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Lattice-tip catheter for single-shot pulmonary vein isolation with pulsed field ablation

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Abstract

Background

A compressible lattice-tip catheter designed for focal ablation using radiofrequency or pulsed-field energies has been recently described. The objective of this study is to describe a new lattice catheter designed for single-shot pulmonary vein isolation (PVI).

Methods

This 8F catheter consists of a compressible lattice tip that is delivered over the wire and is expandable up to 34 mm (SpherePVI™, Affera Inc.). Pulsed field ablation (PFA) was applied from 6 elements using a biphasic waveform of microsecond scale (± 1.3–2.0 kV, 5 s per application). In 12 swine, the superior vena cava (SVC) and right superior pulmonary vein (RSPV) were targeted for isolation. Animals were survived for 12–24 h (n = 6) or 3 weeks (n = 6) for evaluation of short and long-term safety and efficacy parameters. PVI was evaluated immediately after ablation and at the terminal procedure. Ablation-related microbubbles were examined using intracardiac echocardiography and phrenic nerve function by pacing. The tissue was examined by histopathology.

Results

In all 12 animals, PFA resulted in successful acute isolation of the SVC and RSPV using 2.8 ± 1.1 and 3.2 ± 1.2 applications per vein, respectively. After a survival period of 23 ± 5.9 days, all targeted veins remained isolated, and the level of isolation persisted without significant regression or expansion. In one animal, SVC isolation at the level of the right atrial appendage resulted in sinus node arrest. PFA did not affect phrenic nerve function, and it was associated with a few isolated bubbles formation.

Conclusions

In this pre-clinical study, a new expandable lattice catheter designed for single-shot PVI was able to achieve rapid and durable isolation.

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Funding

Dr. Anter receives research grants and speaking honoraria from Biosense Webster, Boston Scientific, and Affera Inc. He received stock from Affera Inc. The other authors report no financial disclosures.

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Authors and Affiliations

  1. Cardiac Electrophysiology Section, Department of Cardiovascular Medicine, Cleveland Clinic, Cleveland, OH, USA

    Hagai D. Yavin, Koji Higuchi, Arwa Younis & Elad Anter

  2. Cardiac Electrophysiology Section, Department of Cardiovascular Medicine, Shamir Medical Center, Be’er Ya’akov, Israel

    Hagai D. Yavin, Koji Higuchi, Arwa Younis & Elad Anter

Authors
  1. Hagai D. Yavin
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  2. Koji Higuchi
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  3. Arwa Younis
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  4. Elad Anter
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Correspondence to Elad Anter.

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Yavin, H.D., Higuchi, K., Younis, A. et al. Lattice-tip catheter for single-shot pulmonary vein isolation with pulsed field ablation. J Interv Card Electrophysiol 66, 1741–1748 (2023). https://doi.org/10.1007/s10840-022-01414-7

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  • DOI: https://doi.org/10.1007/s10840-022-01414-7

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