Download VAD Therapy Changing the Treatment of Heart Failure.

VAD Therapy Changing
the Treatment of Heart Failure.
Katrin,
– Living with the HVAD System since 2013
VAD Therapy
Is becoming an essential part of heart failure programs
around the world.
Ventricular assist devices (VADs) are transforming the treatment of
patients with advanced heart failure. In fact, few advancements in
healthcare today have a greater potential to impact heart failure
than VADs.
VAD therapy is part of the field of Mechanical Circulatory Support
(MCS). VADs are mechanical devices designed to help a weakened
heart pump blood throughout the body by removing blood from the
ventricle and pumping it into the artery. VADs restore cardiac output
and help alleviate the symptoms of heart failure.
There is a real need for better therapeutic options for
patients with advanced heart failure to reduce the
very impaired quality of life of these patients and the
significant personal and economic impact of recurrent
hospitalizations. A substantial number of patients could
benefit from this therapy who are not currently being
referred or considered for LVAD therapy.1
When managing a patient with advanced heart
failure consider discussing referral for VAD therapy
while they still have time to make the choice.
HVAD® System
•2009 CE Mark Approval
•2012 FDA Approval
•2015 More than 10,000
Implants*
*Data on File
HVAD® System
The VAD of Choice
Consistently demonstrating high survival rates.
The Seattle Heart Failure Model (SHFM) is a widely validated risk model. The
below graph illustrates the predicted annual mortality for the HVAD System
patients in ADVANCE BTT+CAP (Bridged to Transplant + Continued Access
Protocol) Clinical Trial if they had continued on optimal medical therapy.
HVAD System Survival vs. Projected Survival*
100
90%
90
90%
80
Observed Survial (%)
87%
80%
84%
70
71%
60
61%
50
40
BTT/CAP (N=382)
30
CE Mark (N=50)
20
SHFM Medical Therapy
10
0
46%
0
30%
180
360
540
720
SHFM performed against the ADVANCE BTT=CAP population (n=382)
§
*Data on file with HeartWare.
Recent Publications
Show the Highest
Survival for any BTT
Pivotal Clinical Trial2
99%
94%
86%
30-Day Survival
180-Day Survival
360-Day Survival
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Refer to the “Instructions
for Use” for complete Indications for Use, Contraindications, Warnings, Precautions, Adverse Events and Instructions
prior to using this device. The IFU can be found at www.heartware.com/clinicians/instructions-use.
The HVAD System successfully supported 74 of 382 patients in the BTT & CAP
study for more than two years.2
Kaplan-Meier Continued Survival in Patients
Supported on HVAD System at least 2 Years2
100
89%
Event Free Rate (%)
90
80
77%
70
60
50
Continued Survival at: 3 years = 89%
40
4 years = 77%
30
20
10
0
2 years
3 years
4 years
Duration of Support
The ReVOLVE registry, conducted post-CE mark approval, demonstrates the
real-world experiences of 248 patients implanted with the HVAD Pump. As the
study shows, it continues to demonstrate long-term survival in commercial use.3
ReVOLVE Long-Term Follow-up: Kaplan-Meier Estimate
of Survival in BTT Patients (N=248)3
100
90
Patient Survival
80
86%
84%
78%
70
68%
63%
60
59%
50
5 Years
40
30
20
10
00
180
360
540
720
900
1080
1260
1440
1620
1800
Duration of Support (days)
Follow-up of patients from the ReVOLVE registry who remained on support revealed continued excellent survival of 68%, 63% and 59% at
three, four, and five years, respectively.3
VAD Therapy Changing the
Treatment of Heart Failure.
VAD Therapy Changing
the Treatment of Heart Failure.
If your patient is persistently symptomatic and
has one or more of the C.H.O.I.C.E. risk factors,
they may be a candidate for VAD therapy.
From the first consideration of LVAD, emphasis should
be placed on the anticipated differences between
ongoing medical therapy and LVAD with respect
to both survival and quality of life. These discussions
should occur before consideration of continuous
outpatient inotropic infusions for hemodynamic
support of deteriorating clinical status.4
C lass IIIB / IV
NYHA classifications symptoms with an ejection
fraction (EF) <30%:6
H ospitalization
Each subsequent hospitalization for heart failure is associated
with a significant further reduction in survival.1
O ptimal
Medical management not effective.6, 7
I notrope
Therapy being considered or initiated.7
C linical
Parameters worsening.8
E volving
Or progressing organ dysfunction.6, 7
Symptoms to Watch for:
• Shortness of breath on mild exertion/
breathless at rest.8
• Increased diuretic requirement.6
• Low six-minute walk test distance(<300 m).6
• Intolerance to neurohormonal antagonists.6
(ACEi/ARB/BB)
• Inability to perform an exercise test.6
• Hypotension.6
• Inability to climb two flights of stairs.
