TransAtlantic Inter-Society Consensus Research Articles

Open and Endovascular Treatment of Trans-Atlantic Inter-Society Consensus II D Aortoiliac Occlusive Lesions: What Determines the Rate of Restenosis?

Background:Open surgery is the preferred approach for the treatment of type D lesions according to the Trans-Atlantic Inter-Society Consensus (TASC) II guideline, but endovascular solutions also appear to be a valid option in selected patients. The study aimed to identify the risk factors of restenosis after open and endovascular reconstruction of symptomatic TASC II D aortoiliac occlusive lesions (AIOLs).Methods:Fifty-six patients (82 limbs) who underwent open repair and endovascular treatment (ET) for symptomatic TASC ΙΙ D AIOLs between March 2005 and December 2012 were retrospectively reviewed. Baseline characteristics, preoperative and postoperative imaging, and operation procedure reports were reviewed and analyzed. Restenosis after revascularization was assessed by duplex ultrasound or computed tomography angiogram. Kaplan-Meier survival analysis, Log-rank test, and multivariate Cox regression were used to evaluate the relevance between risk factors and patency.Results:The mean duration of follow-up was 42.8 ± 23.5 months (ranging from 3 to 90 months). Primary patency rates at 1-, 3-, 5-, and 7-year were 93.6%, 89.3%, 87.0%, and 70.3%, respectively. Restenosis after revascularization occurred in 11 limbs. Kaplan-Meier survival analysis and the Log-rank test revealed that diabetes, Rutherford classification ≥5th and concurrent femoropopliteal TASC II type C/D lesions were significantly related to the duration of primary patency. According to the result of Cox regression, diabetes and femoropopliteal TASC ΙΙ type C/D lesions were identified as the risk factors for restenosis after revascularization.Conclusion:This study demonstrated that diabetes and femoropopliteal TASC ΙΙ type C/D lesions are risk factors associated with restenosis after open and ET of TASC II D AIOLs.

15-Year Patency and Life Expectancy After Primary Stenting Guided by Intravascular Ultrasound for Iliac Artery Lesions in Peripheral Arterial Disease.

The purpose of this study was to evaluate 15-year patency and life expectancy after endovascular treatment (EVT) with primary stenting guided by intravascular ultrasound (IVUS) for iliac artery lesions. Fifteen-year patency, factors causing restenosis, and survival after IVUS-guided EVT are unclear based on the TransAtlantic Inter-Society Consensus II (TASC-II) classification in peripheral arterial disease (PAD). EVT was performed for 507 lesions in 455 patients with PAD. The 15-year endpoints were primary, primary-assisted, and secondary patency; overall survival; freedom from major adverse cardiovascular events (MACE); and freedom from major adverse cardiovascular and limb events (MACLE). The 5-, 10-, and 15-year primary and secondary patencies were 89%, 83%, and 75%, respectively, and 92%, 91%, and 91%, respectively. There were no significant differences among TASC-II categories. IVUS-guided stenting for the iliac artery had favorable 15-year patency in all TASC categories. Life expectancy after EVT was poor, but stenting is feasible for patients with PAD.

Clinical Outcomes after Endovascular Treatment Failure in Patients with Femoropopliteal Occlusive Disease

To analyze the clinical impact derived from endovascular treatment failure on patients with femoropopliteal occlusive disease (FPOD) regarding their preoperative clinical stage. Retrospective review for primary endovascular procedures for FPOD from 2008 to 2013. Primary end point included clinical deterioration defined as acute limb ischemia (ALI) or clinical worsening by, at least, one Rutherford's classification category, related to procedure's failure (restenosis >70% or occlusion). Ninety procedures were analyzed in 85 patients, 87.8% operated due to critical limb ischemia. The lesion treated was classified as Trans-Atlantic Inter-Society Consensus (TASC)-A/B in 76.7%, with a mean length of 98.5 ± 54 mm. Covered stent graft (SG) was used in 31.1% of the cases. Median follow-up was 14.5 months and treatment failure occurred in 33.3% of cases (n = 30, 9 restenosis and 21 occlusions). Clinical worsening was assessed in 40% of treatment failures and 6 of 21 (28.6%) presented as ALI. Twenty-two major adverse limb events (MALEs) were recorded and 8 major amputations. Regarding the type of stent, more occlusions were recorded on patients treated with SG compared with bare metal stent (39.3% vs. 16%; P = 0.02). However, no differences were found between groups regarding clinical worsening attributable to treatment failure (HR, 1.33; CI 95%, 0.5-3.5; P = 0.5). On multivariate analysis, TASC-C/D lesions (HR, 5.5; CI 95%, 2.3-13.3; P < 0.001) and female sex (HR, 4.9; CI 95%, 1.9-12.5; P = 0.001) behaved as significant predictors for failure and dual-antiplatelet therapy as a protective factor (HR, 0.3; CI 95%, 0.3-0.13; P = 0.03). No predictors were obtained regarding clinical worsening and occurrence of MALEs in our series. Patients with failure of endovascular procedures on FPOD appeared with clinical worsening in a no negligible number of cases in our sample regarding their preoperative clinical situation. Thus, we believe that endovascular treatment should be carefully deliberated.

