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15 Quality of Life and Patient Reported Outcome Measures Following Percutaneous Aortic Intervention…
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QOL andPROMS inCatheter
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Ablation ofCardiac Arrhythmia
KathleenL.Withers, HelenMorgan,
andMauroLencioni
16
Introduction
Percutaneous ablation of cardiac arrhythmias is a
relatively safe and effective method for the treatment of sustained and paroxysmal heart rhythm
disorders. It has evolved from open heart excision surgery that was used 60years ago to directly
ablate the AV junction, via the use of focused
high-voltage energy burns to produce scar tissue
in the targeted region without damage to surrounding tissues and structures. The use of surgical cryoablation developed during the 1970s [1],
and in 1981, the rst successful catheter ablation
was performed using DC ablation in a candidate
who was unsuitable for surgical ablation, ultimately leading to a decision to treat him with a
catheter ablation [2]. Despite earlier experimental work using radiofrequency ablation, it was not
until the late 1980s that its safety and efcacy
was established [2] with catheter cryoablation
K. L. Withers (*)
Cedar, Cardiff and Vale University Health Board,
Cardiff Medicentre, Cardiff, UK
e-mail: Kathleen.withers@wales.nhs.uk
H. Morgan
Cedar, Cardiff University, Cardiff Medicentre,
Cardiff, UK
e-mail: MorganHE1@cardiff.ac.uk
M. Lencioni
University Hospitals Birmingham NHS Foundation
Trust, Birmingham, UK
e-mail: mauro.lencioni@uhb.nhs.uk
subsequently coming into use in the 2000s [3].
Over the last decade catheter ablation has been
used increasingly to treat even complex arrhythmias, predominantly using radiofrequency and
cryo-energy delivered through exible catheters
[4]. The success of these operations is highly
dependent on the technical skill of the surgeon
and experience in selecting patients that are likely
to benet from this treatment.
There are three broad categories of indications
for catheter ablation: (1) denitive treatment of
supraventricular tachycardia that includes nodal
re-entrant, nodal dependant and focal arrhythmia
substrates, (2) reduction in arrhythmia burden in
symptomatic atrial brillation that is poorly controlled on anti-arrhythmic medication and (3)
denitive treatment of ventricular tachycardia in
normal hearts or in structural heart disease where
medication has failed in the latter [5, 6].
Technological advances in the eld of AF ablation over the last ten years have made this procedure feasible and this in term has driven demand.
Currently in the UK, catheter ablation for atrial
brillation (AF) accounts for approximately 50%
of these procedures [7].
A number of new advances are currently being
cited as potentially further improving management of patients with cardiac arrhythmias [8, 9],
with strategies including electroporation (pulsedeld ablation), and ultra-low temperature cryoablation being investigated. While the benets of
ultra-low cryoablation are still awaited [10],
© 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_16
301
302
K. L. Withers et al.
studies using pulsed eld ablation have shown it
to be a safe and durable option [11]. However,
quality of life outcomes have yet to be reported
for this treatment strategy.
While atrial brillation is a major cause of
stroke and heart failure [12], the vast majority of
cardiac arrhythmias are not life threating but are
responsible for considerable morbidity.
Paroxysmal SVT’s produce anxiety due to the
unpredictable initiation of attacks and disabling
symptoms during episodes of arrhythmia.
Sustained arrhythmias manifest with chronic,
less dramatic but equally disabling symptoms
[13–15].
Treatment is thus aimed at symptom control
rather than risk reduction [16] as supported by a
number of recent guidelines [17–19]. Additionally
it is well recognised that there is a strong link
between cardiac arrhythmias and anxiety and
depression [20, 21], further exacerbating the detrimental effect on quality of life in this patient
group. It is therefore essential that treatment success is measured not only by objective parameters but also considers the patients view, as
changes in symptoms and quality of life (QoL)
are areas which are best assessed by patients
themselves. Due to this, the use of Patient
Reported Outcome Measures (PROMs) in
patients with cardiac arrhythmias has grown signicantly in recent years as their potential to
measure effectiveness of care in this group has
been recognised. This is reected in the increasing support for their use both in routine use and in
clinical trials, as illustrated by the recent international Task Force for quality indicators in atrial
brillation publication which recommends their
use, as developed with groups including the
European Heart Rhythm Association (EHRA) of
the European Society of Cardiology (ESC), the
Heart Rhythm Society (HRS), the Asia Pacic
Heart Rhythm Society (APHRS), and the LatinAmerican Heart Rhythm Society (LAHRS) [22].
