Kudo Toshifumi, Chandra Fiona A, Ahn Samuel S
Gonda (Goldschmied) Vascular Center, University of California at Los Angeles, 90095, USA.
J Vasc Surg. 2005 Sep;42(3):466-75. doi: 10.1016/j.jvs.2005.05.002.
To review our 11-year experience of iliac angioplasty with selective stenting and to evaluate the safety, short- and long-term patency, clinical success rates, and predictive risk factors in patients with iliac artery occlusive disease.
From August 1993 to November 2004, 151 iliac lesions (149 stenoses, 2 occlusions) in 104 patients were treated by percutaneous transluminal angioplasty (PTA). The patients had chronic limb ischemia described as disabling claudication (the Society for Vascular Surgery clinical category 2 or 3) in 76 (50%), rest pain (category 4) in 38 (25%), and ulcer/gangrene (category 5) in 37 (25%). Forty-six limbs (30%) were treated with concomitant infrainguinal endovascular (36, 24%) or open procedures (10, 6%). Thirty-four limbs (23%) had one or more stents placed for primary PTA failure, including residual stenosis (> or =30%), mean pressure gradient (> or =5 mm Hg), or dissection (stent group); whereas, 117 limbs (77%) underwent PTA alone (PTA group). The affected arteries treated were 28 (19%) common iliac, 31 (20%) external iliac, and 92 (61%) both arteries. According to TransAtlantic Inter-Society Consensus (TASC) classification, 39 limbs (26%) were in type A, 71 (47%) in type B, 36 (24%) in type C, and 5 (3%) in type D. Reporting standards of the Society for Vascular Surgery and the International Society for Cardiovascular Surgery were followed.
There was no perioperative death. Total complication rate was 0.7% (one groin hematoma). The mean follow-up was 21 months (median, 10; range, 1 to 94 months). Only 9 (8%) of 117 of the PTA group had subsequent stent placement for recurrent stenosis. The iliac lesions were more severe and extensive in the stent group than those in the PTA group according to TASC classification (Mann-Whitney U test [M-W], P < .0001) and anatomic location (M-W, P = .0019). The technical success rate was 99%, and the initial clinical success rate was 99%. Overall, the cumulative primary patency rates at 1, 3, and 5 years were 76%, 59%, and 49% (Kaplan-Meier [K-M]). The cumulative assisted primary and secondary patency rates at 7 years were 98% and 99% (K-M). The mean number of subsequent iliac endovascular procedures was 1.4 per limb in patients with primary failure of iliac angioplasty/stenting. The continued clinical improvement rates at 1, 3, and 5 years were 81%, 67%, and 53% (K-M). The limb salvage rates at 7 year were 93% (K-M). Of 15 predictor variables studied in 151 iliac lesions, the significant independent predictors for adverse outcomes were smoking history (P = .0074), TASC type C/type D lesions (P = .0001), and stenotic ipsilateral superficial femoral artery (P = .0002) for the primary patency rates; chronic renal failure with hemodialysis (P = .014), ulcer/gangrene as an indication for PTA (P < .0001), and stenotic ipsilateral superficial femoral artery (P = .034) for the continued clinical improvement (K-M, log-rank test and Cox regression model).
Although the primary patency rates were not high, the assisted primary and secondary patency rates were excellent without primary stenting. Overall, >70% of iliac lesions were treated successfully with PTA alone. The results of this study show that selective stenting offers satisfactory assisted primary and secondary long-term patency after iliac angioplasty. Patients with TASC type C/type D iliac lesions, a stenotic ipsilateral superficial femoral artery, ulcer/gangrene, smoking history, and chronic renal failure with hemodialysis should be followed carefully after endovascular iliac revascularization. These risk factors could be considered indications for primary stenting, although further studies are needed to confirm this.
回顾我们11年来髂血管成形术联合选择性支架置入的经验,并评估髂动脉闭塞性疾病患者的安全性、短期和长期通畅率、临床成功率以及预测风险因素。
1993年8月至2004年11月,对104例患者的151处髂血管病变(149处狭窄,2处闭塞)进行了经皮腔内血管成形术(PTA)治疗。患者中,76例(50%)有慢性肢体缺血,表现为致残性间歇性跛行(血管外科学会临床分级2级或3级),38例(25%)有静息痛(4级),37例(25%)有溃疡/坏疽(5级)。46条肢体(30%)同时接受了股下血管腔内治疗(36条,24%)或开放手术(10条,6%)。34条肢体(23%)因原发性PTA失败(包括残余狭窄(≥30%)、平均压力梯度(≥5 mmHg)或夹层)而置入了一个或多个支架(支架组);而117条肢体(77%)仅接受了PTA(PTA组)。所治疗的受累动脉中,28条(19%)为髂总动脉,31条(20%)为髂外动脉,92条(61%)为双侧动脉。根据跨大西洋两岸血管外科学会共识(TASC)分类,39条肢体(26%)为A型,71条(47%)为B型,36条(24%)为C型,5条(3%)为D型。遵循血管外科学会和国际心血管外科学会的报告标准。
无围手术期死亡。总并发症发生率为(0.7%(1例腹股沟血肿)。平均随访时间为21个月(中位数为10个月;范围为1至94个月)。PTA组117例中只有9例(8%)因再狭窄而随后置入了支架。根据TASC分类(Mann-Whitney U检验[M-W],P <.0001)和解剖位置(M-W,P =.0019),支架组的髂血管病变比PTA组更严重、更广泛。技术成功率为99%,初始临床成功率为99%。总体而言,1年、3年和5年的累积原发性通畅率分别为76%、59%和49%(Kaplan-Meier[K-M])。7年时的累积辅助原发性和继发性通畅率分别为98%和99%(K-M)。髂血管成形术/支架置入原发性失败的患者中,每条肢体随后髂血管腔内手术的平均次数为1.4次。1年、3年和5年时持续临床改善率分别为81%、67%和53%(K-M)。7年时的肢体挽救率为93%(K-M)。在151处髂血管病变中研究的15个预测变量中,原发性通畅率的显著独立预测不良结局的因素为吸烟史(P =.0074)、TASC C型/D型病变(P =.0001)和同侧股浅动脉狭窄(P =.0002);持续临床改善的因素为慢性肾衰竭伴血液透析(P =.014)、溃疡/坏疽作为PTA的指征(P <.0001)和同侧股浅动脉狭窄(P =.034)(K-M、对数秩检验和Cox回归模型)。
虽然原发性通畅率不高,但在不进行原发性支架置入的情况下,辅助原发性和继发性通畅率良好。总体而言,>70%的髂血管病变仅通过PTA即可成功治疗。本研究结果表明,选择性支架置入在髂血管成形术后提供了令人满意的辅助原发性和继发性长期通畅率。对于TASC C型/D型髂血管病变、同侧股浅动脉狭窄、溃疡/坏疽、吸烟史以及慢性肾衰竭伴血液透析的患者,在髂血管腔内血管重建术后应密切随访。这些危险因素可被视为原发性支架置入的指征,尽管还需要进一步研究来证实这一点。