低温球囊治疗下肢动脉狭窄、闭塞的初步探讨
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摘要
目的：1.观察低温球囊治疗下肢动脉狭窄、闭塞的近期疗效及安全性；并初步探讨低温球囊使用经验。2.对低温球囊与普通球囊治疗下肢动脉狭窄与闭塞进行近期疗效及安全性比较。
材料与方法：25例患者(共27条动脉)采用介入方法行下肢动脉狭窄、闭塞症治疗,男21例(占84%),女4例(占16%),年龄63～89,平均年龄(71±5.5)岁。低温球囊组10例,其中男8例(占80%),女2例(占22%),年龄66～89,平均年龄(75.5±7.5)岁,其中合并糖尿病9例(占90%),高血压7例(占70%),TASCⅡ分型A型7例(占70%),B型3例(占30%),C型0例(占0%),D型0例(占0%)；病变血管10条：髂外动脉1条,股浅动脉8条,腘动脉1条；病变长度4.3～7.8cm,平均6.5±0.7,ABI0.38-0.55平均为0.46±0.07,狭窄程度80%～100%平均为91%±6%；普通球囊组15例,其中男13例(占86.7%),女2例(占13.3%),年龄63～73,平均年龄(67.9±3.5)岁,其中合并糖尿病9例(占60%),高血压12例(占80%),TASCⅡ分型A型13例(占86.7%),B型2例(占13.3%),C型0例(占0%),D型0例(占0%)；病变血管17条：髂外动脉1条,股浅动脉14条,胭动脉2条；病变长度3.5～7.2cm,平均6.3±0.5,ABI 0.42～0.53平均为0.48±0.06,狭窄程度75%～100%平均为89%±7%。25例均采用球囊血管成形术治疗,低温球囊组采用工作温度为-10℃的低温球囊,工作压力为6-8Bar；普通球囊组采用常温球囊,工作压力为8～14Bar。
结果：低温囊组10例10条病变血管介入治疗技术成功率100%,无手术死亡病例,术中未发生血管壁损伤(如夹层、血肿或出血),三十天内没有一例截肢发生,治疗后第2天临床症状消失,术后30天内无一例出现临床症状。术后30天低温球囊组临床变化评估：显著改善有8例占80%,中度改善有2例占20%；术后第2天ABI0.89～0.94平均为0.88±0.03,术后30天ABI 0.83～0.92平均为0.84±0.04,术后第2天血管狭窄程度为23%～31%平均27%±2%,术后30天血管狭窄程度为24%～34%平均29%±4%。普通球囊组15例17条病变血管介入治疗技术成功率100%,无手术死亡病例,术中有一例夹层发生,余无并发症发生,三十天内没有一例截肢发生,治疗后第2天临床症状消失,治疗后第28天出现1例(占6.7%)肢体麻痹感；术后三十天临床变化评估：显著改善13例占86.7%,中度改善2例占13.3%；术后2天ABI为0.84-0.93平均0.86±0.06,术后30天ABI为0.80～0.91平均0.84±0.05,术后2天血管狭窄率为25%-34%平均30%±4%,术后30天血管狭窄率为27%-36%平均为32%±4%。低温球囊组和普通球囊组术前与术后30天的近期疗效(如临床症状、ABI及超声观察管腔狭窄等情况较术前改善)有统计学差异(P＜0.01)；但低温球囊组与普通球囊组两种手术方式间疗效没有统计学差异(P=0.55)。
结论：低温球囊组治疗下肢动脉狭窄闭塞安全、有效,但长期效果有待进一步随访观察。低温球囊与普通球囊治疗下肢动脉狭窄闭塞两者之间技术成功率、临床疗效各观察指标没有统计学差异。低温球囊应用时,选择适合靶血管的球囊尺寸,工作时不可移动球囊,球囊表面及输送器尾部不可附着水滴等为操作注意要点。
Objective:1.Observe the Cryoplasty in the treatment of lower extremity arteriosclerosis obliterans of the recent efficacy and safety; and explore the Cryoplasty experience.2. On the Cryoplasty and ordinary balloon treatment for lower extremity arteriosclerosis obliterans term efficacy and safety comparison.
