Superficial Femoral Artery Occlusive Disease Research Articles

Surgical Treatment of Stent Restenosis after Long Segment Placement into the Superficial Femoral Artery

Endovascular stent placement is taking place of the bypass surgery in patients with peripheral arterial disease, over the last decade. However, patency of the long segment stents, below knee disease, advenced age, absence of distal runoff, diabetes and chronic renal disease are still challenging. Surgical bypass for the superficial femoral artery occlusive disease to the below the knee stenosis by using autologous vein graft has still good results. Here we present a 55 year old male who had long segment superficial femoral artery atherosclerotic disease. He had a history of long segment endovascular stent placement. We extracted the restenotic stent and performed bypass with PTFE graft to the below the knee.

Midterm Outcome of Femoral Artery Stenting and Factors Affecting Patency.

Purpose:The purpose of this study was to evaluate the early and midterm results of superficial femoral artery (SFA) stenting with self-expanding nitinol stents and to identify the factors affecting patency.Materials and Methods:SFA stenting was performed in 165 limbs of 117 patients from January 2009 to December 2013. Patients were followed-up for the first occurrence of occlusion or stenosis based on computed tomography and duplex scan results and a decrease in ankle brachial index of >15%.Results:During the follow-up period (mean, 15.3±3.2 months), no early thrombotic reocclusions occurred within 30 days, but in-stent restenosis developed in 78 limbs. The primary patency rates at 6, 12, 18, and 24 months were 78%, 66%, 42%, and 22%, respectively, and the secondary patency rates were 85%, 72%, 58%, and 58%, respectively. TASC II C or D lesions, stent length >8 cm, number of patent tibial arteries and diabetes were significantly associated with reintervention.Conclusion:The midterm results of stenting for SFA occlusive disease were disappointing because the primary and secondary patency rates at two years were 22% and 58%, respectively. Reintervention after SFA stenting remains a major problem, particularly in patients with diabetes mellitus or long TASC II C or D lesions.

Five-Year Outcome of Self-Expanding Covered Stents for Superficial Femoral Artery Occlusive Disease and an Analysis of Factors Predicting Failure

Purpose: To investigate the 5-year outcome of patients treated with self-expanding covered stents for superficial femoral artery (SFA) occlusive disease and identify parameters that could predict loss of primary patency. Methods: In a dual-center study, 315 consecutive patients (mean age 69.0±10.1 years; 232 men) treated for SFA occlusive disease in 334 limbs with Viabahn self-expanding covered stents between 2001 and 2014 were retrospectively analyzed. Mean lesion length was 11.7±8.8 cm, and half of the lesions were classified as TASC II C/D. Five-year patency rates were calculated, and Cox regression analyses were performed to assess potential factors affecting patency. Results: All-cause mortality at 5 years was 14.1%. Primary patency rates at 1, 3, and 5 years were 72.2%, 51.8%, and 47.6%, respectively, with secondary patency rates of 86.2%, 78.7%, and 77.5%. Parameters predicting loss of primary patency in a univariate analysis were covered stent diameter (p=0.001), the number of covered stents per lesion (p=0.015), and TASC II D classification (p=0.007). Covered stent diameter was the only parameter predicting loss of primary patency in the multivariate regression analysis (p=0.001), with 7-mm covered stents having superior performance. Conclusion: Five-year patency rates of self-expanding covered stents inserted for SFA occlusive disease are within an acceptable range. Covered stent diameter is the most relevant factor in predicting loss of primary patency, and thus, an adequate diameter of the distal landing site seems to be among the most important factors in the decision-making process. In smaller vessels, one should not use covered stents but venous conduits, as oversizing may be detrimental.

Efficacy of treatment of edge stenosis of endografts inserted for superficial femoral artery stenotic disease.

