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STANDARD MEDICAL THERAPY*
20%
ABSOLUTE REDUCTION in
all-cause mortality at
one year22
Balloon-expandable
Transcatheter Aortic Valve
Implantation (TAVI)
Aortic Stenosis
A brief summary of prevalence, guidelines,
new treatment options, and current data
New Options for
Aortic Valve Replacement
Epidemiological studies have determined that more than one in eight people aged
75 and older have moderate or severe aortic stenosis (AS).1 Multiple surveys have
shown that many patients with severe AS are not referred to a heart team for valve
replacement evaluation.2 Surgical aortic valve replacement (SAVR) is the gold
standard for treatment of severe AS and transcatheter aortic valve implantation
(TAVI) offers a new treatment option for patients considered high risk for surgery.
Here is how you can help.
A o r t i c Va lv e D i s e a s e I s
C o m m o n i n E l d e r ly P a t i e n t s
“Valvular heart diseases represent an under appreciated yet serious
and growing public health problem that should be addressed.”
—V.T. Nkomo, Mayo Clinic, USA3
Prevalence of Valvular
Heart Disease by Age 3
As the chart illustrates,
aortic valve disease is
common and its prevalence
increases with age. For
people over the age of 75
years, the prevalence of
aortic stenosis is 5%.4 More
than one in eight people
over the age of 75 have
moderate or severe valve
disease.1 As the population
ages, this condition becomes
an important public health
problem.3
P R EVA LE NCE O F MO DE RATE
O R SE VE R E VALVE DISE ASE
14%
All valve disease
Mitral valve disease
Aortic valve disease
12%
10%
8%
6%
4%
2%
0
45
45-54
55-64
A GE (YEARS)
2
65-74
>75
Aortic Stenosis
I s L i f e - T h r e at e n i n g
“Unless investigation and surgery can be performed very quickly,
death, whether sudden or not, is still unacceptably common in
severe aortic stenosis.”
—J.B. Chambers & P. Das, Guy’s and St. Thomas’ Hospitals, London25
Progression of Aortic Stenosis 6
Onset Severe Symptoms
100
S URVIVAL
%
Latent Period
(Increasing Obstruction,
Myocardial Overload)
80%
60%
ANGINA
SYNCOPE
FAILURE
0
2
4
6
AV ER AGE SURV IVAL (Y EARS)
40%
20%
0
40
80
A G E ( YE AR S )
Valvular aortic stenosis is progressive and life-threatening. Once symptoms
appear, untreated patients have a poor prognosis; they will experience
worsening symptoms, eventually leading to death. After the onset of
symptoms, average survival is 50% at two years and 20% at five years.7
3
A ORTIC STENOSIS
T r e at m e n t G u i d e l i n e s
“Surgical intervention should be performed promptly once even
minor symptoms occur.”
—C.M. Otto, University of Washington School of Medicine, Seattle, Washington6
ESC/EACTS AS Treatment Guidelines 8
Severe AS
Symptoms
No
Yes
LVEF < 50%
No
Contraindication
for AVR
Yes
Physically active
No
Yes
No
Yes
High risk for AVR
Short life expectancy
Exercise test
No
Symptoms or fall in blood
pressure below baseline
No
Yes
Yes
TAVI
Med Rx
Yes
Presence of risk factor and low/intermediate
individual surgical risk
No
No
Yes
AVR
AVR or TAVI
Re-evaluate in 6 months
According to the ESC Guidelines, severe AS is defined by these characteristics:
• Aortic valve area: < 1cm2
• Jet Velocity: > 4.0m/sec
• Mean transvalvular pressure: > 40mmHg
The 2012 ESC/EACTS guidelines for AS recommend valve replacement for Class I
patients, i.e. those with severe AS and symptoms 8. TAVI is indicated in patients
with severe symptomatic AS who are not suitable for AVR as assessed by a “heart
team” and should be considered in high risk patients who may still be suitable for
surgery, but in whom TAVI is favoured by a “heart team” based on the individual
risk profile.8
4
2
T r e at m e n t I s U r g e n t a n d A o r t i c
Va lv e R e p l a c e m e n t i s E f f e c t i v e
Patient Survival 1 0
100
90
% Survival
80
70
60
50
40
AV
AV
No
No
30
20
10
0
0
1
2
3
4
5
AVR, Asymptomatic
AVR, Symptomatic
No AVR, Asymptomatic
No AVR, Symptomatic
13
14
15
6
7
8
9
10
11
12
13
14
15
YEARS
There are no medications to reverse or slow the progression of AS. AVR is
the standard of care. Because of the risk of sudden death, AVR should be
performed promptly after the onset of symptoms.9 Without timely aortic valve
replacement, patients with severe AS and symptoms have high mortality:
mortality is 3% to 4% soon after symptoms appear and 7% among patients
on a waiting list for AVR. In contrast, mortality in a fit patient is 1% to 2%
after AVR.5
In recent decades, surgical AVR has consistently produced outstanding
results in prolonging life and improving quality of life.8,11,12,13 Even among
patients over the age of 80 years, functional outcomes have been excellent
in patients after AVR.13 Survival is good, with 60% to 65% of patients who
underwent AVR alive five years later,11,12 with improved quality of life.8 AVR
takes patients out of full-time care or sedentary lifestyles, enabling a return
to independence.
