Department of Vascular Surgery, Policlinico Sant'Orsola Malpighi, IRCCS, Bologna, Italy.
Department of Vascular Surgery, University of Bologna, DIMEC, Bologna, Italy.
Int Angiol. 2023 Jun;42(3):209-215. doi: 10.23736/S0392-9590.23.04992-1. Epub 2023 Apr 17.
Critical limb threatening-ischemia (CLTI) can be due to an extensive involvement of both the aorto-iliac (AI) and the infra-inguinal (II) districts and the efficacy of and extensive AI+II vs. only AI revascularization is still matter of debate. The aim of the present study was to evaluate the outcome in CLTI patients with concomitant AI and II peripheral artery disease (PAD) after revascularization limited to the AI or extended also to the II segment.
Patients with CLTI and concomitant AI (TransAtlantic InterSociety Consensus: C-D) and II PAD (Global-Anatomic-Staging-System: II-III) from 2016 to 2021 were retrospectively evaluated. Patients were compared according to type of revascularization: limited to AI vs. AI+II. Common femoral and profunda artery endarterectomy (C/P-TEA) was considered in both groups. Perioperative mortality, limb salvage, foot healing (within 6 months after surgery), necessity of adjunctive revascularization and survival were analyzed and the follow-up performed with clinical and duplex assessment every six months. The primary endpoint was to evaluate the composite event of limb salvage, wound healing and necessity of adjunctive revascularization during follow-up in AI vs. AI+II groups, through Kaplan Meier and Cox regression analysis.
Over a total of 1105 peripheral revascularizations for CLTI, 96 (8.7%) patients met the inclusion criteria for the study. AI revascularization was performed in 38 (40%) and AI+II in 58 (60%). AI and AI+II groups were similar for preoperative risk factors and extension of PAD with the exception of American Society of Anesthesiology (ASA) Classification (ASA IV: 50% vs. 25%, P=0.02, respectively). The AI group was treated with angioplasty/stenting in all cases and with C/P-TEA in 20 (52%) cases. In the AI+II group, the AI district was treated by angioplasty/stenting in 55 (95%) and by aorto-bifemoral bypass in 3 (5%) and C/P-TEA in 20 (34%). The II revascularization was performed by femoro-popliteal/tibial bypass in 27 (47%); and endovascular revascularization in 31 (53%) patients. Minor amputation rate was similar between AI and AI+II revascularization (39% vs. 48%, P=1.0); length of stay, blood transfusion units, were significantly higher in AI+II group: 7±4 days vs. 12±5 days, P=0.04 and 2±2 vs. 4±2, P=0.02. The 30-day mortality was 7% with no differences according to the type of treatment. At a mean follow-up of 28±10 months, the overall limb salvage was 87±4% with similar results in AI vs. AI+II revascularization (95±5% vs. 86±6%; P=0.56). AI had a higher necessity of adjunctive revascularization and lower wound healing compared to AI+II (18±9% vs. 0%, P=0.02; 72% vs. 100%, P=0.001, respectively). AI+II was associated with a better primary endpoint compared to AI (87±5% vs. 53±9%, P=0.01), and it was confirmed in Rutherford 5 and 6 patients (100% vs. 54±14%, P=0.01; 78±9 vs. 50±13%, P=0.04), and no differences in Rutherford 4 (100% vs. 100%). Cox regression analysis confirmed AI+II as an independent protector for the primary outcome (hazard ratio: 0.23, 95% confidence interval 0.08-0.71).
CLTI with extensive PAD disease can be treated with limited AI revascularization in Rutherford 4 patients however in case of category 5 or 6 an extensive revascularization (AI+II) should be considered.
严重肢体缺血（CLI）可能由于广泛累及腹主动脉-髂动脉（AI）和下肢动脉（II），且 AI+II 与仅 AI 血运重建的疗效和广泛程度仍存在争议。本研究的目的是评估在伴有 AI 和 II 段外周动脉疾病（PAD）的 CLI 患者中，血运重建仅限于 AI 或扩展至 II 段的结果。
回顾性评估了 2016 年至 2021 年患有 CLI 和同时伴有 AI（跨大西洋协会共识：C-D）和 II 段 PAD（全球解剖分期系统：II-III）的患者。根据血运重建类型将患者进行比较：仅限于 AI 与 AI+II。两组均考虑股总动脉和股深动脉内膜切除术（C/P-TEA）。分析围手术期死亡率、肢体存活率、足部愈合（术后 6 个月内）、需要辅助血运重建和生存情况，并每 6 个月通过临床和双功能超声评估进行随访。主要终点是通过 Kaplan-Meier 和 Cox 回归分析，评估 AI 与 AI+II 组在随访期间的肢体存活率、伤口愈合和需要辅助血运重建的复合事件。
在总共 1105 例 CLI 外周血运重建中，96 例（8.7%）患者符合研究纳入标准。38 例（40%）患者行 AI 血运重建，58 例（60%）患者行 AI+II 血运重建。AI 和 AI+II 两组在术前危险因素和 PAD 程度方面相似，但在麻醉科医师协会（ASA）分类方面除外（ASA Ⅳ：50%比 25%，P=0.02）。AI 组所有病例均采用血管成形术/支架置入治疗，20 例（52%）采用 C/P-TEA 治疗。在 AI+II 组中，AI 区通过血管成形术/支架置入治疗 55 例（95%），通过腹主动脉-双侧股动脉旁路治疗 3 例（5%），C/P-TEA 治疗 20 例（34%）。II 段血运重建通过股-腘/胫动脉旁路治疗 27 例（47%）；腔内血运重建 31 例（53%）。AI 和 AI+II 血运重建的小截肢率相似（39%比 48%，P=1.0）；AI+II 组的住院时间和输血量明显更高：7±4 天比 12±5 天，P=0.04；2±2 单位比 4±2 单位，P=0.02。30 天死亡率为 7%，治疗方式无差异。在平均 28±10 个月的随访中，整体肢体存活率为 87±4%，AI 与 AI+II 血运重建的结果相似（95±5%比 86±6%；P=0.56）。AI 的辅助血运重建需求更高，伤口愈合率更低，与 AI+II 相比（18±9%比 0%，P=0.02；72%比 100%，P=0.001）。与 AI 相比，AI+II 与更好的主要终点相关（87±5%比 53±9%，P=0.01），在 Rutherford 5 和 6 患者中得到证实（100%比 54±14%，P=0.01；78±9 比 50±13%，P=0.04），Rutherford 4 患者无差异（100%比 100%）。Cox 回归分析证实 AI+II 是主要结局的独立保护因素（风险比：0.23，95%置信区间 0.08-0.71）。
在 Rutherford 4 患者中，严重肢体缺血伴广泛 PAD 疾病可采用有限的 AI 血运重建治疗，但在 Rutherford 5 或 6 类患者中，应考虑广泛血运重建（AI+II）。
