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308

SF-36

Follow-up

(months) Instrument(s)

No of patients

in Ablation arm

reporting QoL

data

Total

no. of

patients

52 25 12 (QoL

available to

6months)

387 387 36 EQ5D-3L

160 160 EQ5D

K. L. Withers et al.

94 94 75 SF-36

other relevant demographics

(race, employment, obesity,

diabetes, physical activity,

Table 16.1 (continued)

smoking, alcohol, no leisure

physical activity)

enrolled between 2007

and 2013. Patients with

symptomatic paroxysmal

or early persistent AF

sex=female

n (%)

57 NR (22) Single centre RCT

QoL in patients treated

with Catheter ablation

(CA) or minimally

invasive thoracoscopic

PVI and left atrial

appendage ligation

(MIPI) for AF

Paper Study intent age

Buist etal.

[94]

261 patients with PAF;

126 with LSPAF.Patients

prospectively followed

with consecutive

enrolment between Jan

2007 and July 2009

86 (33%

PAF);

27 (21%

LSPAF)

57±10 (PAF group);

59±9 (LSPAF

group)

To compare QoL after

catheter ablation for

longstanding persistent

AF (LSPAS) compared to

Bulkova etal.

[38]

58±10 41 (26) Consecutive patients with

paroxysmal AF (PAF)

using EQ5D-3L

To assess QoL,

Bulkova etal.

QoL data standardised and

AF enrolled in 2007 and

prospectively followed up

for 2years. Patients may

be a subset of Bulkova

etal. [39]

socioeconomic

parameters, and costs of

conventional therapy in

patients treated by

catheter ablation for AF.

[39]

normalised for Spanish

64.4 (SD 10.6) 17 (18.1) Patients with atrial utter.

Long term QoL after

cavotricuspid isthmus

ablation for atrial utter

Cabanas-

Grandio etal.

[40]

population. Consecutively

enrolled between Jan 2003

and May 2005, with

prospective follow up.

16 QOL andPROMS inCatheter Ablation ofCardiac Arrhythmia

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309

(continued)

SF-36

recorded in

12month

extraction

table)

40 36 6 to 18 (data

University Hospital,

Sweden enrolled between

March 2004 and

December 2007. 40

patients in study arm, 36

with QoL pre and post

214 214 6 SF-36;

matched at baseline to a

control group. HRQoL

issues assessed in severe

symptomatic AF before

and after PVI, with

control group, prospective

follow up

Symptom

Checklist (data

not reported

for Symptom

checklist as

disaggregated

pre-post

consecutive patients with

paroxysmal SVT at the

Karolinski University

Hospital, Sweden enrolled

between Feb 2013 to May

2015. Outcomes

compared by gender: 208

ablation data

not available)

1440 1213 12 EQ-5D-3L

women

Patient registry including

those with paroxysmal AF

(PAF) or persistent AF

(PsAF) were treated with

cryoballoon catheter

according to routine

practices at 93 sites across

36 countries. 78.7% of

patients had

PAF.Inclusion, patients

with 12month follow up

during the period May

2016–Jan 2020

53±9 10 (25) Patients at the Karolinski

To investigate the

HRQOL issues in severe

symptomatic AF patients

before and after

pulmonary vein isolation

Carnlof etal.

[41]

54±15 109 (51) A prospective study of

To assess symptoms,

HRQOL and functional

impairment before and

six months after ablation

using a patient and

gender perspective, in

patients with paroxysmal

Carnlof etal.

[42]

61±12 106 2

supraventricular

tachycardia (PSVT),

Report on the safety and

Chun etal.

(36.3)

efcacy of cryoballoon

ablation for the treatment

of AF within a single

registry

[95]

310

Follow-up

(months) Instrument(s)

No of patients

in Ablation arm

reporting QoL

data

K. L. Withers et al.

Total

no. of

patients

80 80 12 AFEQT

other relevant demographics

(race, employment, obesity,

diabetes, physical activity,

smoking, alcohol, no leisure

physical activity)

sex=female

n (%)

61.5 (IQR 55.8 68.0) 38 (47) A single centre United

Kingdom randomised

study with consecutively

enrolled patients with

paroxysmal AF. 40

patients in each arm: 40

single procedure, 40

repeat procedure

140 100 3 SF-36; U22

Prospective study of

Greek patients with SVT

(AVNRT and AVRT),

enrolled between Oct

2016 and April 2017. 100

patients treated with

ablation 40 with

57 (57)

ablation

21 (52.5)

AAD

46.55 ablation pts

43.55 AAD pts

469 133 9 SF-36; AFEQT

AAD.Age of ablation

patients=46.55±11.4;

age of AAD patients

43.55±11.18

A prospective non-

randomised single centre

NR NR

study. Chinese population.

