Femoropopliteal Occlusive Disease Research Articles

MISAGO 2: One-Year Outcomes After Implantation of the Misago Self-Expanding Nitinol Stent in the Superficial Femoral and Popliteal Arteries of 744 Patients

To evaluate the safety and efficacy of the Misago self-expanding rapid-exchange nitinol stent system for the treatment of femoropopliteal occlusive disease in a prospective multicenter observational trial (ClinicalTrials.gov; identifier NCT01118117). Between April and October 2008, the registry enrolled 744 patients (496 men; 69 ± 10 years) who had symptomatic ≥ 70% stenosis or occlusion of the superficial femoral or popliteal arteries treated with the Misago stent. Mean length of the 750 lesions was 63.9 mm; 282 (37.6%) vessels were completely occluded. Primary study endpoints were the need for target lesion revascularization (TLR) and event-free survival rates for the assessment of efficacy and safety, respectively. At 6 and 12 months post intervention, clinical symptoms of recurrent ischemia and/or claudication, Rutherford category, and ankle-brachial index (ABI) at rest were assessed. In the study period, 945 stents were successfully deployed in the 750 lesions. The overall TLR rate was 10.1% among 671 (90.3%) patients evaluated at 1 year [3.1% among 709 (95.3%) patients at 6 months]. Event-free survival at 12 months was 84.9%. Mean ABIs improved by ≥ 0.1 in three quarters of the patients (76.0%) over 12 months. The Rutherford grade improved or remained stable in the majority of patients (95.5%) after 1 year. Stent fractures (13 grade 1, 2 grade 2) in 3.1% of stents examined radiographically (n=484) at 1 year were not related to any clinical events. Primary patency was recorded in 574 (87.6%) patients evaluated at 1 year post procedure. The Misago rapid-exchange nitinol stent showed promising efficacy and safety results, with a low stent fracture rate, in patients with femoropopliteal disease, making it a safe and reliable treatment option.

Primary Nitinol Stenting in Femoropopliteal Occlusive Disease: A Meta-Analysis of Randomized Controlled Trials

To determine the efficacy and safety of balloon angioplasty (BA) with optional stenting vs. routine stenting with current open cell nitinol stents for femoropopliteal occlusive disease by analyzing the overall results from all available randomized controlled trials. A bibliographic search of electronic medical databases (MEDLINE, Embase, ISI Web of Knowledge, and the Cochrane Central Register of Controlled Trials) was conducted to identify relevant articles from 1960 to July 2011. Of the 701 published articles retrieved, 17 clinical trials randomized patients with symptomatic femoropopliteal occlusive disease to either primary BA or primary stenting. Of these, 4 RCTs involved the use of currently employed high flexibility nitinol stents. Thirteen other trials that employed obsolete, steel, or coated stents were excluded. The technical success rate, the target lesion revascularization (TLR) rate, and the binary restenosis rate at 12 months were primary efficacy endpoints; mortality was the primary safety endpoint. The results are reported as the odds ratio (OR) with 2-tailed 95% confidence intervals (95% CI). The study population was made up of 627 patients (416 men; mean age 67±10 years) and 665 lesions (361 assigned to the primary stenting and 304 to BA). The mean length of the treated lesion was similar in both groups (74.6±45.7 mm in the stenting group vs. 66.7±41.3 mm in the BA group). Technical success was significantly higher in the stenting group compared to BA (95.8% vs. 64.2%; OR 0.31, 95% CI 0.09 to 0.92, p<0.001). Follow-up ranged from 12 to 24 months. Based on 3 studies, the TLR at 12 months favored the stent group (OR 2.47, 95% CI 0.72 to 8.49, p=0.065), but the difference did not reach statistical significance. However, the 12-month binary restenosis rate was significantly lower in the primary stenting group (OR 3.02, 95% CI 1.3 to 6.71, p<0.001). With respect to the safety endpoint, mortality was similar in both groups (OR 0.83, 95% CI 0.39 to 1.77, p<0.001). This meta-analysis supports the use of the primary stenting, mainly for long lesions, as a first-line endovascular treatment for symptomatic disease in the femoropopliteal segment, contrary to indications for use in current clinical guidelines.

