Target Extremity Revascularization Research Articles

Impact of hyperuricemia on 5-year clinical outcomes following percutaneous transluminal angioplasty

BackgroundAlthough the correlation between hyperuricemia and cardiovascular disease (CVD) is well known, there have been limited data regarding the impact of hyperuricemia on long-term clinical outcomes in patients with peripheral arterial disease (PAD) after percutaneous transluminal angioplasty (PTA). MethodsA total of 718 patients who underwent PTA for PAD were enrolled. The patients were divided into the hyperuricemia group (N = 168) and the normal group (N = 550). Hyperuricemia was defined as a uric acid level ≥ 7.0 mg/dL in men, and ≥ 6.5 mg/dL in women. The primary endpoint was major adverse cerebral and cardiovascular event (MACCE), including death, myocardial infarction (MI), any coronary revascularization, and stroke, up to 5 years. The secondary endpoint was major adverse limb event (MALE), including any repeated PTA, and target extremity surgery (TES). Inverse probability weighting (IPTW) analysis, derived from the logistic regression model, was performed to adjust potential confounders. ResultsAfter IPTW matching analysis, compared to the normal group, the hyperuricemia group was not associated with increased MACCE but was associated with an increased incidence of MI (2.6 % vs. 0.5 %, p = 0.001), and coronary revascularization (6.7 % vs. 3.9 %, p = 0.018). Also, the hyperuricemia group was associated with a higher incidence of MALE (45.3 % vs. 28.9 %, p < 0.001), including target extremity revascularization (TER; 25.1 % vs. 15.9 %, p < 0.001), non-TER (11.5 % vs. 5.6 %, p < 0.001), and TES (22.8 % vs. 16.2 %, p = 0.002). ConclusionsIn the present study, hyperuricemia was associated with worse clinical outcomes in PAD patients following PTA during 5-year clinical follow-up. Further investigations should be made regarding the clinical benefit of controlling hyperuricemia on clinical outcomes.

Abstract 16546: Impact of Hyperuricemia on 5-year Clinical Outcomes in Patients With Percutaneous Transluminal Angioplasty

Background: Although the correlation between hyperuricemia and cardiovascular disease (CVD) is well known, there have been limited data regarding the impact of hyperuricemia on long-term clinical outcomes in patients with peripheral arterial disease (PAD) after percutaneous transluminal angioplasty (PTA). Methods: A total of 943 patients who underwent PTA for PAD were enrolled. The patients were divided into the hyperuricemia group (N=168) and the normal group (N=550). Hyperuricemia was defined as a uric acid level ≥7.0 mg/dL in men, and ≥6.5 mg/dL in women. The primary endpoint was major adverse cerebral and cardiovascular event (MACCE), including death, myocardial infarction (MI), any coronary revascularization and stroke, up to 5 years. The secondary endpoint was major adverse limb event (MALE), including any repeated PTA, and target extremity surgery (TES). In addition, inverse probability weighting (IPTW) analysis, derived from the logistic regression model, was performed to adjust potential confounders. Results: After IPTW matching analysis, compared to the normal group, the hyperuricemia group was not associated with MACCE but associated with an increased incidence of MI (2.6% vs. 0.5%, p = 0.001), and coronary revascularization (6.7% vs. 3.9%, p = 0.018). Also, the hyperuricemia group was associated with higher incidence of MALE (45.3% vs. 28.9%, p &lt; 0.001), including a target extremity revascularization (TER; 25.1% vs. 15.9%, p &lt; 0.001), non-TER (11.5% vs. 5.6%, p &lt; 0.001), and TES (22.8% vs. 16.2%, p = 0.002). Conclusions: In the present study, hyperuricemia was associated with worse clinical outcomes during 5-year clinical follow-up. Further investigations should be made regarding the clinical benefit of controlling hyperuricemia on clinical outcomes.

Stenting versus balloon angioplasty alone in patients with below-the-knee disease: A propensity score-matched analysis.

Percutaneous transluminal angioplasty (PTA) is considered an effective treatment in patients with critical limb ischemia (CLI). However, the long-term durability of below-the-knee (BTK) PTA is known to be limited. This study sought to compare the 1-year clinical outcomes following stenting versus balloon angioplasty alone in BTK lesions. This study included 357 consecutive patients (400 limbs, 697 lesions) with BTK lesions who underwent PTA from September 2010 to December 2016. All enrolled patients were treated either by stenting (stent group; 111 limbs of 102 patients) or plain old balloon angioplasty (POBA group; 289 limbs of 255 patients). Stent group includes both primary and provisional stenting. Angiographic outcomes, procedural success, complications, and clinical outcomes were compared between the two groups up to 1 year. After propensity score matching (PSM) analysis, 56 pairs were generated, and the baseline and angiographic characteristics were balanced. The procedural success and complications were similar between the two groups; however, the incidence of procedure-related perforation was higher in the POBA group than in the stenting group [5(11.9%) vs.1 (0.9%), P = 0.009]. Six- to 9-month computed tomography or angiographic follow-up showed similar incidences of binary restenosis, primary patency, and secondary patency. In the 1-year clinical follow-up, there were similar incidences of individual hard endpoints, including mortality, myocardial infarction, limb salvage, and amputation rate, with the exception of target extremity revascularization (TER), which tended to be higher in the stenting group than in the POBA group [21 (20.8%) vs. 11 (10.9%), P = 0.054]. Although there was a trend toward a higher incidence of TER risk in the stenting group, stent implantation, particularly in bail-out stenting seemed to have acceptable 1-year safety and efficacy compared to POBA alone in patients undergoing BTK PTA.

