What is the clinical evidence from this study?

Study design: Other. Population: Paroxysmal Atrial Fibrillation (PAF) (n=329). Intervention: CLOSE-guided ablation vs. null. Primary outcome: Quality of Life (QOL) improvement measured by AFEQT score (null, 95% CI null, p=<0.001).

What does this research mean for the field?

CLOSE-guided ablation significantly improves quality of life, as indicated by an increase in AFEQT score from 61.3 to 87.2, and reduces healthcare utilisation by decreasing cardiovascular hospitalisations by 42% at 12 months post-procedure. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

May 5, 2021Open Access

Quality of life and healthcare utilisation improvements after atrial fibrillation ablation

Q: What are the key findings of this study?

CLOSE-guided ablation significantly improved the AFEQT score from 61.3 to 87.2, indicating a mean improvement of 25.7 points (p<0.001) at 12 months post-procedure.

Q: What does this research mean for the field?

CLOSE-guided ablation significantly improves quality of life, as indicated by an increase in AFEQT score from 61.3 to 87.2, and reduces healthcare utilisation by decreasing cardiovascular hospitalisations by 42% at 12 months post-procedure. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

Key Result

CLOSE-guided ablation significantly improved the AFEQT score from 61.3 to 87.2, indicating a mean improvement of 25.7 points (p<0.001) at 12 months post-procedure.

Structured PICO

Does CLOSE-guided pulmonary vein isolation improve quality of life and reduce healthcare utilisation in patients with drug-refractory paroxysmal atrial fibrillation?

Population

329 consecutive patients with drug-refractory paroxysmal atrial fibrillation (PAF), mean age 61.4 years, 60.8% male, multinational (17 centres across 9 European countries).

Intervention

Pulmonary vein isolation (PVI) guided by a standardised CLOSE (contiguous optimised lesions) protocol using contact force-guided radiofrequency ablation.

Outcome

Change in Quality of Life (QOL) measured by Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) and EuroQoL EQ-5D-5L questionnaires at 12 months post-ablation.patient reported

Standardized CLOSE-protocol pulmonary vein isolation significantly improves quality of life and reduces cardiovascular hospitalizations and cardioversions at 1 year in patients with drug-refractory paroxysmal atrial fibrillation.

Main Result

Effect estimate: null (95% CI null)

Absolute Event Rate: 87.2% vs 61.3%

p-value: p=<0.001

Limitations

Single-arm study design limits causal inferences.
Absence of continuous rhythm monitoring via implantable devices.

Abstract

Objective Pulmonary vein isolation (PVI) guided by a standardised CLOSE (contiguous optimised lesions) protocol has been shown to increase clinical success after catheter ablation for paroxysmal atrial fibrillation (PAF). This study analysed healthcare utilisation and quality of life (QOL) outcomes from a large multicentre prospective study, measured association between QOL and atrial fibrillation (AF) burden and identified factors associated with lack of QOL improvement. Methods CLOSE-guided ablation was performed in 329 consecutive patients (age 61.4 years, 60.8% male) with drug-refractory PAF in 17 European centres. QOL was measured at baseline and 12 months post-ablation via Atrial Fibrillation Effect on QualiTy of Life Survey (AFEQT) and EuroQoL EQ-5D-5L questionnaires. All-cause and cardiovascular hospitalisations and cardioversions over 12 months pre-ablation and post-ablation were recorded. Rhythm monitoring included weekly and symptom-driven trans-telephonic monitoring, plus ECG and Holter monitoring at 3, 6 and 12 months. AF burden was defined as the percentage of postblanking tracings with an atrial tachyarrhythmia ≥30 s. Continuous measures across multiple time points were analysed using paired t-tests, and associations between various continuous measures were analysed using independent sample t-tests. Each statistical test used two-sided p values with a significance level of 0.05. Results Both QOL instruments showed significant 12-month improvements across all domains: AFEQT score increased 25.1–37.5 points and 33.3%–50.8% fewer patients reporting any problem across EuroQoL EQ-5D-5L domains. Overall, AFEQT improvement was highly associated with AF burden (p=0.009 for <10% vs ≥10% burden, p<0.001 for <20% vs ≥20% burden). Cardiovascular hospitalisations were significantly decreased after ablation (42%, p=0.001). Patients without substantial improvement in AFEQT (55/301, 18.2%) had higher AFEQT and CHA 2 DS 2 -VASc scores at baseline, and higher AF burden following PVI. Conclusions QOL improved and healthcare utilisation decreased significantly after ablation with a standardised CLOSE protocol. QOL improvement was significantly associated with impairment at baseline and AF burden after ablation. Trial registration number NCT03062046 .

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