Technical success and associated economic implications of conventional re-entry devices in subintimal recanalization of femoro-popliteal chronic total occlusions.

PURPOSE: Re-entry devices contribute to the high success rate of subintimal recanalization of chronic total occlusions (CTO). However, to date, there are no studies comparing the available conventional re-entry devices concerning the impact of their technical success on economic aspects, as these devices differ greatly in their acquisition costs. This prospective observational study intends to contribute to this question. METHODS: Prior to the start of the prospective study, all previous applications of the Outback® in femoro-popliteal CTO since its introduction to our hospital were analyzed retrospectively (n = 31). From June 2018 until January 2020, all patients with femoro-popliteal CTO treated with clear subintimal recanalization were included (n = 109). In the case of failed spontaneous re-entry, either the OffRoad® (study arm I, n = 20) or the Enteer® catheter (study arm II, n = 20) was used. If assisted re-entry failed, the Outback® device was used as a bailout. Baseline demographic and clinical data, morphologic characteristics, and technical success were documented. Additional per-patient costs due to the use of re-entry devices were analyzed. RESULTS: A retrospective evaluation of all Outback® applications revealed a technical success rate of 97% (30/31). In the prospective study, 63% (68/109) were successfully treated without using re-entry devices. The overall procedural success was 95% (103/109). In study arm I, the OffRoad® achieved a success rate of 45% (9/20), with a subsequent successful application of the Outback® in 80% (8/10) of the failed cases. In study arm II, the Enteer® was successfully employed in 60% (12/20) of cases, and the Outback® was then used successfully in a further 62% (5/8) of cases. Too large a distance between the device and the target lumen was a knockout criterion for all tested devices, leading to a subgroup analysis with the exclusion of three cases, resulting in a success rate of 47% for the OffRoad® and 67% for the Enteer® device. Furthermore, in severe calcification, only the Outback® reliably enabled revascularization. Significant savings of almost €600 were only achieved in study arm II according to German prices. CONCLUSION: With proper patient selection, a gradual approach with the Enteer® as the primarily used device, with the Outback® used additionally in case of failure, leads to significant savings and can be recommended. In severe calcification, the Outback® should be used as the primary device.

The impact of female sex on the outcomes of endovascular treatment for iliac lesions.

OBJECTIVE: The aim of this study was to evaluate early and long-term outcomes of stenting for iliac obstructive disease in women, comparing their results with those of men. METHODS: A single-center retrospective analysis of iliac stenting procedures performed from 2010 to 2017 was conducted. Perioperative clinical, anatomic, and operative data, including mean artery diameters and stent diameters, were collected in a dedicated database. Early outcomes and long-term patency rates were compared between men and women; Cox proportional hazards modeling was used to identify independent predictors of patency. RESULTS: There were 210 patients (298 limbs; women, n = 80 limbs [33%]; men, n = 218 limbs [66%]) treated. In comparing women with men, there were no differences in comorbidities (Society for Vascular Surgery score: women, 0.81 ± 0.54; men, 0.84 ± 0.60; P = .69) and TransAtlantic Inter-Society Consensus (TASC) classification (P = .49). At presentation, women had more advanced symptoms (Rutherford categories 5 and 6: women, 36.2%; men, 23.8%; P = .039) and smaller diameter at the level of the aortic bifurcation (women, 14.5 ± 3.6 mm; men, 16.0 ± 3.3 mm; P = .017), common iliac artery (women, 9.3 ± 1.5 mm; men, 10.0 ± 1.6 mm; P < .001), external iliac artery (EIA; women, 8.7 ± 1.5 mm; men, 10.1 ± 2.6 mm; P = .006), and common femoral artery (women, 7.3 ± 2.0 mm; men, 8.5 ± 2.1 mm; P = .034); similarly, the mean stent diameter was smaller (women, 8.9 ± 1.7 mm; men, 10.1 ± 4.4 mm; P = .03). The 30-day medical (P = .22) and surgical (P = .50) complication rates were similar. At 72 months, women had lower primary patency (women, 71%; men, 88%; P = .020) and secondary patency (women, 83%; men, 97%; P < .001) rates compared with men, whereas limb salvage rate was similar (women, 96%; men, 99%; P = .501). Multivariable analysis showed that female sex (hazard ratio [HR], 2.49; P = .04), ischemic tissue loss (HR, 2.48; P = .04), and stent diameter ≤7 mm (HR, 2.86; P = .01) were overall negative predictors of patency. Within women, EIA involvement (HR, 2.01; P = .04) and stent diameter ≤7 mm (HR, 3.79; P = .12) were also negative predictors. CONCLUSIONS: Iliac stenting shows similarly good early outcomes in women and men. However, in the long term, primary and secondary patency rates are significantly lower in women, and this may be explained by smaller arterial diameter. In particular, a stent diameter ≤7 mm and EIA stenting were negative predictors of patency.

