Dr. Sven Bode 24. Treffpunkt Medizintechnik 1. Juli Telemetrische Herzüberwachung Eine Dekade BIOTRONIK Home Monitoring

Transcription

1 Dr. Sven Bode 24. Treffpunkt Medizintechnik 1. Juli 2010 Telemetrische Herzüberwachung Eine Dekade BIOTRONIK Home Monitoring RF GPRS GPRS https 0

2 Agenda Introduction to active implants and Home Monitoring Development steps over the last decade Future trends Summary 1

3 The pathway from an idea for a new active implant to return of investment: 10 years minimum Idea Active Implants 1 2 N=25 3 Research prototype I Animal studies/ in-vitro tests Development prototype II >2 yrs. 1 year >2 yrs. 4 5 N=100 6 Production in small quantities Clinical study N= Health New economic reimbursement study code Market approval (eg. CE, FDA) 0.5 yrs. >2 yrs. 0.5 yrs. Serial production and market introduction >2 yrs. >1 yrs. 0.5 yrs. Typical case numbers Typical duration 2

4 The vision in the late 1990s original picture 3

5 Agenda Introduction to active implants and Home Monitoring Development steps over the last decade Future trends Summary 4

6 The antenna and RF circuitry were integrated in the standard device can and header Pacemaker Antenna in the header ICD 5

7 BIOTRONIK selected a transmission frequency band which is reserved for medical implants only The 300 MHz to 1 GHz Frequency Spectrum European Frequency Spectrum Low-power active medical implants and accessories (licensed) 1. BIO 2. MDT 3. SJM MHz North American Frequency Spectrum 1. BIO 2. MDT 3. SJM Medical implant communications (licensed) General telemetry and telecommand (low-power, licenseexempt) Biomedical telemetry operations in hospitals or medical or convalescent centers, one-way, nonvoice, 100 mw max. (licensed) Biomedical telemetry devices General telemetry and telecommand (low-power, licenseexempt) BSX ISM equipment (unlicensed) MHz

8 The new wireless transmission technology was designed for daily data transmission without compromising battery service time X-Direction Y-Direction Z-Direction Front Front The reliability of the transmission does not depend on the orientation MICS band ( MHz), max. power <25 µw minimal transmission range: 2 meters 1% - 2% battery consumption for RF telemetry 7

9 In April 2002 the technical feasibility trial was finished Technical feasibility study PI: Dr. Stellbrink, Aachen, Germany April 2002 Patients: N = 106 Ø 69,0 days follow-up Results 100% of the messages were correctly transmitted 95% of the patients had gap-free monitoring 8

10 98% of the messages reached the Service Center within 15 minutes Time between implant transmission and reception of the message in Service Center ( messages evaluated) in percentages <= 15 min. 1 2 > 15 min. <= 3 min <= 1 min. 9

11 For more convenient data evaluation the information was put on secure web accounts with automatic alerts Personal, secured Internet access + SMS Automatic and individually configurable notification for events 10

12 The new BIOTRONIK RF 2 technology combined with GPRS allowed to transmit more data N identical repetitions SMS 1x 1x 1x 1x 2006: RF 2 technology Send and confirm 1x GPRS More same energy consumption 11

13 RF 2 telemetry means more data transmission without compromising battery service time Data volume transmitted via Home Monitoring - normalised to technological status at the time of first implantation - BIOTRONIK RF 2 Technology > 10fold data volume Feasibility demonstration of RF technology < 3 months battery service time for all transmissions Technological optimisation

14 BIOTRONIK devices call their doctor and automatically transmit the intracardiac ECG for review 13

15 Based on individual filter settings the patient status is automatically assessed 14

16 Depending on the medical application the patient gets either a wireless mobile or a wireless bedside transmitter CardioMessenger II CardioMessenger II-S GSM connection with GPRS 15

17 After a decade of development, devices implanted all over the world send their data to a central service center Innovation RF link: technical feasibility IEGM Data management via internet Remote follow-up Advanced Patient Management New sensors Time 16

