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JACC Clin Electrophysiol. 2015 Aug;1(4):306-314. doi: 10.1016/j.jacep.2015.04.011. Epub 2015 Jun 21.

Pre-Clinical Investigation of a Low-Intensity Collimated Ultrasound System for Pulmonary Vein Isolation in a Porcine Model.

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Helmsley Electrophysiology Center, Mount Sinai Medical Center, New York, New York.
VytronUS, Inc., Sunnyvale, California.
University of Illinois at Chicago, Chicago, Illinois.
University of Alabama at Birmingham, Birmingham, Alabama.
Helmsley Electrophysiology Center, Mount Sinai Medical Center, New York, New York. Electronic address:



The purpose of this study was to assess the feasibility of pulmonary vein (PV) isolation using low-intensity collimated ultrasound.


Contemporary approaches to PV isolation are limited by the technical complexity of mapping and ablation. We describe a novel approach to left atrial anatomic rendering and PV isolation that aims to overcome some of these limitations by using low-intensity collimated ultrasound (LICU) system, which allows for near real-time geometry creation and automated ablation in a porcine model.


Twenty swine were anesthetized, and the LICU ablation catheter was placed in the left atrium via percutaneous transseptal access. Ultrasound M-mode-based anatomies of the inferior PVs were successfully created, and ablation was performed under automatic robotic control along a user-defined lesion path. One animal was excluded because of device failure.


All target PVs in the 19 remaining animals were isolated acutely, requiring a mean of 1.6 applications. Ten animals were sacrificed acutely, and the remaining 9 survived for 35 ± 11 days. Of these 9, 1 animal was excluded from analysis because the index lasso position could not be reliably recreated. PVs in 5 of 8 animals remained isolated at sacrifice. Of the 77 total histological sections, 62 lesions (80.5%) were noted to be transmural. Lesions were homogeneous and characterized by coagulative necrosis and fibrous tissue. The mean myocardial thickness was 2.66 ± 1.80 mm, and the mean lesion depth was 4.28 ± 1.97 mm. No extra cardiac or collateral lesions were noted.


This study demonstrates the safety and efficacy of a novel noncontact ultrasound mapping and ablation system to produce continuous transmural lesions that can isolate PVs in a porcine model.


ablation; atrial fibrillation; mapping; porcine; ultrasound

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