Superficial femoral artery recanalization with self-expanding nitinol stents: long-term follow-up results.

PURPOSE: Since long-term patency and device integrity of nitinol stents in SFA lesions are not well studied, we examined clinical outcome, patency and device integrity after stenting long lesions using a standardized implantation technique. METHODS: Between 2001 and 2006, 59 patients (74 lesions) were treated with the same nitinol self-expandable stent (Zilver, Cook, USA) and technique for SFA recanalization. Clinical charts and imaging were retrospectively reviewed for patency (primary and assisted-primary), and device integrity. RESULTS: Patients were 74.5 (10.9) years old (range 49 to 93), 64% male, 42% diabetic, 62% hypertensive and 67% current or former smokers. Lesions were 23% TASC B, 16% TASC C, or 61% TASC D. Mean recanalization length was 19 cm (range 3 to 53). Mean number of stents per patient was 2.8 (total 210). Mean follow-up time was 2.4 years (range 3 days to 4.8 years). Kaplan-Meier estimates for primary patency rates were 90%, 78%, 74%, 69%, and 69% at 1, 2, 3, 4 and 4.8 years, respectively. Ten restenoses at a mean of 500 (388) days (1-1251 days) were successfully recanalized. The assisted primary patency rates were 96%, 90%, 90%, 90% and 90% at 1, 2, 3, 4 and 5 years, respectively. Six complete occlusions could not be reverted by a second recanalization procedure, and were treated by surgical bypass (1 case), amputation (3 cases), or medical management (2 cases). One (1.04%) Class II stent fracture was noted. CONCLUSIONS: SFA recanalization with a standardized implantation technique and nitinol stents provides good long-term primary and assisted-primary patency.     

影响股浅动脉硬化闭塞症外科治疗预后的相关因素

目的 明确股胴动脉病变TASCⅡ分级、流出道评分、影响动脉硬化危险因素与外科治疗股浅动脉硬化闭塞症术后疗效的相关性.方法 回顾性分析2006年1月至2009年9月北京同仁医院对股胭动脉硬化闭塞症行股胭动脉段介入或手术治疗142例患者的临床资料.采用TASCⅡ分级标准对股胴动脉段病变分级;使用流出道评分标准对胫腓动脉进行膝下流出道评分.随访患者术后疗效,用Kaplan-Meier法计算一期通畅率,用COX回归分析病变TASCⅡ分级、流出道评分、各种动脉硬化危险因素与术后一期通畅率相关性.结果 本组142例(197条患肢).其中外科手术治疗50例(58条患肢);介入治疗99例(139条患肢).随访患者141例(196条患肢),随访率90.8%.术后随访时间1～26个月,中位随访时间13个月.经COX回归分析,术前股浅动脉病变TASCⅡ分级(RR=1.471,P=0.012)、流出道评分(RR=1.190,P=0.004)、2型糖尿病(RR=2.320,P=0.019)为影响外科治疗股浅动脉病变术后一期通畅率的因素. 结论术前TASCⅡ分级级别较高、流出道评分分值较高及患有2型糖尿病的患者,股浅动脉病变术后一期通畅率不佳.     

