What is the clinical evidence from this study?

Study design: RCT. Population: Paroxysmal atrial fibrillation (n=188). Intervention: Pulmonary vein ablation catheter (PVAC) vs. Wide-area circumferential ablation (WACA). Primary outcome: Freedom from symptomatic or documented >30 s AF off medications for 7 days at 12 months post-procedure (p=ns).

What does this research mean for the field?

Duty-cycled radiofrequency ablation via the circular pulmonary vein ablation catheter (PVAC) is equivalent in efficacy to conventional wide-area circumferential ablation (WACA) for freedom from atrial fibrillation at 12 months, and significantly reduces procedure and fluoroscopy times. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

May 19, 2014EP EuropaceOpen Access

Safety and efficacy of multipolar pulmonary vein ablation catheter vs. irrigated radiofrequency ablation for paroxysmal atrial fibrillation: a randomized multicentre trial

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Key result

PVAC matches WACA for 12-month freedom from AF in randomized comparison.

P ns
n=188

Why the study?

Does duty-cycled radiofrequency ablation via PVAC improve freedom from atrial fibrillation compared to conventional WACA in patients with paroxysmal atrial fibrillation?

Study Design

Type

RCT (n=188)

Blinding

Single-blind

Randomization

Permuted blocks

Multicenter

Yes

Structured PICO

Does duty-cycled radiofrequency ablation via PVAC improve freedom from atrial fibrillation compared to conventional WACA in patients with paroxysmal atrial fibrillation?

Population

188 patients (mean age 62, 38% female) with paroxysmal atrial fibrillation refractory to at least one anti-arrhythmic drug, followed for 12 months.

Intervention

Duty-cycled radiofrequency ablation via the circular pulmonary vein ablation catheter (PVAC) using a 9F deflectable circular multielectrode catheter.

Comparator

Conventional electro-anatomically guided wide-area circumferential ablation (WACA) using a 4 mm open-tip irrigated catheter.

Outcome

Freedom from symptomatic or documented >30 s atrial fibrillation off medications for 7 days at 12 months post-procedure.

Main Result

Absolute Event Rate: 60% vs 56%

p-value: p=ns

PVAC ablation offers equivalent 12-month efficacy to conventional WACA for paroxysmal atrial fibrillation with significantly shorter procedure times, though it carries a potential risk of thromboembolic complications.

Limitations

It was not possible to blind the operators.
There was no prospective strategy to image the pulmonary veins for stenosis post-procedure due to cost limitations.
The study was underpowered to fully examine the causes of neurological events.
No prospective strategy to image the pulmonary veins for stenosis post-procedure due to cost limitations

Implication

PVAC matches WACA efficacy with shorter times; confirms noninferiority and supports its use as alternative in paroxysmal AF.

Abstract

AIMS: The current challenge in atrial fibrillation (AF) treatment is to develop effective, efficient, and safe ablation strategies. This randomized controlled trial assesses the medium-term efficacy of duty-cycled radiofrequency ablation via the circular pulmonary vein ablation catheter (PVAC) vs. conventional electro-anatomically guided wide-area circumferential ablation (WACA). METHODS AND RESULTS: One hundred and eighty-eight patients (mean age 62 ± 12 years, 116 M : 72 F) with paroxysmal AF were prospectively randomized to PVAC or WACA strategies and sequentially followed for 12 months. The primary endpoint was freedom from symptomatic or documented >30 s AF off medications for 7 days at 12 months post-procedure. One hundred and eighty-three patients completed 12 m follow-up. Ninety-four patients underwent PVAC PV isolation with 372 of 376 pulmonary veins (PVs) successfully isolated and all PVs isolated in 92 WACA patients. Three WACA and no PVAC patients developed tamponade. Fifty-six percent of WACA and 60% of PVAC patients were free of AF at 12 months post-procedure (P = ns) with a significant attrition rate from 77 to 78%, respectively, at 6 months. The mean procedure (140 ± 43 vs. 167 ± 42 min, P<0.0001), fluoroscopy (35 ± 16 vs. 42 ± 20 min, P<0.05) times were significantly shorter for PVAC than for WACA. Two patients developed strokes within 72 h of the procedure in the PVAC group, one possibly related directly to PVAC ablation in a high-risk patient and none in the WACA group (P = ns). Two of the 47 patients in the PVAC group who underwent repeat ablation had sub-clinical mild PV stenoses of 25-50% and 1 WACA patient developed delayed severe PV stenosis requiring venoplasty. CONCLUSION: The pulmonary vein ablation catheter is equivalent in efficacy to WACA with reduced procedural and fluoroscopy times. However, there is a risk of thrombo-embolic and pulmonary stenosis complications which needs to be addressed and prospectively monitored. CLINICALTRIALSGOV IDENTIFIER: NCT00678340.

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Cite This Study

McCready et al. (2014) conducted an RCT in Paroxysmal atrial fibrillation (n=188). Pulmonary vein ablation catheter (PVAC) vs. Wide-area circumferential ablation (WACA) was evaluated on Freedom from symptomatic or documented >30 s AF off medications for 7 days at 12 months post-procedure (p=ns). The pulmonary vein ablation catheter (PVAC) demonstrated equivalent efficacy to wide-area circumferential ablation (WACA), with 60% vs 56% of patients free of atrial fibrillation at 12 months (P=ns).

synapsesocial.com/papers/6a1c300cfc87fd06169d1cf3 https://doi.org/10.1093/europace/euu064