NEW YORK (EGMN) – Choice of procedure for lower-leg revascularization, whether angioplasty, atherectomy, or laser treatment, may influence distal embolization rates and the need for embolic protection devices, according to a study presented at the annual meeting of the Eastern Vascular Society.

The study from Columbia University Medical Center in New York found that distal embolization occurred in fewer than 2% of all revascularization procedures studied, but that newer atherectomy devices may be linked to higher complication rates, Dr. Gauram Shrikhande reported. The study reviewed runoff in 2,137 lesions in approximately 1,000 patients treated from 2004 to 2009.

“On angiography, significant embolization occurs at a lower rate during percutaneous low-extremity interventions, and although rare, it does not affect patency and limb salvage rates if runoff can be reestablished using salvage techniques at the time of the procedure,” Dr. Shrikhande said.

However, the analysis showed higher rates of distal embolization with newer atherectomy devices, he said. “Distal embolization during the time of percutaneous lower-extremity intervention is a major concern due to ischemic consequences,” Dr. Shrikhande said. “As percutaneous lower-extremity arterial interventions become commonplace and devices are rapidly introduced, it is necessary that we better define rates of distal embolization.”

The study compared outcomes among five types of interventions: angioplasty alone; angioplasty with stent; the SilverHawk plaque excision system (FoxHollow Technologies); two newer atherectomy devices – the Diamondback 360 (CSI) and the Jet Stream G2 device (Pathway Medical Technologies Inc.); and an excimer laser (Spectranetics Corp.).

In the study, distal embolization rates ranged from less than 1.0% with both angioplasty procedures and 1.9% for the SilverHawk device to 3.6 % for the excimer laser and 22% for the newer atherectomy devices, he said. “Embolic protection may be considered for certain atherectomy devices, in TASC C and D lesions, and for chronic total occlusions and in-stent restenosis,” Dr. Shrikhande said.

The average age of the patients was 71 years; 57% were male, 57% had diabetes mellitus, and 54% had a history of smoking. Indications for intervention were claudication in 44%, tissue loss in 42%, and leg pain at rest in 14%.

The lesions were characterized as stenotic (62.4%), chronic total occlusions (28.8%), and in-stent restenosis (8.8%), according to study results. “Total occlusions and in-stent restenosis lesions had higher rates of embolization than native stenotic lesions,” Dr. Shrikhande said. The average length of treated lesions was 10 cm, and 30% were located in the femoral artery.

One of the problems with the study was the relatively low number of patients treated with the newer atherectomy devices, Dr. Shrikhande acknowledged. “This is an ongoing collection of data, and we hope to continue to collect data and update these results,” he said.

The results provide cause for rethinking the management of specific lesions, Dr. Shrikhande said. “For in-stent restenosis, I would be more cautions using the newer atherectomy devices, and I would heavily consider using a distal embolic protection device at the outset the procedure,” he said.

Dr. Linda Harris of Buffalo, New York, raised an issue of cost with atherectomy. “You’ve shown that all the atherectomy devices have a higher rate of peripheral embolization,” she said. “They already cost more than the balloons we use for angioplasty and/or stents, now you’re adding potentially embolic protection devices and/or catheters to withdraw the clot that you’ve now embolized.” She questioned the utility and cost-benefit of any atherectomy device.

The Columbia study did not include a cost analysis, Dr. Shrikhande said. “I do still feel, however, that the atherectomy devices do have an important role in certain lesions – peripheral lesions, popliteal lesions, and osteal-tibial lesions,” he said. “I would continue to use them in selected situations, with the caveats of potential embolization risks.”

Dr. Shrikhande had no disclosures relevant to the study.

Copyright (c) 2010 Elsevier Global Medical News. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

纽约(EGMN)——据一项研究结果表明，在为小腿血运重建选择手术方法时，无论是采用血管成形术、粥样斑切除术或是激光治疗均可能影响肢体远端血栓形成率及血栓预防设备使用率。

 

本研究对近1,000例患者(纳入时间为2004~2009年间)的2,137处血管病变术后血流畅通情况进行了回顾性调查。患者平均年龄71岁，57%为男性，另有57%的患者存在糖尿病，54%的患者有吸烟史。进行血管介入治疗的适应证分别为间歇性跛行(44%)，组织缺损(42%)，下肢疼痛(14%)。患者的病变类型分别为血管狭窄(62.4%)、慢性完全闭塞(28.8%)和支架内再狭窄(8.8%)。存在慢性完全闭塞和支架内再狭窄的患者血栓发生率高于仅存在血管狭窄的患者。病变平均长度为10 cm，有30%位于股动脉。研究者对下列5种不同术式进行了比较：单用血管成形术，血管成形术外加血管内支架植入，SilverHawk斑块切除系统(FoxHollow技术公司)，2种新型粥样斑切除术设备——Diamondback 360系统(CSI公司)和Jet Stream G2设备(Pathway医疗技术公司)，准分子激光设备(Spectranetics公司)。

 

结果表明，在所有接受血运重建术的患者中，远端血管栓塞发生率＜2%，应用2种血管成形术的患者肢体远端血栓形成率均＜1%，应用SilverHawk设备和准分子激光治疗的患者血栓发生率分别为3.6%和22%。接受经皮近端下肢血管成形术的部分患者出现了明显的血管栓塞，但其发生率较低，且如果在施术时应用血液回收技术成功恢复血运，则不会影响血管通畅和保肢术的成功率。在粥样斑切除术中使用新型设备可能会增大肢体远端血栓形成几率，尤其是接受经皮下肢粥样斑切除术的患者可能会因为下肢远端血运不畅进而导致血栓形成。

 

随着经皮下肢血管介入治疗的普遍应用，新型设备也不断涌现，更精确界定肢体远端血管栓塞的几率是十分必要的。研究结果提示，应重新思考对具体病变的治疗方案，譬如对存在支架内再狭窄的患者行粥样斑切除术时应用新型设备应持谨慎态度，如果患者TASC病变分型为C型和D型，或存在血管慢性完全闭塞及支架内再狭窄，则在手术开始时就应考虑应用肢体远端血栓预防设备。粥样斑切除术是外周病变、腘血管病变、胫骨血管病变的重要备选术式，但患者血栓形成风险较高。鉴于粥样斑切除术的费用原本就高于球囊血管成形术，加用血栓预防设备会使粥样斑切除术在成本-收益比这一指标上劣势更为明显。本研究局限在于粥样斑切除术中应用新型设备的患者数相对较少。

 

研究者表示无研究相关披露。

 

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