One-year outcomes of the U.S. and Japanese regulatory trial of the Misago stent for treatment of superficial femoral artery disease (OSPREY study)

The purpose of this study was to assess the safety and efficacy of the Misago stent (Terumo Corp, Tokyo, Japan) in occlusive and stenotic superficial femoral artery (SFA) disease. The safety and efficacy of the Misago SFA stent were evaluated prospectively in this initial collaboration trial between Japan and the United States. Because this trial enrolled patients mainly from Japan and the United States and because there is a question as to whether a race difference exists in SFA stent performance, the race difference on outcome was also analyzed. In addition, results were compared with a prior SFA stent trial. The Misago stent was implanted in 261 subjects with TransAtlantic Inter-Society Consensus (TASC) type A and type B SFA lesions (201 subjects in the United States, 50 in Japan, 9 in Taiwan, 1 in South Korea). The mean age of the patients was 69.3 ± 10.0 years, and the mean lesion length was 83.8 ± 41.3 mm. The overall 12-month primary patency rate and clinically driven target lesion revascularization were 82.9% and 13.0%, respectively. Regional differences within the Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY) and outcomes between U.S. and Asian patients were similar, including primary patency (82.9% vs 83.0%; P = .889), clinically driven target lesion revascularization (13.4% vs 11.7%; P = .829), stent fracture rate (1.3% vs 0.0%; P = 1.000), and stent thrombosis rate (0.5% vs 0.0%; P = 1.000). OSPREY 12-month data showed satisfactory outcome of the Misago stent for the treatment of TASC type A and type B SFA lesions and appears to be comparable to recent stent trials. In addition, the lack of difference in outcome among races supports the value of international trials.

Predicting outcomes for infrapopliteal limb-threatening ischemia using the Society for Vascular Surgery Vascular Quality Initiative

The outcomes of open surgical or endovascular intervention for limb-threatening ischemia (LTI) involving the infrapopliteal vessels are dependent on complex anatomic, demographic, and disease factors. To assist in decision-making, we used the Vascular Quality Initiative (VQI) to derive a model using only preoperatively available factors to predict important outcomes for open or endovascular revascularization. National VQI data for the infrainguinal bypass and peripheral vascular intervention (PVI) modules were reviewed in a blinded fashion for patients who underwent intervention for LTI of the infrapopliteal vessels. Primary outcomes consisted of major adverse limb event (MALE) and amputation-free survival (AFS). Generalized linear modeling was used for the multivariate analyses, with entry of variables dependent on results of univariate analysis. From January 2003 through August 2014 a total of 19,053 infrainguinal open bypass and 48,739 PVI procedures were identified, among which 5264 and 5252, respectively, represented infrapopliteal (tibial-peroneal-pedal) revascularization for LTI. From these, 3036 infrapopliteal open bypass patients and 1319 infrapopliteal PVI patients had sufficient follow-up data for study inclusion. For open surgery, the reduced generalized linear model revealed that American Society of Anesthesiologists class 4 or 5, previous major amputation, living at home, and female sex had the greatest adverse effect on MALE, and dialysis dependence, low body mass index, and lack of great saphenous vein as a conduit had the greatest negative effect on AFS. For PVI, lesion length from 10 to 15 cm, treatment of three or more arteries, and classification other than A on the Trans-Atlantic Inter-Society Consensus demonstrated the largest adverse effects on MALE, and dialysis dependence, low body mass index, and congestive heart failure most negatively affected AFS. This study on a cross-section of patients selected for intervention in academic and community hospitals offers a "real world" glimpse of factors predictive of outcome. The VQI can be used to derive models that predict the outcomes of open surgical bypass or PVI for LTI involving the infrapopliteal vessels.