Clinical Consequence of Bare-Metal Stent and Stent Graft Failure in Femoropopliteal Occlusive Disease

The optimal role for bare-metal stents (BMS) and stent grafts (SG) in treating femoropopliteal occlusive disease (FPOD) is as yet undefined. Understanding the clinical consequences of failure can help guide initial treatment decisions. The goal of this study was to define the nature and frequency of adverse clinical events related to BMS and SG failure in FPOD. This is a single-institution retrospective review of the primary endovascular intervention for FPOD, treated with BMS or SG, from September 2007 through October 2011. Patient demographics, indications for intervention, anatomic characteristics, procedural details, clinical outcomes, and reintervention details were reviewed. Patients were excluded if they had any previous lower extremity interventions or inadequate follow-up. Of the 127 limbs from 97 patients that met the inclusion criteria, 67 were treated with BMS and 60 with SG. Follow-up averaged 551 days for BMS and 690 days SG. The indication for intervention was similar between groups (49% vs 68% claudication; P = .15). Baseline patient characteristics were similar between groups, with the exception of more TransAtlantic Inter-Society Consensus (TASC) D lesions (9 of 67 vs 26 of 60, P < .01) and chronic total occlusion (18 of 67 vs 35 of 60; P < .01) in the SG group. Freedom from reintervention of the index procedure was more likely with SG (28 of 67 vs 40 of 60, P < .01). For both groups, the indications for reintervention of the index procedure were prompted by changes in symptoms or physical examination findings rather than by abnormal findings on surveillance ultrasound imaging (9 of 39 vs 3 of 20). Only patients in the SG group presented with acute limb ischemia (0 vs 6, P < .01); however, the major adverse limb event rate was not different between groups (11 vs 10, P = .9). The 127 limbs needed 96 primary and secondary interventions during the course of the study. Including both primary and secondary interventions, only patients treated with SG presented with acute limb ischemia (0 vs 11, P < .1). Reinterventions are common in both groups; however, SG failure is more likely to present with acute limb ischemia than BMS failure. These observations should be carefully considered when treating FPOD with BMS or SG.

Comparison of Drug Eluting Stents Versus Bare Metal Stents in Femoropopliteal Artery Occlusive Disease: A Systematic Review and Meta-analysis

OBJECTIVES: To compare the angiographic and clinical outcomes in patients who have undergone peripheral artery intervention using either drug eluting stents (DES) or bare metal stents (BMS). METHODS: A meta-analysis of randomized studies that compare DES and BMS in patients with femoropopliteal occlusive artery disease. RESULTS: Five clinical trials met the inclusion criteria. Results showed that using DES yielded a higher arterial patency rate (RR 1.41; 95% CI 1.23-1.61), reduced restenosis rate (RR 0.46; 95% CI 0.33-0.63), and had a lesser tendency for repeat revascularization (RR 0.29; 95% CI 0.16-0.51) compared with BMS. However, no statistical significance was noted between the two interventions in terms of mortality rate (RR 0.93; 95% CI 0.47-1.83) and ankle brachial index score (mean difference of 0.06; 95% CI 0.02-0.09). KEY WORDS: Peripheral artery disease, peripheral artery intervention, drug eluting stents, bare metal stents, femoropopliteal occlusive disease

Early Results with the Use of Heparin-bonded Stent Graft to Rescue Failed Angioplasty of Chronic Femoropopliteal Occlusive Lesions: TASC D Lesions Have a Poor Outcome

To evaluate early patency rate of the heparin-bonded stent grafts in atherosclerotic long femoropopliteal occlusive disease, and to identify factors that affect outcome. Heparin-bonded Viabahn stent grafts were placed in 33 limbs in 33 patients during 2009-2010. The stents were deployed to rescue failed conventional balloon angioplasty. Mean age was 69 (range 44-88) years, and 67 % (22 of 33) were men. Most procedures (21 of 33, 64 %) were performed for critical limb ischemia (33 % for rest pain, 30 % tissue loss). Kaplan-Meier plots and Cox regression analysis were used to identify significant risk factors. The average length of lesions treated was 25 ± 10 cm, and they were predominantly TASC (Transatlantic Intersociety Consensus) D (n = 13) and C (n = 17) lesions. The median primary patency was 5.0 months (95 % confidence interval 1.22-8.77). The mean secondary patency was 8.6 months (95 % confidence interval 6.82-10.42). Subsequently, 4 patients underwent bypass surgery and 5 patients underwent major amputation. One patient died. There were 5 in-stent or edge-stent stenoses. Cox multivariate regression analysis identified TASC D lesions to be a significant risk factor for early occlusion (p = 0.035). TASC D lesions of femoropopliteal occlusions have poor patency rates with the use of heparin-bonded stent grafts after failed conventional angioplasty. Alternative options should be considered for these patients.

