Application of MCS for the Treatment of Advanced Heart Failure

1. 1
1
Application of MCS for
the Treatment of
Advanced Heart Failure
John B. O’Connell MD
Vice President, Medical Affairs
Thoratec Corporation
Thoratec
Asia
Pacific
Mechanical
Circulatory
Support
(MCS)
Conference
Agenda
15-­‐17
November,
2013
|
Shangri-­‐La
Rasa
Sentosa
Resort,
Singapore

2. 2
Disclosures
Forward-­‐Looking
Statements
This
presenta,on
includes
forward-­‐looking
statements,
including
our
current
expected
,melines
for
product
development,
clinical
trials
and
commercializa,on.
Forward-­‐looking
statements
should
not
be
read
as
a
guarantee
of
future
performance
or
results,
and
may
not
necessarily
be
accurate
indica,ons
of
the
,mes
at,
or
by,
which
such
performance
or
results
will
be
achieved.
Forward-­‐looking
statements
are
based
on
informa,on
available
at
the
,me
those
statements
are
made
and/or
management's
good
faith
belief
as
of
that
,me
with
respect
to
future
events,
and
are
subject
to
risks
and
uncertain,es
that
could
cause
actual
performance
or
results
to
differ
materially
from
those
expressed
in
or
suggested
by
the
forward-­‐looking
statements.
Important
factors
that
could
cause
such
differences
include,
but
are
not
limited
to
those
discussed
from
,me
to
,me
in
Thoratec’s
public
reports
filed
with
the
Securi,es
and
Exchange
Commission,
such
as
those
discussed
under
the
heading,
“Risk
Factors,”
in
Thoratec’s
most
recent
annual
report
on
Form
10-­‐K
and
quarterly
report
on
Form
10-­‐Q,
and
as
may
be
updated
in
subsequent
SEC
filings.
These
forward-­‐looking
statements
speak
only
as
of
the
date
hereof.
Thoratec
undertakes
no
obliga,on
to
publicly
release
the
results
of
any
revisions
to
these
forward-­‐looking
statements
that
may
be
made
to
reflect
events
or
circumstances
aSer
the
date
hereof.
Statement
on
Product
Risk
Please
consult
the
HeartMate
II
and
CentriMag
Instruc,ons
for
Use,
for
indica,ons
for
use,
contraindica,ons,
warnings
and
adverse
events.
hp://www.thoratec.com/medical-­‐professionals/resource-­‐library/index.aspx.
Individual
experiences,
symptoms,
situa,ons
and
circumstances
may
vary.
Possible
serious
adverse
events
include:
neurological
problems
(such
as
stroke),
infec,on,
bleeding,
device
malfunc,on
(pump
replacement),
kidney
and
liver
dysfunc,on,
right
heart
failure,
depression
or
anxiety
and
death.
Pipeline
Programs
Pipeline
programs,
including
the
HeartMate®
III,
HeartMate
X,
HeartMate
PHP,
the
fully
implantable
system
(FILVAS),
and
the
Pocket
Controller,
are
in
development
and
not
approved
for
use.
Trademarks
Thoratec,
the
Thoratec
logo,
HeartMate,
and
HeartMate
II
are
registered
trademarks
of
Thoratec
Corpora,on.
CentriMag
and
PediMag
are
registered
trademarks
of
Thoratec
LLC,
and
PediVAS
is
a
registered
trademark
of
Thoratec
Switzerland
GmbH.

3. 3
Disclosures
• I am an employee of Thoratec
• I am a heart failure cardiologist who after
33 years is tired of helplessly watching
potentially productive people die of
progressive HF and am pro-MCS
• I have either developed or assisted in the
development of advanced HF/VAD/Tx
programs in multiple institutions globally
(academic and community; several in the
absence of transplant programs)
3

4. 4
HF in the US
~6.0
million
Americans
with
HF
(2.8%
of
adult
US
populaUon)
–
NHANES
2008
(2030
>18
million)
• Only
form
of
heart
disease
increasing
in
prevalence
– Life6me
risk
at
age
40
or
80
–
1
in
5
– 825,000
new
cases/year
– Contributes
to
279,098
annual
deaths
(1
in
9
death
cer6ficates
men6on
HF)
– 1.023
million
ADHF
hospitaliza6ons
each
year
• AQer
normal
delivery,
most
common
cause
of
hospitaliza6on
– 30
day
readmission
rate
23%
(50%
not
seen
by
physician)
–
all
cause
penalized
by
Medicare
to
2%
of
all
reimbursement
– 801,000
ambulatory
visits
– Mortality
50%
at
5
years;
34%
at
1
year
aQer
a
single
hospitaliza6on
– #1
reason
for
hospitaliza6on
of
people
>
65
yr.
old
• More
costly
than
all
forms
of
cancer
combined
• Largest
federal
Medicare
(37¢/$1)
and
VA
$
expenditure
– Cost
$30.7
billion
($69.7
billion by 2030 -
$244/adult)
Mul;ple
sources
primarily
AHA
Sta;s;cal
Update
2014

