Shammas Nicolas W, Coiner Denise, Shammas Gail A, Christensen Lori, Dippel Eric J, Jerin Michael
Midwest Cardiovascular Research Foundation, Davenport, Iowa 52803, USA.
J Endovasc Ther. 2009 Apr;16(2):197-202. doi: 10.1583/08-2642.1.
To report the results from a single-center prospective registry (DEEP EMBOLI) established to evaluate distal embolization during percutaneous lower extremity interventions using excimer laser ablative therapy.
Elective patients with infrainguinal occlusive disease were eligible for this registry if the lesion(s) met one or more of these angiographic criteria: (1) moderate or severe calcification of any length, (2) total occlusions of any length, (3) a filling defect, (4) irregular (ulcerated) lesions at least 30 mm in length, and/or (5) smooth, non-ulcerated lesions at least 50 mm in length. In all, 20 patients (15 women; mean age 70.9+/-10.8 years) with 28 lesions (de novo 13, restenotic 15) were enrolled and underwent treatment with laser atherectomy. SpiderFx filters were utilized before laser treatment in 18 of 20 patients and before final definitive treatment with angioplasty +/- stenting in all 20 patients. The primary angiographic outcome was a residual narrowing of <30% or 30% to 50% with <20 mmHg gradient across lesion after final treatment. The primary safety endpoint was the embolization rate produced by the laser based on the presence of clinically significant (>or=2 mm long) macrodebris in the filter.
Adjunctive angioplasty and stenting were performed in 27 (96.4%) and 17 (60.7%) lesions, respectively. All filters were deployed and retrieved successfully, with no complications. The primary angiographic endpoint was met in 100% of patients. Macrodebris was found in 12 (66.7%) of 18 patients after treatment with the laser [4 (22.2%) filters with clinically significant emboli] and in 7 (35%) of 20 patients after adjunctive treatment [4 (20.0%) clinically significant emboli]. One (5.0%) distal embolization occurred after filter removal prior to completion of definitive treatment.
Embolization does occur with laser photoablation in the lower extremity, but the rate of clinically significant macrodebris is low ( approximately 20%) and similar to that found after angioplasty and stenting. Embolic filter protection appears to be very effective in capturing macrodebris, and its use is associated with good acute angiographic outcome. Problems with filter retrieval were not encountered.
报告一项单中心前瞻性注册研究（DEEP EMBOLI）的结果，该研究旨在评估准分子激光消融疗法在经皮下肢介入治疗过程中的远端栓塞情况。
如果病变符合以下一项或多项血管造影标准，则患有腹股沟下闭塞性疾病的择期患者符合该注册研究的条件：（1）任何长度的中度或重度钙化；（2）任何长度的完全闭塞；（3）充盈缺损；（4）长度至少为30 mm的不规则（溃疡）病变；和/或（5）长度至少为50 mm的光滑、非溃疡病变。共有20例患者（15例女性；平均年龄70.9±10.8岁），患有28处病变（初发13处，再狭窄15处），被纳入研究并接受了激光消蚀治疗。20例患者中有18例在激光治疗前使用了SpiderFx滤器，所有20例患者在最终进行血管成形术±支架置入的确定性治疗前均使用了该滤器。主要血管造影结果是最终治疗后残余狭窄<30%或30%至50%，病变两端压力阶差<20 mmHg。主要安全终点是基于滤器中存在临床上有意义的（≥2 mm长）大碎片来确定激光产生的栓塞率。
分别有27处（96.4%）和17处（60.7%）病变进行了辅助血管成形术和支架置入。所有滤器均成功置入和取出，无并发症发生。100%的患者达到了主要血管造影终点。激光治疗后，18例患者中有12例（66.7%）发现有大碎片[4例（22.2%）滤器中有临床上有意义的栓子]，辅助治疗后20例患者中有7例（35%）发现有大碎片[4例（20.0%）临床上有意义的栓子]。在完成确定性治疗前取出滤器后发生了1例（5.0%）远端栓塞。
下肢激光光凝消融确实会发生栓塞，但临床上有意义的大碎片发生率较低（约20%），与血管成形术和支架置入术后的发生率相似。栓塞滤器保护似乎能非常有效地捕获大碎片，其使用与良好的急性血管造影结果相关。未遇到滤器取出问题。