Organizing stroke systems in the field for patients with suspected large vessel occlusion acute stroke.

Introduction: The dawn of endovascular stroke therapy has reshaped stroke care. Eligible patients need to be rushed to capable centers for intervention. This may entail bypassing closer hospitals that could confirm the diagnosis, administer thrombolytic therapy, then transfer patients for intervention. This has created a set of challenges: identifying endovascular candidates in the field, determining the best transport destination, and getting patients there quickly. Areas covered: This review provides a context for these emerging challenges. Current and emerging clinical prediction instruments for large vessel occlusion (LVO) are reviewed. The workflow in the thrombolysis-only primary stroke centers is reviewed, and interventions aimed at minimizing delays are highlighted. Innovations using mathematical modeling and devices for detection of LVO are reviewed. Expert commentary: More patients are expected to receive endovascular therapy as we push the boundaries for time and imaging criteria. Advances in detection and decision-making aids will improve the speed of treatment. Some patients will arrive at thrombolysis-only centers. This need to be triaged, diagnosed, treated, and transported promptly. Therefore, education of practitioners in these centers is paramount. Creating and facilitating infrastructure for imaging acquisition and sharing in such centers will reflect better care for stroke patients overall.

[Objective assessment of the degree of ischaemia and efficacy of treatment in chronic arterial insufficiency of lower limbs]. / Ob''ektivnaia otsenka stepeni ishemii i éffektivnosti lecheniia pri khronicheskoi arterial'noi nedostatochnosti nizhnikh konechnostei.

Presented in the review is the data concerning contemporary criteria for assessing the degree of chronic lower limb ischaemia and quality of the treatment performed. Problems regarding objectivization of the degree of an ischaemic lesion of an extremity and assessment of quality of conservative treatment still remain unresolved. Currently, in the world practice along with instrumental methods (assessment of the ankle-brachial index) subjective criteria are mainly employed: assessment of pain-free walking distance or maximum distance walked. In order to work out appropriate regiments of conservative treatment and compare efficacy of various drugs for treatment of chronic lower limb ischaemia and, in particular, intermittent claudication, it is necessary to use objective criteria. Detailed consideration is hence given to the possibilities of using morphological, biochemical and histological criteria such as determination of vascular endothelial growth factor A (VEGF-A) in peripheral blood and determination of apoptosis markers (BNIP3) and hypoxia-inducible factor (HIF-1) in a biopsy sample of the gastrocnemius muscle of the ischaemized extremity.

Comparative assessment of patient outcomes with intraluminal or subintimal crossing of infrainguinal peripheral artery chronic total occlusions.