Endovascular treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery using the sinus-SuperFlex-635 stent: twelve-month results from the HERO Registry.

The aim of this study was to evaluate the safety and performance of the sinus-SuperFlex-635 self-expandable nitinol stent (Optimed GmbH) for the treatment of steno-occlusive lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA). The prospective, multicenter, observational HERO study recruited 117 eligible patients (83 men; mean age 69.4±9.7y) from 7 centers in Belgium. A total of 129 stents were successfully deployed in 121 lesions in 117 patients (100%). The patients presented with symptomatic ≥50% stenosis or chronic total occlusion (CTO) (30.6%). Mean lesion length was 71.4±56.3 mm. Moderate to severe calcification was present in 82.6% of the lesions. Acute lesion success (<30% residual stenosis) was achieved in 96.0%. There were no in-hospital serious adverse events. Duplex ultrasound-driven primary patency at 12 months was recorded in 84 of 107 (78.5%) lesions. The overall target lesion revascularization (TLR) rate was 8.4% at 12 months; the target extremity revascularization (TER) rate was 4.7%. Clinical assessment at 12 months demonstrated improvement by at least 1 Rutherford class, without the need for TLR (i.e. primary sustained clinical improvement) in 83.9% of patients and with the need for TLR in 90.6% of patients (i.e. secondary sustained clinical improvement). Based on the high primary patency, low stent fracture rate and significant clinical improvement, combined with refined stent design and long stent availability, the sinus-SuperFlex-635 self-expandable nitinol stent proves its value in the treatment of complex femoropopliteal lesions.

Outcomes after Lower Extremity Revascularization for Treatment of Critical Limb Ischemia with Tissue Loss in Patients with Chronic Immune-Mediated Inflammatory Disease

To evaluate outcomes after lower extremity revascularization for critical limb ischemia with tissue loss in patients with chronic immune-mediated inflammatory disease. A retrospective medical record review of all lower extremity revascularization for critical limb ischemia with tissue loss at a university-affiliated hospital over a 3-year period was completed for demographics, comorbidities, lower extremity revascularization indication, angiogram results, complications, mortality, limb salvage, and reintervention. Chronic immune-mediated inflammatory disease (CIID) and control (no autoimmune disease) were compared by chi-squared test, Student's t-test, Kaplan-Meier, and Cox Regression. There were 349 procedures performed (297 patients): (1) 44 (13%) primary amputations and (2) 305 (87%) lower extremity revascularizations, in which 83% were endovascular interventions; 12% was bypass; and 5% was hybrid, in which 40% was infrainguinal and 60% was infrageniculate, 72% Wounds Ischemia Infection Score System (WIFi) tissue loss class 2-3, 35% CIID. No differences were noted between CIID and control for primary amputation (P=0.11), lower extremity revascularization type (P=0.50), or lower extremity revascularization anatomic level (P=0.43). Mean age was 71+13years, and 56% of the patients were of male gender. Those with CIID were of similar age as controls (71±14 vs. 71±13; P=0.87) and presented with comparable runoff: (1) ≤1 vessel (52% vs. 47%; P=0.67), (2) WIFi tissue loss classification class 2-3 (66% vs. 76%; P=0.09), and (3) WIFi infection classification class 2-3 (29% vs. 30%; P=0.9). They were also less likely to be male (47% vs. 61%; P=0.022) or current smokers (13% vs. 27%; P=0.008). Postoperative mortality (P=0.70) morbidity and reoperation (0.31) were comparable. Twenty-four-month survival was similar for CIID and control (83%±5% vs. 86%+3%; P=0.78), as was the amputation-free interval (69%±5% vs. 61%±4%; P=0.18) and need for target extremity revascularization (40% vs. 53%; P=0.04). Use of steroids and other anti-inflammatory medications was associated with improved 24-month amputation-free interval (87%±9% vs. 63%±3%; P=0. 05). Dialysis (odds ratio: 2.6; 1.5-4.7; P=0.001), WIFi infection class 2-3 (odds ratio: 2.8; 1.6-4.9; P<0.001), prerunoff vessel (0-1 vs. 2-3) to the foot (odds ratio: 0.52; 0.37-0.73; P<0.001), steroids/other anti-inflammatory agents (0.29; 0.06-0.96; P=0.04), and statins (0.44; 0.25-0.77; P=0.005) were independent predictors of 24-month amputation-free interval (Cox proportional hazard ratio). Patients with critical limb ischemia, tissue loss, and concomitant CIID can be successfully treated with lower extremity revascularization with similar limb salvage and need for reintervention. Steroid/anti-inflammatory use appears beneficial.