The role of endografts in the treatment of extensive superficial femoral artery (SFA) occlusive disease is enlarging. Results are limited by the occurrence of edge stenosis. The aim of the study was to retrospectively evaluate the efficacy of treatment of edge stenosis of endografts inserted for SFA occlusive disease. All patients, treated between November 2001 and December 2011, with a self-expandable polytetrafluoroethylene-endograft were gathered in a prospective database in three hospitals. The incidence of primary edge stenosis and the incidence of re-edge stenosis after treatment were retrospectively noted and a comparison was made between the results of percutaneous transluminal angioplasty (PTA) and extension of the endograft. A total of 88 patients presented with 115 edge stenoses, of which the majority presented within 1 year after insertion of the endograft (mean time to edge stenosis 10.7 ± 8.2 months). Seventy-three stenoses (63%) manifested at the proximal and 42 at the distal edge (37%). The 1-year incidence of restenosis and/or occlusion was 45% after PTA and 43% after endograft extension, with 1-year patency rates of 81% and 92%, respectively. The incidence of restenosis/occlusion after treatment with PTA was 12% higher at two years compared to extension of the endograft (55% vs. 43%, respectively). Edge stenosis may well be treated with either PTA or extension of the endograft. The incidence of restenosis and/or occlusion after both PTA and extension is high, but patency rates are acceptable. Aggressive surveillance is needed during the first year after insertion.

Three-year outcome of the heparin-bonded Viabahn for superficial femoral artery occlusive disease

Self-expanding covered stents for superficial femoral artery (SFA) occlusive disease have undergone an evolution during the years. Early results of the latest generation, the heparin-bonded Viabahn (W. L. Gore & Associates, Flagstaff, Ariz) with a contoured proximal edge, were promising, with reported 1-year primary patency rates of 73% to 78% in long lesions. The aim of this study was to present the 3-year outcome of the heparin-bonded Viabahn for SFA occlusive disease. All patients treated with a heparin-bonded Viabahn in three centers between April 2009 and December 2011 were included in the study and retrospectively analyzed. Clinical state in Rutherford category, ankle-brachial indexes, and duplex ultrasound scans were the features of follow-up at 6 weeks and 6, 12, 24, and 36 months. Primary end points of the study were the 3-year primary, primary assisted, and secondary patency rates. A total of 73 SFAs in 70 patients were treated with a heparin-bonded Viabahn and included in the study. Fifty-four patients were male (77%), and the mean age was 70.0 ± 9.1 years. The mean lesion length was 17.4 ± 7.0 cm, and 84% were classified TransAtlantic Inter-Society Consensus II types C and D. The median follow-up was 25 months (range, 2-55 months). The 3-year primary, primary assisted, and secondary patency rates were 59%, 71%, and 82%, respectively, with a 3-year freedom from amputation of 100%. The use of a heparin-bonded Viabahn for SFA occlusive disease is related to patency rates within limits of surgical reconstruction. The procedure is related to low morbidity and amputation rates.

Effectiveness of Viabahn in the Treatment of Superficial Femoral Artery Occlusive Disease

Purpose: To evaluate the effectiveness of the Viabahn stent-graft in the treatment of superficial femoral artery (SFA) occlusive disease. Methods: A systematic review and meta-analysis of published studies was performed to evaluate the efficacy of the Viabahn for SFA lesions. Studies were stratified according to controlled vs uncontrolled design and analyzed using random-effects models. Outcomes are reported as the risk ratio (RR) and 95% confidence interval (CI). Four prospective randomized controlled trials, one retrospective controlled study, and 9 uncontrolled studies were identified. Results: In controlled studies, primary patency with the Viabahn was superior to other interventions at 1 year (RR 0.63, 95% CI 0.49 to 0.82, p<0.001) and ankle-brachial index (ABI) improvement was greater at 6 months (mean difference 0.05, 95% CI 0.01 to 0.09, p=0.01) compared with other interventions. Subgroup analysis demonstrated a lower incidence of stent fracture in lesions with >15-cm stented lengths. In uncontrolled studies, ABI improvement was consistently superior at all measurement points during follow-up. Conclusions: Current evidence suggests that the Viabahn stent-graft is a safe and effective option for symptomatic SFA lesions. Prospective multicenter randomized controlled trials with long-term follow-up are needed to confirm the sustained efficacy of the Viabahn device.

