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246
A. Hartley and S. Nijjer
Highlights
What we know already
PROMs are gaining mounting
significance in studies investigating
HRQOL benefits with PCI.
PROMs are especially important in the
management of stable coronary artery
disease, where PCI is performed
principally in the aim of symptomatic
Fig. 13.3 Study highlights
benefit.
What this study adds
In this systematic review, HRQOL
outcome measures generally
demonstrate an improvement from
baseline scores pre-procedure with PCI.
However, the magnitude of HRQOL gains
appears to often be limited or short-
lived, especially when compared to
other methods of revascularisation.
tify the true symptomatic benet of elective
PCI. In addition, there is now consensus in the
cardiology community on what constitutes a
myocardial infarction [55] and major adverse
bleeding [56] for reporting in clinical trials of
PCI.However, no such consensus exists for quality of life outcomes. Thus, there is a real need for
the formulation of an expert working group, aiming to clarify issues and standardise practice on
HRQOL reporting following PCI.
Separately, given that PROMs are ‘soft’ endpoints that can be affected by patient knowledge
of treatment allocation, serious consideration
should be given to the use of placebo procedures,
or some other method of patient blinding, in
future RCTs. Where this is not possible, or in the
case of observational studies, long term follow up
should be supported.
Future outlook
Future studies should focus on a few
well-validated HRQOL tools.
Long term follow up and ideally a
placebo procedure would also increase
the value of PROMs in future studies.
tant and necessary. In this study HRQOL outcome measures with PCI generally demonstrate
an improvement from baseline scores preprocedure. However, the magnitude of these
gains appears to be limited, and in some instances,
relatively short-lived when compared to other
methods of revascularisation or medical therapy.
Future studies should focus on a few wellvalidated HRQOL tools, provide long term follow up and ideally use a placebo procedure.
Figure 13.3 highlights the key ndings of this
analysis.
Funding A.H. is funded by a Wellcome Trust Clinical
Research Fellowship.
Conict of Interest None declared.
Conclusions
PROMs are increasingly fashionable and gaining
mounting signicance in studies investigating
potential HRQOL benets with PCI.This is the
case most pertinently in elective PCI procedures,
predominantly carried out for symptomatic gains,
where quantiable improvements are both impor-
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Quality ofLife andPatient
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Reported Outcome Measures
Following Carotid Artery
Intervention
LeonardL.Shan, AkshatSaxena,
andAlunH.Davies
14
Abbreviations
ACAS Asymptomatic carotid atheroscle-
rosis study
ACST The asymptomatic carotid surgery
trial
CREST Carotid revascularisation endar-
terectomy versus stenting trial
ECST European carotid surgery trial
NASCET The North American symptomatic
carotid endarterectomy trial
SAPPHIRE Stenting and angioplasty with pro-
tection in patients at high risk for
endarterectomy trial
L. L. Shan (*)
St. Vincent’s Hospital Melbourne,
Melbourne, VIC, Australia
Department of Surgery, The University of Melbourne,
Melbourne, VIC, Australia
e-mail: leonard.shan@unimelb.edu.au
A. Saxena
Department of Cardiothoracic Surgery and
Transplantation, Fiona Stanley Hospital,
Murdoch, WA, Australia
A. H. Davies
Charing Cross, London, UK
St. Mary’s Hospital, London, UK
Vascular Surgery, Department of Surgery and Cancer,
Imperial College London, London, UK
e-mail: a.h.davies@imperial.ac.uk
Introduction
Stroke and transient ischemic attacks are a serious public health problem which commonly
causes persistent disability and poor quality of
life (QOL) [1–3]. A signicant proportion of
ischemic strokes (18–29%) are attributable to
carotid artery disease [4, 5] and are preventable
by revascularisation [6]. The benet of carotid
revascularisation by either carotid endarterectomy (CEA) or carotid stenting (CAS) has been
well established previously. However, these focus
on technical outcomes such as morbidity, mortality, and stroke prevention. Whilst these are
important, they provide only one aspect of the
intervention outcome.
