Quality of life (QOL) was a prespecified secondary outcome in the Substrate and Trigger
Ablation for Reduction of atrial fibrillation–Part II (STAR AF II) trial, and Terricabras
et al (JAMA Netw Open 2020;3:e2025473, PMID 33275151) sought to determine whether
QOL measures were affected by procedural outcome. STAR AF II was a randomized controlled
trial assessing 3 atrial fibrillation (AF) ablation strategies in patients with persistent
AF. Patients were followed for 18 months after ablation and the primary outcome was
freedom from AF lasting >30 seconds after a single procedure. There was no difference
in the primary outcome between the 3 groups. Patients were provided with 2 QOL surveys
at baseline and at 6, 12, and 18 months after ablation. The 2 surveys used were the
36-Item Short Form Health Survey (SF-36) and EuroQol Health-Related Quality of Life
5-Dimension 3-Level (EQ-5D-3L) questionnaires. The SF-36 questionnaire assesses both
physical and mental aspects of health in 8 categories and is scored from 0 to 100,
with a higher score indicating better QOL and a 5-point difference validated as being
clinically significant. All patients also underwent extensive monitoring after ablation,
including Holter monitor at 3, 6, 9, 12, and 18 months and transmitted transtelephonic
monitor recordings weekly and with any symptoms of AF. These monitor results were
used to calculate AF burden after the procedure. Preprocedure burden during the 6
months before ablation was calculated on the basis of the patient’s report. Importantly,
76% of patients were persistently in AF during that time for a burden of 100%. Of
the 549 patients studied in the STAR AF II trial, 85% completed all surveys and were
included in this secondary analysis. The mean AF burden preprocedure was 82%. Postprocedure,
the mean AF burden was 6.6%, which is a 92% reduction in AF burden. While 45% had
no AF (0% burden), only 4% had AF burden >20%, with <2% with >50% burden. The scores
of both the SF-36 and the EQ-5D-3L showed significant improvement from baseline to
18 months after ablation in patients in all 3 arms, despite the lack of difference
in the primary outcome of AF episodes >30 seconds between arms. There was no difference
in QOL scores between patients who had any AF postablation and those who did not.
However, there was a graduated response based on AF burden reduction. Those with larger
burden reduction had ≥5-point change in more of the SF-36 subscales, such that those
with 60% AF reduction had 2 of 8 subscales with a ≥5-point change but those with >90%
reduction had a ≥5-point change in 6 of 8 subscales representing a superior improvement
in QOL scores. The authors conclude that ablation of AF resulted in improved QOL regardless of whether
>30 seconds of AF was detected postablation and that greater improvement was seen
in those with larger reduction in AF burden.
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Published online: January 08, 2021
Funding sources: The author has no funding sources to disclose.
Disclosures: The author has no conflicts of interest to disclose.
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