Strategy of Revascularization for Critical Limb Ischemia Due to Infragenicular Lesions—Which Should be Selected Firstly, Bypass Surgery or Endovascular Therapy?

Background and Objectives: In patients with peripheral arterial diseases (PADs) due to infra-popliteal (below-the-knee; BTK) lesions, we often encounter situations requiring the immediate selection of either of two revascularization methods, namely bypass surgery or endovascular therapy (EVT). Howev...

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Published inJapanese Journal of Vascular Surgery Vol. 23; no. 4; pp. 766 - 773
Main Authors Iwasa, Kazuomi, Ohmine, Takahiro, Yamaoka, Terutoshi
Format Journal Article
LanguageJapanese
Published JAPANESE SOCIETY FOR VASCULAR SURGERY 2014
特定非営利活動法人 日本血管外科学会
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ISSN0918-6778
1881-767X
DOI10.11401/jsvs.13-00093

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Abstract Background and Objectives: In patients with peripheral arterial diseases (PADs) due to infra-popliteal (below-the-knee; BTK) lesions, we often encounter situations requiring the immediate selection of either of two revascularization methods, namely bypass surgery or endovascular therapy (EVT). However, the question of whether endovascular or surgical revascularization should be performed initially for critical limb ischemia (CLI) patients with BTK lesions has not been clarified. To assess the efficacy and durability of EVT or bypass as a first approach, we evaluated the short- and mid-term outcomes of the first revascularizations achieved using EVT (EVT First Group; EVT-first) compared with bypass (Bypass First Group; Bypass-first). To verify the validity of each initial revascularization, we explored factors influencing overall survival (OS) rates using multivariate analyses. Methods: A total of 169 consecutive BTK revascularization procedures (150 patients) for CLI conducted at our facility between November 2006 and July 2012 were analyzed. Patients undergoing revascularization were divided into two groups (EVT-first or Bypass-first), with 102 patients undergoing endovascular therapy first (EVT-first) and 51 undergoing bypass surgery first (Bypass-first). No statistically significant differences were noted between the two groups with respect to preoperative background including age, gender, and cardiovascular risk factors (hypertension, diabetes, hyperlipidemia, coronary arterial disease (CAD), chronic heart failure (CHF), cerebrovascular disease, and hemodialysis). Technical success was defined as a single straight-line flow to the ankle after completion angiography of the first revascularization method. Hemodynamic success was defined as a postoperative skin perfusion pressure of the foot exceeding 40 mmHg. Results: The average age of patients was 76.0 years (range, 46–98 years; 65 men and 37 women) and 72.3 years (range, 43–93 years; 35 men and 13 women) in the EVT-first and Bypass-first groups, respectively. Patient follow-up ranged from 1 to 50 months (mean, 15 months). Respective technical and hemodynamic success rates were 96.2% and 66.7% for EVT-first and 100% and 94% for Bypass-first, respectively. Treatment was required an average of 1.5 times for EVT-first and 1.2 times for Bypass-first. Respective rates for other factors examined in the EVT-first and the Bypass-first groups were: major amputation rates 30 days post-procedure, 5.9%, and 3.9%; mortality rates 30 days post-procedure, 3.9%, and 0%; one-year AFS rates, 71.7%, and 79.5%; OS rates, 73.5% and 83.9%; and limb salvage rates, 88.8%, and 91.0%. Multivariate-analysis of all subjects in the two groups revealed that the OS rates was affected by four risk factors as follows: 1) age greater than 80 years, 2) CAD, 3) CHF, and 4) a non-ambulatory limb. Conclusion: For patients with CLI due to BTK lesions and whose saphenous veins are in poor condition or are in poor general condition having two or more of the four severe risk factors, the EVT-First procedure is effective and provides durable results. Overall survival in patients with CLI due to BTK lesions is worse when patients have more than two severe risk factors, which is non-ambulatory limb, aged less than 81 years, with CAD or with CHF.