Materials and Methods:25 patients (27 arteries) with interventions for lower limb arterial stenosis, occlusion treatment,21 males (84%),4 females (16%), aged 63 to 89, average age (71±5.5 years).10 cases of Cryoplasty group, men 8 cases (80%), women 2 cases (representing 22%), age 66～89, average age (75.5±7.5), of which DM 9 cases (90%), hypertensive 7 cases (70%), TASC II classification:type A:7 cases (70%), type B:3 cases (30%), type C:0 cases (0%), type D:0 cases (0%); treated with 10 arteries:1 case of the external iliac artery; 8 cases of the femoral artery and 1 case of the popliteal artery; lesions length 4.3～7.8cm, an average of 6.5±0.7; ABI 0.38～0.55 average of 0.46±0.07, stenosis 80%～100% average of 91%±6%; Ordinary balloon group 15 cases, men 13 cases (86.7%), women 2 cases (13.3%), age 63～73, average age (67.9±3.5), of which DM 9 cases (60%),12 cases of hypertension (80%), TASC II classification:type A:13 cases (86.7%), type B:2 cases (13.3%), type C:0 cases (0%), type D:0 cases (0%); treated with 17 arteries:1 case of the external iliac artery; 14 cases of the femoral artery and 2 cases of the popliteal artery; lesions length 3.5～7.2cm, an average of 6.3±0.5, ABI 0.42～0.53 average of 0.48±0.06, stenosis 75%～100% average of 89%±7%.25 patients were treated with percutaneous transluminal angioplasty, Cryoplasty group operating temperature of-10℃, working pressure 6-8Bar; Ordinary balloon group with normal temperature, working pressure is 8～14Bar.
Result:Cryoplasty group 10 lesions in 10 cases of interventional treatment success rate was 100%, no operative deaths, intraoperative vascular injury not occurred (such as dissection, hematoma, or bleeding), not one case of amputation occurred within 30 days, after treatment Day 2 of clinical symptoms disappeared, within 30 days after surgery without clinical symptoms in one case.day 30 after Cryoplasty change of the clinical assessment:there are 8 cases of significant improvement in 80%, moderate improvement in 2 cases,20%; after day 2 ABI 0.89～0.94 average 0.88±0.03, after day 30 ABI 0.83～0.92 average 0.84±0.04, after day 2 the degree of stenosis was 23%～31% average 27%±2%, after day 30, the degree of stenosis was 24%～34% average 29%±4%, compared with preoperative significant difference (P<0.01).Ordinary balloon group 15 cases in 17 of interventional treatment success rate was 100%, no operative deaths, one case of intraoperative dissection occurred, no other complications, not one case of amputation occurred within day 30, day 2 after treatment clinical symptoms disappeared, day 28 after treatment occurred in 1 case (6.7%) of limb paralysis;Day 30 after ordinary balloon change of the clinical assessment:there are 13 cases of significant improvement in 86.7%, moderate improvement in 2 cases,13.3%; after day 2 ABI 0.84～0.93 average of 0.86±0.06, after day 30 ABI 0.80～0.91 average of 0.84±0.05, after 2-day of Restenosis rate is 25%-34% average 30%±4%, after day 30 artery stenosis rate of 27%-36% average of 32%±4%.Cryoplasty group and ordinary balloon group before and after treatment the 30-day short-term results (such as clinical signs, ABI and ultrasound) has statistical differences (P<0.01); Cryoplasty group and ordinary balloon group temperature of two operation methods no significant difference between the effect (P= 0.55).
Conclusion:Cryoplasty group treatment of arteriosclerosis obliterans are safe, effective, but the long-term effects need to follow-up. Cryoplasty group and ordinary balloon group for the treatment of arteriosclerosis obliterans between technology success rates, clinical observation of the index has no statistical differences. When use the Cryoplasty, select the appropriate balloon size, can not move the balloon when it works, balloon tail and surface is not attached water drops.
