Download Transcatheter aortic valve implantation

In response to an enquiry from the National Planning Forum
Number 38 August 2011
Transcatheter aortic valve implantation (TAVI) for severe
symptomatic aortic stenosis in adults
Introduction
Key points
This Evidence Note was undertaken to inform the
work of the National Planning Forum subgroup
on TAVI. This Evidence Note includes the recently
published results from the PARTNER randomised
controlled trial (cohort A) which reported
on transcatheter versus surgical aortic-valve
replacement in high-risk surgical patients. This
Evidence Note will be reviewed again following
publication of the National Institute for Health
Research HTA on the cost effectiveness of TAVI for
aortic stenosis in patients who cannot undergo
surgery.
Health technology description
�  I n the only randomised controlled trial (RCT)
(PARTNER cohort B), TAVI significantly reduced
the risk of death from any cause after 1 year
compared with medical management in patients
who were unsuitable candidates for surgery.
�  In the only RCT (PARTNER cohort A), TAVI was
not inferior to surgical aortic valve replacement
with respect to death from any cause after 1 year
in candidates for surgery who were at high risk of
increased operative complications and death.
�  In the RCT, TAVI was associated with a significantly
higher incidence of major vascular complications
and neurological adverse events, in both cohorts
A and B.
Surgical aortic valve replacement (AVR) is the
current standard treatment for patients with severe
symptomatic aortic stenosis (AS)1,2. Transcatheter
aortic valve implantation (TAVI) is a minimally
invasive procedure in which a bioprosthetic
replacement valve is delivered percutaneously
through the vascular system inside a catheter.
Transcatheter access to the aortic valve is achieved
mainly by the retrograde transfemoral (TF),
transapical (TA) or transaxillary/subclavian routes1,3.
The TA and transaxillary/subclavian routes have
developed as alternative approaches for patients
with peripheral vascular disease that precludes
femoral access. The TA procedure involves a minithoracotomy to gain access to the aortic valve
through the apex of the left ventricle and hence is
not strictly percutaneous.
have been identified as being in various stages of
development1,3,4.
TAVI devices and delivery systems have developed
rapidly since the first in-man procedure was
reported in 2002. The devices with current European
CE mark approval are the balloon-expandable
Edwards SAPIEN™ and SAPIEN XT™ bovine
pericardium tissue valves (Edwards Lifesciences
Inc, Irving, CA) and the self-expanding Medtronic
porcine pericardium tissue CoreValve® ReValving
system (Medtronic, Minneapolis, MN). The Edwards
SAPIEN™ valves can be implanted using the
retrograde TF or the TA approach, and CoreValve®
devices by the retrograde TF or transaxillary/
subclavian arterial route. At least 20 other devices
TAVI has been advocated for the treatment of patients
who are unsuitable for conventional AVR as the
risks of surgery are unacceptably high because of
advanced age, frailty and/or the presence of cardiac
or non-cardiac co-morbidities. The current alternative
for these patients is palliative medical management
with or without balloon aortic valvuloplasty (BAV),
although BAV is not commonly performed in
Scotland1,3,5. TAVI may also represent a replacement
technology as a possible alternative to conventional
AVR surgery for a wider patient group6. The longterm durability of bioprosthetic percutaneous
prosthetic valves, which are susceptible to
�  There are limited published data on TAVI
outcomes beyond 1 year of follow up.
�There is limited information on the impact of
TAVI on quality of life compared with alternative
interventions.
�There are currently no published evaluations of
the cost effectiveness of TAVI.
�  Patient selection for TAVI should be undertaken by
a multidisciplinary team.
2
degeneration, calcification and inflammation,
is of particular concern when the indication for
TAVI extends to lower-risk patients with longer life
expectancy1,5. TAVI is not currently available in
Scotland.
largely determined by clinical judgement on an
individual patient basis and should, therefore,
be undertaken by a multidisciplinary team
including a cardiologist, cardiac surgeon and
cardiac anaesthetist2.
