(Circulation. 2000;101:2607.)
© 2000 American Heart Association, Inc.
Clinical Investigation and Reports |
From the Department of Cardiology (S.L., P.B., C.B.-L.) and the Department of Thoracic Surgery (L.N., S.O., L.J.), Uppsala University Hospital, Uppsala, Sweden.
Correspondence to Stefan Lönnerholm, Department of Cardiology, Uppsala University Hospital, 751 85 Uppsala, Sweden.
| Abstract |
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Methods and ResultsMaze operations were performed in 48 patients with drug-refractory AF. The majority of patients (80%) had lone AF, and the primary indication for surgery in all patients was AF. The SF-36 Health Survey was used to assess quality of life before operation and at 6 months and 1 year after surgery. Twenty-five patients were available for the 1-year follow-up and completed all questionnaires. Before maze surgery, the SF-36 scores were significantly lower than in the general Swedish population, reflecting significant impairment in well-being, physical and social functioning, and mental health. After maze surgery, the quality of life was significantly improved at 6 months and at 1 year on all scales except for bodily pain, which, however, was not significantly decreased before surgery. At both 6 months and 1 year after maze surgery, quality of life, measured by the SF-36, reached the levels of the general Swedish population.
ConclusionsThe maze operation can significantly improve the health-related quality of life in selected groups of patients with both paroxysmal and chronic AF refractory to antiarrhythmic therapy.
Key Words: maze operation fibrillation quality of life
| Introduction |
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| Methods |
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Concomitant diseases were hypertension (n=6), ischemic heart disease (n=4), stroke (n=4), valvular disease (n=2), hypertrophic cardiomyopathy (n=2), congestive heart failure (CHF, n=1), and sinus bradycardia requiring a permanent pacemaker (n=1). After extensive evaluation, it was concluded that 39 patients had lone AF.
All patients had failed to respond to extensive antiarrhythmic medical therapy. They had tried a mean of 5±1.4 (SD) antiarrhythmic drugs, which had failed to control the arrhythmia or had had to be withdrawn because of intolerable side effects. This included treatment with amiodarone in 30 patients (61%).
Patients with significantly increased risk of surgical complications, such as severely depressed left ventricular ejection fraction and chronic obstructive lung disease, were not referred for surgery.
One patient did not complete the quality-of-life questionnaire at baseline, so the baseline measurements are based on the remaining 48 patients.
Definitions
Paroxysmal AF was defined as an episode of AF that spontaneously
converted to sinus rhythm within 48 hours. Persistent AF was defined as
AF that did not revert to sinus rhythm within 48 hours and generally
needed DC energy for conversion to sinus rhythm. Permanent or chronic
AF was defined as AF that could not be converted to sinus
rhythm.
Surgical Procedure
All patients underwent the standard maze III operation described
by Cox et al.7 Seven patients underwent concomitant
surgical procedures in addition to the maze procedure: coronary
artery bypass graft (n=3), patch closure for the secundum atrial septal
defect (n=1), septal myectomy (n=1), and tricuspid valvuloplasty (n=1).
Except for the hypertrophic cardiomyopathy, all
these cardiac diseases were unknown before the preoperative
investigation. The cardiopulmonary bypass time averaged 177
minutes (range, 98 to 280 minutes), and the aortic cross-clamping time
averaged 70 minutes (range, 39 to 134 minutes).
Quality-of-Life Measurements
Quality of life was assessed with a self-administered
questionnaire handed out by a research nurse before the maze operation
and 6 months and 1 year after surgery. The Swedish SF-36 Health Survey
was used.9 This questionnaire was produced within the
framework of the International Quality of Life Assessment (IQOLA)
project to match the original US Medical Outcomes Study Short-Form
Health (SF-36) Survey Manual and Interpretation Guide.10
The SF-36 Health Survey is a generic instrument that is
validated,11 covers a broad range of quality-of-life
dimensions, and has been widely used in quality-of-life studies.
Furthermore, normative data for the Swedish population have been
published.12 The health questionnaire measures 8
variables: physical functioning, role limitations owing to physical
problems, role limitations owing to emotional problems, social
functioning, mental health, general health perceptions, vitality, and
bodily pain. Scores were transformed into a scale ranging from 0
to 100, with a higher score representing better quality of
life. Missing data (0.7% at baseline, 0.4% at 6 months, 0.0% at 1
year) were handled as suggested by the developers of the SF-36. They
suggest that
50% of all questions related to a specific item must be
answered to calculate a scale score for that item. If questions are
left out but >50% of the item-specific questions are answered, the
total of the scores from the answered questions are divided by the
number of answered questions. Considering the small amount of missing
data in this study, we are convinced that it does not influence the
result.
Follow-Up
At this time, 37 patients have reached the 6-month follow-up.
Three of these patients, however, were lost to follow-up with regard to
quality of life because they are not Swedish citizens. Another 4
patients failed to return
1 of the questionnaires and were excluded
from this study. After the initial 6 months, no additional patients
were lost to follow-up.
Follow-up at 6 months with regard to quality of life is therefore based on the remaining 30 patients (81%). For 25 of these 30 patients, 1-year data are also available.
