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Safety of a single bolus administration of heparin without the measurement of activated clotting time during cryoballoon ablation: a prospective randomized controlled trial

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Abstract

Background

Single-shot ablation has emerged as an effective technique for index atrial fibrillation (AF) ablation, with an advantage of short procedure time. Although recent guidelines recommend peri-procedural uninterrupted oral anticoagulants (OACs), the intra-procedural anticoagulation strategy remains uncertain under non-vitamin K OACs (NOACs). We investigated procedural safety of a single bolus administration of heparin without activated clotting time (ACT) measurement during cryoballoon ablation (CBA).

Methods

Two hundred patients (64.2 ± 10.0 years, 70% with non-paroxysmal AF) who underwent CBA with uninterrupted NOACs were randomly assigned to No-ACT group and ACT group. A bolus of heparin (100 U/kg) was routinely administered immediately after transseptal puncture. In the ACT group, an additional injection of heparin (30 U/kg) was administered if ACT at 30 min after the initial bolus was < 300 s.

Results

There were no differences in baseline characteristics including CHA2DS2-VASc score between the two groups. The left atrium indwelling and procedure times were 60.4 ± 13.1 min and 78.9 ± 13.9 min, respectively, and not significantly different between the two groups. The mean ACT was 335.2 ± 59.9 s in the ACT group. Any bleeding rate was 3.2% in all patients and there was no statistically significant difference in bleeding complications between the two groups. In the ACT group, groin hematoma, laryngopharyngeal bleeding, and hemoptysis occurred in 3, 1, and 1 patient, respectively. Cardiac tamponade occurred in 1 patient in the No-ACT group. No thromboembolic events occurred during the 30-day follow-up after CBA.

Conclusions

Single bolus administration of heparin without ACT measurement is a feasible anticoagulation strategy for CBA in patients with uninterrupted NOAC intake.

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Data availability

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

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Funding

This work was supported by the Medtronic Korea, Ltd. (H20190710).

Author information

Author notes

  1. Dong Geum Shin and Minwoo Lee contributed equally to this work.

Authors and Affiliations

  1. Division of Cardiology, Hallym University Kangnam Sacred Heart Hospital, Seoul, Republic of Korea

    Dong Geum Shin

  2. Department of Neurology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, Anyang-si, Republic of Korea

    Minwoo Lee

  3. Division of Cardiology, Department of Internal Medicine, Pusan National University Hospital, Busan, Republic of Korea

    Jinhee Ahn

  4. Division of Cardiology, Hallym University Sacred Heart Hospital, Hallym University College of Medicine, 22, Gwanpyeong-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, Republic of Korea, 14068

    Sang-Jin Han & Hong Euy Lim

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  1. Dong Geum Shin
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Correspondence to Hong Euy Lim.

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This study protocol was approved by Hallym University Sacred Heart Hospital Institutional Review Board (HALLYM2019-04025).

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Shin, D.G., Lee, M., Ahn, J. et al. Safety of a single bolus administration of heparin without the measurement of activated clotting time during cryoballoon ablation: a prospective randomized controlled trial. J Interv Card Electrophysiol 66, 463–470 (2023). https://doi.org/10.1007/s10840-022-01349-z

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  • DOI: https://doi.org/10.1007/s10840-022-01349-z

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