Impact of Vascular Calcifications on Long Femoropopliteal Stenting Outcomes

Vascular calcifications (VCs) may be a prognostic factor for outcome after endovascular treatment of peripheral arterial disease (PAD). Semiquantitative analysis with X-ray imaging is the main limiting factor for assessing VCs. The aim of the present study was to find a correlation between the amount of VC with computed tomography (CT) scan quantification and midterm results of endovascular treatment of Trans-Atlantic Inter-Society Consensus C/D femoropopliteal (FP) lesions. Patients belonging to 2 previously published registries (STELLA and STELLA PTX) and who underwent a preoperative CT scan were retrospectively included in the study. VC quantification was performed with a dedicated workstation (EndoSize, Therenva) on the basis of Hounsfield units (HU). The VC percentage was calculated as the ratio between VC volume and the volume of the region of interest. For the analysis, patients were divided into 3 groups according to VC percentage, from lowest to highest: group 1 (G1) included the first quartile of VCs, group 2 (G2) included the second and third quartiles, and group 3 (G3) included the fourth quartile. Risk of in-stent thrombosis was analysed using a multivariate model. Thirty-nine patients were included (10 in G1, 19 in G2, and 10 in G3), and mean follow-up duration was 24±14.6months. Patients in G1 and G3 had, respectively, a VC rate of <1% (no VC) and >20% (severe VC). In G2, VC was considered to be intermediate. There was no statistical difference in the cardiovascular risk factors and preoperative medication. A significant difference was found for the healthy FP diameter between G1 (4.6±0.8mm) and G3 (6.8±0.8mm, P<0.0001) and between G2 (5.2±1mm) and G3 (P<0.0001). The rate of drug-eluting stents was similar in all groups. There was no difference between groups concerning the rate of in-stent restenosis, target lesion revascularization, and target extremity revascularization. There was a higher rate of in-stent thrombosis for G1 versus G2 (P=0.037), and no difference was noted between G1 versus G3 (P=0.86) or G2 versus G3 (P=0.12). G3 was associated with early stent thrombosis (<1month), while G1 was associated with late stent thrombosis (6-24months). On multivariate analysis, only one predictive factor for stent thrombosis was found: patients with intermediate VC seemed tobe protected against in-stent thrombosis (odds ratio=0.27, 95% confidence interval: 0.1-0.77; P=0.014). The study showed that VC quantification with CT imaging is feasible and useful for comparing outcomes following PAD endovascular revascularization. Below a certain threshold, the presence of VC might be necessary for plaque stability and may protect against in-stent thrombosis.

Clinical risk factors for loss of stent primary patency in patients with chronic legs ischemia.

The outcome of endovascular therapy can be influenced by a number of factors, either demographic, biochemical, angiographic or procedural. Knowledge about these factors may help in the individualization of therapeutic methods, surveillance intensity, and should, ultimately, improve intervention efficacy. The aim of this study was to estimate the effect of clinical and biochemical factors on the late outcome of lower limb artery stenting. The medical documentation of 91 patients with at least a 1 year follow-up after the stenting of a lower limb artery was retrospectively evaluated. Uniand multivariate analyses were performed. Primary patency within an approximately 1.5-year follow-up amounted to 68.2%. The probability of freedom from target lesion revascularization was significantly greater in patients with dyslipidemia. According to the Cox proportional-hazards analysis, the risk of target extremity revascularization was significantly affected by the following (hazard ratio [HR], 95% confidence interval): Age (0.93, 0.88-0.99); dyslipidemia at inclusion (0.046, 0.01-0.23); LDL blood concentration (1.02; 1.01-1.04); hematocrit (1.2, 1.02-1.42); mean platelet volume (0.66, 0.44-0.99); INR (1.58, 1.13-2.21); and aPTT (1.18, 1.07-1.3). Endovascular treatment with stenting in patients with atherosclerotic peripheral arterial disease is effective, but the risk of primary patency loss was affected by the presence of dyslipidemia, age, and blood coagulation parameters. The effect of dyslipidemia on stent failure occurrence should be evaluated in further studies.

