The Big Debate
All patients should have remote
follow up
Stuart Allen
Principal Cardiac Physiologist
Manchester Heart Centre
Protagonist
Why I might lose this debate
• Cost of remote FU
• Is the need for remote follow up
exaggerated?
• Traditional view of ‘in clinic follow up’. it
works why change it?
• Physiologists love change!
• Is it threat to the physiologists role?
It isn’t remote monitoring
It’s remote management
Remote Patient Management :
Vision
From Remote Device Monitoring to Remote Patient Management
MORE CONTROL. LESS RISK
Economic &
Remote Programming
and Complete Remote
Patient Management
Clinical VALUE
Disease Management
(Disease Alerts: HF, Ischemia...)
Remote Monitoring
(Cellular adapter)
Remote Monitoring
(System Integrity Alerts, Land line)
Remote FU
Remote Device
Monitoring
Remote Patient
Management
TIME
The number of implants is increasing
*Including Austria, Belgium, Switzerland, Denmark, Finland, France, Germany, Ireland, Italy,
Netherlands, Norway, Portugal, Spain, Sweden and the UK. **Adapted from Eucomed 1 and
Stoepel C et al. (2009)2. 1 Eucomed. Available at: http://www.eucomed.be. Accessed: 2010. 2
Stoepel C et al. Telemed J E Health 2009;15(10):1026–30
Increased use of devices creates a significant growth in demand for
device follow-up resources
Growth:
140% (year 2000-2005)- actual
160% (year 2005-2010) - estimated
600,000
500,000
400,000
Total Implants
300,000
Total Followup
200,000
100,000
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Economic modelling based on CCAD data
NICE recommendations are 5 FU per year – model based on 1.3 pacemaker FU and 3 ICD / CRT FU.
Total Enrolment
Remote follow up today….
800
700
600
500
400
300
200
100
0
•
•
•
•
Approx 50% centres < 50 patients enrolled
Approx 10-15% centres >250 patients
Majority 50-250 patients
> 250 patients -where the pain comes!
Miss Geraldine Mcparland has reported “phenomenal”
results in terms of time saved with Medtronics’
CareLink system
•
•
•
– 185 pt transmission were assessed in 15.4 hrs = 2 working day
– Without CareLink these pt checks would have taken 77 hours = 11 working
days
– Hospital staff working days saved = 9
Money Saved
– €1,188 ambulance and other transport fees were avoided
– 11% of patients avoided having to take time of work
– 2 hospital admissions were avoided
– CareLink reduced the overall burden of follow up care
Over 97% of patient preferred the Medtronic CareLink system
100% of patients and carers found the system easy to use
Publication The Irish
Times -2008
Many remote FU trials
Potential Role of remote FU
Relevant Findings During ICD Follow-up Visits
•
Scheduled
Unscheduled
•None
•ICD intervention appropriate
ICD intervention inappropriate
Arrhythmia without ICD therapy
•Device related
Battery depletion (ERI)
Excessive charge time
Shock impedance rise
Pacing lead problem:
pacing ± sensing ± impedance
•Clinical
Heart failure
Angina pectoris
Other clinical findings
n = 1530
78.2%
4.4%
1.6%
3.3%
(1197)
(68)
(25)
(50)
n = 175
19.4%
38.6%
19.4%
9.1%
(34)
(68)
(34)
(16)
1.0%
0.5%
0.0%
(15)
(8)
(0)
0.6%
0.0%
0.6%
(1)
(0)
(1)
0.7%
(10)
0.0%
(0)
2.7%
0.4%
6.7%
(41)
(6)
(102)
2.3%
1.1%
8.6%
(4)
(2)
(15)
Heidbüchel H et al. Europace 2008; 10:351-7
In clinic follow up
• 55% - 75% - no programming changes
• The traditional device clinic needs to
change
• Future -Less device clinics more
Arrhythmia and HF clinics
• Physiologist lead – state registration will
mean we can take a lead in disease
management
Current need
•
•
•
•
More device trained staff
More rooms
More TIME
New Heart Rhythm UK standards – In
clinic follow up time recommended 30 to
45 mins – not just device check!
• With ever increasing diagnostics available
we need to do something different!
today
•
•
•
•
•
ICD’s
CRT-D
CRT-P
Pacemakers
ILR’s
can we manage these patients
differently?
Current devices
• ICD’s – all the studies show that remote follow
up can reduce unnecessary clinic visits –
phantom shocks, single therapies
• CRT – heart failure diagnostics
• Pacemakers – problems are rare but lead
complications can be life threatening.
AF diagnostics – why shouldn’t we treat these
patients earlier?
• Ever increasing sensors and diagnostics
especially HF – including pacemakers
• ILR’s -
And When the Patient Leaves the Clinic…
• Identifying asymptomatic AF may be difficult due to infrequent office visits
• Automatic AF alerts via Merlin@Home® transmitter and Merlin.net PCN can
provide an opportunity for early intervention and anticoagulation
• Early intervention can potentially reduce stroke risk
Scheduled
Follow-up
Wk1 Wk2
Patient
without
Remote
Monitoring
Patient
with Remote
Monitoring
New onset
asymptomatic AF
Wk3
Wk4
Wk5 Wk 6 Wk 7 Wk 8 Wk 9
Scheduled
Follow-up
Wk
10
Wk
11
Patient potentially at increased stroke risk for nine weeks
Alerted next day with daily monitoring. Patient treated as
deemed appropriate by physician
Wk
12
High Incidence of AF in Device
Patients
1
mode switch episodes.