Increasing efficacy of endovascular recanalization with covered stent graft for TransAtlantic Inter-Society Consensus II D aortoiliac complex occlusion

We compared the outcomes and the durability of endovascular recanalization (EVR) with the Viabahn (W.L.Gore and Associates, Flagstaff, Ariz) covered stent graft vs traditional aortobifemoral or aortofemoral bypass grafting for complex aortoiliac occlusions. Between 2008 and 2014, 11 unilateral iliac occlusions and 11 aortobiiliac occlusions were treated by EVR. Also collected were data from the last 21 consecutive patients treated in the same period by aortofemoral (n= 6) or aortobifemoral (n= 15) bypass grafting. In accordance with the TransAtlantic Inter-Society Consensus II (TASC II) document, only patients with type D lesions were considered. Kaplan-Meier estimates for patency were calculated, and Cox proportional hazard modeling was performed. The difference in risk factors between the groups was not significant. General anesthesia was required in 100% of the surgical group, and local or locoregional anesthesia was used for EVR. Suprarenal aortic cross-clamping was required in nine of the open surgical procedures (41%). A brachial percutaneous approach was performed in all patients undergoing EVR, and technical success was 100% in both groups. All of the attempts at EVR were successful. At the 2-year follow-up, primary patency did not differ significantly between the endovascular (91%) and surgical (95%) groups. This was seen in the univariate model (hazard ratio [HR], 0.27; 95% confidence interval [CI], 0.02-2.95; P= .28) and in the multivariate model (HR, 0.77; 95% CI, 0.06-10.07; P= .84) for group (HR, 0.58; 95% CI, 0.04-7.72; P= .68), age (HR, 0.89; 95% CI, 0.73-1.08; P= .24), symptoms (HR, 1.98; 95% CI, 0.42-9.46; P= .39), and occlusion (HR, 3.22; 95% CI, 0.51-20.35; P= .21). The average hospital length of stay was shorter for patients treated with ERV than for those treated with open surgery (3.9± 2.2 vs 5.8± 3.1days, respectively; P= .03). The complication rate was 4% for EVR vs 18% in the surgical group (P= .32). At 2years of follow-up, the results of endoluminal bypass grafting with the Viabahn stent to treat complex aortoiliac disease are promising. Longer-term results are needed to fully evaluate the potential benefits and longer-term patency.

Internal Iliac Artery Stenosis: Diagnosis and How to Manage it in 2015.

Lower extremity arterial disease (LEAD) is a highly prevalent disease affecting 202 million people worldwide. Internal iliac artery stenosis (IIAS) is one of the localization of LEAD. This diagnosis is often neglected when a patient has a proximal walking pain since most physicians evoke a pseudoclaudication. Surprisingly, IIAS management is reported neither in the Trans-Atlantic Inter-Society Consensus II nor in the report of the American College Foundation/American Heart Association guidelines. The aims of this review are to present the current knowledge about the disease, how should it be managed in 2015 and what are the future research trends.

Endovascular Treatment of Chronic Total Occlusions of the Iliac Arteries: Early and Midterm Results

To examine the effects of endovascular therapy on the treatment of chronic total occlusions (CTOs) of the iliac arteries. We analyzed a cohort of 48 patients (56 limbs) who were treated by endovascular means for iliac artery CTOs during a period of 4 years in 2 vascular surgery centers in Greece. The data were collected retrospectively and were statistically analyzed to report on technical success, morbidity, mortality, primary and secondary patency, and limb salvage through different patient and/or lesion stratifications. Recanalization was accomplished without assisting devices, and primary stenting was always performed. The technical success of the endovascular treatment reached 91%. Patients experienced 4.2% major morbidity and 2.1% mortality rate. Mean ankle-brachial pressure index increased from 0.43 ± 0.12 preoperatively to 0.89 ± 0.11 postoperatively. A median improvement by 3 Rutherford clinical categories was recorded at the first-month follow-up. The estimated limb salvage rate for patients suffering from critical limb ischemia (CLI) was 90.9% at 36 months. Kaplan-Meier analysis estimation for overall primary and secondary patency rate of the treated lesions was 91.4% and 95.3%, respectively at 36 months. There were no statistically significant differences in primary and secondary patency rate between patients in different clinical stages (CLI versus intermittent claudication), as well as between CTO lesions of different Trans-Atlantic Inter-Society Consensus (TASC) categories (TASC B versus TASC C versus TASC D). There was not statistical significant difference between the technical success of TASC B, C, and D lesion groups. The endovascular treatment of iliac CTOs seems to be safe and feasible. The technical success of the procedure could be high, whereas primary and secondary patency rates seem to be optimal, with remarkable limb salvage rate and overall clinical improvement. A potential shift to an endovascular-first approach for such lesions might be currently justified.

