Yap Hao Yun, Tang Tjun Yip, Yap Charyl, Chan Sze Ling, Chong Tze Tec
Department of Vascular Surgery, Singapore General Hospital, Singapore.
The Vascular and Endovascular Clinic, Gleneagles Medical Centre, Singapore.
J Endovasc Ther. 2024 Aug 10:15266028241268828. doi: 10.1177/15266028241268828.
This is a prospective study to investigate the clinical outcomes of using noncompliant balloons in lower limb angioplasty for chronic limb threatening ischemia (CLTI).
This is a prospective single-center cohort study performed at a local tertiary hospital in Singapore. Consecutive patients who underwent lower limb angioplasty for CLTI using a noncompliant balloon catheter were enrolled if they were aged 40 years and above, presented with CLTI Rutherford grade 4 to 6, and had TASC C or D lesions in the lower limb vessels that were at least 100mm in length. Patient demographics, Rutherford grading, lesion characteristics, complications, and follow-up data were collected and analyzed. The primary outcomes were 30-day freedom from major adverse events, amputation-free survival (AFS) at 12 months, and freedom from clinically driven target lesion revascularization (cdTLR) at 12 months. Secondary outcomes included clinical success and target lesion primary patency (TLPP) at 12 months. Amputation-free survival, freedom from cdTLR, and TLPP were calculated by Kaplan-Meier analysis.
From May 2020 to December 2021, 50 patients (50 limbs) were enrolled. 43 (86%) patients had diabetes mellitus, while 12 patients (24%) had end-stage renal failure. 85 lesions were treated, including 59 (69.4%) below-the-knee (BTK) lesions. All the lesions were TASC C (n=45, 52.9%) or TASC D (n=40, 47.1%) lesions. Mean lesion length was 231.4±116.2mm. Technical success rate was 96.5%. No patients were lost to follow-up. Median follow-up duration was 282 days (IQR: 31-390 days). One patient died on day 26 due to an acute myocardial infarction. Two patients had groin hematomas postprocedure, both of which were treated conservatively. AFS, freedom from cdTLR, and TLPP at 12 months postprocedure was 70.0% (95% confidence interval [CI]: 58.4%-83.9%), 90.1% (95% CI: 83.4%-97.4%), and 61.1% (95% CI: 50.7%-73.6%), respectively.
Early results have shown that the use of a high-pressure, noncompliant balloon is effective in lower limb angioplasty for CLTI in a highly challenging group of patients with a high prevalence of long BTK disease. Good vessel patency and limb salvage rates can be achieved, with a low complication rate. We await more long-term outcomes on vessel patency.
There are many devices in the market for use in lower limb angioplasty. However, many of them come with an increased financial cost, procedural time and procedural difficulty. We report our prospective results with the exclusive use of a high pressure, non-compliant balloon, in a challening group of patients with a high prevalence of diabetes and end stage renal failure, achieving amputation free surival at 6 and 12 months post-procedure of 84.0% and 70.0% respectively. The use of non-compliant balloon is technically easy and does not add additional steps compared to a standard POBA procedure, thus limiting costs. We believe this article can be a push factor for clinicians to consider the use of these high pressure, non-compliant balloons in their patient care.
本前瞻性研究旨在调查使用非顺应性球囊进行下肢血管成形术治疗慢性肢体威胁性缺血（CLTI）的临床结果。
这是一项在新加坡一家当地三级医院进行的前瞻性单中心队列研究。连续接受使用非顺应性球囊导管进行CLTI下肢血管成形术的患者，若年龄在40岁及以上，表现为CLTI卢瑟福分级4至6级，且下肢血管存在长度至少为100mm的TASC C或D级病变，则纳入研究。收集并分析患者的人口统计学资料、卢瑟福分级、病变特征、并发症及随访数据。主要结局指标为30天无重大不良事件、12个月无截肢生存（AFS）以及12个月无临床驱动的靶病变血运重建（cdTLR）。次要结局指标包括临床成功率及12个月时的靶病变原发通畅率（TLPP）。采用Kaplan-Meier分析计算无截肢生存、无cdTLR及TLPP。
2020年5月至2021年12月，共纳入50例患者（50条肢体）。43例（86%）患者患有糖尿病，12例（24%）患者患有终末期肾衰竭。共治疗85处病变，其中59处（占69.4%）为膝下（BTK）病变。所有病变均为TASC C级（45处，占52.9%）或TASC D级（40处，占47.1%）病变。平均病变长度为231.116.2mm。技术成功率为96.5%。无患者失访。中位随访时间为282天（四分位间距：31 - 390天）。1例患者于第26天因急性心肌梗死死亡。2例患者术后出现腹股沟血肿，均经保守治疗。术后12个月时的AFS、无cdTLR及TLPP分别为70.0%（95%置信区间[CI]：58.4% - 83.9%）、90.1%（95% CI：83.4% - 97.4%）及61.1%（95% CI：50.7% - 73.6%）。
早期结果表明，在患有长段BTK疾病且患病率高的极具挑战性的患者群体中，使用高压非顺应性球囊进行下肢血管成形术治疗CLTI是有效的。可实现良好的血管通畅率及肢体挽救率，且并发症发生率低。我们期待关于血管通畅性的更多长期结果。
市场上有许多用于下肢血管成形术的器械。然而，其中许多器械会增加经济成本以及手术时间和手术难度。我们报告了在患有糖尿病和终末期肾衰竭且患病率高的具有挑战性的患者群体中，独家使用高压非顺应性球囊的前瞻性结果。术后6个月和12个月的无截肢生存率分别为84.0%和70.0%。与标准的单纯球囊血管成形术（POBA）相比，使用非顺应性球囊在技术上易于操作且不增加额外步骤，从而降低了成本。我们认为本文可为临床医生在患者治疗中考虑使用这些高压非顺应性球囊提供推动因素。
