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5 Patient Reported Outcomes andQuality ofLife following Heart Transplantation
103
Mid Long-Term Follow-Up (10–20Years
Post-HTx)
Martinelli et al. [18] studied 137 consecutive
patients surviving more than 10years post-HTx,
aiming to examine the role of age on QoL in this
cohort of long-term survivors. They found that
the SF-36 MCS was not signicantly different
between the young (<70years) and old patients
(≥70years). However, the PCS was found to be
greater in the young patients. The authors identify that “age per se does not represent a major
limiting factor when considering candidates for
this procedure, at least with regard to the issue of
psychologic distress”.
Politi et al. [19] also examined the long-term
QoL of 276 patients surviving at 10 years in a
cross-sectional study. It was found that mental QoL
of 10year survivors were similar to that of the general population. In contrast, the physical QoL was
inferior to that of the general population. Predictors
included older age, being married, the presence of
complications, and impaired renal function.
Extreme Long-Term Follow-Up
(>20years Post-HTx)
The longest term follow up reviewed was that
done by Galeone (2014) [20]. The quality of life
in eight hundred and twenty-seven patients surviving ≥20 years with a single graft was retrospectively assessed. Mean physical and mental
scores were 57 ± 23 and 58± 21, respectively.
These scores were signicantly lower than that of
patients surviving <20years, perhaps reecting
the lower comorbidity and age in the latter cohort.
The mean scores of each SF-36 domain were also
lower in norm-based comparisons to the general
French population.
Discussion
Challenges inQOL Assessment
inTransplant
The follow up period varied widely between the
studies, the earliest after transplant being the
post-Tx ICU transition phase. Of course the stud-
ies are assessing quality of life in survivors as
mortality is an issue when studying heart failure
therapies. The longest follow up period was of
survivors 20years+ incorporating 131 subjects.
Some studies break down the QOL of scores
into their separate physical and mental
domains, while others only provide a summary
score. Therefore, separate analysis of the physical and mental components can only incorporate the former group of studies. A further
challenge is that even this group of studies use
a diverse range of tools, so that one must be
careful in the comparison of alike domains
from different questionnaires (refer Fig.5.1).
For example, the following domains all
describe the physical wellbeing: ‘physical
functioning’ in SF-12 and -36; vs ‘physical
mobility’ in NHP; vs ‘physical limitation’ in
KCCQ. The words ‘functioning’, ‘mobility’
and ‘limitation’ all relate to physical wellbeing
but are subtly different.
Finally, the control groups varied widely.
Some studies used the baseline QOL in pretransplant patients with heart failure as the comparison group. Other used a separate cohort of
patients implanted with LVAD, stabilised on
medical therapy or on the waiting list as the comparison group. Some studies do not have a comparison group at all. These studies can still be
useful as norm-based comparisons can be made
to the general population.
Baseline QOL inPre-transplant Patients
The baseline physical component in those with
heart failure is signicantly more impaired than
the mental component in all of the Short Form
questionnaire studies (all values expressed as
physical functioning score vs mental health
score: Mantovani etal. (2017) 9.5 vs. 24.6 [15],
Martín-Rodríguez et al. (2008) 21.92 vs. 47.07
[21], Karapolat etal. (2007) 35.00 vs. 59.41 [22],
Evangelista etal. (2005) 30.3 vs. 47.6 [13]. The
study using the MLHFQ instrument [14] (11.3
vs. 7.5—note lower score denotes higher QOL)
and an authors’ questionnaire [23] (2.079 vs.
2.56) both agree with this discrepancy in mental
and physical domains.
104
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A. J. Poovathoor et al.
PCS MCS
Post-transplant time (Wu 2019)
Age (Wu 2019)
Fig. 5.2 Predictors of QoL, PCS and MCS. PCS Physical Component Score. MCS Mental Component Score
Stress status (Wu
2019)
Mechanical circulatory
support use during
hospitalisation (Wu 2019)
Comorbidities
(Delgado 2015)
Regardless, both physical and mental scores
are severely impaired compared to the general
population.
Overall
QoL
Complications
(Delgado 2015)
(Grady 2007)
Hospitalisation
(Delgado 2015)
Marriage status
(Grady 2007)
Demoralisation
syndrome (Wu
2019)
Religion (Wu
2019)
Depression
(Evangelista
2003)
Age (Wu 2019)
(Evangelista
2003)
In all studies it appears that the greatest step in
improvement occurs between pre-Tx and
3months post-Tx, which is to be expected considering the severely impaired baseline physical
Physical Activity Post-transplant
Using the Short Form 12 and 36 instruments, a
rapid improvement in the physical component is
seen within the rst year after transplant, then after
1 year it seems to remain steady. Wu et al. [24]
studied 3 groups of patients: group1<1year post-
domain in heart failure patients.
