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EHRA Summit 2010E health and personalized health care in arrhythmiasE‐health and personalized health care in arrhythmias
22‐23 March 2010 – European Heart House Sophia Antipolis
Telemonitoring in arrhythmias and CRM devicesTelemonitoring in arrhythmias and CRM devices
National experiences: Italyp y
Renato P. RicciVice President AIAC
Cardiovascular Department – San Filippo Neri Hospital – Rome, Italy
System availability in Italyy y y
Home Monitoring™ BiotronikHome Monitoring™, Biotronik
CareLink™, Medtronic
Merlin.net SystemTM, St. Jude Medicaly ,
LatitudeTM, Boston Scientific
Biotronik Home Monitoring in Italy(i t d d i 2000 b t 2800 ti t ll d)(introduced in 2000; about 2800 patients enrolled)
2 000
1607
1752
1 600
1.800
2.000
1138
12941378
1.200
1.400
1.600
r
686
872
1001
800
1.000
1.200
Num
ber
290
546
686
400
600
290
0
200
gen-07 dic-07 mar-08 giu-08 set-08 dic-08 mar-09 giu-09 set-09 dic-09
Actively followed patients in the web site
Biotronik Home Monitoring in ItalyBiotronik Home Monitoring in ItalyRegional distribution of patients and centres
PATIENTS CENTRES
608
747
700800900
evic
es
54
40
50
60
ters
608
397400500600
activ
ated
d 40 39
30
40
of a
ctiv
e ce
nt100200300
num
ber
of a
10
20
num
ber
o0
nord centro sud
n
0nord centro sud
Medtronic CareLink in ItalyPilot phase5 t
126
126
Market release
• 5 centres
• 67 patients
nts
in
nts
in
tals
tals
patie
npa
tien
hosp
iho
spi
•• 8 centres •• 62 centres •• 119 centres
5300
5300
pp hh
• 149 pts • 1073 pts • 4224 pts
CL Wireless introduction
55New web site
Nov 06 June 07Sept 07
Dec 07 Dec 08 Dec 09 Feb 10
Medtronic CareLink in ItalyMedtronic CareLink in ItalyDevices
4.000
3 5004.000
2 5003.0003.500
1 5002.0002.500
TachyBradyReveal900
400500
1.0001.500 Reveal
0500
febbraio-10
St Jude Merlin.net System in ItalyIntroductionIntroduction July 6, 2009
Active Active Centres Centres in Italyin Italy 21
NorthNorth 12
MiddleMiddle 5
SouthSouth 4
Patients Patients enrolledenrolled 167
of whom with GSM/UMTSof whom with GSM/UMTS 40
Boston Latitude System in ItalyIntroductionIntroduction July 7, 2009
Active Active Centres Centres in Italyin Italy 33
NorthNorth 13
MiddleMiddle 4
SouthSouth 16
Patients Patients enrolledenrolled 135
of whom with HF sensorsof whom with HF sensors 38
Telecardiology working groupTelecardiology working group
Consensus DocumentConsensus Document
Il monitoraggio remoto dei dispositivi impiantabili: Il monitoraggio remoto dei dispositivi impiantabili: tecnologie disponibili, indicazioni, modelli organizzativi,tecnologie disponibili, indicazioni, modelli organizzativi,tecnologie disponibili, indicazioni, modelli organizzativi, tecnologie disponibili, indicazioni, modelli organizzativi,
accettabilità, responsabilità ed aspetti economici.accettabilità, responsabilità ed aspetti economici.
R. Ricci, G. Calcagnini, A. Castro, F. Giada, D. Igidbashan, M. R. Ricci, G. Calcagnini, A. Castro, F. Giada, D. Igidbashan, M. , g , , , g ,, g , , , g ,Landolina, D. Melissano, G.B. Perego, T. ToselliLandolina, D. Melissano, G.B. Perego, T. Toselli
AIAC web site: AIAC web site: www.aiac.itwww.aiac.it 14 giugno 200914 giugno 2009Giornale Italiano di Aritmologia e Cardiostimolazione 2009,12:92Giornale Italiano di Aritmologia e Cardiostimolazione 2009,12:92--119.119.
Organizational aspects: Human Sources
Nurse
Physiciany
Patient training and educationWeb site data enteringWeb site data enteringHM data and alert reviewingData screeningS b i i i i l h
Informed consentsubmissionOverview and checkSubmitting critical cases to the
physicianContact with the patients
Overview and checkClinical judgement in critical cases
Monitoring of patient complianceand therapy benefits
Organizational Model (based on Primary Nursing Model)(based on Primary Nursing Model)
NURSE or TECHNICIANNURSE or TECHNICIAN PHYSICIANPHYSICIANNURSE or TECHNICIANNURSE or TECHNICIANCheck for appropriate
transmission
PHYSICIANPHYSICIAN
of the data on the web site
YesCall the patients No
Analisys of the reports on the website and submission of the critical cases to the physician.
patients
critical cases to the physician.