From the early 1990s the concept of QOL and
patient reported outcomes measures (PROMS)
were identied as an important assessment of
post-operative outcomes [7]. In particular, QOL
after surgery is a patient-focussed assessment
that complements traditional outcome measures
such as post-operative stroke and death [8].
This chapter summarises the available literature on QOL and PROMS after carotid artery
intervention. The current literature provides
mainly QOL outcomes after CEA or CAS in atherosclerotic disease. This is therefore the focus of
this chapter. Other indications and procedures are
outside of the scope of this chapter.
© Springer Nature Switzerland AG 2022
T. Athanasiou et al. (eds.), Patient Reported Outcomes and Quality of Life in Cardiovascular Interventions,
https://doi.org/10.1007/978-3-031-09815-4_14
249
250
L. L. Shan et al.
Current Interventions
ontheCarotid Artery
Carotid Endarterectomy
Several landmark trials have provided strong
evidence for CEA in stroke prevention. The benet is greatest in symptomatic carotid stenosis as
outlined in the NASCET and ECST trials [9, 10].
The ACAS and ASCT trials demonstrated that
CEA is also benecial in carefully selected
asymptomatic patients with few comorbidities,
good life expectancy, and low institutional perioperative stroke and mortality rates [11–14]. The
combined peri-procedural mortality and stroke
rate after CEA is 3.2–6.7% in symptomatic
patients [10, 15–18] and 2.9–3.1% in asymptomatic patients [13, 19–21]. However, many of
these trials are now outdated with changes in
treatment algorithms. In particular, preoperative
digital subtraction angiography is no longer routine and perioperative medical therapy is much
improved.
Carotid Stenting
Quality ofLife Instruments
andProms inCarotid Intervention
Denition ofQuality ofLife and
Patient Reported Outcome Measures
PROMS ask patients to assess elements of their
own health, QOL, and functioning [25]. The aim
is to understand the impact of a treatment and its
recovery, allow comparison of different patients’
outcomes with the same intervention [25]. QOL
is the major element of PROMS and is dened as
a patient’s perception of health as assessed in
multiple domains [26, 27]. The use of QOL
instruments in carotid revascularisation have
been previously described [28].
One of the important considerations in QOL
assessment is the type of instrument used and the
measurement time points and time frame within
which these assessments will be made. Previous
recommendations have been provided for core
outcome sets and reporting in carotid intervention [29, 30]. However, these documents provide
very little detail on QOL measurement. Until
these are specied in detail for QOL outcomes,
investigators will need to use clinical judgment
on the most appropriate methods of assessment.
Even though CEA is still the preferred method
in most patients [17], the emergence of CAS has
triggered key trials comparing CAS to
CEA.CAS may be more appropriate for younger
patients with favourable anatomy and symptomatic patients at high risk of complications from
CEA [22]. The SAPPHIRE [23] and CREST
[16] trials, and Carotid Stenting Trialist’s
Collaboration meta-analysis [15] showed CAS
prevents strokes and is not inferior to CEA in
highly selected circumstances. The recent
European Society for Vascular Surgery guidelines indicate that CEA should be the rst consideration in symptomatic patients with >50%
carotid stenosis and average risk asymptomatic
patients with >60% carotid stenosis and >5years
life expectancy [24].
Commonly Used Quality ofLife
Instruments inCarotid Intervention
QOL can be assessed by study designed questionnaires, and disease-specic or generic instruments. These instruments assess an individual’s
physical, emotional and psychological health as
well as social and functional status [26, 27].
