Infrapopliteal angioplasty for critical limb ischemia: relation of TransAtlantic InterSociety Consensus class to outcome in 176 limbs

OBJECTIVE: Recent data suggest that percutaneous transluminal angioplasty (PTA) may be appropriate primary therapy for critical limb ischemia (CLI). However, little data are available regarding infrapopliteal angioplasty outcomes based on TransAtlantic InterSociety Consensus (TASC) classification. We report our experience with infrapopliteal angioplasty stratified by TASC lesion classification. METHODS: From February 2004 to March 2007, 176 consecutive limbs (163 patients) underwent infrapopliteal angioplasty for CLI. Stents were placed for lesions refractory to PTA or flow-limiting dissections. Patients were stratified by TASC classification and suitability for bypass grafting. Primary outcome was freedom from restenosis, reintervention, or amputation. Primary patency, freedom from secondary restenosis, limb salvage, reintervention by repeat angioplasty or bypass, and survival were determined. RESULTS: Median age was 73 years (range, 39-94 years). Technical success was 93%. Average follow-up was 10 months (range, 1-41 months). At 1 and 2 years, freedom from restenosis, reintervention, or amputation was 39% and 35%, conventional primary patency was 53% and 51%, and freedom from secondary restenosis and reintervention were 63% and 61%, respectively. Limb salvage was 84% at 1, 2, and 3 years. Within 2 years, 15% underwent bypass and 18% underwent repeat infrapopliteal PTA. Postoperative complications occurred in 9% and intraprocedural complications in 10%. The 30-day mortality was 5% (9 of 181). Overall survival was 81%, 65%, and 54% at 1, 2, and 3 years. TASC D classification predicted diminished technical success (75% D vs 100% A, B, and C; P < .001), primary restenosis, reintervention, or amputation (hazard ratio [HR], 3.4; 95% confidence interval [CI], 2.1-5.5, P < .001), primary patency (HR, 2.2; 95% CI, 1.3-3.9, P < .004), secondary restenosis (HR, 3.2; 95% CI, 1.6-6.4, P = .001), and limb salvage (HR, 2.6; 95% CI, 1.1-6.3, P < .05). Unsuitability for surgical bypass also predicted restenosis, reintervention, or amputation, secondary restenosis, need for repeated angioplasty, and inferior primary patency and limb salvage rates. CONCLUSION: Infrapopliteal angioplasty is a reasonable primary treatment for CLI patients with TASC A, B, or C lesions. Restenosis, reintervention, or amputation was higher in patients who were unsuitable candidates for bypass; however, an attempt at PTA may be indicated as an alternative to primary amputation. Although restenosis, reintervention, or amputation is high after tibial angioplasty for CLI, excellent limb salvage rates may be obtained with careful follow-up and reinterventions when necessary, including bypass in 15%.     

Percutaneous transluminal angioplasty versus surgery for limb-threatening ischemia

This retrospective study compared the results of percutaneous transluminal angioplasty (PTA) with those of infrainguinal bypass procedures in patients with critical arterial ischemia to determine which procedure had superior patency, limb salvage, and durability. The records of 54 patients who underwent 54 PTAs and 56 patients who underwent 63 infrainguinal bypasses (29 femoropopliteal and 34 femorodistal) from 1981 to 1987 were reviewed. In each patient PTA or bypass was the initial vascular procedure. Patients in both groups were comparable with respect to age, sex, and the presence of diabetes, hypertension, obesity, hypercholesterolemia, and smoking. Mean follow-up was 40 months (4 to 88 months) for the PTA group and 28 months (6 to 78 months) for the surgery group. Thirty-nine of the 54 patients (72%) were initially improved after PTA, whereas 15 patients (28%) showed no improvement. During follow-up, 20 initially successful PTAs reoccluded. Thirty-two of 54 patients (59%) underwent subsequent procedures, which included repeat PTA (10) and distal bypass (14). Patency determined by noninvasive Doppler studies was 18% at 2 years. Limb salvage, which included such secondary procedures, was 78%. Two-year patency for femoropopliteal bypasses was 68% with a limb salvage of 90%. Femorodistal bypasses had a 2-year patency of 47% and a limb salvage of 74%. No perioperative deaths occurred. Twenty-one of the 63 patients (33%) had subsequent procedures, which included thrombectomy (5) and bypass revision (9). In patients treated for limb-threatening ischemia the 2-year patency after femoropopliteal bypass (68%) or femorodistal bypass (47%) is significantly better than that from PTA (18%, p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)     

Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia

BACKGROUND: Percutaneous transluminal angioplasty has been used with increasing frequency in the treatment of infrainguinal arterial occlusive disease. This meta-analysis aimed to assess the middle-term outcomes after crural angioplasty in patients with chronic critical limb ischemia and compare results with a meta-analysis of popliteal-to-distal vein bypass graft. METHODS: Data were retrieved from 30 articles published from 1990 through 2006 (63% of articles published between 2000 and 2006). All studies used survival analysis, reported a 12-month cumulative rate of patency or limb salvage, and included at least 15 infrapopliteal angioplasties. The outcome measures were immediate technical success, primary and secondary patency, limb salvage, and patient survival. Data from life-tables, survival curves, and texts were used. RESULTS: The pooled estimate of success was 89.0% +/- 2.2% for immediate technical result. Results at 1 and 36 months were 77.4% +/- 4.1% and 48.6% +/- 8.0% for primary patency, 83.3% +/- 1.4% and 62.9% +/- 11.0% for secondary patency, 93.4% +/- 2.3% and 82.4% +/- 3.4% for limb salvage, and 98.3% +/- 0.7% and 68.4% +/- 5.5% for patient survival, respectively. Studies with >75% of the limbs with tissue loss fared worse than their respective comparative subgroup for technical success and patency but not for limb salvage or survival. No publication bias was detected. CONCLUSION: The technical success and subsequent durability of crural angioplasty are limited compared with bypass surgery, but the clinical benefit is acceptable because limb salvage rates are equivalent to bypass surgery. Further studies are necessary to determine the proper role of infrapopliteal angioplasty.     

膝下动脉球囊血管成形术治疗重症下肢缺血的临床研究

目的 评价膝下动脉闭塞首选球囊血管成形术的临床治疗效果.方法 2005年12月至2009年5月,对于连续收治且符合手术指征的54例(61条肢体)膝下动脉重度狭窄或闭塞的重症下肢缺血患者,采用膝下动脉球囊血管成形术进行治疗.其中男性37例,女性17例,平均年龄66岁.术前踝肱指数平均0.43±0.27.根据病变部位选择手术方法,膝下动脉病变首选球囊血管成形术,合并髂股动脉病变同时进行血管重建(支架置入或动脉旁路术).结果 髂股动脉重建(28条肢体行支架置入,5条肢体行动脉旁路术)均一期成功.膝下动脉球囊血管成形术57条肢体获得一期成功,技术成功率93.4%.围手术期主要并发症为小腿血肿3例(4.9%),膝下截肢2例(3.3%).术后踝肱指数增加至0.86±0.21,与术前相比差异有统计学意义(P<0.01).本组平均随访时间(16±11)个月,一期通畅率61.1%,21条肢体发生再狭窄(38.9%),其中10条肢体再次接受外科干预,二期通畅率75.9%.截肢3条肢体,总的救肢率91.8%.结论 球囊血管成形术是治疗重症下肢缺血安全有效的方法,可以作为膝下动脉病变首选的外科干预手段.     

Patency of infrainguinal polytetrafluoroethylene bypass grafts with distal interposition vein cuffs

Polytetrafluoroethylene (PTFE) prosthetic bypasses in the lower extremity have poor patency rates, particularly in limb salvage cases. Patency and limb salvage rates of PTFE bypasses supplemented by distal interposition vein cuffs were assessed in patients requiring revascularization for critical limb ischemia, in the absence of a suitable autologous saphenous vein. Between October 1993 and April 1996, 163 patients underwent 185 infrainguinal bypasses. Forty-three limbs in 42 patients (12 women, 30 men; mean age 67 years) did not have a suitable autologous saphenous vein (24%) and had femoropopliteal (20) and infrapopliteal (23) bypasses performed. Patients were examined prospectively at 3-month intervals during the first year and at 6-month intervals thereafter to determine graft patency and limb salvage. Postoperative anticoagulation with warfarin was used in 26 patients. Indications for operation included limb salvage in 41 extremities (21 rest pain/ulceration or gangrene, 20 rest pain alone), and disabling claudication in two. Patients were followed clinically for 2–30 months (mean 10 months). Cumulative 2-year life-table patencies for all grafts, femoropopliteal and infrapopliteal bypasses were 64%, 75% and 62%, respectively. Previous primary patencies at the authors' institution for PTFE bypasses without vein cuffs were 35%, 46% and 12% for the same categories. Cumulative life-table limb salvage for all PTFE/vein cuff bypasses in the present series was 76% compared with 37% in previous PTFE bypasses without vein cuffs. Adjunctive use of distal interposition vein cuffs improves prosthetic graft patency, while producing satisfactory limb salvage. Postoperative anticoagulation did not influence graft patency. PTFE/vein cuff for lower-extremity revascularization shows good 2-year patency and is an acceptable alternate conduit in patients with critical limb ischemia when autologous saphenous vein is absent.     