The predictors of the physical component of
quality of life as identied in the selected studies
include: post-transplant time, mechanical circulatory support during hospitalisation, stress status
and age (refer to Fig.5.2).
Tx; group 2 1–3 years post-Tx; and group
3>3years post-Tx. Group 1 patients’ PCS scores
rapidly improved from pre-Tx (38.83) to 3months
post-Tx (44.54) to 6months (45.18) to 12months
(48.15). Comparatively groups 2 and 3, who were
1 year + post-Tx, did not show such a temporal
improvement, and sometimes even a slight
decrease. Martín-Rodriguez [21] corroborates
with the immediate improvement in physical score
(21.92 pre-Tx to 51.92 3months to 75.00 6months
to 69.61 12months). Unfortunately this study does
not follow the cohort beyond 1year to ascertain
corroboration with Wu et al’s ndings. However,
another study [25] disagrees with Wu etal’s study
nding of the stasis in physical score beyond
1year as it showed persistent improvement up to
3years– although it must be noted that this study
used the KCCQ form with its physical limitation
domain and not the Short Form questionnaire.
Mental Well-Being Post-transplant
In direct contrast to the physical component which
showed an immediate improvement within the
rst year post-Tx, the mental component did not
exhibit this improvement but stayed steady within
the rst year (group 1: 48.89 baseline vs. 49.98
3months vs. 48.15 6months vs. 49.27 12months)
[24]. However, again unlike the physical compo-
nent (which slowed down in its improvement after
1 year), the mental component showed a steady
improvement after 1 year. Groups 2 (1–3 years
post-Tx): 45.29 to 48.16 to 49.30, and nally
reaching 50.39in group 3 (>3years post-Tx)).
Perhaps this is because the physical component is severely impaired pre-Tx as compared to
the mental component, and so the benets of
transplantation is seen more in the physical component rst.
5 Patient Reported Outcomes andQuality ofLife following Heart Transplantation
105
The predictors of the mental component of
quality of life as identied in the selected studies
include: religion, depression, demoralisation
syndrome and age (refer to Fig.5.2).
This ‘reversal of changes’ between the physical and mental components show that transplantation has benets in both domains, albeit that the
mental benets can be expected to be more
delayed. However this is not a reason for discouragement, as the baseline mental scores are relatively high to begin with, and while an immediate
improvement is not seen, a depreciation is not
observed either. Furthermore, this can be of some
reassurance to patients that a long-term improvement in their mental wellbeing can be expected
even if it is not immediately experienced.
While the physical domain was consistently
more impaired than the mental domain before
transplant in the Short Form questionnaires, following transplant the difference in the scores are
much less, and the gap progressively diminishes
the longer after transplant [13, 21, 22, 24, 26, 27].
This observation is also seen in the WHOQOLBREF studies [28–30] and the Quality of Life
Index studies [16, 31]. Moreover, it appears that
this phenomena is maintained into the long term
beyond 5years, as unanimously seen in the long
term studies [18–20, 32].
This may be explained by the ‘reversal of
changes’ postulated earlier, as the physical scores
rapidly improve in the immediate aftermath of
transplant and close the gap between the two
domains. After one year, the changes in physical
scores wean and the mental gradually improves.
This hypothesis would suggest that the longest
surviving patients would have near-equal physical and mental scores. Indeed, the longest-term
study is of ≥20years survivors by Galeone etal.
[20], showing similar physical and mental
scores - 57 and 58, respectively. Of course, as
mortality is an issue when studying heart transplantation outcomes, there is not sufcient data
for the extreme long- term, and any conclusions
must be cautiously drawn.
Forsberg [33] proposes a framework for
improving adaptation in heart transplant patients.
It is suggested that endeavoring for control and
predictability results in reducing the patient’s
ability to adjust, thereby prolonging the transition period. The importance given to self management support is identied as problematic.
Furthermore, the importance of conditioning
patients to adjust to their new situation is
stressed: “instead of relying on unrealistic
expectations, they can focus on accepting their
situation and the unknown, as well as on what
can be achieved”.
Key Conclusions
1. There is a signicant impairment in the
physical domain in baseline heart failure patient pre-Tx.
2. There is a signicant difference in the
physical and mental components pre Tx, the physical being worse.