Outcomes of polytetrafluoroethylene-covered stent versus bare-metal stent in the primary treatment of severe iliac artery obstructive lesions

This study compared early and midterm outcomes of polytetrafluoroethylene-covered stents (CSs) vs bare-metal stents (BMSs) in the primary treatment of severe TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) C and D iliac artery obstructive lesions. Between January 2009 and June 2014, 128 patients underwent stenting of 167 iliac arteries; CSs were implanted in 82 iliac arteries (49%) and BMSs in 85 (51%). All patients were prospectively enrolled in a dedicated database. Thirty-day outcomes, mid-term patency, limb salvage, and survival were compared, and follow-up results were analyzed with Kaplan-Meier curves. Clinical presentation, lesion site, extension, and laterality were evaluated for their association with patency in the two groups using multiple logistic regressions. Patients were a mean age of 70± 10.3years, The Society for Vascular Surgery comorbidity score was 0.89± 0.57, with no differences after stratification by CS and BMS (P= .17). Iliac lesions were classified by limb as TASC II C in 86 (51%) and D in 81 (49%). Comparing CS and BMS, technical success was 99% in both groups (P= 1.0); the 30-day cumulative surgical complications rate (7.3% vs 4.7%; P= .53), mortality (1.8% vs 0%; P= .45), and morbidity (1.8% vs 1.4%; P= .99) were equivalent. At 24months (average 22months; range, 30 days-56 months), primary patency of CS vs BMS was similar (93% vs 80%; P= .14), and this finding was maintained after stratification by TASC II C (97% vs 93%; P= .59) and D (88% vs 61%; P= .07); secondary patency was 98% vs 92% (P= .22), and limb salvage was 99% and 95% (P= .35) respectively. Multivariate analysis indicated that BMS in long-segment stenosis involving the common and external iliac arteries was a negative predictor of patency (odds ratio, 0.16; 95% confidence interval, 0.04-0.62; P= .007); within this subgroup of TASC II D lesions, primary patency at 24months was significantly higher for CS than for BMS (88% vs 57%; P= .03). Overall, the use of CSs for severe iliac lesions has similar early and midterm outcomes compared with BMS. In a subcategory of TASC II D lesions with long-segment severe stenosis of both the common and external iliac arteries, CS should be considered as the primary line of treatment.

Determinants of survival and major amputation after peripheral endovascular intervention for critical limb ischemia

Our objective was to analyze periprocedural and 1-year outcomes of peripheral endovascular intervention (PVI) for critical limb ischemia (CLI). We reviewed 1244 patients undergoing 1414 PVIs for CLI (rest pain, 29%; tissue loss, 71%) within the Vascular Study Group of New England (VSGNE) from January 2010 to December 2011. Overall survival (OS), amputation-free survival (AFS), and freedom from major amputation at 1 year were analyzed using the Kaplan-Meier method. Cox proportional hazards models were used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs). The number of arteries treated during each procedure were 1 (49%), 2 (35%), 3 (12%), and ≥4 (5%). Target arterial segments and TransAtlantic Inter-Society Consensus classifications were aortoiliac, 27% (A, 48%; B, 28%; C, 12%; and D, 12%); femoral-popliteal, 48% (A, 29%; B, 34%; C, 20%; and D, 17%); and infrapopliteal, 25% (A, 17%; B, 14%; C, 25%; D, 44%). Technical success was 92%. Complications included access site hematoma (5.0%), occlusion (0.3%), and distal embolization (2.4%). Mortality and major amputation rates were 2.8% and 2.2% at 30 days, respectively. Overall percutaneous or open reintervention rate was 8.0% during the first year. At 1-year, OS, AFS, and freedom from major amputation were 87%, 87%, and 94% for patients with rest pain and 80%, 71%, and 81% for patients with tissue loss. Independent predictors of reduced 1-year OS (C index = .74) included dialysis (HR, 3.8; 95% CI, 2.8-5.1; P < .01), emergency procedure (HR, 2.5; 95% CI, 1.0-6.2; P = .05), age >80 years (HR, 2.2; 95% CI, 1.7-2.8; P < .01), not living at home preoperatively (HR, 2.0; 95% CI, 1.4-2.8; P < .01), creatinine >1.8 mg/dL (HR, 1.9; 95% CI, 1.3-2.8; P < .01), congestive heart failure (HR, 1.7; 95% CI, 1.3-2.2; P < .01), and chronic β-blocker use (HR, 1.4; 95% CI, 1.0-1.9; P = .03), whereas independent preoperative ambulation (HR, 0.7; 95% CI, 0.6-0.9; P = .014) was protective. Independent predictors of major amputation (C index = .69) at 1 year included dialysis (HR, 2.7; 95% CI, 1.6-4.5; P < .01), tissue loss (HR, 2.0; 95% CI, 1.1-3.7; P = .02), prior major contralateral amputation (HR, 2.0; 95% CI, 1.1-3.5; P = .02), non-Caucasian race (HR, 1.7; 95% CI, 1.0-2.9; P = .045), and male gender (HR, 1.6; 95% CI, 1.1-2.6; P = .03), whereas smoking (HR, .60; 95% CI, 0.4-1.0; P = .042) was protective. Survival and major amputation after PVI for CLI are associated with different patient characteristics. Dialysis dependence is a common predictor that portends especially poor outcomes. These data may facilitate efforts to improve patient selection and, after further validation, enable risk-adjusted outcome reporting for CLI patients undergoing PVI.

