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Retrospective review of Arctic Front Advance Cryoballoon Ablation: a multicenter examination of second-generation cryoballoon (RADICOOL trial)

  • Wilber Su
  • G. Joseph Orme
  • Robert Hoyt
  • James Baker
  • Steven Compton
  • Christopher Fellows
  • John Harding
  • J. Thomas Svinarich
  • Marcin Kowalski
  • Bryan Piedad
  • David Kenigsberg
  • John Seger
  • Zeshan K. Ahmad
  • Paul Wang
Article

Abstract

Background

Pulmonary vein isolation (PVI) via catheter ablation is an approved therapy for patients with drug-refractory and symptomatic atrial fibrillation (AF). Furthermore, cryoballoon is now considered to be as effective as focal radiofrequency catheter ablation. This study examines the second-generation cryoballoon performance in a US multicenter review of real-world practices.

Methods

By retrospective chart collections, the long-term efficacy and safety of the cryoballoon procedure were assessed in 15 US centers. All patients had a history of drug-refractory symptomatic paroxysmal AF and were treated with a cryoballoon PVI strategy at the index ablation.

Results

Four hundred fifty-two patients were evaluated, and acute PVI was achieved in 99% of patients by cryoballoon catheter ablation. In 0.88% of patients (4/452), an additional focal ablation catheter was used to achieve acute PVI during the ablation procedure. Average procedure time was 128 (range 82 to 260) min, using an average of 17 (range 1 to 19) min of fluoroscopy. The most frequent adverse event was transient phrenic nerve injury (1.5%; 7/452 patients) which all resolved by the end of the procedure with no diaphragmatic dysfunction at discharge. There were no strokes, transient ischemic attacks, cardiac tamponade, atrioesophageal fistulas, or deaths during the study. At the 12-month efficacy endpoint, single-procedure success of freedom from atrial arrhythmia was 87% (393/452 patients).

Conclusions

This real-world examination of the US practice demonstrates that second-generation cryoballoon ablation by PVI strategy is safe and effective among patients with paroxysmal AF.

Keywords

Cryoballoon Atrial fibrillation Pulmonary vein isolation Second-generation cryoballoon 

Abbreviations

ESC

European Society of Cardiology

AF

Atrial fibrillation

ECG

Electrocardiogram

CB

Cryoballoon

CB-2

Second-generation cryoballoon ablation catheter

PVI

Pulmonary vein isolation

PNI

Phrenic nerve injury

Fr

French

US

United States

RF

Radiofrequency

OR

Odds ratio

CI

Confidence interval

AEF

Atrioesophageal fistula

CMAP

Compound motor action potential

Notes

Compliance with ethical standards

The study protocol and data collection methods were reviewed and approved at each hospital by the local institutional review board before chart collection.

Conflict of interest

Wilber Su, MD FHRS; J Thomas Svinarich, MD FHRS; Paul Wang, MD FHRS; John Harding MD FHRS; and Robert Hoyt MD FHRS received research funding, travel funding, and honorarium from Medtronic.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2018

Authors and Affiliations

  • Wilber Su
    • 1
    • 2
  • G. Joseph Orme
    • 1
  • Robert Hoyt
    • 3
  • James Baker
    • 4
  • Steven Compton
    • 5
  • Christopher Fellows
    • 6
  • John Harding
    • 7
  • J. Thomas Svinarich
    • 8
  • Marcin Kowalski
    • 9
  • Bryan Piedad
    • 10
  • David Kenigsberg
    • 11
  • John Seger
    • 12
  • Zeshan K. Ahmad
    • 1
  • Paul Wang
    • 2
  1. 1.Heart InstituteBanner - University Medical Center PhoenixPhoenixUSA
  2. 2.Stanford UniversityPalo AltoUSA
  3. 3.Iowa Heart Center InstituteDes MoinesUSA
  4. 4.Saint Thomas HeartNashvilleUSA
  5. 5.Alaska Heart InstituteAnchorageUSA
  6. 6.Virginia MasonSeattleUSA
  7. 7.Doylestown Cardiology AssociatesDoylestownUSA
  8. 8.Colorado Heart & VascularDenverUSA
  9. 9.Staten Island University Hospital, Northwell Health SystemStaten IslandUSA
  10. 10.Wellstar Health SystemMariettaUSA
  11. 11.Florida Heart Rhythm SpecialistsFort LauderdaleUSA
  12. 12.Houston Electrophysiology AssociatesHoustonUSA

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