Value of C-Arm Computed Tomography to Evaluate Stent Deployment During Femoro-Popliteal Revascularization

To compare the accuracy of C-arm computed tomography (CT) and digital subtraction angiography (DSA) in detecting incomplete stent expansion (ISE) after superficial femoral artery (SFA) stenting using intravascular ultrasound (IVUS) as a gold standard. Fifty patients with symptomatic SFA occlusive disease requiring angioplasty were prospectively included. Once technical success (<30 % residual stenosis) was obtained on post-procedural DSA, C-arm CT and IVUS were acquired. DSA and C-arm CT examinations were reviewed by 2 investigators and correlated with IVUS. C-arm CT image quality was rated on a four-point scale. Doppler ultrasound was performed at 1-year follow-up. The ankle-brachial index was 0.69 ± 0.10 and 0.99 ± 0.40, respectively, pre- and post-procedure. C-arm CT imaging quality was rated as good or excellent in 80%. In-stent minimal luminal diameter (MLD) was evaluated at 4.71 ± 0.7 mm on DSA, 3.39 ± 0.6 mm on IVUS, and 3.12 ± 0.9 mm on C-arm CT. Compared to IVUS, DSA demonstrated an overestimation of MLD (p = 0.0001), an underestimation of ISE (DSA = 18.8% ± 7.6; IVUS = 29.8% ± 9) (p < 0.0001), and a poor inter-technique intra-class correlation coefficient (ICC = 0.24). No difference was observed between IVUS and C-arm CT in ISE as calculated by diameter (29.8 ± 9 vs. 28.2 ± 12.5%, p = 0.5) and area (30.2 ± 8.4 vs. 33.3 ± 9.5%, p = 0.2). Inter-technique ICC between C-arm CT and IVUS was 0.72 [95%CI 0.49; 0.85] for MLA measurements. The inter-observer ICC for MLD and MLA measurements on C-arm CT were, respectively, estimated at 0.75 [95% CI 0.40, 0.89] and 0.77 [95% CI 0.43, 0.90)]. C-arm CT presents a better correlation with IVUS than DSA to determine lumen diameter and ISE immediately after percutaneous revascularization.

Midterm Results of Endovascular Treatment of Superficial Femoral Artery Disease with Biodegradable Stents: Single-Center Experience

PurposeTo assess the midterm efficacy of a biodegradable poly-l-lactic acid (PLLA) stent in the treatment of superficial femoral artery (SFA) occlusive disease. Materials and MethodsBetween June 2009 and April 2011, 35 de novo SFA lesions were treated with 43 biodegradable stents. This nonrandomized, retrospective, single-center study included patients with moderate or severe claudication, lower-limb rest pain, or ischemic ulceration restricted to the toes; symptoms were classified as Rutherford category 2 (48.6%), 3 (37.1%), 4 (8.6%), or 5 (5.7%). The population included 28 men and had a mean age of 71 years (range, 51–81 y). Follow-up included clinical examination and color-flow duplex imaging. Mean follow-up was 38.3 months (range, 30–58 mo). ResultsTechnical success was reported in all patients (100%). There were no intraoperative or immediate (< 30 d) complications.. During follow-up, one in-stent occlusion and seven in-stent restenoses occurred, all of which were successfully treated with percutaneous transluminal angioplasty. Primary and secondary patency rates were 77.1% and 97.1% at 24 and 36 months, respectively. No stent recoil or stent fracture was encountered. Late follow-up (> 12 mo) by ultrasound confirmed total reabsorption of the stent structures. Clinical improvement (ie, an upward shift of at least two Rutherford categories) was achieved in all 35 patients. ConclusionsMidterm results for biodegradable PLLA stents for atherosclerotic SFA lesions were associated with high technical success and secondary patency rates, without stent recoil and vessel remodeling.

