直接斑块切除术治疗股腘动脉闭塞性病变

目的 评价SilverHawk直接斑块切除术治疗股腘动脉闭塞性病变的临床疗效及其安全性.方法 应用SilverHawk直接斑块切除术治疗11例下肢缺血共18个病变,其中完全闭塞9个,平均病变数(1.6±1.1)个,平均狭窄程度96%±14%,平均长度(3.4±2.2)cm.间歇性跛行4例(Rutherford分级:3),重症下肢缺血7例(Rutherford分级:4).按TASC(TransAtlantic Inter-Society Consensus)股腘动脉病变分型:B型7例,C型1例(支架内闭塞),D型3例.平均踝肱指数(ankle brachial index,ABI)0.5±0.4.除临床症状外,还采用彩超或CT血管成像(CT angiography,CTA)方法对管腔通畅情况进行评估随访.结果 9个完全闭塞病变均经腔内开通成功.其中1例(支架内闭塞)先行预扩,经过平均(8±3)min斑块切除后,18个病变管腔均技术成功(残余狭窄＜50%),平均残余狭窄15%±7%.临床症状均消失或明显改善;Rutherford分级:9例为0,2例为1;平均ABI1.07±0.12.平均随访(9±4)个月,Rutherford分级稳定无变化,平均ABI 0.93±0.14,管腔均通畅.结论 SilverHawk直接斑块切除术是治疗下肢缺血性病变的一种安全有效的新方法.

Abstract：

Objective To evaluate the clinical safety and efficacy of SilverHawk directional atherectomy for femoropopliteal occlusive lesions. Methods Eighteen ischemia occlusive lesions in 11 patients of the lower extremity were treated with SilverHawk directional atherectomy. The mean lesion number was 1.6 ± 1. 1 per patient. The mean lesion length was ( 3.4 ± 2. 2 ) cm. The average degree of diameter stenosis was 96％ ± 14％. 9 lesions were totally occlusive. Clinical symptoms included claudication in 4 cases ( Rutherford classes: 3) and critical limb ischemia ( Rutherford classes: 4) in 7 cases. Lesions characteristics were divided by TASC classification: TASC B in 7 cases; TASC C in 1 case (in-stent occlusion); TASC D in 3 cases. Mean ABI was 0. 5± 0.4. Patency was evaluated with color duplex sonography or CTA besides clinical examination during follow-up. Results Nine totally occlusive lesions were recanalizated successfully via intraluminal approach. 18 lesions achieved technical success (residual stenosis ＜50％ ) leaving 15％ ±7％ mean residual stenosis in mean (8 ±3)min, predilation was needed in one lesion ( in-stent occlusion) prior to atherectomy. Clinical symptoms improved or disappeared with mean ABI 1.07 ±0. 12 and Rutherford grades: 0 (n =9) and 1 (n =2). Patency rate was 100％ with mean 0. 93 ± 0. 14 ABI and Rutherford grades remain unchanged after follow-up of mean ( 9 ± 4 ) monthes.Conclusions SilverHawk directional atherectomy is safe and effective for the treatment of lower extremity ischemia.     