3. “Reversal of Changes”: Immediately
post-Tx there is a rapid improvement in
physical wellbeing and no change in
mental wellbeing. Longer term there is
no change in physical wellbeing and a
gradual improvement in mental
wellbeing.
4. Less discrepancy between physical and
mental component scores post-Tx. This
is maintained in the longer term and
scores equalizes in the extreme long
term.
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QOL andPROMS Following
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Transcatheter Aortic Valve
Implantation
M.Monteagudo-Vela, V.Panoulas,
andG.Krasopoulos
6
Introduction
Aortic stenosis (AS) is an insidious disease with
high mortality after the onset of the symptoms
and with an incidence that increases logarithmically after the sixth decade of life [1]. As life
expectancy has substantially increased over the
past twenty years, (AS) has become the most frequent valvular heart disease [2]. Surgical aortic
valve replacement (sAVR) was until recently, the
only invasive treatment option with conservative/
palliative therapies being the only alternative for
patients who could not have surgery [3].
sAVR is the gold standard therapy for symptomatic aortic stenosis with proven capacity to
alleviate symptoms, improve quality of life and
M. Monteagudo-Vela
Department of Cardiothoracic Surgery, Oxford
University Hospitals NHS Foundation Trust,
Oxford, UK
e-mail: maria.monteagudo-vela@ouh.nhs.uk
V. Panoulas
Department of Cardiology, Royal Brompton and
Hareeld NHS Foundation Trust, London, UK
e-mail: v.panoulas@rbht.nhs.uk
G. Krasopoulos (*)
Department of Cardiothoracic Surgery, Oxford
University Hospitals NHS Foundation Trust,
Oxford, UK
Department of Cardiothoracic Surgery, Oxford
University Hospitals NHS Foundation Trust &
University of Oxford, Oxford, UK
e-mail: george.krasopoulos@ouh.nhs.uk
increase survival [4] and with durability that
extends beyond 15years [5]. The National Adult
Cardiac Surgery Audit (NACSA) published in
2020 presented all cardiac surgical activity levels
and trends in the United Kingdom, over the past
3years (1st April 2016 to 31st March 2019) [6]. In
this report sAVR was found to be the second most
commonly cardiac operation performed in the UK
after coronary artery bypass surgery, with a mortality rate of 0.9% for patients under 75years of
age, and 1.2% for those over 75years. However,
there are many patients that, due to coexisting
comorbidities, high frailty index or advanced age
(>80years), do not qualify for sAVR due to very
high peri-procedural surgical risk [7].
The signicant increase in life expectancy that
our society has been experiencing over the past
couple of decades, and the association of AS and
ageing has generated an ever-expanding population of very elderly with signicant restrictions in
their quality of life due to AS [8]. Since 2002
when the rst procedure of transcutaneous aortic
valve implantation (TAVI) was performed [9],
TAVI has rapidly evolved as the alternative invasive procedure that could be offered to patients
with severe AS. As the procedural risk of TAVI
decreases thanks to technical improvements to
the valve-implants and delivery systems, this
technique has emerged and established itself as
the invasive treatment option of choice for
patients who have been deemed inoperable [10],
for those at high surgical risk due to high frailty
© 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_6
109
110
M. Monteagudo-Vela et al.
index or co-morbidities [11] or those at intermediate or low surgical risk in their ninth or tenth
decade of life [12, 13].
Even though both, sAVR and TAVI, are effective invasive treatment options for the management of symptomatic AS, capable of substantially
improving survival at short and mid-term (up to
7years) [14], sAVR remains the only option with
known durable long-term results that extend
beyond 10years [15]. In the modern era, durability and long-term outcomes are equally important
to quality of life (QoL) for many patients suffering from AS and plays a signicant part in their
decision-making process.
In 2018/19 the numbers of TAVI cases in the
UK (5197) overtook isolated sAVR (5091) [6], a
trend that has been observed in other European
countries such as Germany [16, 17]. So much in
UK but also internationally, the total number of
all procedures for aortic valve disease continued
to increase over the past 5years [6], probably due
to a combination of high prevalence of the disease attributed to an ageing population and the
availability of an alternative interventional option
like TAVI.
This chapter is set out to review and analyse
all currently available published information
related to QoL following sAVR or TAVI as treatment for AS that include QoL in their endpoints.
We will attempt to provide a comprehensive
understanding of the currently available tools in
assessing QoL in patients treated for AS, summarise available knowledge in order to assist
patients and clinicians in their decision-making
process.
Summary ofInterventions
(Surgical, Endovascular/Minimally
Invasive) forAortic Stenosis
Surgical aortic valve replacement (SAVR) and
transcatheter aortic valve implantation (TAVI)
are the mainstays of treatment for severe aortic
stenosis (AS).
