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Файл:Ординатура / Хирургия / Библиотека им академика М.И. Перельмана / Книга_3773_Библиотеки_им_академика_М_И_Перельмана
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318
Follow-up
(months) Instrument(s)
No of patients
in Ablation arm
reporting QoL
data
Total
no. of
patients
360 360 12 BDI; HADS;
K. L. Withers et al.
SF-36; STAI
61 61 12 SF-36
other relevant demographics
(race, employment, obesity,
diabetes, physical activity,
Table 16.1 (continued)
smoking, alcohol, no leisure
physical activity)
APPROVAL Study- A
prospective, randomised,
single blind multicentre
study with centres in Italy
and the USA.Consecutive
patients enrolled between
Jan 2009 and Sept 2011.
sex=female
n (%)
NR (22)
group 1a
NR (28)
group 1b
NR (24)
group 2
63±8 group 1 a
61±11 group 1 b
62±9 group 2
To examine the impact of
different ablation
strategies on atrial
brillation (AF)
recurrence and quality of
life in coexistent AF and
atrial utter (AFL)
Paper Study intent age
Mohanty
etal. [63]
360 enrolled patients with
documented coexistent AF
and AFL were blinded and
randomized to 2 groups:
Group 1 (182 patients)
where 58 patients had
AF+AFL ablation (group
1a) and 124 had AF
ablation only Group 1b).
Group 2 (178 patients):
only AFL was ablated by
achieving bidirectional
isthmus conduction block.
QoL data presented for
total of Group 1 and
Group 2
62±13 NR (29) Prospective single centre,
To report impact of
Mohanty
single arm centre.
Consecutive patients
undergoing rst catheter
ablation or asymptomatic
LSP-AF. 25 patients
experienced recurrence,
21 of these were
catheter ablation on
exercise performance,
QoL and symptom
perception in
asymptomatic
longstanding persistent
AF (LSP-AF)
etal.[64]
symptomatic

16 QOL andPROMS inCatheter Ablation ofCardiac Arrhythmia
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SSQ
319
(continued)
127 66 24 EQ5D
RCT of 127 treatment
naïve patients with
paroxysmal AF treated at
16 centres in Europe and
North America, enrolled
between July 2006 and
Jan 2010. 66 patients
15 (22.7)
ablation
group
16 (26.2)
AAD group
56.3 (9.3) ablation
group
54.3 (11.7) AAD
group
139 139 12 EQ5D-5L;
treated with ablation; 61
treated with anti-
arrhythmia drugs
Prospective single centre
randomised study of
patients with symptomatic
AF. 69 patients treated
with single cryoablation;
21 (30.04)
single cryo
16 (22.9)
routine
61.9±9.08 single
cryo
68.3±10.0 routine
70 with routine
cryoablation. Patients
enrolled between Nov
2014 and March 2016
1040 432 12 AFEQT
multicentre outpatient-
based AF Japanese
registry. Patients with
persistent AF divided into
four groups; those who
underwent catheter
NR NR An observational and
ablation and maintained
sinus rhythm; patients
who underwent catheter
ablation and had
non-sinus rhythm at the
1year follow-up; patients
who maintained sinus
rhythm by AAs; and
patients who did not
undergo catheter ablation
or AA treatment
To compare
radiofrequency ablation
with antiarrhythmic drugs
in treating patients with
paroxysmal AF as a
Morillo etal.
[65]
rst-line therapy
Single cryoballoon (CB)
application per vein for
pulmonary vein isolation
(PVI) compared to the
standard approach of two
consecutive CB
applications in patients
with atrial brillation
Mortsell etal.
[66]
(AF) for long-term
efcacy and safety
To understand whether
use of catheter ablation
would lead to better QOL
in comparison to
Nakajima
[67]
antiarrhythmic drugs