Individual study designed questionnaires are
constructed by study authors as arbitrary measures of QOL outcomes [31–33]. Disease-specic
QOL instruments are validated QOL scoring systems that measure the effect of an illness or treatment on a specic condition [27]. Generic QOL
instruments are validated QOL scoring systems
14 Quality ofLife andPatient Reported Outcome Measures Following Carotid Artery Intervention
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251
that measure QOL in a broad range of health
domains and allow comparisons with other con-
Quality ofLife andPatient Reported
Outcomes
ditions and reference populations [27]. Generic
scoring systems used by studies in this review are
Medical Outcomes Short Form 36 (SF-36) and
12 (SF-12) [34], Sickness Impact Prole (SIP)
[35], Hospital Anxiety and Depression Scale
(HAD) [36], Katz Index of Independence in
Activities of Daily Living (ADL) [37], European
Quality of Life EQ-5D Questionnaire (EQ-5D)
[38], Multidimensional Index of Life Quality
Questionnaire (MILQ) [39], and the World
Health Organisation Quality of Life BREF
(WHOQOL-BREF) [40]. These instruments are
described in previous chapters.
Table 14.1 Study characteristics and quality appraisal
Original studies
Author
Patients
Sirrka [31] 84 R Male: NR, Age: 66,
1992
Study objectives: Long-term QOL and cognitive performance after CEA (CEA vs. non-operative
Martin [32] 200 R CEA Yes SF-36 Yes 83%
1998 Male: 61%, Age:
Study objectives: Short-term QOL after CEA (CEA vs. medical management in those
Vriens [44] 86 P Male: 78.6%, Age:
1998
Study
design
Patient
demographics
Asymptomatic: 0%,
Symptomatic:
100%, Level
stenosis:
“signicant”
group)
65, Asymptomatic:
0%, Symptomatic:
100%, Level
stenosis: >70%
Medical treatment
Male: 62%, Age:
66, Asymptomatic:
0%, Symptomatic:
100%, Level
stenosis: <70%
inappropriate for CEA, CEA or medical therapy vs. general population)
65 (44–82),
Asymptomatic:
34%, Symptomatic:
66%, Level
stenosis: NR
There have been numerous randomised trials and
meta-analyses on CEA and CAS in various subgroups of patients [11–16, 41], but these have
focussed on technical outcomes of the procedure.
Recent reviews have highlighted the importance
of QOL outcomes [28, 42, 43]. This chapter
assesses the currently available evidence. To date
QOL is the primary method of PROMS.Study
characteristics and a brief quality appraisal is
outlined in Table14.1 and the QOL outcomes are
summarised in Table14.2. This section describes
the key QOL ndings.
Validated
QOL
instrument
No Study
Yes SIP No 81.4%
QOL
instruments
used
questionnaire
Follow-up
method
reported
No 49%
Response
rateYear
(continued)
252
Table 14.1 (continued)
Original studies
Author
Patients
Study objectives: To investigate whether QOL improves after CEA (preoperative vs.
Dardik [45] 50 P Male: 78%, Age:
2001
Study objectives: Short-term QOL after CEA (preoperative vs. postoperative, postoperative vs.
Middleton
[46]
2001 Male: 72.8%, Age:
Study objectives: Mid-term QOL after CEA (CEA vs. general population)
Lloyd [47] 100 P Male: 64%, Age:
2004
Study objectives: Short-term QOL and cognitive function after CEA (preoperative vs.
Diethrich
[48]
2005 Male: 63%, Age:
CARESS CAS
Trial Male: 60%, Age:
238 R RPAH Hospital Yes SF-36 Yes 90%
397 P CEA Yes MILQ No 48%
Study
design
Patient
demographics
postoperative)
Does haemodynamic improvement have an impact
67.1 (49–83),
Asymptomatic: 0%,
Symptomatic:
100%, Level
stenosis: >65%
general population)
82.4% <75,
Asymptomatic:
32%, Symptomatic:
68%, Level
stenosis: NR
CRGH Hospital
Male: 66.4%, Age:
69.9% <75,
Asymptomatic:
32%, Symptomatic:
68%, Level
stenosis: NR
Mortality rate and causes of death after CEA
69 (45–87),
Asymptomatic:
13%, Symptomatic:
87%, Level
stenosis: NR
postoperative)
71.4, Asymptomatic:
67%, Symptomatic:
33%, Level stenosis:
89% patients >75%
stenosis
71.2, Asymptomatic:
69%, Symptomatic:
31%, Level stenosis:
94% patients >75%
stenosis
Validated
QOL
instrument
Yes SF-36 No 100%
Yes SF-36, HAD,
QOL
instruments
used
EQ-5D
Follow-up
method
reported
Yes 92%
L. L. Shan et al.
Response
rateYear
14 Quality ofLife andPatient Reported Outcome Measures Following Carotid Artery Intervention
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Table 14.1 (continued)
Original studies
Author
Patients
Study objectives: Short-term QOL after CEA and CAS (CEA vs. CAS)
Abelha [49] 63 P Male: 76%, Age: 70
2008
Study objectives: Short-term QOL and independence with activities of daily living after CEA
Stolker [50] 310 RCT CEA Yes SF-36,
2010 Male: 68%, Age:
SAPHHIRE CAS
Trial Male: 68%, Age:
Study objectives: Short-term QOL after CEA compared to CAS (CEA vs. CAS, preoperative vs.
Attigah [51] 102 P Male: 68.6%, Age:
2011
Study objectives: Short-term QOL and satisfaction after CEA (preoperative vs. postoperative)
Cohen [52] 2502 RCT Male: 65%, Age:
2011
CREST trial
Study objectives: Short-term QOL after CEA compared to CAS (CEA vs. CAS, preoperative vs.
Kazmierski
[33]
2012
102 P Male: 70.6%, Age:
Study
design
Patient
demographics
(44–84),
Asymptomatic:
21%, Symptomatic:
79%, Level stenosis:
all patients ≥65%
(preoperative vs. postoperative, postoperative vs. general population)
72, Asymptomatic:
72%, Symptomatic:
28%, Level stenosis:
symptomatic >50%,
asymptomatic >80%
72, Asymptomatic:
70%, Symptomatic:
30%, Level stenosis:
symptomatic >50%,
asymptomatic >80%
postoperative)
70 (42–86),
Asymptomatic:
74.5%,
Symptomatic:
25.5%, Level
stenosis: >70%
69, Asymptomatic:
47%, Symptomatic:
53%, Level
stenosis: >85% of
patients >70%
stenosis
postoperative)
65.8 (34–84),
Asymptomatic: 0%,
Symptomatic:
100%, Level
stenosis: >50%
Validated
QOL
instrument
Yes SF-36, ADL Yes 76%
Yes HAD, EQ-5D Ye s 100%
Yes SF-36, LS Ye s 85%
Yes SIP, LS No 100%
QOL
instruments
used
EQ-5D, LS
Follow-up
method
reported
No 80%
Response
rateYear
(continued)
253
254
Table 14.1 (continued)
Original studies
Author
Patients
Study objectives: Short-term QOL after CEA (preoperative vs. postoperative)
Hsu [53] 61 P Male: 83%, Age:
2014
Study objectives: QOL after CAS in patients with dizziness (preoperative vs. postoperative)
Kazmierski
[54]
2014
Study objectives: Short-term QOL, neurological status and disability after CEA (preoperative vs.
Yan [55] 65 P CAS Yes
2014 Male: 56%, Age:
Study objectives: Short-term QOL and cognition after CAS in elderly patients (preoperative vs.