Long-Term Outcomes of Common Femoral Artery Stenting

The purpose of this study was to report the 5-year outcome relative to endovascular repair of the common femoral artery (CFA) for occlusive disease. Thirty-six consecutive patients (40 limbs) underwent stenting for CFA lesions. Patients were followed up systematically within a prospectively maintained database over 5years. Follow-up included clinical examination, duplex scan, and biplane X-ray at 1, 6, 12months and yearly thereafter. Indications for endovascular repair of the CFA included 25 patients (70%) for claudication and 11 patients (30%) for critical limb ischemia. Mean follow-up was 64months. Two patients were lost to follow-up. The mortality rate at 5years was 38%. At 3 and 5years, primary sustained clinical improvements were 77% and 73%, respectively. In-stent restenosis rate was 28%. The significant predictors of in-stent restenosis were deep femoral artery stenting (P=0.0007) and type III lesions (P=0.014). Freedom from target lesion revascularization and target extremity revascularization were 79% and 73%, respectively. One stent fracture was noted at the first year follow-up without clinical consequence, and no other stent fracture was noted during the remainder of the study. Endovascular repair of the CFA and its bifurcation seems to provide sustained clinical and morphological long-term results. Fear of stent fracture and local complications due to hip mobility are no longer relevant.

Long-Term Durability of Infrainguinal Endovascular and Open Revascularization for Disabling Claudication

Long-term outcomes after revascularization for disabling claudication (DC) are still unknown. We compared clinical outcomes and long-term durability of infrainguinal endovascular intervention (EVI) and open intervention for DC. Patients with DC who had open intervention (n = 93) or EVI (n = 171) between June 2001 and December 2013 were grouped as open-great saphenous vein (GSV; n = 23), open-polytetrafluoroethylene (PTFE; n = 36), open-femoral endarterectomy (FEA; n = 34), EV-A/B (n = 29), and EV-C/D (n = 51). Patency, sustained clinical success (improvement of symptoms, no target extremity revascularization, no amputation), secondary clinical success (sustained clinical success with target extremity revascularization), and major adverse limb event- and major adverse cardiovascular event-free survival were compared. Mean follow-up was 58 ± 39 (0-161) months. Primary patency was best in FEA and EV-A/B groups, but assisted primary patency and secondary patency were similar in open-GSV, EV-A/B, and FEA groups, which were significantly better than in open-PTFE and EV-C/D groups. Major adverse limb event-free survival was best in the FEA group and similar in others. Ipsilateral amputation rate of the whole cohort was 1.9% (22, 32, 69, 94, and 100 months). Overall major adverse cardiovascular event-free survival and overall survival at 5 years were 62% ± 3% and 72% ± 3% with no difference between groups. Sustained clinical success was best in FEA, less but similar in EV-AB and open-GSV, and worst in open-PTFE and EV-CD groups. Secondary clinical success was similar in open-GSV, EV-A/B, and FEA groups and significantly better than in open-PTFE and EV-C/D groups (Table). In open-GSV and EV-A/B groups, 70% to 81% remained asymptomatic, 17% to 21% presented with recurrent claudication, and 8% to 4% had limb-threatening ischemia; 26% to 24% had EVI ± open reinterventions, 13% to 11% being a bypass. In last follow-up, 96% to 100% remained asymptomatic, with no amputations. In open-PTFE and EV-C/D groups, 44% to 45% remained asymptomatic, 36% to 55% presented with recurrent claudication, 19% to 10% had limb-threatening ischemia, and 39% to 41% had EVI ± open reinterventions, 19% to 16% being a repeated bypass. In last follow-up, 64% to 78% remained asymptomatic and 25% to 9% mildly symptomatic. The durability of FEA is excellent for claudication. Excellent long-term outcomes can be achieved in EV-A/B or GSV bypass, with not insignificant (25%) reintervention rates. For EV-C/D and PTFE bypass, significantly more reinterventions are needed (40%), achieving acceptable long-term outcomes. Patients need to be fully informed of these expected outcomes, particularly reintervention rates, and GSV bypass should be preferred to PTFE or EVI in patients undergoing revascularization for TransAtlantic Inter-Society Consensus C/D disease, when feasible.TableKaplan-Meier patency, freedom from major adverse limb event (MALE) and major adverse cardiovascular event (MACE), and clinical success rates5-yearOpen bypass GSV, % (n = 23)Open bypass PTFE, % (n = 36)EV-A/B, % (n = 62)EV-C/D, % (n = 109)FEA ± EIA stent, % (n = 34)P valuePrimary patency58 ± 1346 ± 972 ± 838 ± 696 ± 4<.001Assisted primary patency85 ± 851 ± 987 ± 651 ± 696 ± 4<.001Secondary patency89 ± 756 ± 996 ± 361 ± 696 ± 4<.001Freedom from MALE73 ± 1370 ± 877 ± 870 ± 597 ± 3.015Freedom from MACE52 ± 1363 ± 861 ± 764 ± 564 ± 10.996Overall survival61 ± 1269 ± 867 ± 776 ± 581 ± 7.783Sustained clinical success58 ± 1346 ± 961 ± 938 ± 689 ± 6<.001Secondary clinical success89 ± 756 ± 996 ± 361 ± 696 ± 4<.001EIA, External iliac artery; FEA, femoral endarterectomy; GSV, great saphenous vein; PTFE, polytetrafluoroethylene. Open table in a new tab

Impact of uncontrolled hypertension on 12-month clinical outcomes following below-the-knee arteries (BTK) interventions in patients with critical limb ischemia.