Statistical Analysis
Students paired and unpaired t tests (2-tailed)
were used for comparison between the groups. Differences were
considered significant at P<0.05. Unless otherwise
specified, results are expressed as mean±1 SD.
| Results |
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Quality of Life
Quality of life before surgery was markedly and significantly
lower on all scales, except for bodily pain, than for the age-matched
general Swedish population (see Figure 1
). The lowest scores were obtained for
role limitation owing to physical problems (24.5±36.7) and vitality
(42.6±20.2). Patients with permanent AF tended to have lower scores on
the physical axis than the group of patients with paroxysmal or
persistent AF, reaching statistical significance for physical
functioning (Table 1
).
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The SF-36 scores obtained at 6 months after MAZE surgery were compared
with the preoperative scores for the same population (Table 2
). All scores improved significantly
except for bodily pain. Bodily pain, however, was the only score that
did not differ from the values for the age-matched general Swedish
population before maze surgery. The most marked improvements from
before to 6 months after the operation were observed for role
limitation owing to physical problems (17.2 versus 69.0), vitality
(41.0 versus 74.2), and role limitation owing to emotional problems
(36.8 versus 88.9).
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The improvements in quality of life were maintained 1 year after the
maze operation, with no significant changes between 6 months and 1 year
after the maze operation (Table 2
). The quality-of-life
measurements obtained at 1 year after surgery reached normal values and
did not differ significantly from the values for the age-matched
general Swedish population (Figure 2
).
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| Discussion |
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The present study was therefore designed to measure what effect an extensive but curative treatment like the maze operation has on quality of life. The use of the SF-36 questionnaire permitted a comparison to be made with published information from the general Swedish population regarding quality of life. In the present study, improvements in quality of life after surgery were remarkable. All scores were significantly improved except for bodily pain, which, however, was already normal before surgery. The quality-of-life measurements 6 months and 1 year after the maze operation reached the levels for the aged-matched general Swedish population.
Our study of the maze operation is difficult to compare with studies of other therapies for drug-refractory AF, such as His-bundle ablation, because different quality-of-life instruments have been used and comparison with the general population has rarely been made. Bubien et al15 published a study of 159 patients evaluating quality of life with the SF-36 instrument at baseline and after catheter ablation for various supraventricular arrhythmias. That study included 22 patients with AF treated with His-bundle ablation. The patients improved on all dimensions of quality of life after His-bundle ablation, but reported values were far from those of the general population and much lower than in our patients.15 However, the results are not directly comparable, because a part of this difference is probably due to higher comorbidity in the population studied by Bubien et al. A good comparison with other nonpharmacological therapies is not possible, because few authors have used the same quality-of-life instrument. Studies published so far have all used quality-of-life measurements to show improvements in quality of life achieved for a particular therapy rather than as a way of comparing different treatment modalities. We chose the SF-36 instrument because it is well validated, scores for the general population have been published, and an increasing number of researchers are using this instrument.
Randomized, prospective studies comparing various nonpharmacological therapies for AF with regard to mortality, morbidity, freedom from AF, and quality of life are needed in the future.
The quality of life in our study population at baseline was markedly lower than in the general population. Poor quality of life was found not only on scores relating to physical functioning but also on such items as social functioning and mental health. Our patients reported a poorer quality of life than patients in the Medical Outcome Study,16 which included patients with serious cardiac conditions, such as CHF, reporting edema, orthopnea, or dyspnea on exertion; hypertensive patients with severe CHF symptoms and/or a history of stroke; survivors of myocardial infarction with severe angina and/or severe symptoms of CHF; and diabetic patients with secondary manifestations of the disease.
The quality of life in a nonselected patient population with AF has not been evaluated. Three studies have evaluated the impact of AF on quality of life using validated instruments, but the patient populations were small and highly selected.14 17 18 Only the study by Bubien et al evaluated quality of life with the SF-36 health survey.15 In that study, the 22 patients with AF had very poor quality of life at baseline, and overall, they reported lower values at baseline than the patients in our study. Possible explanations include the higher average age and the higher comorbidity already mentioned. Two large, ongoing trials will evaluate quality of life in patients with AF by use of validated and standardized instruments.19 20
There are several limitations of the present study that must be recognized. First, this is a selected group of patients with symptomatic, drug-refractory AF willing to undergo a new therapy for AF with the potential for significant complications. This patient selection probably accounts for the low quality of life measured at baseline.
Second, there is no placebo group in this study. A significant placebo effect of the surgical intervention is unlikely, because the quality of life at 1 year was essentially the same as that at 6 months.
Conclusions
Patients with drug-refractory AF who are treated with the
maze operation report significant improvement in physical, mental, and
social indexes of their quality of life after the procedure. The
quality of life measured 6 months after the maze operation does not
differ significantly from that of the age-matched general Swedish
population. These improvements measured at 6 months after surgery are
maintained at 1-year follow-up. This study indicates that the maze
operation can be used in selected patients with drug-refractory
paroxysmal or permanent AF as a primary indication for heart surgery.
However, further studies are needed to provide the best choice of
nonpharmacological therapy in the individual patient.
| Acknowledgments |
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Received August 26, 1999; revision received December 15, 1999; accepted December 24, 1999.
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