Non-invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic - - PowerPoint PPT Presentation

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Jun 12, 2023 226 likes •348 views

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,

SLIDE 1

Non-invasive Lung IMPEDANCE-Guided Preemptive Treatment in Chronic Heart Failure Patients: a Randomized Controlled Trial (IMPEDANCE-HF trial)

M Kleiner Shochat, MD, BSc, PhDa, A Shotan, MDa, DS Blondheim, MDa, M Kazatsker, MDa, I Dahan, MSITa, A Asif, MDa, Y Rozenman, MDb, I Kleiner, MDc, JM Weinstein, MBBS, FRCPc, A Frimerman, MDa, L Vasilenko, MDa, SR Meisel, MD, Msca

aHeart Institute, Hillel Yaffe Medical Center, Hadera, Rappaport School of Medicine, Technion, Haifa, Israel; bCardiovascular

Institute, Wolfson Medical Center, Holon, Sackler Faculty of Medicine, Tel-Aviv University, Israel, cCardiology 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

SLIDE 2

Process of Lung Fluid Accumulation

3 3 STAGE GES S OF OF HEART FAILURE RE:

Stable stage: No fluid accumulation in lung Lung fluid accumulation - without clinical signs

Ideal point to initiate preemptive treatment Current point where treatment is initiated

Dramatic clinical deterioration leading to urgent hospitalization

Functional status Lung Fluid

SLIDE 3

RS MEDICAL MONITORING Ltd.

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 $

The Solution: Edema Guard Monitor/EGM

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

SLIDE 4

The Technology

CWI1 Ω X500~ CWI2 Ω X500~

LI Ω X50~ Transthoracic Impedance A-B (TTIAB) = Target Organ + Lung Impedance + Chest Wall Impedance 2 Chest Wall Impedance 1 A B C W I = “ N O I S E ” I m p e d a n c e

The Challenge :

: 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

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 Possib

ible

SLIDE 5

Measurement using the EGM Device

Placing the vest with contact points

n the chest and back

Measurement takes a few seconds Comment: Vest still in concept phase

SLIDE 6

Publications and Events up to date

ACC 2016

>1200 Patients!

SLIDE 7

All-cause Hospitalizations

p < 0.0001

Cardiac Hospitalizations

p < 0.0001

Heart Failure Hospitalizations

p < 0.0001

Follow Up period Number of hospitalizations Number of hospitalizations Number of hospitalizations Follow Up period Follow Up period

Main Results from IMPEDANCE-HF trial Hospitalizations by Cox regression analysis

39% decrease 56% decrease 52% decrease

SLIDE 8

All-cause Death

Follow Up period

P < 0.001 P < 0.001

Cardiac Death

Follow Up period Follow Up period

p < 0.001

Heart Failure death

Main Results from IMPEDANCE-HF trial Mortality by Kaplan Meyer analysis

55% decrease 62% decrease Control group Monitored group 43% decrease

SLIDE 9

1000 Patients Model

750 250

Current Status

Not hospitalized Hospitalaized

Cost: 3.25 M $

890 110

EGM Use

Not hospitalized Hospitalaized

EGM Cost per 1000 HF patients: 1.2 M $ Cost: 1.4 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

SLIDE 10

100 200 300 400 500 600 700 10.000 100.000 1.000.000 Gross profit from EGM use per year: Million $ Number of Patients

Gross Profit Potential

6.6 660 66

SLIDE 11

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