This study compares procedural complications and clinical outcomes between subintimal crossing versus intraluminal crossing during endovascular treatment of infrainguinal peripheral artery chronic total occlusions (CTO). We identified 1335 CTO interventions in 1001 patients from the multicenter Excellence in Peripheral Artery Disease (XLPAD) registry from January 2005 to October 2015. Outcomes included 30-day and 12-month all-cause death, non-fatal myocardial infarction or stroke, peripheral artery stent, or vessel, thrombosis (ST), need for any target limb endovascular or surgical revascularization, target limb major amputation and procedural complications. A subintimal crossing technique was necessary in 388 lesions (27% overall in 1335 lesions; 34% ( n=351) in 1023 femoropopliteal lesions, and 12% ( n=37) in 312 infrapopliteal lesions, p<0.01) with a lower procedural ( p<0.01) and technical ( p<0.01) success than the intraluminal in both femoropopliteal and infrapopliteal interventions. There were no significant differences in procedural complications, major adverse cardiac events, or clinically driven target limb revascularization at 1 year between the two groups, except a higher residual dissection rate in the subintimal crossing group than the intraluminal group in femoropopliteal target vessels ( p = 0.04).

Are drug-coated balloons cost effective for femoropopliteal occlusive disease? A comparison of bare metal stents and uncoated balloons.

AIM: To perform a cost-effectiveness analysis to help hospital decision-makers with regard to the use of drug-coated balloons compared with bare metal stents and uncoated balloons for femoropopliteal occlusive disease. METHODS: Clinical outcomes were extracted from the results of meta-analyses already published, and cost units are those used in the Quebec healthcare network. The literature review was limited to the last four years to obtain the most recent data. The cost-effectiveness analysis was based on a 2-year perspective, and risk factors of reintervention were considered. RESULTS: The cost-effectiveness analysis indicated that drug-coated balloons were generally more efficient than bare metal stents, particularly for patients with higher risk of reintervention (up to CAD$1686 per patient TASC II C or D). Compared with uncoated balloons, results indicated that drug-coated balloons were more efficient if the reintervention rate associated with uncoated balloons is very high and for patients with higher risk of reintervention (up to CAD$3301 per patient). CONCLUSION: The higher a patient's risk of reintervention, the higher the savings associated with the use of a drug-coated balloon will be. For patients at lower risk, the uncoated balloon strategy is still recommended as a first choice for endovascular intervention.

Severity assessment of intracranial large artery stenosis by pressure gradient measurements: A feasibility study.

BACKGROUND: Fractional flow reserve (FFR)-guided revascularization strategy is popular in coronary intervention. However, the feasibility of assessing stenotic severity in intracranial large arteries using pressure gradient measurements still remains unclear. METHODS: Between March 2013 and May 2014, 12 consecutive patients with intracranial large artery stenosis (including intracranial internal carotid artery, middle cerebral M1 segment, intracranial vertebral artery, and basilar artery) were enrolled in this study. The trans-stenotic pressure gradient was measured before and/or after percutaneous transluminal angioplasty and stenting (PTAS), and was then compared with percent diameter stenosis. A Pd /Pa cut-off of ≤0.70 was used to guide stenting of hemodynamically significant stenoses. The device-related and procedure-related serious adverse events and recurrent cerebral ischemic events were recorded. RESULTS: The target vessel could be reached in all cases. No technical complications occurred due to the specific study protocol. Excellent pressure signals were obtained in all patients. For seven patients who performed PTAS, the mean pre-procedural pressure gradient decreased from 59.0 ± 17.2 to 13.3 ± 13.6 mm Hg after the procedure (P < 0.01). Only one patient who refused stenting experienced a TIA event in the ipsilateral MCA territory. No recurrent ischemic event was observed in other patients. CONCLUSION: Mean trans-stenotic pressure gradients can be safely and easily measured with a 0.014-inch fluid-filled guide wire in intracranial large arteries. © 2016 Wiley Periodicals, Inc.

[Cost and cost-effectiveness in the treatment of peripheral arterial occlusion disease - what is proven?]. / Kosten und Kosteneffizienz bei der Behandlung der peripheren arteriellen Verschlusskrankheit - was ist gesichert?