Risk factors for clinical failure after stent graft treatment for femoropopliteal occlusive disease

Optimal selection of a revascularization strategy in femoropopliteal occlusive disease (FPOD) remains controversial. Among endovascular treatment options for FPOD, covered stent placement has become increasingly used. We sought to examine the influence of clinical, anatomic, and device-related characteristics on the clinical performance of these devices. This was a retrospective, single-center study of consecutively treated limbs that underwent Viabahn (W. L. Gore, Flagstaff, Ariz) stent graft placement for FPOD from 2005 to 2010. Clinical, anatomic, and device-related characteristics were obtained from review of medical records and angiograms. End points were occurrence of any reintervention, major adverse limb event (eg, major amputation, thrombolysis/thrombectomy, or open bypass surgery), or thrombolysis/thrombectomy treatment alone. Univariate predictors were calculated and multivariate models constructed for each clinical end point using Cox proportional hazards models. The study cohort included 87 limbs in 77 unique patients, with a median follow-up time of 382 days. The indication for intervention was claudication in 56%. In 25 cases (29%), the index procedure was a secondary intervention for FPOD, including treatment of in-stent restenosis in 22 cases (25%). Lesions treated included 45% TransAtlantic Inter-Society Consensus (TASC) II D and 58% chronic total occlusions. The observed Kaplan-Meier 1-year event rates for reintervention, major adverse limb event (MALE), and thrombolysis were 43%, 28%, and 17%, respectively. MALE occurred in 18 patients, nine of whom presented with acute limb ischemia; no patient underwent major amputation. Univariate predictors of negative outcomes included lack of dual-antiplatelet usage, advanced TASC II classification, smaller implant diameter, increased number of devices used, longer total implant length, and coverage of a patent distal collateral vessel. Multivariate analysis demonstrated that the presence of dual-antiplatelet usage was protective against all three outcomes, 5-mm device diameter was a risk factor for both reintervention and MALE, and the use of multiple devices and distal collateral coverage were significant risk factors for thrombolysis events. Reintervention is common in the first year after Viabahn placement for FPOD, with more than half of the events being a MALE. Procedural factors such as antiplatelet therapy, stent graft diameter, implant length/number, and distal collateral coverage are strongly associated with adverse clinical outcomes. These factors should be carefully considered to optimize patient selection and intraoperative decision making for this procedure.

Thrombin generation and platelet activation related to subintimal percutaneous transluminal angioplasty

Objective: The purpose of this study was to measure the in vivo platelet activation and thrombin generation in arterial blood after passing a subintimal conduit. Methods: Subintimal percutaneous transluminal angioplasty (SPTA) is a technique where a subintimal channel is created, allowing recanalization of long peripheral arterial occlusion. From 10 patients with intermittent claudication, undergoing successful SPTA for femoropopliteal occlusive disease, we collected antecubital venous blood samples immediately before treatment, preprocedural arterial blood samples taken at the entry level proximal to the vessel occlusion, and subsequently at the reentry level after successful recanalization. Venous follow-up blood samples were taken after 24 hours. Plasma concentrations of β-thromboglobulin (β-TG), RANTES, and Prothrombin fragment (F1 + 2), were determined by immunoassay. Fibrinogen binding to platelets, leukocyte-platelet adhesion, and P-selectin were determined by flow cytometry. Results: We found a statistically significant transluminal increase in the plasma concentrations of RANTES, β-TG and F1 + 2 (p = 0.002, 0.001 and 0.001 respectively), which all normalized within 24 hours. Platelet-leukocyte aggregates significantly decreased after 24 hours compared with preprocedural and preentry levels (3.26% versus 5.26 %, p = 0.017). P-selectin expression on circulating platelets was statistically significantly increased in the blood sample taken at the re-entry level compared with the pre-procedural and pre-entry level (p = 0.007). After 24 hours there was no statistically significant difference to pre-procedural levels. There was no significant change in platelet fibrinogen binding at any levels. Conclusion: When passing a subintimal conduit, in vivo sampled blood demonstrated an extremely rapid and substantial uniform platelet activation and thrombin generation.

