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The Journal of Cardiovascular Surgery 2018 August;59(4):529-37

DOI: 10.23736/S0021-9509.18.10587-8


language: English

Recanalization of CTOs with SoundBite™ Active Wire

Marianne BRODMANN 1, Eric THÉRASSE 2, Andrew BENKO 3, Louis-Philippe RIEL 4, Steven DION 4, Philippe GÉNÉREUX 5, 6, 7, Martin BROUILLETTE 4

1 Medical University of Graz, Graz, Austria; 2 Hospital Center, University of Montreal, Montreal, QC, Canada; 3 Hospital Center, University of Sherbrooke, Sherbrooke, QC, Canada; 4 SoundBite Medical Solutions Inc., Montreal, QC, Canada; 5 Gagnon Cardiovascular Institute, Morristown Medical Center, Morristown, NJ, USA; 6 Clinical Trials Center, Cardiovascular Research Foundation, New York, NY, USA; 7 Sacred Heart Hospital of Montreal, Montreal, QC, Canada


BACKGROUND: The aim of this study was to examine the safety and efficacy of the SoundBite™ Crossing System for the recanalization of infrainguinal chronic total occlusion (CTO) lesions. CTOs are frequent among patients with severe claudication or critical limb ischemia. Failure to recanalize CTOs remains common and is associated with poor prognosis. The SoundBite™ Crossing System (SoundBite Medical Solutions Inc., Montreal, QC, Canada) is a newly developed device that uses a 0.018-inch wire (SoundBite™ Active Wire) to deliver acoustic shock waves to the distal tip of a steerable guidewire to facilitate directed penetration of the proximal cap and crossing of the occlusion.
METHODS: Symptomatic patients with de novo infrainguinal CTOs from 3 centers were enrolled in a prospective, single-arm feasibility study. The primary endpoint was 30-day device success defined as composite of technical success, defined as penetration and progression within the CTO with the SoundBite™ Active Wire followed by complete recanalization, and freedom from device-related major adverse events including death, urgent amputation, clinically-driven target vessel revascularization, perforation, type ≥C dissection, or distal embolization requiring intervention.
RESULTS: Thirty-seven patients including 41 CTO lesions were enrolled in this study. CTO length ranged from 10 mm to 270 mm (mean 97.9±77.4 mm), and moderate-to-severe calcification was present in 24 (58.5%) of the treated lesions. CTOs were successfully crossed in 34 (91.9%) patients. No device-related adverse events occurred, resulting in a 30-day device success rate of 91.9%. Compared with baseline, 30-day ankle brachial index (0.66±0.24 versus 0.89±0.20; P<0.001) and Rutherford class (3 [2, 4] versus 0 [0, 1], P<0.001) significantly improved.
CONCLUSIONS: The SoundBite™ Active Wire Crossing System feasibility study demonstrates a favorable safety and efficacy profile for the SoundBite™ Active Wire in infrainguinal CTOs.

KEY WORDS: Peripheral artery disease - Amputation - Intermittent claudication

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