5. 5
5
Chronic Heart Failure Care:
We’ve come a long way…
Thoratec
Asia
Pacific
Mechanical
Circulatory
Support
(MCS)
Conference
Agenda
15-­‐17
November,
2013
|
Shangri-­‐La
Rasa
Sentosa
Resort,
Singapore

6. 6
Courtesy of Hector Ventura MD

7. 7
Osler’s Recommendations for Heart Failure
• “Special care should be taken of the bowels”
• “A cold tub in the morning, if unsuccessful a
lukewarm tub at night”
• “Young people should be allowed plenty of
sleep including an hour’s rest in the middle of
the day”
• “The question of marriage is always a
distressing one”
• “During the winter months a change in
climate is most helpful”
• “Moderation in all things should be the motto
of the patient”
• “More violent sports, such as football and
hockey, should be interdicted”
• “Golf is a particularly suitable game for
young men”
• “Gymnastic movements may be employed”
• “Dancing is allowed in moderation for young
girls with simple mitral lesions…and the apex
beat not very far out”
Osler:
The
Principles
and
Prac;ce
of
Medicine,
8th
ed
1913

8. 8
Hurst’s The Heart 1974
Treatment of HF
• Decreased physical activity
• Digitalis
• Thiazides plus potassium
• Change to furosemide if no response

9. ACCF/AHA 2013 HF Guidelines JACC 2013 5 June (E-Pub )
9

10. Two Year Survival of “Triple Therapy” in
CHF
10 JACC 2003;7:1234-1237

11. 11

12. Definition of Advanced Heart Failure:
European Society of Cardiology*
• Despite optimal (best tolerated) medical and
device management:
12
– NYHA Class III-IV symptoms
– Clinical signs of fluid retention and/or hypoperfusion
– Objective evidence of severe LV dysfunction
• LVEF < 0.30; pseudonormal or restrictive mitral inflow
pattern on Doppler; high left or right sided filling pressures;
elevated BNP
– Severe reduction in exercise capacity
• 6 MWT < 300 meters; pVO2 < 12-14 ml/kg/min
– > 1 hospitalization in the past 6 months
Eur
Heart
J
2007;9:684-­‐94.
*Adopted
by
ACCF/AHA
in
2013
chronic
HF
guideline

13. 13
For the Advanced Heart Failure
Program: The True Failures!
§ CRT non-responders
§ Recurrent appropriate ICD discharges
§ HFpEF with tenuous fluid balance
§ Suboptimal neurohormonal inhibitor dosage
limited by hypotension or cardiorenal syndrome
§ Require IV diuretics or thiazides with loop
diuretics – diuretic resistance
§ Require IV inotropes
§ A recent HF hospitalization (34% one year
mortality)
§ Persistent symptoms with ADLs despite optimal
medical and device therapy
§ Multiple comorbidities

14. 14
Options for the Advanced Heart
Failure Patient
§ Optimize neurohormonal inhibition and
device therapy
§ High risk conventional cardiac surgery
§ Heart transplantation
§ Mechanical circulatory support
§ Palliative care/hospice (chronic IV inotropes)

15. 15
Heart Transplantation
will never meet the
demands

16. Even though transplants are considered the ‘gold
standard’, the supply has been historically flat
and limited
16
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
Number of Heart Transplants Reported by Year1
“Proposing
heart
transplantaUon
to
cure
heart
failure
is
analogous
to
proposing
the
loZery
to
cure
poverty”
3,514
awa
it
heart
t
ransplant
aUon
(Ma
y
10,
2013
)1
2500
2000
1500
1000
500
0
1.
UNOS
Website:
hap://optn.transplant.hrsa.gov
2.
O’Connell
Advanced
Heart
Failure
Therapies
Forum
Atlanta
2013
-­‐
LW
Stevenson2