5
Ma n y A o r t i c S t e n o s i s P a t i e n t s
A r e N o t T r e at e d
“Too many patients with severe symptomatic valve disease are denied
surgery.” —B. Iung, Bichat Hospital, Paris2
Surgery vs No Surgery in AS Pati ents 1 4
Guidelines are not consistently
followed. In actual practice,
more than one third of patients
eligible for AVR are not
referred for evaluation. As the
chart illustrates, five different
surveys identified 30% to 60%
of patients not referred for
surgery. Additionally, the Euro
Heart Survey of 5000 patients
from 92 centers in 25 European
countries determined that
32.3% of patients over the age
of 75 were denied surgery.2
100%
41
80%
33
30
100%
80%
41
33
30
60
48
50
67
70
40
52
Pellikka17
2005
Charlson18
2006
Bach19
2007
60%
40%
20%
0
60
Bouma15
1999
Iung16
2005
No Surgery
48
Surgery
60%
R e a s o n s m a n y a o r t i c s t e n o s i s pa t i e n t s
d50o n ’ t67 g e t70 n e e 40d e d 52t r e a t m e n t
40%
20%
0
14
Reasons
for AVR
Non-Referral
Charlson
Bach
Iung
Pellikka
Bouma15
1999
16
2005
18
17
2005
Patient
Preference
12%
2006
19
2007
High Risk
45%
AS Not
Severe
18%
Mild Symptoms
25%
6
Treatment decisions for older patients
with severe AS are challenging due
to comorbidity; they have a higher
operative risk and have reduced life
expectancy. In addition, their risk is
increased by comorbidities such as
heart disease and other conditions that
are often present in this age group.8
No S
T r a n s c at h e t e r t r e at m e n t o p t i o n
add r e s s e s a n u n m e t n e e d
“Today, TAVI allows patients who are at very high surgical risk or
with contraindications to surgical AVR to benefit from an effective
treatment of AS.”
—D. Himbert, Bichat-Claude Bernard Hospital, Paris20
Transcatheter Aortic Valve
Implantation
Transaortic
Valve
Implantation
Transfemoral
Valve
Implantation
Transapical
Valve
Implantation
A new option for patients with severe AS considered to be high risk for surgical
AVR is transcatheter aortic valve implantation, or TAVI. In this procedure, the
valve is delivered via transfemoral, transapical or transaortic access without
open-heart surgery. TAVI received the CE mark in 2007.
7
t h e pa r t n e r t r i a l
The PAR TNER Trial Protocol 2 2
Symptomatic Severe Aortic Stenosis
ASSESSMENT
Operability
Yes
No
Cohort A
Cohort B
C o h o rt B p o p u l at i o n p r o f i l e
Mean age n = 358
n = 700
Yes
ASSESSMENT
Transfemoral Access
No
NYHA Class III-IV 93%
COPD, O 2 dependent
23%
PVD
28%
Porcelain aorta 15%
Chest wall deformity 1:1 Randomization
Transfemoral
VS
Standard
Therapy
Not in
Study
83 y
7%
CAD
71%
Frail 23%
CAD, coronary artery disease; COPD, chronic
obstructive pulmonary disease; NYHA, New York
Heart Association; PVD, peripheral vascular
disease; BAV, balloon aortic valvuloplasty.
The PARTNER (Placement of AoRtic TraNscathetER Valves) trial represents a
paradigm shift in clinical investigation and interpretability. As the world’s first
prospective, randomized, and controlled trial for transcatheter heart valves,
the PARTNER trial sets new standards in site selection, case screening,
study management, multidisciplinary teamwork, and patient follow-up.22
The PARTNER Trial consists of two individually powered patient cohorts.
• In Cohort A, the safety and effectiveness of the Edwards SAPIEN
transcatheter heart valve (THV) was compared to surgical aortic valve
replacement (sAVR) in high-risk patients with severe aortic stenosis.
