经皮深层静脉动脉化联合不同技术和普通腔内治疗装置治疗慢性肢体严重缺血患者的 12 个月临床结局：DEPARTURE 日本研究结果。
Twelve-Month Clinical Outcomes of Percutaneous Deep Venous Arterialization with Alternative Techniques and Ordinary Endovascular Therapy Devices for Patients with Chronic Limb-Threatening Ischemia: Results of the DEPARTURE Japan Study.
机构信息
Department of Cardiology, Tokyo Bay Medical Center, 3-4-32, Todaijima, Urayasu, Chiba, 279-0001, Japan.
Department of Radiology, Nara University Hospital, Kashihara, Japan.
出版信息
Cardiovasc Intervent Radiol. 2022 May;45(5):622-632. doi: 10.1007/s00270-022-03095-1. Epub 2022 Mar 11.
PURPOSE
A dedicated treatment strategy is not yet established for patients with no-option chronic limb-threatening ischemia. This study aimed to evaluate the clinical outcomes of percutaneous deep venous arterialization in Japanese patients with no-option chronic limb-threatening ischemia.
MATERIALS AND METHODS
Data of 18 consecutive patients with chronic limb-threatening ischemia (18 limbs; mean age: 75.5 ± 8.5 years; 14 men) who underwent percutaneous deep venous arterialization between January 2016 and November 2020 were retrospectively reviewed. The limb salvage, amputation-free survival, and wound healing rates were evaluated using the Kaplan-Meier method.
RESULTS
Among 18 patients, 14 (77.8%) had diabetes, 6 (33.3%) had a non-ambulatory status, 16 (88.9%) received hemodialysis, and 15 (83.3%) had wound, ischemia, and foot infection of clinical stage 4. Rutherford 5 was observed in 33.7% of the patients and Rutherford 6 in 66.7%. The technical success rate of percutaneous deep venous arterialization was 88.9%. Four patients required major amputation within 30 days; percutaneous deep venous arterialization failed in two of these patients. At 6 and 12 months, the limb salvage rates, amputation-free survival rates, and complete wound healing rates were 72.2 and 72.2%, 55.6 and 49.4%, and 23.0 and 53.2%, respectively. The median time to complete wound healing was 234 (interquartile range, 127-306) days.
CONCLUSION
This study presented the clinical outcomes of patients with chronic limb-threatening ischemia who underwent percutaneous deep venous arterialization in Japan. Acceptable, safe, and efficacious results were reported. Before major amputation, percutaneous deep venous arterialization can be considered for patients with no-option chronic limb-threatening ischemia.
LEVEL OF EVIDENCE
Level 3. Non-randomized, follow-up study.
目的
对于无选择的慢性肢体威胁性缺血患者，尚未建立专门的治疗策略。本研究旨在评估经皮深静脉动脉化在日本无选择慢性肢体威胁性缺血患者中的临床疗效。
材料与方法
回顾性分析 2016 年 1 月至 2020 年 11 月期间接受经皮深静脉动脉化治疗的 18 例慢性肢体威胁性缺血患者（18 条肢体；平均年龄 75.5±8.5 岁；14 例男性）的临床资料。采用 Kaplan-Meier 法评估保肢率、无截肢生存率和创面愈合率。
结果
18 例患者中，14 例（77.8%）患有糖尿病，6 例（33.3%）为非卧床状态，16 例（88.9%）接受血液透析，15 例（83.3%）创面、缺血和足部感染处于临床 4 期。33.7%的患者为 Rutherford 5 期，66.7%的患者为 Rutherford 6 期。经皮深静脉动脉化技术成功率为 88.9%。4 例患者在 30 天内需要进行大截肢，其中 2 例患者经皮深静脉动脉化治疗失败。6 个月和 12 个月时，保肢率、无截肢生存率和完全创面愈合率分别为 72.2%和 72.2%、55.6%和 49.4%、23.0%和 53.2%。完全创面愈合的中位时间为 234（四分位间距，127-306）天。
结论
本研究报告了日本接受经皮深静脉动脉化治疗的慢性肢体威胁性缺血患者的临床疗效。结果显示该方法安全有效。对于无选择的慢性肢体威胁性缺血患者，在进行大截肢前，可考虑行经皮深静脉动脉化治疗。
证据等级
3 级，非随机、随访研究。
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