17. 17
Heart Transplants in Major
Metropolitan Statistical Areas
(2010)
MSA Population Transplants Per 100,000
New York 21,976,224 110 0.5
Los Angeles 17,775,984 143 0.8
Chicago 9,725,317 76 0.8
Philadelphia 6,382,714 98 1.5
Houston 5,641,077 107 1.9
Total 61,501,316 534 0.9

18. Defined Strategies for Durable VADs
18
• Bridge to Transplant (BTT)* – Inserted for short to
intermediate term support in patients actively
listed for transplant
• Destination Therapy (DT)* – Inserted with the
intention of long term support in patients who are
not transplant candidates
• Bridge to Recovery – Inserted for short term
support in a condition that is anticipate to
reverse
• Bridge to Candidacy (Decision) – Inserted for
support when ultimate therapy is not able to be
determined at the time of implantation or
contraindication for transplant could be
ameliorated by MCS
*only
strategies
recognized
by
payers

19. Continuous Flow LVADs
19

20. 20
HM II Competing Outcomes for
BTT
Starling et al J Am Coll Cardiol 2011;57:1890-8.

21. 21
HeartMate II Improvements in BTT Survival
From clinical trial to commercial Use
85%
0 3 6 9 12
Months
Percent Survival
100
90
80
70
60
50
40
30
20
10
0
P < 0.001 log-rank test
Post-Trial (N=1496)
Trial (N=486) 76%
John, Naka, Smedira et al Ann Thor Surgery 2011

22. 22
ADULT HEART TRANSPLANTS:
% of Patients Bridged with Mechanical Circulatory
Support* (Transplants: 2000 – 2010)
50
40
30
20
10
0
2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010
Year
%
of
patients
J Heart Lung Transplant. 2012 Oct; 31(10): 1045-1095

23. 23
Reasons for Transplant Exclusion in DT
Supplementary
Appendix
-­‐
Slaughter
et
al
N
Engl
J
Med
2009;361:2241-­‐51.
1. Age (39%)
2. Obesity (12%)
3. Pulmonary Hypertension (9%)
4. IDDM (8%)
5. Renal failure (7%)
Recent history of cancer (7%)
Patient refuses transplant (7%)
6. Social issue/compliance (5%)
PAD (5%)
8. Sensitization to potential donors (3%)
9. Other (3%)

24. Summary of DT Outcomes
100
90
80
70
60
50
40
30
20
10
24
DT Trial (n=133)1
90 + 2%
1Slaughter, Rogers, Milano NEJM 2009;361:2241-51
61 + 3%
92 + 2%
0 6 12 18 24
LVAD Destination Therapy
(HMII Post Approval Study)
0 6 12 18 24
100
90
80
70
60
50
40
30
20
10
Jorde, ISHLT 2013
Months
Percent Survival
0
DT Post Approval (n=247)
68 + 4%
58 + 4%
74 + 3%
Remaining at Risk:
247 192 169 151 130
133 95 82 69 62
Months
Percent Survival
0
Medical Management
(REMATCH, NEJM 2001)

25. HM II Quality of Life & Functional Outcome
Improvement
25
HM II DT trial
• 100% of patients were NYHA Class
IIIB/IV status at baseline
• 81% of patients improved to NYHA
Class I or II by 24 months
BTT 6 minute walk test
• 16% of patients were capable of completing the test at baseline
• 94% of HeartMate II recipients completed the test at 6 months
Park SJ, et al; Outcomes in advanced heart failure patients with LVAD for DT. Circ Heart Fail. 2012;5(2):241-248
John R, et al. Continuous flow LVAD outcomes in commercial use compared with the prior clinical trial. Ann Thorac Surg. 2011;92(4):1406-1413.

26. Projected VAD US market growth and
impact of Destination Therapy
U.S.
Chronic
VAD
Implants
vs.
Heart
Transplants,
2007-­‐2012
26
Projected
U.S.
Chronic
VAD
implants
by
Indica;on
(Analyst
Es;mates),
2013-­‐2016
5,935
3,702
5,089
2,895
2,193
4,468
2,365
2,103
DT
1,914
125
DesUnaUon
Therapy
centers
in
the
US
today
~3,400
~2,750
VADs
Transplants
~2,200 ~2,150 ~2,200 ~2,300 ~2,300
~2,150
~1,850
~1,325
2007 2008 2009 2010 2012
2,233
2016
2013 2014
2015
3,906
1,993
Source:
Thoratec
Es6mates;
Average
analyst
projec6ons
for
VAD
market
(Wells
Fargo,
JP
Morgan,
Credit
Suisse,
Oppenheimer)
'13-'16
CAGR
15%
25%
4%
BTT