Infrainguinal atherectomy: a retrospective review of a single-center experience

By decreasing plaque burden, atherectomy provides an alternative to angioplasty and stenting as a means of revascularizing patients with peripheral arterial disease. A new atherectomy device (SilverHawk) has recently been approved by the Food and Drug Administration, but the results with its use are unclear. We analyzed a series of consecutive patients undergoing atherectomy. We retrospectively reviewed the charts of 35 patients undergoing infrainguinal (IF) atherectomy in 38 limbs. The Trans-Atlantic Inter-Society Consensus (TASC) classification and Society of Vascular Surgery runoff scores were calculated. Time to event analysis was performed using Kaplan-Meier estimates. Risk factors affecting patency were analyzed with a multivariate Cox model. Mean patient age was 70 +/- 9.6 years. Indications for intervention were claudication (26%), rest pain (21%), and tissue loss (53%). Femoropopliteal (FP) atherectomy was performed in 68% and tibial atherectomy in 32%. For FP lesions, the TASC distribution was A, 42%; B, 23%; C, 4%; and D, 15%. The average lesion treatment length was 9.4 +/- 10.6 cm (range 1-40), and the runoff score was 5.1 +/- 3.5. For tibial lesions, the TASC distribution was A, 0%; B, 17%; C, 8%; and D, 75%. The average lesion treatment length was 9.2 +/- 6.0 cm (range 2-20), with a runoff score of 5.4 +/- 2.4. A total of 39% of patients had prior IF interventions. Adjunctive angioplasty of the atherectomized lesion was performed in 55% of cases, stenting in 0%, and adjunctive therapy for tandem lesions in 39%. The postoperative ankle-brachial index increased by 0.30 +/- 0.14 and toe pressures increased by 40 +/- 32.4 mm Hg. Mean follow-up was 10 +/- 8 months (range 0.3-23). During the studied period, seven patients required major limb amputation and five open surgical revascularization. Total primary and secondary patency rates were 66% and 70% at 1 year, respectively. Primary and secondary patency rates for FP atherectomy were 68% and 73% at 1 year, respectively. The limb salvage rate was 74% at 6 months. Patients with prior interventions in the atherectomized segment had an almost 10-fold decrease in primary patency. Atherectomy produces acceptable results, similar to those in reported series of conventional balloon angioplasty/stenting. Patients with prior IF interventions had a nearly 10-fold decrease in primary patency. A greater than sixfold decrease in patency rates was noted in patients who underwent simultaneous inflow or outflow procedures, but this finding did not reach statistical significance (p = 0.082). Future studies should focus on cost comparisons with other treatments such as angioplasty and stenting, and prospective randomized trials should be performed to compare these treatment alternatives.     

Directional atherectomy versus balloon angioplasty in segmental femoropopliteal artery disease: Two-year follow-up with color-flow duplex scanning

Purpose: Directional atherectomy is an endovascular interventional technique for excision and removal of obstructive arterial lesions. To evaluate whether atherectomy would provide better results than conventional balloon angioplasty (BA) in symptomatic femoropopliteal disease, a prospective randomized study comparing the early and late outcomes of these techniques was conducted. The rate of restenosis or occlusion was assessed by use of color-flow duplex scanning during the follow-up period.Methods: Seventy-three patients were randomized between atherectomy (38 patients) and BA (35 patients). All patients had segmental lesions of the femoropopliteal arteries amenable to either technique. The median follow-up duration was 13 months (range 1 to 39). Follow-up comprised regular clinical and hemodynamic assessment and color-flow duplex examinations. Restenosis was defined on the basis of a peak systolic velocity ratio of 2.5 or greater, and occlusion of the treated segment was diagnosed if flow signals were absent, that is, loss of patency.Results: Residual stenoses (≥ 30% diameter reduction) resulted in five patients (13%) undergoing atherectomy and three patients (9%) undergoing BA. At 1 month clinical and hemodynamic improvement by Society for Vascular Surgery/International Society for Cardiovascular Surgery criteria for lower limb ischemia was observed in 34 patients (89%) treated with atherectomy and in 34 (97%) treated with BA. By life-table analysis the cumulative rate of clinical and hemodynamic success at 2 years was 52% in patients treated with atherectomy and 87% in patients treated with BA (p = 0.06). The patency rate at 2 years of treated segments was 34% in the atherectomy group and 56% in patients treated with BA (p = 0.07). In patients with lesions greater than 2 cm, the 1-year patency rate of AT was significantly lower than BA (p = 0.03).Conclusions: Atherectomy does not result in an improved clinical and hemodynamic outcome. Furthermore atherectomy of segmental atherosclerotic femoropopliteal disease does not result in a better patency rate than BA, and, in lesions with greater length than 2 cm, the atherectomy results are significantly worse. (J VASC SURG 1995;21:255-69.)     