Transcatheter aortic valve implantation
(TAVI) is a minimally invasive procedure that
entails different approaches of implanting a bio-
logical prosthetic valve, within a usually calcied
native aortic valve. TAVI can be performed under
local anaesthesia and sedation or under general
anaesthesia. These techniques are based in gaining arterial access, either percutaneously or with
a surgical cut down. The most common access to
deliver the valve is via the femoral arteries (over
90% in most major registries), followed by
trans- carotid and trans-subclavian/trans-axillary.
Trans-apical and trans-aortic are fading as
options, due to their more invasive nature. Transcaval access is also used in select centres, however its generalizability has been questioned due
to its complexity. The TAVI valve is mounted
onto a stent, and it is advanced to the heart using
specialised intravascular equipment, known as
delivery systems. The diseased native aortic valve
is stretched open and the new bioprosthetic valve
is implanted within the old diseased (usually stenotic) native aortic valve of the patient. The
majority of commercially available valves are
either balloon expandable or self-expanding and
come with a skirt, aiming to improve sealing and
reduce paravalvular leaks [13, 18].
Surgical aortic valve replacement is carried
out under general anaesthesia. sAVR is performed with the help of cardiopulmonary bypass
machine. The heart is arrested in order to access
the aortic valve and replace it. Although the traditional approach is a median sternotomy, modern
techniques of minimally invasive approaches
with smaller incisions can minimise the trauma
to the patient, reduce complications and accelerate the postoperative recovery [19] (Fig. 6.1).
sAVR has the capacity to fully replace the diseased aortic valve and it can treat native aortic
valves that suffer from both stenosis and insufciency. Under the generic terminology of sAVR
come a number of different procedures, with
choices of different prosthesis that are ranging
from biological valves to homografts, mechanical valves or even preserving the patient’s own
aortic valve and repairing it. Stented biological
and mechanical valves are the most widely used
valves currently and they need to be sutured onto
the patient’s aortic valve annulus. Sutureless bioprostheses represent a contemporary option for
sAVR and offer the possibility of replacing the
Sternotom
• Aortic valve repairs
6 QOL andPROMS Following Transcatheter Aortic Valve Implantation
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Aortic valve
replacement
111
sAVR
Mini
Minimally
invasive
Mini
Sternotomy
Conventional
y
• Sutured valves: biological + mechanical
• Sutureless valves: biological
• Homografts
Fig. 6.1 Summary of interventions for aortic valve replacement
thoracotomy
TAVI
Transfemoral
Transcarotid
Transsubclavian
Transapical
Transaortic
Trancaval
• Biological valves
diseased native aortic valve without the need of
having to suture the implant onto the heart. When
sutureless technology is combined with
conventional or minimally invasive sAVR, can
offer further advantages in reducing perioperative exposure of patients to risk, augment patients’
recovery and positively inuence post-procedural
QoL [20, 21].
Analysis oftheUtility ofDierent
QOL Tool
There are plenty of quality-of-life tools available
to analyse health related issues. These are multidimensional assessment instruments and are
designed to assess patient’s subjective health perception, related to a procedure or a condition
[22]. These questionnaires integrate both physical/functional and emotional dimensions and
some of them include social dimensions as well.
The aim is to convert qualitative information into
quantitative data and generate a score that can
universalize and compare differences.
Methods
After Entrez, PubMed, MEDLINE, Scopus and
Google Scholar were searched using the MeSH
terms ‘Quality of life’ AND ‘TAVI’, we identied 159 articles referred to Quality of life in
patients after TAVI procedures and 15 were
nally included into the review.
Within the included articles, health status was
assessed at different time points depending on the
study (pre-procedural and 1, 2, 3-, 6-, 12- and
24-months post-procedural). Health-related
Quality of Life questionnaires used in this review
were the Kansas City Cardiomyopathy
Questionnaire, the Short Form-12, the Short
Form-36, the EuroQol-5D and 3D and the
Minnesota Living with Heart Failure
Questionnaire.
112
M. Monteagudo-Vela et al.
These questionnaires investigate several
dimensions and grade them to different levels, in
order to target the answer and link them, as best
as possible, with the age group and personal
expectations of the cohort of patients included at
each study. However, none of them are age specic or age weighted, and this could potentially
lead to bias, as expectations and perceptions
related to QoL differ greatly amongst different
age groups. The diversity among the different
QoL questionnaires used makes it difcult to
compare outcomes, summarise or meta-analyse
reported outcomes.