Mid-Term Outcomes of Endovascular Treatment for TASC-II D Femoropopliteal Occlusive Disease with Critical Limb Ischemia.

The purpose of the study was to assess the safety and midterm effectiveness of endovascular treatment in Trans-Atlantic Inter-Society Consensus II (TASC-II) D femoropopliteal occlusions in patients with critical limb ischemia (CLI). Patients with CLI who underwent endovascular treatment for TASC-D de novo femoropopliteal occlusive disease between September 2008 and December 2013 were selected. Data included anatomic features, pre- and postprocedure ankle-brachial index, duplex ultrasound, and periprocedural complications. Sustained clinical improvement, limb salvage rate, freedom from target lesion revascularization (TLR), and freedom from target extremity revascularization (TER) were assessed by Kaplan-Meier estimation and predictors of restenosis/occlusion with Cox analysis. Thirty-two patients underwent treatment of 35 TASC-D occlusions. Mean age was 76 ± 9. Mean lesion length was 23 ± 5 cm. Twenty-eight limbs (80 %) presented tissue loss. Seventeen limbs underwent treatment by stent, 13 by stent-graft, and 5 by angioplasty. Mean follow-up was 29 ± 20 months. Seven patients required major amputation and six patients died during follow-up. Eighteen endovascular and three surgical TLR procedures were performed due to restenosis or occlusion. Estimated freedom from TLR and TER rates at 2 years were 41 and 76%, whereas estimated primary and secondary patency rates were 41 and 79%, respectively. Endovascular treatment for TASC II D lesions is safe and offers satisfying outcomes. This patient subset would benefit from a minimally invasive approach. Follow-up is advisable due to a high rate of restenosis. Further follow-up is necessary to know the long-term efficacy of these procedures.

Lesion complexity drives the cost of superficial femoral artery endovascular interventions

Patients who undergo endovascular treatment of superficial femoral artery (SFA) disease vary greatly in lesion complexity and treatment options. This study examined the association of lesion severity and cost of SFA stenting and to determine if procedure cost affects primary patency at 1 year. A retrospective record review identified patients undergoing initial SFA stenting between January 1, 2010, and February 1, 2012. Medical records were reviewed to collect data on demographics, comorbidities, indication for the procedure, TransAtlantic Inter-Society Consensus (TASC) II severity, and primary patency. The interventional radiology database and hospital accounting database were queried to determine cost drivers of SFA stenting. Procedure supply cost included any item with a bar code used for the procedure. Associations between cost drivers and lesion characteristics were explored. Primary patency was determined using Kaplan-Meier survival curves and a log-rank test. During the study period, 95 patients underwent stenting in 98 extremities; of these, 61% of SFA stents were performed for claudication, with 80% of lesions classified as TASC II A or B. Primary patency at 1 year was 79% for the entire cohort. The mean total cost per case was $10,333. Increased procedure supply cost was associated with adjunct device use, the number of stents, and TASC II severity. Despite higher costs of treating more complex lesions, primary patency at 1 year was similar at 80% for high-cost (supply cost >$4000) vs 78% for low-cost (supply cost <$4000) interventions. SFA lesion complexity, as defined by TASC II severity, drives the cost of endovascular interventions but does not appear to disadvantage patency at 1 year. Reimbursement agencies should consider incorporating disease severity into reimbursement algorithms for lower extremity endovascular interventions.