469 patients enrolled:

Following

matching—151in the

ablation group (75 with

paroxysmal AF, 76 with

persistent AF) and 318in

the drug group (162 with

paroxysmal AF and 156

with persistent AF)

Table 16.1 (continued)

patients with single AF

ablation versus

re-isolation regardless of

Paper Study intent age

Das etal. [43] Comparing QoL in

symptoms

validate the arrhythmia-

specic Umea22 (U22)

questionnaire and (2)

assess the impact of

radiofrequency (RF)

To (1) translate, culturally

adapt, and preliminarily

Domeyer

etal. [44]

ablation and medical

treatment on the quality

of life of patients with

supraventricular

tachycardias (SVTs).

outcomes and health-

related quality of life of

ablation therapy in a real

Du etal. [45] To assess the clinical

world setting

16 QOL andPROMS inCatheter Ablation ofCardiac Arrhythmia

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Depression

Inventory

(BDI): SF36;

State-Trait

Anxiety

Inventory

checklist;

SF-36

(STAI);

CCS-SAF;

SF12

Ablation

PROM;

EQ-5D-5L

311

(continued)

105 97 24 AF symptom

patient-controlled study

(CLOSE to CURE),

enrolled patients from

July 2016. Patients with

paroxysmal AF implanted

with an ICM 65days

62±8 40 (38) A Belgian prospective,

57 57 6 Beck

consecutive Greek

patients with

symptomatic, drug

before PVI ablation

56.9±12.2 23 (40.4) Prospectively evaluated

refractory paroxysmal AF

230 217 12 AFEQT;

who underwent left atrial

ablation

including multipolar duty

cycled phased RF ablation

(PVAC, Medtronic Inc.)

57.30±10.80 68 (29.6) Two ablation strategies

390 390 12 Cardiff Cardiac

consecutive patients in an

and traditional point-by-

point RF catheter ablation.

Patients enrolled between

2012 and 2017 at six

tertiary centres.

observational UK study,

62.04±11.83 150 (43.6) Prospectively evaluated

enrolled between March

2013 and August 2014.

Includes patients with

varied arrythmia

substrates including AF/

AVNRT/Atrial Flutter

To determine the

longer-term impact of

optimized CA on atrial

tachyarrhythmia burden

by using an insertable

cardiac monitor.

Duytschaever

etal. [101]

To investigate

Efremidis

etal. [46]

after ablation.

To investigate the effect

of AF-ablation success

and atrial brillation

Essebag etal.

[47]

burden (AFB) on QOL

measures.

To investigate long-term

Evans etal.

efcacy of cardiac

[48]

generic and arrhythmia-

related QoL data using

patient-reported outcome

measures before and after

ablation for symptomatic

arrhythmia by gathering

ablation

associations of pre-

ablative QoL and stress

parameters with AF

ablation outcomes, as

well as possible changes

in QoL, anxiety, and

depression parameters

312

K. L. Withers et al.

Follow-up

(months) Instrument(s)

No of patients

in Ablation arm

reporting QoL

data

Total

other relevant demographics

(race, employment, obesity,

diabetes, physical activity,

64 64 2 EQ-5D-3L;

no. of

patients

smoking, alcohol, no leisure

physical activity)

PPAQ

202 202 12 EQ5D

study of patients in Poland

with AVNRT or

AVRT.Data available by

gender

203 consecutive patients

from a single centre

prospective registry with

long-standing persistent

atrial brillation (LSPAF)

treated with an index

ablation between July

2006 and December 2011.

Data for 171 with restored

scale; AF

symptom

133 133 48+ AF severity

sinus rhythm at 12month

follow up, 31 with AT/AF

at 12month follow up.

consecutive patients

enrolled at a German

checklist; Illness

Intrusiveness;

Major

depression

inventory; Sleep

and Vegetative

disorder; WHO

5-Wellbeing

Index; Vital

centre between July 2004

and August 2006. 46

patients with persistent

AF; 87 patients with

paroxysmal AF

Exhaustion

Table 16.1 (continued)

23 (36) Single centre prospective

sex=female

n (%)

44.9±13.4 women

To describe gender-

Paper Study intent age

Farkowski

44.5±14.4 men

related differences in

clinical presentation,

radiofrequency ablation

outcomes, and healthcare

resource utilization in a

group of patients with

etal. [49]

35 (20.5%)

restored

sinus

rhythm at

follow up

59+9 restored sinus

rhythm at follow up

61+8 AF/AT at

follow up

AVNRT and AVRT.