The Minnesota Living with Heart Failure
Questionnaire (MLHFQ) score is widely used for
heart failure patients, has well-documented validity, reliability, and sensitivity, and is also validated in patients referred for valvular surgery
[23]. However, despite its proven validity in
physical and emotional subscales in patients with
HF, it lacks social dimension, which is particularly important when QoL is assessed in a cohort
of elderly TAVI patients [24].
EQ-5D-3L and EQ-5D-5L questionnaires,
introduced by the EuroQol Group in 1990 and
2009, are comprised of ve dimensions, as
explained in Table 6.1. In the latest EQ-5D-3L,
the number of levels of perceived problems per
dimension was changed from 3 to 5, increasing
the sensitivity and reducing the ceiling effect
caused by the big gap between “severe and
extreme problems”, mostly enhancing the assessment of the mobility dimension of the
questionnaire.
The Short Form 36 Health Survey
Questionnaire (SF-36) has been widely used in
cardiac patient populations. Its complexity however (36 items, covering eight domains of health
(Table6.1) [25]), makes it difcult to implement,
as it has a considerable burden upon both patients
and investigators. The SF-12 was derived from
the larger SF-36, and the physical and mental
summary scores obtained from the SF-12 correlate highly with those calculated using the original, longer questionnaire (Table6.2).
The Kansas City Cardiomyopathy
Questionnaire (KCCQ) has 23 items. It is
designed and validated to evaluate self-reported,
disease-specic health status in patients with
heart failure. The analysed domains include
symptoms, physical limitation, social limitation,
self-efcacy and knowledge, and quality-of-life.
The KCCQ summary scores have previously
been reported to correlate well with New NYHA
classication for shortness of breath and has
shown to independently predict mortality and
health care costs in heart failure populations [26].
Discussion
In this chapter we reviewed and analysed contemporaneous information related to QoL following treatment for AS after TAVI. Our goal
was to identify the most common tools used to
assess quality of life and summarise this knowledge to improve decision-making process for
both patients and clinicians, while we can identify areas of potential future research
opportunities.
As life expectancy increases and TAVI is
offered as treatment option to patients in their
eighth but mainly in their ninth and tenth decade
of life, quality of life assessment has fundamental
implications in the decision-making process for
this particular group of patients [27]. sAVR can
be offered as a treatment option to all ages, it has
a wider range of therapeutic proles, has a lower
overall cost to healthcare systems [23] and it has
a well-documented and established durability
that extends well beyond 15years.
In recent years, TAVI has been widely accepted
and recognised as a safe and effective treatment
for severe aortic stenosis in patients that are inoperable, those with high frailty index or the ones
with very high risk for sAVR. TAVI indications
have recently been expanded to intermediate and
low risk groups, but this is normally reserved for
patients in the eighth, ninth or 10thdecade of their
life. Despite sufcient favourable outcome data
in short- and mid-term follow up for TAVI, there
is a clear paucity of data with regards to longterm quality of life and valve durability beyond
7years [28].
In 1966 Elkinton described quality of life as
‘not just the absence of death but life with the
6 QOL andPROMS Following Transcatheter Aortic Valve Implantation
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Ceiling effect due to number of levels
perceived
– 36-items making it tedious
– Physical component and a mental
component: difcult to interpret
113
Two levels more to increase sensitivity
More responsive with musculoskeletal disorders
[25]
discomfort, anxiety/depression
discomfort, anxiety/depression
– Physical activities
Questionnaire Dimensions studied Advantages Disadvantages
MLHFQ Physical and emotional Short and easy Lack of social dimension
EQ-5D-3L Mobility, self-care, usual activities, pain/
EQ-5D-5L Mobility, self-care, usual activities, pain/
Table 6.1 Quality of life questionnaires
SF-36 Limitations in:
emotional related)
– Social activities
– Usual role activities (physical/
– Bodily pain
Correlates with New NYHA class and predicts
mortality and health care costs in heart failure
populations [26]
– General mental health
– Vitality
– General health perceptions
above
self-efcacy and knowledge, and quality of
life
SF-12 Shorter version of SF-36 questionnaire with good correlation in the physical and mental summary scores with the larger version described
KCCQ Physical function, symptoms, social function,
MLHFQ: Minnesota Living with Heart Failure Questionnaire; SF-12: Short Form 12 Health Survey Questionnaire; SF-36: Short Form 36 Health Survey Questionnaire;
EQ-5D-3L: EuroQol 3L questionnaire; EQ-5D-5L: EuroQol 5L questionnaire; KCCQ: Kansas City Cardiomyopathy Questionnaire
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