The Business Case for Public Funding
of Remote Monitoring of Cardiac
Implantable Electronic Devices
Medical Technology Association of Australia Limited
Level 12, 54 Miller Street
North Sydney NSW 2066 Australia
P: (02) 9900 0650
E: reception@mtaa.org.au
www.mtaa.org.au
Copyright © 2011 Medical Technology Association of Australia Limited (MTAA)
To the extent permitted by law, all rights are reserved and no part of this publication
covered by copyright may be reproduced or copied in any form or by any means except
with the written permission of MTAA Limited.
Contents
Summary of the business case ................................................................................ 1
1.
Overview .......................................................................................................5
2.
About the medical technology industry .......................................................... 2
3.
Background ...................................................................................................3
4.
Patient Population and Clinical Need ............................................................. 3
5.
Remote Monitoring for CIEDs ........................................................................ 3
6.
Clinical Benefits of Remote Patient Monitoring .............................................. 5
7.
Current Reimbursement for Remote Monitoring of CIED Patients.................. 6
8.
Telehealth on the Medicare Benefit Schedule ................................................ 6
9.
Economic Impact of Remote Monitoring ........................................................ 7
10.
Cost Effectiveness of Remote Monitoring of Patients with CIEDs .................. 8
11.
Current Cost to Medicare for CIED In-Office Follow-Up Checks .................... 9
12.
Proposed Models for Public Funding of Remote Monitoring of CIEDs ......... 10
13.
Conclusion ................................................................................................... 15
Appendix A .............................................................................................................. 16
Appendix B .............................................................................................................. 23
Appendix C .............................................................................................................. 24
Summary of the business case
Remote monitoring of cardiac implantable electronic devices (CIED) is a health equity
issue. It is also an issue about the future sustainability of the healthcare system.
Currently rural and remote patients do not have equal access to cardiac monitoring.
Further, remote monitoring contributes to judicious use of clinician time and resource.
Remote monitoring of CIED patients:
•
Maintains patient safety and improves patient care
•
Eliminates the need for unnecessary in-office follow up visits
•
Involves no setup costs for physicians
•
Increases productivity
•
Addresses the current and future skilled workforce shortage
•
Offers potential cost savings to health care budget
•
Contributes to a culture of sustainability in health care provision.
Remote monitoring is already endorsed by the Cardiac Society of Australia/New Zealand
(also by the US Heart Rhythm Society and European Society of Cardiology). In
Australia the only tangible barrier to the technology is lack of reimbursement. Two large
clinical trials (Trust & Comps) showed that 70% to 90% of follow up checks are not
actionable and in hindsight could have been skipped (wasted healthcare infrastructure,
wasted physician, nurse and patient time, lost productivity of patients and carers,
emissions from healthcare related travel).
Demand and costs for CIED follow up will increase exponentially in the future due to
wide-ranging device efficacy and population aging.
Clinicians will support a new patient care model involving remote monitoring as long as
the reimbursement covers their costs for providing the service.
The objectives of MTAA are to:
1. Improve patient care, quality of life and access to modern technology
2. Provide a fair and adequate reimbursement to clinicians for this service
3. Achieve a cost saving to the Commonwealth budget by introducing efficiencyenhancing technology.
Three options to achieve these outcomes are provided:
1. MBS item numbers based on existing items with an included loading for remote
monitoring
2. Capitated costing model
3.
Improved capitated model (flat fee per quarter).
Option one, whilst simple, may result in over-servicing of patients. Capitated models, on
the other hand, ensure there is no over servicing as physicians are paid for a service
regardless of the number of data transmissions or reviews. Option 2, the capitated
costing model, is budget neutral proposing an annual fee based on current utilisation.
The flat fee per quarter model, option 3, proposes significant long term cost savings to
the Commonwealth budget.
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 1
1. Overview
The Medical Technology Association of Australia (MTAA) presents this business case to
government for consideration for funding to address a healthcare equity and healthcare
sustainability issue.
The Federal Government Telehealth Initiative: Connecting Health Services with the
Future: Modernising Medicare by Providing Rebates for Online Consultations provides
people in remote, regional and outer metropolitan areas with access to telehealth
through online consultations. This initiative provides patients with easier access to
specialists, without the time and expense involved in travelling to major cities. MTAA
applauds this policy initiative but raises concerns regarding a patient group that has
been excluded in the range of new telehealth Medicare rebates. The exclusion of
remote monitoring of CIEDs from the telehealth initiative effectively limits the potential
benefits that could be realised by all stakeholders – payers, patients, clinics and doctors.
A policy response is appropriate as remote monitoring is not a different service from inoffice monitoring; rather it is a way to deliver the same service from a remote location.
National and international experience demonstrates that this service can be delivered
safely and effectively
The diagnosis, surgical intervention and on-going in-clinic care of Australian patients
with CIED is well-established and sufficiently reimbursed by Medicare. However, more
efficient and cost-effective use of existing resources leading to improved health
outcomes for Australian patients with CIEDs can be achieved.
Remote monitoring can be established as a publicly funded service in Australia with
positive Federal Budget impact. There are no barriers to adoption except Medicare
funding.
Additional savings to the healthcare system are possible, due to prevention of costly
episodes of care such as strokes and hospitalisations due to heart failure.
Cost savings (especially for rural patients) are likely due to reduced travel to in-office
visits by patients and their carers (time off work).
The proposed Medicare rebate models address budget restraints and offer time and
financial savings to patients and clinics.
2. About the medical technology industry
MTAA represents the manufacturers, exporters and suppliers of medical technology
products in Australia. Medical technologies are products used in the diagnosis,
prevention, treatment and management of disease and disability. Products range from
consumable items such as wound care products and syringes, to high technology
implantable devices such as cochlear implants, cardiac defibrillators and orthopaedic
joints, diagnostic imaging equipment, and products which use biological materials.
The medical technology industry had sales in Australia of more than $7.5 billion in 200910 and employs more than 17,500 people. It is strongly research-based, often working
closely with healthcare professionals to design and develop products for improved
patient benefit. MTAA represents companies supplying approximately 70% of all nonpharmaceutical medical products on the Australian market.
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 2
3. Background
CIEDs have expanded in number and complexity since their introduction in 1958 and
include cardiac pacemakers, implantable cardioverter-defibrillators, implantable cardiac
resynchronisation devices and implantable loop recorders. These devices are widely
used for the treatment of chronic cardiac conditions such as bradycardia, tachycardia,
heart failure and for arrhythmia monitoring i.
There are approximately 3.5 million people in Australia with long-term cardiovascular
disease (CVD) ii. CVD costs more lives in Australia and has the greatest level of health
expenditure of any group of diseases. Deaths due to cardiac arrhythmias account for
over half of all deaths attributable to CVD in Australia each year iii. Treatment for CVD
costs over $5.9 billion in 2004-05 with over half of this money spent on patients admitted
to hospital. The cost burden of CVD in Australia is expected to rise due to increasing
incidence and prevalence.
Telemetric remote monitoring of implanted devices represents a simple evolution in the
method of delivering a standard medical service within a mature therapeutic field. The
expertise, technology and infrastructure are all well-established and do not require
additional expenditure to implement this telehealth service. However, the lack of
Medicare rebates for remote monitoring of patients with a CIED prevents the widespread
adoption of this telehealth service and encourages a continued reliance on traditional,
inefficient in-office monitoring
4. Patient population and clinical need
Implantation of cardiac devices in Australia has grown from 11,649 in 2000-01 to 21,223
in 2007-08 – representing an average growth rate of 11.74% per year. Therapeutic
procedures for CVD and cardiac arrhythmias include pacemaker insertion and cardiac
defibrillator implant. Between 2007 and 2008 there were 17,010 pacemaker insertion
procedures and 3,318 cardiac defibrillator implantation procedures performed among
hospitalised patients iv. Growth in the use of implantable devices to treat cardiac
conditions is expected to rise with an increase in prevalence associated with Australia’s
ageing population.
Remote monitoring of patients with CIEDs is particularly well-suited to Australia which
has approximately one-third of the population v, but only 12% of practicing cardiologists vi
living in rural and remote regions. Furthermore, due to a shortage of cardiac clinics and
electrophysiologists in Australia the time between in-clinic visits has increased for both
urban and rural patients, which can compromise patient health outcomes vii. This forces
local general practitioners to carry the burden of cardiac management for these
patients viii.
5. Remote monitoring for CIEDs
CIEDs are therapeutic devices used to treat a range of cardiac conditions. Long term
(lifelong) follow-up of patients with CIEDs is necessary to monitor and optimize device
function and to identify clinical and/or device-related problems. Most new CIEDs have
the potential to be remotely monitored. While they cannot be reprogrammed remotely,
this feature is being tested in pilots. There are two general types of remote monitoring
systems, those that transmit data automatically and those where the patient is actively
involved in data transmission.
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 3
Remote monitoring is the exchange of medical data between a patient who is at home
and a healthcare professional, such as a cardiologist, based in a medical setting. Data
from CIEDs can be automatically transferred using wireless technology and the internet.
All manufacturers of CIEDs can now be monitored remotely for clinical or device
assessment.
Figures 1 and 2 below illustrate the difference between in-clinic and remote telemetric
monitoring (follow-up).
Figure 1: Telemetric in-clinic follow-up
Figure 2: An example of telemetric remote follow-up*
ix
*Adapted from Orlov MV et al. (2009) - example of Medtronic’s CareLink remote follow-up system
The purpose of both the remote and in-clinic monitoring is to assess the device
performance noting that remotely transmitted data is identical to that available to the
specialist during in-clinic monitoring.
Remote monitoring of CIEDs removes the requirement for additional facilities, resources
or technology and simply uses the existing resources more efficiently. This model would
therefore be ideally suited for inclusion in the telehealth initiative.