Similarly, the International Consortium for
Health Outcomes Measurement (ICHOM) atrial
brillation group have developed a set of suggested outcome measures for use in patients with
AF [23]. These include clinical and procedural
outcomes such as complications and long term
consequences of the disease as well as suggested
PROMs tools and their timings.
PROM tools in combination with clinical
assessment are ideal at assessing effectiveness of
arrhythmia treatment. At the clinical level, both
patient and operator are able to quantify baseline
health and quality of life issues and to review
treatment outcome, while published PROMs outcomes can allow patients to make informed decisions about treating centres. Clinicians are also
able to use PROM data to rene their selection
criteria, offering treatment to patients that are
most likely to improve their QoL as well as setting patient treatment expectations. Aggregated
PROM outcomes are useful at national level,
used by commissioners to determine the value of
the treatment and plan future investment. This is
increasingly important as growing nancial pressures on health service provision means it is
essential that the care provided is both effective
and economically efcient. Using PROMs in
these varied ways can drive improvement in treatment quality and ultimately patient care.
As with other clinical areas, both generic
PROMs tools and condition specic tools have
been utilised to collect data from this patient
group [5, 24, 25]. This chapter provides an overview of the tools which have been used to measure health related quality of life in studies
involving patients treated with percutaneous
catheter ablation in arrhythmia care.
Search Strategy
A literature search was performed using
EMBASE (Ovid); Medline (Ovid) including
Medline in Process and Medline Epub Ahead of
Print; Scopus (Elsevier); and Web of Science
(Science Citation Index). The search strategies
used a range of free text terms and, where applicable, subject headings to describe cardiac
arrhythmia, catheter ablation and tools used to
measure quality of life and patient-reportedoutcome measures in patients treated with catheter ablation. The Medline search strategy is
available as supplementary material (Appendix).
The search period was from 1st January 2010 to
16 QOL andPROMS inCatheter Ablation ofCardiac Arrhythmia
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303
18th December 2021 and limited to English language publications.
Inclusion andExclusion Criteria
Studies in English which reported HRQoL in
adults treated with catheter ablation for any
cardiac arrhythmias were included. Studies
involving surgical approaches such as Cox-Maze
procedures and thorascopic ablation, and studies
focusing on patients with implantable devices
were excluded as these will be dealt with in other
chapters. Studies where the primary diagnosis
was not arrhythmia and those using experimental
techniques were also excluded. Due to the large
number of studies available, this review focuses
on those studies reporting disaggregated health
related quality of life data at baseline and post
ablation only.
Data Extraction
Relevant articles were independently identied
by two reviewers and conicts discussed to reach
agreement. Full texts were reviewed to identify
whether they met the inclusion criteria. As for
previous chapters the information extracted
included the following: author and year of publication; study intent; total number of patients; age
and gender of patients; length of follow up;
instruments used and baseline and follow up
patient reported outcome data.
Quality Scoring
A quality assessment of the included studies was
not conducted for this overview.
Results
Selected Studies andTheir Objectives
The literature search identied 718 studies.
Where abstracts and full text publications were
available, only the full text paper was selected.
Where more than one full text manuscript was
available from a single study, all were included as
part of the review into factors impacting on quality of life, but data extraction was limited to one
paper. Ultimately, 77 papers reporting on 74 studies were selected for review. Kloosterman et al.
[26] and Picini et al. [27] both reported on the
same study, as did Andrade etal., Samuel etal.,
and Yao et al. [28–30]. For expediency, where
study details are reported below, only
Kloosterman etal. [26] and Andrade etal. [28]
will be referenced. The data extracted from all
identied studies is available to view in
Table16.1.
