Evropské zkušenosti s úhradou dálkové monitorace pacientů s implantáty (CIED) M. Táborský
11.04.2013
Vývoj populační struktury v EU: 1990-2060
Source: Eurostat; excludes French overseas departments in 1990; 2010, provisional; 2020-2060 data are projections (EUROPOP2010 convergence scenario).
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Význam dálkové monitorace pro komplexní pokročilý management pacienta
ICD/KS Adheres to device parameters requirements for remote FU
HRS/EHRA Expert Consensus on Remote Monitoring
Meets recommendations for frequency of remote monitoring
Advanced patient management
Systém dálkové monitorace
Principy dálkové monitorace Dálková monitorace KS a ICD: zahájena celosvětově 2000 a v ČR 2003
Patient with Home Monitoring implant
Mobile patient device: CardioMessenger
Data transmission via cellular network
BIOTRONIK Service Center
View data via Internet, email, SMS
BIOTRONIK Home Monitoring designed to Enhance patient care & device surveillance Perform remote monitoring & remote follow-ups Optimize clinic resources Výsledky studií TRUST a EVATEL prokazují efektivitu a bezpečnost dálkové monitorace KS a ICD systémů
Klinické aspekty dálkové monitorace Immediate clinical response to critical HM-reports
Change in antiarrhythmia therapy
44%
Change in anticoagulation
30%
No changes in therapy
17%
Cardioversion procedure
Source:
Ricci RP et al., Europace 2008; 10: 164-170
9%
White Book ICD Data: Implantace na 1 mil. obyvatel 2011
% nárust implantátů: 2005-2010
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In the US, the burden of ICD monitoring is even more dramatic There is a need to manage more patients more efficiently • Currently 235,000 ICD patients in North America • 2,065,000 ICD follow-ups in 2006 • 36 years of ICD follow-up time required to check patients just in 2008 (assume 20 minutes per follow-up) • ICD patients will increase by 4.65% each year* • By 2013, there will be 308,000 patients requiring 47 years of follow-up time per year * Growth projections from the 2009 Global Markets for Cardiac Rhythm Management minus death rates estimated from MADIT II Study.
ECOST Study
European Heart Journal (2013) 34, 605-614 doi:10.1093/eurheartj/ehs425
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ECOST: Výsledky
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Koncensus EHRA/ESC/HRS DaMo
Dubner S, Auricchio A, Steinberg JS et al: Ann Noninvasive Electrocardiol 2012:17:36-56
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Experts’ Consensus of Remote Monitoring (Dubner/Auricchio, et al.) proposes a guidance for optimal monitoring of cardiac implantable devices
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“Remote monitoring of CIEDs is indicated when the patient’s medical condition is stable and no anticipated device programming is required.”
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“…it is recommended that any patient with a CIED be assessed in person at least once a year.”
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“Remote monitoring has value during the maintenance phase of CIED follow-up (stable device function), during accelerated follow-up to plan elective device replacement and in the case of a field safety corrective action/safety alert where accelerated monitoring may detect a CIED malfunction.”
CIED - Cardiovascular Implantable Electronic Device
Dubner S, Auricchio A, Steinberg JS et al: Ann Noninvasive Electrocardiol 2012:17:36-56.
Definice cílů DaMo Equipment
Devices
PM-ICD-CRT-ILR
Remote FU
Devices interrogation Device programming Programmer Home monitoring Remote monitoring Remote FU Remote monitoring Pt initiated interrogations
Telemetry to retrieve information Bidirectional telemetry Receive and transmit info via telemetry Remote device able to communicate with CIED Remote wireless communication systems Programmable scheduled transmissions Automatically unscheduled transmissions Nonscheduled FU as a result of a patient experiencing a real or perceived clinical event
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Přehled dostupných systémů Medtronic CareLinkTM
Biotronik Home MonitoringTM
Boston Scientific LatitudeTM
Sorin SMARTVIEWTM
St Jude Merlin.netTM
Wireless communication with implanted device
Radiofrequency
Radiofrequency
Radiofrequency
Radiofrequency
Radiofrequency
Data transmission
GSM network
Analog phoneline and GSM network
Analog phoneline
Analog or GSM
Analog or GSM
Transmitter
Mobile or stationary (GSM)
Stationary
Stationary
Stationary
Stationary
Frequency of transmissions
Scheduled FU; Daily FU; Alert events
Scheduled FU; Alert events; on patient demand
Scheduled FU; Alert events
Sheduled FU; Alert events
Scheduled FU; Alert events
Remote follow-up
Yes
Yes
Yes
Yes
Yes
Remote monitoring
Yes
Yes
Yes
Yes
Yes
Physician notification
SMS, e-mail, fax
SMS, e-mail
Fax, phone
Fax, e-mail, SMS
Fax, e-mail, SMS
Feedback to patient via transmitter
LED indicating normal status or call to clinic
Confirmation for successful interrogation and transmission
Automatic text and audio messages
LED indicating HM status
LED indicating call to clinic, automated phone calls
IEGM (real time at remote follow-up)
30 seconds (monthly periodic EGMs)
10 seconds
10 seconds
7 seconds
30 seconds
IEGM (arrhythmic episodes)
All memorized episodes
All memorized episodes
All memorized episodes
All memorized episodes
All memorized episodes
FDA & CE Mark system approval
Yes
Yes
Yes
No
Yes
Special features
Automatic RV and LV thresholds Send phone calls to pts Comprehensive heart failure monitor, intrathroracic impedance measurement (CE-Mark only) Configurable red and yellow alerts Alerts fully configurable online Patient callback Electronic health record export compatibility Devices available for remote monitoring
Automatic RA, RV and LV (Consulta and Protecta XT) pacing thresholds Optivol® lung fluid status alert Configurable red and yellow alerts ILR Remote Monitoring PDF export of patient reports Any already implanted devices available for remote monitoring
Optional wireless weight scales and BP cuffs Configurable data transmission to associated caregivers Configurable red and yellow alerts Electronic health record data export capability
Patient initiated transmissions SMARTVIEW HF featuring Ph.D. clinical status PDF export of patient reports Access for heart failure specialists and general cardiologist
Alerts fully configurable online Send phone calls to pats. CoRVUE fluid status alert Automatic RA, RV, and LV pacing thresholds (next generation of ICDs)
RA, right atrial; RV, right ventricular; LV, left ventricular; IEGM, intracardiac electrogram; BP, blood pressure. Modified from Burri and Senouf.6
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Úhrada dálkové monitorace
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EHRA /ESC Aktivita
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Klíčové prvky úhrady
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Přehled úhrad v 5 klíčových zemích EU
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Potencionální benefity úhrady DaMo
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Principy specifické úhrady DaMo v SRN
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Doporučení pro další postup
• v každé zemi EU – specifický přístup národní principy úhrady • výrobci ekonomicky akceptovatelné systémy – bez dalšího zbytečného zatížení systému • klinici akceptace DM pozitivní edukace pacientů verifikace ekonom. aspektů 21
Situace v České republice
• Není reimburstment technologie • Od roku 2010 : specifický kód číselníku VZP pro DM (lékařský výkon) • Tento výkon nebyl nasmlouván žádnému ZZ v ČR • DM jako součást CIED je plátci ZP vnímána jako „nepodstatná luxusní zbytečnost“ 22
Implementace nejnovějších metod eHealth do výuky lékařských oborů CZ.1.07/2.2.00/28.0146
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