Carta [56] 46 P CEA Yes SF-12 Yes 87%
2015 Male: 57%, Age:
Study objectives: Short-term QOL, mood, cognition after CEA compared to medical treatment
Hye [57] 53 RCT Male: 62%, Age:
2015
CREST trial
102 P Male: 71%, Age:
Study
design
Patient
demographics
73.3, Asymptomatic:
71%, Symptomatic:
29%, Level stenosis:
symptomatic >60%,
asymptomatic >80%
65.8, Asymptomatic:
0%, Symptomatic:
100%, Level
stenosis: >70%
postoperative)
72.1, Asymptomatic:
0%, Symptomatic:
100%, Level
stenosis: >70%
Medical treatment
Male: 48%, Age:
73.1, Asymptomatic:
0%, Symptomatic:
100%, Level
stenosis: >70%
postoperative, CAS vs. medical treatment)
71.6, Asymptomatic:
69%, Symptomatic:
31%, Level stenosis:
symptomatic >50%,
asymptomatic >70%
Medical treatment
Male: 80%, Age:
72.1, Asymptomatic:
64%, Symptomatic:
36%, Level stenosis:
symptomatic >50%,
asymptomatic >70%
(preoperative vs. postoperative, CEA vs. medical treatment in those who
refused surgery)
67, Asymptomatic:
43%, Symptomatic:
57%, Level stenosis:
>85% of patients
>70% stenosis
Validated
QOL
instrument
Yes SF-36, LS No 66%
Yes mRS, LS No NR
Yes SF-36, LS Ye s 98%
QOL
instruments
used
WHOQOLBREF,
HAM-D,
HAM-A
Follow-up
method
reported
Yes NR
L. L. Shan et al.
Response
rateYear
14 Quality ofLife andPatient Reported Outcome Measures Following Carotid Artery Intervention
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Table 14.1 (continued)
Original studies
Author
Patients
Study objectives: QOL after CEA in those who sustained cranial nerve injury
Reviews
Al-Damluji
[42]
2013
Study objectives: Periprocedural safety and long-term efcacy of CEA compared to CAS
Shan [28] Review Total studies: 12, Studies on QOL: 12, Total patients in studies on QOL: 4224
2015
Study objectives: QOL after CEA, QOL after CAS, QOL after CEA vs. CAS, QOL compared to
Chabowski
[43]
2017
Study objectives: QOL in stroke survivors and after CEA
ADL activities of daily living, CaRESS carotid revascularization using endarterectomy or stenting systems trial, CAS carotid
artery stenting, CEA carotid endarterectomy, CREST carotid revascularization endarterectomy versus stenting trial, HAD
hospital anxiety and depression scale, QOL quality of life, MILQ multidimensional index of life quality, NA not applicable,
NR not recorded, P prospective, R retrospective, RCT randomized control trial, SAPPHIRE stenting and angioplasty with
protection in patients at high risk for endarterectomy, SF-36 medical outcomes survey short form 36 questions, SIP sickness
impact prole, LS Likert scale, EQ-5D Euro-QOL 5 dimensions, mRS modied Rankin scale, HAM-D Hamilton depression
rating scale, HAM-A Hamilton anxiety rating scale, WHOQOL-BREF World Health Organisation quality of life-BREF
Study
design
Review Total studies: 28, Studies on QOL: 2, Total patients in studies on QOL: 2812
Review Total studies: NR, Studies on QOL: NR, Total patients in studies on QOL: NR
Patient
demographics
reference populations
Validated
QOL
instrument
QOL
instruments
used
Follow-up
method
reported
255
Response
rateYear
Table 14.2
Original studies
Author
Sirrka [31] CEA 8–11years NR NR
1992
Martin [32] CEA 1year 3% 1%
1998
Vriens [44] CEA 3months 0% 3%
1998
Quality of life results
Procedure Follow-up time
Key
ndings:
Key
ndings:
Key
ndings:
Perioperative
mortality
QOL similar between CEA and non-operated groups at long-term follow-up
Non-operative patients who had a stroke had better physical condition than those
who had CEA
SF-36 scores similar between CEA and medical therapy group at 1year across all
domains
Superior improvement in self-perceived general health and treatment success after
CEA compared to medical therapy.
Similar levels of anxiety over future strokes or TIAs
CEA and medical groups both have worse physical health domains at 1year
compared to general population, but mental health domains are similar
No signicant change in QOL observed 3months post-op based on SIP
measurement
Signicant QOL improvement after CEA limited to only patients with
contralateral carotid occlusion.
Perioperative
strokeYear
(continued)
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