AbstractList Background and Objectives: In patients with peripheral arterial diseases (PADs) due to infra-popliteal (below-the-knee; BTK) lesions, we often encounter situations requiring the immediate selection of either of two revascularization methods, namely bypass surgery or endovascular therapy (EVT). However, the question of whether endovascular or surgical revascularization should be performed initially for critical limb ischemia (CLI) patients with BTK lesions has not been clarified. To assess the efficacy and durability of EVT or bypass as a first approach, we evaluated the short- and mid-term outcomes of the first revascularizations achieved using EVT (EVT First Group; EVT-first) compared with bypass (Bypass First Group; Bypass-first). To verify the validity of each initial revascularization, we explored factors influencing overall survival (OS) rates using multivariate analyses. Methods: A total of 169 consecutive BTK revascularization procedures (150 patients) for CLI conducted at our facility between November 2006 and July 2012 were analyzed. Patients undergoing revascularization were divided into two groups (EVT-first or Bypass-first), with 102 patients undergoing endovascular therapy first (EVT-first) and 51 undergoing bypass surgery first (Bypass-first). No statistically significant differences were noted between the two groups with respect to preoperative background including age, gender, and cardiovascular risk factors (hypertension, diabetes, hyperlipidemia, coronary arterial disease (CAD), chronic heart failure (CHF), cerebrovascular disease, and hemodialysis). Technical success was defined as a single straight-line flow to the ankle after completion angiography of the first revascularization method. Hemodynamic success was defined as a postoperative skin perfusion pressure of the foot exceeding 40 mmHg. Results: The average age of patients was 76.0 years (range, 46–98 years; 65 men and 37 women) and 72.3 years (range, 43–93 years; 35 men and 13 women) in the EVT-first and Bypass-first groups, respectively. Patient follow-up ranged from 1 to 50 months (mean, 15 months). Respective technical and hemodynamic success rates were 96.2% and 66.7% for EVT-first and 100% and 94% for Bypass-first, respectively. Treatment was required an average of 1.5 times for EVT-first and 1.2 times for Bypass-first. Respective rates for other factors examined in the EVT-first and the Bypass-first groups were: major amputation rates 30 days post-procedure, 5.9%, and 3.9%; mortality rates 30 days post-procedure, 3.9%, and 0%; one-year AFS rates, 71.7%, and 79.5%; OS rates, 73.5% and 83.9%; and limb salvage rates, 88.8%, and 91.0%. Multivariate-analysis of all subjects in the two groups revealed that the OS rates was affected by four risk factors as follows: 1) age greater than 80 years, 2) CAD, 3) CHF, and 4) a non-ambulatory limb. Conclusion: For patients with CLI due to BTK lesions and whose saphenous veins are in poor condition or are in poor general condition having two or more of the four severe risk factors, the EVT-First procedure is effective and provides durable results. Overall survival in patients with CLI due to BTK lesions is worse when patients have more than two severe risk factors, which is non-ambulatory limb, aged less than 81 years, with CAD or with CHF.
Background and Objectives: In patients with peripheral arterial diseases (PADs) due to infra-popliteal (below-the-knee; BTK) lesions, we often encounter situations requiring the immediate selection of either of two revascularization methods, namely bypass surgery or endovascular therapy (EVT). However, the question of whether endovascular or surgical revascularization should be performed initially for critical limb ischemia (CLI) patients with BTK lesions has not been clarified. To assess the efficacy and durability of EVT or bypass as a first approach, we evaluated the short- and mid-term outcomes of the first revascularizations achieved using EVT (EVT First Group; EVT-first) compared with bypass (Bypass First Group; Bypass-first). To verify the validity of each initial revascularization, we explored factors influencing overall survival (OS) rates using multivariate analyses. Methods: A total of 169 consecutive BTK revascularization procedures (150 patients) for CLI conducted at our facility between November 2006 and July 2012 were analyzed. Patients undergoing revascularization were divided into two groups (EVT-first or Bypass-first), with 102 patients undergoing endovascular therapy first (EVT-first) and 51 undergoing bypass surgery first (Bypass-first). No statistically significant differences were noted between the two groups with respect to preoperative