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April 8, 2013Journal of Cardiovascular Electrophysiology104 citations

Improved In Vivo Performance of Second‐Generation Cryoballoon for Pulmonary Vein Isolation

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NCNicolas CoulombeJPJaime PaulinWSWilber Su

Key Result

The Arctic Front Advance cryoballoon achieved 100% (10/10) full pulmonary vein isolation compared to 60% (6/10) with the first-generation Arctic Front balloon in a canine model.

Structured PICO

Does the second-generation Arctic Front Advance cryoballoon improve pulmonary vein isolation compared to the first-generation Arctic Front balloon in a canine model?

P
Population
10 healthy dogs (20 pulmonary veins) undergoing ablation with 30-day follow-up to assess pulmonary vein isolation.
I
Intervention
Ablation with the second-generation Arctic Front Advance (AFA) cryoballoon (23 mm or 28 mm) using a single 4-minute ablation
C
Comparator
Ablation with the first-generation Arctic Front (AF) cryoballoon
O
Outcome
Electrical pulmonary vein isolation and ablation completeness via gross and histological examination at 30 days post-treatmentsurrogate

The second-generation Arctic Front Advance cryoballoon demonstrated improved pulmonary vein isolation and lesion completeness compared to the first-generation device in a canine model.

Main Result

Absolute Event Rate: 100% vs 60%

Abstract

INTRODUCTION: A novel cryoballoon with improved refrigerant distribution promises better pulmonary vein (PV) isolation success rate without sacrificing the technology's safety profile. This study aimed to compare the Arctic Front® (AF) balloon to the new Arctic Front Advance™ (AFA). METHODS AND RESULTS: Twenty pulmonary PVs from 10 healthy dogs weighing 29.8 ± 1.1 kg were assigned to ablation with AF and AFA, using a 23 mm or 28 mm balloon. A single 4-minute ablation was performed in each vessel, with no phrenic nerve monitoring. The Achieve™ mapping catheter was used to confirm acute isolation. Thirty days post-treatment the ablation sites were assessed for electrical PV isolation and ablation completeness via gross and histological examination. The phrenic nerve, PVs, lungs, esophagus, kidneys, and brain were collected for evaluation of potential damage. A preprocedural and prenecropsy CT were performed to assess incidence of PV stenosis. All 10 PVs were fully isolated with AFA; 6 of 10 PVs were fully isolated with AF. In all cases, lesion gaps with AF are believed to stem from inadequate cooling of the most distal balloon segment that was in contact with the unablated PV tissue. No untoward findings were detected on gross examination of the heart, esophagus, kidneys, brain, or PVs. One phrenic nerve had cross-sectional ablation associated with an AFA 23 mm balloon. Superficial regions of subpleural lung fibrosis were noted adjacent to 7 PVs. CONCLUSIONS: PV isolation and lesion completeness were improved with Arctic Front Advance, while no unexpected findings were found related to safety.

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Cite This Study

Coulombe et al. (2013) studied Pulmonary vein isolation (healthy dogs) (n=10). Arctic Front Advance (AFA) cryoballoon vs. Arctic Front (AF) cryoballoon was evaluated on Full pulmonary vein isolation. The Arctic Front Advance cryoballoon achieved 100% (10/10) full pulmonary vein isolation compared to 60% (6/10) with the first-generation Arctic Front balloon in a canine model.

synapsesocial.com/papers/6a20dbd96dd54ee3d3eb1565https://doi.org/10.1111/jce.12157
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