Percutaneous angioplasty and stenting of the superficial femoral artery

OBJECTIVES: The objectives of this study were to examine factors predictive of success or failure after percutaneous angioplasty (PTA) and stenting (S) of the superficial femoral artery (SFA) and to compare the results of PTA/S with a contemporary group of patients treated with femoropopliteal bypass. METHODS: A database of patients undergoing PTA and/or S of the SFA between 1986 and 2004 was maintained. Intention-to-treat analysis was performed. Patients underwent duplex scanning follow-up at 1, 3, and every 6 months after the intervention. Angiograms were reviewed in all cases to assess lesion characteristics and preprocedure and postprocedure runoff. Results were standardized to current TransAtlantic Inter-Society Consensus (TASC) and Society for Vascular Surgery (SVS) criteria. Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Cox proportional hazard analyses were performed to assess factors associated with patient survival and treatment efficacy. RESULTS: Three hundred eighty total limbs underwent PTA/S in 329 patients (67% male, 33% female; average age, 65 years). Mean follow-up was 1.8 years from the date of initial intervention. Indications for intervention were claudication in 66%, rest pain in 16%, and tissue loss in 18%. Runoff at the tibial level was 2.1 +/- 0.8 patent vessels. Mean SVS ischemia grade was 3.1 (range, 1 to 5). TASC lesion grades were A (48%), B (18%), C (22%), and D (12%). Angioplasty alone was used in 63% of cases. Primary treatment failure (inability to cross lesion) was seen in 7% of patients. There was one periprocedural death. Primary patency rates were 86% at 3 months, 80% at 6 months, 75% at 12 months, 66% at 24 months, 60% at 36 months, 58% at 48 months, and 52% at 60 months. Assisted primary patency rates were slightly higher ( P = not significant). By Cox proportional hazards analysis, patency of PTA/S was associated with higher preoperative ankle/brachial index ( P = .016) and the performance of angioplasty only ( P = .011). Failed or occluded PTA/S was associated with TASC C ( P < .0001) and TASC D lesions ( P < .0001). Patient death was associated with the presence of congestive heart failure ( P = .003). Subgroup analysis revealed that primary patency rates are highly dependent on lesion type (A > B > C > D, P < .0001). PTA/S patency for TASC A and B lesions compared favorably to prosthetic and venous femoropopliteal bypass. Surgical bypass was superior to PTA/S for TASC C and D lesions. CONCLUSIONS: PTA and stenting of the SFA can be performed safely with excellent procedural success rates. Improved patency of these interventions was seen with increased ankle/brachial index and the performance of angioplasty only. Worse patency was seen with TASC C and TASC D lesions. Patency rates were strongly dependent on lesion type, and the results of angioplasty and stenting compared favorably with surgical bypass for TASC A and B lesions.     

Angioplasty and Primary Stenting of High-grade,Long-segment Superficial Femoral Artery Disease: Is It Worthwhile?

The purpose of this study was to determine the long-term results and efficacy of angioplasty and stenting of long-segment, high-grade superficial femoral artery disease. Seventy-three consecutive primary balloon angioplasty procedures with immediate stenting in 70 patients with SVS/ISCVS grade B2 or C superficial femoral artery (SFA) disease exceeding 5 cm in length were evaluated. The mean lesion length was 16 cm and occlusion constituted 62%, with a runoff score of 8. Forty-nine procedures (67%) were performed for critical ischemia. A total of 135 stents were placed. Follow-up was with 3-month duplex ultrasound; stenosis >50% was considered the end point for failure. Mean follow-up time was 26 months. Initial technical success with intent to treat was 90%. Initial success according to anatomic, hemodynamic, and clinical criteria was 90%, 88%, and 88%, respectively, with intent to treat. Limb salvage in the critical ischemia group was 71%. Overall cumulative primary patency rates at 12, 24, and 48 months were 56%, 35%, and 22%, and secondary patency rates were 69%, 47%, and 37%, respectively. A stented segment length >10 cm and procedure in claudicants incurred an inferior patency rate. Treatment of high-grade SFA lesions with angioplasty and primary setting results in lower long-term patency rate than those with surgery, but combined with secondary interventions this treatment option may be an acceptable alternative in selected patients with critical ischemia. Femoropopliteal bypass remains the procedure of choice.     

Nitinol stenting for treatment of 'below-the-knee' critical limb ischemia: 1-year angiographic outcome after Xpert stent implantation

AIM: We investigated the efficacy of Xpert (Abbott Vascular Devices) nitinol stents for the treatment of infrapopliteal lesions in patients with critical limb ischemia (CLI). METHODS: Between May and October 2005, 47 CLI patients (35 men, mean age 73 years) received 67 Xpert stents for the treatment of 58 infrapopliteal lesions in 51 limbs; 43 patients (84.3%) were classified in Rutherford Category 4 and 8 (15.7%) in Category 5. Clinical examination and quantitative vascular analysis (QVA) were performed before and after the intervention and at 12-months follow-up. The primary endpoint was defined as 1-year angiographic binary restenosis rate (>50% stenosis on QVA); the secondary endpoints were 1-year primary patency and limb salvage rate. RESULTS: QVA after 1 year showed a binary restenosis rate of 20.45%. Kaplan-Meier analysis revealed 1-year primary patency and limb salvage rates of 76.3% and 95.9%, respectively. The limb salvage rate was significantly better in patients with proximal below-the-knee (BTK) than in those with mid-section or distal lesions (100% vs 81.8%; P=0.0071). CONCLUSION: Our results suggest that treatment with nitinol Xpert stents in CLI patients is effective and yields satisfactory angiographic and clinical outcome.     