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
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Routine follow-up visits have traditionally required the patient to physically attend a clinic
to allow specially trained staff to interrogate the device via telemetry and verify clinical
events. These consultations can be time-consuming and place a substantial burden on
already stretched healthcare resources x. Approximately 90% of patients who attend a
clinic for routine monitoring do not require changes to either their device or their medical
treatment xi.
One of the key benefits of remote monitoring is that the clinician can be provided with
automatic alerts of events that occur between routine visits. Devices are programmed to
relay data if a certain heart condition is detected by the device, if therapy is delivered by
the device for clinical purposes or if a safety issue is detected due to malfunctioning of a
component. For many Australians with CIEDs remote monitoring would provide more
practical and affordable access to their specialist.
Remote monitoring systems include the implanted device, a remote sensor device
(usually located in the patient’s home), a data transmission system and a remote
monitoring service centre. Additional features of these systems may include networked
monitors for vital signs such as blood pressure and weight. Patients may be actively
involved in symptom monitoring and the system may prompt them to answer questions
regarding their health. A recent meta-analysis of >6,000 patients found that remote
monitoring of both symptoms and measures of heart failure status such as weight and
blood pressure resulted in improved survival ratesxii.
The goals for remote CIED monitoring have been outlined by an expert consensus group
involving cardiac electrophysiologists representing 11 professional associations listed in
Appendix Bxiii:
There are a number of remote monitoring systems available in Australia. Some devices
with remote monitoring capabilities listed on the Australian Register of Therapeutic
Goods (ARTG) are shown in Appendix C.
6. Clinical benefits of remote patient monitoring
The clinical benefits of remote monitoring for patients with CIEDs include:
•
•
•
•
•
•
•
•
•
•
•
•
•
1
Lower mortality rates xiv 1
Reduced number of hospitalisations xv
Shorter duration of hospitalisations xvi
Discovery of previously undetected clinical symptoms xvii
Increased adherence to treatment program and follow-up xviii
Improved continuity of follow-up xix
Reduction in the number of inappropriate shocks xx
Improved quality of life
Avoidance of further cardiac events xxi
Reduction in anxiety associated with possible failure of the device xxii
Efficient, timely follow-up for patients who live in remote locations xxiii
Early detection of clinical events such cardiac arrhythmias and/or deterioration of
clinical status xxiv
Early detection of device related issues such as battery depletion, out-of-range
leads or inappropriate delivery of shocks xxv
Proof pending from randomized controlled trials
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 5
Appendix A contains a detailed list of clinical findings from relevant cohort studies and
randomised control trials (RCTs) evaluating remote monitoring of patients with CIEDs.
7. Current reimbursement for remote monitoring of CIED patients
Heart failure is increasingly being managed through specialist clinics. The diagnosis,
surgical intervention and on-going in-clinic care of Australian patients with CIEDs are
well-established and sufficiently reimbursed.
Surgeons are reimbursed through
Medicare for the implantation of the cardiac device and the actual device is reimbursed
for eligible patients with private health insurance through the Prostheses List
(manufacturers do not receive extra reimbursement for additional device capabilities
such as remote monitoring).
Medicare funding is available for routine, in-clinic monitoring of patients with an CIED (inclinic monitoring is covered by Medicare Benefits Schedule (MBS) item numbers 11718,
11721, 11722 and 11727). Despite a wealth of evidence for the value of remote
monitoring for patients with CIEDs, Medicare only reimburses clinicians for face-to-face
assessments.
There has been a Medical Services Advisory Committee (MSAC) application
(Application 1111) for public funding of remote monitoring of CIEDs in Australia. The
2008 MSAC review found that while remote monitoring is safe, clinical effectiveness was
not demonstrated and there was insufficient data for a formal economic assessment xxvi.
For these reasons, MSAC did not recommend public funding for remote monitoring of
patients with CIEDs at that time. However, the results of several landmark trials in the
field of remote monitoring (ALTITUDE, COMPAS, CONNECT and TRUST) have been
published since. The results of these trials (which include over 188,000 patients with
CIEDs) significantly addresses the uncertainty presented in the review of Application
1111 and establishes the evidence for clinical effectiveness xxvii.
Canada has undertaken a recent health technology assessment of remote monitoring of
CIED. The Ontario Health Technology Advisory Committee (OHTAC) reviewed the
effectiveness and safety of internet-based device-assisted remote monitoring systems
for therapeutic CIEDSxxviii. The review identified six systematic reviews, seven RCTs
and 16 cohort studies and concluded that there was significant evidence for a reduction
in in-office clinical follow-ups in the first year after implantation and that the rate of
detecting clinically significant events is higher in patients followed up remotely. The
review concluded that remote monitoring is a safe, effective substitute for in-office followup care and that these systems should be increasingly used in areas where
geographical distance prevents regular follow-up.
8. Telehealth on the Medicare Benefit Schedule
Public funding for telehealth was introduced in July 2011, with $620 million being
allocated for telehealth services over 4 years. Currently the definition of telehealth has
been restricted to videoconference consultations and reimbursement is only made in
cases where there is an audiovisual link between the patient and practitioner. This
proposal seeks the extension of public funding to the remote monitoring of cardiac
implantable electronic devices.
There are now 11 specialist telehealth items, which allow a specialist to consult with a
patient by videoconference. These telehealth items are billed with an existing specialist
consultation item under the MBS, and increase the base schedule fee for the
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 6
consultation item by 50%. Twenty-three new patient-end attendance items have also
been introduced to support telehealth consultations with remote specialists. The
schedule fees for these new patient-end item numbers effectively represent a 35%
loading on the standard consultation item fees. General practitioners, (and practice
nurses and Aboriginal health workers on behalf of GPs), midwives, nurse practitioners,
and other medical practitioners will be able to bill the relevant patient end attendance
item in combination with both a telehealth service incentive and a bulk billing incentive.
MBS item numbers for telehealth (video consultations) are currently associated with a
$6,000 incentive when a health practitioner provides their first video consult.
Reimbursement for remote monitoring of CIEDs should not be associated with such an
incentive as there are no set up costs. It is assumed that clinicians who assess CIED
data already have access to computer equipment that is appropriate for data review.
While remote monitoring of CIEDs can be considered a telehealth item, MTAA does not
propose to adapt those MBS codes for this purpose. Remote monitoring of CIEDs does
not rely on a video link between physician and patient. Hence, there are no setup costs
involved. In addition, the health care specialist does not consider patient symptoms,
merely the downloaded data from the implanted cardiac device. Hence, the existing
items for in-office follow up provide a better starting point. These items concern the
same specialist group (cardiologists and electrophysiologists) and offer efficiency gains
similar time commitments.
9. Economic impact of remote monitoring
Eucomed 2 recently submitted CIEDs as one of its four proposals to the European
Commission’s Active and Healthy Ageing Innovation Union Strategy because it believes
this form of treatment has not only the potential to significantly improve chronic cardiac
care but also because this treatment can potentially save billions of Euros xxix.
In Australia, direct cost savings may be achieved as the result of:
•
•
•
•
•
•
Reducing the number of clinical visits (including specialist visits) xxx
Reducing the distance travelled by healthcare professionals
Early detection of symptom exacerbations and early intervention xxxi
Fewer and/or shorter hospital stays xxxii
Delaying the move into residential care
Decreased utilisation of healthcare resources xxxiii.
Indirect cost savings may be achieved as the result of:
•
•
•
2
Reduced travel for patients and carers xxxiv
Increased patient and carer productivity (i.e. less disruption to work
schedule)
Reduced number of inappropriate ICD shocks resulting in less battery
drain and thus longer service time of the device xxxv. This leads to a
smaller number of replacement devices per patient including a smaller
number of replacement surgeries.
EUCOMED is the European Medtech industry body
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 7
10.
Cost effectiveness of remote monitoring of patients with
CIEDs
The costs of remote monitoring include the cost of the patient monitor device and the
cost of data monitoring by appropriate staff. There have been few economic studies of
the cost-effectiveness of remote monitoring for cardiac devices. Results are dated and
not generally applicable to Australia. A brief summary of the available economic
evidence is presented in Table 1.
Table 1: Summary of economic data on remote monitoring of CIEDs
Author
Study
Findings
Elsner et al.
(2006) xxxvi
Assessed the costs of
remote monitoring for
115 patients with ICDs
There were significant cost reductions associated with a
decrease in office visits for the RM group. For 100 patients a
total of 81 physician hours and €712.31 could have been
saved p.a. using RM. Replacing office visits with RM
reduced transportation costs by 63% and time taken to
analyze results by 41%
Fauchier et al.
(2005) xxxvii
Assessed potential cost
savings for the longterm care of ICDs
using
remote
monitoring from a
database
of
502
patients
Compared the costs of conventional follow-up and RM.
Costs included: number of visits, clinical fees, ECGs, ICD
surveillance and transportation. Results showed that RM may
obviate up to 2 visits per year. Cost savings began at
approximately 33.5 months. The time to onset of cost saving
was dependent on distance, RM reduces overall costs,
particularly when the distance between home and medical
facility is >100 km
Klersy et al.
(2009) xxxviii
Meta-analysis of 21
RCTs
comparing
remote monitoring with
usual care in 5,715
patients with heart
failure
RM was associated with a significant decrease in the number
of hospitalisations. Direct cost savings associated with RM
ranged from €300 to €1000 and when combined with a
QALYs gain of 0.06, the authors concluded that RM
‘dominated’ existing standard care for heart failure patients
Raatikainen et
al. (2008) xxxix
Assessed
the
cost
effectiveness of remote
monitoring
in
41
patients with ICDs
Replacing two office visits with RM was associated with a
41% saving (the total annual saving associated with RM was
€524–749 per patient). The authors concluded that the use of
RM for all new ICD patients within Western Europe may
save €16–23 million annually
ECGs = electrocardiogram, QALY = quality-adjusted life year
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 8
11.