BACKGROUND: This overview comments on the health-care relevance of peripheral arterial occlusive disease (PAOD) in patients with intermittent claudication (IC) and critical limb ischaemia (CLI). We evaluated different treatment modalities in terms of cost-effectiveness. METHOD: For the literature review, the Medline database (PubMed) was searched under the key words "critical limb ischemia AND cost", "critical limb ischemia AND economy", "peripheral arterial disease AND cost", "peripheral arterial disease AND economy". RESULTS: In the years 2005 to 2009, the hospitalisations of patients with PAOD rose disproportionately in Germany by 20 %, to 483,961 hospital admissions. By comparison, hospital admissions altogether increased by only 8 %. The average in-patient costs were estimated to be approximately € 5000 per PAOD-patient - a rather conservative estimate. For the patient with IC the economic data position is clear, supervised exercise training is by far the most cost-effective treatment option, followed by percutaneous transluminal angioplasty (PTA) and finally the peripheral bypass. In accordance with the guidelines of the UK, the latter is therefore indicated only if PTA fails or is technically not possible. In patients with CLI, the situation is not obvious. Indeed, a short-term economic advantage can be calculated for the PTA, the long-term comparison of both methods, however, is impossible due to insufficient data. In addition, the risk factors for the patient have to be included in the calculation. This was indeed demonstrated in the short-term, but could not be analysed in the long-term follow-up. CONCLUSION: The issue of greater cost-effectiveness of open or endovascular treatment in patients with CLI is uncertain, the studies and patient populations are too heterogeneous. Further studies are urgently needed to structure the sequence of the various treatment options in guidelines and clinical pathways.

Calcium burden assessment and impact on drug-eluting balloons in peripheral arterial disease.

PURPOSE: This study was designed to assess the effect of calcium on the efficacy of DEB during revascularization of steno-obstructive SFA lesions. METHODS: Sixty patients with de novo lesions of the superficial femoral artery underwent endovascular treatment with drug eluting balloons (DEB). DEB was selected according to vessel reference diameter (1:1). In case of residual stenosis > 50 % or flow-limiting dissection, postdilatation with conventional balloon or provisional stenting was done. Patients were classified into eight groups according to circumferential distribution of calcium on CT-angiography axial images (from 0° to 360°) and to its length (length < or > 3 cm) evaluated with digital-subtraction-angiography. Ankle-brachial index (ABI), late lumen loss (LLL), target lesion revascularization (TLR), primary (PP) and secondary (SP) patency, major adverse events (MAE), and Rutherford shift were evaluated at 1-year follow-up and correlated with the amount of calcium. RESULTS: Revascularization was successful in all cases. Flow-limiting dissection occurred in five cases (8.3 %) with a higher circumferential degree of calcium and solved in three cases with postdilatation and in the other two with provisional stenting. DEB effect was lower in patients with higher degree of calcium (>270° vs. <90°): ABI 0.71 ± 0.07 versus 0.92 ± 0.07; LLL 0.75 ± 0.21 versus 0.45 ± 0.1; PP 50 versus 100 %; SP 50 versus 100 %; TLR 25 versus 0 %; MAE 25 versus 0 %. CONCLUSIONS: Calcium represents a barrier to optimal drug absorption. Circumferential distribution seems to be the most influencing factor with the worst effect noticed in 360° calcium presence.

Enhancements to angioplasty for peripheral arterial occlusive disease: systematic review, cost-effectiveness assessment and expected value of information analysis.