• CRT non-responder / not indicated.9
• Inability to walk two blocks.
• Increasing plasma BNP or NT-proBNP levels
despite adequate heart failure treatment.10
Median Survival Decreases After Each Heart
Failure Related Hospitalization5
3.0
Medial Survival (years)
1st
2.0
2nd
hospitalization
(n=14,374)
3rd
hospitalization
(n=3,358)
1.0
4th
hospitalization
(n=1,123)
hospitalization
(n=417)
0.0
Average age of heart failure hospitalization in community =74.77 years
Observed Mortality by Number of the Specified Risk Factors8
100
Survival Rates (%)
80
0 Risk Fac
tors
60
1 Risk Fac
tor
40
No. at Risk 0
Risk Factors 1
2
3-5
•Systolic blood
pressure ≤90 mm Hg
2 Risk Fac
tors
20
0
One or more risk factors
should trigger generalist
to refer to an advanced
heart failure center.8
3-5 Risk Fa
ctors
0
3156
1343
369
80
1
3156
1343
369
80
2
2446
979
246
45
•Creatinine ≥160 μmol/l
3
4
5
6
1893
708
157
29
1318
494
100
18
869
329
63
13
530
192
32
6
Years
•Hemoglobin ≤120 g/l
•No treatment with
renin-angiotensin
system antagonist
•No treatment with
beta-blocker
VADs Address a Need
There is a shortage of hearts—heart transplantation rates remain steady,
yet demand continues to rise with more patients waiting for a transplant.
Heart Failure Trends
• Projections show that by 2030, the prevalence of heart failure in the United
States will increase 25%, resulting in >8 million people with heart failure (1 in
every 33).11, 22
• At 40 years of age, the lifetime risk of developing heart failure for both men
and women is 1 in 5.11
• Survival after heart failure diagnosis has improved over time; however, the
death rate remains high: ≈50% of people diagnosed with heart failure will die
within five years.11
Wait times frequently exceed one year.
400%
increase in VAD
volume outside the
U.S. since 2008.21
• United States:
As of October 2015, nearly half (48%) of
the 4,243 people listed had been waiting
for a heart for more than one year. 13
• Europe:
In 2014 the median Eurotransplant waiting
time was 15 months. 14
Many heart failure patients waiting for a donor
heart become inotrope-dependent.11 While these
drugs can alleviate symptoms, they are associated
with no reduction in recurrent hospitalization and
as high as 80% mortality at 1 year.1
Global Endorsement
A simple solution that can transform patients’ lives.
VAD therapy does not cure heart failure, but the data
and trends demonstrate that VAD therapy may offer a
C.H.O.I.C.E. for your advanced heart failure patients.
42%
of heart transplant patients
worldwide are bridged-totransplant with a VAD.15
VAD therapy has been globally endorsed as an
option by the:
• American Heart Association (AHA)
• European Society of Cardiology (ESC)
• International Society for Heart and Lung
Transplantation (ISHLT)
“A decreasing number of patients on the heart
transplant waiting list died because of the
availability of VAD therapy. However a significant
percentage of that number die of progressive
heart failure without the use of LVADs.”1
Key facts:
• Heart failure is a serious disease that currently affects
an estimated 38 million patients worldwide.16
• Heart failure is the leading cause of hospitalization in
the U.S. and Europe.17
• Heart failure has the highest readmission rate of any
diagnosis related group, averaging 20% at 1 month
and 50% at 6 months.1
• An estimated 10% of heart failure patients have
an advanced condition18 with symptoms, such as
shortness of breath, even while resting.
• Worldwide 50,000 candidates are waiting for heart
transplantation19, yet only approximately 4,000 heart
transplants are performed each year.20
Early Referral Equals
a C.H.O.I.C.E.for
Your Patients
Give patients the C.H.O.I.C.E. of VAD
therapy; consider referring before they
reach a critical stage.
Evidence shows that survival rates are
higher when patients receive a VAD prior
to reaching critical stages. Identifying the
right time to intervene with VAD therapy can
enhance the risk/benefit ratio, both in the
short and long term.
When might referral for VAD
therapy be considered?
When your patient is persistently symptomatic
and exhibits the C.H.O.I.C.E. risk factors they
may be a candidate for VAD therapy.