Current efficacy of open and endovascular interventions for advanced superficial femoral artery occlusive disease

There has been a marked paradigm shift in the treatment of symptomatic femoro-popliteal disease with a shift from open to endoluminal therapy. The consequence of this shift in therapy is poorly described. The aim of this study is to examine the clinical efficacy of this shift in treatment strategies. A database of patients undergoing open (OPEN) and endoluminal (ENDO) intervention for TASC II C and D femoro-popliteal lesions between 1990 and 2010 was retrospectively queried. Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Factor analyses were performed using a multivariant Cox proportional hazard model for time-dependent variables. A total of 2593 limbs underwent either OPEN or ENDO treatment for symptomatic and anatomically advanced femoro-popliteal disease over a 20-year period. There was a two-fold rise in endovascular interventions between the first and second decade. In the first decade, 80% of the interventions were OPEN, while in the second decade, 61% of the interventions were ENDO. There were equivalent comorbidities in both groups, and survival was also equivalent. Endoluminal therapy was more commonly performed on claudicants. Thirty-day mortality was equivalent, but major morbidity was higher in OPEN compared with ENDO. Cumulative patency was equivalent in both groups with a similar reintervention rate. In contrast, clinical efficacy (freedom from recurrent symptoms, maintenance of ambulation, and avoidance of major amputation) was significantly higher in the OPEN group (P= .002). The presence of critical limb ischemia, diabetes, end-stage renal disease, and poor tibial runoff were predictors of poor anatomic and functional outcomes in both groups. There has been a marked shift in treatment modality for advanced femoro-popliteal disease with a lowering of the symptomatic threshold for intervention over 2 decades, likely spurred by the ease of endoluminal interventions. Although peri-procedural and anatomic outcomes for both procedures are equivalent, it appears that open surgery carries a superior long-term clinical efficacy. This superiority is negatively influenced by poor preoperative ambulation status, high modified Cardiac Risk Score, worse presenting symptoms, the occurrence of major adverse cardiovascular events, poor tibial runoff, the absence of hemodynamic success, and occlusion of the original bypass.

Comparison of above-the-knee prosthetic femoro-popliteal bypass versus percutaneous transluminal angioplasty and stenting for treatment of occlusive superficial femoral artery disease

Treatment of occlusive femoro-popliteal artery disease has changed during the last decade because of intensive development of endovascular technology. The aim of this study was to evaluate patient treated endovascularly or surgically for femoro-popliteal atherosclerotic lesions and to assess perioperative and mid-term outcome. This is a retrospective analysis of consecutive patients who had undergone prosthetic above-the-knee femoro-popliteal bypass or percutaneous transluminal angioplasty and stenting of superficial femoral artery stenosis or occlusion at Tampere University Hospital, Finland, between January 2007 and December 2009. Patients who were alive were re-evaluated in 2010. Primary and secondary patency and outcomes were assessed. A total of 131 patients were treated; surgically 63 patients (69 procedures) and endovascularly 68 patients (74 procedures). The mean follow-up time was 17 months (SD ± 13 months). In the late follow-up visit, 8 (18%) patients in the bypass group suffered from claudication and 9 (20%) from critical limb ischemia. The corresponding figures for the endovascular group were 20 (36%) and 8 (20%), respectively. The primary patency was 60% at 2 years in the bypass group and 73% in the endovascular group (p = 0.092); the primary assisted patency was 62% versus 76%, respectively (p = 0.068). The secondary patency was 74% in the bypass group versus 79% in the endovascular group (p = 0.487). According to current results following TASC II guideline, satisfied overall mid-term results can be achieved in the treatment of superficial femoral artery atherosclerotic disease.

Heparin-Bonded Covered Stents Versus Bare-Metal Stents for Complex Femoropopliteal Artery Lesions: The Randomized VIASTAR Trial (Viabahn Endoprosthesis With PROPATEN Bioactive Surface [VIA] Versus Bare Nitinol Stent in the Treatment of Long Lesions in Superficial Femoral Artery Occlusive Disease)