Peripheral atherectomy in TransAtlantic InterSociety Consensus type C femoropopliteal lesions for limb salvage

BACKGROUND: The optimal therapy for TransAtlantic Societal Consensus (TASC) type C femoropopliteal lesions remains a critical issue in the treatment of infrainguinal occlusive disease. The purpose of this study was to evaluate the outcome of limbs with TASC C femoropopliteal lesions and critical limb ischemia treated with the FoxHollow SilverHawk atherectomy catheter. METHODS: From September 2004 to September 2005, 18 consecutive femoropopliteal procedures performed in 17 limbs in 16 patients were reviewed. Demographic data, baseline angiographic findings, and indications for the procedures were recorded. Clinical outcomes including symptom resolution and limb salvage were determined for the 17 primary procedures. Hemodynamic improvement was compared by using the paired Student t test. Stenosis-free patency was determined by the Kaplan-Meier method. RESULTS: The mean age was 72.5 years (range, 47-88 years). Fifty percent of the patients had four or more of the following risk factors: hypertension, diabetes, tobacco use, hyperlipidemia, renal insufficiency, and coronary artery disease. The indication was tissue loss in 13 limbs and rest pain in 4. All patients had a second level of disease, either inflow or tibial/pedal, which was treated concurrently when appropriate. Initial resolution of symptoms was achieved in 12 limbs, and partial healing was achieved in 2 others. Early amputation was necessary in the remaining three patients, but this was likely due to severe inframalleolar disease and advanced forefoot ischemia at the time of presentation. Five patients have remained symptom-free without restenosis at a mean follow-up of 6 months. Two patients have required late amputation for hemodynamic failure. The ankle-brachial index improved from 0.39 +/- 0.08 (mean +/- SEM) before surgery to 0.75 +/- 0.08 in the immediate postoperative period (P = .02). However, it returned toward baseline at 6 months after surgery, with a mean of 0.48 +/- 0.07. Stenosis-free patency of the femoropopliteal segment was 22% at 12 months. CONCLUSIONS: Peripheral atherectomy can achieve good early clinical and hemodynamic success in patients with TASC C lesions and critical limb ischemia. However, mid-term restenosis rates are high in this challenging cohort of patients.     

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.     

Mid-term results with laser atherectomy in the treatment of infrainguinal occlusive disease

BACKGROUND: Laser atherectomy offers a potential intervention for multivessel infrainguinal disease in patients with poor revascularization options. Despite promising early results reported in the literature, the proper patient population who might benefit from laser atherectomy has yet to be determined. METHODS: From July 2004 to June 2006, patients undergoing laser atherectomy were retrospectively reviewed and assessed for comorbidities, operative and follow-up variables potentially associated with the end points of nondefinitive therapy, and limb salvage. RESULTS: During the study period, 40 patients (21 women, 19 men) underwent laser atherectomy, and the average follow-up was 461 +/- 49 days (range, 17 to 1050 days). Their average age was 68 +/- 2 years (range, 43 to 93 years). The indication for laser atherectomy was critical limb ischemia in 26 (65%) and lower limb claudication in 11 (35%). A total of 47 lesions were treated in the following arterial segments: 34 femoropopliteal and 13 infrapopliteal. Femoropopliteal distribution by the Trans-Atlantic Society Classification (TASC) was A in 3, B in 17, C in 10, D in 4, and infrapopliteal lesions distribution was A in 1, B in 3, C in 4, and D in 5. Adjunctive angioplasty was used in 75% of cases. The overall technical success rate (<50% residual stenosis) was 88%. Laser atherectomy-based treatment was the definitive therapy for 23 patients (58%), and the overall 12-month primary patency was 44%. The limb salvage rate at 12 months in 26 patients with critical limb ischemia was 55%. Renal failure was a risk factor for amputation (P < .001) and failed primary patency (P < .05), type 2 diabetes mellitus was a risk factor for amputation (P < .05), and poor tibial runoff was associated with failed primary patency and amputation (P < .05). Outcome was associated with the number of patent infrapopliteal runoff vessels. CONCLUSION: These data demonstrate that laser atherectomy can be used with high initial technical success rate. Chronic renal failure and diabetes are risk factors for a negative outcome. Poor results in patients with diabetes and renal failure necessitate careful case selection in this subgroup, in which laser atherectomy is less likely to provide a definitive revascularization result or limb salvage.     