320
Follow-up
(months) Instrument(s)
No of patients
in Ablation arm
reporting QoL
data
Total
no. of
patients
79 79 12 AFQLQ
259 45 12 AFQLQ
State-Trait
70 70 3 SF36;
Anxiety
Inventory
(STAI)
K. L. Withers et al.
218 107 12 AFEQT: SF-36
other relevant demographics
(race, employment, obesity,
diabetes, physical activity,
Table 16.1 (continued)
smoking, alcohol, no leisure
physical activity)
patients with
asymptomatic persistent
AF treated at Tenri
hospital. Unclear if any
cross over with Onishi et
al. [69]
sex=female
n (%)
NR NR Retrospective analysis of
To examine the effect of
CA for asymptomatic AF
patients
Paper Study intent age
Onishi etal.
[68]
A retrospective single-
centre study with patients
undergoing an initial RF
ablation CA of AF in
Tenri Hospital (Japan)
from January 2012 to
March 2014.
62.9±8.6 5 (11.1)
To assess the
improvement of QOL and
long-term prognosis after
CA of asymptomatic
persistent AF
Onishi etal.
[69]
49.31±15.29 50 (71) Consecutive patients with
To investigate effects of
Papiashvili
AVNRT/AVRT or Atrial
Tachycardia, enrolled
between July 2016 and
April 2017 and
prospectively followed up.
Results compared by
gender, age and SVT type
catheter ablation on
HRQoL related to age,
gender and type pf
paroxysmal
supraventricular
tachycardia
etal. [70]
A multicentre (Europe,
Argentina and Australia),
prospective, open
blind-endpoint, controlled
randomized (1:1) study
evaluating PVI using CBA
vs AAD therapy in
patients with symptomatic
Ablation
group=31
(29)
AAD
group=39
(35.1)
Ablation
(n=107)=50.5
(13.1)
AAD
(n=111)=54.1
(13.4)
To present the impact of
pulmonary vein isolation
(PVI) using CBA
compared to AAD
therapy on symptom
recurrence and QoL
Pavlovic etal.
[71]
paroxysmal AF

16 QOL andPROMS inCatheter Ablation ofCardiac Arrhythmia
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321
(continued)
SF-12
≥12
229 163
patients scheduled for PVI
in Vienna between 2009
and 2013 with a diagnosis
of paroxysmal, persistent
or longstanding AF.SF12
available for 163 patients
regarding 187 PVI
SF12
518 518 3 EQ-5D-5L;
procedures
AXAFA–AFNET 5
enrolled patients
scheduled for a de novo/
rst AF ablation with at
least one established
stroke risk factor
(age>65years, heart
failure, hypertension,
diabetes or prior stroke).
For the purpose of this
analysis, the study
population included all
patients from the AXAFA
trial population who were
44 44 3 SF-36
randomised, underwent
catheter ablation and had
available baseline and
follow-up QoL data.
N.B.Sub group of
Kloosterman etal.
cohort of patients with
symptomatic drug
refractory ventricular
arrhythmia. 23 patients
with VT; 21 with PVCs.
Patients enrolled between
1999 and 2004
58±11 NR (27) A retrospective analysis of
paroxysmal or non-
paroxysmal AF increases
HRQoL
To determine if PVI for
Pezawas etal.
[98]
(33.6%)
Overall=64 (58–70) 174
To investigate changes in
quality of life (QoL),
cognition and functional
status according to
arrhythmia recurrence
after atrial brillation
Piccini etal.
[27]
N.B.Same
study
population as
Kloosterman
(AF) ablation
etal. [26]
45.5±14.2 34 (NR) Single centre prospective
To evaluate the HRQoL
of patients with
structurally normal hearts
undergoing elective RF
ablation (RFA) of
ventricular tachycardia
(VT) or premature
Pytkowski
etal. [72]
ventricular contractions
(PVC’s).

322
Follow-up
(months) Instrument(s)
No of patients
in Ablation arm
reporting QoL
data
Total
no. of
patients
80 80 3 AFEQT; SF-36
Symptom
checklist
159 103 3 SF-36; AF
HADS; SF-36
24 AFEQT;
cardiac
rehabilitation
group; 105in
210 210 (105in
usual care
group)
K. L. Withers et al.
EQ-5D-3L
12 AFEQT;
115 CRYO-2
115 CRYO-4
346 115 CF-RF
other relevant demographics
(race, employment, obesity,
diabetes, physical activity,
Table 16.1 (continued)
smoking, alcohol, no leisure
physical activity)
scheduled for their rst
ablation, with prospective
follow up: 44 patients
with Paroxysmal AF; 36
patients with persistent
AF
sex=female
n (%)
57±10years 22 (27) Consecutive patients
To assess the effect of
catheter ablation on AF
symptoms and QoL
Paper Study intent age
Raine etal.
[73]
A prospective, randomised
multicentre trial for
patients with paroxysmal
AF not controlled by
drugs. 103 patients in
ablation group; 56 patients
32 (31)
ablation
group;
21 (37)
AAD group
55.5±9.4 ablation
group
55.8±13.1 AAD
group
To assess effects of
catheter ablation and
antiarrhythmic drugs
(AAD) on QoL in
patients with paroxysmal
AF
Reynolds
etal. [74]
in AAD group
2 Danish university
hospitals treated with
ablation for AF were
screened. Patients were
randomized 1:1 to
59 26% Consecutive patients from
To assess outcomes at 12
and 24months after
participation in a
multidisciplinary cardiac
rehabilitation program
plus usual care compared
Risom etal.
[75]
comprehensive cardiac
rehabilitation plus usual
care vs usual care
stratied by age and type
of AF
the CIRCA-DOSE study
([28]; [30]). Patients
60(52-66 IQR) 115 (33.3) A secondary analysis of
with usual care alone for
patients treated for atrial
brillation with catheter
ablation
To determine the
association between
change in AF burden and
Samuel etal.
[29]
N.B.Same
enrolled between Sept
2014 and July 2017
quality of life in the year
following ablation
study
population as
Andrade etal.
[28], Yao
etal. [30]