Cost Per Day of Patency: Long-term Implications of Patency and Reinterventions After Endovascular vs Surgical Lower Extremity Revascularizations

Using an amortized cost model, we prospectively evaluated the long-term costs associated with all initial and reinterventions of lower extremity endovascular revascularization (ER) and surgical revascularization (SR) for femoropopliteal occlusive disease. Since 2004, 183 patients with femoropopliteal occlusive disease had ER (85 [46%]) or SR (98 [54%]) for claudication (44% ER vs 36% SR, P = NS) or chronic limb ischemia (56% ER vs 64% SR, P = NS). An amortized cost model that included patency data end points and all direct and indirect hospital costs of the initial and subsequent reinterventions was applied to a prospectively collected vascular database. Analysis was done via Student t test and log-ranked Kaplan-Meier analysis. The mean length in the ER group was 18.5 cm. A prosthetic conduit was used in 51% of SR group. Patency at 1 year was similar in both groups and superior for SR thereafter. The rate of all reinterventions was 28 of 85 (33%) in ER and 40 of 98 (41%) in SR. The average hospital costs for the SR group were significantly greater than costs for the ER group ($18,506 ± $,877 vs $11,740 ± $709, P < .005); however, this difference was not significant when comparing amortized costs per day of patency at 1 year ($82 ± $21 vs $136 ± 103), 2 years ($55 ± $28 vs $152 ± 134), 3 years ($56 ± $44 vs $16 ± 3), or 4 years ($8 ± $1 vs $10 ± $2) in patients with claudication or chronic limb ischemia. The amortized cost/day model is valuable for evaluating resource utilization, enabling us to examine the cost efficacy of the procedure, patency, and reinterventions. Our findings indicate that although initially endovascular therapy for femoropopliteal occlusive disease is associated with significant savings, long term the amortized cost per day is comparable in selected patients undergoing ER or SR.

Long-term Resource Utilization and Survival After Major Amputation for Critical Limb Ischemia

direct and indirect hospital costs of the initial and subsequent reinterventions was applied to a prospectively collected vascular database. Analysis was done via Student t test and log-ranked Kaplan-Meier analysis. Results: The mean length in the ER group was 18.5 cm. A prosthetic conduit was used in 51% of SR group. Patency at 1 year was similar in both groups and superior for SR thereafter. The rate of all reinterventions was 28 of 85 (33%) in ER and 40 of 98 (41%) in SR. The average hospital costs for the SR group were significantly greater than costs for the ER group ($18,506 $,877 vs $11,740 $709, P .005); however, this difference was not significant when comparing amortized costs per day of patency at 1 year ($82 $21 vs $136 103), 2 years ($55 $28 vs $152 134), 3 years ($56 $44 vs $16 3), or 4 years ($8 $1 vs $10 $2) in patients with claudication or chronic limb ischemia. Conclusions: The amortized cost/day model is valuable for evaluating resource utilization, enabling us to examine the cost efficacy of the procedure, patency, and reinterventions. Our findings indicate that although initially endovascular therapy for femoropopliteal occlusive disease is associated with significant savings, long term the amortized cost per day is comparable in selected patients undergoing ER or SR.

Gender-related outcomes in the endovascular treatment of infrainguinal arterial obstructive disease

