1 Vascular and Oncological Interventional Radiology, Hôpital Européen Georges-Pompidou, Université Paris Descartes Paris Cité Sorbonne, Paris, France.
2 Radiology Department, Policlinico Tor Vergata, Tor Vergata University, Rome, Italy.
J Endovasc Ther. 2019 Apr;26(2):191-198. doi: 10.1177/1526602819829904. Epub 2019 Feb 11.
To evaluate the safety and efficacy of low-frequency, high-intensity ultrasound energy delivered via a new dedicated ultrasound catheter followed by conventional balloon angioplasty to treat calcified infrapopliteal lesions.
A prospective, nonrandomized, single-center pilot study enrolled 12 patients (mean age 72.2±5.3 years; 8 men) with critical limb ischemia (9 Rutherford category 5 and 3 category 6) between January and November 2017. Of the 19 target lesions, 11 had severe calcification. Patients were treated with the Kapani ultrasound system before conventional balloon dilation. Primary safety endpoints included 30-day death, major target limb amputation, and target vessel acute occlusion. The main efficacy outcome was primary patency at 6 months, defined as freedom from both clinically-driven target lesion revascularization (TLR) and angiographically-defined restenosis (>50% lumen reduction).
Technical success (<30% residual stenosis) was achieved in all lesions without complications or stent implantation. Ultrasound energy was delivered over a mean 185.2±67.3 seconds followed by low-pressure dilation (mean 6.1±1.9 atm). Angiography confirmed primary patency at 6 months in 18 (95%) of 19 lesions. No death, TLR, or amputation was reported in follow-up. Complete ulcer healing was observed in all 12 patients at 6 months.
This pilot trial with a small number of patients suggests that low-frequency, high-intensity ultrasound energy delivery followed by plain balloon angioplasty is a safe approach to treat infrapopliteal atherosclerotic lesions. Angiographically-documented results at 6 months indicate a potential for this combined therapy in the treatment of CLI patients with calcified BTK lesions. Further studies on a larger randomized cohort are needed to confirm these positive clinical outcomes.
评估新型专用超声导管低频高强度超声能量传递联合常规球囊血管成形术治疗钙化性膝下病变的安全性和有效性。
一项前瞻性、非随机、单中心的初步研究于 2017 年 1 月至 11 月纳入了 12 名（平均年龄 72.2±5.3 岁；8 名男性）患有严重肢体缺血（9 例 Rutherford 5 级和 3 例 6 级）的患者。19 个靶病变中，有 11 个严重钙化。在常规球囊扩张前，采用 Kapani 超声系统对患者进行治疗。主要安全性终点包括 30 天内死亡、主要靶肢体截肢和靶血管急性闭塞。主要疗效终点为 6 个月时的一期通畅率，定义为免于临床驱动的靶病变血运重建（TLR）和血管造影定义的再狭窄（>50%管腔减少）。
所有病变均实现了技术成功（残余狭窄<30%），无并发症或支架植入。平均每个病变给予 185.2±67.3 秒超声能量后，行低压扩张（平均 6.1±1.9 atm）。血管造影显示，19 个病变中有 18 个（95%）在 6 个月时达到一期通畅。随访期间无死亡、TLR 或截肢。12 例患者的所有溃疡均在 6 个月时完全愈合。
这项初步研究纳入了少数患者，表明低频高强度超声能量传递联合普通球囊血管成形术治疗膝下动脉粥样硬化性病变是安全的。6 个月时血管造影显示的结果表明，这种联合治疗可能适用于治疗伴有钙化 BTK 病变的 CLI 患者。需要进一步进行更大规模随机队列研究以确认这些积极的临床结果。