Femoral-distal bypass with in situ greater saphenous vein. Long-term results using the Mills valvulotome.

During a 7-year period, 440 consecutive in situ saphenous vein grafts originating in the groin were performed in 371 patients, exposing the entire vein for valvulotomy with a modified Mills valvulotome. critical ischemia was the indication for bypass in 68%, and the distal anastomosis was to an infrapopliteal artery in 46%. Thirty-day operative mortality was 2.0%. Postoperative surveillance identified 18 stenotic grafts (4.1%), which were revised while still patent (primary revised patency); 36 grafts (8.2%) underwent revision after graft occlusion (secondary patency). Five-year life-table analysis showed overall primary revised patency of 78%, secondary patency of 83%, limb salvage of 88%, and patient survival of 66%. Femoroperoneal and inframalleolar bypasses fared well. The presence of diabetes did not diminish late graft patency. In contrast to reversed vein grafts, long infrapopliteal in situ grafts had long-term secondary patency similar to shorter femoropopliteal bypass grafts (p greater than 0.05). These results, coupled with the versatility and simplicity of the technique as used in the present series, suggest that in situ vein grafting is the procedure of choice for long infrapopliteal bypass.     

Subintimal angioplasty as the first-choice revascularization technique for infrainguinal arterial occlusions in patients with critical limb ischemia

Our aim was to appraise the feasibility and outcomes of subintimal angioplasty (SA) for the percutaneous revascularization of infrainguinal arterial occlusions in patients with critical limb ischemia (CLI). We retrospectively assessed 117 SA procedures in 109 limbs with complete infrainguinal occlusions from 105 patients with CLI. Among these, the superficial femoral artery (SFA) was the only occluded vessel in 27 limbs, while infrapopliteal (IP) occlusions occurred in 82. Average clinical follow-up was 13.5 months (range 1-37). Outcomes were assessed according to the site of SA (SFA vs. IP) and the length of the occlusion (< vs. > or =10 cm). Univariate analyses for the rate of limb salvage and patient survival according to the Kaplan-Meier method were performed. SA-based revascularization had a success rate of 84.4% per limb (89% in SFA and 83% in IP occlusions). During follow-up 12 patients (11.3%) underwent major limb amputation, 11 (10.3%) underwent bypass surgery, and 14 (13.7%) died. Most amputations occurred in patients in whom SA had been unsuccessful and were associated with long (> or =10 cm) occlusions (p = 0.055). Clinical restenosis occurred in seven (6.6%) patients. Survival analysis showed at 6, 12, and 24 months limb salvage rates of 90%, 87%, and 85% and overall survival rates of 90%, 88%, and 83%, respectively. Complications of SA were uncommon (4.7%) and all were successfully managed percutaneously. Infrainguinal SA is an effective revascularization technique that provides a high likelihood of limb salvage and should be the first-choice strategy in the management of patients with CLI.     

Limb salvage after infrainguinal bypass graft failure

OBJECTIVE: The purpose of this study was to examine the outcome of patients in whom an infrainguinal bypass graft failed. METHODS: This was a retrospective analysis of consecutive patients undergoing infrainguinal bypass grafting in a single institution over 8 years. RESULTS: Six hundred thirty-one infrainguinal bypass grafts were placed in 578 limbs in 503 patients during the study period. The indication for surgery was limb-threatening ischemia in 533 patients (85%); nonautologous conduits were used in 259 patients (41%), and 144 (23%) were repeat operations. After a mean follow-up of 28 +/- 1 months (median, 23 months; range, 0-99 months), 167 grafts (26%) had failed secondarily. The rate of limb salvage in patients with graft failure was poor, only 50% +/- 5% at 2 years after failure. The 2-year limb salvage rate depended on the initial indication for bypass grafting: 100% in patients with claudication (n = 16), 55% +/- 8% in patients with rest pain (n = 49), and 34% +/- 6% in patients with tissue loss (n = 73; P <.001). The prospect for limb salvage also depended on the duration that the graft remained patent. Early graft failure (<30 days; n = 25) carried a poor prognosis, with 2-year limb salvage of only 25% +/- 10%; limb salvage was 53% +/- 5% after intermediate graft failure (<2 years, n = 110) and 79% +/- 10% after late failure (>2 years, n = 15; P =.04). Multivariate analysis revealed shorter patency interval before failure (P =.006), use of warfarin sodium (Coumadin) postoperatively (P =.006), and infrapopliteal distal anastomosis (P =.01) as significant predictors for ultimate limb loss. CONCLUSION: The overall prognosis for limb salvage in patients with failed infrainguinal bypass grafts is poor, particularly in patients with grafts placed because of tissue loss and those with early graft failure.     