The hypothesis that endovascular treatment with covered stents has equal risks but higher efficacy than bare-metal stents (BMS) in long femoropopliteal artery disease was tested. Although endovascular treatment of short superficial femoral artery lesions revealed excellent results, efficacy in long lesions remains unsatisfactory. In a prospective, randomized, single-blind, multicenter study, 141 patients with symptomatic peripheral arterial disease were assigned to treatment with heparin-bonded, covered stents (Viabahn 72 patients) or BMS (69 patients). Clinical outcomes and patency rates were assessed at 1, 6, and 12 months. Mean ± SD lesion length was 19.0 ± 6.3 cm in the Viabahn group and 17.3 ± 6.6 cm in the BMS group. Major complications within 30 days were observed in 1.4%. The 12-month primary patency rates in the Viabahn and BMS groups were: intention-to-treat (ITT) 70.9% (95% confidence interval [CI]: 0.58 to 0.80) and 55.1% (95% CI: 0.41 to 0.67) (log-rank test p = 0.11); treatment per-protocol (TPP) 78.1% (95% CI: 0.65 to 0.86) and 53.5% (95% CI: 0.39 to 0.65) (hazard ratio: 2.23 [95% CI: 1.14 to 4.34) (log-rank test p = 0.009). In lesions ≥20 cm, (TransAtlantic Inter-Society Consensus class D), the 12-month patency rate was significantly longer in VIA patients in the ITT analysis (VIA 71.3% vs. BMS 36.8%; p = 0.01) and the TPP analysis (VIA 73.3% vs. BMS 33.3%; p = 0.004). Freedom from target lesion revascularization was 84.6% for Viabahn (95% CI: 0.72 to 0.91) versus 77.0% for BMS (95% CI: 0.63 to 0.85; p = 0.37). The ankle-brachial index in the Viabahn group significantly increased to 0.94 ± 0.23 compared with the BMS group (0.85 ± 0.23; p < 0.05) at 12 months. This randomized trial in symptomatic patients with peripheral arterial disease who underwent endovascular treatment for long femoropopliteal lesions demonstrated significant clinical and patency benefits for heparin-bonded covered stents compared with BMS in lesions ≥20 cm and for all lesions in the TPP analysis. In the ITT analysis for all lesions, which was flawed by major protocol deviations in 8.5% of the patients, the difference was not significant. (GORE VIABAHN® endoprosthesis with bioactive propaten surface versus bare nitinol stent in the treatment of TASC B, C and D lesions in superficial femoral artery occlusive disease; ISRCTN48164244).

Three-year results of the VIBRANT trial of VIABAHN endoprosthesis versus bare nitinol stent implantation for complex superficial femoral artery occlusive disease

The predominant mode of bare nitinol stent failure is diffuse in-stent restenosis, and failure rates correlate to the length and complexity of the treated lesion. Addition of an expanded polytetrafluoroethylene lining to a nitinol stent frame, as found in the VIABAHN endoprosthesis, mitigates the ingrowth of intimal hyperplasia. We compared the long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endoprosthesis to those obtained with bare nitinol stent implantation. One hundred forty-eight patients with symptomatic complex superficial femoral artery disease (TransAtlantic Inter-Society Consensus I class C and D lesions, accompanied by intermittent claudication or ischemic rest pain) were randomized to endovascular intervention using either bare nitinol stent implantation (76 patients) or nonheparin-bonded VIABAHN endoprosthesis deployment (72 patients). Patency, limb hemodynamics, and quality of life were evaluated at 1, 6, 12, 24, and 36 months following intervention. The average treated lesion measured 18 ± 8 cm in length, and 58.8% of lesions displayed segmental or complete occlusion. At 3 years, primary patency rates (defined by peak systolic velocity ratio ≤ 2.0 and no target lesion revascularization) did not significantly differ between patients treated with the VIABAHN stent graft and those who received a bare nitinol stent (24.2% vs 25.9%; P = .392). Stent fractures were significantly more common in bare nitinol stents (50.0%) than in the VIABAHN endoprostheses (2.6%). Primary-assisted patency rates were higher in those receiving bare nitinol stents than the VIABAHN stent graft (88.8% vs 69.8%; P = .04), although secondary patency rates did not differ between bare nitinol stent and stent graft recipients (89.3% vs 79.5%; P = .304). There were no instances of procedure-related mortality or amputation. The hemodynamic improvement and quality measures improved equally in both groups. The long-term outcomes of complex superficial femoral artery disease intervention using the VIABAHN endograft and bare nitinol stents are similar. Although primary patency rates are low in both study arms, excellent primary-assisted and secondary patency rates were achieved, with sustained augmentation of limb perfusion and quality-of-life measures. Patency rates diminish most rapidly in the first year after device implantation.