Current cost to Medicare for CIED in-office follow-up
checks
The Medicare Benefits Schedule lists a number of items for the in-office testing of
CIEDs. However, as the in-office check is performed by a specialist, other items are
usually co-claimed for a patient visit. When looking at the total cost of in-office CIED
checks to the Commonwealth, those costs must be taken into consideration as well.
The items and their individual benefits (100% benefit level) are shown in Table 2.
Table 2: Current benefits for in-office assessment of cardiac devices (100% benefit shown,
benefits are current as of November, 2011)
3
MBS Item
Service
Benefit
11718*
Implanted pacemaker pacemaker testing involving ECG, measurement of
rate, width and amplitude of stimulus, including reprogramming when
required
$34.10
11721*
Implanted pacemaker testing of atrioventricular sequential, rate
responsive, or antitachycardia pacemakers, including reprogramming when
required
$68.45
11722*
Implanted ECG loop recording, for investigation of recurrent unexplained
syncope, including re-programming of device, retrieval of stored data,
analysis, interpretation and report
$34.10
11727*
Implanted defibrillator testing involving electrocardiography, assessment
of pacing and sensing thresholds for pacing and defibrillation electrodes,
download and interpretation of stored events and electrograms, including
programming when required
$93.00
116
Subsequent attendance for follow-up with a consultant
$74.10
* Note, other MBS item numbers can be claimed in conjunction with this item
In the 2010-11 financial year the benefit paid by Medicare purely for CIED follow up was
$8,456,202. This amount does not include co-claimed items. The costs are split as
shown in Table 3 4.
Table 3: Spending on current model: Patients are scheduled for periodic in-office consultations
3
MBS Item
Device
Count of Services
2010/11
Medicare contribution to
service 2010/11*
11718
Single-chamber
Pacemaker
8,968
$254,309
11721
Dual-chamber
Pacemaker
99,164
$5,630,470
11722
Implantable ECG Loop
Recorder
2,408
$68,833
http://www.mbsonline.gov.au/, data accessed November 2011 Medicare Benefits Schedule.
4
Statistics from www.medicareaustralia.gov.au/statistics/mbs_item.shtml accessed online 7 November
2011.
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 9
11727
ICD
32,480
$2,502,590
* Note, that the amount for Medicare contribution is smaller than the product of Count of Services and Item
Benefit (Table 2) due to less than 100% benefit being paid by Medicare on some occasions.
On the basis of MBS data from January 2008 to December 2010 and assuming only
50% of patients appear on MBS statistics data, the projected number of patients for
implanted pacemakers 5 and implantable cardioverter/defibrillators (ICDs) 6 in 2015 will be
112,000.
The average number of in-office checks performed during the financial years 2008, 2009
and 2010 for pacemaker and ICD patients in Australia is shown in Table 3.
Table 3: Average number of in-office checks per patient per year 7
Average number of
pacemaker checks per
patient
Average number of ICD
checks per patient
2.4
3.0
During an in-office follow up other items are usually co-claimed depending on the
additional diagnostic and therapeutic interventions by the health practitioner during the
check. For simplicity, only the most frequently claimed item “Specialist Consultation”
(MBS item 116) is considered when calculating the current average cost per patient per
year. MTAA acknowledges that this might underestimate the actual cost:
Current Cost per ICD patient p.a.
Item code 11727 (ICD check)
Item code 116 (specialist consultation)
Average total cost
Average cost per ICD patient per annum for follow up checks:
3.0 checks p.a. * $167.10
$93.00
$74.10
$167.10
$501.30
(Equation 1)
Similarly, the current cost per pacemaker patient is $342 per year.
12.
Proposed models for public funding of remote monitoring
of CIEDs
The following models are potential ways Medicare could implement the reimbursement
of remote monitoring services for CIEDs. However, there may be alternative solutions
that address the priorities of Medicare while supporting patient access and fair clinician
reimbursement. MBS items for reimbursement of remote monitoring could be arranged
in the following ways:
5
Projected for 2015 based on MBS data from Jan 08 to Dec 10 (MBS item 11718 and 11721) and assuming
50% of patients on MBS only.
6
Projected for 2015 based on MBS data from Jan 08 to Dec 10 (MBS item 11727) and assuming only 50%
of patients appear on MBS statistics (no public patients).
7
Source: Medicare Australia, 2011
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 10
Example A: MBS item numbers based on existing items with an included loading for
remote monitoring
Example B: Capitated costing model
Example C: Improved capitated model (flat fee per quarter).
Example A: CIED routine follow up PLUS
MBS item numbers could be based on existing item numbers for CIED routine
assessment with an included loading for remote assessment (Table 4).
Table 4: New MBS item numbers for remote monitoring based on existing item numbers for
CIED in-office assessment with an included loading for remote assessment
MBS item Service
11721
Remote
remote
monitoring
for implanted
pacemaker
testing
11722
Remote
remote
monitoring
for implanted
ECG
loop
recorders
11727
Remote
remote
monitoring
for implanted
defibrillator
testing
116 remote Subsequent
attendance
Fee
$102.67
[derived fee: using item 11721 $68.45 (implanted pacemaker
testing) including similar loading as for telehealth items currently on
MBS (50%)]
$51.15
[derived fee: using item 11722 $34.10 (implanted ECG loop
recorder testing) including similar loading as for telehealth items
currently on MBS (50%)]
$139.50
[derived fee: using item 11727 $93 (implanted defibrillator testing)
including similar loading as for telehealth items currently on MBS (50%)]
$111.15
[derived fee: using item 116 $74.10 (subsequent attendance for
follow-up with a consultant) including similar loading as for telehealth
items currently on MBS (50%)]
It is anticipated that in most cases MBS item numbers for telehealth patient-end services
would not be used as the monitoring takes place asynchronously, i.e. data transmission
and evaluation by the specialist do not take place at the same time.
While this model appears intuitive and straight forward, it has a few shortcomings, the
main one being that there is no cap on the number of services provided using those item
numbers. Potentially, this could lead to over servicing of patients with CIEDs with
resulting cost blow outs of the Commonwealth budget. Using this model it would be hard
to delineate between conventional in-office follow up and providing the service remotely
as in theory an in-office follow up on one day could be followed by another claim for a
remote check the following day (which may be legitimate to check whether a device
reprogramming had the intended effect, for instance on atrial fibrillation recurrence). The
loading of 50% seems somewhat arbitrary as telehealth items may not be the best
comparator due to the missing same-time-interaction between patient and health care
provider.
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 11
Example B: Capitated Costing Model
An MBS item could be developed using a capitated model whereby a clinician is paid
once per year per patient to provide the service. This would ensure there was no over
servicing, i.e. the physician would be paid once regardless of how many data
transmissions and reviews occur. Calculations for an annual fee could be made based
on the number of online consultations expected per year (and could also include in-office
visits).
Remuneration model and budget impact
Based on established MBS in-clinic monitoring item codes 11721, 11727 and 11722,
there are various remuneration models that could be considered by Medicare for remote
monitoring of CIEDs. The proposed model is designed to ensure that the overall budget
impact is cost neutral and predictable. Remuneration models successfully implemented
in other jurisdictions include capitation. A capitation model involves paying the clinician
a set annual fee for each patient enrolled in a remote monitoring program. The clinician
is then responsible for the management of the patient regardless of the amount of care
required or whether the consultation is in-office or a remote monitoring service. Not all
patients are suitable for remote monitoring; some may wish to move between remote
and in-clinic monitoring, while others may be suitable for remote monitoring at one
period but not in another. Such changes may be due to variations in a patient’s clinical
status, their physical location or because their personal preferences change. Doctors
also must have flexibility in the method of monitoring their patients and be able to move
between models. However, the proposed capitation model is a single fee to cover inoffice and remote monitoring for an individual patient and is not intended to be used in
addition to the current in-office items.
Studies have shown that remote monitoring can be used to replace 50–63% of in-clinic
visits without adversely affecting patient outcomes such as CV hospitalisations, ER visits
and mortality xl. As a result, remote monitoring could safely and effectively replace a
portion of scheduled and unscheduled services – thereby decreasing the demand on
hospital resources, physician time and associated transportation costs xli .
Table 5: Capitation model (example): Doctors receive a set annual fee for each patient with a
CIED enrolled in a remote monitoring program
MBS Item
Follow-up
for
Device
11721c remote
Pacemakers
11722c remote
11727c remote
MBS
Fee**
Estimated
Estimated Medicare
Item Count
of contribution
to
Services***
service****
$164.30
41,318
$ 6,788,547
Implantable
Loop Recorder
$137
1,911
$
ICD
$279
10,827
$ 3,020,733
261,807
** Formula: MBS Item for in-office multiplied by the Average Annual per Patient Utilisation in Table 3
*** Formula: Count of Services (Table 6) divided by the Average Annual per Patient Utilisation in 3
**** Formula: MBS Item Fee multiplied by Count of Services
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 12
The capitation model as presented does not require additional funding. The proposed
annual fee is based on current utilisation. The annual capitation fee could be higher
than proposed to be consistent with the recent Medicare initiative providing higher
rebates for video consultations than for in-office consultations and considerable
incentives to encourage the uptake of the remote monitoring service.
Example C: Improved Capitated Model (Flat Fee per Quarter)
This model takes the previous Example B and improves on possibilities for tracking of
the new items as well as unscheduled in-office checks that may occur for remotely
monitored patients. In addition by calculating the actual cost to the provider of providing
the remote monitoring service, it will be possible to realize a cost benefit to the
Commonwealth budget. This becomes possible by passing on savings created by
efficiency improvements to the payer (Medicare) while at the same time providing a fair
reimbursement to the health care provider.