Unilateral aortofemoral bypass: a safe and effective option for the treatment of unilateral limb-threatening ischemia

To determine whether unilateral aortofemoral (AUF) bypass is a safe and effective option for the treatment of unilateral limb-threatening ischemia in patients with aortic or bilateral iliac occlusive disease, we reviewed the results of 42 AUF bypasses performed using polytetrafluoroethylene grafts in patients operated on for limb salvage; 11 (26%) of the patients also underwent femoropopliteal or femorodistal (FP/D) bypasses. The indications for surgery were tissue necrosis or ulceration in 18 (43%) patients and rest pain in 17 (40%) patients. The 5-year primary graft patency and limb salvage rates for AUF bypass were 74% and 84%, respectively. The perioperative mortality rate was 5%. There were no significant differences in the primary graft patency or limb salvage rates in patients who underwent AUF bypass with or without FP/D bypass. Only 3 of 41 (7%) AUF bypass patients required subsequent femorofemoral bypass. We conclude that: (1) AUF bypass is a safe and effective surgical option in patients with unilateral limb-threatening ischemia and aortic or bilateral iliac occlusive disease; (2) the routine performance of an aortobifemoral or axillobifemoral bypass in patients with unilateral limb-threatening ischemia may be unnecessary; and (3) AUF bypass facilitates the combined inflow and infrainguinal operations that are frequently required for limb salvage in these patients.     

腘以远动脉闭塞所致下肢严重缺血的血供重建

目的 评价腘以远动脉闭塞所致下肢严重缺血(critical limb ischemia,CLI)的血供重建.方法 回顾性分析2003年12月至2009年1月,腘以远动脉闭塞所致CLI行经皮血管腔内成形(percutaneous transluminal angioplasty,PTA)和开放性重建(open reconstruction,OR)术的患者,详细记录患者的病史、病变特点、手术过程、并发症和随访信息.采用Kaplan-Meier生存分析重建血管通畅率和救肢率.结果 本组腘以远动脉闭塞所致CLI患者共167例,182条患肢.123条动脉硬化闭塞(arterios-clerosis occlusions,ASO)的患肢行腘以远动脉PTA治疗,33条血栓闭塞性脉管炎(thromboangiitis obliterans,TAO)和23条ASO患肢行腘以远动脉OR手术.PTA再管化通道6、12、24个月的通畅率分别是67%、54%和49%,其救肢率分别是91%、85%和78%,OR术后移植物6、12、24个月的通畅率分别是90%、83%和79%,其救肢率分别是92%、87%和80%,PTA重建血管的通畅率低于开放性手术(P＜0.05),但PTA和OR术的救肢率差异无统计学意义(P＞0.05).结论 对腘以远动脉ASO的CLI患者,PTA有效、安全,可作为首选治疗方式.PTA治疗失败可选择OR术.对TAO患者腘以远动脉闭塞者OR术仍是最好的治疗选择.

Abstract：

Objective To assess reconstructive options for critical limb ischaemia in infrapopliteal arteries. Methods A retrospective review of all CLI patients who underwent infrapopliteal reconstruction was carried out. Patient history, demographics, procedure details, complications, and follow-up information were collected and analyzed. Patency, limb salvage rate was determined by Kaplan-Meier analysis. Results During the period (from December 2003 to January 2008 ), 123 CLI patients with arteriosclerosis occlusions were treated on an intention-to-treat basis with infrapopliteal percutaneous transluminal angioplasty (PTA).Thirty-three thromboangiitis obliterans and twenty-three arteriosclerosis occlusions suffering CLI were treated by infrapopliteal bypass procedures. Primary patency and limb salvage rate of infrapopliteal PTA at 6, 12 and 24 months was 67%, 54%, 49% and 91%, 85%, 78% respectively, Primary patency and limb salvage rate of infrapopliteal surgical bypass at 6, 12 and 24 months was 90%, 83%, 79% and 92%,87%, 80% respectively, the patency of infrapopliteal PTA was lower than infrapopliteal surgical bypass (P ＜0. 01 ), but the limb salvage rate of infrapopliteal PTA and open surgery was no significant difference (P ＞ 0. 05 ). Conclusion Endovascular treatment (PTA) in patients with infrapopliteal arteriosclerosis occlusions and critical ischaemia is safe, effective. Infrapopliteal PTA can be used as the choice of therapy and surgical bypass reserved in those endovascular treatment failed. While in CLI patients with thromboangiitis obliterans infrapopliteal artery bypass remains the best treatment option.     

Duplex scanning allows selective use of arteriography in the management of patients with severe lower leg arterial disease.

