Vol 74, No 3 (2016)
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Kardiologia Polska 2016 nr 3-14

ARTYKUŁ ORYGINALNY / ORYGINAL ARTICLE

Quality of life in patients with paroxysmal atrial fibrillation after circumferential pulmonary vein ablation

Iwona M. Woźniak-Skowerska1, Mariusz J. Skowerski2, Andrzej Hoffmann1, Seweryn Nowak1, Maciej Faryan1, Jarosław Kolasa1, Tomasz Skowerski3, Krzysztof Szydło1, Anna Maria Wnuk-Wojnar1, Katarzyna Mizia-Stec1

11st Department of Cardiology, Medical University of Silesia, Upper Silesian Medical Centre, Katowice, Poland
2Department of Cardiology, School of Health Sciences, Medical University of Silesia, Katowice, Poland
32nd Department of Cardiology, Medical University of Silesia, Upper Silesian Medical Centre, Katowice, Poland

Address for correspondence:
Iwona M. Woźniak-Skowerska, MD, PhD, 1st Department of Cardiology, School of Medicine, Medical University of Silesia, ul. Ziołowa 47, 40–635 Katowice, Poland, e-mail: iskowerska@hoga.pl
Received: 22.02.2015 Accepted: 30.06.2015 Available as AoP: 19.08.2015

Abstract

Background: Atrial fibrillation (AF) is the most common arrhythmia and is associated with a deterioration of quality of life (QoL). Catheter ablation is a therapeutic strategy for some patients with AF. The effectiveness of pulmonary vein isolation is still under assessment.

Aim: To assess the long-term influence of circumferential pulmonary vein ablation (CPVA) on QoL in patients with AF.

Methods: The study population consisted of 33 patients (26 males, age 54.2 ± 9 years) with highly symptomatic (EHRA II–III) drug refractory paroxysmal AF, who underwent CPVA. A clinical examination, electrocardiogram (ECG), and Holter ECG were performed before and during a one-year follow-up. The SF-36 Medical Outcomes Survey Short-Form QoL questionnaire, scored on a 0–100 scale for each of eight domains: bodily pain (BP), general health (GH), mental health (MH), physical functioning (PF), role-emotional (RE), role-physical (RP), social functioning (SF), and vitality (V), was collected before and one year after CPVA.

Results: In the one-year follow-up 27 (82%) patients were free of AF. EHRA symptoms were improved one-year after CPVA regardless of CPVA efficacy. After the follow-up the SF-36 questionnaire results improved significantly in all of the subscales in patients without a recurrence of AF after CPVA. In subjects with a recurrence of AF, all of the subscales did not indicate any statistically significant differences. There was an association between the CPVA and the following QoL domains: GH (p = 0.018), PF (p = 0.042), and V (p = 0.041). The highest values of the GH and V domains were found in the non-recurrence patients one year after CPVA.

Conclusions: CPVA results in the clinical improvement of patients with symptomatic AF regardless of the final arrhythmia termination. Patients after successful CPVA experienced a significant improvement in all of the subscales of the QoL.

Key words: atrial fibrillation, pulmonary vein isolation, quality of life

Kardiol Pol 2016; 74, 3: 244–250

INTRODUCTION

Atrial fibrillation (AF) is a common heart arrhythmia, which occurs frequently in the general population with an increasing prevalence that is associated with age. It is well known that AF impairs the quality of life (QoL), which is manifested as a sensation of irregularity of heartbeat, and decreased exercise tolerance and social functioning. AF is associated with a higher frequency of emergency room admissions, hospitalisations, and side effects of the medications that are used to treat the arrhythmia. The evaluation of QoL in patients with paroxysmal, symptomatic AF is an increasingly important aim [1–4]. The SF-36 questionnaire has been proven to assess the patient’s own perception of his/her state of health with satisfactory accuracy [5]. Recently, pulmonary vein isolation (PVI) has become a widely used method for AF treatment [6]. The safety and effectiveness of PVI in patients with AF is still under intensive clinical investigation [3, 4, 7]. A previous report [8] on the outcome of the radiofrequency catheter ablation performed in patients with extremely symptomatic premature ventricular contractions suggested that the procedure significantly improves the QoL as well. It could be expected that PVI may be an intervention as a method of treatment of patients with symptomatic AF, which might lead to an improvement in the patient’s well-being and QoL, and a reduction in utilisation of health-care resources.

