斑块旋切术联合药物涂层球囊治疗股腘动脉病变的应用研究
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摘要
目的:探讨TurboHawk斑块旋切导管(DA)联合紫杉醇药物涂层球囊(PCB)治疗下肢股腘动脉(FPA)狭窄及闭塞性病变的疗效及安全性。方法:选取2016年9月-2017年8月我院收治的17例下肢动脉硬化闭塞症患者,男11例,女6例,平均年龄(73.2±7.5)岁,14例(82%)患肢Rutherford分级>4级,表现为患肢严重缺血,靶病变为股腘动脉,接受了DA联合PCB的腔内治疗方案。术前、术后常规双联抗血小板治疗,术后3、6、12个月复查患肢踝肱指数(ABI)、彩色超声或CTA随访。结果:17例患者接受了上述治疗方案,平均病变长度为(286.1±69.4)mm,全部靶病变血管再通成功,1例顽固性狭窄行支架补救,技术成功率为94.1%(16/17),8例术前已有足趾坏死者接受截趾术,均经治疗创面完全愈合且不影响行走。术后即刻患肢缺血症状改善,Rutherford分级明显下降,差异均有统计学意义,术后ABI比术前明显提高(0.99±0.10 vs.0.30±0.19,t=15.31,P<0.05)。随访3~14个月,平均(7.4±3.8)个月,全部患者下肢缺血症状无复发,保肢率为100%;随访期间未见明显需手术干预的复发狭窄,一期管腔通畅率为100%。住院及随访期间无严重手术相关并发症。结论:DA联合PCB治疗下肢股腘动脉病变是安全有效的,近期通畅率高。
Objective: To evaluate the safety and effect of directional atherectomy(DA) combined with paclitaxel-coated balloon(PCB) angioplasty in treatment of atherosclerotic lesions in femoropopliteal artery. Methods: Seventeen cases with femoropopliteal occlusion[mean age of(73.2±7.5) years-old; 11 male and 6 female] were analyzed. In 14 cases(82%), the Rutherford level of the affected limb was >4 grade,presented with critical limb ischemia, underwent treatment with DA and PCB angioplasty under filter protection between September 2016 and August 2017. Dual antiplatelet therapy was indicated per-and post-operation.The ankle-brachial index(ABI) was detected before the intervention, after 3, 6 and 12 months. Also clinical examination and target lesion duplex ultrasound scans or computed tomographic angiography(CTA) were done in the observation period. Results : There were 17 cases enrolled, the treated lesion length was( 286. 1 ±69. 4) mm. Successful recanalization of all target lesions, one refractory stenosis was treated with bailout stenting. The technical success rate was 94. 1 %. In eight cases with toe necrosis before operation, foot finger amputations were performed after procedure, to reach complete wound healing and/or preserve deambulation. The post-operation ABI was significantly higher than per-operation( 0. 99 ± 0. 10 vs. 0. 30 ±0. 19, t = 15. 31, P < 0. 05). The mean follow-up was( 7. 4 ± 3. 8) months( 3-14 months). During follow-up, no restenosis requiring re-intervention was found, the primary patency was 100 %, and no DA-related adverse event and symptom recurrence was observed, with the limb salvage rate of 100 %.Conclusion: The DA combined with PCB might be an effective and safe method with a promising high rate of patency.