PURPOSE: Until April 1997 we routinely performed intra-arterial digital subtraction angiography (iaDSA) in all patients with severe lower leg ischemia requiring intervention. After a comparative study of duplex scanning (DS), pulsegenerated runoff, and iaDSA of the lower leg arteries, we postulated that management could be based on DS/pulse-generated runoff in 59% of patients. We prospectively evaluated the safety of such a noninvasive workup strategy. METHODS: All consecutive patients referred with severe lower leg ischemia between April 1997 and September 1998 were eligible. Management was based on DS with iaDSA being performed only on indication. Complications within 30 days and 12- and 24-month patency, survival, and limb salvage rates were recorded and compared with historical controls. RESULTS: A total of 125 limbs in 114 patients were evaluated (74% rest pain or tissue loss). In 97 (78%) of 125 limbs, management was based on DS. It comprised conservative treatment (n = 33, 0% after iaDSA), percutaneous transluminal angioplasty (n = 25, 16% iaDSA), femoropopliteal bypass graft (n = 29, 17% iaDSA), femorotibial bypass graft (n = 29, 62% iaDSA), and other surgical procedures (n = 8, 4% iaDSA). Overall, the mortality within 30 days was 4% (5/114), and 2-year survival was 83%. Two-year primary and secondary patency and limb salvage rates were 75%, 93%, and 93% after a femoropopliteal bypass operation, respectively. One-year primary and secondary patency and limb salvage rates were 35%, 73%, and 74%, respectively, after a femorocrural bypass operation. There were no differences in patient characteristics, indication for specific treatment, and immediate and intermediate term outcome between the study and reference population. CONCLUSION: In a vascular unit with wide expertise in DS of the lower leg arteries, management of patients with severe lower leg ischemia can be based on DS in most patients without negative effects on clinical outcome within 30 days and at 2-years' follow-up.     

Is infrainguinal bypass grafting successful following failed angioplasty?

OBJECTIVES: Angioplasty is often used in the management of lower limb ischaemia and can reduce the need for infrainguinal bypass in some patients. There is an associated failure rate with this technique and bypass surgery is often used in this situation as a secondary limb salvage procedure. We aimed to evaluate the outcome of infrainguinal bypass grafting following failed attempt at angioplasty. METHODS: All cases of infrainguinal bypass at a single centre over a seven year period were identified and notes reviewed. Cases were divided into four groups according to their indication for surgery; acute ischaemia, chronic critical ischaemia, failed angioplasty and an 'other' group including aneurysmal disease and claudicants. The failed angioplasty group was compared with the other three groups. Survival analysis was performed using Kaplan Meier curves and groups compared in terms of long term patency and survival. RESULTS: Primary patency was 61.2% in the failed angioplasty group at 12 months compared with 60.6% in the other groups (P=1.11). There was also no significant difference in primary patency at 60 months (50% vs 40.6%, P=0.26). Survival at 12 months was also comparable between the groups (failed angioplasty group 74.2% compared with 77.3% in the other groups, P=0.662) as was 60 months survival (33.3% and 35.4% respectively, P=0.166). DISCUSSION: In this study, outcome of infrainguinal bypass following failed angioplasty was comparable to outcome of surgery performed for another indication. This paper supports the use of distal bypass surgery for limb salvage in cases where minimal access techniques have failed.     

Results of infrainguinal bypass surgery: an analysis of 263 consecutive operations.

BACKGROUND AND AIMS: The purpose of this clinical study was to assess the success of infrainguinal revascularization in the treatment of lower limb ischaemia. MATERIAL AND METHODS: 226 consecutive patients underwent 263 femoropopliteal (n = 194) or femorodistal (n = 69) bypass operations during 1988-1996 at a university hospital. Records of all patients were reviewed. Late control visits including clinical and colour doppler ultrasound examinations were programmed for 109 patients. Initial success, primary and secondary patencies, limb salvage and survival rates were determined and factors affecting outcome were analysed in various patient categories. RESULTS: Initial success rate was 92% (243/263). The primary and secondary patencies were 70/83% and 52/63% at one and five years, respectively. The corresponding limb salvage rates for patients with chronic critical ischaemia were 82% and 77%. The number of diseased vessels in the treated limb correlated negatively with the primary patency. Advanced age did not affect primary patency or limb salvage rates. Diabetes and the use of distal revascularizations were independent predictors of poorer limb salvage. Diabetes and renal insufficiency proved to shorten life expectancy. CONCLUSIONS: Infrainguinal revascularizations are effective regardless of patient's age. The extent of atherosclerotic changes in the operated limb, diabetes and renal insufficiency are factors affecting outcome.     

