Non-invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial (IMPEDANCE-HF trial) M Kleiner Shochat, MD, BSc, PhD a , A Shotan, MD a , DS Blondheim, MD a , M Kazatsker, MD a , I Dahan, MSIT a , A Asif, MD a , Y Rozenman, MD b , I Kleiner, MD c , JM Weinstein, MBBS, FRCP c , A Frimerman, MD a , L Vasilenko, MD a , SR Meisel, MD, Msc a a Heart Institute, Hillel Yaffe Medical Center, Hadera, Rappaport School of Medicine, Technion, Haifa, Israel; b Cardiovascular Institute, Wolfson Medical Center, Holon, Sackler Faculty of Medicine, Tel-Aviv University, Israel, c Cardiology Department, Soroka University Medical Center, Beer Sheva. American College of Cardiology. Chicago. Late Braking Clinical Trial Session. Apr.04. 2016 Presenter – Prof. Michael Kleiner Shochat Conflict of interest: Michael Kleiner Shochat is a co-founder and member of the board of directors of the RSMM Company that manufactured and supplied the devices for the study
Process of Lung Fluid Accumulation Stable stage: No fluid accumulation in lung 3 3 STAGE GES S OF OF Lung fluid accumulation - without clinical signs HEART FAILURE RE: Dramatic clinical deterioration leading to urgent hospitalization Functional status Lung Fluid Current point where treatment is initiated Ideal point to initiate preemptive treatment
The Solution: Edema Guard Monitor/EGM Each year 20 20-25 25% of HF patients are being emergently hospitalized. In the US alone: >1.1 Million hospitalization a year Costing the healthcare system more than 40 40 billion $ RSMM developed the EGM, a non-invasive device able to register very small changes in lung fluid content of NYHA class I-IV patients and prompt preemptive treatment at an early & critical stage RS MEDICAL MONITORING Ltd.
The Technology Chest Wall + Chest Wall + Lung Transthoracic Impedance A-B ( TTI AB ) = Impedance 1 Impedance 2 Impedance C W I = “ N O I S E ” I m p e d a n c e A The Challenge : : CWI 1 Ω X500~ Identifying small changes in the Lung Impeda edance ce as 1-3 3 Ω from the total TTI I which is 1050 50 Ω Impossib ible le Target Organ LI Ω X50~ The Solution : : RSMM TECHN HNOLOGY GY helps to eliminate the NOISE SE Che hest Wall ll Impeda edance ce (500 00 Ω +500 500 Ω ) from TTI I (1050 50 Ω ), enabling to identify small changes in the Lung Impeda edance ce CWI 2 Ω X500~ Possib ible B
Measurement using the EGM Device Placing the vest with contact points on the chest and back Measurement takes a few seconds Comment: Vest still in concept phase
Publications and Events up to date >1200 ACC 2016 Patients!
Main Results from IMPEDANCE-HF trial Hospitalizations by Cox regression analysis Number of hospitalizations Number of hospitalizations Number of hospitalizations 56% decrease 39% decrease 52% decrease p < 0.0001 p < 0.0001 p < 0.0001 Follow Up period Follow Up period Follow Up period All-cause Hospitalizations Cardiac Hospitalizations Heart Failure Hospitalizations
Main Results from IMPEDANCE-HF trial Mortality by Kaplan Meyer analysis 62% decrease 43% decrease 55% decrease p < 0.001 P < 0.001 P < 0.001 Follow Up period Follow Up period Follow Up period All-cause Death Cardiac Death Heart Failure death Monitored group Control group
1000 Patients Model EGM Use Current Status 110 Cost: 250 Cost: 1.4 M $ 3.25 M $ Not hospitalized Not hospitalized Hospitalaized Hospitalaized 750 890 EGM Cost per 1000 HF patients: 1.2 M $ Total expense: 2.6 M Total expense: 3.25 M 3.25 M $ – 2.6 M $ (1.4 +1.2 )= )= 0.66 M $ $ Gross ss Profit it
Gross Profit Potential 660 700 600 500 Million $ 400 Gross profit from EGM use per year: 300 200 66 100 6.6 0 10.000 100.000 1.000.000 Number of Patients
Summary Study Conclusions: Treatment protocol using EGM will Decrease • Heart failure hospitalization by 56% • Mortality from heart failure by 62% • All cause of mortality by 43 % Data based on studies which include more than 1200 patients supports the following claims regarding use of EGM device : • Can considerably reduce risk of mortality and hospitalization • Can considerably lighten the economic burden of the healthcare system
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