BackgroundDespite intensive anti-hypertensive treatment, overall control rates of only 30 ~ 50 % have been reported in patients with hypertension (HTN). However, clinical significance and angiographic characteristics of patients with uncontrolled HTN following Below-the-knee arteries (BTK) interventions in patients with critical limb ischemia (CLI) are not clarified yet as compared to those with controlled HTN.MethodsA total 165 consecutive hypertensive patients with BTK lesions from August 2004 to November 2012 were enrolled for this study. Uncontrolled HTN was defined as a blood pressure of > 140 mmHg systolic and 90 mmHg diastolic under anti-hypertensive treatment. A total of 112 patients (67.8 %) had uncontrolled HTN. We compared the clinical and angiographic characteristics of patients with uncontrolled HTN following BTK interventions to those with controlled HTN at 12-month follow-up.ResultsThe baseline characteristics are well balanced between the two groups. At 12 months, there was no difference in the incidence of mortality, target lesion revascularization (TLR), target extremity revascularization (TER), and limb salvage rate in both groups. However, amputation rates were higher in patients with controlled HTN (33.9 vs. 19.6 %, P = 0.045).ConclusionRegardless of blood pressure control, HTN itself was an independent risk factor for BTK lesions, suggesting more intensive medical therapy with close clinical follow up will be required for all BTK patients with HTN.

Abstract 14864: Impact of Chronic Atrial Fibrillation on 1-year Clinical Outcomes Following Percutaneous Transluminal Angioplasty in Patients With Symptomatic Peripheral Arterial Disease

Background: To date, there is no study regarding the impact of chronic atrial fibrillation (AF) on clinical outcomes following percutaneous transluminal angioplasty (PTA) in patients (pts) with symptomatic peripheral arterial disease (PAD). Methods: We investigated the 512 consecutive symptomatic PAD pts underwent PTA from September 2004 to December 2013. Individual and composite cumulative clinical outcomes of PAD pts with AF (n=465) at 1 year were compared with those of PAD pts with normal sinus rhythm (NSR, n=47). Results: In baseline characteristics, there were no significant differences in baseline clinical characteristics including gender, smoking, hypertension, diabetes, dyslipidemia, cerebrovascular accident (CVA), chronic renal insufficiency, dialysis, coronary artery disease, myocardial infarction, symptoms of PAD such as claudication, resting pain, wound, and gangrene between the two groups except age; The AF group tended to be elder than non-AF group (67.15±10.56 years vs. 70.21±8.93 years, respectively, p=0.051). At 1 year, there was no significant differences in major clinical outcomes such as the incidence of repeat PTA, target lesion revascularization (TLR), target extremity revascularization (TER), target extremity surgery (TES), above-the-knee amputation, above-the-ankle amputation, below-the-ankle amputation, acute myocardial infarction (AMI), percutaneous coronary intervention (PCI), and major adverse cerebrocardiovascular events (MACCEs) between the two groups. However, after adjustment of baseline confounders, the incidence of total death, cardiac death, and CVA were higher in the AF group as compared with non-AF group (Table). Conclusions: In our study, symptomatic PAD pts underwent PTA combined with AF was associated with higher incidence of mortality and stroke up to 1-year as compared with PAD pts with NSR.

Abstract 14816: Twelve-month Outcomes of Stenting versus Standard Balloon Angioplasty for the Below-the-Knee Arterial Disease Patients Underwent Percutaneous Transluminal Angioplasty

Background: Although percutaneous transluminal angioplasty (PTA) is considered as an effective treatment strategy in patients (pts) with critical limb ischemia (CLI), below-the-knee (BTK) lesions with CLI is particularly challenging. This study sought to compare the 12-month outcomes following stenting versus standard plain old balloon angioplasty (POBA) alone in BTK lesions. Method: This study consisted of 339 consecutive lower extremity arterial disease pts (394 limbs, 1026 lesions included 716 BTK lesions) with BTK lesions from Sep 2004 to Dec 2013. All the enrolled pts were treated by stenting (bare metal stents, primary or provisional, 78 limbs in 73 pts) or POBA (316 limbs in 266 pts) with PTA. Procedural success, complications and clinical outcomes were compared between the two groups up to 12 months. To adjust potential confounders, a propensity score matched (PSM) analysis was performed using the logistic regression model. Results: After PSM analysis, 2 propensity-matched groups (56 pairs in pts, n= 112; 61 pairs in limbs, n=122, C-statistic=0.808) were generated, and the baseline &amp; angiographic characteristics of the two groups were balanced. Procedural success, complication incidences were similar between the two groups. Six to 9-month CT or angiographic follow-up, there were similar incidence of binary restenosis, primary, and secondary patency. At 12 months, there were similar incidence of individual hard endpoints including mortality, myocardial infarction, limb salvage, and any extremity amputations except the target lesion and extremity revascularization. Repeat PTA incidence was higher in the stenting group than POBA group (table). Conclusion: Although the repeat PTA risk was increased with BTK stenting, other major individual clinical outcomes and limb salvage rates were similar between the POBA and stenting for the BTK lesions.