BACKGROUND: There have been rapid technological developments aimed at improving short- and long-term results of percutaneous transluminal balloon angioplasty (PTA) in peripheral arterial occlusive disease (PAD). OBJECTIVES: To assess current clinical effectiveness and cost-effectiveness evidence of additional techniques to standard PTA for PAD, develop a health economic model to assess cost-effectiveness and to identify where further research is needed. DATA SOURCES: Relevant electronic databases, including MEDLINE, EMBASE and The Cochrane Library were searched from inception to 2011, between May and October 2011. METHODS: Systematic reviews were conducted of clinical effectiveness and cost-effectiveness. The population was participants with symptomatic PAD undergoing endovascular treatment for disease distal to the inguinal ligament. Interventions were modifications of and adjuncts to PTA in the peripheral circulation, compared with conventional PTA. Outcomes included measures of clinical effectiveness and costs. Data were extracted from randomised controlled trials (RCTs), which were quality assessed using standard criteria. Where appropriate, meta-analyses using fixed- and random-effects methods produced relative risks (RRs). A discrete-event simulation model was developed to assess the relative cost-effectiveness of the interventions from a NHS perspective over a lifetime. The patient populations of intermittent claudication (IC) and critical limb ischaemia (CLI) were modelled separately. Univariate and probabilistic sensitivity analyses were undertaken. RESULTS: In total, 40 RCTs were included, many of which had small sample sizes. Significantly reduced restenosis rates were shown in meta-analyses of self-expanding stents (SES) {RR 0.67 [95% confidence interval (CI) 0.52 to 0.87]}, endovascular brachytherapy (EVBT) [RR 0.63 (95% CI 0.48 to 0.83)] at 12 months and drug-coated balloons (DCBs) at 6 months [RR 0.40 (95% CI 0.23 to 0.69)], and single studies of stent-graft or drug-eluting stent (DES), compared with PTA; a single study showed improvements with DES versus bare-metal stents (BMSs). Compared with PTA, walking capacity was not significantly affected by cutting balloon, balloon-expandable stents or EVBT; in SES, there was evidence of improvement in walking capacity after up to 12 months. The use of DCBs dominated both the assumed standard practice of PTA with bailout BMS and all other interventions because it lowered lifetime costs and improved quality of life (QoL). These results were seen for both patient populations (IC and CLI). Sensitivity analyses showed that the results were robust to different assumptions about the clinical benefits attributable to the interventions, suggesting that the use of DCBs is cost-saving. LIMITATIONS: Differing definitions of restenosis made direct comparison across trials difficult. There were few data available for walking capacity and QoL. CONCLUSIONS: The evidence showed a significant benefit to reducing restenosis rates for self-expanding and DESs, stent-graft, EVBT and DCBs. If it is assumed that patency translates into beneficial long-term clinical outcomes, then DCB and bail-out DES are most likely to be the cost-effective enhancements to PTA. A RCT comparing current recommended practice (PTA with bail-out BMS) with DCB and bail-out DES could assess long-term follow-up and cost-effectiveness. Data relating patency status to the need for reintervention and to the probability of symptoms returning should be collected, as should health-related QoL measures [European Quality of Life-5 Dimensions (EQ-5D) and maximum walking distance]. STUDY REGISTRATION: This study is registered as PROSPERO CRD42012002014. FUNDING: The National Institute for Health Research Health Technology Assessment programme.

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.

Cost-effectiveness analysis of infrapopliteal drug-eluting stents.

INTRODUCTION: There are no cost-utility data about below-the-knee placement of drug-eluting stents. The authors determined the cost-effectiveness of infrapopliteal drug-eluting stents for critical limb ischemia (CLI) treatment. METHODS: The event-free individual survival outcomes defined by the absence of any major events, including death, major amputation, and target limb repeat procedures, were reconstructed on the basis of two published infrapopliteal series. The first included spot Bail-out use of Sirolimus-eluting stents versus bare metal stents after suboptimal balloon angioplasty (Bail-out SES).The second was full-lesion Primary Everolimus-eluting stenting versus plain balloon angioplasty and bail-out bare metal stenting as necessary (primary EES). The number-needed-to-treat (NNT) to avoid one major event and incremental cost-effectiveness ratios (ICERs) were calculated for a 3-year postprocedural period for both strategies. RESULTS: Overall event-free survival was significantly improved in both strategies (hazard ratio (HR) [confidence interval (CI)]: 0.68 [0.41-1.12] in Bail-out SES and HR [CI]: 0.53 [0.29-0.99] in Primary EES). Event-free survival gain per patient was 0.89 (range, 0.11-3.0) years in Bail-out SES with an NNT of 4.6 (CI: 2.5-25.6) and a corresponding ICER of 6,518 (range 1,685-10,112). Survival gain was 0.91 (range 0.25-3.0) years in Primary EES with an NNT of 2.7 (CI: 1.7-5.8) and an ICER of 11,581 (range, 4,945-21,428) per event-free life-year gained. Two-way sensitivity analysis showed that stented lesion length >10 cm and/or DES list price >1000 were associated with the least economically favorable scenario in both strategies. CONCLUSIONS: Both strategies of bail-out SES and primary EES placement in the infrapopliteal arteries for CLI treatment exhibit single-digit NNT and relatively low corresponding ICERs.