background including age, gender, and cardiovascular risk factors (hypertension, diabetes, hyperlipidemia, coronary arterial disease (CAD), chronic heart failure (CHF), cerebrovascular disease, and hemodialysis). Technical success was defined as a single straight-line flow to the ankle after completion angiography of the first revascularization method. Hemodynamic success was defined as a postoperative skin perfusion pressure of the foot exceeding 40 mmHg. Results: The average age of patients was 76.0 years (range, 46–98 years; 65 men and 37 women) and 72.3 years (range, 43–93 years; 35 men and 13 women) in the EVT-first and Bypass-first groups, respectively. Patient follow-up ranged from 1 to 50 months (mean, 15 months). Respective technical and hemodynamic success rates were 96.2% and 66.7% for EVT-first and 100% and 94% for Bypass-first, respectively. Treatment was required an average of 1.5 times for EVT-first and 1.2 times for Bypass-first. Respective rates for other factors examined in the EVT-first and the Bypass-first groups were: major amputation rates 30 days post-procedure, 5.9%, and 3.9%; mortality rates 30 days post-procedure, 3.9%, and 0%; one-year AFS rates, 71.7%, and 79.5%; OS rates, 73.5% and 83.9%; and limb salvage rates, 88.8%, and 91.0%. Multivariate-analysis of all subjects in the two groups revealed that the OS rates was affected by four risk factors as follows: 1) age greater than 80 years, 2) CAD, 3) CHF, and 4) a non-ambulatory limb. Conclusion: For patients with CLI due to BTK lesions and whose saphenous veins are in poor condition or are in poor general condition having two or more of the four severe risk factors, the EVT-First procedure is effective and provides durable results. Overall survival in patients with CLI due to BTK lesions is worse when patients have more than two severe risk factors, which is non-ambulatory limb, aged less than 81 years, with CAD or with CHF. 要旨:【背景】膝下重症下肢虚血に対する初回治療としてEVT を行うかバイパスを行うかは議論が分かれる.【目的】初回治療として下腿病変に対するEVT を行った群(E 群)と下腿足関節バイパスを行った群(B 群)の短期中期成績を検討する.さらに生命予後に関与する危険因子を検討し層別化を行う.【対象と方法】対象は2006 年11 月~2012 年7 月に重症虚血肢に対し下腿足関節領域の血行再建を行った全症例(150 例169 肢)とした.初回治療によりE 群(102 例118 肢)とB 群(48 例51 肢)に分け検討した.【結果】平均観察期間は15 カ月であった.術前背景(年齢・性別・高血圧・糖尿病・虚血性心疾患・脳血管疾患・透析・心不全)は2 群間に有意な差を認めなかった.術後30 日成績は手術死亡E 群3.9% /B 群0%,大切断E 群5.9% /B 群3.9% であった. 短期中期成績(1 年・3 年)は非大切断生存E 群71.7%・41.6% /B 群79.5%・65.4%,生存率E 群73.5%・55.3% /B 群83.9%・57.6%,救肢率E 群88.8%・83.2% /B 群91.0%・80.1%で両群間に有意差を認めなかった.多変量解析にて生存率に関与した因子は高齢(81 歳以上),虚血性心疾患合併・慢性心不全合併および非歩行であった.【結論】膝下病変に対するEVT は一期的自家静脈バイパスに適さないと考えられる症例に対して有用性がある.膝下重症下肢虚血患者における遠隔期死亡の独立した危険因子は高齢・虚血性心疾患合併・慢性心不全合併・非歩行であった.
Author Ohmine, Takahiro
Yamaoka, Terutoshi
Iwasa, Kazuomi
Author_FL 岩佐 憲臣
大峰 高広
山岡 輝年
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References 3) Suzuki K, Iida O, Soga Y, et al. Long-term results of the S.M.A.R.T. ControlTM stent for superficial femoral artery lesions, J-SMART registry. Circ J 2011;75:939–944.
15) 2011 Writing Group Members; 2005 Writing Committee Members; ACCF/AHA Task Force Members. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (Updating the 2005 Guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 2011;124:2020–2045.
2) Soga Y, Iida O, Kawasaki D, et al. Contemporary outcomes after endovascular treatment for aorto-iliac artery disease. Circ J 2012;76:2697–2704.
14) Bradbury AW, Adam DJ, Bell J, et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: analysis of amputation free and overall survival by treatment received. J Vasc Surg 2010;51:18S–31S.
9) Adam DJ, Beard JD, Cleveland T, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 2005;366:1925–1934.
11) Conte MS. Understanding objective performance goals for critical limb ischemia trials. Semin Vasc Surg 2010;23:129–137.
5) Iida O, Nakamura M, Yamauchi Y, et al. Endovascular treatment for infrainguinal vessels in patients with critical limb ischemia: OLIVE registry, a prospective, multicenter study in Japan with 12-month follow-up. Circ Cardiovasc Interv 2013;6:68–76.
16) Iida O, Soga Y, Yamauchi Y, et al. Clinical efficacy of endovascular therapy for patients with critical limb ischemia attributable to pure isolated infrapopliteal lesions. J Vasc Surg 2013;57:974–981.e1.
8) Abola MT, Bhatt DL, Duval S, et al. Fate of individuals with ischemic amputations in the REACH Registry: three-year cardiovascular and limb-related outcomes. Atherosclerosis 2012;221:527–535.
12) Iida O, Soga Y, Kawasaki D, et al. Angiographic restenosis and its clinical impact after infrapopliteal angioplasty. Eur J Vasc Endovasc Surg 2012;44:425–431.
1) Soga Y, Iida O, Hirano K, et al. Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent. J Vasc Surg 2010;52:608–615.