Epidemiology
Clinical effectiveness
AS is the most common native heart valve disease
in adults in Europe7. In most cases, the aetiology
is degenerative hence it is most often seen in the
elderly, increasing with age due to degenerative
calicification7,8. Most people with mild to moderate
AS are asymptomatic whereas patients with severe
AS are likely to develop symptoms associated
with narrowing of the valve and overload of
the left ventricle, including syncope, exerciseinduced angina, dyspnoea and congestive heart
failure. Without intervention, patients with severe
symptomatic AS have a poor prognosis with an
average survival of 2–3 years9.
Published data are available from one RCT,
the multicentre PARTNER (Placement of Aortic
Transcatheter Valves) trial sponsored by Edwards
Lifesciences14,15. The trial recruited patients
at 22 sites in the USA, three in Canada and
one in Germany. Patients with severe calcific
AS and New York Heart Association (NYHA)
functional class ≥II were randomised in two
separate cohorts: high-risk surgical patients
were randomised to undergo TAVI with
the SAPIEN™ valve or surgical AVR (cohort
A)15 while those who were considered not
to be suitable candidates for surgery were
randomised to TAVI or medical management
It has been estimated that more than one third
(usually BAV) (cohort B)14. The exclusion criteria
of elderly patients with severe symptomatic AS
included coronary artery disease requiring
in Europe are not referred for surgical AVR8.
revascularisation, severe renal insufficiency, and
Patients who are not referred for surgery are more
life expectancy <12 months due to non-cardiac
likely to be older than those who are, and more
co-morbid conditions. The trial appears to have
likely to have left ventricular dysfunction and cobeen generally well conducted, although it is
morbidities8. Coronary heart disease is a frequent
unclear from the trial reports that adequate
co-morbidity in the elderly and the risk of surgical
steps were taken to minimise selection bias.
mortality is higher among patients who undergo
A large body of evidence from published and
concurrent coronary artery bypass graft (CABG) and unpublished TAVI case series and registry
valve surgery compared with valve surgery alone10. data has been summarised in five technology
The UK cardiac surgical register of procedures
assessments4,16-19, and three systematic
performed in NHS hospitals, including units in
reviews20-22. Data from the UK TAVI registry
Scotland, recorded 17,797 isolated AVR procedures have been published subsequently12.
and 12,646 combined AVR and CABG procedures in
2004–200811. In that period, 64.5% of isolated AVR PARTNER trial cohort A
implants were bioprosthetic valves11. Information
The eligibility criteria for cohort A in the
Services Division recorded 867 surgical AVR
procedures in NHS hospitals in Scotland in 200911. PARTNER trial included high risk of operative
The UK TAVI registry recorded 862 TAVI procedures complications or death, defined as predicted
mortality ≥15% at 30 days and/or STS score
in England between January 2007 and December
≥1015. The primary outcome was all-cause
200912.
mortality at 1 year (Kaplan-Meier analysis) in
an intention-to-treat analysis of non-inferiority
Patient selection
comparing TAVI (TF and TA) with AVR. The prePatient eligibility for TAVI in the UK has been
defined margin of non-inferiority (ie the degree
estimated at between 16 per million and 21 per
of acceptable inferiority of TAVI compared with
million population, the former representing around AVR) was 7.5 percentage points difference in
80 procedures per year in Scotland6. The European treatment effect, and interpretation of nonSystem for Cardiac Operative Risk Evaluation
inferiority was based on the upper limit of a
(EuroSCORE) and the Society of Thoracic Surgeons one-sided 95% Confidence Interval (CI)15.
(STS) predicted risk of mortality are commonly used
in the assessment of cardiac surgical risk. High risk is The 699 patients recruited to cohort A were
generally defined as a logistic EuroSCORE ≥20% or categorised as being eligibile for TF (n=492)
an STS score of ≥10%1. The ability of these scoring or TA (n=207) TAVI and randomised in those
groups to TAVI (n=244 TF retrograde, n=104
systems alone to accurately predict surgical risk in
TA) or AVR (n=351). The mean age was 83.6
patients undergoing AVR, or to select patients for
TAVI, is limited3,13. Patient selection for TAVI remains years (Standard Deviation (SD) 6.8) in the TAVI
3
group and 84.5 years (SD 6.4) in the AVR group.