材料与方法：25例患者(共27条动脉)采用介入方法行下肢动脉狭窄、闭塞症治疗,男21例(占84%),女4例(占16%),年龄63～89,平均年龄(71±5.5)岁。低温球囊组10例,其中男8例(占80%),女2例(占22%),年龄66～89,平均年龄(75.5±7.5)岁,其中合并糖尿病9例(占90%),高血压7例(占70%),TASCⅡ分型A型7例(占70%),B型3例(占30%),C型0例(占0%),D型0例(占0%)；病变血管10条：髂外动脉1条,股浅动脉8条,腘动脉1条；病变长度4.3～7.8cm,平均6.5±0.7,ABI0.38-0.55平均为0.46±0.07,狭窄程度80%～100%平均为91%±6%；普通球囊组15例,其中男13例(占86.7%),女2例(占13.3%),年龄63～73,平均年龄(67.9±3.5)岁,其中合并糖尿病9例(占60%),高血压12例(占80%),TASCⅡ分型A型13例(占86.7%),B型2例(占13.3%),C型0例(占0%),D型0例(占0%)；病变血管17条：髂外动脉1条,股浅动脉14条,胭动脉2条；病变长度3.5～7.2cm,平均6.3±0.5,ABI 0.42～0.53平均为0.48±0.06,狭窄程度75%～100%平均为89%±7%。25例均采用球囊血管成形术治疗,低温球囊组采用工作温度为-10℃的低温球囊,工作压力为6-8Bar；普通球囊组采用常温球囊,工作压力为8～14Bar。
结果：低温囊组10例10条病变血管介入治疗技术成功率100%,无手术死亡病例,术中未发生血管壁损伤(如夹层、血肿或出血),三十天内没有一例截肢发生,治疗后第2天临床症状消失,术后30天内无一例出现临床症状。术后30天低温球囊组临床变化评估：显著改善有8例占80%,中度改善有2例占20%；术后第2天ABI0.89～0.94平均为0.88±0.03,术后30天ABI 0.83～0.92平均为0.84±0.04,术后第2天血管狭窄程度为23%～31%平均27%±2%,术后30天血管狭窄程度为24%～34%平均29%±4%。普通球囊组15例17条病变血管介入治疗技术成功率100%,无手术死亡病例,术中有一例夹层发生,余无并发症发生,三十天内没有一例截肢发生,治疗后第2天临床症状消失,治疗后第28天出现1例(占6.7%)肢体麻痹感；术后三十天临床变化评估：显著改善13例占86.7%,中度改善2例占13.3%；术后2天ABI为0.84-0.93平均0.86±0.06,术后30天ABI为0.80～0.91平均0.84±0.05,术后2天血管狭窄率为25%-34%平均30%±4%,术后30天血管狭窄率为27%-36%平均为32%±4%。低温球囊组和普通球囊组术前与术后30天的近期疗效(如临床症状、ABI及超声观察管腔狭窄等情况较术前改善)有统计学差异(P＜0.01)；但低温球囊组与普通球囊组两种手术方式间疗效没有统计学差异(P=0.55)。
结论：低温球囊组治疗下肢动脉狭窄闭塞安全、有效,但长期效果有待进一步随访观察。低温球囊与普通球囊治疗下肢动脉狭窄闭塞两者之间技术成功率、临床疗效各观察指标没有统计学差异。低温球囊应用时,选择适合靶血管的球囊尺寸,工作时不可移动球囊,球囊表面及输送器尾部不可附着水滴等为操作注意要点。
Objective:1.Observe the Cryoplasty in the treatment of lower extremity arteriosclerosis obliterans of the recent efficacy and safety; and explore the Cryoplasty experience.2. On the Cryoplasty and ordinary balloon treatment for lower extremity arteriosclerosis obliterans term efficacy and safety comparison.