18 TRUST Study Design Timeline 3 months follow-up 6 months follow-up 9 months follow-up 12 months follow-up 15 months follow-up 2 : 1 Home Monitoring Control BIOTRONIK Home Monitoring group Requires Home Monitoring follow-ups at 3, 6, 9, 12 and 15 months post-implant Requires an office device follow-up after 3 and 15 months Control group Requires office device follow-ups at 3, 6, 9, 12 and 15 months post-implant Home Monitoring turned off 17

19 TRUST Study Sites WA26 OR ID CA 46 NV UT 1914 AZ Patients Academic 185 MT WY CO NM SD ND NE 84 TX KS OK 14 MN IA 20 MO AR WI LA IL MS IN KY 11 TN MI AL OH WV GA FL PA 12 VA NY NC 88 21SC NH VT DE MD DC ME 11 RI MA CT NJ Community 1258 Study Site >10 patients 18 Total 1443 Study Site <10 patients

20 TRUST BIOTRONIK Home Monitoring to ensure patient safety BIOTRONIK Home Monitoring is as safe as conventional in-office follow-ups Percent of patients with morbidity n. s. 8.7% 9.1% TRUST demonstrated comparable rate of death, stroke and events requiring surgical intervention in both groups. Control (n = 414) Home Monitoring (n = 898) 19 n.s. = not statistically significant

21 TRUST BIOTRONIK Home Monitoring to significantly reduce follow-up burden BIOTRONIK Home Monitoring delivers a reduction of 43% in-office follow-up visits 3.5 p<0.001 Mean number in-office visits per patient year -43% 2.0 BIOTRONIK Home Monitoring delivers a reduction of 43% in-office follow-up visits Control (n = 414) Home Monitoring (n = 898) 20

22 TRUST BIOTRONIK Home Monitoring to provide early detection of clinically relevant events The time to evaluation of clinically relevant tachyarrhythmia events was significantly reduced with BIOTRONIK Home Monitoring VF VT SVT 35 days gained 34 days gained 26 days gained Days gained using BIOTRONIK Home Monitoring to identify arrhythmia events in comparison with conventional in-office follow-up visits Early Detection with BIOTRONIK Home Monitoring 21

23 Clinical application of the Home Monitoring for remote FU and early detection was approved in 2009 FDA Approval May 12, 2009 CE Approval Sep. 24, 2009 Remote Follow-up Early Detection symptomatic asymptomatic physiological 43% less follow-ups in the hospital Early detection of silent, asymptomatic arrhythmias 22

24 Disease Management with Home Monitoring in CRM patients could save about 1 billion p.a. in EU Health economic simulation * of savings due to remote device check/ disease management in CRM patients in EU [million p.a.] Less strokes - Less cost & complications with Warfarin - Less effort in Warfarin Monitoring - Increased efficiency - Less transportation Less frequent and severe decompensation Heart Failure Atrial Fibrillation Remote Device Check Overall Savings 23 * 1 QALY valued at Euro; CRM patients in EU p.a.; model data based on publications and expert interviews Source: Health economic simulation model for strategic business development; Handelshochschule Leipzig and BIOTRONIK

25 Agenda Introduction to active implants and Home Monitoring Development steps over the last decade Future trends Summary 24

26 New sensors incorporated in the implanted device will further improve focused patient management Increasing CHF patient population Daily monitoring Automatic classification Focused patient care Advanced patient care for heart failure patients HF Monitor Lung edema Hemodynamics 25

27 More and more parameters will contribute to sharpen the information on the patient s HF status Hemodynamic Sensor (Intracardiac impedance) Mean heart rate VES/h Lung Fluid Sensor (Intrathoracic impedance) Atrial Tachycardia Heart Rate Variability Ventricular Tachycardia Lead impedance Patient activity 26

28 In order to protect the device battery data processing is outsourced to the remote Service Center Battery service time constant for new predictors 1% for daily SC Trend = 99.85% 99% for Tx 27

29 e-health (3/5) Device data export to EMR Patient data upload SW Download Clinic IT HL7 Service Center Service Provider 1: Home Monitoring 2: in-office follow-up data upload 3: fleet management 4: export to EMR EMR/ Cardiology system

30 e-health (5/5) Regulatory induced Patient data upload SW Download 3 Device and Disease Management with FDA/ CE approved systems Service Center HL7 Service Provider Clinic IT Administration/ billing and long-term EMR/ Cardiology system 29