■这是一项前瞻性研究,旨在研究在下肢血管成形术中使用非顺应性球囊治疗慢性威胁肢体缺血(CLTI)的临床结果。
■这是一项在新加坡当地三级医院进行的前瞻性单中心队列研究。连续纳入使用非顺应性球囊导管进行下肢CLTI血管成形术的患者,如果他们年龄在40岁及以上,表现为CLTI卢瑟福4至6级,下肢血管有TASCC或D病变,长度至少为100mm。患者人口统计学,卢瑟福分级,病变特征,并发症,收集和分析随访数据。主要结局是30天无主要不良事件,12个月时无截肢生存期(AFS),12个月时无临床驱动的靶病变血运重建(cdTLR)。次要结果包括12个月时的临床成功和靶病变原发通畅(TLPP)。无截肢生存,从cdTLR自由,通过Kaplan-Meier分析计算TLPP。
■从2020年5月至2021年12月,招募了50名患者(50条肢体)。43(86%)患者患有糖尿病,而12例患者(24%)有终末期肾功能衰竭。治疗85个病灶,包括59(69.4%)膝下(BTK)病变。所有病变均为TASCC(n=45,52.9%)或TASCD(n=40,47.1%)病变。平均病变长度为231.4±116.2mm。技术成功率为96.5%。无患者失访。中位随访时间为282天(IQR:31-390天)。一名患者在第26天因急性心肌梗塞死亡。两名患者术后腹股沟血肿,两者都被保守地对待。AFS,从cdTLR自由,术后12个月TLPP为70.0%(95%置信区间[CI]:58.4%-83.9%),90.1%(95%CI:83.4%-97.4%),和61.1%(95%CI:50.7%-73.6%),分别。
■早期结果表明,使用高压,对于长期BTK疾病患病率高的极具挑战性的CLTI患者组,非顺应性球囊在下肢血管成形术中有效.可以实现良好的血管通畅性和肢体抢救率,并发症发生率低。我们等待更多的长期结果在血管通畅。
结论:市场上有许多用于下肢血管成形术的设备。然而,他们中的许多人增加了财务成本,程序时间和程序难度。我们报告了我们的预期结果,仅使用高压,不合规的气球,在糖尿病和终末期肾功能衰竭患病率高的患者群体中,术后6个月和12个月的无截肢存活率分别为84.0%和70.0%。使用非顺应性球囊在技术上很容易,并且与标准POBA程序相比不会增加额外的步骤。从而限制成本。我们相信这篇文章可以推动临床医生考虑使用这些高压,病人护理中的不合规气球。
UNASSIGNED: This is a prospective study to investigate the clinical outcomes of using noncompliant balloons in lower limb angioplasty for chronic limb threatening ischemia (CLTI).
UNASSIGNED: 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.
UNASSIGNED: 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.
UNASSIGNED: 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.
CONCLUSIONS: 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.