Under this model, two items for remote monitoring could be added to MBS with a flat fee
per quarter. It might be advantageous to add two further items for in-office checks
prompted by remote monitoring at the same benefit levels as existing items (11721 and
11727) to track spending (Table 6). This model would allow retention of the existing
items for pacemaker, loop recorder and ICD checks (11718, 11721, 11722 and 11727)
and their respective benefits for legacy devices and late technology adopters.
Table 6: Proposed New Item Codes
Pacemakers and CRT-Ps
ICDs and CRT-Ds
Remote Monitoring
(flat fee per quarter)
“Item Code 1”
“Item Code 3”
In-office Testing (indicated
by Remote Monitoring)
“Item Code 2”
“Item Code 4”
The new Item Code 1 and Item Code 3 would include the remote monitoring service and
one optional in-office follow up per year. The landmark clinical trials for remote
monitoring TRUST (ICDs) and COMPAS (pacemakers) used a setup where the regular
in-office follow up was replaced by remote monitoring plus one in-office check after 12
months (TRUST) and 18 months (COMPAS). However, with additional clinical data
becoming available, it is anticipated that the time between two in-office checks will
increase. Hence, MTAA proposes to make the in-office check in Item Codes 1 and 3
optional. The benefits for those two items could be claimed quarterly rather than
annually in order to better align the time of service delivery and benefit payment. That
way, the health care provider is not forced into a position of having to provide a service
in advance and only get paid after one year. Vice versa, Medicare does not have to pay
a benefit in advance but only after the service has been provided for the quarter.
Naturally, the same advantages of capitation as discussed for Example B do apply.
During any quarter for which Item Code 1 or 3 are claimed, items 11721 or 11727 for inoffice checks cannot be claimed. This allows a clear transition of patients from the old to
the new system.
Item Code 2 and Item Code 4 are similar to the existing items for in-office checks of
pacemakers and ICDs respectively. However, they are applied for in-office checks that
became necessary after reviewing remote monitoring data transmitted by the device.
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 13
Using separate items for those checks would allow tracking of spending and gathering of
valuable information on the real-life incidence of those checks. Documentation of the
necessity of those checks is facilitated by all remote monitoring systems on the market.
Again, potential for over servicing can be further reduced by limiting the number of
claims possible for those items in any given year.
Remuneration model and budget impact
Following are calculation examples for the case of ICD patients only. However, the
calculations for other patients with CIEDs are available. The cost for providing remote
monitoring service is mainly influenced by the time that the specialist has to spend to
review the data for each of his or her patients. In order to estimate the time of the health
care provider required per remotely monitored patient, MTAA anticipates the following
based on clinical evidence:
• There will be 4 messages per year per ICD patient xlii
• Dealing with one message will require an effort on part of the clinician similar to
reading and reporting on a 12-lead ECG (MBS#11702: $15.25)
• Remote monitoring takes about 10 minutes per 100 patients per day of clinician
time, i.e. 20 minutes per patient per year (200 working days) xliii
o Comparable MBS item is a 20 minute consultation by a specialist
(MBS#133: $129.65)
Therefore, the cost of providing the remote monitoring service (including one optional inoffice check annually) would be $283.65 per annum. Hence, the proposed benefit for
Item Code 3 is $70.90 (quarterly). Similarly with slightly differing assumptions the
proposed benefit for pacemaker patients (Item Code 1) would be $57.15.
Following from that, the annual cost per remotely monitored patient (as example for ICD
patients) can be calculated as follows:
Remote Monitoring Fee (Item Code 3)
Consultation fee (MBS item 116)
0.78 unscheduled checks (according to the TRUST RCT)
reimbursed at proposed Item Code 4 ($93.00)
Total cost (per annum)
$283.65
$74.10 8
$72.54
$430.29
In order to calculate the cost savings by employing the model proposed in Example C
the annual cost per ICD patient can be compared as follows:
Current Model as per (Equation 1):
$ 501.30
Proposed Model (Example C):
$ 430.29
This model leaves some latitude for additional consultations.
Assuming 34,000 ICD patients in Australia in 2015 9 (and 100% uptake of remote
monitoring based on the availability of public funding), the cost savings to the
Commonwealth budget would be in the order of $2.4 million. A similar calculation can be
8
This is for the specialist consultation provided as part of the optional in-office follow up once annually as
part of the remote monitoring reimbursement.
9
Projected for 2015 based on MBS data from Jan 08 to Dec 10 (MBS item 11727) and assuming only 50%
of patients appear on MBS statistics (no public patients).
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 14
made for pacemaker patients. The annual cost savings to the Commonwealth budget
would be an additional $350,000. Therefore, MTAA argues that remote monitoring for
CIED patients can be introduced in Australia to improve patient care while at the same
time having a strongly positive effect on the Commonwealth budget (with cost savings of
nearly $3 million). This is due to the reduction of unnecessary and resource-intense inoffice checks and their replacement by remote monitoring.
13.
Conclusion
For many Australians, the opportunity to use remote monitoring would provide a more
practical, reliable and affordable access to medical care, without the time and expense
involved in travelling to major cities. Preliminary evidence from clinical trials suggests
that remote monitoring could mediate the need for costly episodes of care such as
strokes and hospitalisations due to heart failure. The efficiency gains associated with
remote monitoring are obvious from the perspective of the service provider and payer,
but patients and their carers also benefit. When compared to in-clinic monitoring, the
reductions in time, costs and opportunity costs (such as time off work) for both the
patient and informal caregiver are particularly relevant for those living in rural and remote
areas.
Finding the best way forward can be readily included in current initiatives. In terms of
quality of life outcomes, remote follow-up has been shown to be safe, and is preferred by
both patients and physicians to in-office visits. In addition, remote monitoring ties in
neatly with the Australian Government’s current telehealth Initiative. Clearly there are a
variety of courses of action that can be taken to provide this patient-physician preferred
service in a cost neutral manner or even realizing inherent cost savings to the
Commonwealth budget.
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 15
Appendix A
Cohort studies evaluating remote monitoring of ICDs – Arrhythmia and heart failure monitoring (modified from xliv)
Author
Country
N
Device
Follow-Up
Findings
Burgada et al.
(2006) xlv
Belgium
271
ICD
12 months
908 pairs of RM and standard care data follow-up were compared. Physicians
indicated that based on observation of remote data 81% of standard visits could
have been avoided. The false-negative detection rate was 14%
Ellery et
(2006) xlvi
al.
United
Kingdom
123
CRT
CRT-D
3 months
Assessed the potential of RM to predict hospitalization in HF patients. There
were 11 unplanned readmissions during follow-up. In 70% of these cases a
retrospective data review detected an increase in mean heart rate preceding
hospital admission. A decrease in cardiac resynchronization therapy was reported
in 43% of patients who were re-admitted
Hauck et
(2009) xlvii
al.
Germany
69
ICD
CRT
18±9
months
A total of 206 event reports were transmitted: 94% were prompted by clinical
episodes, 3% by ineffective ICD shocks, 2% by abnormal pacing impedance and
1% by battery depletion. There were 8 serious adverse events, 6 of which were
discovered by RM. Without RM there would have been a delay in clinical
follow-up of 1.9±0.5 months in the first year (quarterly follow-up) and 4.9±0.5
months in following years (bi-annual follow-up)
Joseph et
(2004) xlviii
al.
United States
124
ICD
6 months
Assessed physician and patient acceptability, diagnostic value and safety of RM.
Patients were highly satisfied with the ease of learning to transmit data, time
savings and convenience of routine follow-up in >90% of cases
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 16
Lazarus et al.
(2007) xlix
France
(multicenter
registry,
global
database
covering
23
countries)
11,624
PM
ICD
CRT
10.5
months
Transmitted events included medical (e.g. arrhythmias), configuration (e.g.
pacing functions) and system related events (e.g. battery status). 86% of events
were medical, 1.3% were alerts of abnormal function indicating device
inactivation and 4% were alerts indicating an ineffective shock had been
delivered. The mean interval between last follow-up and occurrence of
unconfirmed asymptomatic events notified by RM was 26 days (this represented
detection of an event 64 or 154 days earlier in patients usually followed up at 3
and 6 month intervals respectively). The authors concluded that the lifesaving
potential of RM is due to early detection of clinical events
Marzegalli et al.
(2008) l
Italy
67
CRT-D
3 months
Assessed ease of use and patient satisfaction. RM data were judged as complete
and as providing the same level of care as an in-clinic visit. 97% of patients
would recommend RM to others and 78% had a preference for RM
Masella et al.
(2008) li
Italy
67
CRT-D
3 months
Follow-up by RM was more efficient than a standard face-to-face visit in terms of
time savings for both physicians (5 vs 15 mins) and patients (6.6 vs 116 mins).
Of a total of 23 clinical events detected by RM, only 2 necessitated a clinical
visit, decreasing the number of unnecessary hospital admissions
Mullens et al.
(2010) lii
United States
194
ICD
CRT-D
4 months
Assessed the feasibility of a nurse run RM program. Data were analysed daily
and the patient was called if parameters crossed a pre-defined threshold (this
occurred in 18% of patients). In 38% of cases where data crossed the threshold
patients reported non adherence to drug and/or dietary plans. The authors
concluded that RM of trends was feasible as part of routine daily management for
HF
Nielson et al.
(2008) liii
Germany
260
ICD
10.5
months
The majority of events were medically related. Over 60% of new events occurred
within the first month after follow up. RM was associated with the early detection
of medical and technical events
Raatikainen
al. (2008) liv
Finland
41
ICD
9 months
Assessed whether RM is a safe, cost-effective alternative to standard in-clinic
follow-up visits. In 99% of cases physicians found that data were comparable to a
traditional device interrogation. All unscheduled data transmissions were able to
be addressed remotely. Over 90% of patients found the system easy to use. In
comparison to in-clinic visits, RM required significantly less time from
physicians (8±5 vs 26±17 mins) and patients (7±5 vs 182±148 mins). The
substitution of two routine in-office visits by RM reduced the overall cost of
routine ICD follow-up by 41% per patient
et
(multicenter
registry)
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 17
Ricci et
(2008) lv
al.
