Skip to main content

Advertisement

SpringerLink
Log in

Key characteristics for effective acute pulmonary vein isolation when using a novel cryoballoon technology: insights from the CHARISMA registry

  • Published:
Journal of Interventional Cardiac Electrophysiology Aims and scope Submit manuscript

Abstract

Purpose

A new cryoballoon (CB) technology (POLARx™; Boston Scientific) for pulmonary vein (PV) isolation in patients with atrial fibrillation (AF) has recently been introduced. The aim of this study was to evaluate procedural and biophysical parameters resulting in acute PV isolation when using this new CB.

Methods

We assessed the first 69 consecutive patients indicated for AF ablation who underwent PV isolation by means of a novel CB system. Procedural metrics were prospectively recorded.

Results

A total of 274 PVs were targeted in 69 patients. PV isolation was achieved in all patients by means of cryoablation alone. The median time to isolation (TTI) was 44 [31–68] s (median temperature at TTI =  − 49 [− 53 to − 41] °C). The median duration of CB ablation was 180 [180 to 240] s. The median nadir temperature was − 56.0 [− 61 to − 52] °C, and the median thaw time to 0 °C was 18 [15–21] s. The median grade of PV occlusion was 4 [3 to 4]. On the basis of ROC analysis, we defined the following cut-off values for acute PV isolation: − 56 °C for nadir temperature (sensitivity = 73.3%, specificity = 64.6%, AUC = 0.716; positive predictive value = 88.1%), 30 s for TTT (60.2%, 53.3%, 0.578; 79.7%), thaw time > 17 s (65.3%, 70.0%, 0.709; 86.9%), and grade of PV occlusion = 4 (79.4%, 66.7%, 0.738; 88.5%). No major procedure-related adverse events were observed at 30-day post-procedure.

Conclusions

The new POLARx™ CB appears to be effective and safe. A nadir temperature of − 56 °C, a thaw time to 0 °C ≥ 17 s, and complete PV occlusion were the best predictors of acute PV isolation.

Clinical trial registration

Catheter Ablation of Arrhythmias with a High-Density Mapping System in Real-World Practice (CHARISMA). URL: http://clinicaltrials.gov/Identifier: NCT03793998. Registration date: January 4, 2019.

This is a preview of subscription content, log in via an institution to check access.

Access this article

Log in via an institution

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others

Data availability

The data underlying this article will be shared on reasonable request to the corresponding author.

Code availability

Not applicable.

References

  1. Calkins H, Hindricks G, Cappato R, et al. 2017 HRS/EHRA/ECAS/APHRS/SOLAECE expert consensus statement on catheter and surgical ablation of atrial fibrillation. Europace. 2018;20(1):e1–160.

    Article  Google Scholar 

  2. Kuck KH, Brugada J, Fürnkranz A, FIRE AND ICE Investigators, et al. Cryoballoon or radiofrequency ablation for paroxysmal atrial fibrillation. N Engl J Med. 2016;374:2235–45.

    Article  Google Scholar 

  3. Yap SC, Anic A, Breskovic T, et al. Comparison of procedural efficacy and biophysical parameters between two competing cryoballoon technologies for pulmonary vein isolation: insights from an initial multicenter experience. J Cardiovasc Electrophysiol. 2021;32:580–7.

    Article  Google Scholar 

  4. Creta A, Kanthasamy V, Schilling RJ, et al. First experience of POLARxTM versus Arctic Front AdvanceTM: an early technology comparison. J Cardiovasc Electrophysiol. 2021. https://doi.org/10.1111/jce.14951.

    Article  PubMed  Google Scholar 

  5. Kochi AN, Moltrasio M, Tundo F, et al. Cryoballoon atrial fibrillation ablation: single-center safety and efficacy data using a novel cryoballoon technology compared to a historical balloon platform. J Cardiovasc Electrophysiol. 2021;32:588–94.

    Article  Google Scholar 

  6. Su W, Kowal R, Kowalski M, et al. Best practice guide for cryoballoon ablation in atrial fibrillation: the compilation experience of more than 3000 procedures. Heart Rhythm. 2015;12:1658–66.

    Article  Google Scholar 

  7. Aryana A, Braegelmann KM, Lim HV, Ellenbogen KA. Cryoballoon ablation dosing: from the bench to the bedside and back. Heart Rhythm. 2020;17:1185–92.

    Article  Google Scholar 

  8. Avitall B, Kalinski A. Cryotherapy of cardiac arrhythmia: from basic science to the bedside. Heart Rhythm. 2015;12:2195–203.

    Article  Google Scholar 

  9. Ciconte G, de Asmundis C, Sieira J, et al. Single 3-minute freeze for second generation cryoballoon ablation: one-year follow-up after pulmonary vein isolation. Heart Rhythm. 2015;12:673–80.

    Article  Google Scholar 

  10. Miyazaki S, Hachiya H, Nakamura H, et al. Pulmonary vein isolation using a second-generation cryoballoon in patients with paroxysmal atrial fibrillation: one-year outcome using a single big-balloon 3-minute freeze technique. J Cardiovasc Electrophysiol. 2016;27:1375–80.

    Article  Google Scholar 

  11. Aryana A, Mugnai G, Singh SM, et al. Procedural and biophysical indicators of durable pulmonary vein isolation during cryoballoon ablation of atrial fibrillation. Heart Rhythm. 2016;13:424–32.