The purpose of this study was to retrospectively analyze early and midterm results of endovascular infrainguinal peripheral revascularizations in female patients in our single-center experience, paying particular attention to clinical, anatomic, and technical factors affecting perioperative and follow-up outcomes. From January 2000 to December 2010, 258 endovascular interventions for femoropopliteal disease were performed. Interventions were retrospectively divided into two groups: interventions performed in women (80 interventions, group 1) and interventions performed in men (178 interventions, group 2). The two groups of patients were compared in terms of demographic data, common risk factors for atherosclerosis, and comorbidities. Early (intraoperative and <30-day) results were analyzed in terms of technical success, conversion to open surgery, primary patency, secondary patency, and, for patients with critical limb ischemia, limb salvage. The follow-up program consisted of clinical and duplex scanning examinations with ankle-brachial index (ABI) measurement within the third postoperative month, at 6 and 12 months, and yearly thereafter. Follow-up results were analyzed in terms of survival, primary and secondary patency, assisted primary patency, and, for patients with critical ischemia, limb salvage. There were no differences between the two groups in terms of risk factors for atherosclerosis, comorbidities, clinical, and anatomic status. Technical success was 96.9% and technical failure rates were 1.2% in group 1 and 3.9% in group 2 (P = .2). Three in-hospital deaths were recorded, all in group 2, whereas in-hospital thromboses occurred in five patients, two in group 1 and three in group 2; with conversion to surgical bypass in all these cases, and in three of the cases, major amputation was necessary (two in group 1 and one in group 2). Cumulative 30-day mortality was 1.1%, with no difference between women (no deaths) and men (three deaths, 1.6%; P = .4). Overall amputation rate at 30 days was 1.2%, again with no differences between the two groups (2.5% and 0.6%, respectively; P = .4); also, the rate of perioperative thrombosis (overall 2.7%) was similar between the two groups (2.5% and 3.3%, respectively; P = .9). Mean duration of follow-up was 17 months (range, 1-85 months). Estimated 36-month survival rates were 95% in group 1 and 84.5% in group 2 (P = .4; log-rank, 0.7). Cumulative primary patency rates at 36 months were 38% in group 1 and 42% in group 2 (P = .4; log-rank, 0.5). Assisted primary patency at 36 months was 45.1% in group 1 and 60.5% in group 2, whereas secondary patency rates were 63.5% and 76%, respectively (P = .8; log-rank, 0.03). Endovascular treatment of femoropopliteal occlusive disease provides similar results between men and women at an intermediate follow-up. There is, however, a trend toward poorer results in women requiring further analysis at a longer follow-up period.

Viabahn Treatment for Femoropopliteal Occlusive Disease: Relationship between Implant Length and Clinical Outcomes

Viabahn Treatment for Femoropopliteal Occlusive Disease: Relationship between Implant Length and Clinical Outcomes

Late outcomes of balloon angioplasty and angioplasty with selective stenting for superficial femoral-popliteal disease are equivalent

Several trials have reported early superior patency of stenting over isolated angioplasty (plain old balloon angioplasty [POBA]) for infra-inguinal occlusive disease, yet long-term data are sparse. The purpose of this study was to contrast long-term clinical outcomes and costs of angioplasty alone vs angioplasty with selective stenting in the treatment of femoropopliteal occlusive disease. Patients undergoing primary endovascular treatments of the native femoropopliteal arteries from 2002 to 2009 were divided into two groups, POBA alone or stenting based on final treatment received at their index procedure. Study end points included actuarial 5-year primary patency (using strict criteria of any hemodynamic deterioration or return of symptoms), 5-year limb salvage, and 5-year survival and hospital costs. Eight hundred twenty-four primary procedures were performed during the study interval; 517 (63%) were POBA and 307 (37%) were stenting. The mean follow-up duration was 33 months (range, 0-98 months). The indication for intervention in the stenting group was claudication in 71% of the patients, whereas the remaining 29% had critical limb ischemia (CLI). In the POBA cohort, the indication for treatment was claudication in 59% of the patients and CLI in the remaining 41%. A higher percentage of POBA lesions were TransAtlantic Inter-Society Consensus (TASC) II A & B when compared to stenting (91% POBA vs 73% stenting; P < .001). There was no difference in overall 5-year primary patency (POBA 36% ± 3%; stenting 41% ± 4%; P = .31), nor was there a difference in patients with claudication (POBA 42% ± 4%; stenting 45% ± 4%; P = .8). In patients with CLI, the 4-year primary patency was 27% ± 5% (POBA) vs 36% ± 8% (stenting), P = .22; the 4-year limb salvage was 80% ± 4% (POBA) vs 90% ± 5% (stenting), P = .18. There was no difference in survival between the two groups (claudication: 83% ± 3% POBA vs 84% ± 4% stenting at 5 years (P = .65), CLI: 44% ± 4% POBA vs 49% ± 6% stenting at 4 years (P = .40). Subgroup analysis by lesion anatomy showed similar primary patency between POBA and stenting for TASC II A & B lesions, while the primary patency was significantly higher at 5 years after stenting of TASC II C & D lesions (34% ± 6% vs 12% ± 9%; P < .05). Stenting increased the procedural cost by 57% when compared to POBA (P < .001) regardless of treatment indication. In addition, stenting added 45% (P < .001) to the overall hospital cost of patients treated for claudication. Stenting resulted in equivalent long-term outcomes compared to POBA when stratified by indications. However, stenting yielded statistically better primary patency in patients with TASC II C & D lesions. The lack of improved clinical outcomes and significantly higher cost of stenting supports a posture of selective use of stents (especially in TASC II A & B) in the endovascular treatment of femoropopliteal occlusive disease.