Italy
117
PM
ICD
CRT
227 days
Assessed the impact of RM on treatment and health care utilization. The device
was programmed to transmit data daily. There were 2,249 analyses undertaken:
92% had no events and no action. 53 in-hospital visits were needed for
unscheduled follow-up due to alerts transmitted (91% of these were medical and
9% were device transmission interruptions). There was an overall decrease in inhospital visits in the RM group. There was a significant learning curve on the use
of the system: mean web connection times were significantly shorter for the last
vs the first 50 connections. The authors concluded that RM had a positive effect
due to early detection of life-threatening cardiac events and device failures
Ricci et
(2009) lvi
al.
Italy
166
PM
ICD
CRT
488 days
Assessed the impact of RM on detection and treatment of AF: 26% (n=43) of
patients had alerts for AF, 22 of who had no history of AF prior to implant. The
median time to the first intervention for AF was 50 days (148 days before the
scheduled follow-up)
Ricci et
lvii
(2010)
al.
Italy
119
PM
ICD
CRT
12 months
Evaluated patients’ acceptance of RM. There was a high level of acceptance and
satisfaction. At 1-year follow-up, 93% of patients in the trial wished to continue
with RM
Sacher et
(2009) lviii
al.
France
(multicenter
registry)
70
ICD
33±17
months
Assessed RM in patients with Brugada syndrome who are at risk of sudden
cardiac death. At follow-up the number of cardiology consultations was
significantly lower in the RM group. Inappropriate shocks occurred in 8.5% of
the RM group vs 17% of the standard care group (ns). The authors concluded that
RM decreased outpatient consultations and may help prevent inappropriate
shocks
Santini et
(2009) lix
al.
Italy
67
CRT-D
3 months
Assessed whether RM improves clinical management of tachy-arrhythmias and
HF episodes. In 70% of cases a patient could be managed remotely, avoiding a
hospital visit. In a number of cases RM led to either adjustment of drug therapy
over the phone or patient reassurance and no action
Saxon et
(2010) lx
al.
United States
185,778
ICD
CRT
Up to
years
ALTITUDE
Survival Study
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
5
Assessed long term survival data and shock therapy with standard and RM
follow-up. For the 69,556 ICD and CRT-D patients receiving remote follow-up,
1- and 5-year survival rates were significantly higher in comparison to the
116,222 patients who received follow-up in device clinics only (50% reduction in
mortality). 4% of CRT-D patients also transmitted weight and blood pressure data
on average 2.5 times per week. These patients had the lowest mortality risk (vs
other networked CRT-D patients). The one year incidence of shock was 14% (8%
were appropriate and 6% were inappropriate)
Page 18
Schoenfeld
al. (2004) lxi
et
United States
59
ICD
1 week
Assessed the impact of RM on patients and clinicians. Practitioners reported that
in 97% of occasions the service enabled them to provide care comparable to an
in-office visit. Nurses reported a higher degree of satisfaction than physicians.
98% of patients indicated that the RM system was very easy or somewhat easy to
use. RM detected a number of previously unobserved clinically significant
findings, e.g. unobserved atrial undersensing
Theuns et al.
(2009) lxii
Netherlands
146
ICD
CRT
22±16
months
Data were transmitted daily or in the case of pre-specified events (e.g. out-ofrange leads, arrhythmia). A total of 57,148 remote transmissions were recorded,
64% were classified as clinical and 6% as system-related. Only 1.8% of events
were data transmissions triggered by critical events. The authors concluded that
there was minimal additional burden on clinical workload despite the large
number of data transmissions
Varma et
(2005) lxiii
United States
(multicenter)
107
PM
3 months
Assessed RM in AF patients. Review of data was retrospective: 29 patients
experienced 645 AF days (10.5% of implants). Data from 20 patients found that
RM detected new-onset silent AF in 3 patients which resulted in anticoagulation
therapy being started (tailored treatments were provided to the other 17 patients)
al.
Randomised controlled trials evaluating remote monitoring of ICDs – Arrhythmia and heart failure episodes (modified from lxiv)
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 19
Author
Country
System
N
Follow-Up
Findings
Al-Khatib et al.
(2010) lxv
United
States
Medtronic
Care Link®
151
6,
12
months
RM was compared to standard quarterly in-clinic device interrogations. The rate of
the composite endpoint (hospitalization, emergency room visits, unscheduled clinic
visits) did not differ significantly between groups. There was a significantly higher
detection rate of AF at follow-up in the RM group. There were no between-group
differences in cost
Bikou
et
(2010) lxvi
United
Kingdom
St Jude House
Call Plus®
20
1, 3,
months
To determine work impact and cost of RM. Total time for RM follow-up was
significantly shorter in the RM group, the in-clinic waiting time (30±18 mins) was
eliminated in the RM group, the time for actual device interrogation did not differ
between groups
al.
6
ICD/CRT-D
Crossley et
(2009) lxvii
al.
United
States
Medtronic
Care Link®
897
3 years
Assessed whether RM decreases the duration of post-operative hospitalization,
while maintaining safety levels. The event rate detected for clinically actionable
events (CAEs) was higher in the RM group: 66% of CAE events were detected
remotely, whereas for controls only 2% were detected during a standard
transtelephonic transmission. The median time to detect a CAE was significantly
faster in the RM group (4.9 vs 6.3 months)
United
States
Medtronic
Care
Link
Network®
1,997
15 months
To determine whether RM with wireless (automatic) physician notification reduces
the time from a clinical event to a clinical decision. There were no between-group
differences in mortality. The mean time from a clinical event to the clinical
decision was significantly faster (by 17 days) in the RM group. More alerts were
noted for out-of-range lead impedance in the RM group and the time to detect these
critical events was significantly faster. Replacing 4 clinic follow-up visits with RM
reduced total clinical visits by 38% (6.3 to 3.3 patient visits per year). There were
no between-group differences in health care utilization visits. The overall mean
length of hospitalization was significantly shorter for the RM group
115
12 months
Compared RM to conventional in office 3 month follow-up in ICD patients. There
were no significant between-group differences in hospitalisations or patient
mortality. There was a 63% reduction in office visits in the RM group. Over 80%
PREFER
(Pacemaker
Remote Followup
Evaluation
and Review)
Crossley et
(2011) lxviii
al.
CONNECT
(Clinical
Evaluation
of
Remote
Notification
to
Reduce Time to
Clinical decision)
Elsner
et
al.
(2006) lxix
REFORM Study
ICD/CRT
Germany
Biotronik
Home
Monitoring®
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 20
ICD/CRT
Halimi et
(2008) lxx
al.
of the home monitoring-induced events had high need evaluation
France/
Belgium
Biotronik
Home
Monitoring®
379
United
States
Biotronik
Home
Monitoring®
1,450
OEDIPE
Assessed the ability of RM to detect clinically actionable information sooner than
with current transtelephonic transmission and in office follow-up. There was a
significant decrease in medical reaction time to an event in the RM group. The
duration of hospitalization was significantly shorter in the RM group with the
majority of patients leaving hospital the same or next day. QOL was similar
between the two groups at 1 month follow up. Costs were lower after one month in
the RM group (but not significantly so)
(Optimized postoperative
surveillance
of
permanent
pacemakers
by
home monitoring)
Varma et al.
(2010) lxxi TRUST
(Lumos-T Safety
Reduced Routine
Office
Device
Follow-Up) Trial
15 months
ICD
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Assessed whether RM could safely reduce in-hospital device evaluations. There
were no between-group differences for morbidity. Adherence to the protocol
follow-up schedule was significantly higher in the RM group. The mean number of
in-clinic and in-hospital visits was significantly lower in the RM group (scheduled
in-office visits were reduced by 61%). The overall rate of adverse events did not
differ between groups. The time from onset of first arrhythmia to physician
evaluation was significantly faster in the RM group (1 day vs 35.5 days). The time
to detect clinically asymptomatic arrhythmia was also significantly shorter in the
RM group. In-office follow-up visits were reduced by 45% at 1 year. The authors
concluded that 1-2 minute follow-ups by RM provide a viable alternative to
outpatient or doctor visits which typically take 15 minutes twice a year
Page 21
Current (unpublished trials)
Author
Country
System
N
Follow Up
Findings
Kacet
et
al.
(2011) lxxii
Effectiveness and
Cost of ICD
Follow-up
Schedule
with
Telecardiology
(ECOST)
43 French
centres
Biotronik
Home
Monitoring®
433
27 months
Patients were randomly assigned to either daily RM or quarterly in-clinic
follow-up. Device- or patient-related event notifications by the RM system
could trigger in-clinic follow-up. RM was as safe as in-office visits and there
were no between-group differences in major adverse events. The RM group
had a 52% reduction in the number of inappropriate shocks (5% versus 10% in
the usual care group) and a 72% reduction in the risk of hospitalisations
related to inappropriate shock. RM had positive effects on battery longevity.
A secondary analysis of costs will be performed
Mabo (2010) lxxiii
Comparative
Follow-up
Schedule
with
Home Monitoring
(COMPAS)
43 French
centres
538
18 months
Randomized, multicenter clinical study evaluating the long-term follow up,
safety and efficacy of RM of pacemakers. RM was found to be comparable to
standard follow-up in terms of safety. Adverse events (e.g. death,
cardiovascular or pacemaker-related events) occurred significantly less
frequently in the RM group. There was a significant decrease in the time to
event management with the average time dropping from 145 days with
conventional follow-up to 28 days with RM. RM was associated with a 36%
decrease in the number of in-clinic visits
Mabo
et
al.