The mean baseline logistic EuroSCORE was 29.3
(SD 16.5) in the TAVI group and 29.2 (SD 15.6) in
the AVR group; the respective STS scores were 11.8
(SD 3.3) and 11.7 (SD 3.5). Thirty-eight patients
randomised to AVR did not undergo treatment,
the main reasons being refusal and withdrawal,
compared with four patients allocated to TAVI.
TAVI was aborted or converted to open surgery
in 16 patients, and one patient allocated to AVR
underwent TA TAVI15.
(five patients), and TAVI (four patients). In the
TAVI group, TF access was unsuccessful in two
patients and two procedures were aborted
because of inaccurate intraprocedural aortic
annulus measurement.
All-cause mortality at 1 year was significantly
lower in the TAVI group (30.7%) compared
with the control group (50.7%) (Hazard Ratio
(HR)=0.55; 95% CI 0.40 to 0.74; p<0.001).
The number needed to treat to prevent one
additional death in the first year was five (95%
CI 4 to 9 (estimated by Healthcare Improvement
All-cause mortality at 1 year was 24.2% in the
Scotland)). Repeat hospitalisation due to AS
TAVI group and 26.8% in the AVR group, a nonstatistically significant difference of -2.6 percentage or complications of the valve procedure was
also significantly lower in the TAVI group at
points (95% CI -9.3 to 4.1; p=0.44). The upper
1 year (22.3% versus 44.1%; p<0.001). A
limit of the one-sided 95% CI for the treatment
significantly higher proportion of survivors in
effect was 3.0% and within the pre-defined nonthe TAVI group (74.8%) compared with the
inferiority margin of 7.5% thereby demonstrating
non-inferiority of TAVI compared with AVR (p=0.001 control group (42.0%) were asymptomatic at
1 year or had mild symptoms defined as NYHA
for non-inferiority). TAVI was associated with a
functional class I or II (p<0.001). Six-minute
statistically significantly shorter length of stay in
walk test distances at 1 year showed statistically
an intensive care unit (ICU) (3 days versus 5 days;
p<0.001) and index hospital stay (8 days versus 12 significant improvement from baseline among
days; p<0.001). There was no statistically significant TAVI patients who were able to undertake the
test, and no significant change in the control
difference between TAVI and AVR with respect to
repeat hospitalisation at 30 days (p=0.64) or 1 year group14. Unpublished data on QOL among
(p=0.38), or in cardiac symptoms (NYHA functional survivors eligible for assessment showed a
class ≤II) or 6 minute walk test distance among
statistically significant difference in Kansas City
evaluable patients at 1 year15. Quality of life (QOL) Cardiomyopathy Questionnaire summary scores
(primary outcome) up to 1 year in favour of
outcomes have not been published.
TAVI (p<0.001)23.
PARTNER trial cohort B
The eligibility criteria for cohort B in the PARTNER
trial included agreement among a cardiologist and
at least two cardiovascular surgeons that co-existing
conditions precluded surgery on the basis of a
predicted ≥50% probability of surgical mortality at
30 days or serious irreversible morbidity14. Patients
found to have severe peripheral vascular disease
that precluded TF access were excluded. The main
primary outcome was all-cause mortality (KaplanMeier analysis). The median duration of follow up
was 1.6 years (range 1.0 to 2.8). Analysis was by
intention-to-treat for effectiveness outcomes and ‘as
treated’ for adverse events14.
