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Radiofrequency ablation using the second-generation temperature-controlled diamond tip system in paroxysmal and persistent atrial fibrillation: results from FASTR-AF

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Abstract

Background

Catheter ablation (CA) technology development reflects the need to improve the effectiveness of atrial fibrillation (AF) treatment. Recently, the DiamondTemp Ablation (DTA) RF generator software was updated with a more responsive power ramp.

Methods

DIAMOND FASTR-AF was a prospective, single-arm, multicenter trial. This study sought to characterize the performance of the updated DTA system for the treatment of patients with drug-refractory paroxysmal and persistent AF (PAF and PsAF). The primary effectiveness endpoint was freedom from atrial arrhythmia recurrence following a 90-day blanking period through 12 months, and the primary safety endpoint was a composite of serious adverse events.

Results

In total, 60 subjects (34 PAF and 26 PsAF) underwent CA at three centers. Patients were 71.7% male, (age 63.9 ± 10.2 years, with an AF diagnosis duration 3.1 ± 3.9 years and left atrial size 4.4 ± 0.8 cm). Pulmonary vein isolation-only ablation strategy was performed in 34 (56.7%) subjects. The procedural characteristics show a procedure time 90.8 ± 31.6 min, total RF time 14.7 ± 7.7 min, ablation duration 10.7 ± 3.6 s, and fluid infusion 284.7 ± 111.5 ml. The serious adverse event rate was 8.3% (5/60), 3 pulmonary edema and 2 extended hospitalizations. Freedom from atrial arrhythmia recurrence was achieved in 67.6% of subjects by 12 months.

Conclusions

The updated DTA system demonstrated long-term safety and effectiveness through 12 months of post-ablation follow-up for patients with atrial fibrillation. Additionally, procedures were demonstrated to be highly efficient with short procedure times and low levels of fluid infusion.

Trial registration

Sponsored by Medtronic, Inc.; FASTR-AF ClinicalTrials.gov; NCT03626649.

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Abbreviations

AAD:

Anti-arrhythmic drug

AF:

Atrial fibrillation

AFL:

Atrial flutter

AT:

Atrial tachycardia

CA:

Catheter ablation

ECG:

Electrocardiogram

DTA:

DiamondTemp Ablation

LA:

Left atrial

PAF:

Paroxysmal atrial fibrillation

PsAF:

Persistent atrial fibrillation

PV:

Pulmonary vein

PVI:

Pulmonary vein isolation

RF:

Radiofrequency

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Acknowledgements

The authors would like to acknowledge the invaluable contributions of the trial team, including the trial participants, FASTR-AF sites and their dedicated staff, and the Medtronic staff (Nina Kristiansen, Bob Hokanson, and Hae Lim).

Funding

This study was sponsored by Epix Therapeutics, Inc. (EPIX; Sunnyvale, CA, USA), which was acquired by Medtronic, Inc. in March 2019.

Author information

Authors and Affiliations

  1. Na Homolce Hospital, Roentgenova 37/2 150 00, Prague 5, Prague, Czech Republic

    Petr Neuzil, Jan Petru & Moritoshi Funasako

  2. Clinique du Tonkin, Valleurbanne, France

    Herve Poty & Alexis Durand-Dubief

  3. CHU de Nancy, Nancy, France

    Christian de Chillou

  4. Medtronic, Inc, Minneapolis, MN, USA

    Michael K. Getman & Shufeng Liu

  5. Clinique Pasteur, Toulouse, France

    Stéphane Combes & Jean-Paul Albenque

Authors
  1. Petr Neuzil
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  2. Herve Poty
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  3. Christian de Chillou
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  4. Jan Petru
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  5. Michael K. Getman
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  6. Shufeng Liu
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  7. Moritoshi Funasako
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  8. Alexis Durand-Dubief
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  9. Stéphane Combes
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  10. Jean-Paul Albenque
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Corresponding author

Correspondence to Petr Neuzil.

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Ethics approval

The Institutional Review Boards of each participating center reviewed and approved the study protocol. Written informed consent was obtained from all patients in accordance with the Declaration of Helsinki.

Conflict of interest

MKG and SL receive compensation as employees of Medtronic, Inc. All other authors declare no competing interests.

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Neuzil, P., Poty, H., de Chillou, C. et al. Radiofrequency ablation using the second-generation temperature-controlled diamond tip system in paroxysmal and persistent atrial fibrillation: results from FASTR-AF. J Interv Card Electrophysiol 66, 343–351 (2023). https://doi.org/10.1007/s10840-022-01234-9

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  • DOI: https://doi.org/10.1007/s10840-022-01234-9

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