The aim of this study was to determine the long-term influence of circumferential pulmonary vein ablation (CPVA) on QoL using the SF-36 questionnaire in highly symptomatic patients with drug refractory AF, and to compare the results obtained from SF-36 score in patients with and without a recurrence of AF after CPVA.

METHODS

Study population

The study population consisted of 33 consecutive patients (26 males, mean age 54.2 ± 9 years, range 24–62 years) with highly symptomatic (EHRA II–III) drug refractory paroxysmal nonvalvular AF, who were referred to our department for CPVA using a three-dimensional (3D) mapping system. The episodes of AF in all of the patients were documented using a Holter electrocardiogram (ECG) and/or surface ECG before the procedure. The treatment with two or more anti­arrhythmic drugs was unsuccessful, and the patients were often admitted to the outpatient clinics and/or hospitalised. In some patients, electrical cardioversions were performed due to persistent AF episodes. The baseline demographic and clinical characteristics of the study population are presented in Table 1. Before and after CPVA all of the patients received oral anticoagulation for at least six weeks, and the international normalised ratio was maintained between two and three. The following exclusion criteria were used in the study: persistent or permanent AF, valvular AF, unstable angina, and moderate and severe systemic hypertension.

Table 1. The baseline demographic and clinical characteristics of the study population

All patients (n = 33)

NR group (n = 27)

R group (n = 6)

Age [years]

54.2 ± 9

54.2 ± 9

54.9 ± 9

Sex (male / female)

26 / 7

23 / 4

3 / 3

AF episodes in history [years]

2–14

2–6

2–14

AF frequency (episodes/month)

4–15 range (7 mean)

4–6 range (3 mean)

4–15 range (7 mean)

AAD treatment (number)

1–3 range (2.6 mean)

1–3 range (1.6 mean)

2–3 range (2.4 mean)

Cardioversion in history (number)

1–9 range (2.6 mean)

1–6 range (2.2 mean)

2–9 range (2.6 mean)

Hypertension (n / %)

20 / 60%

14 / 52%

6 / 100%

CHA2DS2VASC score

0–3 range (1.9 mean)

0–2 range (1.6 mean)

1–3 range (1.9 mean)

TTE:

LVEF (%)

IVS > 12 mm (n / %)

LA > 40 mm (n / %)

 

50–60%

6 / 18%

5 / 15%

 

54–60%

2 / 8%

2 / 8%

 

50–55%

4 / 67%

3 / 50%

EHRA I/II/III/IV (n / %):

Before

 

n: 0 / 22 / 11 / 0

%: 0 / 67 / 33 / 0

 

n: 0 / 21 / 6 / 0

%: 0 / 78 / 22 / 0

 

n: 0 / 1 / 5 / 0

%: 0 / 17 / 83 / 0

One-year after CPVA

n: 28 / 5 / 0 / 0

%: 82 / 18 / 0 / 0

n: 27 / 0 / 0 / 0

%: 100 / 0 / 0 / 0

n: 1 / 5 / 0 / 0

%: 17 / 83 / 0 / 0

AAD — antiarrhythmic drugs; AF — atrial fibrillation; CPVA — circumferential pulmonary vein ablation; IVS — intraventricular septum; LA — left atrium; LVEF — left ventricular ejection fraction; NR — non-recurrence group, R — recurrence group; TTE — transthoracic echocardiography

CPVA procedure

The CPVA procedure using a 3D mapping system was done according to the Pappone technique [9]. Circular left atrial linear lesions were created in the left atrium around the ostia of the pulmonary veins using a 3D mapping system. The CPVA procedure was performed using a 3D CARTO mapping system. The mapping/ablation catheter (Navistar Thermocool) was introduced to the left atrium via the transseptal access. An electroanatomical map of the left atrium and pulmonary veins was performed. Subsequently, it was merged with a computed tomography reconstruction of the left atrium that had previously been done. Circular left atrial linear lesions around the ostia of the pulmonary veins were created. After ablation a second electroanatomical voltage map was done. If low voltage areas appeared inside the lines and no captured stimulation was obtained from these regions, the veins were treated as isolated (procedure end-point). To reduce the risk of left atrial macroreentry tachycardia, no additional lines in the left atrium were done. Each patient underwent only one ablation procedure. No early or late complications after CPVA procedure were observed.