(2011) lxxiv
Evaluation
of
Tele Follow-up
(EVATEL) study
30 French
centres
1,501
12 months
Patients were randomised to receive either conventional in-office follow-up
visits or remote transmission of data from the ICD to the implant center every
three months. RM was shown to be a safe alternative to in-office follow-up.
There were no between-group differences in major adverse events (death,
hospitalization). Significantly fewer patients in the RM group experienced
inappropriate or ineffective therapy from their device. There was a 27%
reduction in the number of inappropriate shocks delivered by the ICDs in the
RM group (5% vs. 8% in controls)
Year
ICD
Biotronik
Home
Monitoring®
ICD
All brands of
devices
(4
types of ICDs)
AF = atrial fibrillation, CRT = cardiac resynchronization therapy, CRT-D = CRT defibrillator, HF = heart failure, ICD = implantable
cardioverter
defibrillators,
PM
=
pacemaker,
QOL
=
quality
of
life,
RM
=
remote
monitoring.
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 22
Appendix B
Appendix B: Goals of CIED remote monitoring systems
Patient related
Optimize quality of life
Optimize system to meet clinical requirements
Identify at-risk patients and initiate appropriate follow-up with safety corrective
actions and alerts
Triage other health problems and make appropriate referrals
CIED related
Document function
Identify and correct abnormal function
Safely maximise longevity of pulse generator
Identify when battery is approaching end of life, identify leads at risk of failure
Disease related
Document nature/frequency of arrhythmias, correlate with symptoms, determine
appropriateness of device response
Document (where possible) other physiologic parameters as part of chronic
disease monitoring
Monitor response to therapy
Communication
Maintain a patient database
Communicate clinical and device-related information to patients and healthcare
providers
Provide technical expertise and education
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 23
Appendix C
ARTG listing numbers for devices with remote monitoring capabilities
ARTG #
Manufacturer
Description
116038
Medtronic
CareLink programmer, model 2090-Pacemaker programmer
122545
Biotronik
Cardio Messenger - Telemetry transmitter, instrument data
123599
Boston Scientific
130439
Biotronik
ICS 3000 (with implantation module) - Pacemaker programmer
140355
Biotronik
CardioMessenger II – Telemetry transmitter, instrument data
142199
St Jude Medical
155884
Biotronik
163472
St Jude Medical
174544
St Jude Medical
176910
Boston Scientific
179170
Biotronik
ZOOM LATITUDE Programming System -
Rapid Programmer model 3831 – Active implantable device
communicator
CardioMessenger II-S - Telemetry transmitter, instrument data
Merlin@home Transmitter Model EX1100 - Pacemaker system
analyser, transtelephonic
Merlin Pacing System Analyzer Model EX3100 - Pacemaker system
analyser, noninvasive
LATITUDE AUNZ Communicator - transtelephonic
CardioMessenger-S - Telemetry transmitter, instrument data
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 24
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Varma N. (2009). Therapeutic Implications of Automatic Home Monitoring of Implantable
Cardiac Devices. Current Treatment Options in Cardiovascular Medicine, 11:336-72.
viii Clarke R.A., Driscoll A. 2009. Access and quality of heart failure management programs in
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Orlov M.V., Szombathy T., Chaudhry G.M., Haffeajee C.I., 2009. Remote
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Clarke R.A., Driscoll A. 2009. Access and quality of heart failure management programs in
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Nielsen, J.C., Kottkamp, H., Zabel, M., Aliot, E., Kreutzer, U., Bauer, A., Schuchert, A.,
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xi Heidbüchel, H., Lioen, P., Foulon, S., Huybrechts, W., Ector, J., Willems, R., & Ector, H.
(2008). Potential role of remote monitoring for scheduled and unscheduled evaluations of
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xii Klersy, C., De Silvestri, A., Gabutti, G., Regoli, F., & Auricchio, A. (2009). A meta-analysis
of remote monitoring of heart failure patients. Journal of the American College of Cardiology,
54:1683-94.
xiii Wilkoff, B.L., Auricchio , A., Brugada, J., Cowie, M., Ellenbogen, K.A., Gillis, A.M., Hayes,
D.L., Howlett, J.G., Kautzner, J., Love, C.J., Morgan, J.M., Priori, S.G., Reynolds, D.W.,
Schoenfield, M.H., & Vardas, P.E. (2008). HRS/EHRA Expert consensus on the monitoring of
Cardiovascular Implantable Electronic Devices (CIEDs): Description of techniques,
indications, personnel, frequency and ethical considerations. Europace, 10(6):707-25.
xiv Saxon, L.A., Hayes, D.L., Gilliam, R., Heidenreich, P.A., Day, J., Seth, M., Meyer, T.E.,
Jones, P.W. & Boehmer, J.P. (2010). Long-term outcome after ICD and CRT implantation
and influence of remote device follow-ip. The ALTITUDE Survival Study. Circulation,
122:2359-67.
Burri, H.,Heidbüchel, H., Jung, W., & Brugada, P. Remote monitoring: a cost or an
investment? Europace (2011) 13(suppl 2): ii44-ii48 doi:10.1093/europace/eur082
xv Klersy, C., De Silvestri, A., Gabutti, G., Regoli, F., & Auricchio, A. (2009). A meta-analysis
of remote monitoring of heart failure patients. Journal of the American College of Cardiology,
54:1683-94.
Heidbüchel, H., Lioen, P., Foulon, S., Huybrechts, W., Ector, J., Willems, R., & Ector, H.
(2008). Potential role of remote monitoring for scheduled and unscheduled evaluations of
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National Health and Hospitals Reform Commission: A Healthier Future For All Australians –
final report June 2009. Canberra: Department of Health and Ageing, 2009.
xvi Crossley, G.H. Chen, J., Choucair, W., Cohen, T.J., Gohn, D.C., Johnson, W.B., Kennedy,
E.E., Mongeon, L., R., Serwer, G.A., Qiao, H., & WiIlkoff, B.W., for the PREFER Study
Investigators. (2009). Clinical benefits of remote versus transtelephonic monitoring of
implanted pacemakers. Journal of the American College of Cardiology, 54(22):2012-9.
Crossley, G.H., Boyle, A., Vitense, H., Chang, Y., Mead, R.H., and CONNECT investigators.
(2011). The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical
Decision) Trial: The value of wireless remote monitoring with automatic clinician alerts.
Journal of the American College of Cardiology, 57:1181-89.
xvii Schoenfeld, M.H., Compton, S.J., Mead, R.H., Weiss, D.N., Sherfesee, L., Englund, J., &
Mongeon, L.R. (2004). Remote monitoring of implantable cardioverter defibrillators: a
prospective analysis. PACE - Pacing and Clinical Electrophysiology, 27(6 (Pt 1):757-63.
Varma, N., Stambler, B., & Chun, S. (2005). Detection of atrial fibrillation by implanted
devices with wireless data transmission capability. Pacing and Clinical Electrophysiology,
28(Suppl. 1):S133-S6.
xviii Varma, N., Epstein, A.E., Irimpen, A., Schweikert, R., & Love, C. for the TRUST
Investigators. (2010). Efficacy and safety of automatic remote monitoring for implantable
cardioverter-defibrillator for follow-up. The Lumos-T safely reduces routine office device
follow-up (TRUST) trial. Circulation, 122:325-32.
xix Varma, N., Epstein, A.E., Irimpen, A., Schweikert, R., & Love, C. for the TRUST
Investigators. (2010). Efficacy and safety of automatic remote monitoring for implantable
cardioverter-defibrillator for follow-up. The Lumos-T safely reduces routine office device
follow-up (TRUST) trial. Circulation, 122:325-32.
xx Kacet, S., & Daubert, J.C. (2011). ECOST: Safety of implantable cardioverter defibrillator
follow-up using remote monitoring: a randomized controlled trial. Program and abstracts of
the European Society of Cardiology Congress; August 27-31, 2011; Paris, France. Session
#707003 - 707004. 2011.
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 26
Mabo, P., & Auricchio, A. (2011). PURE: EVATEL: Remote follow-up of patients implanted
with an ICD: the prospective randomized EVATEL study. Program and abstracts of the
European Society of Cardiology Congress; August 27-31, 2011; Paris, France. Session
#707001 - 707002.
xxi Mabo, P. (2010). Home monitoring for pacemaker follow-up: Results of randomized
COMPAS trial. France. Session Pacing and ICDs. Cardiostim, 2010; Nice, France.
xxii Al-Khatib, S.M., Piccini, J.P., Knight, D., Stewart, M., Clapp-Channing, N., & Sanders,
G.D. (2009). Remote Monitoring of Implantable Cardioverter Defibrillators versus Quarterly
Device Interrogations in Clinic: Results from a Randomized Pilot Clinical Trial. Journal of
Cardiovascular Electrophysiology,1-6.
Marzegalli, M., Landolina, M., Lunati, M., Perego, G.B., Pappone, A., Guenzati, G., Campana,
C., Frigerio, M., Parati, G., Curnis, A., Colangelo, I., & Valsecchi, S. (2009). Design of the
evolution of management strategies of heart failure patients with implantable defibrillators
(EVOLVO) study to assess the ability of remote monitoring to treat and triage patients more
effectively. Trials, 10(42).
xxiii Fauchier, L., Sadoul, N., Kouakam, C., Briand, F., Chauvin, M., Babuty, D., & Clementy,
J. (2005). Potential cost savings by telemedicine-assisted long-term care of implantable
cardioverter defibrillator recipients. PACE - Pacing and Clinical Electrophysiology, 28(Suppl
1):S255-9.
xxiv Ricci, R.P., Morichelli, L., & Santini, M. (2009). Remote control of implanted devices
through Home Monitoring technology improves detection and clinical management of atrial
fibrillation. Europace, 11(1):54-61.