To identify the factors

associated with global

functional improvement

after successful RF

catheter ablation of long

Fiala etal.

[50]

10 (32.3%)

AF/AT at

follow up

57±10 NR (26) Prospective study of

standing persistent atrial

brillation (LSPAF)

To prospectively assess

Fichtner etal.

different aspects of

short- and long-term

quality of life (QoL) after

catheter ablation for AF.

[102]

16 QOL andPROMS inCatheter Ablation ofCardiac Arrhythmia

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EQ-5D-5L

12 AFEQT

with ablation

and QoL data

(99 with a

family history

of AF, 411

with no

family history

of AF)

313

(continued)

1514 510 patients

A retrospective analysis of

1514 newly diagnosed and

referred patients with AF

recorded on a multicentre

Japanese registry between

Family

history of

AF=57

(27.9)

No family

Family history of

AF=63.3±10.9

No family history of

AF=67.3±11.2

2012 and 2015. At their

initial visit, patients

provided information

about their family history

of AF, and the presence or

absence of AF in their

history of

AF=309

(28.6)

329 305 12 AFEQT;

parents, siblings, and

children.

was performed in 329

consecutive patients (age

61.4years, 60.8% male)

with drug-refractory PAF

61.4±10.0 129 (39.2) CLOSE-guided ablation

303 NR 24 EQ5D

in 9 European countries.

Patients enrolled between

Jan 2017 and March 2018

enrolled between April

2004 and August 2012,

with prospective follow-up,

57 131 (43) Consecutive Czeck patients

with paroxysmal, persistent

or longstanding persistent

AF. 489 ablation

procedures in 303 AF

patients. Paroxysmal=157

patients; persistent

(duration

1-12months)=94 patients;

longstanding persistent

(>12months)=52 patients

The association between

a family history (FHx) of

AF and patient-reported

symptom burden and

perception towards

treatment.

Fujisawa

etal. [51]

Analysis of healthcare

utilisation and quality of

life (QOL) outcomes,

measured association

between QOL and atrial

brillation (AF) burden

and factors associated

with lack of QOL

Gupta etal.,

[52]

improvement

To conduct a single

centre study with long

term follow up of patients

with paroxysmal AF

Haman etal.

[53]

314

SF-36; subset

Follow-up

(months) Instrument(s)

No of patients

in Ablation arm

reporting QoL

data

Total

no. of

patients

105 105

of U22

≈ 10 (data

entered at

9month cells)

1097 1021 12 AFEQT

12 AFQLQ

without

recurrence, 26

119 119; 93

with

recurrence

K. L. Withers et al.

other relevant demographics

(race, employment, obesity,

diabetes, physical activity,

Table 16.1 (continued)

smoking, alcohol, no leisure

physical activity)

atrial catheter ablation for

paroxysmal and persistent

AF at a Swedish centre

between 2006 and 2011

with prospective follow

up. 52 paroxysmal; 52

sex=female

n (%)

58 27 (26) Patients treated with left

The use of U22 to

measure symptom

improvement following

AF ablation

Paper Study intent age

Hoglund etal.

[54]

non-paroxysmal. All rst

time ablations

study designed to recruit

patients with atrial

64 (56–70) 261 (23.8) A registry-based cohort

To examine baseline and

1-year HRQoL outcomes

of patients with atrial

Ikemura etal.

[55]

brillation newly referred

to 11 hospitals, with data

from 1097 consecutive

registry patients with

atrial brillation who

underwent CA between

2012 and 2019.

brillation after CA in

daily practice

patients (paroxysmal AF,

n=133; persistent AF,

n=20) who underwent

PVI between October

66.3±9.5 31 (26.1) 153 consecutive AF

To clarify the

effectiveness of durable

PVI in improving the

QOL of patients with AF

Inagaki etal.

[56]

2014 and December 2017

at the Tokyo Metropolitan

Hiroo Hospital were

enrolled

16 QOL andPROMS inCatheter Ablation ofCardiac Arrhythmia

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315

(continued)

335 335 36 SF-12

observational trial at sites

in the USA and Canada.