Is the length of follow-up evaluation in published reports on the treatment of infrainguinal occlusive disease decreasing?

BackgroundThere is increasing pressure for the rapid development and implementation of new techniques and procedures. This study examined whether or not there has been a trend toward increasingly short follow-up times for studies evaluating the treatment of lower-extremity occlusive disease. MethodsA search was performed of PubMed using the term “femoropopliteal occlusive disease” from 1976 to 2006. Reports describing the open and/or endovascular treatment of femoropopliteal occlusive disease were classified according to the number of patients, method of treatment, and follow-up time. ResultsA total of 103 of the 435 reports met the inclusion criteria. Average follow-up times from 1976 to 1986 were a mean of 43.3 months and a median of 38.8 months, from 1986 to 1996 were a mean of 32.4 months and a median of 16.9 months, from 1996 to 2006 were a mean of 22.6 months and a median of 16.5 months. ConclusionsThe number of reports on femoropopliteal occlusive disease treatment has increased. The length of follow-up period was 2- to 3-fold longer for reports on open procedures compared with those on endovascular procedures. Whether length of follow-up evaluation and reporting intervals should be standardized warrants further investigation.

When Surgery is not the Competitor but the Best Partner of Medical Therapy: Results from the Propaten Trial

In an era where significant progress in endovascular technologies has drastically altered the treatment paradigm for patients with femoro-popliteal occlusive disease and catheter-based interventions have become the initial treatment of choice in many patients with intermittent claudication or critical limb ischemia (CLI), surgical revascularization of the lower leg is performed less frequently but still remains the reference for treatment due to demonstrated durability and efficacy. This has been endorsed by the recent results form the Scandinavian Propaten study, a large multicenter randomized trial analyzing outcomes of PTFE grafts with heparin bonded luminal surface compared to ordinary pure PTFE grafts in patients with peripheral disease. After randomizing 569 patients through eleven Scandinavian centers, Lindholt et al. found that the use of heparin bounded PTFE grafts was associated with a significant decrease of primary graft failure by 37% at 1 year. Risk reduction was particularly evident (50%) in the subgroups of patients with CLI and with femoro-popliteal by-pass. The first lesson from this recent study is that surgery is no more considered competitor of medical therapy. For many vascular diseases medicine and surgery are today the best companions to reach and optimize the same goals. Vascular research for peripheral disease is rapidly moving forward with sophisticated and innovative combinations of

Results of second-time angioplasty and stenting for femoropopliteal occlusive disease and factors affecting outcomes

Repeat percutaneous endoluminal interventions for femoropopliteal occlusive disease are common, but the outcomes are poorly understood. We sought to determine the results of second-time femoropopliteal percutaneous transluminal angioplasty/stenting (SPTAS) and identify factors associated with success or failure of a continued endoluminal revascularization strategy. A retrospective review of patients undergoing multiple percutaneous endoluminal lower extremity interventions at a single institution from 2002 and 2009 identified 70 SPTAS in 70 limbs. Patient comorbidities, anatomic severity of disease, and procedural characteristics were analyzed with respect to outcomes with descriptive statistics, Kaplan-Meier curves, and Cox proportional hazards modeling. Patency rates were determined from the time of SPTAS. Patients included 37 men (63%) and 22 women (27%) at a mean age of 70 ± 10 years. Indications for SPTAS included claudication in 54 limbs (77%) and critical limb ischemia (CLI) in 16 (23%). Median time from the initial endoluminal intervention to SPTAS was 330 days. Lesion TransAtlantic InterSociety Consensus II (TASCII) classification was A in 18 (25.7%), B in 18 (25.7%), C in 25 (35.7%), and D in 9 (12.9%). Technical success was achieved in 68 (97%) with low rates of intraprocedural (10%) and postprocedural (4%) complications as well as initial clinical improvement in 61 (87%) patients. Over a median follow-up of 22.9 months following SPTAS, 2-year primary patency, secondary patency, limb salvage (in patients with CLI), and survival were 33% ± 7%, 63% ± 7%, 87% ± 9%, and 88% ± 5%, respectively. Cox proportional hazard modeling showed that SPTAS within 180 days of the initial endovascular intervention was the only significant predictor of failure of primary patency (hazard ratio, 2.65; 95% confidence interval, 1.4-5.2) and secondary patency (hazard ratio, 3.1; 95% confidence interval, 1.4-7.1) of SPTAS. Second-time femoropopliteal angioplasty/stenting has excellent technical success but limited midterm primary and secondary patency. Early failure of the initial endovascular intervention strongly predicts poor outcome following SPTAS and in this cohort was more significant than comorbidities, anatomic factors, or procedural characteristics. These data suggest that after early endovascular failure, alternatives to a continued endoluminal strategy should be adopted.