A budget impact model for paclitaxel-eluting stent in femoropopliteal disease in France.

PURPOSE: The Zilver PTX drug-eluting stent (Cook Ireland Ltd., Limerick, Ireland) represents an advance in endovascular treatments for atherosclerotic superficial femoral artery (SFA) disease. Clinical data demonstrate improved clinical outcomes compared to bare-metal stents (BMS). This analysis assessed the likely impact on the French public health care budget of introducing reimbursement for the Zilver PTX stent. METHODS: A model was developed in Microsoft Excel to estimate the impact of a progressive transition from BMS to Zilver PTX over a 5-year horizon. The number of patients undergoing SFA stenting was estimated on the basis of hospital episode data. The analysis from the payer perspective used French reimbursement tariffs. Target lesion revascularization (TLR) after primary stent placement was the primary outcome. TLR rates were based on 2-year data from the Zilver PTX single-arm study (6 and 9 %) and BMS rates reported in the literature (average 16 and 22 %) and extrapolated to 5 years. Net budget impact was expressed as the difference in total costs (primary stenting and reinterventions) for a scenario where BMS is progressively replaced by Zilver PTX compared to a scenario of BMS only. RESULTS: The model estimated a net cumulative 5-year budget reduction of 6,807,202 for a projected population of 82,316 patients (21,361 receiving Zilver PTX). Base case results were confirmed in sensitivity analyses. CONCLUSION: Adoption of Zilver PTX could lead to important savings for the French public health care payer. Despite higher initial reimbursement for the Zilver PTX stent, fewer expected SFA reinterventions after the primary stenting procedure result in net savings.

Radial artery spasm during transradial cardiac catheterization and percutaneous coronary intervention: incidence, predisposing factors, prevention, and management.

Transradial cardiac catheterization and percutaneous coronary intervention are increasingly being performed worldwide in elective and emergency procedures, with many centers adopting the transradial route as their first choice of arterial access. One of the most common complications encountered during transradial procedures is radial artery spasm. This article reviews the current literature on the incidence, predisposing factors, preventive, and treatment measures for radial artery spasm.

Utility of new classification based on clinical and lesional factors after self-expandable nitinol stenting in the superficial femoral artery.