The results of Cohort A were published in 2011.22
• In Cohort B, the safety and effectiveness of the Edwards SAPIEN THV
was compared to best medical management (standard therapy) in inoperable
patients with severe aortic stenosis. Patient selection required at least two
cardiothoracic surgeons and an interventional cardiologist to agree that
patients were not suitable candidates for surgery.22
8
T h e Ed w a r d s S A P IEN TH V
S i g n i f i c a n t ly I m p r o v e s S u r v i va l
Co-Primary Endpoint:
All-Cause Mort ality 2 2
All-Cause Mortality, %
100
P < .001
∆ at 1 y = 20.0%
NNT = 5.0 pts
80
“On the basis of a rate
of death from any cause
at 1 year that was 20
percentage points
lower with TAVI than
with standard therapy,
balloon-expandable
TAVI should be the
new standard of care
for patients with aortic
stenosis who are not
suitable candidates for
surgery.”
Standard Medical Therapy*
50.7%
60
Edwards THV
40
30.7%
20
0
0
6
12
18
24
Months
—The Partner trial
Investigators21
* P a t i e n t s i n co n tro l arm recei ved bes t m edic a l ma na ge me nt whic h
f requ en tl y (7 8 .2 %) i n cl u ded bal l o o n aortic va lvulop la sty.
T h e Ed w a r d s S A P IEN TH V
S i g n i f i c a n t ly I m p r o v e s P a t i e n t
Symptoms and Quality of Life
—David J. Cohen, St Luke’s
Mid-America Heart and
Vascular Institute, Kansas
City, Missouri23
Kansas City Cardiomyopathy
Questionnaire (KCCQ)
Scores Over T ime 2 1
MCID = 5 pts
70
6070
5060
KCCQ Score
KCCQ Score
“The dramatic
improvement in quality
of life scores in the
Edwards SAPIEN THV
group is equivalent to a
10-year reduction in age.”
MCID = 5 pts
4050
3040
∆ = 13.9
P < .001
∆ = 13.9
P < .001
2030
1020
010
0
0
2
0
4
2
∆ = 20.7
P < .001
∆ = 20.7
P < .001
6
8
4Months
6
∆ = 24.5
P < .001
∆ = 24.5
P < .001
10
8
12
10
12
Months
Edwards THV
Edwards THV
Control*
Control*
*Pa tie nts in c ontrol a rm re c e ive d b e st me d ic a l ma na ge me nt whi ch
fre q ue ntly (78.2%) inc lud e d b a lloon a ortic va lvulop la sty.
9
R e f e r S y m p t o m at i c A o r t i c s t e n o s i s
Pat i e n t s t o a H e a r t T e a m
Heart Team Evaluation
Patient is referred to a heart team
Low Risk
Surgical
AVR
High Risk
Transcatheter
Valve Implantation
Balloon Aortic
Valvuloplasty
Medical
Management
An increasing number of heart centers offer all of the available
AS solutions. Referral to such a center offers the most options for your
patients. A multidisciplinary approach is necessary in order to direct each
patient toward the best therapeutic option. The team will evaluate patients
for surgical AVR, balloon valvuloplasty, TAVI, or medical management.
10
N e w T r e a t m e n t Op t i o n s L e ad t o
Increased Referral, awareness,
a n d p r o p e r t r e at m e n t
“A significant population of patients with AS are still treated medically.”
—S.C. Malaisrie, Bluhm Cardiovascular Institute, Northwestern University Memorial Hospital,
Chicago, Illinois24
Impact of TAVI on Referrals 2 4
80%
70%
60%
50%
40%
30%
20%
(A) Unoperated AS (Pre-TAVI vs. Post-TAVI, p=.002)
10%
(B) Referral for Surgery (Pre-TAVI vs. Post-TAVI, p=.003)
0
2006 (N=179)
2007 (N=183)
2008 (N=214)
Pre-TAVI
2009 (N=265)
Post-TAVI
YEAR
A retrospective study determined that the introduction of TAVI was
associated with an increase in aortic valve replacement referrals and a
decrease in the rate of unoperated AS. This positive impact was due
to increases in both TAVI and AVR volume. Increased volume was not
associated with worse patient survival.24
11
Want to Know More?
You can access more information on both surgical AVR and TAVI on the
Edwards Lifesciences’ web site Edwards.com/eu. The site will also help you
to locate a heart center and to identify specialists near you who are trained
in the TAVI procedure.
References
1. National Heart Lung and Blood Institute, U.S. National Institutes of Health. Heart Valve Disease.
Accessed at www.nhlbi.nih.gov/health/dci/Diseases/hvd/hvd_whatis.html. November 12, 2010.
2. lung B, Baron G, Tornos P, et al. Valvular heart disease in the community: a European experience. Curr Probl Cardiol 2007; 32:609-61.
3. Nkomo VT, Gardin JM, Skelton TN et al. Burden of valvular heart diseases: a population-based study. Lancet 2006; 368:1005-11.
