Key Points
Question Is
pulmonary vein isolation more effective than optimized antiarrhythmic
drug therapy for improving general health in patients with
symptomatic atrial fibrillation?
Findings In this
randomized clinical trial that included 155 patients with paroxysmal
or persistent symptomatic atrial fibrillation despite use of
antiarrhythmic medication, the improvement in quality of life at 12
months for those treated with catheter ablation compared with
antiarrhythmic medication was 11.9 vs 3.1 points on the 0- to
100-point 36-Item Short-Form Health Survey questionnaire, a
difference that was statistically and clinically significant.
Meaning In patients
with either paroxysmal or persistent symptomatic atrial fibrillation
despite medication, catheter ablation may help improve quality of
life.
Abstract
Importance Quality
of life is not a standard primary outcome in ablation trials, even
though symptoms drive the indication.
Objective To assess
quality of life with catheter ablation vs antiarrhythmic medication
at 12 months in patients with atrial fibrillation.
Design, Setting, and
Participants Randomized clinical trial at 4 university hospitals in
Sweden and 1 in Finland of 155 patients aged 30-70 years with more
than 6 months of atrial fibrillation and treatment failure with 1
antiarrhythmic drug or β-blocker, with 4-year follow-up. Study dates
were July 2008–September 2017. Major exclusions were ejection
fraction less than 35%, left atrial diameter greater than 60 mm,
ventricular pacing dependency, and previous ablation.
Interventions
Pulmonary vein isolation ablation (n = 79) or previously untested
antiarrhythmic drugs (n = 76).
Main Outcomes and
Measures Primary outcome was the General Health subscale score
(Medical Outcomes Study 36-Item Short-Form Health Survey) at baseline
and 12 months, assessed unblinded (range, 0 [worst] to 100 [best]).
There were 26 secondary outcomes, including atrial fibrillation
burden (% of time) from baseline to 12 months, measured by
implantable cardiac monitors. The first 3 months were excluded from
rhythm analysis.
Results Among 155
randomized patients (mean age, 56.1 years; 22.6% women), 97%
completed the trial. Of 79 patients randomized to receive ablation,
75 underwent ablation, including 2 who crossed over to medication and
14 who underwent repeated ablation procedures. Of 76 patients
randomized to receive antiarrhythmic medication, 74 received it,
including 8 who crossed over to ablation and 43 for whom the first
drug used failed. General Health score increased from 61.8 to 73.9
points in the ablation group vs 62.7 to 65.4 points in the medication
group (between-group difference, 8.9 points; 95% CI, 3.1-14.7;
P = .003). Of 26 secondary end points, 5 were analyzed; 2 were
null and 2 were statistically significant, including decrease in
atrial fibrillation burden (from 24.9% to 5.5% in the ablation group
vs 23.3% to 11.5% in the medication group; difference –6.8% [95%
CI, –12.9% to –0.7%]; P = .03). Of the Health Survey
subscales, 5 of 7 improved significantly. Most common adverse events
were urosepsis (5.1%) in the ablation group and atrial tachycardia
(3.9%) in the medication group.
Conclusions and
Relevance Among patients with symptomatic atrial fibrillation
despite use of antiarrhythmic medication, the improvement in quality
of life at 12 months was greater for those treated with catheter
ablation compared with antiarrhythmic medication. Although the study
was limited by absence of blinding, catheter ablation may offer an
advantage for quality of life.