The outcome of failed endografts inserted for superficial femoral artery occlusive disease

Endografts represent a relatively new treatment modality for occlusive disease of the superficial femoral artery, with promising results. However, endografts may occlude collateral arteries, which may affect outcome in case of failure. The purpose of this study was to analyze the clinical outcome of failed endografts in patients with superficial femoral artery occlusive disease. All patients treated with one or more polytetrafluorethylene-covered stents between November 2001 and December 2011 were prospectively included in a database. Patients with a failure of the endograft were retrospectively analyzed. Clinical and hemodynamic parameters were assessed before the initial procedure and at the time of failure. Outcome of secondary procedures was analyzed. Among the 341 patients who were treated during the study period, 49 (14.4%) failed during follow-up. Mean (standard deviation) Rutherford category at failure did not differ from the category as scored before the initial procedure (3.1 [1.3] vs 3.3 [0.6]; P= .33). Forty-three percent of patients (n= 21) presented with the same Rutherford category as before the initial procedure, 37% (n= 18) with an improved category, and 20% (n= 10) with a deteriorated category. The ankle-brachial index was significantly lower at the time of failure (0.66 [0.19] vs 0.45 [0.19[; P <.002). Seventy-six percent of patients with a failure needed secondary surgery, of which 25% were below knee. The 1-year primary, primary-assisted, and secondary patency rates of secondary bypasses were 55.1%, 62.3%, and 77.7%, respectively. The amputation rate was 4.1% (n= 2). Failure of endografts is not associated with a deterioration in clinical state and is related to a low amputation rate. The hypothesis that covered stents do not affect options for secondary reconstructions could not be confirmed, as 25% of patients with a failure underwent a below-knee bypass. Secondary surgical bypasses are correlated with poor patency. The amputation rate after failure is low.

Outcomes in the Elderly of Open and Endovascular Interventions for Advanced Superficial Femoral Artery Occlusive Disease

Outcomes in the Elderly of Open and Endovascular Interventions for Advanced Superficial Femoral Artery Occlusive Disease

Iliac Artery Stent Placement Relieves Claudication in Patients with Iliac and Superficial Femoral Artery Lesions

To evaluate the efficacy of iliac artery stent placement for relief of claudication in patients with both iliac and superficial femoral artery (SFA) lesions. Stent placement for only iliac artery occlusive disease was performed in 94 limbs (74 patients) with both iliac and SFA occlusive disease on the same limb. All procedures were performed because intermittent claudication did not improve after continuation of antiplatelet medication therapy and home-based exercise for 3 months. Rutherford classification was 2 in 20 limbs and 3 in 74 limbs. Patients with critical limb ischemia were excluded. Median duration of follow-up was 40 months. Primary patency rates of the iliac stent, clinical improvement rates, and risk factors for requiring additional SFA procedures were evaluated. Primary patency rates of the iliac stent at 1, 3, 5, and 7 years were 97, 93, 79, and 79 %, respectively. The initial clinical improvement rate was 87 %. Continued clinical improvement rates at 1, 3, 5, and 7 years were 87, 81, 69, and 66 %, respectively. SFA Trans-Atlantic Inter-Society Consensus (TASC) II C/D lesion was a significant risk factor for requiring additional SFA procedures. Intermittent claudication was relieved by iliac stent placement in most patients with both iliac and SFA lesions. Thus, the indications for treatment of the SFA intended for claudicants should be evaluated after treatment of the iliac lesion.

The Use of Endografts to Create an Endoluminal Femoropopliteal Bypass After Failed Above-Knee Femoropopliteal Open Bypass Surgery

Redo femoropopliteal bypass surgery is associated with increased morbidity and related to a poorer outcome than primary procedures. Endografts might provide an alternative, avoiding dissection of a previously operated groin. Patients treated with a polytetrafluoroethylene-covered stents for superficial femoral artery occlusive disease between February 2009 and September 2011 were prospectively gathered. Demographics, clinical status, procedural aspects, and follow-up were retrieved. Seventy-four patients were included of which 5 (7%) were treated before with a femoropopliteal bypass. Indication for intervention was Rutherford category 3 in all patients and the median ankle-brachial index (ABI) was 0.68. Technical success was achieved in all cases. The postoperative course was uneventful in all and the ABI increased to 0.95. After a follow-up period of 18 months, 4 of 5 endografts remained patent. The use of endografts after failed femoropopliteal bypass surgery is feasible and safe and could be used to avoid or minimize a difficult and hazardous dissection of a previously operated area.

