Evropské zkušenosti s úhradou dálkové monitorace pacientů s implantáty (CIED)

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1 Evropské zkušenosti s úhradou dálkové monitorace pacientů s implantáty (CIED) M. Táborský

Vývoj populační struktury v EU: 1990-2060 Source: Eurostat; excludes French overseas departments

2 Vývoj populační struktury v EU: Source: Eurostat; excludes French overseas departments in 1990; 2010, provisional; data are projections (EUROPOP2010 convergence scenario). 2

Význam dálkové monitorace pro komplexní pokročilý management pacienta ICD/KS Adheres to device parameters requirements for remote FU Advanced

3 Význam dálkové monitorace pro komplexní pokročilý management pacienta ICD/KS Adheres to device parameters requirements for remote FU Advanced patient management HRS/EHRA Expert Consensus on Remote Monitoring Meets recommendations for frequency of remote monitoring Systém dálkové monitorace

4 Principy dálkové monitorace Dálková monitorace KS a ICD: zahájena celosvětově 2000 a v ČR 2003 Patient with Home Monitoring implant Mobile patient device: Cardio- Messenger Data transmission via cellular network BIOTRONIK Service Center View data via Internet, e- mail, 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

5 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 9 % Source: Ricci RP et al., Europace 2008; 10:

6 White Book ICD Data: Implantace na 1 mil. obyvatel 2011

7 % nárust implantátů:

8 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 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.

9 ECOST Study European Heart Journal (2013) 34, doi: /eurheartj/ehs425 9

10 ECOST: Výsledky 10

11 Koncensus EHRA/ESC/HRS DaMo Dubner S, Auricchio A, Steinberg JS et al: Ann Noninvasive Electrocardiol 2012:17:

12 Experts Consensus of Remote Monitoring (Dubner/Auricchio, et al.) proposes a guidance for optimal monitoring of cardiac implantable devices Remote monitoring of CIEDs is indicated when the patient s medical condition is stable and no anticipated device programming is required. it is recommended that any patient with a CIED be assessed in person at least once a year. 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.

13 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 13

14 Přehled dostupných systémů Wireless communication with implanted device Biotronik Home Medtronic CareLink TM Boston Scientific Latitude TM Sorin SMARTVIEW TM St Jude Merlin.net TM Monitoring TM 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, , fax SMS, Fax, phone Fax, , SMS Fax, , SMS Feedback to patient via transmitter IEGM (real time at remote follow-up) LED indicating normal status or call to clinic 30 seconds (monthly periodic EGMs) Confirmation for successful interrogation and transmission Automatic text and audio messages LED indicating HM status 10 seconds 10 seconds 7 seconds 30 seconds LED indicating call to clinic, automated phone calls IEGM (arrhythmic episodes) All memorized episodes All memorized episodes All memorized episodes All memorized episodes All memorized episodes FDA & CE Mark system approval Special features Yes Yes Yes No Yes 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 RA, right atrial; RV, right ventricular; LV, left ventricular; IEGM, intracardiac electrogram; BP, blood pressure. Modified from Burri and Senouf.6 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) 14

15 Úhrada dálkové monitorace 15

16 EHRA /ESC Aktivita 16

17 Klíčové prvky úhrady 17

18 Přehled úhrad v 5 klíčových zemích EU 18

19 Potencionální benefity úhrady DaMo 19

20 Principy specifické úhrady DaMo v SRN 20

21 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

22 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

23 Implementace nejnovějších metod ehealth do výuky lékařských oborů CZ.1.07/2.2.00/

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