Department of Vascular Surgery, Singapore General Hospital, Singapore.
Duke-NUS Graduate Medical School, Singapore.
Vasa. 2020 Oct;49(6):475-482. doi: 10.1024/0301-1526/a000888. Epub 2020 Jul 22.
: The aim was to evaluate the safety and efficacy of a high pressure, non-compliant balloon in the treatment of infrapopliteal occlusive disease in Asian patients with chronic limb threatening ischaemia (CLTI) from Singapore. : Prospective, multi-centre, single arm, non-randomized study. Immediate technical success, 6-month primary vessel patency (determined by Duplex ultrasonography), limb salvage, one-year clinically driven target lesion re-intervention (TLR) and amputation free survival (AFS) were the efficacy endpoints of interest. : 86 patients (63% males, mean age 68.9 ± 9.9 years) were enrolled over a 15-month period. Diabetes mellitus (DM) and end-stage renal failure (ESRF) were present in 94% and 38% of patients respectively. All had some degree of tissue loss at baseline (Rutherford scale 5 and 6 = 91% and 9% respectively). Of the 86 legs, 72% had 3 crural vessel disease and 84% had moderate/severe vessel wall calcification. 90% had > = 1 TASC D tibial lesion. Acute technical success was 89%. One month mortality was 3.5% and one-year freedom from TLR was 91%. 6-month tibial patency was 73%. 54/66 (82%) patients had at least one target treated tibial artery open at 6 months. A lower baseline toe pressure (OR 1.03, 95%CI 1.00-1.05) and elastic recoil post angioplasty (OR 0.20, 95%CI 0.05-0.79) were associated with a worse 6 month tibial patency. One-year AFS was 67%. 47/66 (71%) patients had a clinical improvement of at least one Rutherford class at 6 months and 52/59 (88%) experienced complete wound healing at 12 months. : Use of a high pressure non-compliant balloon is safe and efficacious in treating highly complex infra-popliteal atherosclerotic lesions in an otherwise challenging population of CLTI patients with a high incidence of DM and ESRF. It is associated with highly satisfactory acute technical success, 6-month target lesion patency and one-year limb salvage.
目的是评估高压非顺应性球囊在治疗来自新加坡的伴有慢性肢体威胁性缺血（CLTI）的亚临床肢体严重缺血（CLTI）的下肢动脉阻塞性疾病患者中的安全性和疗效。
这是一项前瞻性、多中心、单臂、非随机研究。主要的即刻技术成功、6 个月的主要血管通畅率（通过双功能超声检查确定）、肢体挽救率、1 年临床驱动的目标病变再介入（TLR）率和保肢存活率（AFS）是本研究的有效性终点。
在 15 个月的时间内，共纳入了 86 名患者（63%为男性，平均年龄 68.9±9.9 岁）。94%的患者患有糖尿病（DM），38%的患者患有终末期肾病（ESRF）。所有患者基线时均有不同程度的组织丢失（Rutherford 分级 5 和 6 分别为 91%和 9%）。86 条肢体中，72%有 3 处小腿血管病变，84%有中重度血管壁钙化。90%的患者有≥1 处 TASC D 胫骨病变。急性技术成功率为 89%。1 个月死亡率为 3.5%，1 年 TLR 无复发率为 91%。6 个月时胫骨的通畅率为 73%。66 例中有 54 例（82%）患者至少有 1 条经治疗的胫骨动脉在 6 个月时保持通畅。基线时足趾压较低（OR 1.03，95%CI 1.00-1.05）和血管成形术后弹性回缩较低（OR 0.20，95%CI 0.05-0.79）与 6 个月时胫骨的通畅率较差相关。1 年的 AFS 为 67%。66 例中有 47 例（71%）患者在 6 个月时至少有 1 个 Rutherford 分级改善，59 例中有 52 例（88%）在 12 个月时完全愈合。
在 DM 和 ESRF 发病率高的 CLTI 患者中，使用高压非顺应性球囊治疗复杂的下肢动脉粥样硬化病变是安全且有效的。该方法具有极高的急性技术成功率、6 个月时的目标病变通畅率和 1 年时的肢体挽救率。
