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. 2020 Dec 1;3(12):e2025473.
doi: 10.1001/jamanetworkopen.2020.25473.

Association Between Quality of Life and Procedural Outcome After Catheter Ablation for Atrial Fibrillation: A Secondary Analysis of a Randomized Clinical Trial

Maria Terricabras  1 , Roberto Mantovan  2 , Chen-Yang Jiang  3 , Timothy R Betts  4 , Jian Chen  5 , Isabel Deisenhofer  6 , Laurent Macle  7 , Carlos A Morillo  8 , Wilhelm Haverkamp  9 , Rukshen Weerasooriya  10 , Jean-Paul Albenque  11 , Stefano Nardi  12 , Endrj Menardi  13 , Paul Novak  14 , Prashanthan Sanders  15 , Atul Verma  1 ; Substrate and Trigger Ablation for Reduction of Atrial Fibrillation Trial–Part II (STAR AF II) Investigators
Affiliations

Association Between Quality of Life and Procedural Outcome After Catheter Ablation for Atrial Fibrillation: A Secondary Analysis of a Randomized Clinical Trial

Maria Terricabras et al. JAMA Netw Open. .

Abstract

Importance: Catheter ablation is effective in reducing atrial fibrillation (AF), but the association of ablation for AF with quality of life is unclear.

Objective: To evaluate whether the procedural outcome of ablation for AF is associated with quality of life (QOL) measures.

Design, setting, and participants: This was a prespecified secondary analysis of the Substrate and Trigger Ablation for Reduction of Atrial Fibrillation-Part II (STAR AF II) prospective randomized clinical trial, which compared 3 strategies for ablation of persistent AF. This analysis included 549 of the 589 patients enrolled in the trial who underwent ablation. Enrollment occurred at 35 centers in Europe, Canada, Australia, China, and Korea from November 2010 to July 2012. Data for the current study were analyzed on December 11, 2019.

Interventions: Patients underwent AF ablation with 1 of 3 ablation strategies: (1) pulmonary vein isolation (PVI), (2) PVI plus complex fractionated electrograms, or (3) PVI plus linear lesions.

Main outcomes and measures: Quality of life was assessed at baseline and at 6, 12, and 18 months after ablation for AF using the 36-Item Short Form Health Survey and the EuroQol Health-Related Quality of Life 5-Dimension 3-Level questionnaire. Scores were also converted to a physical health component score (PCS) and a mental health component score (MCS). Individual AF burden was calculated by the total time with AF from Holter monitors and the percentage of transtelephonic monitor recordings showing AF.

Results: Among the 549 patients included in this secondary analysis, QOL was assessed in 466 (85%) at baseline and at 6, 12, and 18 months after ablation for AF. The mean (SD) age of the study population was 60 (9) years; 434 (79%) individuals were men, and 417 (76%) had continuous AF for 6 months or more before ablation. The AF burden significantly decreased from a mean (SD) of 82% (36%) before ablation to 6.6% (23%) after ablation (P < .001). Significant improvements in mean (SD) PCS (68.3 [20.7] to 82.5 [18.6]) and MCS (35.3 [8.6] to 37.5 [7.6]) occurred 18 months after ablation (P < .05 for both). Significant QOL improvement occurred in all 3 study arms and regardless of AF recurrence, defined as AF episodes lasting more than 30 seconds: for no recurrence, mean (SD) PCS increased from 66.5 (20.9) to 79.1 (19.4) and MCS from 35.3 (8.7) to 37.7 (7.7); for recurrence, mean (SD) PCS increased from 70.2 (20.4) to 86.4 (16.8) and MCS from 35.3 (8.6) to 37.1 (7.4) (P < .05 for all). When outcome was defined by AF burden reduction, in patients with less than 70% reduction in AF burden, the increase in PCS was significantly less than in those with greater than 70% reduction, and only 3 of 8 subscales showed significant improvement.

Conclusions and relevance: In this secondary analysis, decreases in AF burden after ablation for AF were significantly associated with improvements in QOL. Quality of life changes were significantly associated with the percentage of AF burden reduction after ablation.

Trial registration: ClinicalTrials.gov Identifier: NCT01203748.

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Conflict of interest statement

Conflict of Interest Disclosures: Dr Betts reported receiving grants from St Jude Medical outside the submitted work. Dr Chen reported receiving grants from Medtronic and personal fees from Johnson & Johnson and Abbott outside the submitted work. Dr Macle reported receiving grants from Abbott and Biosense Webster and personal fees from Biosense Webster and BMS-Pfizer outside the submitted work. Dr Morillo reported serving on the advisory boards of Abbott, Medtronic, Servier, and Bayer; serving as a speaker for Medtronic and Servier; receiving personal fees from Abbott, Medtronic, Servier, and Bayer; and receiving grants from Novartis outside the submitted work. Dr Albenque reported receiving grants and consulting fees from Abbott and grants from Biosense Webster outside the submitted work. Dr Sanders is supported by a practitioner fellowship from the National Health and Medical Research Council of Australia and the National Heart Foundation of Australia and reported receiving a clinical trials contract from Abbott Medical; receiving grants from Microport, Medtronic, Boston Scientific, and Abbott Medical; and serving on the advisory boards of Medtronic, Abbott Medical, CathRx, Boston Scientific, and PaceMate outside the submitted work. Dr Verma reported receiving grants from Medtronic, Biosense Webster, Bayer, and Biotronik and personal fees from Servier outside the submitted work. No other disclosures were reported.

Figures

Figure 1.
Figure 1.. Distribution of Atrial Fibrillation (AF) Burden After Ablation at 18-Month Follow-up
Less than 2% of the patients had more than 50% AF burden after ablation.
Figure 2.
Figure 2.. Change in Quality of Life by Recurrence of Arrhythmia Lasting More Than 30 Seconds
There was no significant difference in the magnitude of change for the physical component summary (PCS) score between patients with no documented recurrence and patients with documented recurrence (A) or for the mental component summary (MCS) score between patients with no documented recurrence and patients with documented recurrence (B). Whiskers indicate standard errors.
Figure 3.
Figure 3.. Improvement in 36-Item Short Form Health Survey (SF-36) Score Based on 60% to 90% Cutoff Value
Patients with an atrial fibrillation (AF) burden reduction above the thresholds experienced a significant improvement in all of the SF-36 subscales. Patients with reduction in AF burden below the 90% threshold still experienced an improvement in quality of life (QOL) in all 8 of the subscales. Patients with reduction in AF burden below the 80% threshold had a significant improvement in only 4 of 8 subscales. Patients with a reduction in AF burden below the 70% threshold had a significant improvement in only 3 of 8 subscales, and those with reduction in AF burden below the 60% threshold had a significant improvement in only 2 of 8 subscales.
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