Heart Rhythm 2007; 4 (5S):S129-30.
NSVT
0.8
0.7
AFib
0.6
0.5
0.0
CHARM Preserved clinical trial.
CTOPP, MOST UKPACE clinical trials.
3 SOLVD clinical trial.
4 Augostini RS et al. A novel lead design reduces far
field R-waves (FFRWS)
and decreases the incidence of inappropriate automatic
2
VF
VTsust
0.9
Events Free
• 40% of patients with heart
failure1 and 10-30% of those
with bradycardia2 and
tachycardia3 have atrial
fibrillation (AF)
• 27% of acute MI (myocardial
infarction) patients had
new onset of AF in one year4
1.0
0
200
400
600
Time (days)
27% of acute MI patients had
a new onset of AF in one year
800
Which Patients are Affected by AF?
Prevalence of AF increases with age in both men and women.
Go AS, Hylek EM, Phillips KA, et al. Prevalence of diagnosed atrial fibrillation in adults. JAMA. 2001;
285:2370-2375.
Manchester Heart Centre Sept
2012
• Device population 4000+ - 1108 patients on
remote follow up
- 133 ICD’s
- 368 CRT-D’s
- 147 CRT -P
- 190 ILR’s
- 270 pacemakers
Carelink. Merlin, Cardio messenger and Latitude
The next challenge
• Looking at different models of ‘remote
follow up
• Cost - particularly with brady
• Patient access
Remote management
• Empowers patients
• Doesn’t have to be costly – walk in
centres, GP surgeries, pharmacies, Tesco
etc
• The technology bus is arriving and we
need to be driver!
“Unpaired” Mode Merlin@home®
Shortens time to interrogation, enables faster clinical decisions
Interrogation on site w/out programmer:
Emergency Department, Device Clinic,
Remote Dispensary etc.
Merlin.net® PCN
ISO 27001
Fax Report
Email Report
128 Bit SSL Encryption
Report contains:
 Fastpath™ summary
 Episodes summary
 Most recent VT/VF
episode + SEGM
 Diagnostics
summary
 Parameters
summary
Reports can be
emailed to
designated
person(s) for
remote consultation
Transmission
to Merlin.net
Inductive “Unpaired” M@h located at the site:
Capable of interrogating any SJM CRM device
compatible with Merlin@home – Accent/Anthem,
Epic/Atlas, Current/Promote, Unify/Fortify,
Ellipse/Assura
24
Mobile
DirectAlerts
Transmission also
sent to home EP
clinic* (if patient is
enrolled in
Merlin.net). Alerts can
be delivered via
Mobile DirectAlerts®
*Transmission appears as patient initiated on recent transmissions page.
Additional note in the ‘Alerts Summary’ Report
In hospital remote follow up
• CCU –
• A&E - analysis of syncope, device
therapies
• In clinic – patients wont have to
wait
CareLink Express™
Connected Care Solution
The CareLink ExpressTM
Solution
Carelink Express
•
•
•
•
Pilot studies are near completion
Looking at streamlining in clinic follow up
Patients download and go home
Triage – arrhythmias, HF and device
issues
CareLink Express™
Designs
• Pilot studies are near completion
• Looking at streamlining in clinic
follow up
• Patients download and go home
• ?Triage – arrhythmias, HF and
device issues
www.eetimes.com/
gizmodo.com
electronics-news/4229302/Plessey-samples-electric-potenti al-sens or
/5119681/totos-intelligence-toilet-ii-smartl y-meas ures-the-tempe rature-of-your-pee-among-ot her-things
stroke avoided
your doctor
alerted
Sensor detects changes in electric field through clothing and through walls for
www2.electronicproducts.com/E
ECG monitor. siliconsouthwest.co.uk/index.php/2011/06/plessey-launches-first-electric-potential-sensor-chip/
The EPIC series sensors are the first to measure changes in an electric field much
as a magnetometer detects changes in a magnetic field, requiring no physical or
resistive contact to take readings. Medical devices that are simply held close to
a patient’s chest, without wetting or shaving off hair, to obtain a detailed ECG.
Driven Right Leg circuit
This video is a practical demonstration of the automotive
application for non-contact ECG measurements, through
clothing in the difficult environment of a car.
www.plesseysemiconductors.com/products/epic/videos/
EPIC Technical Details
www.plesseysemiconductors.com/products/epic/technical/
The release of EPIC technology into the wider commercial
environment has been talked about as being disruptive.
The technology is certainly novel in its operation and opens up a wide range of fields.
Conclusions
• All device patients WILL have remote
follow up
• AF + HF management protocols needed
• Remote follow up still needs significant
staff resources
• The way Physiologists work will change
• Don’t do a debate after the gala dinner!!
Thank you