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.