27. 27

28. Timeframe for Definitive Interventions
based on INTERMACS classifications
1
INTERMACS
levels
Brief
descriptions
Timeframe for
definitive
intervention
Advanced
NYHA Class
III
Exertion
limited/
“Walking
wounded”
Exercise
intolerant/
“House-bound”
Recurrent
decompen-sation/
“Frequent
flyer”
Stable but
inotrope-dependent/
“Dependent
stability”
Progressive
decline/
“Sliding on
inotropes”
Critical
cardiogenic
shock/ “Crash
and burn”
Transplan-tation
or
circulatory
support not
currently
indicated
Variable,
depends upon
nutrition, organ
function, and
activity
Variable,
depends upon
nutrition, organ
function, and
activity
Elective over
weeks to
months as long
as treatment of
episodes
restores stable
baseline,
including
nutrition
Elective over a
few weeks
Needed within
a few days
Needed within
hours
7 6 5 4 3 2
NYHA
classifications
Class III Class IIIb/IV Class IV
AHA/ACC
classification
Stage C Stage D
Note: This grid was based on the best interpretation of the information provided in the sources listed below
Sources: “Heart Failure”. NEJM 2003; 348:2007-18. “On the Fledgling Field of Mechanical Circulatory Support”. JACC 2007; (50) 8.
“Characteristics of Stage D heart failure: Insights from the Acute Decompensated Heart Failure National Registry Longitudinal Module
(ADHERE LM)”. Am J Heart 2008; 155:341-9. INTERMACS Manual of Operations version 2.2, User’s Guide

29. Patient Selection and Outcomes of LVAD
29
Implantation for DT
Lietz et al Circulation 2007 Vol 116

30. Courtesy of P. Eckman
30

31. Clinical Outcomes Based on INTERMACS
Profile
Group 1: INTERMACS 1
Group 2: INTERMACS 2 or 3
Group 3: INTERMACS 4-7
Length of Stay Post-VAD Actuarial Survival Post-VAD
Less acutely ill, ambulatory patients in INTERMACS profiles 4-7 had better
survival and reduced length of stay compared to patients who were more
acutely ill in profiles 1-3.
Boyle, Ascheim, Russo, et.al. JHLT. 2011; 30:4,

32. The Late Stage Heart Failure Patient
• Severe exercise intolerance
• Heart failure wasting
syndrome
• Cardiorenal syndrome
• Right heart failure
• Inotrope dependence
Courtesy of J. Rogers

33. High Mortality Associated with Advanced Heart Failure
Less Than a 10% Survival Rate
*J Cardiac *N Engl J Med 2001; 345:1435-43 Failure 2003;9:180-7
*INTrEPID Trial1
*Survival with continuous inotropes 4
1 Rogers JG, Butler J, Lansman SL, et al. Chronic mechanical circulatory support for inotrope-dependent
heart failure patients who are not transplant candidates: results of the INTrEPID trial. J Am Coll Cardiol.
2007;50(8):741-47.

34. VAD Recipient Selection by INTERMACS Profile
A Dynamic Process
1.9
42.7
46.7
42.0
2006 2007 2008 2009 2010
Kirklin et al JHLT 2012;131:117-26.
40.8
45.2
38.8
7.8
5.8
0.0
35.6
9.6
7.3
1.8
0.6
29.3
15.2
9.1
1.21 .0
21.5
17.1
9.9
2.31 .7
12.3
25.3
13.9
3.2
2.0
InItnetremrmacasc sP rPorfoilfeilse 1123456- 6
% of total implants

35. Early Referral Suggested: AHA Statement
Circulation 2012; 126
“Implantation of MCS in patients before the
development of advanced HF (ie, hyponatremia,
hypotension, renal dysfunction, and recurrent
hospitalizations) is associated with better outcomes.
Therefore, early referral of advanced HF patients
is reasonable” (IIa; B)

36. Natural History of Heart Failure
Goodlin SJ J Am Coll Cardiol 2009;54:386-96.

37. “Better to put the device in 5
months too early than 5
minutes too late…”
Walter Dembitsky MD,
Cardiac Surgery
Sharp Memorial Hospital
San Diego

38. Complementary Studies Exploring HeartMate II in
Earlier-Stage Heart Failure
Class IV
(On Inotropes)
3 2 1
NYHA Class III Class IIIb Class IV
(Ambulatory)
INTERMACS Profiles 7 6 5 4
FDA Approval: Class IIIb / IV
CMS Coverage: Class IV
Currently Not Approved Limited Adoption Growing Acceptance