16 QOL andPROMS inCatheter Ablation ofCardiac Arrhythmia
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Anxiety Scale
(SAS);
Self-Rating
Depression
Scale (SDS);
SF-36. No
disaggregated
follow-up data
available for
SDS or SAS
scales
SF-36; AF
Severity Scale;
EQ-5D;
Symptom
Checklist
323
(continued)
(SCL) Score
166 82 12 Self-Rating
Consecutive patients with
a primary diagnosis of
symptomatic paroxysmal
AF enrolled between Feb
2009 and Jan 2010 for
prospective review. 84
patients included in
27 (32.9) in
ablation
group
26 (30.9) in
AAD group
55.9±6.1in ablation
group
57.2±5.4in AAD
group
95 95 12 SF-36
antiarrhythmic drug
(AAD) group; 82 patients
in ablation group
patients with Atrial Flutter
64±11 18 (18.9) Consecutive Spanish
219 76 3 AFEQT;
referred between Jan 2003
and March 2005, with
prospective follow up
study of patients with
paroxysmal, persistent,
62.1±12 91 (42.5) A multicentre prospective
longstanding persistent or
permanent AF recruited in
Canada and the US between
Aug 2008 and July 2009.
Three groups in study.
Before and after treatment
QoL presented here for two
groups: Group 1—
pharmacological change in
therapy following baseline
assessment (n=66; mean
age 66; 32 females); Group
2—ablation after baseline
assessment (n=76; mean
age 60.1; 27 females)
To assess if depression,
anxiety, and QoL improve
after catheter ablation in
patients with paroxysmal
Sang etal.
[76]
AF
To measure HRQoL
changes in patients with
typical atrial utter
following catheter
ablation with results
standardised and
normalised to the Spanish
Seara etal.
[77]
population
To develop and validate
the AFEQT in patients
with AF in a 6 centre
Spertus etal.
[78]
prospective study

324
Follow-up
(months) Instrument(s)
No of patients
in Ablation arm
reporting QoL
data
Total
no. of
patients
2008 636 12 AFEQT
165 165 12 AFEQT; SF-12
K. L. Withers et al.
SF-36
549 549 18 EQ-5D-3L;
other relevant demographics
(race, employment, obesity,
diabetes, physical activity,
Table 16.1 (continued)
smoking, alcohol, no leisure
physical activity)
The ORBIT-AF registry is
a national, US prospective
cohort study of outpatients
with AF, enrolled from
June 2010 to August 2011.
The study was managed
and coordinated by the
sex=female
n (%)
(47.2%)
74.0 (67.0–81.0) 300
To identify patients who
experience large
improvements in HRQoL;
to understand patient
factors associated with
large improvements in
HRQoL; and to describe
Paper Study intent age
Steinberg
etal. [79]
Duke Clinical Research
Institute
interval interventions and
outcomes among these
patients with large
refractory symptomatic
PsAF were enrolled into
65±9 49 (29.7) Patients with drug
improvements in HRQoL
efcacy of PVI using the
cryoballoon catheter to
Su etal. [80] To assess the safety and
the STOP Persistent AF
trial (US, Canada and
Japan) between March
2017 and July 2018. 165
patients were treated by
cryoballoon PVI, and 145
treat patients with
persistent AF
completed the required
12-month follow up
follow-up schedule
STAR AF II RCT, patients
enrolled at 35 centres in
Europe, Canada,
Australia, China, and
60 (SD 9) 115 (21) Secondary analysis of the
To evaluate whether the
procedural outcome of
ablation for AF is
associated with quality of
life (QOL) measures
Terricabras
etal. [81]
Korea from November
2010 to July 2012