One-year prospective quality-of-life outcomes in patients treated with angioplasty for symptomatic peripheral arterial disease

BACKGROUND: Despite lower reported patency rates than open bypass, percutaneous transluminal angioplasty (PTA) may result in symptom relief, limb salvage, maintenance of ambulation and independent living, and overall improved quality of life. The goal of this study was to prospectively assess quality of life and functional outcomes after angioplasty and stenting in patients with chronic leg ischemia. METHODS: From August to December 2002, 84 patients with 118 chronically ischemic limbs underwent PTA with or without stenting as part of an ongoing prospective project performed to examine management of symptomatic peripheral arterial disease. All patients completed a preprocedure health questionnaire (Short Form 36) to provide adequate baseline data. Each patient was followed up every 3 months after treatment for 1 year to determine traditional outcomes of arterial patency, limb salvage, survival and amputation-free survival, and functional outcomes assessed according to improvement in quality of life, maintenance of ambulatory status, and maintenance of independent living status. The entire cohort was analyzed, as were subgroups of patients with lifestyle-limiting claudication and those with critical limb ischemia. Outcomes were analyzed by using Kaplan-Meier life-table analysis, the log-rank test for survival curves, and the one-sample t test. A Cox proportional hazard model was used to determine whether presentation and level of disease were independent predictors of outcome. RESULTS: Of the 84 patients, 54 (64.3%) were treated for claudication (34 aortoiliac occlusive disease and 20 infrainguinal disease), and 30 (35.7%) were treated for critical limb ischemia (11 aortoiliac occlusive disease and 19 infrainguinal disease). One-year results for the 54 patients with claudication were as follows: primary patency, 78.5%; limb salvage, 100%; amputation-free survival, 96.3%; survival, 96.3%; maintenance of ambulation status, 100%; and maintenance of independence, 100%. There was statistical improvement in all physical function categories, including physical function (29.4 +/- 8.9 vs 37.1 +/- 11.3; P < .0001), role-physical (32.5 +/- 11.3 vs 39.5 +/- 13.0; P = .0001), bodily pain (35.8 +/- 8.5 vs 42.9 +/- 10.9; P < .0001), and aggregate physical scoring (31.1 +/- 9.7 vs 38.1 +/- 11.5; P < .0001). One-year results for the 30 patients with critical limb ischemia were as follows: primary patency, 35.2%; limb salvage, 77.2%; amputation-free survival, 50.0%; survival, 60.0%; maintenance of ambulation status, 75.8%; and maintenance of independence, 92.8%. There was statistical improvement in bodily pain resolution (35.3 +/- 12.0 vs 46.6 +/- 12.0; P = .0009). Cox models with hazard ratios (HRs) revealed that presentation was a significant predictor for outcomes of primary patency (HR, 4.2; P= .0002), secondary patency (HR, 6.0; P < .0001), limb salvage (HR, 20.2; P = .0047), survival (HR, 10.9; P = .0002), and amputation-free survival (HR, 11.2; P < .0001). Conversely, the level of disease was predictive of outcome only for primary patency (HR, 1.8; P = .00289). CONCLUSIONS: Despite inferior reconstruction patency rates when compared with the historical results of open bypass, PTA provides excellent functional outcomes with good patient satisfaction, especially for treating claudication. These findings support a more liberal use of PTA intervention for patients with vasculogenic claudication.     

Intermediate results of percutaneous endovascular therapy of femoropopliteal occlusive disease: a contemporary series

BACKGROUND: Percutaneous endovascular therapy is becoming a primary option for managing infrainguinal occlusive disease. This study examined the results of femoropopliteal percutaneous transluminal angioplasty (PTA) with intermediate (mean, 24 months) follow-up in a contemporary series of patients presenting with critical limb ischemia or claudication. METHODS: Femoropopliteal PTA was performed on 238 consecutive limbs (208 patients) from January 2002 to July 2004. Study end points, including primary patency, assisted patency, and limb salvage (Society of Vascular Surgery reporting standards), were assessed by Kaplan-Meier life-table analysis, and factors predictive of hemodynamic or clinical failure, or both, were evaluated by univariate and multivariate methods. RESULTS: Clinical and demographic features included a mean age, 72 years; male (62%); critical limb ischemia (46%); diabetes mellitus (49%); and renal insufficiency (creatinine >or= 1.5 mg/dL) (29%). Lesions were classified as TransAtlantic Inter-Society Consensus (TASC) A (11%), B (43%), C (41%), and D (5%). PTA was confined to the femoropopliteal segment in 77 patients (33%), and 161 (67%) underwent concurrent interventions in other anatomic locations. Femoropopliteal interventions included angioplasty only in 183 (78%), and the remaining 53 (22%) received at least one stent. Technical success was achieved in 97% of patients, with no deaths and a major morbidity rate of 3%. The 36-month actuarial primary patency was 54.3%, and assisted patency was 92.6% (37 peripheral reinterventions), resulting in a limb preservation rate of 95.4% in all patients regardless of clinical presentation. Interval conversion to bypass surgery occurred in 19 patients (8%). Comparison between critical limb ischemia and claudication revealed a primary patency of 40.8% vs 64.8%, assisted patency of 93.8% vs 92.6%, and limb salvage of 89.7% vs 100%, respectively. Negative predictors of primary patency determined by multivariate analysis included history of congestive heart failure (P = .02) and TASC C/D (P = .02). However, further evaluation of TASC C/D vs A/B revealed an assisted patency of 89.7% vs 94.3% (P = .37) and limb salvage of 94.3% vs 96.4% (P = .58). CONCLUSIONS: Femoropopliteal PTA can be performed with a low perioperative morbidity and mortality. Intermediate primary patency is directly related to TASC classification. Although secondary intervention is often necessary to maintain patency in TASC C/D lesions, these data suggest that it would be appropriate to use PTA as initial therapy for chronic femoropopliteal occlusive disease regardless of clinical classification at presentation or TASC category of lesion severity.     

