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Профессиональный Документы
Культура Документы
Alia4on/Financial Rela4onship
Company
Grant/Research
Support
Consul4ng
Fees/Honoraria
None
Biotronik,
Cardiokine4x,
CardioMEMS,
Medtronic,
St.
Jude
Medical,
Paracor,
Sunshine
Heart
None
None
None
None
None
Background
Despite
Current
Therapies,
Heart
Failure
Morbidity
and
Mortality
Remain
High
30%
to
40%
of
pa4ents
are
in
NYHA
class
III
or
IV
Re-hospitaliza4on
rates
are
high
2%
at
2
days
25%
at
1
month
50%
at
6
months
Percutaneous
Interface
Lead
Babery
Pack
Driver
Extra-Aortic Counterpulsation
Heart
Fills
-
Cu
Inates
to body
to
heart
reduce
workload
56 9 (34-71)
Gender
Female
Male
8
12
Race
African
American
Caucasian
3
17
18
2
INTERMACS
Classica4on
3.
Stable
but
inotrope
dependent
5.
Exer4on
intolerant
6.
Exer4on
limited
7.
Advanced
NYHA
Class
III
3
8
7
2
E4ology
Ischemic
Non-ischemic
8
12
0
at
30
days
1
at
6
months
Aor4c Disrup4on
P = 0.0008
3.5
NYHA Class
3
2.5
2
1.5
1
0.5
0
Baseline
3 Months
6 Months
100
P = 0.0139
80
60
40
20
0
Baseline
3 Months
6 Months
400
P = 0.1432
350
300
250
200
150
100
50
0
Baseline
3 Months
6 Months
P
=
0.0432
40
P = 0.1933
35
30
25
20
15
10
5
0
Baseline
3 Months
6 Months
Conclusions
The
C-Pulse
Study
demonstrates
the
feasibility
and
preliminary
safety
and
ecacy
of
the
C-Pulse
System
in
pa4ents
with
moderate
to
severe
heart
failure
A
prospec4ve,
randomized
controlled
trial
to
conrm
and
extend
these
observa4ons
is
warranted