Treatment of TASC C and D Femoropoliteal Lesions with Paclitaxel eluting Stents: 12 month Results of the STELLA-PTX Registry

The aim was to evaluate the safety and the efficacy of primary stenting with paclitaxel eluting stents for TASC C and D femoropopliteal lesions. Patients with TASC C/D de novo femoropopliteal lesions were treated by implanting paclitaxel eluting stents. Patients were included in a single center registry and prospectively followed by clinical and ultrasound evaluation. X-ray of the stented zone was systematically performed 12 months after implantation. The primary endpoint was primary sustained clinical improvement after 12 months. A total of 45 patients (48 limbs) suffering from claudication (25 limbs) or CLI (23 limbs) were enrolled. Lesions were either TASC C (28 limbs) or TASC D (20 limbs). The mean length of the treated segment was 252±90mm. The mean number of stents was 2.9±1 (2-5). Mean follow up was 12.7 months. No patient was lost to follow up. At 1 year post procedure, primary and secondary sustained clinical improvements were 56.3±7.4% and 80.1±5.9% respectively. Freedom from target lesion and target extremity revascularization were 63.6% and 90.1%, respectively. Primary and secondary patency rates were 52.5% and 79.6%. One year primary sustained clinical improvement rates for TASC C/D were 63.3±9.2% and 45.6±11.7%, respectively (p=.34). One year primary sustained clinical improvement rates for claudication/CLI patients were 68±9.3% and 41.6±11.1%, respectively (p=.13). The incidence of in stent re-stenosis and in stent thrombosis were 25% and 14%, respectively. The incidence of stent fracture was 12.5% on a limb basis and 9% on a per stent basis. The paclitaxel eluting stent did not achieve its goal in terms of prevention of in stent re-stenosis for TASC C/D femoropopliteal lesions. It requires frequent re-interventions during the first year to maintain satisfactory clinical results.

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.

Clinically-Driven Need for Secondary Interventions After Endovascular Revascularization of Tibial Arteries in Patients With Critical Limb Ischemia

To assess the need for clinically-driven secondary revascularization in critical limb ischemia (CLI) patients subsequent to tibial angioplasty during a 2-year follow-up. Between 2008 and 2010, a total of 128 consecutive CLI patients (80 men; mean age 76.5±9.8 years) underwent tibial angioplasty in 139 limbs. Rutherford categories, ankle-brachial index measurements, and lower limb oscillometries were prospectively assessed. All patients were followed at 3, 6, 12 months, and annually thereafter. Rates of death, primary and secondary sustained clinical improvement, target lesion (TLR) and target extremity revascularization (TER), as well as major amputation, were analyzed retrospectively. Primary clinical improvement was defined as improvement in Rutherford category to a level of intermittent claudication without unplanned amputation or TLR. All-cause mortality was 8.6%, 14.8%, 22.9%, and 29.1% at 3, 6, 12, and 24 months. At the same intervals, rates of primary sustained clinical improvement were 74.5%, 53.0%, 42.7%, and 37.1%; for secondary improvement, the rates were 89.1%, 76.0%, 68.4%, and 65.0%. Clinically-driven TLR rates were 14.6%, 29.1%, 41.6%, 46.2%; the rates for TER were 3.0%, 13.6%, 17.2%, and 27.6% in corresponding intervals, while the rates of major amputation were 1.5%, 5.5%, 10.1%, and 10.1%. Clinically-driven TLR is frequently required to maintain favorable functional clinical outcomes in CLI patients following tibial angioplasty. Dedicated technologies addressing tibial arterial restenosis warrant further academic scrutiny.