Impact of diabetes mellitus on outcomes of superficial femoral artery endoluminal interventions

BACKGROUND: Although aggressive endoluminal therapy for superficial femoral artery (SFA) occlusive disease is commonplace, the implications of diabetes mellitus (DM) on long-term outcomes in this population are unclear. We examined the consequences of endovascular treatment of the SFA in patients with and without DM. METHODS: A database of patients undergoing endovascular treatment of the SFA between 1986 and 2005 was maintained. Three groups were defined: nondiabetic patients, those with non-insulin-dependent DM (NIDDM), and those with insulin-dependent DM (IDDM). Intention-to-treat analysis was performed. Results were standardized to TransAtlantic Inter-Society Consensus (TASC) and Society for Vascular Surgery criteria. Time-dependent outcomes were assessed with Kaplan-Meier survival analyses. Factor analyses were performed using a Cox proportional hazard model for time-dependent variables. Data are presented as mean +/- SD where appropriate. RESULTS: Endovascular treatment (ie, balloon angioplasty +/- adjuvant stenting in 38%) was initiated in 525 limbs in 437 patients (68% male; average age, 66 +/- 14 years) for claudication failing conservative therapy or chronic critical limb ischemia (CLI). Of these, 50% were nondiabetic, 26% had NIDDM, and 24% had IDDM. Analyses were separated by those presenting with claudication (61%) and those presenting with CLI (39%). Among patients presenting with claudication, those with IDDM had significantly lower assisted primary patency (P < .01) and a higher incidence of restenosis (P = .04). Patencies at 3 years for nondiabetic, NIDDM, and IDDM were 62%, 72%, and 54% (primary), and 81%, 86%, and 65% (assisted primary), respectively. Patency and restenosis rates were associated with lesion calcification, TASC D lesion categorization, and acute periprocedural occlusion. Among patients presenting with CLI, patency and restenosis rates were equivalent across all groups; however, limb salvage was significantly worse for both groups of diabetic patients compared with nondiabetic (NIDDM, P = .01; IDDM, P = .02). Reduction in limb salvage rates was associated with presence of tissue loss at presentation, end-stage renal disease, and progression of distal disease on follow-up. CONCLUSIONS: Endoluminal therapy for SFA occlusive disease yields lower assisted patency rates and higher restenosis rates for those patients presenting with claudication who have more advanced diabetes (ie, IDDM). Among those patients presenting with CLI, particularly those with tissue loss, limb salvage rates are lowered for the diabetic groups (NIDDM and IDDM) despite equivalent patency and restenosis rates.     

Plaque excision with the Silverhawk catheter: early results in patients with claudication or critical limb ischemia

OBJECTIVE: This study was conducted to detail the early experience after infrainguinal atherectomy using the Silverhawk plaque excision catheter for the treatment of symptomatic peripheral vascular disease. METHODS: A prospective database was established in August 2004 in which data for operations, outcomes, and follow-up were recorded for patients undergoing percutaneous plaque excision for peripheral arterial occlusive disease. Society for Vascular Surgery (SVS) ischemia scores and femoropopliteal TransAtlantic Inter-Society Consensus (TASC) criteria were assigned. A follow-up protocol included duplex ultrasound surveillance at 1, 3, and 6 months and then yearly thereafter. Standard statistical analyses were performed. RESULTS: During a 17-month period, 66 limbs of 60 patients (37 men [61.7%]) underwent 70 plaque excisions (four repeat procedures). Indications included tissue loss based on SVS ischemia at grades 5 and 6 (25/70), rest pain at grade 4 (22/70), and claudication at grades 2 to 3 (23/70). The mean lesion length was 8.8 +/- 0.7 cm. The technical success rate was 87.1% (61/70). Adjunctive treatment was required in 17 procedures (24.3%), consisting of 14 balloon angioplasties and three stents. Femoropopliteal TASC criteria included 5 TASC A lesions, 14 TASC B lesions, 32 TASC C lesions, and 19 TASC D lesions. Although 17 plaque excisions included a tibial vessel, no patient underwent isolated tibial atherectomy. The mean increase in ankle-brachial index was 0.27 +/- 0.04 and in toe pressure, 20.3 +/- 6.9 mm Hg. Mean duplex ultrasound follow-up was 5.2 months (range, 1 to 17 months). One-year primary, primary assisted, and secondary patency was 61.7%, 64.1%, and 76.4%, respectively. Restenosis or occlusion developed in 12 patients (16.7%) and was detected at a mean of 2.8 +/- 0.7 months. Restenosis or occlusion was significantly more common (P < .05) in patients with TASC C and D lesions compared with patients with TASC A and B lesions. Six (8.3%) of 12 patients underwent reintervention on the basis of duplex ultrasound surveillance results. Four (33.3%) of 12 patients experienced reocclusion during the same hospitalization, and amputation and open revascularization were required in two patients each. CONCLUSIONS: Percutaneous plaque excision is a viable treatment option for lower extremity revascularization. Outcomes are related to ischemia and lesion severity. Patency and limb salvage rates are equivalent to other endovascular modalities.     