Objective: To evaluate the safety and effect of directional atherectomy(DA) combined with paclitaxel-coated balloon(PCB) angioplasty in treatment of atherosclerotic lesions in femoropopliteal artery. Methods: Seventeen cases with femoropopliteal occlusion[mean age of(73.2±7.5) years-old; 11 male and 6 female] were analyzed. In 14 cases(82%), the Rutherford level of the affected limb was >4 grade,presented with critical limb ischemia, underwent treatment with DA and PCB angioplasty under filter protection between September 2016 and August 2017. Dual antiplatelet therapy was indicated per-and post-operation.The ankle-brachial index(ABI) was detected before the intervention, after 3, 6 and 12 months. Also clinical examination and target lesion duplex ultrasound scans or computed tomographic angiography(CTA) were done in the observation period. Results : There were 17 cases enrolled, the treated lesion length was( 286. 1 ±69. 4) mm. Successful recanalization of all target lesions, one refractory stenosis was treated with bailout stenting. The technical success rate was 94. 1 %. In eight cases with toe necrosis before operation, foot finger amputations were performed after procedure, to reach complete wound healing and/or preserve deambulation. The post-operation ABI was significantly higher than per-operation( 0. 99 ± 0. 10 vs. 0. 30 ±0. 19, t = 15. 31, P < 0. 05). The mean follow-up was( 7. 4 ± 3. 8) months( 3-14 months). During follow-up, no restenosis requiring re-intervention was found, the primary patency was 100 %, and no DA-related adverse event and symptom recurrence was observed, with the limb salvage rate of 100 %.Conclusion: The DA combined with PCB might be an effective and safe method with a promising high rate of patency.
引文
[1]Schillinger M,Sabeti S,Loewe C,et al.Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery[J].N Engl J Med,2006,354(18):1879-1888.
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[9]Brodmann M,Rief P,Froehlich H,et al.Neointimal hyperplasia after silverhawk atherectomy versus percutaneous transluminal angioplasty(PTA)in femoropopliteal stent reobstructions:a controlled,randomized pilot trial[J].Cardiovasc Intervent Radiol,2013,36(1):69-74.
[10]李伟浩,张韬,沈晨阳.下肢动脉血管成形术后再狭窄的腔内治疗进展[J].中华医学杂志,2014,(32):2553-2556.
[11]Stavroulakis K,Bisdas T,Torsello G,et al.Combined Directional Atherectomy and drug-eluting balloon angioplasty for isolated popliteal artery lesions in patients with peripheral artery disease[J].J Endovasc Ther,2015,22(6):847-852.
[12]Soga Y,Tomoi Y,Sato K,et al.Clinical outcome after endovascular treatment for isolated common femoral and popliteal artery disease[J].Cardiovasc Interv Ther,2013,28(3):250-257.
[13]Sixt S,Carpio COG,Treszl A,et al.Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries[J].J Vasc Surg,2013,58(3):682-686.
[14]Zeller T,Rastan A,Macharzina R,.Atherectomy and drug-coated balloon angioplasty for long and calcified femoropopliteal lesions:The DEFINITIVE AR trial[C].VIVA 2014:429-436.
[15]Cioppa A,Stabile E,Popusoi G,et al.Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon:One-year single centre clinical results[J].Cardiovasc Revasc Med,2012,13(4):219-223.
[16]Schnorr B,Albrecht T.Drug-coated balloons and their place in treating peripheral arterial disease[J].Expert Rev Med Devices,2013,10(1):105-114.
[17]Fanelli F,Cannavale A,Gazzetti M,et al.Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease[J].Cardiovasc Intervent Radiol,2014,37(4):898-907.
[18]郭建明,谷涌泉,郭连瑞,等.Turbohawk斑块切除系统治疗下肢动脉硬化闭塞病变[J].中国普通外科杂志,2015,(6):915-916.
[19]Mendes BC,Oderich GS,Fleming MD,et al.Clinical significance of embolic events in patients undergoing endovascular femoropopliteal interventions with or without embolic protection devices[J].J Vasc Surg,2014,59(2):359-367.
[20]Wholey M.The role of embolic protection in peripheral arterial atherectomy[J].Tech Vasc Interv Radiol,2011,14(2):65-74.
[21]Shammas NW,Dippel EJ,Coiner D,et al.Preventing lower extremity distal embolization using embolic filter protection:results of the PROTECT registry[J].J Endovasc Ther,2008,15(3):270-276.
[2]Jia X,Zhang J,Zhuang B,et al.Acotec drug-coated balloon catheter:randomized,multicenter,controlled clinical study in femoropopliteal arteries:evidence from the Aco Art I trial[J].JACC Cardiovasc Interv,2016,9(18):1941-1949.
[3]Debing E,Aerden D,Vanhulle A,et al.Paclitaxel-coated versus plain old balloon angioplasty for the treatment of infrainguinal arterial disease in diabetic patients:the Belgian diabetic IN.PACT Trial[J].J Cardiovasc Surg(Torino),2017,58(4):528-534.