7) Pomposelli FB, Kansal N, Hamdan AD, et al. A decade of experience with dorsalis pedis artery bypass: analysis of outcome in more than 1000 cases. J Vasc Surg 2003;37:307–315.
13) Liistro F, Porto I, Angioli P, et al. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation 2013;128:615–621.
6) Söderström M, Arvela E, Albäck A, et al. Healing of ischaemic tissue lesions after infrainguinal bypass surgery for critical leg ischaemia. Eur J Vasc Endovasc Surg 2008;36:90–95.
10) 横井良明.重症虚血肢に対する血管内治療.下肢救済・足病学会誌 2012;4:3–12.
4) 大峰高広,山岡輝年.浅大腿動脈病変に対する血行再建術の中期成績,当施設での治療方針.血管外科2010;29:100–109.
References_xml – reference: 8) Abola MT, Bhatt DL, Duval S, et al. Fate of individuals with ischemic amputations in the REACH Registry: three-year cardiovascular and limb-related outcomes. Atherosclerosis 2012;221:527–535.
– reference: 14) Bradbury AW, Adam DJ, Bell J, et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL) trial: analysis of amputation free and overall survival by treatment received. J Vasc Surg 2010;51:18S–31S.
– reference: 10) 横井良明.重症虚血肢に対する血管内治療.下肢救済・足病学会誌 2012;4:3–12.
– reference: 13) Liistro F, Porto I, Angioli P, et al. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation 2013;128:615–621.
– reference: 15) 2011 Writing Group Members; 2005 Writing Committee Members; ACCF/AHA Task Force Members. 2011 ACCF/AHA focused update of the guideline for the management of patients with peripheral artery disease (Updating the 2005 Guideline): a report of the American College of Cardiology Foundation/American Heart Association Task Force on practice guidelines. Circulation 2011;124:2020–2045.
– reference: 2) Soga Y, Iida O, Kawasaki D, et al. Contemporary outcomes after endovascular treatment for aorto-iliac artery disease. Circ J 2012;76:2697–2704.
– reference: 1) Soga Y, Iida O, Hirano K, et al. Mid-term clinical outcome and predictors of vessel patency after femoropopliteal stenting with self-expandable nitinol stent. J Vasc Surg 2010;52:608–615.
– reference: 12) Iida O, Soga Y, Kawasaki D, et al. Angiographic restenosis and its clinical impact after infrapopliteal angioplasty. Eur J Vasc Endovasc Surg 2012;44:425–431.
– reference: 3) Suzuki K, Iida O, Soga Y, et al. Long-term results of the S.M.A.R.T. ControlTM stent for superficial femoral artery lesions, J-SMART registry. Circ J 2011;75:939–944.
– reference: 11) Conte MS. Understanding objective performance goals for critical limb ischemia trials. Semin Vasc Surg 2010;23:129–137.
– reference: 9) Adam DJ, Beard JD, Cleveland T, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet 2005;366:1925–1934.
– reference: 4) 大峰高広,山岡輝年.浅大腿動脈病変に対する血行再建術の中期成績,当施設での治療方針.血管外科2010;29:100–109.
– reference: 5) Iida O, Nakamura M, Yamauchi Y, et al. Endovascular treatment for infrainguinal vessels in patients with critical limb ischemia: OLIVE registry, a prospective, multicenter study in Japan with 12-month follow-up. Circ Cardiovasc Interv 2013;6:68–76.
– reference: 6) Söderström M, Arvela E, Albäck A, et al. Healing of ischaemic tissue lesions after infrainguinal bypass surgery for critical leg ischaemia. Eur J Vasc Endovasc Surg 2008;36:90–95.
– reference: 16) Iida O, Soga Y, Yamauchi Y, et al. Clinical efficacy of endovascular therapy for patients with critical limb ischemia attributable to pure isolated infrapopliteal lesions. J Vasc Surg 2013;57:974–981.e1.
– reference: 7) Pomposelli FB, Kansal N, Hamdan AD, et al. A decade of experience with dorsalis pedis artery bypass: analysis of outcome in more than 1000 cases. J Vasc Surg 2003;37:307–315.
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Snippet Background and Objectives: In patients with peripheral arterial diseases (PADs) due to infra-popliteal (below-the-knee; BTK) lesions, we often encounter...
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SubjectTerms below the knee lesions
bypass surgery
critical limb ischemia
endovascular therapy
peripheral arterial diseases
下腿EVT
層別化
生命予後規定因子
足部バイパス
重症虚血肢
Title Strategy of Revascularization for Critical Limb Ischemia Due to Infragenicular Lesions—Which Should be Selected Firstly, Bypass Surgery or Endovascular Therapy?
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