Iliac artery stenting versus surgical reconstruction for TASC (TransAtlantic Inter-Society Consensus) type B and type C iliac lesions

OBJECTIVE: The TransAtlantic Inter-Society Consensus (TASC) document did not define the best treatment for moderately severe iliac artery lesions, ie, TASC type B and type C iliac lesions, because of insufficient solid evidence to make firm recommendations. The purpose of this study was to evaluate the influence of risk factors on outcome of iliac stenting and operative procedures used to treat TASC type B and type C lesions. METHODS: Over the 5 years from 1996 to 2001, 188 endovascular and direct aortoiliac surgical reconstruction procedures were performed in 87 women and 101 men with TASC type B and type C iliac lesions and chronic limb ischemia. The criteria prepared by the Ad Hoc Committee on Reporting Standards (Society for Vascular Surgery/International Society for Cardiovascular Surgery (SVS/ISCVS) were followed to define variables. Both univariate analysis (Kaplan-Meier method) and multivariate analysis (Cox proportional hazards model) were used to determine the association between variables, cumulative patency rate, limb salvage, and survival. RESULTS: Indications for revascularization were disabling claudication (73%), limb salvage (25%), and blue toe syndrome (2%). Patients in the surgery group (n = 52) had significantly higher primary patency rates compared with patients in the stent group (n = 136) at univariate analysis (Kaplan-Meier method, log-rank test; P =.015). Primary patency rates at 1, 3, and 5 years were 85%, 72%, and 64% after iliac stenting, and 89%, 86%, and 86% after surgical reconstruction, respectively. Univariate and multivariate Cox regression analysis enabled identification of poor runoff (ie, runoff score >5 for unilateral procedures or >2.5 for bilateral outflow procedures; relative risk, 2.5; 95% confidence interval [CI], 1.4-4.2; P =.001) as the only independent predictor of decreased primary patency in all patients. However, stratified analysis including only patients with poor runoff revealed that patients undergoing iliac stenting had significantly lower primary patency rates compared with those undergoing surgical reconstruction (Kaplan-Meier method, log-rank test; P =.05). External iliac artery disease and female gender were also identified as independent predictors of decreased primary stent patency. CONCLUSIONS: Poor infrainguinal runoff is the main risk factor for decreased primary patency after surgical reconstruction and iliac stenting to treat TASC type B and type C iliac lesions. However, primary patency is less affected by poor runoff in patients undergoing surgical procedures. The presence of poor runoff, external iliac artery disease, and female gender are independent predictors of poor outcome after iliac stenting, and therefore these risk factors should determine the need for surgical reconstruction.     

