getemed Medizin- und Informationstechnik AG Oderstraße 77 14513 Teltow Germany Ambulatory Monitoring of Physiological Parameters Robert Downes ehealth Conference, Berlin April 19, 2007
Contents Introduction Background Monitoring Method Feasibility Study Results Conclusion Next Steps 2
Company Overview 1984 Founded in West Berlin as GeTeMed Gesellschaft für Technische Medizin mbh Development, manufacture, sales & marketing of medical electronic equipment 1991 Move to Teltow in Land Brandenburg 2000 Change company name to getemed Medizinund Informationstechnik AG in preparation for planned IPO (Initial Public Offer) Currently 45 employees, 15 in R&D 2006 Move to new company building in Teltow 3
Expertise ECG Systems CardioOffice ECG Data Management System VitaData Rest ECG CardioLink Stress ECG CardioLink Holter ECG / 24h ECG CardioDay Digital Recorders CardioMem Ambulatory Monitoring of Risk Patients Monitoring of Heart Rate & Respiration VitaGuard VG 2100 Monitoring of Heart Rate, Respiration & Oxygen Saturation VitaGuard VG 3100 Monitoring of Oxygen Saturation VitaGuard VG 310 Telemonitoring Applications Congestive Heart Failure Telemonitoring / Home Health Care brings together our two areas of expertise 4
Co-operation Partner Telemonitoring of Patients Suffering from Congestive Heart Failure (CHF) Implementation in Brandenburg, Germany, together with the Telemedizin-Zentrum Brandenburg (TMZB) which is affiliated with the Städtisches Klinikum Brandenburg / Havel Responsible cardiologist: Prof. Dr. med. M. Oeff Previous results published by Oeff et al. in Herzschrittmachertherapie & Elektrophysiologie 16:1-9 (2005) 5
Telemonitoring Model Telemonitoring model showing the interaction between the various strategic partners Ambulatory Stationary Contract Insurance company Reimbursement provides service to Medical device supplier(s) Training & tech. support Tech. support for patient Home health care provider contracts send data Clinic Telemonitoring center Reports & expert opinion Patient Patient/doctor relationship GP 6
Background Key aspects of CHF Chronic illness Slow progression Ambulatory treatment However, decompensation events reoccur regularly Prevalence is continuously increasing High economic impact Treatment is well suited for telemonitoring applications 7
Background 10 9 8 7 6 5 4 3 2 1 0 KH-Aufenth/1000 Ew 1980 1985 1990 1995 2000 Incidence of CHF 13,200 cases in Brandenburg alone, based on a population of approx. 2.7 million people Up to 2.5% of the German population suffer from CHF and up to 15% of people aged >65 200,000 new cases each year in Germany Estimated 10 million cases in Europe 8
Background Reasons for increase in CHF Demographic development Improved medication available Improved therapy / survival of acute heart attack patients Problems with the therapy of CHF Patient compliance Not enough specialists in sparsely populated areas Tendency to underdose medication because of fear of side-effects 9
Background Costs associated with CHF Data from England have shown that 70% of the hospitalisation costs related to heart disease result from patients with congestive heart failure Cost of treatment rose from 1.2% to 2.2% of National Health Service budget between 1990 and 2000 i.e. costs nearly doubled in just 10 years! For the year 2000 alone, 391,000 hospitalisation cases were due to CHF, resulting in 5.9 million days in hospital 10
ehealth Conference 2007 Monitoring Method Monitoring Patients with Congestive Heart Failure Recording Data analysis Data transfer Reports 150 140 130 Pat 0073: R.W., m, 65 J, DCM Hf / m in Gewicht / kg Sinus VoFli RRs ys t / m mhg RRdias t / mm Hg O2-Sätt / % 120 110 100 90 Communication with the general practitioner 80 70 60 01 9. 03 03 9. 05 03 9. 07 03 9. 09 03 9. 11 03 9. 13 03 9. 15 03 9. 17 03 9. 19 03 9. 21 03 9 23 3 9. 25 03 9. 27 03 9. 29 03 9. 01 03.1 0. 03 03.1 0. 05 03.1 0. 07 03.1 0. 09 03.1 0. 11 03.1 0 3 ECG, blood pressure, weight, oxygen saturation, respiration, condition, medication 11
Monitoring Method 12
Monitoring Method Physiological parameters measured 2 3 times each day Weight Blood pressure ECG heart rate and rhythm Respiration pattern Oxygen saturation (SpO 2 ) Subjective parameters Current state of health? Medication taken? Breathlessness? Contact requested? 13
Monitoring Method Respiration Respiration rate Heart rate ECG overview SpO 2 ECG 14