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.     

Percutaneous intervention for infrainguinal occlusive disease in women: equivalent outcomes despite increased severity of disease compared with men

OBJECTIVES: Experience with open surgical bypass suggests similar overall outcomes in women compared with men, but significantly increased risk of wound complications. Percutaneous treatment of lower extremity occlusive disease is therefore an attractive alternative in women, although it is not clear whether there is a difference in outcomes between women and men treated with this technique. We sought to determine the results and predictors of failure in women treated by percutaneous intervention. METHODS: Percutaneous infrainguinal revascularization was performed on 309 women between 2001 and 2006. Procedures, complications, demographics, comorbidities, and follow-up data were entered into a prospective database for review. Patency was assessed primarily by duplex ultrasonography. Outcomes were expressed by Kaplan-Meier curves and compared by log-rank analysis. RESULTS: A total of 447 percutaneous interventions performed in 309 women were analyzed and compared with 553 interventions in men. Mean age in women was 73.2 years; comorbidities included hypertension (HTN) (86%), diabetes melitus (DM) (58%), chronic renal insufficiency (CRI) (15%), hemodialysis (7%), hypercholesterolemia (52%), coronary artery disease (CAD) (42%), and tobacco use (47%). Indications in women included claudication (38.0%), rest pain (18.8%), and tissue loss (43.2%). Overall primary & secondary patency and limb-salvage rates for women were 38% +/- 4%, 66% +/- 3%, and 80% +/- 4% at 24 months. In this patient sample, women were significantly more likely than men to present with limb-threatening ischemia (61.6% vs 47.3%, P < 0.001) and have lesions of TASC C and D severity (71.4% vs 61.7%, P < .005). However, there were no significant differences in primary and secondary patency rates or limb-salvage rates between genders. Furthermore, while women with limb-threat, diabetes, and advanced TASC severity lesions were at increased risk of failure overall, there were no differences between women and men with these characteristics. CONCLUSIONS: Percutaneous infrainguinal revascularization is a very effective modality in women with lower extremity occlusive disease. Although women in this sample were more likely to present with limb-threat than men, patency and limb-salvage rates were equivalent between genders, even in high-risk subsets such as diabetics or those with lesions of increased TASC severity.     

Midterm patency following atherectomy for infrainguinal occlusive disease: a word of caution

There has been widespread initial enthusiasm for peripheral atherectomy using the SilverHawk device. We sought to evaluate our midterm patency following infrainguinal atherectomy. Nineteen consecutive patients underwent 23 separate atherectomy procedures on 20 limbs from March 2005 through June 2006 (11 males, age 66 +/- 14 years). The primary lesions were atherosclerotic (n = 18) and vein graft stenoses (n = 2). Three additional procedures were redo atherectomies for restenotic lesions. The TASC classification of the primary lesions was A in 3, B in 9, and C in 8. The median number of treated lesions per limb was 2 (range 1-4). The location of the most distal native vessel stenosis was the superficial femoral artery in 12, popliteal artery in six, and crural artery in two. Atherectomy was successful in 18 primary procedures and all three repeat atherectomy procedures. Touch-up balloon dilatation was used in five procedures. Complications included one groin hematoma and two perforations, treated with stenting in one and bypass grafting in one. Preoperative ankle-brachial index and transmetatarsal pulse volume recording were 0.51 +/- 0.16 and 3.3 +/- 0.8, respectively, which at 1-month improved to 0.80 +/- 0.16 and 2.4 +/- 0.4 (p < 0.001). Only two vessels remained patent at 12 months. Recurrence developed in 16 of the successful primary procedures, including both vein graft lesions and all three repeat atherectomy procedures. The mode of recurrence was restenosis in 14 and occlusion/thrombosis in five. Secondary interventions included balloon angioplasty/thrombolysis in two, stenting in three, redo atherectomy in three, vein bypass grafting in five, and observation alone in one. Major limb amputation was required in five patients. Primary patency rates per treated limb at 3, 6, and 12 months were 38%, 10%, and 10%. The corresponding assisted patency rates were 50%, 23%, and 10%. Our experience suggests a very poor midterm patency of excisonal atherectomy using the SilverHawk device, although a 74% limb salvage rate was maintained through secondary interventions. Liberal use of this technology is associated with high cost and frequent requirement of reintervention.     