The studies identied included a total of
20,118 patients with the largest study comprising
2008 patients and the smallest 31 patients. Where
the time period was specied the included studies
enrolled or followed up patients between the
years 1999 and 2020. The majority (n = 38;
51.35%) of the studies were conducted in Europe,
including 4 from the UK.Others originated from
Asia (n=15; 20.27%), and North America (n=9;
12.16%), while a further 12 studies (16.22%)
were inter-continental.
The included studies comprised twenty randomised trials [28, 36, 43, 57, 60–63, 65, 66, 74,
81, 84, 85, 88, 89, 93–96], and another six were
studies of patients on clinical registries [32, 34,
50, 51, 55, 67]. There were four retrospective
studies [68, 69, 97, 98] while the remaining forty-
four- studies consisted of prospective cohorts of
patients [26, 31, 33, 35, 37–42, 44–49, 52–54, 56,
58, 59, 64, 70–73, 75–80, 82, 83, 86, 87, 90–92,
99–102].
Sixty studies focused only on patients treated
for atrial brillation (AF) alone [26, 28, 32–39, 41,
43, 45–47, 50–58, 60–62, 64–69, 71, 73–76, 78–
81, 84–91, 93–102] while two studies included
patients with AF and other types of arrhythmia:
Mohanty etal. [63] included patients with co-existent AF and atrial utter while Evans et al. [48]
was a PROMs validation study which enrolled
patients with a broad range of arrhythmia substrates including AF, atrioventricular nodal reentry tachycardia (AVNRT), atrial utter,
accessory pathway and ventricular tachycardia.
304
Follow-up
(months) Instrument(s)
No of patients
in Ablation arm
reporting QoL
data
Total
no. of
patients
31 31 6 ASTA
EQ-5D-3L
12 AFEQT;
115 CRYO-2
115 CRYO-4
346 115 CF-RF
K. L. Withers et al.
other relevant demographics
(race, employment, obesity,
diabetes, physical activity,
smoking, alcohol, no leisure
physical activity)
centre, cohort study
conducted in Indonesia
sex=female
n (%)
43.06 (17–74) 19 (61.3) Observational, single-
To compare symptom
burden and the quality of
life before and 6months
Paper Study intent age
Amir etal.
Table 16.1 Data from identied studies
[31]
from January through
December 2019. Treating
patient’s refractory to
anti-arrhythmic with
low-burden premature
ventricular complexes
NR NR CIRCA-DOSE
after ablation
To evaluate the impact of
Andrade etal.
multicentre prospective
parallel-group, single-
blinded RCT with blinded
endpoint conducted at 8
clinical centres in Canada.
346 patients with
paroxysmal AF refractory
contact force–guided
radiofrequency ablation
versus cryoballoon
ablation on quality of life
and health care utilization
[28]
to at least 1 Class I or III
AAD randomized in a
1:1:1 ratio to: (1) contact
force–guided point
by-point RF ablation
(CF-RF); (2) short 2-min
cryoballoon ablation
duration (CRYO-2); and
(3) standard 4-min
cryoballoon ablation
duration (CRYO-4).
(Secondary analysis
reported by Samuel etal.
[29] and Yao etal. [30]
16 QOL andPROMS inCatheter Ablation ofCardiac Arrhythmia
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SF-36
305
(continued)
222 44 6 AFEQT
Nine hundred AF patients
with low CHADS2 score
from the Chinese Atrial
Fibrillation Registry
prospectively enrolled
After
matching:
27 (36.49)
RFA group
55 (37.16)
After matching:
61.82±8.90in RFA
group
62.42±10.52in
non-RFA group
192 192 12 ASTA; HADS:
between 2011 and 2013.
After a propensity score
matching a cohort of 222
patients was constructed
with 74in the RFA group
and 148in the non-RFA
group
non-RFA
group
60.5±10.2 56 (29) Observational study with
data from SMURF study,
single centre in Sweden.
Patients with rst RFA
ablation for AF
prospectively enrolled
between Jan 2012 and
April 2014
99 99 12 SF-36
consecutive patients
prospectively enrolled
between 1st Jan 2008 and
31st Dec 2010. Patients
with recurrence of AF
55.4±8.9 20 (25) Dutch population,
(n=52) compared to
those with no recurrence
of a single RF ablation
(RFA) on QoL in atrial
brillation (AF) patients
with low stroke risk.