Subintimal angioplasty for femoro-popliteal occlusive disease

There has been a longstanding debate about the roles of surgical bypass graft, percutaneous transluminal angioplasty, subintimal angioplasty, and conservative management for femoro-popliteal occlusive disease. Subintimal angioplasty was first described in 1987 as a method of performing an endovascular arterial bypass. The subintimal space at the start of the occlusion is entered with a catheter and a wire loop is used to cross the occlusion and reenter the vessel lumen distally. In patients with critical limb ischemia, there is high quality evidence demonstrating that the limb salvage rate and amputation-free survival rates for surgery and endovascular treatment are similar, but surgery is more expensive than angioplasty in the short term. In patients with intermittent claudication, surgical bypass using an autologous saphenous vein graft is currently believed to be the gold standard, but this is increasingly questioned in the light of recent advances in endovascular techniques. Surgical bypass with vein graft offers a 2-year patency of 81%, compared with 67% for a polytetrafluoroethylene (PTFE) graft and at best 67% for subintimal angioplasty. The better patency offered by surgery must be balanced against a higher morbidity and mortality. To conclude, subintimal angioplasty is an extremely valuable technique in the management of critical limb ischemia. Based on the evidence to date, this technique is likely to have an increasing role in the management of intermittent claudication over the coming years, particularly if the risk of general anaesthesia is high or there is no suitable vein.

How to Interpret Data from the Superficial Femoral Artery Stenting Trials and Registries

Recent advances in endovascular technologies have made catheter-based interventions a preferred treatment strategy in patients with intermittent claudication or ischemic rest pain of the lower extremity. Although the current body of literature is inundated with clinical reports favoring countless endovascular devices and treatment techniques for femoropopliteal occlusive disease, analysis of available clinical reports regarding femoropopliteal lesions can be an overwhelming undertaking. In this report, we examine various challenges associated with data interpretation of clinical literature on endovascular treatment of femoropopliteal occlusive disease. Particular attention is focused on prospective randomized trials and clinical registries evaluating treatment efficacy of self-expanding nitinol stent implantation in femoropopliteal lesions. Prospective trials on the efficacy of drug-eluting stent placement and covered stent implantation of the superficial femoral artery are also discussed. Understanding current literature related to prospective randomized trials on femoropopliteal disease interventions is important to formulate an optimal treatment strategy based on appropriate patient selection and disease stratification so that successful treatment outcome can be achieved.

Tratamiento de las oclusiones crónicas en el sector femoropoplíteo mediante técnicas endovasculares

Introduction Advances in endovascular techniques have provided new options in the treatment of complex infrainguinal occlusive lesions. Aims To evaluate the effectiveness and patency of endovascular treatment in patients with femoropopliteal occlusive disease. Methods All patients undergoing endovascular interventions for superficial femoral artery and above knee popliteal artery obstructions between February 1997 and February 2009 were retrospectively reviewed and assessed for comorbidities, operative and follow-up variables potentially associated with restenoses and limb salvage. Results During the study period, 52 patients were treated. Patients were 71.7 years (range 40 to 94), 69.2% male, 53.8% diabetic, 69.2% current or former smokers, and 67.3% hypertensive. Lesions were 28.8% TASC II C, 46.2% TASC II B, and 25% TASC II A. Mean recanalization length was 73.6 mm (range 20 to 150 mm). There were three embolizations, and four early thrombosis. Mean follow-up time was 18 months (range 1 to 115), based on clinical, hemodynamic, and ultrasound data. Primary patency rates were 85%, 76.8%, 60% and 52.5% at 3, 6, 12 and 24 months. Ten restenoses were successfully treated. The assisted primary patency rates were 85%, 82.3%, 74% and 74% at 3, 6, 12 and 24 months. Eight complete occlusions could not be reverted by a second recanalization procedure, and were treated by surgical bypass (6 cases) and amputation (2 cases). The secondary patency rates were 91.4%, 86%, 76.4% and 76.4% at 3, 6, 12, and 24 months. Conclusions Endovascular recanalization is a viable and effective strategy for lower limb revascularization in selected patients.

