Huang Hsuan-Li, Chou Hsin-Hua, Wu Tien-Yu, Chang Shang-Hung, Tsai Yueh-Ju, Hung Shuo-Suei, Lu Chun-Te, Cheng Shih-Tsung, Yeh Kuan-Hung, Chang Heng-Chia
Section of Cardiology, Department of Medicine, Buddhist Tzu Chi General Hospital, Taipei Branch, Taiwan.
Section of Cardiology, Department of Medicine, Buddhist Tzu Chi General Hospital, Taipei Branch, Taiwan.
J Formos Med Assoc. 2014 Oct;113(10):688-95. doi: 10.1016/j.jfma.2012.10.022. Epub 2013 Jan 18.
BACKGROUND/PURPOSE: Midterm outcomes of endovascular intervention (EVI) for critical limb ischemia (CLI) have not been previously reported in Taiwan. This study assessed the safety, feasibility, and patient-oriented outcomes for CLI patients after EVI.
From June 2005 to December 2011, 270 patients underwent EVI for CLI of 333 limbs. Primary patency (PP), assisted primary patency (AP), limb salvage, sustained clinical success (SCS), secondary SCS (SSCS), and survival were assessed using Kaplan-Meier analysis.
The procedural success rate was 89%, and the periprocedural mortality and major complication rates within 30 days were 0.6% and 6.9%, respectively. During the mean follow-up time of 27 ± 20 months (1-77), 64 patients died and 25 legs required major amputation. Eighty-one percent of the patients with tissue loss had wound healing at 6 months and 75% of the patients were ambulatory, with or without assisting devices, at 1 year. The overall survival and limb salvage rates at 3 years were 70% and 90%, respectively. The PP and AP at 1 and 3 years were 58% and 37% and 79% and 61%, respectively. The SCS and SSCS were 65% and 46% and 80% and 64% at 1 and 3 years, respectively.
In Taiwan, EVI was a safe and feasible procedure for CLI patients, with a high procedural success rate and lower complication rate. Sustained limb salvage and clinical success can be afforded with an active surveillance program and prompt intervention during midterm follow-up.
背景/目的:台湾此前尚未报告过针对严重肢体缺血(CLI)的血管内介入治疗(EVI)的中期结果。本研究评估了EVI术后CLI患者的安全性、可行性及以患者为导向的结果。
2005年6月至2011年12月,270例患者因333条肢体的CLI接受了EVI治疗。采用Kaplan-Meier分析评估主要通畅率(PP)、辅助主要通畅率(AP)、肢体挽救率、持续临床成功率(SCS)、二次SCS(SSCS)和生存率。
手术成功率为89%,围手术期30天内的死亡率和主要并发症发生率分别为0.6%和6.9%。在平均27±20个月(1 - 77个月)的随访期内,64例患者死亡,25条腿需要进行大截肢。81%有组织缺损的患者在6个月时伤口愈合,75%的患者在1年时可独立行走,无论是否使用辅助装置。3年时的总生存率和肢体挽救率分别为70%和90%。1年和3年时的PP和AP分别为58%和37%以及79%和61%。1年和3年时的SCS和SSCS分别为65%和46%以及80%和64%。
在台湾,EVI对于CLI患者是一种安全可行的手术,手术成功率高且并发症发生率低。通过积极的监测计划和中期随访期间的及时干预,可以实现持续的肢体挽救和临床成功。