The PORTLink study is a randomized controlled multicentre study that aims to assess whether the use of

CareLink system (Medtronic Inc.) for remote monitoring of cardiac implantable electronic devices improves

patient satisfaction and consumption of resources, when compared with conventional follow-up.

1 INTRODUCTION

Remote monitoring of implantable cardiac devices is

a safe and effective alternative to conventional

follow-up only with ambulatory clinical visits

(Dubner, 2012). Previous studies have shown that

remote monitoring is feasible in clinical practice,

reducing the number of ambulatory scheduled visits,

and contributing to higher patient safety and

satisfaction, and better use of health resources

(Dubner, 2012); (Burri, 2012). Nevertheless, patient

satisfaction and impact at health resources should be

confirmed at local level, since economic and cultural

aspects may influence these outcomes (Burri, 2012).

The Portuguese Research on Telemonitoring

with CareLink (PORTLink) study evaluates whether

the use of Medtronic CareLink® system for remote

monitoring of individuals with implantable

cardioverter-defibrillators (ICD) or cardiac

resynchronization therapy devices (CRT-D)

improves the follow-up efficiency, in particular with

regards to patient satisfaction and consumption of

resources, when compared with conventional

follow-up and independently of patient previous

experience of conventional follow-up.

2 STUDY DESIGN

The PORTLink study is a prospective randomized,

controlled, open-label, multicentre study conducted

in Portuguese hospitals. The study was approved by

the three participant centres in the pilot phase, and

by the Portuguese Authority on Data Protection. All

patients provided their consent to participate.

The sample of 240 patients is being recruited

between 2012 and 2013 and will be followed-up for

12 months. Included patients should be ≥18 years-

old, implanted with a Medtronic ICD or CRT-D, and

eligible to use the CareLink service.

Participants are randomly assigned on a 1:1:1:1

basis: recently implanted starting follow-up on the

remote monitoring protocol (group A) or starting

conventional follow-up (group B); with previous

experience on conventional follow-up changing to

the remote monitoring protocol (group C) or without

changing to the remote protocol (group D).

Clinical forms and patient questionnaires are

filled during ambulatory visits and after each remote

data transmission. The study primary endpoints are

the proportion of patients satisfied with the

monitoring protocol, the resources consumed and the

clinicians’ satisfaction with the CareLink service.

The statistical analysis assumes a confidence level of

95%. For the baseline data of the pilot phase

descriptive data are presented for the main clinical

and socio-demographic variables.

Fernandes M., Oliveira M., Primo J., Reis H. and Nicola P..

PORTLink Study - Portuguese Research on Telemonitoring with CareLink

 - Baseline and Preliminary Data of the Pilot Phase.

 2013 SCITEPRESS (Science and Technology Publications, Lda.)

3 PRELIMINARY RESULTS

From April 2012 until May 2013, a total of 53

patients were included. Table 1 presents the baseline

characteristics of the enrolled patients. No

significant differences were observed between

groups. The enrolment rate ranged from 1 to 12

participants per month (mean 4 participants/month).

The patients had a mean time of follow-up of

7.7±4.3 months (mean±standard deviation).

The 36 (67.9%) initial consecutive patients with

at least 6 months of study participation had a mean

number of 0.7±0.9 in-office appointments and only 2

patients had one unscheduled appointment. The 21

(58.3%) patients in the CareLink groups had fewer

appointments than the 15 (41.7%) patients in the

control groups (0.3±0.7 vs. 1.2±0.9, p<0.05).

Patients in the CareLink groups had a total of 48

remote transmissions, from which 6 were

unscheduled and due to patient decision. Regarding

overall satisfaction of the centres with the use of the

CareLink website during remote transmissions, all

were satisfied (97.1%) or very satisfied (2.9%). The

patient’s use with the CareLink monitor was very

easy for 14 (28%), and easy for 18 (38%) of the

transmissions, while 16 (32%) were classified as

wireless without any reported problems.

4 DISCUSSION

The enrolled participants are mainly man, older than

50 years-old and presenting ischaemic heart disease.

Some information is being completed at the time,

which explains the observed missing data.

Preliminary data seems to confirm a significant

reduction of in-office appointments with remote

monitoring, the patient ease of use of the CareLink

monitor and the clinicians’ satisfaction with the

service.

It is still necessary to clarify the impact of

remote monitoring regarding patient outcomes,

including quality of life and long-term satisfaction.

These will be evaluated in the PORTLink study in

different groups of a population of patients and

compared with conventional practice for the

Portuguese reality.

ACKNOWLEDGEMENTS

To the participant patients and clinical centres. The

study is funded by Medtronic Portugal, Lda.

REFERENCES

Dubner, S. et al., 2012. ISHNE/EHRA expert consensus

on remote monitoring of cardiovascular implantable

electronic devices (CIEDs). Europace, 14(2), pp.278-

293.

Burri, H., 2012. Remote Management of Pacemakers and

Implantable Defibrillators – Role and Long-term

Viability. European Cardiology, 8(2), pp.94–97.

Table 1: Baseline characteristics of the enrolled patients.

Total

(n=57)

Group A

(n=15)

Group B

(n=10)

Group C

(n=19)

Group D

(n=13)

Age, years, mean±sd

57.6±10.1 52.9±8.2 54.3±8.1 60.5±10.2 62.7±10.0

Men, n (%)

42 (87.5) 8 (80.0) 8 (88.9) 16 (88.9) 10 (90.9)

Implant interval, months, mean±sd

25.3±28.2 2.9±4.6 1.6±1.4 35.7±26.9 36.3±30.8

Education, years, mean±sd

6.6±3.8 5.6±1.5 5.3±2.4 6.5±4.1 8.8±4.4

Professional status - retired, n (%)

27 (55.1) 2 (22.2) 6 (60.0) 12 (63.2) 7 (63.6)

Accompanied patients, n (%)

21 (44.7) 4 (44.4) 4 (40.0) 7 (38.9) 6 (60.0)

Device, n (%)

ICD 40 (70.2) 10 (66.7) 7 (70.0) 13 (68.4) 10 (76.9)

CRT-D 17 (29.8) 5 (33.3) 3 (30.0) 6 (31.6) 3 (23.1)

NYHA functional class, n (%)

I 9 (20.0) 1 (12.5) 2 (22.2) 3 (16.7) 3 (30.0)

II 26 (57.8) 7 (87.5) 4 (44.4) 10 (55.6) 5 (50.0)

III/ IV 10 (22.2) 0 (0.0) 3 (33.3) 5 (27.8) 2 (20.0)

Underlying heart disease, n (%)

Ischaemic cardiomyopathy 15 (30.6) 2 (20.0) 1 (11.1) 8 (40.1) 4 (36.4)

Myocardial infarction 14 (28.6) 1 (10.0) 3 (33.3) 3 (15.8) 7 (63.6)

Others 45 (91.8) 8 (80.0) 7 (77.7) 19 (100.0) 11 (100.0)

History of arrhythmia, n (%)

35 (71.4) 6 (60.0) 7 (77.8) 14 (73.7) 8 (72.7)

Note: statistics are related to the available data, namely:

n =32,

n=48,

n=41,

n=49,

n=47,

n=45;

more than one option