Follow-up

Outpatient follow-up visits were scheduled regularly every three months up to one year after the ablation. Long-term efficacy was assessed clinically on the basis of clinical symptoms, the ECG, and a seven-day 24-h Holter recording (performed one year after CPVA). Some of the patients (10 patients) used an “event recorder”. The recurrence of AF was defined as a documented AF episode of at least 30 s duration.

QoL assessment

The SF-36 questionnaire, when used as a generic health scale, measures several health domains, including eight variables: bodily pain (BP), general health perception (GH), mental health (MH), physical functioning (PF), social functioning (SF), role limitations related to emotional problems (RE), role-physical (RP), and vitality perceptions (V). The scores range from 0 (indicating the worse health status) to 100 (indicating the best health status). The patients completed the SF-36 questionnaire at the baseline and one year after CPVA. The scores were calculated within the range of 0–100. The EHRA scale was handed out at the same time as the SF-36 questionnaire.

Statistical analysis

The baseline clinical parameters and the results of ancillary investigations were compared using the two-sample t-tests for normally distributed continuous variables (Student’s t-test); in the case of an abnormal distribution, the Mann-Whitney U test was used. Categorical variables were compared using the χ2 test. All of the text and table results are expressed as means ± standard deviation (SD) or a number (percentage). To compare the change in QoL domain values over time, the data were analysed as a repeated measure analysis of variances, taking into account the recurrence of AF, the intervention factor (CPVA), and time. A value p < 0.05 was considered statistically significant.

RESULTS

Clinical results of CPVA

After CPVA 27 (82%) patients were free of documented AF (non-recurrence group — NR group). Twenty-two of them (81%) were still being treated with beta-blockers, mostly due to mild hypertension. Seventeen (62%) patients were treated with antiarrhythmic drugs; mainly with propafenone — 14 (83%) patients and sotalol — three (17%) patients. They tended to use the drugs occasionally when they needed them (self-diagnosed palpitations) as a “pill in the pocket” strategy. They took the medicine very quickly when they felt only short palpitations, which in fact were diagnosed in the seven-day Holter ECG and event recorder reports as extra systoles.

Six (18%) patients had documented episodes of AF (recurrence group — R group). Similarly, five (83%) patients were treated with beta-blockers, five (83%) patients with propafenone, and one (17%) patient with sotalol. None of the patients received amiodarone.

All of the patients continued anticoagulation therapy with acenocoumarol.

EHRA classification

CPVA improved the clinical status of the patients. Before CPVA, EHRA symptoms were present in 22 (67%) patients — class II, and in 11 (33%) patients — class III. One year after CPVA, the symptoms were as follows: 28 (82%) patients — class I; five (18%) patients — class II; zero (0%) patients — class III. The improvement in EHRA was observed in both the NR and R groups — data are presented in Table 1.

QoL before and after CPVA

Before ablation, all of the patients reported lower than expected results in all eight categories of the SF-36 scores (Fig. 1).

223309.jpg

Figure 1. Results of the SF-36 questionnaire in patients without a recurrence of atrial fibrillation (non-recurrence group) after circumferential pulmonary vein ablation (CPVA); p < 0.05; abbreviations as in Table 2

CPVA improved the results of the QoL assessments of all the subjects (Table 2).