Materials and Methods:25 patients (27 arteries) with interventions for lower limb arterial stenosis, occlusion treatment,21 males (84%),4 females (16%), aged 63 to 89, average age (71±5.5 years).10 cases of Cryoplasty group, men 8 cases (80%), women 2 cases (representing 22%), age 66～89, average age (75.5±7.5), of which DM 9 cases (90%), hypertensive 7 cases (70%), TASC II classification:type A:7 cases (70%), type B:3 cases (30%), type C:0 cases (0%), type D:0 cases (0%); treated with 10 arteries:1 case of the external iliac artery; 8 cases of the femoral artery and 1 case of the popliteal artery; lesions length 4.3～7.8cm, an average of 6.5±0.7; ABI 0.38～0.55 average of 0.46±0.07, stenosis 80%～100% average of 91%±6%; Ordinary balloon group 15 cases, men 13 cases (86.7%), women 2 cases (13.3%), age 63～73, average age (67.9±3.5), of which DM 9 cases (60%),12 cases of hypertension (80%), TASC II classification:type A:13 cases (86.7%), type B:2 cases (13.3%), type C:0 cases (0%), type D:0 cases (0%); treated with 17 arteries:1 case of the external iliac artery; 14 cases of the femoral artery and 2 cases of the popliteal artery; lesions length 3.5～7.2cm, an average of 6.3±0.5, ABI 0.42～0.53 average of 0.48±0.06, stenosis 75%～100% average of 89%±7%.25 patients were treated with percutaneous transluminal angioplasty, Cryoplasty group operating temperature of-10℃, working pressure 6-8Bar; Ordinary balloon group with normal temperature, working pressure is 8～14Bar.
Result:Cryoplasty group 10 lesions in 10 cases of interventional treatment success rate was 100%, no operative deaths, intraoperative vascular injury not occurred (such as dissection, hematoma, or bleeding), not one case of amputation occurred within 30 days, after treatment Day 2 of clinical symptoms disappeared, within 30 days after surgery without clinical symptoms in one case.day 30 after Cryoplasty change of the clinical assessment:there are 8 cases of significant improvement in 80%, moderate improvement in 2 cases,20%; after day 2 ABI 0.89～0.94 average 0.88±0.03, after day 30 ABI 0.83～0.92 average 0.84±0.04, after day 2 the degree of stenosis was 23%～31% average 27%±2%, after day 30, the degree of stenosis was 24%～34% average 29%±4%, compared with preoperative significant difference (P<0.01).Ordinary balloon group 15 cases in 17 of interventional treatment success rate was 100%, no operative deaths, one case of intraoperative dissection occurred, no other complications, not one case of amputation occurred within day 30, day 2 after treatment clinical symptoms disappeared, day 28 after treatment occurred in 1 case (6.7%) of limb paralysis;Day 30 after ordinary balloon change of the clinical assessment:there are 13 cases of significant improvement in 86.7%, moderate improvement in 2 cases,13.3%; after day 2 ABI 0.84～0.93 average of 0.86±0.06, after day 30 ABI 0.80～0.91 average of 0.84±0.05, after 2-day of Restenosis rate is 25%-34% average 30%±4%, after day 30 artery stenosis rate of 27%-36% average of 32%±4%.Cryoplasty group and ordinary balloon group before and after treatment the 30-day short-term results (such as clinical signs, ABI and ultrasound) has statistical differences (P<0.01); Cryoplasty group and ordinary balloon group temperature of two operation methods no significant difference between the effect (P= 0.55).
Conclusion:Cryoplasty group treatment of arteriosclerosis obliterans are safe, effective, but the long-term effects need to follow-up. Cryoplasty group and ordinary balloon group for the treatment of arteriosclerosis obliterans between technology success rates, clinical observation of the index has no statistical differences. When use the Cryoplasty, select the appropriate balloon size, can not move the balloon when it works, balloon tail and surface is not attached water drops.
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64. Samson RH, Showalter DP, Lepore MR J r. CryoPlasty therapy of the superficial femoral and popliteal arteries:a single center experience[J]. Vase Endovascular Surg,2006,40 (6):4462450.
65. Karthik S, Tuite DJ, Nicholson AA. Cryoplasty for arterial restenosis[J]. Eur J Vase Endovasc Surg,2007,33 (1):40243.
66. Joye JD. The clinical application of cryoplasty for infrainguinal peripheral arterial disease [J]. Tech Vase Interv Radiol,2005, (4):160 2164.
67. Tatsutani K, Joye JD, Virmani R, et al. In vitro evaluation of vascular endothelial and smooth muscle cell survival and apoptosis in response to hypothermia and freezing [J] Cryo Lett,2005,26 (1):55264.
68. Fava M, Loyola S, Polydorou A, et al. Cryoplasty for femoropopliteal arterial disease:late angiographic follow-up of initial human experience [J]. J Vase Interv Radiol,2004,15 (11):123921243.
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70.杨静,童强等.介入治疗糖尿足下肢动脉血管的临床应用.西部医学,oct2009第21卷第10期.