Correlation between Angiographic Runoff and Intraoperative Hydraulic Impedance with Regard to Graft Patency

The aim of this study was to evaluate the correlation between peripheral runoff estimated by the SVS/ISCVS scoring system and intraoperatively measured outflow. Sixty-six patients received 27 femoropopliteal and 39 femorocrural ePTFE grafts. During the operation, peripheral resistance and hydraulic impedance were measured by means of the extracorporeal-bypass-flow method. Angiographic runoff was estimated according to the revised SVS/ISCVS system. Patients were entered in a graft surveillance program and patency was calculated after 3 years. The relation between the angiographic runoff score and graft patency as well as correlations between hemodynamic data, peripheral resistance, and hydraulic impedance were calculated. Primary and secondary patency rates for femoropopliteal grafts were 44% and 60% and those for femorocrural bypasses were 35% and 45%. Mean angiographic vessel diameters for above-knee and below-knee popliteal arteries were 0.51 ± 0.02 mm and 0.47 ± 0.04 mm. Diameters of crural arteries were 0.34 ± 0.03 mm (posterior tibial artery), 0.27 ± 0.02 mm (anterior tibial artery) and 0.26 ± 0.21 mm (peroneal artery). The differences in diameter between popliteal and crural grafts were statistically significant (p < 0.01). Calculated correlations between the preoperative score and hemodynamic, resistance, and impedance values or patency rates were generally poor and statistically not significant. A statistical significant correlation was found only between SVS/ISCVS score and recipient vessel diameters. The angiographic runoff did not correlate with peripheral resistance, impedance, or patency rates. Patients with angiographically poor outflow should additionally be evaluated with duplex sonography or magnetic resonance angiography and should not be denied peripheral reconstructions.     

Percutaneous Transluminal Revascularization for Iliac Occlusive Disease: Long-term Outcomes in TransAtlantic Inter-Society Consensus A and B Lesions

Percutaneous transluminal intervention for atherosclerotic iliac occlusive disease is now commonplace. We examine the long-term outcomes of TransAtlantic Inter-Society Consensus (TASC) A and B lesions. We performed a retrospective anonymous analysis of records from patients who underwent iliac artery angioplasty with or without stenting between January 1990 and June 1999. Indications for intervention were symptomatic claudication (77%) or critical ischemia (23%). Altogether, 276 patients (all men; average age 64 ± 11 years range 32-87 years) underwent 394 interventions. Co-morbidities included hypertension (61%), hypercholesterolemia (45%), diabetes (28%), and chronic renal insufficiency (26%). A total of the 62% of the lesions were TASC category A, and the remainder were category B. Of the 394 primary interventions, 51% included placement of stents. Technical success (defined by < 30% residual stenosis) was achieved in 98% of treated vessels. The procedure-related mortality rate was 1.8% at 30 days and 4.7% at 90 days; the procedure-related complication rate was 7%. Hemodynamic success (defined as a rise in the ankle/branchial index > 0.15) was achieved in 82%. The average Society for Vascular Surgery symptom score was 3.4 ± 0.9 before intervention, which improved to 1.9 ± 0.8 following intervention. Within 3 months, 84% of patients demonstrated clinical improvement. Patient survival by life-table analysis was 38% at 10 years. The cumulative assisted patency rate was 71 ± 7% at 10 years. The presence of two-vessel femoral runoff, two or more patent tibial vessels, or both was associated with improved patency. Limb salvage was 95 ± 2% and 87 ± 9% at 5 and 10 years, respectively. Using Cox proportional hazards analysis, the presence of hypertension, hypercholesterolemia, or chronic renal insufficiency was associated with the occurrence of primary failure, whereas increased patency intervals were associated with the presence of immediate hemodynamic improvement. Use of a stent did not influence outcome. Endoluminal iliac intervention for TASC A and B lesions is a safe, durable intervention in patients with good femoral and tibial runoff. The presence of hypertension, hypercholesterolemia, or poor tibial runoff is associated with failure.     

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 superficial femoral artery interventions for claudication--does runoff matter?