The association of statin therapy with the primary patency of femoral and popliteal artery stents

Objective

It has long been known that hydroxymethylglutaryl-coenzyme A reductase inhibitors (statins) broadly reduce cardiovascular events in patients with peripheral vascular disease. It was the goal of this study to determine whether there is an association between statin therapy and primary patency after stenting of superficial femoral and popliteal arteries.

Silverhawk斑块旋切系统治疗下肢动脉硬化闭塞症

目的探讨Silverhawk斑块旋切系统治疗下肢动脉硬化闭塞症的安全性及近期疗效。方法对术前超声及MRA检查诊断为下肢动脉硬化闭塞症的10例患者行Silverhawk斑块旋切治疗,术后行常规抗凝治疗,定期彩色多普勒超声复查随访。结果 10例患者下肢动脉均再通成功,技术成功率100%,术后即刻缺血症状改善明显,术后平均踝肱指数为0.87±0.06,高于术前的0.26±0.06（P〈0.0001）。住院期间无并发症发生,随访3～15个月,中位随访时间9个月,患肢均保肢成功。结论使用Silverhawk斑块旋切系统治疗下肢动脉硬化闭塞症及支架内再狭窄、闭塞病变创伤小,安全性高,近期疗效显著。     

Contemporary outcomes after superficial femoral artery angioplasty and stenting: the influence of TASC classification and runoff score

OBJECTIVE: A recent randomized trial suggested nitinol self-expanding stents (SES) were associated with reduced restenosis rates compared with simple percutaneous transluminal angioplasty (PTA). We evaluated our results with superficial femoral artery (SFA) SES to determine whether TransAtlantic InterSociety Consensus (TASC) classification, indication for intervention, patient risk factors, or Society of Vascular Surgery (SVS) runoff score correlated with patency and clinical outcome, and to evaluate if bare nitinol stents or expanded polytetrafluoroethylene (ePTFE) covered stent placement adversely impacts the tibial artery runoff. METHODS: A total of 109 consecutive SFA stenting procedures (95 patients) at two university-affiliated hospitals from 2003 to 2006 were identified. Medical records, angiographic, and noninvasive studies were reviewed in detail. Patient demographics and risk factors were recorded. Procedural angiograms were classified according to TASC Criteria (I-2000 and II-2007 versions) and SVS runoff scores were determined in every patient; primary, primary-assisted, secondary patency, and limb salvage rates were calculated. Cox proportional hazard model was used to determine if indication, TASC classification, runoff score, and comorbidities affected outcome. RESULTS: Seventy-one patients (65%) underwent SES for claudication and 38 patients (35%) for critical limb ischemia (CLI). Average treatment length was 15.7 cm, average runoff score was 4.6. Overall 36-month primary, primary-assisted, and secondary rates were 52%, 64%, and 59%, respectively. Limb salvage was 75% in CLI patients. No limbs were lost following interventions in claudicants (mean follow-up 16 months). In 24 patients with stent occlusion, 15 underwent endovascular revision, only five (33%) ultimately remained patent (15.8 months after reintervention). In contrast, all nine reinterventions for in-stent stenosis remained patent (17.8 months). Of 24 patients who underwent 37 endovascular revisions for either occlusion or stenosis, eight (35%) had worsening of their runoff score (4.1 to 6.4). By Cox proportional hazards analysis, hypertension (hazard ratio [HR] 0.35), TASC D lesions (HR 5.5), and runoff score > 5 (HR 2.6) significantly affected primary patency. CONCLUSIONS: Self-expanding stents produce acceptable outcomes for treatment of SFA disease. Poorer patency rates are associated with TASC D lesions and poor initial runoff score; HTN was associated with improved patency rates. Stent occlusion and in-stent stenosis were not entirely benign; one-third of patients had deterioration of their tibial artery runoff. Future studies of SFA interventions need to stratify TASC classification and runoff score. Further evaluation of the long-term effects of SFA stenting on tibial runoff is needed.     

