Recanalization of CTOs with SoundBite™ Active Wire.

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.

Feasibility of extended use of an electromagnetic lithotripter beyond the manufacturer's recommended maintenance schedule.

OBJECTIVES: The study evaluates the effect of chronic usage, beyond the recommended maintenance schedule, on the efficacy of electromagnetic lithotripter. To our knowledge, there is no publication investigating the effect of chronic usage on the electromagnetic lithotripter, despite the maintenance schedule established by the manufacturers. Our goal is to verify if the acoustic parameters of the shock wave changed with usage, and if this change could be associated with change in clinical efficacy. METHODS: This study lasted 18 months. Every 6 months the lithotripter's efficacy was evaluated in two ways: objectively and clinically. Objective efficacy was measured using a piezoelectric hydrophone and artificial stones to capture the acoustic parameters and the crater of fragmentation, respectively. Clinical efficacy data was collected by studying the rate of successful extracorporeal shock wave lithotripsy treatment in patients with urolithiasis. The changes in clinical efficacy, acoustic parameters, and craters of fragmentation were compared and analyzed with appropriate statistical methods. RESULTS: Five hundred twenty five patients participated in the study. The clinical efficacy remained stable throughout the three observation periods (55.7%, 66.2% and 55.5%; p = 0.11). The focal head of the lithotripter was used three times the recommended schedule. There was no obvious change in the acoustic parameters of the shock waves, and the focal zone remained stable. CONCLUSIONS: The clinical efficacy of the electromagnetic lithotripter appears to be stable despite usage beyond the recommended maintenance schedule. More studies are needed to validate the safety of this practice.

Novel Crossing System for Chronic Total Occlusion Recanalization: First-in-Man Experience With the SoundBite Crossing System.

Chronic total occlusion (CTO) lesions are frequent in patients with peripheral and coronary artery disease, and are associated with a higher risk of adverse events, including mortality, decreased quality of life, and increased health-care costs. Percutaneous intervention of CTO lesions has been associated with a lower procedural success rate, and current dedicated CTO devices may be of limited use for non-CTO experts, and associated with increased intraprocedural complication rates. The SoundBite Crossing System (SoundBite Medical Solutions, Inc) is a newly-developed device using shockwaves (short-duration, high-amplitude pressure pulses) delivered to the tip of guidewire to facilitate penetration of the proximal cap and crossing of the occlusion. The current report describes the first-in-man use of the SoundBite Crossing System in the recanalization of two occluded lower-limb arteries.

Novel Crossing System for the Recanalization of Complex Chronic Total Occlusions: Ex vivo Proof of Concept of the SoundBite Crossing System.

Chronic total occlusion (CTO) lesions are frequent in patients with peripheral and coronary artery disease, and associated with a higher risk of adverse events, including mortality, decreased quality of life, and increased health-care costs. Percutaneous intervention of CTO lesions has been associated with a lower procedural success rate, and current dedicated CTO devices may be of limited use for the non-CTO expert, and associated with increased intraprocedural complication rates. The SoundBite Crossing System (SoundBite Medical Solutions, Inc) is a newly developed device using shockwaves (short-duration, high-amplitude pressure pulses) to facilitate penetration of the proximal cap and crossing of the occlusion. The current report describes the first use of the SoundBite Crossing System in the recanalization of human ex vivo occluded arteries below the knee during a simulated procedure performed under fluoroscopy. Microcomputed tomography and histologic evaluation of the occluded and recanalized segment are provided to support therapeutic mechanism.