Endoluminal therapy for superficial femoral artery (SFA) occlusive disease for claudication is commonplace, but the implications of tibial vessel runoff on long-term outcomes of these interventions in patients with claudication are unclear. Runoff is known to negatively affect graft patency, but no data are available on the impact of runoff on percutaneous SFA interventions and their implications during follow-up. We examined the impact of distal popliteal and tibial runoff on long-term outcomes of SFA interventions for claudication. A prospective database of patients undergoing endovascular treatment of the SFA between 1986 and 2007 was queried. Patients with Rutherford symptom classifications 1, 2, and 3 were selected; those with concomitant tibial interventions were excluded. Angiograms were reviewed preoperatively in all cases to assess distal popliteal and tibial runoff and scored according to modified Society for Vascular Surgery criteria for both vessels such that a higher score implies worse runoff (minimum 1, maximum 19). Three run-off score groups were identified: <5 (good), 5-10 (compromised), and >10 (poor). Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Multivariate and factor analyses were performed. There were 481 limbs in 347 patients (70% male, average age 66 years) that underwent endovascular SFA treatment for claudication: 87% had hypertension, 51% had diabetes mellitus, 67% had hyperlipidemia, and 16% had chronic renal insufficiency (1% on hemodialysis). Technical success was 92%, with 63% SFA undergoing angioplasty, 26% SFA undergoing primary stenting, and 3% SFA undergoing atherectomy. Overall mortality was 1.1% and overall morbidity was 17% at 90 days after the procedure. At 5 years, vessels with compromised and poor runoff had significantly lower freedom from recurrent symptoms and lower freedom from restenosis. Primary and assisted primary patency rates were significantly worse in patients with poor runoff. However, secondary patency was equivalent between the groups. Compromised or poor runoff was associated with incremental lower limb salvage. Following SFA percutaneous interventions for claudication, runoff can identify patients more likely to develop restenosis and recurrent symptoms and, more importantly, those at higher risk of limb loss. Defining such subgroups allows a clear risk stratification of patients with claudication and can guide the intensity of surveillance in the outpatient setting.     

Results of endovascular superficial femoral endarterectomy

BACKGROUND: Endovascular superficial femoral artery (SFA) endarterectomy with a ring stripper/cutter and distal stenting has been suggested to have a patency comparable with above-knee bypass surgery. We report our initial experience with this technique. METHODS: Seventeen patients (13 men and 4 women; mean age, 64 years) with SFA occlusion and above-knee popliteal reconstitution underwent attempted remote endarterectomy with a ring cutter system combined with primary stenting of the distal end point. Analysis was performed in a prospective manner with patency rates determined by Kaplan-Meier life-table analysis. RESULTS: The indication for operation was claudication in 8 patients, rest pain in 6, and tissue loss in 3. Initial technical success was achieved in 11 patients (65%). Reasons for technical failure included SFA perforation (4), inability to traverse a calcified/diseased segment (1), and inability to retract/remove the ring cutter (1). Life-table analysis of all patients revealed a primary patency at 1 year of 26% +/- 11%. Primary-assisted patency was 38% +/- 12% at 1 year, with 59% of patients ultimately requiring surgical bypass grafting. In patients in whom initial technical success was achieved, the 1-year primary and primary-assisted patency rates were 40% and 59%, respectively. There were four reocclusions requiring surgical revascularization with below-knee popliteal (2) or tibial (2) bypass grafting, 1 symptomatic restenosis requiring repeat angioplasty, and 1 symptomatic restenosis treated conservatively. CONCLUSION: The results of endovascular SFA endarterectomy were disappointing, with technical success in less than two thirds of patients and a 1-year primary patency of only 26%. Remote SFA endarterectomy appears less effective than above-knee femoropopliteal bypass grafting, and after early failure, patients may require more distal revascularization for limb salvage.     

Outcomes of combined superficial femoral endovascular revascularization and popliteal to distal bypass for patients with tissue loss