Patients with drug

refractory symptomatic

paroxysmal AF.Post hoc

NR NR A multicentre

222 222 12 SF-36

analysis of prospectively

collected data

NR NR The EARNEST-PVI trial

was a multi-centre RCT

comparing clinical

outcomes of pulmonary

vein isolation (PVI) alone

and more intensive

ablation in addition to PVI

including complex

60 60 6 SF-36

fractionated atrial

electrogram (CFAE) and

linear ablation (PVI plus)

in patients with persistent

65.5 (9.5) 14 (23.3) Consecutive patients with

PAF and PerAF who

developed no AF

recurrence 6months after

their rst PVI from April

2014 to April 2016 were

enrolled and QoL data

collected prospectively. 38

patients with Paroxysmal

AF; 22 with persistent AF

cryoballoon ablation on

long term QoL

(STOP-AF study)

Jain etal. [97] To evaluate the effect of

To investigate the QoL

change after persistent

AF ablation and the

differences between the

PVI-alone strategy and

the PVI plus strategy

Kanda etal.

[57]

To compare the changes

in QOL after extended

PVI between patients

with Persistent AF

(PerAF) and paroxysmal

AF (PAF).

Kato etal.

[58]

316

SF-36; subset

Follow-up

(months) Instrument(s)

No of patients

in Ablation arm

reporting QoL

data

Total

no. of

patients

141 63

of U22

≈7months

(data entered

at 6months)

K. L. Withers et al.

SF12

674 633 3 EQ-5D-5L;

other relevant demographics

(race, employment, obesity,

diabetes, physical activity,

Table 16.1 (continued)

smoking, alcohol, no leisure

physical activity)

ablation for accessory

pathway and atrioventricular

nodal re-entrant tachycardia

between April 2006 and

May 2008. Prospective

HRQoL data available for

sex=female

n (%)

32 (50.8) Swedish patients undergoing

AP group=43.9

(17.9);

AVNRT

group=57.1 (14.0)

To evaluate U22in a

well-dened group of

patients with paroxysmal

supraventricular

tachycardia, undergoing

an intervention with a

distinct end-point and a

Paper Study intent age

Kesek etal.

[59]

63 patients: SVTA

(accessory pathway

(AP)=26 patients;

atrioventricular nodal

re-entrant tachycardia

high success rate

(AVNRT)=37 patients

a prospective, multicentre

(Europe and America),

study comparing continuous

209 (33) AXAFA-AFNET 5 trial was

Overall=64 (58–70)

Females=66

(60-72)

Males=63 (57-69)

To study sex-differences

in efcacy and safety of

atrial brillation (AF)

ablation

Kloosterman

etal. [26]

non-vitamin K antagonist

apixaban therapy to vitamin

K antagonist therapy in

patients undergoing rst AF

ablation. All patients had

symptomatic non-valvular

AF, a clinical indication for

catheter ablation on

continuous anticoagulant

therapy, and at least one

established stroke risk

factor. This analysis

population included all

patients from the AXAFA-

AFNET 5 trial population

who were randomized and

underwent catheter ablation

16 QOL andPROMS inCatheter Ablation ofCardiac Arrhythmia

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ED5D-3L;

SF-12

(disaggregated

QoL data

presented up

to 12months)

317

(continued)

750 525 30

ICE RCT including

patients with drug

refractory symptomatic

paroxysmal AF. 374

patients treated with

cryoballoon ablation; 376

treated with RFC

NR NR Subset of the FIRE and

223 NR 15 EQ-5D-5L

symptomatic persistent

atrial brillation

65.4±10.1 (30.9) Patients with recurrent

100 100 12 SF-36

multicentre study of

57±10 26 (26) The STAR AF Randomised

patients undergoing rst

time ablation for high

burden paroxysmal or

persistent AF.AF was

classied as high-burden

paroxysmal in 64 patients

(64%) and persistent in 36

patients (36%).Patients

randomized to PVI

(n=32), CFE (n=34), and

PVI with CFE (n=34)

To assess outcome

parameters that are

important for the daily

clinical management of

patients using key

secondary analyses.

Specically,

reinterventions,

rehospitalizations, and

QoL were examined in

this randomized trial of

cryoballoon vs. RFC

catheter ablation (FIRE

and ICE Trial)

ablation with a magnetic

sensor enabled optical

contact force sensing

ablation catheter was safe

and effective for the

treatment of drug

refractory, recurrent

symptomatic persistent

atrial brillation.

To Compare 3 ablations

strategies for high burden

paroxysmal/persistent

atrial brillation (AF):

complex fractionated

electrogram ablation

(CFE), pulmonary vein

isolation (PVI), or a

combined approach (PVI

with CFE).

Kuck etal.

[60]

Lo etal. [61] To demonstrate that RF

Mantovan

etal. [62]

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