Cryoplasty as Endovascular Treatment in the Femoropopliteal Region: Hemodynamic Results and Follow-up at One Year

Cryoplasty represents an alternative endovascular approach to current techniques for femoropopliteal occlusive disease treatment. Its theoretical advantage compared to angioplasty is associated with the lower appearance of recoil, dissection, and intimal hyperplasia. The aim of this study is to assess the efficacy of cryoplasty in femoropopliteal disease. Eleven patients presenting with critical limb ischaemia (CLI) and Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II type A or B lesions in the femoropopliteal region were prospectively included in the study between November 2006 and April 2007. All patients but those with severely calcified lesions underwent cryoplasty (Polarcath Cryoplasty System(R)), and were followed up clinically and by Doppler ultrasound. Outcomes evaluated were technical success, patency at 1, 3, 6, and 12 months, mortality, limb salvage, freedom from restenosis, and freedom from occlusion rates. Statistical analysis used Kaplan-Meier curves. The mean age of the patients was 76 years (range, 65-89), and 81% of them were females. 73% diabetes mellitus, 73% arterial hypertension, 64% dyslipemia, 9% smokers. Clinical: 91% CLI IV and 9% CLI III. Location of lesions: 45% popliteal; 18% superficial femoral; 18% superficial femoral and popliteal; 18% popliteal and anterior tibial. Lesion morphology: 73% stenosis, 27% occlusions. TASC II classification: 64% TASC B and 36% TASC A.Technical success: 100%. Primary, primary assisted, and secondary patency: 91%, 91% and 91% at 3 months; 63%, 82%, and 91% at 6 months; 55%, 73% and 91% at 12 months, respectively. Limb salvage and survival of 91% at 3, 6, and 12 months. Cryoplasty in the femoropopliteal region showed a good success rate, with no dissections or significant residual stenosis. However, primary patency and freedom from restenosis rates at 1 year are 55%, both demonstrating a low efficacy of the technique in this territory.

Endovascular interventions for TASC II D femoropopliteal lesions

Advances in endovascular techniques have provided new options in the treatment of complex infrainguinal occlusive lesions. The purpose of this study was to evaluate outcomes of endovascular interventions on TransAtlantic InterSociety (TASC) II D femoropopliteal occlusive disease. All patients undergoing endovascular interventions for femoropopliteal occlusive disease between July 2004 and July 2009 were reviewed. Patient demographics, pre- and postprocedure ankle-brachial indices (ABI) and anatomic factors were analyzed. Outcomes evaluated included primary patency, assisted-patency, secondary patency, predictors of restenosis, and wound healing. Five hundred eighty-five limbs were treated during the period reviewed. The study group included 79 TASC D limbs in 74 patients (mean age 76.5 +/- 11.9 years, male sex: 53%). Fifty-six limbs (71%) underwent treatment for critical limb ischemia, including 42 (53%) with tissue loss. Eleven patients (15%) had previous failed bypasses. Preoperative ABIs were unobtainable for 23 patients, while the remaining 56 had a mean baseline ABI of 0.54 +/- 0.28. There was one periprocedural mortality. Five patients (6.3%) had periprocedural complications. Mean increase in ABI postprocedure was 0.49 +/- 0.35. Follow-up was available for 74 limbs at a mean of 10.7 months (range, 1-35). There were 18 mortalities (24.3%) during the follow-up period. No patient required a major amputation during this follow-up period. Twenty-one limbs (26.6%) experienced restenosis and nine limbs (11.4%) experienced occlusion. Twenty-nine limbs underwent reintervention during the follow-up time, including nine which underwent multiple reinterventions. Primary, assisted-primary, and secondary patency rates at 12 and 24 months were 52.2%, 88.4%, 92.6% and 27.5%, 74.2%, and 88.9%, respectively. Predictors of restenosis/occlusion included hypercholesterolemia, the presence of a popliteal artery stent, and patients who were current or former smokers. Endovascular interventions for TASC II D lesions can be safely performed with excellent hemodynamic improvement and limb salvage rates. Restenosis is not uncommon in this population, which mandates strict follow-up. Further follow-up is necessary to determine the long-term efficacy of these interventions.