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November 18, 2024JAMAOpen Access

Pulmonary Vein Isolation With Optimized Linear Ablation vs Pulmonary Vein Isolation Alone for Persistent AF

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Why the study?

PVI has modest success in persistent AF, and additional linear ablation has not proved superior to PVI alone. It was unknown whether combining linear ablation with ethanol infusion of the vein of Marshall improves sinus rhythm maintenance over PVI alone.

Does linear ablation combined with ethanol infusion of the vein of Marshall (EIVOM) added to pulmonary vein isolation (PVI) improve freedom from atrial arrhythmias compared to PVI alone in patients with persistent atrial fibrillation?

Population

498 patients aged 18 to 80 years with persistent AF undergoing first-time AF ablation

Comparison

PVI plus EIVOM and linear ablation vs PVI alone

Design

Multicenter open-label randomized trial

Follow-up

12 months

Key result

PVI plus EIVOM and linear ablation significantly improved freedom from atrial arrhythmias at 12 months compared with PVI alone (70.7% vs 61.5%; HR 0.73; 95% CI 0.54-0.99; P=0.045).

Authors

CSCaihua SangQLQiang LiuYLYiwei Lai

Discussion

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Overview

Supports adjunctive EIVOM plus linear ablation with PVI in persistent AF; extends RCT evidence for strategies beyond isolation alone.

Key Points

  • To evaluate whether adding ethanol infusion of the vein of Marshall and linear radiofrequency ablation to pulmonary vein isolation improves sinus rhythm maintenance in patients with persistent atrial fibrillation.
  • Multicenter, open-label randomized trial (PROMPT-AF; NCT04497376) conducted across 12 tertiary hospitals in China.
  • Enrolled 498 patients (aged 18-80 years) with atrial fibrillation persisting for >3 months undergoing first-time catheter ablation, randomized to pulmonary vein isolation (PVI) alone or PVI plus ethanol infusion of the vein of Marshall (EIVOM) and linear ablation.
  • Patients were monitored over a 12-month follow-up using weekly 24-hour single-lead ECG patches, symptom-triggered ECGs, and Holter monitoring.
  • Freedom from documented atrial arrhythmias without antiarrhythmic drugs at 12 months was 70.7% (174/246) in the PVI plus EIVOM and linear ablation group vs 61.5% (153/249) in the PVI-alone group (hazard ratio, 0.73; 95% CI, 0.54-0.99; P = .045).
  • The treatment effect was consistent across all prespecified subgroups, whereas comparisons of secondary outcomes revealed no statistically significant differences between groups.

Study Design

Type

RCT (n=498)

Blinding

open-label

Randomization

randomized

Multicenter

Yes

Structured PICO

Does linear ablation combined with ethanol infusion of the vein of Marshall (EIVOM) added to pulmonary vein isolation (PVI) improve freedom from atrial arrhythmias compared to PVI alone in patients with persistent atrial fibrillation?

P
Population
498 patients aged 18 to 80 years with persistent AF for >3 months undergoing first-time ablation, followed for 12 months.
I
Intervention
Pulmonary vein isolation (PVI) plus ethanol infusion of the vein of Marshall (EIVOM) and linear ablation of the left atrial roof, mitral isthmus, and cavotricuspid isthmus.
C
Comparator
Pulmonary vein isolation (PVI) alone.
O
Outcome
Freedom from any documented atrial arrhythmias lasting more than 30 seconds, without the use of antiarrhythmic drugs within 12 months.

Main Result

Hazard Ratio: 0.73 (95% CI 0.54–0.99)

Absolute Event Rate: 70.7% vs 61.5%

p-value: p=.045

In patients with persistent atrial fibrillation, adding ethanol infusion of the vein of Marshall and linear ablation to pulmonary vein isolation significantly improved 12-month freedom from atrial arrhythmias compared to pulmonary vein isolation alone.

Cite This Study

Sang et al. (2024) conducted an RCT in persistent atrial fibrillation (n=498). PVI plus EIVOM and linear ablation vs. PVI alone was evaluated on freedom from any documented atrial arrhythmias lasting more than 30 seconds, without the use of antiarrhythmic drugs within 12 months (HR 0.73, 95% CI 0.54-0.99, p=.045). PVI plus EIVOM and linear ablation significantly improved freedom from atrial arrhythmias at 12 months compared with PVI alone (70.7% vs 61.5%; HR 0.73; 95% CI 0.54-0.99; P=0.045).

synapsesocial.com/papers/6a7da35614e877b18fa140b5https://doi.org/10.1001/jama.2024.24438
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Anatomy versus physiology-guided ablation for persistent atrial fibrillation2020 · 2 citations
  2. 2Pulmonary vein isolation alone vs. more extensive ablation with defragmentation and linear ablation of persistent atrial fibrillation: the EARNEST-PVI trial2020 · 84 citations
  3. 3Long‐Term Impact of Additional Ablation After Pulmonary Vein Isolation: Results From EARNEST‐PVI Trial2023 · 28 citations
  4. 4Prospective randomized comparison between upgraded ‘2C3L’ vs. PVI approach for catheter ablation of persistent atrial fibrillation: PROMPT-AF trial design2023 · 15 citations
  5. 5Efficacy and Safety Ablation Index-Guided High-Energy Linear Ablation for Persistent Atrial Fibrillation: PVI Plus Linear Ablation of Mitral Isthmus and Posterior Box Isolation2023 · 3 citations