    Article  Google Scholar 

  12. Aryana A, Kenigsberg DN, Kowalski M, Cryo-DOSING Investigators, et al. Verification of a novel atrial fibrillation cryoablation dosing algorithm guided by time-to-pulmonary vein isolation: results from the Cryo-DOSING study (Cryoballoon-ablation DOSING Based on the Assessment of Time-to-Effect and Pulmonary Vein Isolation Guidance). Heart Rhythm. 2017;14:1319–25.

    Article  Google Scholar 

  13. Chun KR, Stich M, Fürnkranz A, et al. Individualized cryoballoon energy pulmonary vein isolation guided by real-time pulmonary vein recordings, the randomized ICE-T trial. Heart Rhythm. 2017;14:495–500.

    Article  Google Scholar 

  14. Ferrero-de-Loma-Osorio A, García-Fernandez A, Castillo-Castillo J, et al. Time-to-effect-based dosing strategy for cryoballoon ablation in patients with paroxysmal atrial fibrillation: results of the plusONE Multicenter Randomized Controlled Noninferiority Trial. Circ Arrhythm Electrophysiol. 2017;10:e005318.

    Article  Google Scholar 

  15. Reissmann B, Wissner E, Deiss S, et al. First insights into cryoballoon-based pulmonary vein isolation taking the individual time-to-isolation into account. Europace. 2017;19:1676–80.

    Article  Google Scholar 

  16. Stabile G, Tondo C, Curnis A, et al. Efficacy of cryoballoon ablation in patients with paroxysmal atrial fibrillation without time to pulmonary vein isolation assessment. Int J Cardiol. 2018;272:118–22.

    Article  Google Scholar 

  17. Straube F, Dorwarth U, Pongratz J, et al. The fourth cryoballoon generation with a shorter tip to facilitate real-time pulmonary vein potential recording: feasibility and safety results. J Cardiovasc Electrophysiol. 2019;30:918–25.

    Article  Google Scholar 

Download references

Author information

Author notes

  1. Saverio Iacopino and Giuseppe Stabile have equally contributed to this work.

Authors and Affiliations

  1. Maria Cecilia Hospital, Cotignola, Ravenna, Italy

    Saverio Iacopino, Andrea Petretta, Filippo Placentino, Francesca Pesce & Jacopo Colella

  2. Laboratorio Di Elettrofisiologia, Clinica San Michele, Maddaloni, Caserta, Italy

    Giuseppe Stabile, Antonio De Simone, Vincenzo La Rocca & Assunta Iuliano

  3. Department of Clinical Electrophysiology & Cardiac Pacing, Heart Rhythm Center, Centro Cardiologico Monzino IRCCS, Milan, Italy

    Gaetano Fassini, Massimo Moltrasio, Stefania Riva, Fabrizio Tundo & Claudio Tondo

  4. Arrhythmology Unit, San Giovanni Calibita Hospital, Fatebefratelli, Isola Tiberina, Rome, Italy

    Pietro Rossi

  5. Department of Cardiovascular Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy

    Gemma Pelargonio

  6. Institute of Cardiology, Catholic University of Sacred Heart, Rome, Italy

    Gemma Pelargonio

  7. Department of Biochemical, Surgical and Dentist Sciences, University of Milan, Via Carlo Parea, 4, 20138, Milan, Italy

    Claudio Tondo

Authors
  1. Saverio Iacopino
    View author publications

    You can also search for this author in PubMed Google Scholar

  2. Giuseppe Stabile
    View author publications

    You can also search for this author in PubMed Google Scholar

  3. Gaetano Fassini
    View author publications

    You can also search for this author in PubMed Google Scholar

  4. Antonio De Simone
    View author publications

    You can also search for this author in PubMed Google Scholar

  5. Andrea Petretta
    View author publications

    You can also search for this author in PubMed Google Scholar

  6. Massimo Moltrasio
    View author publications

    You can also search for this author in PubMed Google Scholar

  7. Vincenzo La Rocca
    View author publications

    You can also search for this author in PubMed Google Scholar

  8. Filippo Placentino
    View author publications

    You can also search for this author in PubMed Google Scholar

  9. Stefania Riva
    View author publications

    You can also search for this author in PubMed Google Scholar

  10. Francesca Pesce
    View author publications

    You can also search for this author in PubMed Google Scholar

  11. Pietro Rossi
    View author publications

    You can also search for this author in PubMed Google Scholar

  12. Gemma Pelargonio
    View author publications

    You can also search for this author in PubMed Google Scholar

  13. Assunta Iuliano
    View author publications

    You can also search for this author in PubMed Google Scholar

  14. Fabrizio Tundo
    View author publications

    You can also search for this author in PubMed Google Scholar

  15. Jacopo Colella
    View author publications

    You can also search for this author in PubMed Google Scholar

  16. Claudio Tondo
    View author publications

    You can also search for this author in PubMed Google Scholar

Corresponding author

Correspondence to Claudio Tondo.

Ethics declarations

Ethics approval

This study was performed in line with the principles of the Declaration of Helsinki. The locally appointed Ethics Committee approved the research protocol.

Consent to participate

Informed consent was obtained from all individual participants included in the study.

Consent for publication

Patients signed informed consent regarding publishing their data.

Competing interests

The authors declare no competing interests.

Additional information

Publisher's note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Iacopino, S., Stabile, G., Fassini, G. et al. Key characteristics for effective acute pulmonary vein isolation when using a novel cryoballoon technology: insights from the CHARISMA registry. J Interv Card Electrophysiol 64, 641–648 (2022). https://doi.org/10.1007/s10840-021-01063-2

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: https://doi.org/10.1007/s10840-021-01063-2

Keywords

Search

Navigation