Endovascular interventions for infrapopliteal arterial disease: an update

Surgical revascularization has been the cornerstone of limb salvage for patients with critical limb ischemia due to infrapopliteal arterial atherosclerotic disease. Endovascular procedures such as balloon angioplasty and stenting are gaining popularity for treatment of such patients, although level 1 evidence to support the superiority of endovascular treatment over saphenous vein bypass is still lacking. A review of the literature from the past 2 years reveals that balloon angioplasty of the tibial arteries in patients with critical limb ischemia carried a 1-year primary patency rate between 33% and 37%, a secondary patency rate of 56% to 63%, and a limb-salvage rate of 75% to 100%. Two randomized controlled trials failed to show the superiority of primary infrapopliteal stenting over balloon angioplasty alone. One randomized controlled trial reported the benefit of drug-eluting stents over bare metal stents. Other studies documented good early results after secondary stenting, cryoplasty, and using retrograde access for tibial interventions. In conclusion, balloon angioplasty or stenting, if angioplasty fails, have emerged as reasonable options for limb salvage in patients with critical limb ischemia. More studies are needed to evaluate the role of percutaneous transluminal angioplasty as the primary modality of choice. There is a real need for a new randomized controlled trial to compare tibial angioplasty/stenting with autologous surgical bypass.     

Outflow resistance measurement during infrainguinal arterial reconstructions: a reliable predictor of limb salvage

Criteria for abandoning infrainguinal arterial reconstructions in favor of major amputations should include reliable predictors not only of graft patency, but more importantly, of limb salvage. To evaluate the efficacy of intraoperative outflow resistance measurements in predicting limb salvage after infrainguinal bypasses, we have reviewed 134 such operations (64 femoropopliteal and 70 femorodistal bypasses) performed for critical ischemia. Outflow resistance measurements were divided into quartiles for femoropopliteal bypasses (Group A 0.17 mm Hg/ml/min or less, Group B 0.18 to 0.24 mm Hg/ml/min, Group C 0.25 to 0.4 mm Hg/ml/min, and Group D greater than 0.4 mm Hg/ml/min) and femorodistal bypasses (Group A 0.4 mm Hg/ml/min or less, Group B 0.4 to 0.58 mm Hg/ml/min or less, Group C 0.6 to 1 mm Hg/ml/min, and Group D 1 mm Hg/ml/min or greater). One year limb salvage rates for patients who underwent femoropopliteal bypass were 95 percent, 92 percent, 87 percent, and 67 percent from the lowest to the highest quartile (difference not statistically significant), and for those who had femorodistal bypass, they were 51 percent, 75 percent, 48 percent, and 0, respectively (p less than 0.05). Interestingly, 12 month graft patency and limb salvage rates for patients who underwent femorodistal bypass with outflow resistances between 0.59 and 1 mm Hg/ml/min did not correlate well (22 percent and 48 percent, respectively), whereas for those with outflow resistance greater than 1 mm Hg/ml/min, they were 22 percent and 22 percent, respectively. Thus, measurement of intraoperative outflow resistance is a very accurate predictor of limb salvage after infrainguinal bypass operations.     