39. Adapted from Russell SD, Miller LW, Pagani FD. Advanced
heart failure: a call to action. Congest Heart Fail.
2008;14:316-321
39
Ideal time for referral
NYHA IV plus one of the fo llowing:
§ Inability to walk < 1 block without dyspnea
§ Intolerant or refractory to ACE-I / ARB / BB
§ Diuretic dose > 1.5mg/kg/d
§ One or more CHF related hospital admissions
within 6 months in setting of medical and
dietary compliance
§ Measured peak VO2 < 14 ml/kg/min or < 50%
age-gender predicted on treadmill

40. The population of these patients is large:
In the US, ~300K AHF patients
40
PotenUal
VAD
/
TX
paUent
populaUon
-­‐
NaUonal
~240
M
US
Popula6on
≥
20
years
old
6.24
M
HF
=
2.6%
of
the
popula6on
3.12
M
Systolic
HF
=
50%
of
HF
popula6on
124,800
Adv.
Stage
C
/
NYHA
IIIB
Advanced
Stage
C
=
3-­‐4%
156,000
Stage
D
/
NYHA
IV
=
0.5-­‐5%
70,200
25%
Accessible
AHF
Pa6ents
Virginia
PopulaUon
8M
~
2400
VADs
and
~550/yr
Richmond
MSA
PopulaUon
1.25M
~375
VADs
and
~90/yr
117
PaUents
/
100,000
PopulaUon
30
PaUents
/
100,000
PopulaUon
Current
es6mates
of
adult
pa6ents
with
advanced
heart
failure
(HF)
in
the
United
States,
with
projected
leQ
ventricular
assist
device
(LVAD)
candidates.
U.S.
popula6on
es6mate
is
derived
from
U.S.
Census
data.
Es6mate
of
HF
prevalence
is
derived
from
latest
American
Heart
Associa6on
(AHA)
sta6s6cs.
Es6mates
of
HF
with
reduced
ejec6on
frac6on
and
preserved
ejec6on
frac6on
based
on
popula6on
studies.
Es6mates
of
prevalence
of
HF
stages
and
New
York
Heart
Associa6on
(NYHA)
class
derived
from
Ammar
et
al,
Goda
et
al,
and
Ceia
et
al.
Source:
Mechanical
Circulatory
Support:
A
Companion
to
Braunwald’s
Heart
Disease;
“25%
Accessible
AHF
Pa6ents”
from
Thoratec
es6mates
AHF
Pa;ents:
Poten;al
VAD
/
TX
Pa;ents:
Incidence:
7
/
100,000
each
year

41. 41
HeartMate II Implants per 100,000 Population (2013)
20 Largest Metro Areas (US)
≈
5
4
3
2
1
0
Detroit
Minneapolis
Baltimore
St. Louis
Tampa
San Francisco
Denver
Los Angeles
Philadelphia
Dallas
Houston
Chicago
San Diego
Seattle
Washington DC
Miami
Atlanta
Boston
Phoenix
New York
30
Estimated Number of Candidates
30 / 100,000
29
28

42. 42
Outcomes Critical to the
Success of LVAD Therapy
• Survival (near term and long term)
• Quality of Life
• Adverse Events
– Drive application and cost in part by
accounting for readmissions
• Application to the appropriate patient
population

43. 43
Mechanical Support Devices
ACUTE
INTERMEDIATE CHRONIC
Short-term Months to 1 year Months to 1-7+ years
Bridge to Decision
or Wean
Bridge to Transplant Bridge to Transplant
Destination Therapy
CentriMag*
PediMag
PVAD HeartMate II
*See
slide
#6
for
U.S.
Indica6ons
for
Use

44. Adverse Events in the ADVANCE Trial and
CAP - HVAD
44
44
Slaughter et al J Heart Lung Transplant 2013;32:675-83.

45. N=1270
Walt Dembitsky– Presented at the Economic Summit on VADs, October 3, 2013

46. Walt Dembitsky– Presented at the Economic Summit on VADs, October 3, 2013
COST REDUCTION
TARGETS

47. 47
Technologic Advances: Potential
Impact on Adverse Events
• Bleeding, Thrombosis, Anticoagulation (HM III)
• Full magnetic levitation reduces blood
trauma and less likely to cleave vWF
• Pulsatility (HM III)
• Reduce mucosal AVMs, AI, Stroke
• Wash out reduces pump thrombosis
• Full implantation (FILVAS – HM III)
• Eliminate driveline infections
• BiVAD (HM III)
• RV failure, ventricular arrhythmia