Lesion severity and treatment complexity are associated with outcome after percutaneous infra-inguinal intervention

OBJECTIVES: Percutaneous revascularization has become increasingly utilized for the treatment of lower extremity ischemia. Patients with limb-threat have been shown to be at increased risk of failure, although the reasons for this remain unclear. This study analyzed factors associated with percutaneous treatment failure, focusing specifically on lesion characteristics and treatment complexity. METHODS: We retrospectively reviewed percutaneous infra-inguinal interventions performed for peripheral occlusive disease between 2002 and 2005 using a prospectively maintained database. Lesion characteristics were assessed by angiography, and lesions were graded according to the TransAtlantic InterSociety Consensus (TASC) criteria. Patency was expressed by Kaplan-Meier method and compared by log-rank analysis. Multivariate Cox-regression analysis was used to assess significant factors on univariate analysis. Mean follow-up was 11.8 months. RESULTS: A total of 324 interventions for claudication (55.8%), rest pain (18.4%), or tissue loss (25.8%) were analyzed, including 284 primary interventions and 40 re-interventions in 258 patients (mean age 72.1 +/- 10 years, 51.0% male). TASC lesion grades included: A (4.9%), B (29.3%), C (37.7%), and D (28.1%). Isolated single-level interventions (femoral, popliteal, or tibial) were performed in 38.9%, while two-level interventions were performed in 46.2% and three-level interventions in 14.9%. Overall primary patency (+/- SD) at 6, 12, and 18 months was 87 +/- 2%, 66 +/- 2% and 59 +/- 4%, respectively. Secondary patency at 6, 12, and 18 months was 89 +/- 2%, 76 +/- 3%, and 69 +/- 5%. One-year limb salvage rate (limb-threat patients) was 85 +/- 3%. Limb-threatening ischemia as the indication for intervention was most highly associated with failure of both primary and secondary patency and was associated with four indicators of lesion severity and treatment complexity, including increasing TASC grade, multilevel intervention, tibial intervention, and reduced tibial outflow. One-year primary patency was inversely correlated with TASC severity (TASC A-C: 67 +/- 6%, D: 61 +/- 4%; P < .05), multilevel intervention (76 +/- 5% and 49 +/- 9% for single vs multilevel, P = .002), distal interventions (74 +/- 5% and 57 +/- 7% for femoral vs tibial, P < .05), and decreased tibial runoff (83 +/- 6% and 52 +/- 6% for three- vs < three-vessels, P < .02). No differences in secondary patency or limb-salvage rates existed for these lesion- and treatment-related variables. Multilevel intervention and tibial intervention remained significant independently associated with primary patency on multivariate analysis. CONCLUSIONS: Patients with limb-threatening ischemia are at increased risk of initial failure compared with claudicants, likely as a result of the increased prevalence of advanced lesion severity and treatment complexity, which are associated with decreased primary patency. However, this finding did not extend to secondary patency or limb-salvage in the overall patient population. Although additional studies with longer follow-up are needed, these findings argue that percutaneous intervention may still be considered as a primary treatment modality with the understanding that these patients may have higher re-intervention rates and may ultimately require salvage open surgical bypass for persistent failures of percutaneous therapy.     