Six-year prospective multicenter randomized comparison of autologous saphenous vein and expanded polytetrafluoroethylene grafts in infrainguinal arterial reconstructions

Autologous saphenous vein (ASV) and polytetrafluoroethylene (PTFE) grafts were compared in 845 infrainguinal bypass operations, 485 to the popliteal artery and 360 to infrapopliteal arteries. Life-table primary patency rates for randomized PTFE grafts to the popliteal artery paralleled those for randomized ASV grafts to the same level for 2 years and then became significantly different (4-year patency rate of 68% +/- 8% [SE] for ASV vs. 47% +/- 9% for PTFE, p less than 0.025). Four-year patency differences for randomized above-knee grafts were not statistically significant (61% +/- 12% for ASV vs. 38% +/- 13% for PTFE, p greater than 0.25) but were for randomized below-knee grafts (76% +/- 9% for ASV vs. 54% +/- 11% for PTFE, p less than 0.05). Four-year limb salvage rates after bypasses to the popliteal artery to control critical ischemia did not differ for the two types of randomized grafts (75% +/- 10% for ASV vs. 70% +/- 10% for PTFE, p greater than 0.25). Although primary patency rates for randomized and obligatory PTFE grafts to the popliteal artery were significantly different (p less than 0.025), 4-year limb salvage rates were not (70% +/- 10% vs. 68% +/- 20%, p greater than 0.25). Primary patency rates at 4 years for infrapopliteal bypasses with randomized ASV were significantly better than those with randomized PTFE (49% +/- 10% vs. 12% +/- 7%, p less than 0.001). Limb salvage rates at 3 1/2 years for infrapopliteal bypasses with both randomized grafts (57% +/- 10% for ASV and 61% +/- 10% for PTFE) were better than those for obligatory infrapopliteal PTFE grafts (38% +/- 11%, p less than 0.01). These results fail to support the routine preferential use of PTFE grafts for either femoropopliteal or more distal bypasses. However, this graft may be used preferentially in selected poor-risk patients for femoropopliteal bypasses, particularly those that do not cross the knee. Although every effort should be made to use ASV for infrapopliteal bypasses, a PTFE distal bypass is a better option than a primary major amputation.     

Infrainguinal bypass grafting in patients with end-stage renal disease and critical limb ischaemia: is it worthwhile?

Patients with end-stage renal disease (ESRD) constitute an increasing proportion of patients undergoing infrainguinal bypass surgery for critical limb ischaemia (CLI). The aim of this retrospective study was to determine graft patency, healing of pedal lesions, limb salvage and survival following infrainguinal arterial reconstruction in this high-risk subset of patients. 34 patients with ESRD undergoing 37 bypass procedures for CLI (rest pain 2; tissue loss 35) were identified from the vascular registry. These included 13 femoropopliteal and 24 femorotibial bypasses with autogenous (67.6%) or prosthetic (32.4%) materials. The median age in this series was 62 years and 79% were diabetics. Using life-table analysis, the cumulative primary patency rate was 88% at 1 month and 81% at 2 years. The resulting limb salvage rate amounted to 94 and 86% at 1 month and 2 years, respectively. Healing of the pedal lesions was accomplished in only 50% of patients at 6 months. Toe lesions could be treated more successfully than forefoot and deep heel defects (p = 0.04). With a perioperative mortality of 3/37 cumulative survival rate declined to 21% at 2 years. Late mortality correlated significantly with a history of previous myocardial infarction or congestive heart failure (p = 0.001). Infrainguinal revascularisation can be performed in dialysis-dependent patients with acceptable patency and limb salvage rates. However, bypass grafting should be mainly reserved to patients without severe cardiac disease and to those without extensive tissue loss.     

Venous Allografts Preserved at 4°C for Infrainguinal Bypass: Long-Term Results from 170 Procedures

n = 35) or composite (n= 135) venous allografts preserved at 4°C as a substitute for saphenous autografts in 146 patients. The mean age of the patient population was 74 years. The indication was critical lower limb ischemia in 71% of cases. Seventy-five percent of procedures were below the knee and 26% were infrapopliteal. Mean length and diameter were 19.5 ± 0.5 cm and 4.8 ± 0.5 mm, respectively. After December 8, 1993, a reinforcement net was placed over the graft to prevent expansion in 71% of cases. Primary and secondary 5-year patency, calculated according to the Kaplan-Meier method, were 33 ± 6% and 43 ± 6%, respectively. Factors correlated with secondary patency were studied using the log-rank test. Previous ipsilateral infrainguinal revascularization was associated with a 40% decrease in secondary patency at 2 years (71% vs. 31%). Patency at 5 years was correlated with the level of anastomosis (47% for low popliteal anastomosis vs. 30% for infrapopliteal anastomosis). The likelihood of stenosis or dilatation of the allograft was 8% and 29.5%, respectively, at 5 years. The 5-year limb salvage and survival rates were 84% and 57%, respectively. The encouraging results of this series suggest that venous allografts provide a useful alternative for infrainguinal bypass when autologous grafts or other more reliable conduits are unavailable.