Non-randomised studies
International TAVI registries have reported
procedural success rates of 87.3% to 98.2%
for the TF retrograde approach and 87.5% to
98.3% using the TA approach1,17-22. The UK
TAVI registry recently reported a 98.8% success
rate overall using Edwards SAPIEN™ and
CoreValve® devices implanted by retrograde TF
and other routes12. The mean length of hospital
stay ranged from 7 to 17 days in 12 published
case series from Europe and Canada22. SOURCE
registry data from 10 European countries
indicated an average length of hospital stay
of 9.5 days (range 6.5 to 11.4) following TF
Of the 358 patients recruited to cohort B, 179 were TAVI and 11.4 days (range 5.2 to 12.9) for TA
allocated to TF retrograde TAVI and 179 to medical implantation24. The average length of stay in
management, of whom 150 (83.8%) underwent
ICU was 2.8 days and 3.5 days, respectively24.
BAV. The mean age of patients in both groups was
One-year mortality rates ranged from 20% to
83 years (SD 8.6 TAVI group, 8.3 control group).
35% in TF retrograde series and 34% to 45.3%
The mean baseline logistic EuroSCORE was lower
in TA series21. The UK TAVI registry (Kaplanin the TAVI group (26.4, SD 17.2) than in the
Meier analysis) reported 82.4% survival in
control group (30.4, SD 19.1) whereas the mean
the TF group at 1 year and 78.3% at 2 years
STS scores were similar (11.2, SD 5.8 and 12.1, SD compared with 75.5% and 66.5%, respectively,
6.1, respectively). Despite their inoperable status,
for other routes (p=0.017)12. The longest follow
21 patients in the control group underwent surgical up data to be published are from a Canadian
intervention including AVR (12 patients), left
single-centre patient series that showed 61%
ventricular apical-aortic conduit and AVR
4
survival at 3 years among high risk patients who
were unsuitable for surgery and who underwent
TF or TA TAVI and survived past 30 days (n=70)25;
and 58% (SD 9.5) overall survival to 3 years among
a larger cohort of TA TAVI patients (n=71)26. Four
case series that used various generic instruments
to measure QOL in TAVI patients have reported
statistically significant improvements in some
domains, however without control groups the
observed benefits cannot be directly compared with
surgical AVR or medical management27-30.
Safety
PARTNER trial cohort A
The PARTNER trial found a statistically significant
reduction in all-cause mortality at 30 days in the
TAVI group compared with AVR by intention-totreat (3.4% versus 6.5%; p=0.07) but not in the
as-treated analysis (5.2% versus 8.0%; p=0.15)15.
Major vascular complications were significantly more
common in the TAVI group compared with AVR at
30 days (11.0% versus 3.2%; p<0.001) and 1 year
(11.3% versus 3.5%; p<0.001), as were neurological
adverse events (comprising major and minor stroke
and transient ischaemic attack) at 30 days (5.5%
versus 2.4%; p=0.04) and 1 year (8.3% versus 4.3%,
p=0.04). The rate of major strokes was 3.8% in the
TAVI group versus 2.1% in the AVR group at 30 days
(p=0.20) and 5.1% versus 2.4% (p=0.07) at 1 year.
Major bleeding was significantly more common
with AVR at both time points (19.5% versus 9.3%
at 30 days and 25.7% versus 14.7% at 1 year; both
p<0.001). There was no statistically significant
difference in rates of myocardial infarction or acute
kidney injury. Moderate or severe paravalvular aortic
regurgitation was significantly more common in
the TAVI group at 30 days (12.2% versus 0.9%;
p<0.001) and 1 year (6.8% versus 1.9%; p<0.001).
Multiple (≥2) transcatheter valves were implanted
in seven patients due to residual aortic regurgitation
(five patients) or valve embolisation (two patients).
Seven other patients who experienced valve
embolisation underwent conversion to AVR (five
patients) or had transcatheter placement aborted
(two patients). There was no statistically significant
difference between TAVI and AVR in the number of
patients requiring a new pacemaker at 30 days or 1
year15.