Revision of critical cases
In case of trouble both may call the patients for further follow-up
or therapy adjustement
Home Monitoring in clinical practiceWeb data analysis (April 2006 – June 2007)
Analysis number: 2512 (nurse 2249 – physician 263)
Web data analysis (April 2006 June 2007)
Mean number of analysis per patient: 22 + 19 (1-100)
b d l b hb d l b h
NumberNumber PercentagePercentageClassification of eventsClassification of events
web data analysis by the nurseweb data analysis by the nurse
Number Number
Everything fineEverything fine
PercentagePercentageClassification of eventsClassification of events
20612061 92%92%
Ask the physician
Call the patient for follow-up
133133 6%6%
55 0.2%0.2%Call the patient for follow up
Contact the patient by phone
55 0.2%0.2%
5050 2.2%2.2%
transmissiontransmissioninterruptioninterruption
Ricci R, Morichelli L, Santini M: Home monitoring in clinical practice… Europace 2008;10:164-70
Home MonitoringTM in clinical practiceWeb site sessions – health care source consumptionWeb site sessions – health care source consumption
tempo medio connessione per paziente Time consumption per 100 patients/weektempo medio connessione per paziente
01.55 6070
p p p
6151
01.36
02.48 totale
medico
IP
p< 10-7 30
4050
min
00.00 01.26 02.53 04.19 05.46minuti 0
1020
overall nurse physician
10
overall nurse physician
Ricci R, Morichelli L, Santini M: Home monitoring in clinical practice… Europace 2008;10:164-70
AIAC to certify nurses / technicians
1° course 2008 – 2009 with final exam on September 24 20091 course 2008 2009 with final exam on September 24, 2009 in Bellaria: 70 nurses / technicians certified
2° course 2009 – 2010 with final exam on April, 17, 2010 in Catania, in progress
Telecardiology working groupTelecardiology working group
National ModelNational Model
Information to the patient regarding the use of remote monitoring system of implanted electronic devicesmonitoring system of implanted electronic devices (pacemaker, loop recorder, ICD): purposes, technical aspects, privacy, organizational aspects, patient and clinical staff p y, g p , pduties, emergency management.
P i i f d h f i iPatient informed consent to the use of remote monitoring system of implanted electronic devices
Reimbursement issues
COUNTRYCOUNTRY IInn--clinicclinicdevice checkdevice check
RemoteRemote device device checkcheck
RemoteRemote disease disease managementmanagement
GermanyGermany XX
Portugal Portugal XX
SpainSpain n/an/a n/an/a n/an/a
UKUK XXUKUK XX
NetherlandsNetherlands ∞∞ XX
NordicsNordics ∞∞ XX
FranceFrance XX XX
ItalyItaly XX XXSwitzerlandSwitzerland XX XX
BelgiumBelgium XX XX
Remote Monitoring of implanted devices R i i h fi AF l Reaction time to the first AF alert
InterquartileInterquartile interval(days)
Median (days)
10 24450Median time from the last in-hospitalfollow-up visit to the detection and
75 170148
the first intervention for AF
Median value of reaction time to AF 75 170148Median value of reaction time to AFin advance to the scheduled follow-up
166 pts, follow-up 488 ± 203 days33 pts (20%) alerts for AF (52% no prior history of AF)73% asymptomatic 18% mildly symptomatic 9% severely symptomatic
Ricci R, Morichelli L, Santini M: HM management of AF… Europace 2009;11:54-61.
73% asymptomatic,18% mildly symptomatic 9% severely symptomatic
(J Cardiovasc Electrophysiol, Vol. 20, pp. 1244-1251, November 2009)
Home Guide Registry(Biotronik Home Monitoring System)
Objectives of the Registry
T l tTo evaluate:clinical application of a New Organizational Model in standard practice;
clinical benefits obtained through remote control of patients with implanted devices;control of patients with implanted devices;
H lth tiHealth care resource consumption.
Home Guide Registry enrollment curveHome Guide Registry enrollment curve
800
700
800
749
500
600749
300
400
d pa
tient
s
200
300
Enro
lled
0
100
Nov‐07
Feb‐08
Jun‐08
Sep‐08
Dec‐08
Mar‐09
Jul‐09
Oct‐09
Jan‐10
May‐10
MORE – CARE studyMedtronic Care Link system
The MORE-CARE study is aimed at demonstrating f f Cthe superiority of a management strategy of CRT-D
patients based on continuous remote monitoring, i h h d dwith respect to the standard management strategy
based only on scheduled in-office visits.
Study Steering Committee: G. Boriani, Bologna, Italy, H. Burri, Genéve,Study Steering Committee: G. Boriani, Bologna, Italy, H. Burri, Genéve, Switzerland, A. Da Costa, Saint-Etienne, France, S. Favale, Bari, Italy, J. Kautzner, Prague, Czech Republic, X. Navarro Medtronic Iberica, Spain, A. Quesada Valencia Spain R P Ricci Rome ItalyQuesada, Valencia, Spain, R.P. Ricci, Rome, Italy
MORE CARE t dMORE – CARE study
TARIFF studyHealth Economics Evaluation Registry
For Remote Followupp
Study Purposes
1.To evaluate costs and effects of remote monitoring f ICD b th M li @h t hof ICD by the Merlin@home system when
compared with standard in-hospital follow up.
2. To identify through the actually measured overall t d b fit th i t t fcosts and benefits the appropriate amount of
reimbursement for remote monitoring of implanted d idevices
TARIFF studyTARIFF studyEndpointsp
To evaluate the actual costs related to remote monitoring and to standard follow-up during 1-year g p g yfollow-up from the point of view of:
the patientpthe hospitalthe National Health Care System.y
To evaluated patient quality of life.
Sample size: 200 patients (100 remote follow-up and 100 standard follow-up. As of March 17, 2010,21 patients enrolled.