Vascular medicine department, Groupe Hospitalier Paris Saint-Joseph, Resident Sorbonne Université, Paris, France; Department of Clinical Research, GH Paris Saint-Joseph, 185, rue Raymond Losserand, 75014 Paris, France.
Vascular medicine department, Groupe Hospitalier Paris Saint-Joseph, Resident Sorbonne Université, Paris, France.
J Med Vasc. 2022 Oct;47(4):175-185. doi: 10.1016/j.jdmv.2022.10.007. Epub 2022 Oct 29.
Revascularization procedures are considered the cornerstone of therapy in patients with critical limb ischemia (CLI) and multiple procedures are often required to attain limb salvage. The aim of the present study is to determine the prevalence of peri-procedural complications after endovascular procedure, and to determine the clinical and biological characteristics of patients associated to the risk of peri-procedural complications.
From November 2013 to May 2021, 324 consecutive patients were retrospectively included, of whom 99 underwent more than one revascularization procedure for contralateral CLI or clinical recurrence of CLI. A total of 532 revascularizations were performed. Clinical and biological parameters were recorded at baseline before endovascular revascularization. The occurrence of a peri-procedural complication (local complications, fatal and non-fatal major bleeding or cardiovascular events) was recorded up to 30days after revascularization. Univariate and multivariate analyses were performed to study the parameters associated with per-procedural complications. A P<0.05 was considered as statistically significant.
A total of 324 consecutive patients were included, 177 men and 147 women with CLI, with a mean age of 77.6±11.9years. Most of these patients had cardiovascular comorbidities (41% with a history of coronary heart disease, 78% treated hypertensive patients, 49% diabetic patients). Peri-procedural mortality occurred in 13 patients (4%) and 9 patients (2.8%) experienced major amputation at one-month following revascularization. Among the 532 revascularization procedures, 99 major bleeding events (22.8% of the cohort population) and 31 cardiovascular events (8.6% of the cohort population), were recorded in the peri-procedural period. Cardiovascular events were associated with peri-procedural mortality. Complications at the puncture site occurred during 38 of the 532 procedures (10.2% of the cohort population). Compared with patients undergoing a single revascularization procedure, patients with multiple procedures presented a higher risk of major bleeding events (48.5% vs. 11.6%, P<0.0001) and access site complications (20.2% vs. 5.78%, P<0.0001). In multivariate analysis, pulse pressure <60mmHg and hemoglobin level <10g/dl were correlated with the occurrence of major bleeding events; left ventricular ejection fraction<60% and the absence of statin treatment were correlated with the occurrence of cardiovascular complications; a high chronological rank of revascularization was correlated with the occurrence of local complication. Finally, age and gender were not associated with the occurrence of peri-procedural complication.
The present results highlight that multiple revascularization procedures for limb salvage are required in almost one third of the population with critical limb ischemia and were associated with the risk of major bleeding events and access site complications. The most frequent complications of peripheral vascular interventions were major bleeding events. Adverse cardiovascular events were related with peri-procedural mortality. Anemia, blood pressure, left ventricular ejection fraction and statin treatment are important parameters to consider for peri-procedural outcomes, independently of age, gender and the chronological rank of revascularization procedure.
血运重建术被认为是治疗严重肢体缺血（CLI）患者的基石，通常需要多次手术才能实现肢体挽救。本研究旨在确定血管腔内手术后围手术期并发症的发生率，并确定与围手术期并发症风险相关的患者的临床和生物学特征。
回顾性纳入 2013 年 11 月至 2021 年 5 月期间的 324 例连续患者，其中 99 例因对侧 CLI 或 CLI 临床复发而行多次血运重建术。共进行了 532 次血运重建术。在血管腔内血运重建前记录基线时的临床和生物学参数。记录血管重建术后 30 天内围手术期并发症（局部并发症、致命和非致命大出血或心血管事件）的发生情况。进行单因素和多因素分析以研究与围手术期并发症相关的参数。P<0.05 被认为具有统计学意义。
共纳入 324 例连续患者，其中 177 例为男性，147 例为女性，CLI 患者平均年龄为 77.6±11.9 岁。这些患者大多存在心血管合并症（41%有冠心病病史，78%为高血压患者，49%为糖尿病患者）。术后 13 例（4%）发生围手术期死亡，9 例（2.8%）在血管重建术后 1 个月发生主要截肢。在 532 次血运重建术中有 99 例发生大出血事件（占队列人群的 22.8%）和 31 例心血管事件（占队列人群的 8.6%）。在围手术期期间，有 38 次血运重建术（占队列人群的 10.2%）发生穿刺部位并发症。与单次血运重建术相比，多次血运重建术的患者大出血事件（48.5% vs. 11.6%，P<0.0001）和入路并发症（20.2% vs. 5.78%，P<0.0001）的风险更高。多因素分析显示，脉压<60mmHg 和血红蛋白水平<10g/dl 与大出血事件的发生相关；左心室射血分数<60%和未接受他汀类药物治疗与心血管并发症的发生相关；血运重建术的时间顺序较高与局部并发症的发生相关。最后，年龄和性别与围手术期并发症的发生无关。
本研究结果表明，近三分之一的严重肢体缺血患者需要多次血运重建术来挽救肢体，这与大出血事件和入路并发症的风险相关。外周血管介入术最常见的并发症是大出血事件。不良心血管事件与围手术期死亡率相关。贫血、血压、左心室射血分数和他汀类药物治疗是围手术期结局的重要参数，与年龄、性别和血运重建术的时间顺序无关。