16 QOL andPROMS inCatheter Ablation ofCardiac Arrhythmia
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EQ5D-3L;
SF-36
ASTA
325
(continued)
EQ-5D-5L
37 37 12 SF-36; MASQ
study enrolling patients
with ventricular
extrasystoles between
2016 and 2019
49±22 26 (70.3) Single centre Belgian
176 156 12 EQ-5D-3L;
consecutive patients with
AVNRT or PSVT treated
at a single centre in
48.3±16.3 91 (52) Prospective design with
294 146 24 SF-36;
A Swedish multicentre
prospective RCT
Sweden. Age and gender
matched to Swedish
population
including patients with
46 (32)
RFA group
42 (28)
56±9 RFA group;
54±10 AAD group
PAF. 146 patients treated
with RFA; 148 treated
with AAD.
AAD group
203 104 12 AFEQT;
Part of the STOP-AF
Study. Patients with
symptomatic AF not
previously receiving
rhythm control therapy
41 (39.4)
Ablation
group
42 (42.4)
AAS group
60.4±11.2
(Ablation group)
61.6±11.2 (AAD
group)
were randomized to AAD
(class I or III) or CBA
study of the MANTRA-
PAF) trial, and symptom
burden at 12 and
Evaluation of the impact
of catheter ablation for
ventricular extrasystoles
(VES) in structurally
normal hearts on quality
of life (QOL) and
symptomatology
Timmers
etal. [82]
To evaluate the impact of
RFA on HRQOL in
patients with paroxysmal
supraventricular
tachycardia (PSVT)
Walfridsson
etal. [83]
To assess long-term effect
on HRQoL of
radiofrequency ablation
(RFA) vs. antiarrhythmic
Walfridsson
etal. [96]
drug therapy (AAD) as
rst-line treatment for
patients with PAF (sub
24months
To evaluate the change in
quality of life (QoL) and
symptoms after rst-line
CBA vs AAD therapy
Wazni etal.
[84]

326
AF Symptom
Follow-up
(months) Instrument(s)
No of patients
in Ablation arm
reporting QoL
data
Total
no. of
patients
167 106 9 (QoL data
Checklist;
SF-36
reported only
at 3months)
502 323 24 SF-36
K. L. Withers et al.
33 33 12 SF-36
other relevant demographics
(race, employment, obesity,
diabetes, physical activity,
Table 16.1 (continued)
smoking, alcohol, no leisure
physical activity)
randomised study with
sites in the USA, Europe,
Canada and Latin America
involving patients with
symptomatic AF who had
not improved with at least
sex=female
n (%)
NR(33.5) Prospective multicentre
55.7 (95% CI,
54.1-57.4)
To determine the efcacy
of catheter ablation
compared with
antiarrhythmic drug
therapy (ADT) in treating
symptomatic paroxysmal
AF
Paper Study intent age
Wilber etal.
[85]
1 drug. 167 patients with
paroxysmal AF:106
patients treated with
catheter ablation; 61
treated with
AAD.Patients enrolled
between Oct 2004 and Oct
2007
symptomatic AF treated at
a single US centre.
Patients prospectively
followed between Dec
55.9±0.3 98 (18) Consecutive patients with
To determine the
relationship between AF
ablation efcacy, QoL,
and AF-specic
symptoms at 2years
Wokhlu etal.
[86]
available for patients with
2001 and July 2006 and
data collected
prospectively until March
2008.323 patients with
2year QoL follow up
and without recurrence of
54.2±9 7 (21) Prospective study. Data
To assess the long-term
inuence of
circumferential
Wozniak-
Skowerska
etal. [87]
AF
pulmonary vein ablation
(CPVA) on QoL in
patients with AF

16 QOL andPROMS inCatheter Ablation ofCardiac Arrhythmia
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327
(continued)
648 327 60 SF-36
From 2012 to 2014, 648
patients with persistent
AF (PAF) or longstanding
persistent AF LS-PAF)
were enrolled in a
multicentre RCT. 267
(41.2%) patients had PAF
and 381 (58.8%) had
109 (33.3)
Ablation
group
118 (36.8)
Pharmaco-
therapy
group
64.1±11.3 Overall
64.8±12.6 Ablation
group
64.4±13.6
Pharmacotherapy
group
130 122 12 AFEQT; SF-36
LS-PAF
UK based RCT of patients
with persistent AF or
sustained paroxysmal AF
with risk for
atrial substrate. 64
61.9±0.5 42 (32) Prospective multicentre
123 66 6 SF-36
patients treated with PVI
only; 66 with PVI and
additional linear ablation
lines
Prospectively enrolled
patients with AF: 66
patients treated with
CPVI; 57 treated with
CPVI=21;
ADT =22
61.5±10.1 CPVI
group: 60.9±13.7
ADT group
ADT
34 34 6 SF-36
patients with
asymptomatic persistent
AF, prospective follow up
60.4±9.2 7 (21) Consecutively enrolled
RFCA and
pharmacotherapy on the
prognosis of patients with
persistent and long
standing AF
Wu etal. [88] To compare the effects of
To assess the impact of
additional linear ablation
lines compared to PVI
alone
Wynn etal.
[89]
circumferential pulmonary
vein isolation (CPVI)
compared with
antiarrhythmic drug therapy
(ADT) in treating AF.
To assess the QoL,
exercise performance,
and plasma B-type
natriuretic peptide levels
following catheter
ablation in patients with
asymptomatic AF.
Xu etal. [90] To evaluate QoL after
Yagishita
etal. [91]
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