Despite optimal medical management, your
patient continues to be readmitted to the
hospital for acute heart failure symptoms,
becoming a “frequent flyer” and potentially
inotrope-dependent. Of those, 50% who
have three hospital stays will die within
one year.6 These patients may be good
candidates for referral to an advanced
heart failure center for assessment.
‘’Any patient who is considered for chronic
inotropic therapy, and who otherwise has a
reasonable prognosis for 3 to 5 years, should
first be evaluated for candidacy for chronic
LVAD therapy or transplant.’’1
Karl-Heinz,
– Living with the HVAD System since 2014
VAD Therapy Changing
the Treatment of Heart Failure.
References
1. Miller, L. Is left ventricular assist device therapy underutilized in the treatment of heart failure? Circulation. 2011;123:1552-1558.
2. Aaronson, K, et al. Patients awaiting heart transplantation on HeartWare ventricular assist device support for greater than two years. AHA Poster. 2014.
Chicago, IL.
3. Schmitto, J, et al. Long-term support of patients receiving an LVAD for advanced heart failure: follow-up analysis of the registry to evaluate the HeartWare left
ventricular assist system (The ReVOLVE Registry), presentation at ISHLT, April 16, 2015, Nice, France.
4. Stewart, G, et al. Who wants a left ventricular assist device for ambulatory heart failure? Early insights from the MEDAMACS screening pilot. J Heart Lung
Transplant. 2015;34:1630-1633.
5. Miller L, Guglin M. Patient selection for ventricular assist devices: A moving target. J Am Coll Cardiol. 2013;61:1209-21.
6. Peura, J, et al. AHA. Recommendations for the use of mechanical circulatory support: device strategies and patient selection.2012;126:2653-2667.
7. McMurray JJV, et al. ESC guidelines for the diagnosis and treatment of acute and chronic heart failure 2012. Eur Heart J. 2012;33:1787-1847.
8. Thorvaldsen, T, et al. Triage of patients with moderate to severe heart failure who should be referred to a heart failure center. J Am Coll
Cardiol.2014;63:661-671.
9. Daubert, J, et al. 2012 EHRA/HRS expert consensus statement on cardiac resynchronization therapy in heart failure: Implant and follow-up recommendations
and management. Europace. 2012;14:1236-1286.
10.Banner, N, et al. UK Guidelines for referral and assessment of adults for heart transplantation. Heart. 2011;97:1520-1527.
11.Go, A, et al. AHA statistical update. Heart disease and stroke statistics - 2013 update. A report from the American Heart Association. Circulation.
2013;127:e199-e201.
12.McMurray, JJV, Stewart S. The burden of heart failure. Eur Heart J Suppl. 2002;4(suppl D):D50-D58.
13.http://optn.transplant.hrsa.gov/converge/latestData/rptData.asp. Accessed December 15, 2015.
14.Eurotransplant 2014 Report.
15.Lund, L, et al. For the International Society for Heart and Lung Transplantation, The Registry of the International Society for Heart and Lung Transplantation.
Thirty-second Official Adult Heart Transplantation Report -- 2015; Focus Theme: Early Graft Failure, J Heart Lung Transplant. 2015;34:1244-1254.
16.Braunwald, E. The war against heart failure: the Lancet lecture. Lancet. 2015;385: 812-824.
17.Ambrosy, P, et al. The global health and economic burden of hospitalizations for heart failure. Lessons learned from hospitalized heart failure registries. J Am
Coll Cardiol. 2014;63:1123 -1133.
18.http://www.heart.org/HEARTORG/Conditions/HeartFailure/Advanced-Heart-Failure_UCM_441925_Article.jsp. Accessed December 15, 2015.
19.HealthResearchFunding.org. Accessed December 16, 2015.
20.Stehlik, J, et al. The Registry of the International Society for Heart and Lung Transplantation: 29th official adult heart transplant report - 2012. J Heart Lung
Transplant. 2012;31:1052-1064.
21.Based on financial analyst reporting. (Public record).
22.Heidenreich, P, et al. AHA Policy Statement. Forecasting the impact of heart failure in the United States. A policy statement from the American Heart
Association. Circ Heart Fail. 2013;6:606-619.
CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician.
Refer to the “Instructions for Use” for complete Indications for Use, Contraindications,
Warnings, Precautions, Adverse Events and Instructions prior to using this device. The IFU
can be found at www.heartware.com/clinicians/instructions-use.
HEARTWARE, HVAD, and the HEARTWARE logo are trademarks of HeartWare, Inc.
© 2016 HeartWare, Inc. GL1165 Rev01 2/16
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Miami Lakes, FL 33014 USA
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