Results of heparin-bonded ePTFE-covered stents for chronic occlusive superficial femoral artery disease

The purpose of this study was to assess the 1-year patency rates of heparin-bonded covered stents in the treatment of chronic occlusive disease of the superficial femoral artery (SFA). All patients treated with a heparin-bonded endograft between April 2009 and October 2010 for chronic occlusive disease of the SFA were prospectively gathered in a database and retrospectively analyzed. Primary, primary-assisted, and secondary patency rates, assessed by ultrasound scanning, were analyzed at 1-year, as were the complication rates and mortality. A total of 56 limbs were treated with a heparin-bonded covered stent in 53 patients for chronic ischemia Rutherford category 3 (n = 36), 4 (n = 5), 5 (n = 11), and 6 (n = 1). Lesions were classified as TransAtlantic Inter-Society Consensus (TASC)-2-B (n = 9), C (n = 14), and D (n = 33), and the mean treated lesion length was 18.5 ± 7.7 cm. Postoperative complications occurred in 7.5%, including hematoma (n = 1), edema (n = 1), pneumonia (n = 1), and urinary retention (n = 1), and the 30-day mortality rate was 0%. The mean follow-up was 413 ± 208 days. At 1 year, the primary patency was 76%, the primary-assisted patency 82%, and the secondary patency 89%. The limb salvage rate was 100%. Heparin-bonded covered stents seem to provide a valid alternative to surgical treatment of long occlusive lesions in the SFA. Randomized trials and long-term data are required before considering the technique as a new standard of care.

Results for primary bypass versus primary angioplasty/stent for intermittent claudication due to superficial femoral artery occlusive disease

Percutaneous transluminal angioplasty ± stent (PTA/S) and surgical bypass are both accepted treatments for claudication due to superficial femoral artery (SFA) occlusive disease. However, long-term results comparing these modalities for primary intervention in patients who have had no prior intervention have not been reported. We report our results with 3-year follow-up. We reviewed all lower extremity bypass procedures at Beth Israel Deaconess Medical Center from 2001 through 2009 and all PTA/S performed from 2005 through 2009 for claudication. We excluded all limb salvage procedures and included only those that were undergoing their first intervention for claudication due to SFA disease. We recorded patient demographics, comorbidities, perioperative medications, TASC classification, and runoff. Outcomes included complications, restenosis, symptom recurrence, reinterventions, major amputation, and mortality. We identified 113 bypass grafts and 105 PTA/S of femoral-popliteal lesions without prior interventions. Bypasses were above the knee in 62% (45% vein) and below the knee in 38% (100% vein). Mean age was 63 (bypass) versus 69 (PTA/S; P < .01). Mean length of stay (LOS) was 3.9 versus 1.2 days (P < .01). Bypass grafts were used less for TASC A (17% vs 40%; P < .01) and more for TASC C (36% vs 11%; P < .01) and TASC D (13% vs 3%; P < .01) lesions. There were no differences in perioperative (2% vs 0%; not significant [NS]) or 3-year mortality (9% vs 8%; NS). Wound infection was higher with bypass (16% vs 0%; P < .01). None involved grafts. Bypass showed improved freedom from restenosis (73% vs 42% at 3 years; hazard ratio [HR], 0.4; 95% confidence interval [CI], .23-.71), symptom recurrence (70% and 36% at 3 years; HR, 0.37; 95% CI, .2-.56), and freedom from symptoms at last follow-up (83% vs 49%; HR, 0.18; 95% CI, .08-.40). There was no difference in freedom from reintervention (77% vs 66% at 3 years; NS). Multivariable analysis of all patients showed that restenosis was predicted by PTA/S (HR, 2.5; 95% CI, 1.4-4.4) and TASC D (HR, 3.7; 95% CI, 3.5-9) lesions. Recurrence of symptoms was similarly predicted by PTA/S (HR, 3.0; 95% CI, 1.8-5) and TASC D lesions (HR, 3.1; 95% CI, 1.4-7). Statin use postoperatively was predictive of patency (HR, 0.6; 95% CI, .35-.97) and freedom from recurrent symptoms (HR, 0.6; 95% CI, .36-.93). Surgical bypass for the primary treatment of claudication showed improved freedom from restenosis and symptom relief despite treatment of more extensive disease, but was associated with increased LOS and wound infection. Statins improved freedom from restenosis and symptom recurrence overall.