Durability of antegrade synthetic aortomesenteric bypass for chronic mesenteric ischemia

OBJECTIVE: The optimal treatment (endovascular/open repair, conduit, configuration) for chronic mesenteric ischemia (CMI) remains unresolved. This study was designed to review the outcome of patients with CMI treated with antegrade synthetic aortomesenteric bypass. METHODS: The study was designed as a retrospective review in an academic tertiary care medical center. Patients with CMI who underwent antegrade synthetic aortomesenteric bypass were identified from a computerized vascular registry (from January 1987 to January 2001) with antegrade synthetic aortomesenteric bypass as intervention. Outcome measures were functional outcome (symptom relief, weight gain) and both graft patency (duplex ultrasound/angiography) and survival rates as determined with life-table analysis. RESULTS: Forty-seven patients (female, 70%; age, 62 +/- 12 years) underwent aortomesenteric bypass (aortoceliac/aortosuperior mesenteric, n = 45; aortosuperior mesenteric, n = 2) for CMI (abdominal pain, 98%; weight loss, 83%). In-hospital mortality rate was 11% (four multiple organ dysfunction, one bowel infarction), mean length of stay was 32 +/- 30 days, three patients (6%) were discharged to a nursing home, and one (2%) was discharged home on parenteral nutrition (duration 4 months). At a mean follow-up period of 31 +/- 27 months, all patients had relief of abdominal pain and 86% had gained weight (at > or =1 year follow-up: mean ideal body weight 103 +/- 22%; versus before surgery: 87 +/- 17%; P <.001). Fourteen patients (34%) had diarrhea at discharge that persisted more than 6 months in 10. One patient had acute mesenteric ischemia develop from a failed graft (at 20 months), two patients had recurrent CMI develop from failing grafts (at 46 months and 49 months), and one asymptomatic patient was found to have a failing graft with duplex ultrasound scan (at 17 months); all grafts were revised. Primary, primary assisted, and secondary 5-year graft patency rates with life-table analysis were 69% (standard error [SE], 17%), 94% (SE, 7%), and 100%, respectively, and the 5-year survival rate was 74% (SE, 12%). CONCLUSION: Antegrade synthetic aortomesenteric bypass for CMI is associated with good functional outcome and long-term graft patency.     

Pedal bypass grafting on arteriographically invisible foot arteries detected by duplex ultrasound for limb salvage

AIM: In this study the long-term outcomes in patients undergoing pedal bypass grafting were evaluated and the risk of graft occlusion was related to whether, preoperatively, the pedal arteries were visualized by angiography or not and were only detected by duplex ultrasonography. METHODS: In 2000-2005, 81 pedal bypass grafts were performed in patients with chronic critical lower-limb ischemia, of which 54 (66.7%) had diabetes. Tissue loss (SVS/ISCVS-category 5) was recorded in 68 (84%) limbs and rest pain (SVS/ISCVS-category 4) in 13 (16%) limbs. In 24 limbs (29.6%) bypass grafts were implanted on the pedal arteries that had not been visualized by preoperative angiography, but had been detected only by duplex ultrasound. RESULTS: During the follow-up (median, 17 months; range, 3-69 months), 18 grafts (22.2%) failed. Seven limbs had to be treated by early thrombectomy, which resulted in long-term graft patency and limb salvage. The early postoperative mortality rate was 2.5%. Cumulative primary and secondary graft patency rates, and limb-salvage rates were 70.2%, 80.2% and 82.4%, respectively. No significant difference in graft occlusion was found between the patients with visible and those with not visible pedal arteries on preoperative arteriograms (Fisher's exact test). CONCLUSIONS: Duplex ultrasonography is a reliable modality for detection of target pedal arteries not visualized by preoperative arteriography and it helps reduce the number of patients with non-operable arterial occlusion disease by about 25%.     

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.     