Predictors of restenosis in the use of helical interwoven nitinol stents to treat femoropopliteal occlusive disease

The femoropopliteal arteries are subjected to considerable axial and bending deformity due to flexion at the hip and knee joints. The Supera helical interwoven nitinol stent system (IDEV Technologies, Inc/Abbott Laboratories, Inc, Webster, Tex) has good conformability and flexibility, with a very low incidence of mechanical fatigue. This study reviewed our experience with the use of Supera stents for femoropopliteal atherosclerotic lesions and identified risk factors for restenosis or occlusion. Patients with symptomatic femoropopliteal atherosclerotic diseases who underwent lower limb angioplasty and Supera stent insertion were studied. All patients had regular clinical follow-up and underwent a Doppler ultrasound examination at 3months and then every 6months, and radiography of the stents at 6, 12, 18, 24, 30, and 36months. Patency rates were analyzed using Kaplan-Meier curves. We also evaluated the prospectively maintained cohort to identify predictors of restenosis. From October 2011 to December 2014, 164 legs in 153 symptomatic patients (96 male, 57 female) with femoropopliteal occlusive disease, with mean age of 76.7years (range, 46-100years), were included. Ninety-five patients (58%) had claudication, nine (5%) had rest pain, and 60 (37%) had tissue loss. Disease distribution was 64 proximal superficial femoral arteries (SFAs; 39%), 107 middle SFAs (65%), 127 distal SFAs (77%), 78 above-knee popliteal arteries (48%), and 19 below-knee popliteal arteries (12%). Lesion classification by TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II) A, B, C, and D was 49 (30%), 79 (48%), 31 (19%), 3 (1%), respectively. The mean lesion length was 105.6mm (range, 3-400mm), and more than one Supera stent was inserted in 26 patients. Procedure success (residual stenosis<30%) was achieved in 100% of procedures. The primary patency rates (>50% patency) at 6, 12, 24, and 30months were (±standard error) 86.7%± 3.1%, 81.4%± 3.7%, 79.9%± 4.0%, and 77± 3.0%, respectively. The ankle-brachial pressure index increased from 0.57± 0.15 preoperatively to 0.87± 0.14 postoperatively. No stent fractures occurred. There were three 30-day deaths not related to the procedure or device, one major amputation 3months after revascularization, and 29 late deaths (>30days) of unrelated medical causes in follow-up. In-stent restenosis was associated with younger patient age and with dyslipidemia, long lesion, and stent length. Our midterm experience showed that the implantation of the helical interwoven nitinol stents in patients with femoropopliteal occlusive disease is safe and effective, with encouraging patency rates and clinical results.

Laser Atherectomy for Treatment of Femoropopliteal In-Stent Restenosis

Purpose: To investigate if laser atherectomy with adjunctive balloon angioplasty can improve endovascular treatment outcomes for femoropopliteal in-stent restenosis (ISR). Methods: A dual center study included 135 symptomatic patients (mean age 71 years; 76 men) who underwent endovascular treatment of femoropopliteal ISR between 2006 and 2013. Of these, 54 (40%) were treated with laser atherectomy and the remaining 81 patients with balloon angioplasty alone. Angiographic images were reviewed for lesion morphology and characteristics, TransAtlantic InterSociety Consensus (TASC) II classification, and distal runoff. Class I ISR was defined as focal lesions ≤50 mm, class II ISR as lesions >50 mm, and class III ISR as stent total occlusion. Recurrent ISR was determined by a peak systolic velocity ratio >2.4 by duplex ultrasound. Results: Patients treated with laser atherectomy had longer mean ISR lesion length (222 vs 114 mm, p<0.001) and more class III ISR (69% vs 20%, p=0.001). There was no association between laser atherectomy and rates of recurrent restenosis or occlusion for patients with class I/II ISR, but there was a significantly lower rate of target lesion revascularization at 2 years among patients treated with laser atherectomy (14% vs 44%, p=0.05). In comparison, patients with class III ISR treated with laser atherectomy had lower rates of recurrent restenosis at 1 year (54% vs 91%, p=0.05) and 2 years (69% vs 100%, p=0.05). Patients with class III ISR treated with laser atherectomy also had lower rates of recurrent in-stent occlusion at 2-year follow-up (33% vs 71%, p=0.04). Conclusion: When used to treat complex ISR, including in-stent occlusions, laser atherectomy with adjunctive balloon angioplasty may be associated with improved patency.