Feasibility Study Patients 58 patients (46 male, 12 female, age: 64 ± 10 years, (48-79 years)) Illnesses: 23 with coronary heart disease (CHD), 30 with dilitative cardiomyopathie (DCM), 3 with hypertensive microvascular disease and 2 with chronic obstructive pulmonary disease (COPD) Inclusion criteria Hemodynamic instability with increasing breathlessness (dyspnoe, NYHA class III or IV) or increasing peripheral edema (fluid accumulation), and One or more stays in hospital over the previous 12 months 15
Feasibility Study Multiparameter monitoring Measurements, 2 3 daily 23,000 patient days 45,000 measurements Analysis in telemonitoring center (TMZB) Daily analysis of the incoming data, including compliance check Immediate action taken if individual alarm limits exceeded, or if the patient reports a degradation in the state of his/her health, if medication changed or direct contact requested Weekly report to general practitioner 16
Feasibility Study Short ventricular tachycardia Alarm 17
Feasibility Study Changes in the physiological parameters over a period of 6 weeks intervention necessary! 150 140 130 120 110 100 90 80 70 60 014.2004 R.W., m, 65 J, DCM 084.2004 154.2004 224.2004 294.2004 065.2004 Hf / min Gewicht / kg Sinus VoFli RRsyst / mmhg RRdiast / mmhg O2-Sätt / % 18
100,0 99,0 98,0 97,0 96,0 95,0 94,0 93,0 92,0 91,0 90,0 ehealth Conference 2007 Feasibility Study Trends with and without adequate intervention Intervention 64,0 63,0 62,0 61,0 60,0 59,0 58,0 57,0 56,0 55,0 19 2784 0394 1094 1794 2494 01.104 08.104 23.124 30.124 0615 1315 2015 2715 0325 16.124 09.124
Feasibility Study Extract of a report for the general practitioner 20
Results Events detected / reported 103 episodes of weight increase (31 patients) 26 episodes of blood pressure decompensation (12 patients) 9 patients with SpO 2 desaturations with subsequent weight increase 26 patients with arrhythmias: previously undiagnosed atrial fibrillation detected in 4 patients, intermittent bigeminy in 1 patient, ventricular tacyhcardia detected in 3 patients 17 patients with permenant arterial fibrillation and 15 with paroxysmic arterial fibrillation 23 reports based on degradation of state of health which could be correlated with weight increase 21
Results 58 patients 23,000 patient days Telemonitoring for 4 23 months 396 days on average 100 80 60 40 20 96 before TelMon with TelMon 21 Before telemonitoring 96 cases of hospitalsation accounting for 1374 days 0 1400 Cases of hospitalisation 1374 With telemonitoring 21 cases of hospitalsation (- 78 %) accounting for 207 days (- 85 %) 1200 1000 800 600 400 200 before TelMon with TelMon 207 0 Days in hospital 22
Conclusion The availability of objective, multi-parameter medical data on a daily basis leads to early detection and prevention of critical situations Simultaneous assessment of subjective data helps to access the clinical status and can assist in the interpretation of the measured data Continuously checking the medication increases patient compliance and helps to determine the cause of decompensation events Telemonitoring enables many patients suffering from CHF to be kept in a stabile medical state, resulting in a large reduction of re-admissions into hospital Active participation by the patients provides a better feeling of security and an increase in the quality of life for the patients and their families. Also, stress associated with journeys to hospital reduced. 23
Acknowledgements PuV Programme (Produkt- und Verfahrensinnovation) 51.4% funding from Land Brandenburg and the European Regional Development Fund (EFRE), 48.6% getemed AG BIEM Programme (Brand. Innovationsprog. E- Business/Medienkonvergenz) 36.4% funding from Land Brandenburg and the European Regional Development Fund (EFRE), 63.6% getemed AG 24
Next Steps Next steps: Approach health insurance companies and clinics to implement the scheme contract already in place between Städisches Klinikum Brandenburg and AOK- Brandenburg Develop marketing models for the scheme to suit the individual situations in other areas/countries Further improvements in technology next generation device currently under development 25
getemed AG Contact Information Mr. Michael Scherf Mr. Robert Downes E-Mail: scherf@getemed.de E-Mail: downes@getemed.de Address: getemed Medizin- und Informationstechnik AG Oderstr. 77 14513 Teltow, Germany Tel.: +49 33 28-39 42 0 Fax: +49 33 28-39 42 99 Web: http://www.getemed.de E-Mail: info@getemed.de 26