Shammas Nicolas W, Dippel Eric J, Coiner Denise, Shammas Gail A, Jerin Michael, Kumar Alisha
Midwest Cardiovascular Research Foundation, Davenport, IA 52803, USA.
J Endovasc Ther. 2008 Jun;15(3):270-6. doi: 10.1583/08-2397.1.
To report the results from a single-center prospective registry (PROTECT) established to evaluate the safety and effectiveness of embolic filter protection (EFP) in reducing distal embolization during percutaneous lower extremity interventions.
Patients undergoing angioplasty, stenting, or SilverHawk atherectomy and adjunctive balloon angioplasty for infrainguinal occlusive disease were eligible 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. The primary angiographic outcome was the ability of the filter to prevent angiographically visible distal embolization, slow flow, and loss of distal tibial runoff with or without capturing macrodebris.
Forty patients (23 men; mean age 71.4+/-11.5 years) with 56 lesions (42 de novo and 14 restenotic) underwent treatment with angioplasty/stenting (group A, n = 29; 43 lesions) or SilverHawk atherectomy (group B, n = 11; 13 lesions). One filter was used per patient (25 SpiderFX and 15 EmboShield). Macroembolization occurred in 22 (55.0%) patients, 11 (37.9%) in group A and 11 (100%) in group B (p<0.001). Clinically significant (> or =2 mm in diameter) macrodebris was found in 18 (45.0%) patients: 8 (27.6%) in group A and 10 (90.9%) in group B (p<0.001). All filters were retrieved successfully with no complications. One side-branch embolization occurred proximal to the filter. In another case, the filter was overfilled, resulting in no distal flow; it was retrieved, with subsequent tibial embolization when the procedure was continued without protection.
Macroembolization is very frequent in patients undergoing lower extremity interventions, particularly with SilverHawk atherectomy. EFP appears to be very effective in capturing macrodebris, and its use is associated with good acute angiographic outcome. The clinical significance of these findings needs to be determined in future studies.
报告一项单中心前瞻性注册研究（PROTECT）的结果，该研究旨在评估栓塞滤器保护（EFP）在经皮下肢介入治疗中减少远端栓塞的安全性和有效性。
因下肢缺血性疾病接受血管成形术、支架置入术或SilverHawk斑块旋切术及辅助球囊血管成形术的患者，若病变符合以下一项或多项血管造影标准则符合入选条件：（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30 mm的不规则（溃疡）病变；和/或（5）长度至少50 mm的光滑、非溃疡病变。主要血管造影结果是滤器预防血管造影可见的远端栓塞、缓慢血流以及有无捕获大碎片情况下胫后动脉血流减少的能力。
40例患者（23例男性；平均年龄71.4±11.5岁）有56处病变（42处初发病变和14处再狭窄病变）接受了血管成形术/支架置入术治疗（A组，n = 29；43处病变）或SilverHawk斑块旋切术治疗（B组，n = 11；13处病变）。每位患者使用一个滤器（25个SpiderFX滤器和15个EmboShield滤器）。22例（55.0%）患者发生了大栓塞，A组11例（37.9%），B组11例（100%）（p<0.001）。在18例（45.0%）患者中发现了直径≥2 mm的具有临床意义的大碎片：A组8例（27.6%），B组10例（90.9%）（p<0.001）。所有滤器均成功取出，无并发症发生。在滤器近端发生了1例侧支血管栓塞。在另一例中，滤器过度充盈，导致无远端血流；滤器被取出，在未使用保护装置继续进行手术时随后发生了胫后动脉栓塞。
在接受下肢介入治疗的患者中，尤其是接受SilverHawk斑块旋切术的患者，大栓塞非常常见。EFP在捕获大碎片方面似乎非常有效，其使用与良好的急性血管造影结果相关。这些发现的临床意义需要在未来的研究中确定。
