Brodmann Marianne, Thérasse Eric, Benko Andrew, Riel Louis-Philippe, Dion Steven, Généreux Philippe, Brouillette Martin
Medical University of Graz, Graz, Austria.
Hospital Center, University of Montreal, Montreal, QC, Canada.
J Cardiovasc Surg (Torino). 2018 Aug;59(4):529-537. doi: 10.23736/S0021-9509.18.10587-8. Epub 2018 May 23.
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.
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.
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.
The SoundBite™ Active Wire Crossing System feasibility study demonstrates a favorable safety and efficacy profile for the SoundBite™ Active Wire in infrainguinal CTOs.
本研究旨在探讨SoundBite™穿越系统用于股腘以下慢性完全闭塞（CTO）病变再通的安全性和有效性。CTO在严重间歇性跛行或严重肢体缺血患者中很常见。未能成功再通CTO仍然很常见，且与预后不良相关。SoundBite™穿越系统（SoundBite Medical Solutions Inc.，加拿大魁北克省蒙特利尔）是一种新开发的设备，它使用一根0.018英寸的导丝（SoundBite™活性导丝）将声波冲击波传递到可操纵导丝的远端尖端，以促进近端帽的定向穿透和闭塞病变的穿越。
来自3个中心的有症状的股腘以下新发CTO患者被纳入一项前瞻性单臂可行性研究。主要终点是30天器械成功率，定义为技术成功（定义为使用SoundBite™活性导丝在CTO内穿透并推进，随后完全再通）与无器械相关的主要不良事件（包括死亡、紧急截肢、临床驱动的靶血管血运重建、穿孔、≥C型夹层或需要干预的远端栓塞）的复合情况。
本研究共纳入37例患者，包括41处CTO病变。CTO长度范围为10毫米至270毫米（平均97.9±77.4毫米），24处（58.5%）治疗病变存在中度至重度钙化。34例（91.9%）患者的CTO病变成功穿越。未发生与器械相关的不良事件，30天器械成功率为91.9%。与基线相比，30天时踝肱指数显著改善（0.66±0.24对0.89±0.20；P<0.001），卢瑟福分级也显著改善（3[2,4]对0[0,1]，P<0.001）。
SoundBite™活性导丝穿越系统可行性研究表明，SoundBite™活性导丝在股腘以下CTO病变中具有良好的安全性和有效性。