71. Wang S, Zhang HT, Liu CZ, et al:Interventional therapy on diabetic foot with below hnee artery disease:half year follow-up investigation. J Fouth Mil Med Univ 2008 29(5)
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42. Bolia A, Miles KA, Brennan J, etal. Percutaneous transluminal angioplasty of the femoral and popliteal arteries by subintimal dissection (J). Cardiovasc Intervent Radiol,1990,13(6):357-363
43. A.M. Lazaris, C. Salas, A. C. Tsiamis, Factors Affecting Patency of Subintimal Infrainguinal Angioplasty in Patients with Critical Lower Limb Ischemia, Eur J Vase Surg 32,668-674.2006
44. A. Antusevas, N, Aleksynas, R. S. Kaupas, Copmarison of Reasults of SA and PTA in SFA Occlusions. Eur J Vase Endovasc Sug 2008 36,101-106.
45. Fava M, Loyola S, Polydorou A, et al. Cryoplasty for femoropopliteal arterial disease:late angiographic follow-up of initial human experience [J]. J Vase Interv Radiol,2004,15 (11):123921243.46. Fava, M, Loyola, S, Polydorou, A, Papapavlou, P, Polydorou, A, Mendiz,0, Joye, JD. Cryoplasty for femoropopliteal arterial disease:Late angiographic results of initial human experience. J Vase Interv Radiol,2004, 15:1239-1243
47. Laird J, Jaff MR, Biamino G, et al. Cryoplasty for the treatment of femoropopliteal arterial disease:results of a prospective,multicenter registry[J]. J Vase Interv Radiol,2005,16 (8):106721073.
48. McNamara TO, Anaya CA, Quinn BJ. Extended follow-up results of the PolarCath IDE study of the use of cryoplasty in femoropopliteal lesions [J]. J Vase Interv Radiol,2006,17:S3.
49. Samson RH, Showalter DP, Lepore MR J r. CryoPlasty therapy of the superficial femoral and popliteal arteries:a single center experience[J]. Vase Endovascular Surg,2006,40 (6):4462450.
50. Karthik S, Tuite DJ,Nicholson AA. Cryoplasty for arterial restenosis[J]. Eur J Vase Endovasc Surg,2007,33 (1):40243.
51. Lyden SP. Indications and results with cryoplasty in the treatment of infrainguinal arterial occlusive disease [J]. Vascular,2006,14 (5):2902296.
52. Selvin E, Erlinger TP. Prevalence of and risk factors for peripheral arterial disease in the United States:results from the National Health and Nutrition Examination Survey,1999-2000 Circulation,2004, 110(6):738-43.
53. Pastemak RC, Criqui MH, Benjamin EJ, etal. Atherosclerotic Va scu lar Disease Conference:Writing Group 1:epidemiology Circulation,2004, 109(21):2605-612.
54卫生部心血管病防治研究中心外周血管病／／中国心血管病报告2005.北京：中国大百科全书出版社,2006：108-109.
55. Hankey GJ, Norman PE, Eikelboom JW. Medical treatment of peripheral arterial disease. JAMA,2006,295(5):547-53.
56. Norgren L, Hiatt WR, Dormandy JA, etal. Lnter-Society Consensus for the Management of Peripheral Arterial Disease (TASC 11). Eur J Vasc Endovasc surg,2007,33(Suppl)51-57 5.
57.景在平,高瀚,曹贵松等.腔内血管外科在阻塞性动脉疾病中的应用研究[J]普外临床,1993,8(8)：129
58. James D, Joye, Do, FACC, et al:The Clinical Application of Cryoplasty for Infrainguinal Peripheral Arterial Disease. Vasc Interventional Rad 8:160-164 2005
59. Venkatasubramanian RT, Grassl ED,Barocas VH, et al. Effects of freezing and cryopreservation on the mechanical properties of arteries [J]. Ann Biomed Eng,2006,34 (5):8232832.
60. Grassl ED, Bischof JC. In vitro model systems for evaluation of smooth muscle cell response to cryoplasty [J]. Cryobiology,2005,50 (2):1622173.
61. Mandeville AF, McCabe BF. Some observations on the cryobiology of blood vessels [J]. Laryngoscope,1967,77 (8):13282 1350.