The Antegrade Approach Using Transbrachial Access Improves Technical Success Rate of Endovascular Recanalization of TASC C-D Aortoiliac Occlusion in Case of Failed Femoral Access

Technical success rates of endovascular recanalizations for Trans-Atlantic Inter-Society Consensus (TASC) C-D chronic occlusions are highly variable and depend on the characteristics and sites of the lesions as well as on the operator experience. We hypothesized that an antegrade approach via transbrachial access could improve the technical success rate of endovascular treatment of TASC C-D occlusions in case of failed femoral access. From January 2010 to December 2012, all patients with symptomatic chronic TASC C-D aortoiliac occlusion were treated with an endovascular-first approach. Recanalization was first attempted using a femoral access. In case of failure, an antegrade approach using a transbrachial access was performed. Patient characteristics, anatomic details, procedural data, and immediate outcomes were prospectively recorded. During the study period, 73 patients (99 arteries) were included. Twenty-seven (37%) patients had TASC C occlusions including 11 bilateral common iliac artery occlusions and 16 external iliac artery (EIA) occlusions involving the common femoral or the internal iliac arteries. Forty-six (63%) patients had TASC D occlusions including 10 aortoiliac occlusions, 31 unilateral occlusions of both common and EIAs, and 5 bilateral EIA occlusions. Technical success with femoral access has been obtained in 53 arteries. An antegrade approach via transbrachial access allowed technical success in the other arteries, except in 7 arteries. Overall technical success rate was 93%, and 2 complications were related to the brachial accesses including 1 thrombosis and 1 pseudoaneurysm both requiring a reintervention. Brachial access for TASC C-D aortoiliac chronic occlusion improves the technical success rate without the need for reentry devices.

The effect of demographic factors and lesion severity on iliac stent patency

The aim of our study was to perform a large multivariate analysis to identify demographic, anatomic, or procedural factors that affect iliac artery stent primary patency (PP). Patients receiving iliac stents from 2007 to 2013 were retrospectively reviewed. Univariate analysis assessed cohort characteristics and their effect on PP. Variables considered significant (P < .05) were brought forward in the multivariate analysis. A total of 213 patients underwent primary iliac artery stenting, and 307 limbs were analyzed. The average age was 66 years (range, 38-93 years), 54% were male, and 55% were Caucasian. Indications for procedure were claudication in 68%, rest pain in 20%, and tissue loss in 12%. All TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC) II classifications were included: 51% TASC II A, 25% TASC II B, 13% TASC II C, and 11% TASC II D. The treated anatomic locations were 27% isolated external iliac artery (EIA), 56% isolated common iliac artery, and 17% combined common iliac artery and EIA. Multivariate analysis found three factors were correlated with decreased PP: non-Caucasian race (hazard ratio [HR], 1.84; 95% confidence interval [CI], 1.08-3.13; P = .025), younger age (HR, 1.04; 95% CI, 1.01-1.08; P = .006), and presence of EIA occlusion (HR, 2.02; 95% CI, 1.05-3.89; P = .036). Overall, Kaplan-Meier analysis at 1 and 3 years revealed a PP of 86% and 53%, assisted PP of 98% and 89%, and secondary patency of 99% of 98%. Kaplan-Meier analysis showed PP at 1 year for was 91% Caucasian patients vs 77% for non-Caucasian (P = .001). PP was 75% in patients aged <60 years, 86% in patients aged 60-70 years, and 96% in patients aged >70 years, with a significant difference between all groups (P < .001). PP was significantly different for those with and without EIA occlusion (P = .002), with 1-year PP of 71% and 88%, respectively. In our experience with a large number of iliac interventions, younger age, non-Caucasian race, and EIA occlusion were strong predictors for loss of PP.

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.

Outcomes of endovascular treatment for patients with TASC II D femoropopliteal occlusive disease: a single center study.

BackgroundAdvances in endovascular technology led to an alternative treatment option for TASC II D (TransAtlantic Inter-Society Consensus II class D) lesions. This study was aimed to evaluate the outcomes of endovascular treatment for TASC II D femoropopliteal lesions.MethodsEndovascular intervention with bare nitinol stent implantation was performed on 58 limbs (53 patients) with TASC II D femoropopliteal lesions from January 2011 to March 2013. Kaplan-Meier curves of primary patency, assisted patency and second patency were performed. Predictive factors of re-stenosis/occlusion were evaluated by univariate methods.ResultsTotal 53 patients with mean age of 74.2 ± 8.2 (range, 58.0–91.0 years) and mean lesion length of 314.8 ± 64.3 mm (188.2–400.4 mm) were enrolled. The mean follow-up time was 12.2 ± 6.1 months (5–38 months). Revascularization was successfully on 95 % lesions by bare nitinol stent implantation. Primary patency rates at 1, 2 and 3 years were 63 %, 12 % and 12 %, respectively. Assisted primary patency rates at 1, 2 and 3 years were 77 %, 31 % and 31 %, respectively. Secondary patency rates at 1, 2 and 3 years were 96 %, 63 % and 63 %. During one-year follow-up, no major amputation was occurred. Univariate analysis revealed that number of run-off vessels was a potential predictor of re-stenosis/occlusion.ConclusionEndovascular treatment of TASC II D femoropopliteal artery occlusion has a high technical success rate with acceptable one-year patency rate. The long-term outcomes are poor, but endovascular intervention could be a good alternative for patients unsuitable for surgical bypass.

