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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
Process of Lung Fluid Accumulation
3 STAGES OF
HEART FAILURE:
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 Fu
nct
ion
al s
tatu
s Lu
ng
Flu
id
RS MEDICAL MONITORING Ltd.
Ea c h ye a r 2 0 - 2 5 % o f H F p at i e nt s a re b e i n g e m e rge nt l y h o s p i ta l i ze d .
I n t h e U S a l o ne : > 1 . 1 Mi l l i o n h o s p i ta l i zat i o n a ye a r C o st i n g t h e h e a l t h care syste m m o re t h a n 4 0 b i l l i o n $
The Solution: Edema Guard Monitor/EGM
RS MM d e ve l o pe d t h e EG M, a n o n - i nva s i ve d e v i c e a b l e t o re g i s te r v e r y s m a l l c h a n ge s i n l u n g f l u i d c o nte nt o f N Y H A c l a s s
I - I V p at i e nt s a n d p ro mpt p re e mpt i ve t re at ment a t a n e a r l y & c r i t i ca l s ta ge
The Technolog y
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 Cha l lenge :
Identifying small changes in the
Lung Impedance as 1-3 Ω from
the total TTI which is
1050 Ω
Impossible
The Solut ion :
RSMM TECHNOLOGY helps to
eliminate the NOISE Chest Wall
Impedance (500 Ω+500 Ω) from
TTI (1050 Ω), enabling to identify
small changes in the Lung
Impedance
Possible
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
ACC 2016 >1200
Patients!
All-cause Hospitalizations
p < 0.0001
Cardiac Hospitalizations
p < 0.0001
Heart Failure Hospitalizations
p < 0.0001
Follow Up period
Nu
mb
er
of
ho
spit
aliz
atio
ns
Nu
mb
er
of
ho
spit
aliz
atio
ns
Nu
mb
er
of
ho
spit
aliz
atio
ns
Follow Up period Follow Up period
Main Results from IMPEDANCE-HF trial Hospitalizations by Cox regression analysis
39% decrease 56% decrease 52% decrease
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
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 Profit
0
100
200
300
400
500
600
700
10.000 100.000 1.000.000
Gross profit from EGM useper year:
Mill
ion
$
Number of Patients
Gross Prof it Potential
6.6
660
66
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