62. Durand E, Mallat Z, Addad F, et al. Time courses of apoptosis and cell proliferation and their relationship to arterial remodeling and restenosis after angioplasty in an atherosclerotic rabbit model [J]. J Am Coll Cardiol,2002,39(10):168021685.
63. McNamara TO, Anaya CA,Quinn BJ. Ex tended follow-up results of the PolarCath IDE study of the use of cryoplasty in femoropopliteal lesions [J]. J Vase Interv Radiol,2006,17:S3.
64. Samson RH, Showalter DP, Lepore MR J r. CryoPlasty therapy of the superficial femoral and popliteal arteries:a single center experience[J]. Vase Endovascular Surg,2006,40 (6):4462450.
65. Karthik S, Tuite DJ, Nicholson AA. Cryoplasty for arterial restenosis[J]. Eur J Vase Endovasc Surg,2007,33 (1):40243.
66. Joye JD. The clinical application of cryoplasty for infrainguinal peripheral arterial disease [J]. Tech Vase Interv Radiol,2005, (4):160 2164.
67. Tatsutani K, Joye JD, Virmani R, et al. In vitro evaluation of vascular endothelial and smooth muscle cell survival and apoptosis in response to hypothermia and freezing [J] Cryo Lett,2005,26 (1):55264.
68. Fava M, Loyola S, Polydorou A, et al. Cryoplasty for femoropopliteal arterial disease:late angiographic follow-up of initial human experience [J]. J Vase Interv Radiol,2004,15 (11):123921243.
69. Mario Fava MD, Soledad Loyola MD, Cryoplsty for Femoropopliteal Arterial Disease:Late Angiopraphic Results of Initial Human Experience, Journal of Vase and Radiology, Vol 15,Issue 11, NOV 2004,1239-1243
70.杨静,童强等.介入治疗糖尿足下肢动脉血管的临床应用.西部医学,oct2009第21卷第10期.
71. Wang S, Zhang HT, Liu CZ, et al:Interventional therapy on diabetic foot with below hnee artery disease:half year follow-up investigation. J Fouth Mil Med Univ 2008 29(5)
1. Diehm C, Schuster A, Allenberg JR, et al. High prevalence of peripheral arterial disease and comorbidity in 6880 primary care patients:A cross sectional study. Atherosclerosis, 2004,172(1):195-205.
2. Bakhai A. The burden of coronary cerebro vascular and peripheral arterial disease. Pharmacoeconomics,2004,22(Suppl 4):11-18.
3.李小鹰,王洁,王全义,等.周围动脉硬化闭塞症在老年血脂异常人群中的现患率调查[J].中华老年心脑血管病杂志,2005;7(1)：36.
4. Hirsch AT, Haskal ZJ, Hertzer NR, et al. ACC/AHA Guidelines for the management of patients with peripheral arterial disease. J Vasc Interv Radiol,2006,17(9):1383-1398.
5. Dierk S, Andrej S, Giancarlo B. Techniques for peripheral interventions. Urban&Vogel GmbH,Munich,2007:27-71.
6. Dormandy JA, Rutherford RB. Management of peripheral arterial disease (PAD). TASC Working Group. Trans Atlantic Inter Society Consensus (TASC)(J). Vasc Surg,2000; 31(1 pt 2):S1 296.
87. Norgren L, Hiatt WR, Dormandy JA, et al. Inter society consensus for the management of peripheral arterial disease(TASC Ⅱ) [J].Eur J Vasc Endovasc Surg,2007: 33(Suppl 1):S1 75.
8. Albers M, Fratezi AC, De Luccia, et al. Assessment of quality of life of patients with severe ischemia as a result of infrainganal arterial occlusive disease (J). Vasc Surg,1997; 14:91 5.
9. Poredos P, Jug B.The prevalence of peripheral arterial disease in high risk subjects and coronary or cerebrovascular patients [J]. Angiology,2007; 58(3):309 15.
10. Scharn DM, Dirven M, Barendregt WB, et al. Human umbilical vein versus heparin bonded polyester for femoropopliteal bypass:5 year results of a prospective randomized multicentre trial (J). Eur J Vasc Endovasc Surg,2008; 35(1):61 7.
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