BACKGROUND: The aim of this study was to investigate the predictive value of clinical classification schemes that assess primary patency after self-expandable nitinol stent in the superficial femoral artery (SFA). METHODS: This study was a multicenter retrospective study of prospective databases. From April 2004 to December 2009, 1001 limbs (807 patients) that underwent successful nitinol stent implantation for de novo SFA lesions were identified and analyzed. Primary patency was defined as treated vessel without restenosis (defined as >2.4 of peak systolic velocity ratio by duplex) and repeat revascularization. Six items were included in the classification: female, diabetes, dialysis, critical limb ischemia (CLI), lesion length > 150 mm, and poor runoff; the FeDCLIP score. A lesion length >150 mm was scored as 2 points. The others were assigned 1 point each. The scores of 0 to 2, 3 to 4, and ≥5 points were classified as low-, moderate-, and high-risk patients, respectively. Outcome measures were primary and secondary patency and all-cause mortality up to 6 years in each risk group. RESULTS: The mean follow-up interval was 26.8 ± 14.6 months. Primary patencies were 85.7%, 77.3%, and 74.2% in the low-risk group; 71.5%, 54.7%, and 51.9% in the moderate-risk group; and 53.0%, 24.3%, and 20.8% in the high-risk group at 1, 3, and 5 years, respectively. The secondary patencies were 94.6%, 92.3%, and 90.8% in the low-risk group; 89.5%, 83.1%, and 83.1% in the moderate-risk group; and 82.7%, 73.1%, and 73.1% in the high-risk group at 1, 3, and 5 years, respectively. There were significant differences in primary and secondary patency among the three risk groups (P < .0001 and P < .0001, respectively). Overall survival rates were 96.8%, 89.5%, and 81.8% in the low-risk group; 91.5%, 74.4%, and 68.7% in the moderate-risk group; and 78.2%, 63.2%, and 48.7% in the high-risk group at 1, 3, and 5 years, respectively. There were also significant differences in mortality (P < .0001). CONCLUSIONS: New classification schemes based on FeDCLIP score were useful for risk stratification in vessel patency and mortality after self-expandable nitinol stenting for SFA disease.

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

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

In-hospital outcomes and cost comparison of femoropopliteal reopening strategies.

PURPOSE: Atherectomy has emerged as an alternative to percutaneous transluminal angioplasty (PTA) for endovascular reopening. Despite increasing use of atherectomy (and higher cost of atherectomy catheters compared with balloon catheters), few studies have compared outcomes and costs with other reopening strategies. METHODS: We performed a retrospective cohort study involving all patients undergoing isolated femoropopliteal PTA (n=69) or atherectomy (n=92) at our institution from 1/2005 to 4/2006. The choice of reopening strategy was left to the treating physician, and no patients with relative contraindications to stent placement (specifically common femoral artery lesions) were included. Device and supply costs were calculated using the hospital resource-based accounting system, and other costs were calculated using the hospital micro-cost accounting system. Professional fees were calculated from the Medicare Fee Schedule. RESULTS: Baseline characteristics were generally well matched. There were no significant differences in complications (vascular complications, urgent repeat reopening, death, myocardial infarction, or stroke) between groups (PTA 8.7% vs. atherectomy 5.4%, P=.53). PTA required more balloons (2.0±0.8 vs. 0.7±1.0, P<.001) and stents (1.5±0.8 vs. 0.2±0.5, P<.001), but fewer atherectomy catheters (0.0±0.0 vs. 1.2±0.4, P<.001). Neither procedural supply costs (PTA $3137±1459 vs. atherectomy $3338±1505, P=.20) nor total costs differed between PTA and atherectomy patients ($10,945±4521 vs. $10,783±3857, P=.42). CONCLUSIONS: Initial outcomes and costs are comparable for femoropopliteal PTA and atherectomy. The choice of reopening strategy should therefore be based on operator experience and anatomic suitability. Further studies are required to determine whether there are differences in long-term outcomes or costs between these approaches.

Current assessment of endovascular therapy for infrainguinal arterial occlusive disease in patients with diabetes.

Endovascular therapy (EVT) has increasingly become the initial clinical option for treatment of lower extremity peripheral arterial disease (PAD), not only for patients with claudication, but also for those with critical limb ischemia. Despite this major clinical practice paradigm shift, the outcomes of EVT for PAD are difficult to evaluate and compare with established surgical benchmarks because of the lack of prospective, randomized trials, incomplete characterization of indications for intervention, mixing of arterial segments and extent of disease treated, the multiplicity of EVT techniques used, the exclusion of early treatment failures, crossover to open bypass during follow-up, and the frequent lack of intermediate and long-term patency and limb salvage rates in life-table format. These data limitations are especially problematic when one tries to assess the outcome of EVT in patients with diabetes. The purpose of the present report is to succinctly review and objectively analyze available data regarding the results of EVT in patients with diabetes.