Over the last 5 years there has been a significant shift toward lower limb revascularization using endoluminal techniques. However, in many instances endoluminal techniques alone are unable to salvage limbs that exhibit tissue loss. Many of these patients do not have adequate conduit for a long leg bypass, while tibial angioplasty does not appear to restore adequate perfusion to heal many significant foot lesions, making combined procedures attractive. However, previously available data evaluating combined endoluminal and bypass procedures have been too anatomically heterogeneous to be easily applied to patients with infrainguinal disease and tissue loss. From January 2002 to December 2005, intraoperative superficial femoral artery (SFA) percutaneous transluminal angioplasty (PTA) with selective stenting combined with simultaneous popliteal to distal vein bypass was evaluated in 22 limbs of 22 patients with isolated infrainguinal disease and tissue loss. There were 12 men and 10 women, average age 69. All the patients were diabetic, all had tissue loss, and three had end-stage renal disease (ESRD). Four patients underwent common femoral endarterectomy at the time of the SFA PTA; all had the PTA performed first, with antegrade punctures and flow maintained. Fourteen patients had PTA without stenting, eight had self-expanding stents placed for residual stenosis or dissection. There were no failures, with three TASC A, 13 TASC B, and six TASC C lesions addressed. The origin of the bypass was the above-knee popliteal in eight patients and the below-knee popliteal in 14 patients. The target vessel was the dorsalis pedis in six patients, the posterior tibial at the malleolus in three, the proximal posterior tibial in five, the peroneal in five, and the anterior tibial in three. The conduit was greater saphenous vein in 16 cases, femoral vein in three cases, and arm vein in three cases. Follow-up ranged from 3 months to 4 years. The primary patency rate was 21/22 (95%), and the secondary patency rate was 22/22 (100%). There was one amputation for ongoing gangrene in an ESRD patient with a patent bypass, resulting in an early limb salvage rate of 95%. For patients with inadequate conduit and tissue loss secondary to multilevel infrainguinal disease, simultaneous angioplasty with selective stenting of the SFA followed by distal vein bypass is a viable long-term solution that allows for limb salvage. Simultaneous performance is not associated with increased morbidity and decreases overall hospital use.     

Efficacious use of nitinol stents in the femoral and popliteal arteries

OBJECTIVE: To evaluate the performance and identify predictors of outcome after the use of self-expanding nitinol stents in the treatment of femoropopliteal arterial occlusive disease. METHODS: A retrospective analysis of a prospectively collected database was performed. Outcomes of patients who underwent placement of a nitinol stent in the femoral or above-knee popliteal arteries between 1999 and 2002 were studied. Patency, limb salvage, and patient survival were determined by Kaplan-Meier estimation and intergroup comparisons by log-rank test and Cox proportional hazards model. To define individual factors associated with clinical outcomes, stepwise regression analysis was performed. RESULTS: A total of 41 patients (mean age, 70 +/- 10 years; gender, 26 men and 15 women) underwent percutaneous placement of nitinol stents. Limb salvage was the indication for intervention in 68% of patients. Diabetes was present in 54%, and 36% had end-stage renal disease. Nitinol stents were placed in the superficial femoral (35 patients) or the above-knee popliteal (6 patients) arteries. The mean postprocedural increase in ankle-brachial index was 0.32 +/- 0.19. The 6-month, 1-year, and 2-year primary patency and limb-salvage rates were 95%, 84%, and 84%, and 92%, 89%, and 89%, respectively. Major amputations occurred only in patients undergoing limb-salvage procedures presenting with major tissue loss. No statistically significant differences in patency were seen with regard to diabetes, end-stage renal disease, runoff score, length of vessel stented (median, 80 mm), hypertension, or smoking. CONCLUSIONS: Our initial experience with self-expanding nitinol stents for femoropopliteal occlusive disease appears to demonstrate acceptable patency and limb-salvage rates at these early time points. Further evaluation of clinical outcome with these devices in this and larger groups of patients is warranted.     

Efficacy of Hemobahn in the treatment of superficial femoral artery lesions in patients with acute or critical ischemia: a comparative study with claudicants.

PURPOSE: To assess the results of covered stents in the treatment of superficial femoral artery (SFA) occlusive disease. METHOD: From July 2000 till June 2003, 32 patients (34 limbs) were scheduled for procedures including Hemobahn deployment in the SFA. Indication for treatment was claudication (group I, N=15 patients and 16 limbs, 31.2% occlusions) or critical and acute ischemia (group II, N=17 patients and 18 limbs, 61.1% occlusions). TASC D SFA lesions were excluded. No limb artery was patent pre-operatively in 19% and 89% of limbs in groups I and II, respectively (p=0.00001). RESULTS: Outflow procedures were performed simultaneously in one limb in group I and 12 in group II (p=0.0003). The technical, hemodynamic and clinical success rates were 100, 100 and 94.1%, respectively. Mean follow-up was 18.1 months. Primary patency rates at 12 months were 81.3+/-10.6% in group I and 88.6+/-9.0% in group II (p=0.547). At 12 months, the secondary patency and limb salvage rates were, respectively, 87.5+/-8.9 and 100% in group I and 87.5+/-8.93 and 94.45+/-6.71% in group II. CONCLUSION: Treatment of SFA occlusive lesions (excluding TASC D lesions) with the Hemobahn covered stent yielded good results for both claudicants with good outflow and patients with critical or acute ischemia with bad outflow, if concomitant outflow-improving procedures were performed.     