PARTNER trial cohort B
The PARTNER trial found no statistically significant
difference in 30-day mortality rates between TF
retrograde TAVI (5.0%) and medical management
including BAV (2.8%)14. Major vascular
complications and major bleeding events were
significantly more common in the TAVI group at 30
days (16.2% versus 1.1%, and 16.8% versus 3.9%
respectively; both p<0.001) and at 1 year
(16.8% versus 2.2%; p<0.001, and 22.3 versus
11.2%; p=0.007). The rate of major stroke
was 5.0% in the TAVI group versus 1.1% in
the control group at 30 days(p=0.06) and
7.8% versus 3.9% at 1 year (p=0.18).There
was no statistically significant difference in
rates of myocardial infarction or acute kidney
injury. Moderate or severe paravalvular aortic
regurgitation was present in 11.8% of TAVI
patients at 30 days and in 10.5% at 1 year.
Valve embolisation occurred in one patient
(0.6%), and three patients (1.7%) underwent
a repeat TAVI procedure to treat clinically
significant aortic regurgitation.
There was no statistically significant difference
in the number of patients requiring a new
pacemaker at 30 days or 1 year14.
Non-randomised studies
International registries and case series have
reported 30-day mortality rates ranging from
6.4% to 25%, with higher procedure-related
mortality rates reflecting higher surgical
risk scores in TA cohorts compared with TF
implantation4,16,18,21,31,32. Similarly, analysis of
UK TAVI registry data showed 94.8% survival
to 30 days in the TF group with a mean logistic
EuroSCORE of 20.3% compared with 89.1%
survival and a mean logistic EuroSCORE of
24.5% in the other routes group (p<0.01)12.
Complication rates observed in TAVI patient
series varied widely. Vascular complications
occurred especially with the TF approach, with
an incidence of 10–15%, and stroke occurred in
around 3–10% of cases4,12,31,33. New permanent
pacemaker implantation was required by 7%
of Edwards SAPIEN™ and 26% of Medtronic
CoreValve® recipients reported to the UK
registry12, similar to rates recorded in other
registries31,33. Few studies have published data
on the durability of implanted valves beyond
1 year: a Canadian patient series (n=70) with
a median follow up of 3.7 years (interquartile
range 3.4 to 4.3) reported no cases of structural
deterioration of Edwards SAPIEN™ valves at 3
years25.
Cost effectiveness
Currently, there are no published evaluations
of the cost effectiveness of TAVI compared with
surgical AVR or medical management4,16,18.
Several unpublished developmental economic
models that were identified have important
limitations.
5
Equality and Diversity
About Evidence Notes
Healthcare Improvement Scotland is committed to
equality and diversity in respect of the six equality
groups defined by age, disability, gender, race,
religion/belief and sexual orientation.
For further information about the Evidence Note
process, see
www.healthcareimprovementscotland.org
The Evidence Note process has been assessed and
no adverse impact across any of these groups is
expected. The completed equality and diversity
checklist is available on
www.healthcareimprovementscotland.org
To propose a topic for an Evidence Note, email
[email protected]
References can be accessed via the internet
(where addresses are provided), via the NHS
Knowledge Network
http://www.knowledge.scot.nhs.uk, or by
contacting your local library and information
service.
Acknowledgements
Healthcare Improvement Scotland would like to acknowledge the helpful contribution of the
following, who gave advice on the content of this Evidence Note:
•
•
•
•
Mr Geoff Berg, Consultant Cardiothoracic Surgeon, NHS Greater Glasgow and Clyde
Dr Malcolm Metcalfe, Consultant Cardiologist, NHS Grampian
Dr Barry Vallance, Consultant Cardiologist, NHS Lanarkshire
Members of the Working Group for SHTG
And also Edwards Lifesciences and Medtronic Limited for helpful contributions and comment
on the content of the Evidence Note
Healthcare Improvement Scotland Development Team
•
•
•
•
•
Healther McIntosh, Author/Health Services Researcher
Jenny Harbour, Information Scientist
Susan Downie, Medical Writer
Doreen Pedlar, Project Co-ordinator
Marina Logan, Team Support Administrator
© Healthcare Improvement Scotland 2011
ISBN 1-84404-929-9
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* NICE are currently updating this interventional procedure guidance with an anticipated
publication date of November 2011.