Cool Excimer Laser-Assisted Angioplasty (CELA) and Tibial Balloon Angioplasty (TBA) in Management of Infragenicular Arterial Occlusion in Critical Lower Limb Ischemia (CLI)

We aim to compare cool excimer laser-assisted angioplasty (CELA) versus tibial balloon angioplasty (TBA) in patients with critical limb ischemia (CLI) with tibial artery occlusive disease. The primary end point is sustained clinical improvement (SCI) and amputation-free survival (AFS). The secondary end points are binary restenosis, target extremity revascularization (TER), and cost-effectiveness. From June 2005 to October 2010, 1506 patients were referred with peripheral vascular disease and 572 with CLI. A total of 80 patients underwent 89 endovascular revascularizations (EVRs) for tibial occlusions, 47 using TBA and 42 using CELA. All patients were Rutherford category 4 to 6. Three-year SCI was enhanced with CELA (81%) compared to TBA (63.8%; P = .013). Three-year AFS significantly improved with CELA (95.2%) versus TBA (89.4%; P = .0165). Three-year freedom from TER was significantly improved with CELA (92.9%) versus 78.7% TBA (P = .026). Three-year freedom from MACE was comparable in both the groups (P = .455). Patients with CELA had significantly improved quality time without symptoms of disease or toxicity of treatment (Q-TWiST) at 3 years (10.5 months; P = .048) with incremental cost of €2073.19 per quality-adjusted life year gained. Tibial EVR provides exceptional outcome in CLI. The CELA has superior SCI, AFS, and freedom from TER, with improved Q-TWiST and cost-effectiveness.

Prognosis of Critical Limb Ischemia in Hemodialysis Patients After Isolated Infrapopliteal Balloon Angioplasty: Results From the Japan Below-the-Knee Artery Treatment (J-BEAT) Registry

To evaluate the long-term clinical results after isolated infrapopliteal balloon angioplasty for critical limb ischemia (CLI) in end-stage renal disease patients on hemodialysis. Between April 2004 and October 2010, 406 CLI consecutive patients (275 men; mean age 71±11 years) who underwent balloon angioplasty for primary treatment of isolated infrapopliteal artery lesions in 465 limbs were enrolled in a multicenter, non-randomized registry. The patients were classified into 2 groups, those on hemodialysis (242 patients with 283 limbs) and those not (164 patients with 182 limbs), for a retrospective comparative study of clinical outcomes [target extremity revascularization (TER), major amputation (MA), and survival] at an average 3.4±1.9 years. Freedom from TER at 5 years was lower in the hemodialysis patients (48.3% vs. 65.4% in non-hemodialysis patients, p<0.001); 9.9% of hemodialysis patients had undergone bypass surgery in contrast to 3.8% of non-hemodialysis patients (p=0.011). Freedom from MA was 77.1% in hemodialysis patients and 85.1% in non-hemodialysis patients at 5 years (p=0.058). Hemodialysis patients had significantly poorer survival (24.3% vs. 48.0%, p<0.001) and MA-free survival (20.8% vs. 42.9%, p<0.001) than non-hemodialysis patients at 5 years. Multivariate predictors of MA or all-cause death were non-ambulatory status (p<0.001), gangrene (p=0.036), and higher C-reactive protein levels (p=0.048). Although hemodialysis patients have a higher TER rate compared to the general population, the long-term limb salvage rate after balloon angioplasty for isolated infrapopliteal lesions is acceptable; nevertheless, the MA-free survival rate is very low.

Clinical efficacy of concomitant tibial interventions associated with superficial femoral artery interventions in critical limb ischemia

Combined superficial femoral artery (SFA) and tibial angioplasty (TA) are a common treatment for critical limb ischemia. Poor tibial runoff significantly compromises durability and clinical effectiveness of SFA interventions. The aim of this study is to determine clinical and anatomic outcomes of SFA interventions in patients with equally compromised runoff, with and without concomitant TA. The database of patients undergoing endovascular treatment of SFA (1999-2009) was retrospectively queried. Patients with poor runoff, scored>10 by modified Society for Vascular Surgery criteria, were selected. Preoperative angiograms were reviewed to assess distal popliteal and tibial runoff. Kaplan-Meier analyses were performed to assess time-dependent outcomes. Factor analyses were performed for time-dependent variables. A total of 162 limbs with a runoff score>10 (56% men; average age, 69 years) underwent endovascular intervention for symptomatic SFA disease: 61 (54% men) underwent TA but the remaining 101 (57% men) did not. The groups were matched for age, sex, and SFA anatomy (Trans-Atlantic Inter-Society Consensus II C/D lesions: 56% no TA vs 62% TA; P=.5). Presenting symptoms were similar between no TA and TA groups (rest pain: 40% vs 32%; tissue loss: 60% vs 68%; P=.3). Three-year survival favored the TA group (79%±5%) vs no TA (68%±5%; P=.06). Three-year anatomic outcomes in no TA vs TA group, including primary patency (45%±6% vs 63%±8%; P=.04), assisted primary patency (55%±6% vs 75%±7%; P=.03), and secondary patency (57%±6% vs 77%±7%; P=.03) were all superior in the TA group. Target vessel revascularization in no TA vs TA (61%±6% vs 74%±8%; P=.002) and target extremity revascularization (42%±6% vs 59%±8%; P=.06) also favored the TA group. However the comparison of no TA vs TA for clinical success (39%±6% vs 47%±8%; P=.6), freedom from recurrent symptoms (59%±6% vs 60%±9%; P=.1), amputation-free survival (46%±5% vs 63%±7%; P=.06), and limb salvage at 3 years (63%±6% vs 74%±7%; P=.6) were similar. TA in patients with poor runoff has a positive effect on SFA anatomic outcomes. However, clinical success was not affected. Concomitant TA appears not to add clinical benefit to SFA intervention in critical limb ischemia.