48. There are a number of approaches you can
take to manage these patients
48
Referring
for
Care
• Begin active
management of AHF
population
• Provide
comprehensive
educational program
on AHF for CV staff
• Target early referral of
“frequent fliers” to
outside AHF program
Sharing
Care
Fully
integrated
MCS
program
• Begin caring for VAD
patients post implant
• Potentially invest in
building a HF clinic
• Explore adding
additional AHF
treatments, e.g.,
– IV diuretics
– INR clinics
– Other DM programs
• Fully-integrate as an
AHF program
• Become an OHC
• Serve as a referral
center in the
community

49. Shared Care provides Shared Benefits
• Reduced travel time and increased convenience for routine
monitoring appointments
• Ability to maintain close relationship with their cardiologists
• Reduced burden of ongoing patient care while still participating
in maintaining strong outcomes
• Drives program growth through deeper relationships with
community cardiologists
• Continued hands-on involvement in the care of their patients
• Greater familiarity with the benefits of VAD treatment and quality-of-life
(QoL) improvements

50. 50
50
Outcomes of Patients
Implanted with a Left
Ventricular Assist Device
at Non-transplant Open
Heart Surgery Centers
Marc R. Katz, MD, MPH
Bon Secours Heart and Vascular
Institute, Richmond, VA
ISHLT
2012

51. INTERMACS Profiles
51
Profile
OHC
N
-­‐
130
(%)
TX
Center
N
-­‐
3067
(%)
1
9
(7)
409
(13)
2
50
(38)
1252
(41)
3
50
(38)
772
(25)
4
14
(11)
417
(14)
5
1
(1)
116
(4)
6
1
(1)
63
(2)
7
5
(4)
38
(1)
83%
79%

52. Survival
52
1.00
0.90
0.80
0.70
0.60
0.50
0.40
0.30
0.20
0.10
0.00
Total
implants
267
(36%
BTT)
0 1 2 3 4 5 6 7 8 9 10 11 12
Percent Survival
Months
Logrank Analysis P = 0.9859
Baseline
6
Month
12
Month
N
Survival
N
Survival
N
OHC
130
89%
64
83%
25
HTC
3067
88%
1864
82%
1012
Presented
by
Marc
Katz
MD
OHC
Summit
Mar
2014

53. 53
And the therapy is no longer just in
specialized, academic centers
Na6onal
Need
Source:
Centers
as
of
October
2013;
Shared
Care
as
of
July
2013
from
Thoratec
data
on
file;
Thoratec
Corpora6on;
UNOS
Transplant
Centers
Non-­‐Tx
Centers
Shared
Care
Sites
As
of
October
2013:
169
US
HMII
Centers
125
DT-­‐CerUfied
HMII
Centers

54. Local/Regional VAD Centers of Excellence Networks
Hub and Spoke model n Transplant center
n Implanting Center
n AHF Mgmt Center
n Referral Practice
n Out of Network
Courtesy of Confidential F. Dennis property of Optum. Do Irwin not distribute MD, or reproduce Medical without express permission Director
from Optum.

55. 55
The State of VAD Therapy Today
• MCS is one of multiple options for managing AHF
• Outcomes justify considering MCS earlier in the
pathophysiologic perturbation
• Continued technologic advances will justify
application to a broader population
• Support of controlled studies to assess the value
of earlier implantation should be a priority
• Destination Therapy is the major growth area in
the US

56. 100
90
80
70
60
50
40
30
20
10
56
Summary of Post Approval
Outcomes*
85%
0 3 6 9 12
*John et al Ann Thorac Surg 2011
**Jorde et al J Am Coll Cardiol 2014
DT Trial (n=133)1
90 + 2%
1Slaughter, Rogers, Milano NEJM 2009;361:2241-51
61 + 3%
92 + 2%
0 6 12 18 24
Months
Percent Survival
100
90
80
70
60
50
40
30
20
10
0
DT Post Approval (n=247)
68 + 4%
58 + 4%
74 + 3%
Remaining at Risk:
247 192 169 151 130
133 95 82 69 62
Months
Percent Survival
0
P < 0.001 log-rank test
Post-Trial (N=1496)
Trial (N=486) 76%
BTT*
DT**
*derived
from
INTERMACS