Table 2. Comparison of the quality of life domains in the study population (baseline vs. one year after CPVA)

Mean

SD

Difference

SD difference

P

BP before

54.6

26.4

–17.4

21.8

0.0000

BP one year after

72.0

23.8

GH before

40.2

14.4

–16.9

21.2

0.0001

GH one year after

57.1

20.2

MH before

47.8

18.9

–13.3

22.4

0.0017

MH one year after

61.1

20.7

PF before

55.3

28.0

–20.2

21.7

0.0000

PF one year after

75.5

25.2

RE before

4.06

1.06

–1.03

1.13

0.0000

RE one year after

5.09

1.31

RP before

5.45

1.72

–1.27

1.66

0.0001

RP one year after

6.73

1.48

SF before

6.09

1.77

–1.21

1.96

0.0012

SF one year after

7.30

1.67

V before

12.42

3.56

–3.24

3.46

0.0000

V one year after

15.67

3.68

BP — bodily pain; CPVA — circumferential pulmonary vein ablation; GH — general health; MH — mental health; PF — physical functioning; RE — role-emotional; RP — role-physical; SD — standard deviation; SF — social functioning; V — vitality

After the follow-up the SF-36 questionnaire results improved significantly in all of the domains in the NR group (Table 3). The greatest improvements were noticed in the PF (34% improvement), RE (46% improvement), RP (79% improvement), and V (30% improvement) domains.

Table 3. The quality of life domains obtained baseline and one year after CPVA in the non-recurrence group

Mean

SD

Difference

SD difference

P

BP before

52.9

26.4

–19.3148

22.5658

0.0001

BP one year after

72.3

25.1

GH before

41.0

15.7

–18.9630

22.7384

0.0002

GH one year after

59.9

21.1

MH before

47.4

19.9

–15.5556

23.4116

0.0019

MH one year after

63.0

21.8

PF before

52.0

26.7

–22.5926

21.0937

0.0000

PF one year after

74.6

24.7

RE before

3.89

0.97

–1.2593

1.0595

0.0000

RE one year after

5.15

1.38

RP before

5.37

1.71

–1.4444

1.6013

0.0000

RP one year after

6.81

1.52

SF before

6.00

1.80

–1.4444

1.9282

0.0006

SF one year after

7.44

1.74

V before

12.18

3.77

–3.7037

3.3491

0.0000

V one year after

15.89

3.92

Abbreviations as in Table 2

In the R group none of the domains showed statistically significant differences. Figures 1 and 2 illustrate the changes in eight domains in the patients without and with AF recurrence, respectively.

223404.jpg

Figure 2. Results of the SF-36 questionnaire in patients who had a recurrence of atrial fibrillation after circumferential pulmonary vein ablation (CPVA); p < 0.05 for bodily pain (BP) and general health (GH); abbreviations as in Table 2

ANOVA analysis

The ANOVA analysis did not reveal a statistically significant association of the QoL domains and the group or the interaction of the group (NR group vs. R group) and intervention (before vs. one year after CPVA).

There was an association between the intervention and the following QoL domains: GH (p = 0.018), PF (p = 0.042), and V (p = 0.041). The highest values of GH and V domains were found in the NR group one year after CPVA (Table 4).