Laser atherectomy for lower extremity revascularization: An adjunctive endovascular treatment option

Excimer laser atherectomy (LA) employs precision laser energy control (shallow tissue penetration) and safer wavelengths (ultraviolet as opposed to the infrared spectra in older laser technology), which decreases perforation and thermal injury to the treated vessels. Though extensively used by cardiologists for severe obstructive coronary artery disease, peripheral interventionalists have not accepted LA as a routine adjunctive technique for stenotic or occluded vessels. We report herein the technical and clinical outcomes with LA for complex peripheral vascular disease in patients deemed high-risk for conventional surgical revascularization. Over a 6-month period, 19 lesions in 15 high-risk patients (mean age 72 +/-10 years) were treated with LA (308-nm spectral wavelength) followed by balloon angioplasty for limb-threatening ischemia (n = 10) and severe disabling claudication (n = 5). The lesions were located at the superficial femoral artery (n = 8), popliteal artery (6), and/or tibial vessels (5). The mean occlusion length was 10.3 +/-2.3 cm. Laser catheter choice ranged from 1.4 to 2.5 mm depending on the target vessel diameter. Clinical examination, duplex ultrasound, and ankle-brachial indices were performed in follow-up visits. Immediate technical success was achieved in 16 (84%) lesions. In the 3 technical failures, inability to cross the lesion with a wire (n = 2) or vessel perforation (n = 1) precluded successful LA. Overall, primary patency as assessed by duplex was 57% (superficial femoral artery 71%, popliteal 60%, tibial vessels 25%). Clinical improvement was seen in 10 lesions (77%) that were successfully treated initially. One patient required below-knee amputation. At an average of 2-year follow-up, 6 patients who were initially successfully treated were alive (46%), including 3 patients (50%) with stable symptoms without the need for major amputation. Laser atherectomy is a useful adjunctive revascularization technique for high-risk patients with limb-threatening ischemia. This technique is especially beneficial in the treatment of ostial lesions, which may be prone to distal embolization, as well as total occlusions that can be traversed by a guide wire but not a balloon. Vascular surgeons should add LA to their endovascular armamentarium for the treatment of complex peripheral vascular disease in the high surgical risk patients. Further study of clinical outcome measures and comparison to other interventional techniques are warranted.     

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.     

Cryoballoon angioplasty broadens the role of primary angioplasty and reduces adjuvant stenting in complex superficial femoral artery lesions

BACKGROUND: Cryoballoon angioplasty (CP) for superficial femoral artery (SFA) occlusive disease has attracted attention as an adjunct to primary high-pressure balloon angioplasty (HP) and as an alternative to primary stenting in the SFA. STUDY DESIGN: A retrospective review from 1999 to 2005 of patients with chronic critical ischemia because of complex SFA lesions (TransAtlantic Inter-Society Consensus [TASC] C and D) was performed. Those patients treated with either standard HP or CP were examined. Vessels treated by primary stenting or atherectomy were excluded. RESULTS: Eight-five patients with 93 (67%) limbs underwent HP and 39 patients with 45 (33%) limbs underwent CP. Rest pain, tissue loss, or both, were the presenting symptoms in 49% of the HP group and 69% of the CP group. There was no significant difference in the final technical success rate between HP and CP, but significantly more stents were required in HP (75% versus 22%, HP versus CP; p < 0.05). Stenosis rather than occlusion is the more common mode of failure after CP (HP: 68% versus 32%; CP: 38% versus 62%). Despite this, there was no change in 1-year primary (66 +/- 6% versus 69 +/- 9%; HP versus CP; mean +/- SEM), assisted (78 +/- 5% versus 80 +/- 8%), or secondary patencies (78 +/- 5% versus 80 +/- 8%) between the 2 modalities. Freedom from recurrent symptoms and limb salvage for critical ischemia were equivalent. CONCLUSIONS: CP substantially increases the number of TASC C and D lesions for which balloon angioplasty alone is effective. Adjuvant stent usage is markedly reduced without a decrease in cumulative patency. Cryoballoon angioplasty should be considered a viable alternative for sole therapy for complex lesions of the SFA.