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膝下吸收性生物可吸收血管支架的初步经验:六个月的临床和影像学结果。

Initial experience with the absorb bioresorbable vascular scaffold below the knee: six-month clinical and imaging outcomes.

作者信息

Varcoe Ramon L, Schouten Olaf, Thomas Shannon D, Lennox Andrew F

机构信息

Prince of Wales Hospital, Sydney, New South Wales, Australia University of New South Wales, Sydney, New South Wales, Australia

Prince of Wales Hospital, Sydney, New South Wales, Australia.

出版信息

J Endovasc Ther. 2015 Apr;22(2):226-32. doi: 10.1177/1526602815575256.

DOI:10.1177/1526602815575256
PMID:25809367
Abstract

PURPOSE

To investigate a new bioresorbable vascular scaffold for the treatment of focal tibial and distal popliteal lesions.

METHODS

Tibial and distal popliteal angioplasty was performed in 15 limbs of 14 patients (9 men; median age 82 years) with critical limb ischemia (CLI, n=7) or severe claudication. The 18 lesions (mean length 22.2±14.0 mm) were implanted with 22 everolimus-eluting bioresorbable scaffolds (Absorb). Clinical and ultrasound follow-up was performed at 1, 3, 6, and 12 months to detect restenosis and evaluate safety, midterm restenosis rate, and clinical improvement.

RESULTS

Immediate technical success was 100%, although a single limb suffered 2 scaffold thromboses on the first day; it was salvaged with repeat endovascular intervention. All patients were available for surveillance examinations during a follow-up of 6.1±3.9 months; no patient died. Of the 15 limbs in the analysis, clinical improvement was present in 12 (4 of 7 CLI patients); there was no amputation, bypass surgery, or evidence of binary restenosis on follow-up sonographic examination.

CONCLUSION

Midterm follow-up for this small pilot sample demonstrates acceptable safety and patency results, together with freedom from all major adverse limb events, using the Absorb bioresorbable vascular scaffold below the knee.

摘要

目的

研究一种用于治疗胫骨局部和腘动脉远端病变的新型生物可吸收血管支架。

方法

对14例患者(9例男性;中位年龄82岁)的15条肢体进行胫骨和腘动脉远端血管成形术,这些患者患有严重肢体缺血(CLI,n = 7)或重度间歇性跛行。18处病变(平均长度22.2±14.0 mm)植入了22个依维莫司洗脱生物可吸收支架(Absorb)。在1、3、6和12个月时进行临床和超声随访,以检测再狭窄并评估安全性、中期再狭窄率和临床改善情况。

结果

即刻技术成功率为100%,尽管有1条肢体在第一天发生了2次支架血栓形成;通过重复血管内介入治疗得以挽救。在6.1±3.9个月的随访期间,所有患者均接受了监测检查;无患者死亡。在分析的15条肢体中,12条肢体有临床改善(7例CLI患者中的4例);随访超声检查未发现截肢、搭桥手术或二元再狭窄证据。

结论

对这个小样本的中期随访表明,使用膝下Absorb生物可吸收血管支架具有可接受的安全性和通畅结果,且无所有主要肢体不良事件。

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