Long-term outcomes following 282 consecutive cases of infrapopliteal PTA and association of risk factors with primary patency and limb salvage

We aimed to determine the long-term results after infrapopliteal PTA (primary patency, limb salvage, survival) and examine for association with risk factors (e.g. diabetes, infection, etc). We studied 268 patients with 282 critically ischemic limbs treated with PTA of at least one crural artery during a six-year period. Data included TASC II morphological classification of lesions and risk factors. Technical success rate was 97.2%, and overall mortality 0.7%. Patients with milder TASC lesions preserved primary patency longer than patients with more severe lesions. Similar results were obtained for limb salvage and survival. Fontaine stage, TASC class and postoperative infection of operated limb increased the risk for loss of primary patency and major amputation. Concomitant carotid stenosis was associated with loss of primary patency. Diabetes mellitus, preoperative ulcer or gangrene were associated with need of major amputation. PTA was a safe and effective treatment for CLI due to lesions of infrapopliteal vessels.     

Laser angioplasty for limb salvage: observations on early results

During a 27-month period laser thermal angioplasty (LTA) was attempted in 15 patients who had totally occluded segments of their superficial femoral--popliteal arteries (SFA) with limb-threatening ischemia (rest pain or tissue necrosis). In five patients (33%) laser perforation of the SFA precluded successful angioplasty, and those five patients have been excluded from further analysis. In the remaining 10 patients the prelaser angiogram demonstrated an average SVS/ISCVS runoff score of 7.7 (best possible score, 1; worst possible score, 10). Seven patients (70%) had occlusions of all infrapopliteal arteries. All 10 patients were available for clinical follow-up, and follow-up angiograms were available for eight patients (80%). Clinical failure was defined as recurrence of the clinical signs or symptoms for which the LTA was performed. After 6 months of follow-up clinical failures occurred in nine patients (90%). Four patients had no clinical improvement. Five patients had transient clinical improvement after LTA, and all subsequently had early recurrence of symptoms. The average time from LTA to recurrence of symptoms was 1.7 months. Seven patients had subsequent bypasses or amputations an average of 2.2 months after laser angioplasty. The SFA patency rate by life-table analysis was 25% at 6 months. The single patient with clinical success (at 12 months) had no tibial vessel disease evident on his prelaser angiogram, and he underwent a concomitant inflow procedure at the time of his LTA. We believe that the disappointing results in this small series of patients can be attributed to tibial vessel disease that was not addressed by this technique.(ABSTRACT TRUNCATED AT 250 WORDS)     

Present and future of endovascular SFA treatment: stents, stent-grafts, drug coated balloons and drug coated stents

The current evolution towards treating more complex femoropopliteal lesions as seen in the renewed TASC II recommendations clearly reflects the continuous evolutions in femoropopliteal stent design. Recent stent design improvements focus on decreasing stent fractures rates which can negatively impact patency rates. By rearranging strut alignment towards helical connecting bridges or full helical stent designs, stent designers have successfully improved the fracture resistance of their stents. The superior fracture resistance of the latest stent generation in combination with the production of long nitinol stents of up to 20 cm in length allow that more difficult and complex lesions can be treated endovascularly. The continuous perfection of nitinol stent platforms followed by the transfer of coronary technologies (e.g. active coatings) towards peripheral devices might broaden the indications for the minimal invasive strategy towards TransAtlantic Inter-Society Consensus (TASC) II C&D lesions.     

多层螺旋CT评价冠状动脉支架通畅的可行性

目的验证多层螺旋CT(MSCT)评价冠状动脉支架通畅的可行性。方法使用MSCT对17例患者的23个支架进行评价,并以常规冠状动脉造影作为金标准进行对照。结果使用MSCT平均只有45%的支架内腔能被显示,另有3个支架内腔不能用于狭窄评价。MSCT显示16个支架通畅,与常规冠状动脉造影相符合的有14个;MSCT显示4个支架闭塞,均得到常规冠状动脉造影证实。结论虽然16层螺旋CT只能显示部分支架内腔,但在评价支架通畅性方面CT能提供有用的信息。