Outcomes after endovascular intervention for chronic critical limb ischemia

This study evaluated outcomes after endovascular intervention (EVI) for chronic critical limb ischemia (CLI) by Rutherford category (RC) 4, rest pain; and 5, tissue loss. The medical records of all EVI performed for RC-4 to RC-5 by vascular surgeons at a single institution during a 3-year period were reviewed for sustained clinical success (SCS), defined as Rutherford improvement score (RIS) 2(+), without target extremity revascularization (TER). The RC-5 group was evaluated for patency until healing and healing ≤4 months without recurrence or new ulceration. Secondary sustained clinical success (SSCS) was a RIS of 2(+) with TER. The RC-5 group was evaluated for patency until healing and healing at any time during follow-up, without recurrent or new ulceration. Significance was established at the 0.05 level. Of 106 EVI performed for CLI, 78 (74%) were RC-5. There were 39 (37%) men. Mean age was 73 ± 12 years. Mean follow-up was 19 months (range, 1-44 months). RC-5 patients were significantly more likely than RC-4 to be diabetic (58% vs 32%; P = .020), dialysis dependent (14% vs 0%; P = .036), and to require distal EVI (53% vs 29%; P = .029). RC-4 patients were more likely to be current smokers (57% vs 32%; P = .023). At 24 months, survival was comparable, with RC-4 at 84% ± 8% vs RC-5 at 62% ± 7% (P = .09), but limb salvage was significantly better for RC-4 (100%) vs RC-5 (83% ± 4%; P = .026), as was SCS (48% vs 21%; P = .006) and SSCS (85% vs 39%; P < .001). Independent predictors of failed SSCS were diabetes (odds ratio [OR], 2.83; 95% confidence interval [CI], 1.07-7.46; P = .036), congestive heart failure (CHF; OR, 3.62; 95% CI, 1.19-10.99; P = .023), and RC-5 (OR, 5.5; 95% CI, 2.4-30.3; P = .001). SSCS was 94% in RC-4 patients without diabetes mellitus (DM) or CHF and 10% in RC-5 with DM or CHF (P < .001) but improved to 67% in RC-5 when neither CHF nor DM were present (P = .004). RC-4 have fewer comorbidities, less advanced ischemia, and better outcome than RC-5. These groups should be evaluated individually. Limb salvage was acceptable, yet early wound healing without TER (SCS) occurred in only 21%. RC-5, DM, and CHF were predictors of poor SSCS. Careful selection of patients should improve outcome.

Endovascular Intervention for Treatment of Claudication: Is It Cost-Effective?

Treatment of claudication with endovascular intervention (EVI), a procedure designed to enhance quality of life, is on the rise despite being expensive. We examined clinical outcomes and costs for treatment of claudication with EVI. Records of all EVI performed at a University Health Center during a single year were reviewed for functional capacity, Trans-Atlantic Inter-Society Council (TASC) classification, procedure, reintervention, and financial data. Sustained clinical success (SCS) (improvement without target extremity revascularization [TER]) and secondary sustained clinical success (SSCS) (improvement with TER) were tracked over 2 years follow-up. There were 77 patients (90 limbs). Mean follow-up was 14.8 +/- 7.7 months (1-30). Procedural success was 94%. Two-year SCS and SSCS were found to be 28 +/- 9% and 49 +/- 11%, respectively. SCS differed significantly from TASC (p = 0.02), whereas SSCS did not (p = 0.33). Mean time to reintervention was 11.7 +/- 6.6 months. Two-year TER-free rate (65 +/- 7%) did not differ significantly by procedure (p = 0.26), the artery treated (p = 0.24), or TASC (p = 0.18). Two-year costs for EVI were $13,886, differing significantly by TASC (p = 0.017) and by the artery treated (p < 0.001). Estimated cost for a 3-month trial of supervised exercise and pharmacotherapy was $1,376, and the maintenance cost over a 2 year follow-up period was $6,602. TER was necessary in more than one-third of limbs to maintain 2-year SSCS in 49% of patients. EVI was twice as expensive as estimated 2-year costs for supervised exercise and pharmacotherapy, and 10 times more costlier than a 3-month trial. Mandating a trial of conservative therapy before EVI merits consideration.