Bai etal. [32] To investigate the impact
Exploration of predictors
of improvement in
arrhythmia specic
symptoms and HRQoL
following RF ablation for
AF
Barmano
etal. [99]
To explore the
relationship between
documented AF
recurrences and QoL in
patients following PVI
Berger etal.
[33]
306
Follow-up
(months) Instrument(s)
No of patients
in Ablation arm
reporting QoL
data
Total
no. of
patients
736 462 12 AFEQT
57 54 24 AF6; SF-36;
K. L. Withers et al.
412 153 60 SF-36
other relevant demographics
(race, employment, obesity,
diabetes, physical activity,
Table 16.1 (continued)
smoking, alcohol, no leisure
physical activity)
US patients with AF
already prospectively
enrolled in a prospective
observational registry. 381
patients aged <65years;
355 patients aged 65+
sex=female
n (%)
284 (38.6) Analysis uses data from
71.1 older group
53.6 younger group
To quantify the healthcare
utilization and quality of
life benets of catheter
ablation for AF, for
patients ≥65years
compared to patients
<65years
Paper Study intent age
Biviano etal.
[34]
years. Mean age of older
group was 71.1 (SD 4.9)
years. Mean of Younger
group 53.6 (SD 9.1) years.
Older group=fewer
males; higher rates of
anticoagulation usage,
hypertension, TIA, CAD,
higher CHADS2 risk
scores
prospectively enrolled
between 2009 and 2013
57±9 23 (40) Scandinavian AF patients
To evaluate the use of an
AF-specic and a generic
patient-reported outcomes
instrument during
continuous rhythm
Bjorkenheim
etal. [35]
A prospective study of
consecutive patients with
persistent AF.Elderly
patients aged ≥70: Group
A 153 patients treated
with ablation; Group B
44 (29)
ablation
group
73 (28)
AAD group
75±5 ablation
group
76±5 AAD group
monitoring 2years after
AF ablation
To compared the efcacy,
safety, and QoL impact of
catheter ablation versus
antiarrhythmic drugs
(AAD) in elderly patients
with persistent AF.
Blandino
etal. [100]
259 patients treated with
AAD.Enrolled between
Jan 2005 and Jan 2009
16 QOL andPROMS inCatheter Ablation ofCardiac Arrhythmia
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307
(continued)
155 79 12 SF-36
Patients in Sweden and
Finland, enrolled between
July 2008 and Sept 2017
on the CAPTAF RCT
Trial—Patients with AF
treated with Pulmonary
vein isolation ablation
(n=79) or antiarrhythmic
21 (26.6)
ablation
group
14 (18.4)
AAD group
55.8 (10.6) ablation
group
56.3 (8.9) AAD
group
1054 943 12 AFEQT
was a prospective,
drugs (n=76).
60.6±10.9 341 (32.4) The GOLD AF Registry
observational, multi-
centre, registry with 40
worldwide sites in France,
Germany, Greece,
Hungary, Italy, the
Netherlands, Poland,
Portugal, Spain,
Switzerland, UK, Georgia,
Israel, and South Korea.
Enrolled patients between
2015 and 2017. It
included adults (≥18years
old) with PAF, persistent
AF (PersAF), or LS
PersAF who underwent a
phased RF ablation.
101 101 12 SF-36
Patients followed up in
person or by telephone.
multicentre, single-arm
trial in Germany, France
and Greece including
61.8±10.5 26 (25.7) A prospective,
patients with AF enrolled
between Dec 2014 and
May 2016
examination of standard-
of- care use for the
treatment of paroxysmal
and persistent atrial
To assess quality of life
with catheter ablation vs
antiarrhythmic
medication at 12months
in patients with atrial
brillation
Blondstrom-
Lundqvist
etal. [36]
To prospectively assess
the population,
indications, and outcomes
using second-generation
phased radiofrequency
(RF) ablation (pulmonary
vein ablation catheter
Boersma etal.
[93]
GOLD) in a global
brillation
To report long term
outcomes after single PVI
ablation in persistent AF
patients
(CRYO4PERSISTENT
AF Trial)
Boveda etal.
[37]
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