Crossley, G.H., Boyle, A., Vitense, H., Chang, Y., Mead, R.H., and CONNECT investigators.
(2011). The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical
Decision) Trial: The value of wireless remote monitoring with automatic clinician alerts.
Journal of the American College of Cardiology, 57:1181-89.
Halimi, F., Clementy, J., Attuel, P., Dessenne, X., & Amara, W. (2008). Optimized postoperative surveillance of permanent pacemakers by home monitoring: the OEDIPE trial.
Europace, 10(12):1392-9.
Lazarus, A. (2007). Remote, wireless, ambulatory monitoring of implantable pacemakers,
cardioverter defibrillators and cardiac resynchronization therapy systems: analysis of a
worldwide database. PACE - Pacing and Clinical Electrophysiology, 30 (Suppl 1):S2-S12.
Ricci, R.P., Morichelli, L., & Santini, M. (2008). Home monitoring remote control of pacemaker
and implantable cardioverter defibrillator patients in clinical practice: Impact on medical
management and health-care resource utilization. Europace, 10(2):164-70.
xxv Hauck, M., Bauer, A., Voss, F., Weretka, S., Katus, H.A., & Becker, R. (2009). "Home
monitoring" for early detection of implantable cardioverter-defibrillator failure: a single-center
prospective observational study. Clinical Research in Cardiology, 98(1):19-24.
Sacher, F., Probst, V., Bessouet, M., Wright, M., Maluski, A., Abbey, S., Bordachar, P.,
Deplagne, A., Ploux, S., Lande, G., Jaïs, P., Hocini, M., Haïssaguerre, M., Le Marec, H., &
Clémenty, J. (2009). Remote implantable cardioverter defibrillator monitoring in a Brugada
syndrome population. Europace, 11(4):489-94.
xxvi Remote monitoring systems for patients with implanted cardiac devices, June 2008,
MSAC application 1111.
xxvii Saxon, L.A., Hayes, D.L., Gilliam, R., Heidenreich, P.A., Day, J., Seth, M., Meyer, T.E.,
Jones, P.W. & Boehmer, J.P. (2010). Long-term outcome after ICD and CRT implantation
and influence of remote device follow-ip. The ALTITUDE Survival Study. Circulation,
122:2359-67.
Varma, N., Epstein, A.E., Irimpen, A., Schweikert, R., & Love, C. for the TRUST Investigators.
(2010). Efficacy and safety of automatic remote monitoring for implantable cardioverter-
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 27
defibrillator for follow-up. The Lumos-T safely reduces routine office device follow-up
(TRUST) trial. Circulation, 122:325-32.
Mabo, P. (2010). Home monitoring for pacemaker follow-up: Results of randomized COMPAS
trial. France. Session Pacing and ICDs. Cardiostim, 2010; Nice, France.
Crossley, G.H., Boyle, A., Vitense, H., Chang, Y., Mead, R.H., and CONNECT investigators.
(2011). The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical
Decision) Trial: The value of wireless remote monitoring with automatic clinician alerts.
Journal of the American College of Cardiology, 57:1181-89.
xxviii Medical Advisory Secretariat. (2011, April). Internet-based device-assisted remote
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xxx
Crossley, G.H., Boyle, A., Vitense, H., Chang, Y., Mead, R.H., and CONNECT
investigators. (2011). The CONNECT (Clinical Evaluation of Remote Notification to Reduce
Time to Clinical Decision) Trial: The value of wireless remote monitoring with automatic
clinician alerts. Journal of the American College of Cardiology, 57:1181-89.
Schoenfeld, M.H., Compton, S.J., Mead, R.H., Weiss, D.N., Sherfesee, L., Englund, J., &
Mongeon, L.R. (2004). Remote monitoring of implantable cardioverter defibrillators: a
prospective analysis. PACE - Pacing and Clinical Electrophysiology, 27(6 (Pt 1):757-63.
Ricci, R.P., Morichelli, L., & Santini, M. (2008). Home monitoring remote control of pacemaker
and implantable cardioverter defibrillator patients in clinical practice: Impact on medical
management and health-care resource utilization. Europace, 10(2):164-70.
Sacher, F., Probst, V., Bessouet, M., Wright, M., Maluski, A., Abbey, S., Bordachar, P.,
Deplagne, A., Ploux, S., Lande, G., Jaïs, P., Hocini, M., Haïssaguerre, M., Le Marec, H., &
Clémenty, J. (2009). Remote implantable cardioverter defibrillator monitoring in a Brugada
syndrome population. Europace, 11(4):489-94.
xxxi Ricci, R.P., Morichelli, L., & Santini, M. (2009). Remote control of implanted devices
through Home Monitoring technology improves detection and clinical management of atrial
fibrillation. Europace, 11(1):54-61.
Crossley, G.H., Boyle, A., Vitense, H., Chang, Y., Mead, R.H., and CONNECT investigators.
(2011). The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical
Decision) Trial: The value of wireless remote monitoring with automatic clinician alerts.
Journal of the American College of Cardiology, 57:1181-89.
Varma, N., Epstein, A.E., Irimpen, A., Schweikert, R., & Love, C. for the TRUST Investigators.
(2010). Efficacy and safety of automatic remote monitoring for implantable cardioverterdefibrillator for follow-up. The Lumos-T safely reduces routine office device follow-up
(TRUST) trial. Circulation, 122:325-32.
Kacet, S., & Daubert, J.C. (2011). ECOST: Safety of implantable cardioverter defibrillator
follow-up using remote monitoring: a randomized controlled trial. Program and abstracts of
the European Society of Cardiology Congress; August 27-31, 2011; Paris, France. Session
#707003 - 707004. 2011.
Mabo, P., & Auricchio, A. (2011). PURE: EVATEL: Remote follow-up of patients implanted
with an ICD: the prospective randomized EVATEL study. Program and abstracts of the
European Society of Cardiology Congress; August 27-31, 2011; Paris, France. Session
#707001 - 707002.
Mabo, P. (2010). Home monitoring for pacemaker follow-up: Results of randomized COMPAS
trial. France. Session Pacing and ICDs. Cardiostim, 2010; Nice, France.
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
Page 28
Al-Khatib, S.M., Piccini, J.P., Knight, D., Stewart, M., Clapp-Channing, N., & Sanders, G.D.
(2009). Remote Monitoring of Implantable Cardioverter Defibrillators versus Quarterly Device
Interrogations in Clinic: Results from a Randomized Pilot Clinical Trial. Journal of
Cardiovascular Electrophysiology,1-6.
xxxii Crossley, G.H. Chen, J., Choucair, W., Cohen, T.J., Gohn, D.C., Johnson, W.B.,
Kennedy, E.E., Mongeon, L., R., Serwer, G.A., Qiao, H., & WiIlkoff, B.W., for the PREFER
Study Investigators. (2009). Clinical benefits of remote versus transtelephonic monitoring of
implanted pacemakers. Journal of the American College of Cardiology, 54(22):2012-9.
Ricci, R.P., Morichelli, L., & Santini, M. (2008). Home monitoring remote control of pacemaker
and implantable cardioverter defibrillator patients in clinical practice: Impact on medical
management and health-care resource utilization. Europace, 10(2):164-70.
Santini, M., Ricci, R.P., Lunati, M., Landolina, M., Perego, G.B., Marzegalli, M., Schirru, M.,
Belvito, C., Brambilla, R., Guenzati, G., Gilardi, S., & Valsecchi, S. (2009). Remote
monitoring of patients with biventricular defibrillators through the CareLink system improves
clinical management of arrhythmias and heart failure episodes. Journal of Interventional
Cardiac Electrophysiology, 24(1):53-61.
xxxiii Klersy, C., De Silvestri, A., Gabutti, G., Raisaro, A., Curti, M., Regoli, F., & Auricchio, A.
(2011). Economic impact of remote patient monitoring: an integrated economic model derived
from a meta-analysis of randomized controlled trials in heart failure. European Journal of
Heart Failure, 13(4):450-9.
xxxiv Varma N. (2009). Therapeutic Implications of Automatic Home Monitoring of
Implantable Cardiac Devices. Current Treatment Options in Cardiovascular Medicine, 11:33672.
Al-Khatib, S.M., Piccini, J.P., Knight, D., Stewart, M., Clapp-Channing, N., & Sanders, G.D.
(2009). Remote Monitoring of Implantable Cardioverter Defibrillators versus Quarterly Device
Interrogations in Clinic: Results from a Randomized Pilot Clinical Trial. Journal of
Cardiovascular Electrophysiology,1-6.
Raatikainen M.J.P. Uusimaa, P., Van Ginneken, M.M.E., Janssen, J.P.G., & Linnaluoto, M.
(2008). Remote monitoring of implantable cardioverter defibrillator patients: A safe, timesaving, and cost-effective means for follow-up. Europace, 10(10):1145-51.
xxxv Kacet, S., & Daubert, J.C. (2011). ECOST: Safety of implantable cardioverter
defibrillator follow-up using remote monitoring: a randomized controlled trial. Program and
abstracts of the European Society of Cardiology Congress; August 27-31, 2011; Paris,
France. Session #707003 - 707004. 2011.
xxxvi Elsner, C.H., Sommer, P., Piorkowski, C., Taborsky, M., Neuser, H., Bytesnik, J., Geller,
J.C., Kottkamp, H., Wiesmeth, H., & Hindricks, G. (2006). A prospective multicenter
comparison trial of home monitoring against regular follow-up in MADIT II patients: additional
visits and cost impact. Computational Cardiology, 33:241-4.
xxxvii Fauchier L SN, Kouakam C, Briand F, Chauvin M, Babuty D, Clementy J. Potential cost
savings by telemedicine-assisted long-term care of implantable cardioverter defibrillator
recipients. PACE - Pacing and Clinical Electrophysiology. 2005;28(Suppl 1):S255-9.
xxxviii Klersy, C., De Silvestri, A., Gabutti, G., Raisaro, A., Curti, M., Regoli, F., & Auricchio,
A. (2011). Economic impact of remote patient monitoring: an integrated economic model
derived from a meta-analysis of randomized controlled trials in heart failure. European
Journal of Heart Failure, 13(4):450-9.
xxxix Raatikainen M.J.P. Uusimaa, P., Van Ginneken, M.M.E., Janssen, J.P.G., & Linnaluoto,
M. (2008). Remote monitoring of implantable cardioverter defibrillator patients: A safe, timesaving, and cost-effective means for follow-up. Europace, 10(10):1145-51.
xl Crossley G.H., Boyle A., Vitense H., Chang Y., Mead R.H., and CONNECT investigators.
The CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical
Decision) Trial: The Value of Wireless Remote Monitoring With Automatic Clinician Alerts. J.
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Al-Khatib S.M., Piccini J.P., Knight D., Stewart M., Clapp-Channing N., Sanders G.D., 2009
Remote Monitoring of Implantable Cardioverter Defibrillators versus Quarterly Device
Interrogations in Clinic: Results from a Randomized Pilot Clinical Trial. J Cardiovasc
Electrophysiol (1-6)
Elsner C., Sommer P., Piorkowski C. et al. 2006. A prospective multicenter comparison trial of
Home Monitoring against regular follow-up in MADIT II patients: additional visits and cost
impact. Comput Cardiol, 33: 241-4
xli Orlov M.V., Szombathy T., Chaudhry G.M., Haffeajee C.I., 2009. Remote Surveillance of
Implantable Cardiac Devices. PACE, 32: 928-39
xlii
Lazarus A.: Remote, Wireless, Ambulatory Monitoring of Implantable Pacemakers,
Cardioverter Defibrillators, and Cardiac Resynchronization Therapy Systems: Analysis of a
Worldwide Database. PACE 2007; 30:S2-S12.
xliii Elsner CH et al. A Prospective Mulitcenter Comparison Trial of Home Monitoring against
Regular Follow-up in MADIT II Patients: Additional Visits and Cost Impact. Computers in
Cardiology 2006; 33: 241-244.
xliv Medical_Advisory_Secretariat. Internet-based device-assisted remote monitoring of cardiovascular
implantable electronic devices: an evidence-based analysis (DRAFT). 2011.
xlv Brugada P. (2006). What evidence do we have to replace in-hospital implantable
cardioverter defibrillator follow-up? Clinical Research in Cardiology, 95(Suppl 3):III3-III9.
xlvi Ellery, S., Pakrashi, T., Paul, V., & Sack, S. (2006). Predicting mortality and
rehospitalization in heart failure patients with home monitoring--the Home CARE pilot study.
Clinical Research in Cardiology, 95(Suppl 3):III29-III35.
xlvii Hauck, M., Bauer, A., Voss, F., Weretka, S., Katus, H.A., & Becker, R. (2009). "Home
monitoring" for early detection of implantable cardioverter-defibrillator failure: a single-center
prospective observational study. Clinical Research in Cardiology, 98(1):19-24.
xlviii Joseph, G.K., Wilkoff, B.L., Dresing, T., Burkhardt, J., & Khaykin, Y. (2004). Remote
interrogation and monitoring of implantable cardioverter defibrillators. Journal of Interventional
Cardiac Electrophysiology, 11(2):161-6.
xlix Lazarus, A. (2007). Remote, wireless, ambulatory monitoring of implantable pacemakers,
cardioverter defibrillators and cardiac resynchronization therapy systems: analysis of a
worldwide database. PACE - Pacing and Clinical Electrophysiology, 30 (Suppl 1):S2-S12.
l Marzegalli, M., Lunati, M., Landolina, M., Perego, G.B., Ricci. R.P., Guenzati, G., Schirru,
M., Belvito, C., Brambilla, R., Masella, C., Di Stasi, F., Valsecchi, S., & Santini, M.(2008).
Remote monitoring of CRT-ICD: the multicentre Italian CareLink evaluation - ease of use,
acceptance, and organizational implications. PACE - Pacing and Clinical Electrophysiology,
31(10):1259-64.
li Masella, C., Zanaboni, P., Di, S.F., Gilardi, S., Ponzi, P., & Valsecchi, S. (2008).
Assessment of a remote monitoring system for implantable cardioverter defibrillators. Journal
of Telemedicine & Telecare, 14(6):290-4.
lii Mullens, W., Oliveira, L.P.J., Verga, T., Wilkoff, B.L., & Wilson Tang, W.H. (2010). Insights
from internet-based remote intrathoracic impedance monitoring as part of a heart failure
disease management program. Congestive Heart Failure, 16(4):159-63.
liii Nielsen, J.C., Kottkamp, H., Zabel, M., Aliot, E., Kreutzer, U., Bauer, A., Schuchert, A.,
Neuser, H., Schumacher, B., Schmidinger, H., Stix, G., Clémenty, J., Danilovic, D., &
Hindricks G. (2008). Automatic home monitoring of implantable cardioverter defibrillators.
Europace, 10(6):729-35.
Medical Technology Association of Australia
Business case for public funding of remote monitoring of CIEDs
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liv Raatikainen M.J.P. Uusimaa, P., Van Ginneken, M.M.E., Janssen, J.P.G., & Linnaluoto, M.
(2008). Remote monitoring of implantable cardioverter defibrillator patients: A safe, timesaving, and cost-effective means for follow-up. Europace, 10(10):1145-51.
lv Ricci, R.P., Morichelli, L., & Santini, M. (2008). Home monitoring remote control of
pacemaker and implantable cardioverter defibrillator patients in clinical practice: Impact on
medical management and health-care resource utilization. Europace, 10(2):164-70.
lvi Ricci, R.P., Morichelli, L., & Santini, M. (2009). Remote control of implanted devices
through Home Monitoring technology improves detection and clinical management of atrial
fibrillation. Europace, 11(1):54-61.
lvii
Ricci RP, Morichelli, L., Quarta, L., Sassi, A., Porfili, A., Laudadio, M.T., Gorgaro, A.,
Santini, M. Long-term patient acceptance of and satisfaction with implanted device remote
monitoring. Europace. 2010;12(5):674-9.
lviii Sacher, F., Probst, V., Bessouet, M., Wright, M., Maluski, A., Abbey, S., Bordachar, P.,
Deplagne, A., Ploux, S., Lande, G., Jaïs, P., Hocini, M., Haïssaguerre, M., Le Marec, H., &
Clémenty, J. (2009). Remote implantable cardioverter defibrillator monitoring in a Brugada
syndrome population. Europace, 11(4):489-94.
lix Santini, M., Ricci, R.P., Lunati, M., Landolina, M., Perego, G.B., Marzegalli, M., Schirru, M.,
Belvito, C., Brambilla, R., Guenzati, G., Gilardi, S., & Valsecchi, S. (2009). Remote
monitoring of patients with biventricular defibrillators through the CareLink system improves
clinical management of arrhythmias and heart failure episodes. Journal of Interventional
Cardiac Electrophysiology, 24(1):53-61.
lx Saxon, L.A., Hayes, D.L., Gilliam, R., Heidenreich, P.A., Day, J., Seth, M., Meyer, T.E.,
Jones, P.W. & Boehmer, J.P. (2010). Long-term outcome after ICD and CRT implantation
and influence of remote device follow-ip. The ALTITUDE Survival Study. Circulation,
122:2359-67.
lxi
Schoenfeld, M.H., Compton, S.J., Mead, R.H., Weiss, D.N., Sherfesee, L., Englund, J., &
Mongeon, L.R. (2004). Remote monitoring of implantable cardioverter defibrillators: a
prospective analysis. PACE - Pacing and Clinical Electrophysiology, 27(6 (Pt 1):757-63.
lxii
Theuns, D.A.M.J., Rivero-Ayerza, M., Knops, P., Res, J.C.J., & Jordaens, L. (2009).
Analysis of 57,148 transmissions by remote monitoring of implantable cardioverter
defibrillators. PACE - Pacing and Clinical Electrophysiology, 32(1).
lxiii Varma, N., Stambler, B., & Chun, S. (2005). Detection of atrial fibrillation by implanted
devices with wireless data transmission capability. Pacing and Clinical Electrophysiology,
28(Suppl. 1):S133-S6.
lxiv Medical_Advisory_Secretariat. Internet-based device-assisted remote monitoring of cardiovascular
implantable electronic devices: an evidence-based analysis (DRAFT). 2011.
lxv Al-Khatib, S.M. Piccini, J.P., Knight D., Stewart M., Clapp-Channing N., & Sanders G.D.
(2010). Remote monitoring of implantable cardioverter defibrillators versus quarterly device
interrogations in clinic: results from a randomized pilot clinical trial. Journal of Cardiovascular
Electrophysiology, 21(5):545-50.
lxvi Bikou, O., Licka, M., Kathoefer, S., Katus, H.A., & Bauer, A. (2010). Cost savings and
safety of ICD remote control by telephone: a prospective observational study. Journal of
Telemedicine & Telecare, 16(7):403-8.
lxvii Crossley, G.H. Chen, J., Choucair, W., Cohen, T.J., Gohn, D.C., Johnson, W.B.,
Kennedy, E.E., Mongeon, L., R., Serwer, G.A., Qiao, H., & WiIlkoff, B.W., for the PREFER
Study Investigators. (2009). Clinical benefits of remote versus transtelephonic monitoring of
implanted pacemakers. Journal of the American College of Cardiology, 54(22):2012-9.
lxviii Crossley, G.H., Boyle, A., Vitense, H., Chang, Y., Mead, R.H., and CONNECT
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