4. Lindroos M et al. Epidemiological studies estimate the prevalence of aortic stenosis at 5% in subjects over the age of 75 years. J Am Coll Cardiol 1993; 21:1220-5.
5. Chambers JB. Aortic stenosis. Eur J Echocardiography 2009; 10:111-19.
6. Otto M. Valve disease: timing of aortic valve surgery. Heart 200 Chart. In: Ross J Jr, Braunwald E. Aortic Stenosis. Circulation 1968; 38(suppl 1):61-7.
7. Lester SJ, Heilbron B, Gin K, et al. The natural history and rate of progression of aortic stenosis. Chest 1998; 113:1109-14.
8. Vahanian A, Alfieri O, Andreotti F, et al. Guidelines on the management of valvular heart disease. Eur Ht J 2012. Aug 24. Epub ahead of print.
9. Bonow RO, Carabello BA, Chatterjee K, et al. ACC/AHA 2006 Guidelines for the management of patients with valvular heart disease. Circulation 2006 Aug 1; 111(5):e84-231.
10. Brown ML, Pellikka PA, Schaff HV, et al. The benefits of early valve replacement in asymptomatic patients with severe aortic stenosis. J Thorac Cardiovasc
Surg 2008; 135(2): 308-15.
11. Conti V, Lick SD. Cardiac surgery in the elderly: indications and management options to optimize outcomes. Clin Geriatr Med 2006; 22:559-74.
12. Chiappini B, Camurri N, Loforte A, et al. Outcome after aortic valve replacement in octogenarians. Ann Thorac Surg 2004; 78:85-9.
13. Sundt TM, Bailey MS, Moon MR, et al. Quality of life after aortic valve replacement at the age of >80 years. Circulation 2000; 102[suppl III]:III-70-111-74.
14. van Geldorp MW, van Gameren M, Kappetein AP, et al. Therapeutic decisions for patients with symptomatic severe aortic stenosis: room for improvement?
Eur J Cardiothorac Surg 2009; 35:953-7.
15. Bouma BJ, van Den Brink RB, van Der Meulen JH, et al. To operate or not on elderly patients with aortic stenosis: the decision and its consequences. Heart 1999; 82:143-8.
16. Iung B, Cachier A, Baron G, et al. Decision-making in elderly patients with severe aortic stenosis: why are so many denied surgery? Eur Heart J 2005; 26:2714-20.
17. Pellikka PA, Sarano ME, Nishimura RA, et al. Outcome of 622 adults with asymptomatic, hemodynamically significant aortic stenosis during prolonged
follow-up. Circulation 2005; 111:3290-5.
18. Charlson E, Legedza AT, Hamel MB. Decision-making and outcomes in severe symptomatic aortic stenosis. J Heart Valve Dis 2006; 15:312-21.
19. Bach DS, Cimino N, Deeb GM. Unoperated patients with severe aortic stenosis. J Am Coll Cardiol 2007; 50:2018-9.
20. Himbert D, Descoutures F, Al-Attar N, et al. Results of transfemoral or transapical aortic valve implantation following a uniform assessment in high-risk
patients with aortic stenosis. J Am Coll Cardiol 2009; 54:303-11.
21. Reynolds MR et al; PARTNER Trial Investigators. Health-related quality of life after transcatheter aortic valve replacement in inoperable patients with severe aortic stenosis.
Circulation 2011; 124(18):1964-1972.
22. Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med 2010; 363:1597-1607.
23. Cohen DJ. Health-related quality of life after transcatheter aortic valve implantation vs non-surgical therapy among inoperable patients with severe aortic stenosis.
Results from the PARTNER trial. Presented at the American Heart Association’s Scientific Sessions, Chicago, IL, November 2010.
24. Malaisrie SC, Tuday E, Lapin B, et al. Transcather aortic valve implantation decreases the rate of unoperated aortic stenosis. Eur J Cardiotherac Surg; e-pub Jan 11, 2011.
25. Chambers JB, Das P. Treadmill exercise in apparently asymptomatic aortic stenosis. Heart 2001; 86:361-362.
*Patients in control arm received best medical management which frequently (78.2%) included balloon aortic valvuloplasty
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warnings, precautions and adverse events.
Edwards Lifesciences devices placed on the European market meeting the essential requirements referred to in Article 3 of the
Medical Device Directive 93/42/ECC bear the CE marking of conformity.
Any quotes used in this material are taken from independent third-party publications and are not intended to imply that such third party reviewed
or endorsed any of the products of Edwards Lifesciences.
Edwards, Edwards Lifesciences, the stylized E logo, Edwards SAPIEN, PARTNER and SAPIEN are trademarks of Edwards Lifesciences Corporation.
© 2012 Edwards Lifesciences Corporation. All rights reserved. E3154/08-12/THV
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