Initial clinical experience with a new low-profile thoracic endograft

The Zenith Alpha thoracic endograft (William Cook Europe, ApS, Bjaeverskov, Denmark) is a new low-profile thoracic endograft that has recently become commercially available in Europe. The reduced profile offers potential benefits and extended applicability, especially in patients with small or diseased iliofemoral vessels. The aim of this study was to evaluate the safety and efficacy of thoracic endovascular aortic repair performed with the new Zenith Alpha thoracic endograft. From November 2013 to the present, Zenith Alpha thoracic stent grafts have been employed to treat 42 patients (31 men; median age, 71 years; range, 54-83 years) suffering from descending thoracic aortic disease: 34 degenerative aneurysms, 4 aortic ulcers, 2 false aneurysms following prior thoracic open repair, and 2 traumatic blunt injuries. The mean proximal neck length was 25 mm (range, 17-40 mm), with a mean access vessel diameter of 6.7 mm (range, 6-11 mm). In 11 cases, aortoiliac occlusive disease (TransAtlantic Inter-Society Consensus type B and C lesions) was present. The proximal landing was in zone 1 in 2 cases, in zone 2 in 25 cases, in zone 3 in 11 cases, and in zone 4 in 4 cases. Fifty-one endografts (45 proximal components and 6 distal components) were deployed in 42 patients. The endografts were deployed safely and effectively from one surgical femoral access site in all cases. In patients with associated aortoiliac disease, no adjunctive procedures for device insertion, except for predilation with balloon angioplasty in two cases, were required. No major complications related to the devices were observed in any of the patients during the postoperative course, and there was no perioperative mortality, paraparesis, or paraplegia. At 30 days, morbid events included one case of major stroke, two cases of transient acute renal failure, and one case of postimplantation syndrome. No access-related complications were recorded. Computed tomography performed within 6 months was obtained in 39 patients and confirmed 100% clinical success without device-related complications. No type I endoleaks or bird's beak effects were documented. Our early experience shows that deployment of the new Zenith Alpha endograft from a surgical femoral access is safe and effective in treating thoracic aortic aneurysms, aortic ulcers, and traumatic blunt injuries, even in patients with small or diseased access vessels. Endograft conformance to the aorta and exclusion of the aneurysm were satisfactory. Long-term durability remains to be evaluated.

Long Term Stability Evaluation of Prostacyclin Released from Biomedical Device through Turbiscan Lab Expert.

Therapeutic guidelines indicate prostacyclin as the first line of treatment in inflammation and vascular diseases. Prostacyclins prevent formation of the platelet plug involved in primary hemostasis by inhibiting platelet activation and, combined with thromboxane, are effective vasodilators in vascular damage.Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease II guidelines indicates prostacyclins; in particular, Iloprost, as the first therapeutic option for treating peripheral arterial disease. However, therapeutic efficacy of Iloprost has witnessed several drawbacks that have occurred in patients receiving repeated weekly administration of the drug by intravenous infusions. Adverse reactions arose under perfusion with Iloprost for 6 h and patient compliance was drastically decreased. Biomedical devices could provide a suitable alternative to overcome these drawbacks. In particular, elastomeric pumps, filled with Iloprost isotonic solution, could slowly release the drug, thus decreasing its side effects, representing a valid alternative to hospitalization of patients affected by peripheral arterial disease. However, the home therapy treatment of patients requires long-term stability of Iloprost in solution-loaded elastomeric pumps.The aim of this work was to investigate the long-term stability of Iloprost isotonic solution in biomedical devices using Turbiscan technology. Turbiscan Lab Expert (L’Union, France) predicts the long-term stability of suspensions, emulsions and colloidal formulations by measuring backscattering and transmission of particulates dispersed in solution. The formulations were evaluated by measuring the variation of physical-chemical properties of colloids and suspensions as a function of backscattering and transmission modifications. In addition, the release profile of Iloprost isotonic solution from the biomedical device was evaluated.