[4]Ramaiah V,Gammon R,Kiesz S,et al.Midterm outcomes from the TALON Registry:treating peripherals with Silver Hawk:outcomes collection[J].J Endovasc Ther,2006,13(5):592-602.
[5]Mc Kinsey JF,Zeller T,Rocha-Singh KJ,et al.Lower extremity revascularization using directional atherectomy:12-month prospective results of the DEFINITIVE LE study[J].JACC Cardiovasc Interv,2014,7(8):923-933.
[6]Roberts D,Niazi K,Miller W,et al.Effective endovascular treatment of calcified femoropopliteal disease with directional atherectomy and distal embolic protection:final results of the DEFINITIVE Ca??trial[J].Catheter Cardiovasc Interv,2014,84(2):236-244.
[7]Tepe G,Zeller T,Albrecht T,et al.Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg[J].N Engl J Med,2008,358(7):689-699.
[8]Werk M,Albrecht T,Meyer DR,et al.Paclitaxel-coated balloons reduce restenosis after femoro-popliteal angioplasty:evidence from the randomized PACIFIER trial[J].Circ Cardiovasc Interv,2012,5(6):831-840.
[9]Brodmann M,Rief P,Froehlich H,et al.Neointimal hyperplasia after silverhawk atherectomy versus percutaneous transluminal angioplasty(PTA)in femoropopliteal stent reobstructions:a controlled,randomized pilot trial[J].Cardiovasc Intervent Radiol,2013,36(1):69-74.
[10]李伟浩,张韬,沈晨阳.下肢动脉血管成形术后再狭窄的腔内治疗进展[J].中华医学杂志,2014,(32):2553-2556.
[11]Stavroulakis K,Bisdas T,Torsello G,et al.Combined Directional Atherectomy and drug-eluting balloon angioplasty for isolated popliteal artery lesions in patients with peripheral artery disease[J].J Endovasc Ther,2015,22(6):847-852.
[12]Soga Y,Tomoi Y,Sato K,et al.Clinical outcome after endovascular treatment for isolated common femoral and popliteal artery disease[J].Cardiovasc Interv Ther,2013,28(3):250-257.
[13]Sixt S,Carpio COG,Treszl A,et al.Drug-coated balloon angioplasty after directional atherectomy improves outcome in restenotic femoropopliteal arteries[J].J Vasc Surg,2013,58(3):682-686.
[14]Zeller T,Rastan A,Macharzina R,.Atherectomy and drug-coated balloon angioplasty for long and calcified femoropopliteal lesions:The DEFINITIVE AR trial[C].VIVA 2014:429-436.
[15]Cioppa A,Stabile E,Popusoi G,et al.Combined treatment of heavy calcified femoro-popliteal lesions using directional atherectomy and a paclitaxel coated balloon:One-year single centre clinical results[J].Cardiovasc Revasc Med,2012,13(4):219-223.
[16]Schnorr B,Albrecht T.Drug-coated balloons and their place in treating peripheral arterial disease[J].Expert Rev Med Devices,2013,10(1):105-114.
[17]Fanelli F,Cannavale A,Gazzetti M,et al.Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease[J].Cardiovasc Intervent Radiol,2014,37(4):898-907.
[18]郭建明,谷涌泉,郭连瑞,等.Turbohawk斑块切除系统治疗下肢动脉硬化闭塞病变[J].中国普通外科杂志,2015,(6):915-916.
[19]Mendes BC,Oderich GS,Fleming MD,et al.Clinical significance of embolic events in patients undergoing endovascular femoropopliteal interventions with or without embolic protection devices[J].J Vasc Surg,2014,59(2):359-367.
[20]Wholey M.The role of embolic protection in peripheral arterial atherectomy[J].Tech Vasc Interv Radiol,2011,14(2):65-74.
[21]Shammas NW,Dippel EJ,Coiner D,et al.Preventing lower extremity distal embolization using embolic filter protection:results of the PROTECT registry[J].J Endovasc Ther,2008,15(3):270-276.