Table 4. ANOVA analysis

QoL domains

R group

NR group

P value

Before CPVA

One-year after CPVA

Before CPVA

One-year after CPVA

Source of variance

G

I

GxI

BP

62.0 ± 27.0

Median 68

70.8 ± 19.2

Median 74

52.9 ± 26.4

Median 45

63.3 ± 25.1

Median 74

0.6397

0.0876

0.5205

GH

36.5 ± 4.2

Median 36

44.3 ± 6.8

Median 43.5

41.0 ± 15.7

Median 35

59.9 ± 21.1

Median 57

0.0725

0.018

0.3146

MH

49.3 ± 15.3

Median 52

52.7 ± 13.0

Median 50

47.4 ± 19.9

Median 44

63.0 ± 21.8

Median 72

0.5135

0.1431

0.3409

PF

65.0 ± 41.7

Median 87.5

79.2 ± 29.6

Median 87.5

52.0 ± 26.7

Median 50

74.6 ± 24.7

Median 85

0.3257

0.042

0.3409

RE

4.83 ± 1.17

Median 5.0

4.83 ± 0.98

Median 5.0

3.89 ± 0.97

Median 4.0

5.15 ± 1.38

Median 6.0

0.4048

0.0984

0.0984

RP

5.83 ± 1.83

Median 5.5

6.33 ± 1.37

Median 6.0

5.37 ± 1.71

Median 4.0

6.81 ± 1.52

Median 8.0

0.9858

0.0646

0.3543

SF

6.50 ± 1.76

Median 7.0

6.67 ± 1.21

Median 6.5

6.00 ± 1.80

Median 6.0

7.44 ± 1.74

Median 8.0

0.8022

0.1495

0.2516

V

13.50 ± 2.34

Median 13.5

14.67 ± 2.34

Median 14.5

12.18 ± 3.77

Median 12.0

15.89 ± 3.92

Median 16.0

0.9684

0.041

0.2797

Data are expressed as the mean ± standard deviation and as median for abnormally distributed variables; NR — non-recurrence group; R — recurrence group; G — group, I — intervention (CPVA), GxI — interaction of the group and intervention; QoL — quality of life; other abbreviations as in Table 2

DISCUSSION

In the prospective study, we evaluated the QoL in patients with paroxysmal, nonvalvular AF, who were undergoing CPVA. After CPVA 82% of patients were free from recurrence of arrhythmia and reported an improvement of QoL. Patients after successful CPVA, especially, experienced a significant benefit in QoL. Unsuccessful CPVA also eliminated some symptoms of AF and improved the clinical status of the patients.

Previous studies have shown that the SF-36 questionnaire is an appropriate tool for a QoL assessment in patients with cardiac disorders [8, 10, 11]. It is well known that the prevalence of AF is more frequent in elderly patients, with the range of sensitivity of arrhythmia from asymptomatic to symptomatic, which is associated with underlying cardiac diseases. The population that was studied in this research was relatively young (54.2 ± 9 years) and had not experienced significant symptoms of other co-morbid health conditions that may have had an impact on the SF-36 questionnaire results. The effect of the therapy that was applied on health-related QoL in patients with AF has been investigated in several studies [7, 12, 13], and these data are consistent with our findings.

It should be noted that our study population, who had been diagnosed with AF before CPVA, was characterised by a poor level of QoL.

The results are consistent and describe a health-related improvement of the QoL in patients with highly symptomatic drug-resistant AF after CPVA [7, 12, 13]. Eighteen per cent of the patients had documented episodes of AF after CPVA (R group); however, their symptoms were limited. Thus, it has been suggested that the ablation procedure can modulate the feeling of arrhythmia without entirely curing it. Similarly, data reported by Berkowitsch et al. [12] about the QoL outcomes in patients with paroxysmal AF after ablation indicated that the improvement in patients with a recurrence of AF may be caused by a modification of the underlying arrhythmogenic process or cardiac denervation, or may originate from the placebo effect. Further studies suggest that the improvement in QoL seems to be caused by changing previously symptomatic events into asymptomatic ones [12, 13]; however, in our study we did not observe asymptomatic episodes of AF during Holter monitoring.

Limitations of the study

There are some limitations of our study. The paper represents a prospective, observational study and is subject to limitations of its design. The number of the patients who were examined was limited. Antiarrhythmic medication was used by some of the patients in both study groups one year after CPVA. Therefore, the results of our study should be interpreted with caution.

CONCLUSIONS

Circumferential pulmonary vein ablation results in a clinical improvement of patients with symptomatic AF regardless of the final arrhythmia termination. Patients after successful CPVA experienced a significant improvement in all of the domains of the QoL.

Conflict of interest: none declared

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Cite this article as: Woźniak-Skowerska IM, Skowerski MJ, Hoffmann A et al. Quality of life in patients with paroxysmal atrial fibrillation after circumferential pulmonary vein ablation. Kardiol Pol, 2016; 3: 244–250. doi: 10.5603/KP.a2015.0160.




Polish Heart Journal (Kardiologia Polska)