Current Efficacy of Open and Endovascular Interventions for Advanced Superficial Femoral Artery Occlusive Disease

There has been a marked paradigm shift in the treatment of symptomatic femoro-popliteal disease with a shift from open to endoluminal therapy. The consequence of this shift in therapy is poorly described. The aim of this study is to examine the clinical efficacy of this shift in treatment strategies. A database of patients undergoing open (OPEN) and endoluminal (ENDO) intervention for TASC II C and D femoro-popliteal lesions between 1990 and 2010 was retrospectively queried. Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Factor analyses were performed using a Cox proportional hazard model for time dependent variables. 2593 limbs underwent either OPEN or ENDO treatment for symptomatic and anatomically advanced femoro-popliteal disease over the 20 year period (Table). There was a 2-fold rise in endovascular interventions between the first and second decade. In the first decade, 80% of the interventions were OPEN while in the second decade, 61% of the interventions were ENDO. There were equivalent co-morbidities in both groups and survival was also equivalent. Endoluminal therapy was more commonly performed on claudicants (Table). 30-day mortality was equivalent but major morbidity was higher in OPEN compared to ENDO. Cumulative patency was equivalent in both groups with a similar re-intervention rate. In contrast, clinical efficacy (freedom from recurrent symptoms, maintenance of ambulation and avoidance of major amputation) was significantly higher in the OPEN group. The presence of critical limb ischemia, diabetes, ESRD and poor tibial runoff were predictors of poor anatomic and functional outcomes in both groups.Table 1OPENENDOP valueNumber limbs at risk (n)14161177–Male gender (%)58%64%.05Age67 + 1767 + 14nsClaudication (%)50%64%.05Rest pain / tissue loss (%)50%36%30-day mortality (%)2%1.5%nsAll-cause 30-day morbidity (%)8%3%.01Reintervention rate27%22%nsFiver year clinical efficacy (%)91 ± 368 ± 4.01Five year cumulative patency (%)72 ± 774 ± 5ns Open table in a new tab There has been a marked shift in treatment modality for advanced femoro-popliteal disease with a lowering of the symptomatic threshold for intervention over two decades likely spurred by the ease of ENDO. Although, peri-procedural and anatomic outcomes for both procedures are equivalent, it appears that open surgery continues to carry a superior long-term clinical efficacy.

The combined ipsilateral antegrade-retrograde approach to insert an endoluminal femoropopliteal bypass

The endoluminal femoropopliteal bypass is a minimally invasive treatment modality for occlusive superficial femoral artery disease. Technical failure of endovascular treatment of chronic total occlusions is often caused by the inability to re-enter the true lumen. Re-entry devices have a high technical success-rate, but increased procedural costs. We describe an alternative technique using an ipsilateral combined antegrade-retrograde approach to insert an endoluminal femoropopliteal bypass. In a supine position, with the leg elevated at 30 degrees, the popliteal artery is punctured and a 4F introducer sheath is introduced. The occlusion is crossed from distal to proximal and the wire is advanced through a 6F sheath that is positioned in the common femoral artery. The occlusion is predilated from proximal and the "re-entry" site is identified on an angiogram. The wire is then withdrawn into the balloon catheter and advanced intraluminally into one of the crural vessels. After confirming the intraluminal position of the wire, the 4F sheath is removed, and the endoluminal bypass is created in a standardized fashion. The ipsilateral antegrade-retrograde approach is a fast, inexpensive, and easy-to-learn technique, using standard materials only. The distal entry of the occlusion will lead to a minimization of the length of the endoluminal bypass, thereby possibly sparing collaterals and future surgical options.