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Cryoballoon ablation of atrial fibrillation is effectively feasible without previous imaging of pulmonary vein anatomy: insights from the 1STOP project

  • A. Sagone
  • S. Iacopino
  • P. Pieragnoli
  • G. Arena
  • R. Verlato
  • G. Molon
  • G. Rovaris
  • A. Curnis
  • W. Rauhe
  • M. Lunati
  • G. Senatore
  • M. Landolina
  • G. Allocca
  • S. De Servi
  • C. Tondo
Article
  • 45 Downloads

Abstract

Background

Pulmonary vein isolation by cryoablation (PVI-C) is a standard therapy for the treatment of atrial fibrillation (AF); however, PVI-C can become a challenging procedure due to the anatomy of the left atrium and pulmonary veins (PVs). Importantly, the utility of imaging before the procedure is still unknown regarding the long-term clinical outcomes following PVI-C. The aim of the analysis is to evaluate the impact of imaging before PVI-C on procedural data and AF recurrence.

Methods

Patients with paroxysmal AF underwent an index PVI-C. Data were collected prospectively in the framework of 1STOP ClinicalService® project. Patients were divided into two groups according to the utilization of pre-procedural imaging of PV anatomy (via CT or MRI) or the non-usage of pre-procedural imaging.

Results

Out of 912 patients, 461 (50.5%) were evaluated with CT or MRI before the PVI-C and denoted as the imaging group. Accordingly, 451 (49.5%) patients had no pre-procedural imaging and were categorized as the no imaging group. Patient baseline characteristics were comparable between the two cohorts, but the ablation centers that comprised the imaging group had fewer PVI-C cases per year than the no imaging group (p < 0.001). The procedure, fluoroscopy, and left atrial dwell times were significantly shorter in the no imaging cohort (p < 0.001). The rates of complications were significantly greater in the imaging group compared to the no imaging group (6.9% vs. 2.7%; p = 0.003); this difference was attributed to differences in transient diaphragmatic paralysis. The 12-month freedom from AF was 76.2% in the imaging group and 80.0% in the no imaging group (p = 0.390).

Conclusions

In our analysis, PVI-C was effective regardless of the availability of imaging data on PV anatomy.

Keywords

Paroxysmal atrial fibrillation Cryoballoon Outcomes AF recurrences Cardio imaging 

Abbreviations

AAD

Anti-arrhythmic drug

AF

Atrial fibrillation

BMI

Body mass index

CKD

Chronic kidney disease

CBA

Cryoablation

EHRA

European Heart Rhythm Association

LVEF

Left ventricular ejection fraction

PAF

Paroxysmal atrial fibrillation

PVI-C

Pulmonary vein isolation by cryoablation

TE

Thromboembolic event

TIA

Transient ischemic attack

Notes

Funding sources

This research was performed within the framework of the Italian ClinicalService, a project funded by Medtronic Italy, an affiliate of Medtronic Inc. No other funding sources were involved in the research.

Compliance with ethical standards

All procedures performed in this project involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.

Conflict of interest disclosures

Maurizio Lunati and Roberto Verlato received modest consultancy and speaker’s fees from Medtronic. Maurizio Landolina received modest consultancy and speaker’s fees from Medtronic, Boston Scientific, and Boehringer Ingelheim. Giulio Molon received modest consultancy fees from Medtronic and Boston Scientific and speaker’s fees from Medtronic, Boston Scientific, St. Jude, and Boehringer Ingelheim. Claudio Tondo serves as a member of Medtronic European Advisory Board and Boston Scientific International Advisory Board. He received lecture and proctor fees from Medtronic, Abbott Medical, Biosense Webster, and Boston Scientific. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Ethical approval

This project was approved by each site’s Institutional Review Board and Local Ethics Committees.

Informed consent

Each patient included in the ClinicalService project provided informed consent for data collection and analysis.

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Copyright information

© Springer Science+Business Media, LLC, part of Springer Nature 2019

Authors and Affiliations

  • A. Sagone
    • 1
  • S. Iacopino
    • 2
  • P. Pieragnoli
    • 3
  • G. Arena
    • 4
  • R. Verlato
    • 5
  • G. Molon
    • 6
  • G. Rovaris
    • 7
  • A. Curnis
    • 8
  • W. Rauhe
    • 9
  • M. Lunati
    • 10
  • G. Senatore
    • 11
  • M. Landolina
    • 12
  • G. Allocca
    • 13
  • S. De Servi
    • 1
  • C. Tondo
    • 14
  1. 1.Policlinico IRCCS Multimedica Sesto San GiovanniSesto San GiovanniItaly
  2. 2.Maria Cecilia Hospital, GVM Care & Research GroupCotignolaItaly
  3. 3.Azienda Ospedaliera CareggiFlorenceItaly
  4. 4.Nuovo Ospedale delle ApuaneMassaItaly
  5. 5.ULSS 6 EuganeaCamposampieroItaly
  6. 6.IRCCS Sacro Cuore Don Calabria Don CalabriaNegrarItaly
  7. 7.ASST San GerardoMonzaItaly
  8. 8.Azienda Ospedaliera Spedali CiviliBresciaItaly
  9. 9.Ospedale Centrale di BolzanoBolzanoItaly
  10. 10.A De Gasperis’ CardioCenterASST GOM NiguardaMilanItaly
  11. 11.Presidio Ospedaliero RiunitoCirièItaly
  12. 12.Department of CardiologyOspedale MaggioreCremaItaly
  13. 13.Santa Maria dei BattutiConeglianoItaly
  14. 14.Cardiac Arrhythmia Research CentreCentro Cardiologico Monzino IRCCS Milan AziendaMilanItaly

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