Endovascular Approach Versus Aortobifemoral Bypass Grafting: Outcomes in Extensive Aortoiliac Occlusive Disease.

OBJECTIVE: Compare technical, clinical, and economic outcomes between endovascular and open approaches in patients with type D aortoiliac occlusive disease according to the TransAtlantic Inter-Society Consensus. METHODS: Patients undergoing revascularization for type D aortoiliac lesions, either endovascular or open surgery approach, from 2 Portuguese institutions between January 2011 and October 2017 were included. The surgical technique was left to the surgeon discretion. Patients with common femoral artery affection, both obstructive and aneurysmatic, were excluded. RESULTS: Twenty-seven patients underwent aortobifemoral bypass and 32 patients were submitted to endovascular repair. The patients undergoing endovascular procedure were more likely to present with chronic heart failure (P = .001) and chronic kidney disease (P = .022) and less likely to have a history of smoking (P = .05). The mean follow-up period was 67.84 (95% confidence interval = 61.85-73.83) months. The open surgery approach resulted in a higher technical success (P = .001); however, limb salvage and patency rates were not different between groups. Endovascular approach was associated with a shorter length-of-stay, both inpatient (6 vs 9 days; P = .041) and patients admitted in the intensive care unit (0 vs 3.81 days; P = .001) as well as lower hospital expenses (US$9281 vs US$23 038; P = .001) with a similar procedure cost (US$2316 vs US$1173; P = .6). No differences were found in the postsurgical quality of life. CONCLUSION: Endovascular approach is, at least, clinically equivalent to open surgery approach and is more cost-efficient. The "endovascular-first" approach should be considered for type D occlusive aortoiliac lesions.

The Consequences of Negligence Claims in Arterial Surgery - An Analysis of Two Periods with an Increasing Use of Endovascular Treatment.

OBJECTIVES: Patient treatment within the Swedish medical service system can claim negligence injuries to the malpractice insurance review board and request financial compensation. The aim of this paper was to analyse the consequences of a negligence claim after arterial surgery between two periods with increasing use of endovascular treatment. METHODS: This was a retrospective cohort study of the arterial surgery negligence claims from two three year periods 2005-2007 (Period A) and 2012-2014 (Period B) from the County Council's Mutual Insurance Company. The analysis was restricted to aortic, carotid, and lower limb arterial diseases. The magnitude of surgery for vascular diseases was obtained from the Swedish vascular register (Swedvasc). RESULTS: The number of patients undergoing arterial procedures increased from 16 628 to 20 709 (p = .01). There was an increase of 54% in the number of negligence claims between the periods. In Period A, the number of compensated claims was 22 out of 83 (29%) and in Period B 60 out of 151 (41%) (p = .06). Patients treated for aortic disorders and peripheral arterial surgery received compensation with increasing frequency whereas carotid diseases decreased. Claimants treated for aortic disorders were compensated in four out of 23 (17%) and 21 out of 54 (39%) in the two periods (p = .07), and after lower limb arterial surgery in six out of 34 (18%) and in 24 out of 71 (34%) (p = .09). After carotid surgery the corresponding figures were 12 out of 26 (46%) and 14 out of 25 (46%) (p = .48). The increasing use of endovascular procedures (but not in carotid artery surgery) did not seem to influence the pattern of negligence claims. CONCLUSIONS: Between the two three year periods there has been an increase in negligence claims but not in compensated ones. The increased use of endovascular procedures has not influenced the pattern of compensated negligence claims.

[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.

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.

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.

Comparison of transperitoneal and retroperitoneal approach in aorto iliac occlusive disease.

INTRODUCTION: Despite the fact that the transperitoneal approach (TP) is most widely accepted approach to the aortic surgery because it is simple, fast, and provides good exposure of the abdominal cavity and vascular structures, lately have been increasingly advocated as an alternative retroperitoneal (RP) approach in order to avoid entering peritoneal sac, achieving lower physiological trauma and faster establishment of gastrointestinal function. OBJECTIVE: The aim of this study was to compare the basic peri and postoperative results of TP and RP approaches in the surgical treatment of AIOD. PATIENTS AND METHODS: The study included 114 patients with aortoiliac occlusive disease (AIOD) that underwent surgical treatment at the Department of Vascular Surgery, Clinical Center University of Sarajevo from January 2010 until December 2012 year. In view of the surgical technique used subjects were divided into two groups. Group A consisted of 57 patients on who had been used RP approach, and group B 57 subjects with TP used approach. RESULTS: In patients from group A were observed significantly lower values: the length of operation (201.66 +/- 43.9 minute vs. 267.36 +/- 47.57 min, p < 0.001), amount of postoperative drainage (56.14 +/- 55.5 ml versus 130.71 +/- 92.34 ml, p < 0.001), length of stay in the intensive care unit (ICU) (1.10 +/- 0.36 days versus 2.46 +/- 1.25 days, p < 0.001), time required for the restoration of gastrointestinal motility (4.38 +/- 5.59 versus 1.05 days +/- 1.19 days, p < 0.001), length of hospitalization (9.26 +/- 1, 95 +/- 11 days versus 1.96 days, p < 0.001), costs of hospitalization (2394.98 +/- BAM 346.67 versus 2933.72 +/- 428.10 BAM, p < 0.001). Analysis of the incidence of postoperative complications (8 vs. 7 complication complications, p > 0.05) and mortality (3 versus 3, p > 0.05) showed no statistically significant difference between the analyzed groups. CONCLUSION: RP approach in vascular reconstructive surgery in AIOD offers better postoperative results when compared to TP approach.

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.

The impact of socioeconomic factors on outcome and hospital costs associated with femoropopliteal revascularization.

INTRODUCTION: Within the context of healthcare system reform, the cost efficacy of lower extremity revascularization remains a timely topic. The impact of an individual patient's socioeconomic status represents an under-studied aspect of vascular care, especially with respect to longitudinal costs and outcomes. The purpose of this study is to examine the relationship between socioeconomic status and clinical outcomes as well as inpatient hospital costs. METHODS: A retrospective femoropopliteal revascularization database, which included socioeconomic factors (household income, education level, and payor status), in addition to standard demographic, clinical, anatomical, and procedural variables were analyzed over a 3-year period. Patients were stratified by income level (low income [LI] <200% federal poverty level [$42,400 for a household of 4], and higher income [HI] >200% federal poverty level) and revascularization technique (open vs endovascular) and analyzed for the endpoints of primary assisted patency, amortized cost-per-day of patency, and limb salvage. Data were analyzed with univariate and multivariate techniques. RESULTS: A total of 187 cases were identified with complete data for analysis, 146 in the LI and 41 in the HI cohorts. LI patients differed from HI patients by mean age (66.2 +/- 1.0 vs 61.8 +/- 1.5 years, P = .04), high school graduate rate (51.4% vs 85.4%, P < .001), presence of tissue loss (30.1% vs 14.6%, P = .05), female gender (43.7% vs 22.0%, P = .01) and preoperative statin use (45.8% vs 75.6%, P < .001). There were no differences with respect to other comorbidities including smoking status, presence of diabetes, renal insufficiency, anatomic factors or treatment modality (open vs endovascular). Ninety-seven patients underwent endovascular revascularization. The following outcomes were noted in the endovascular subset of LI and HI patients respectively: primary assisted patency (66% vs 71%, P = NS) and 12-month cost-per-day of patency ($166.30 +/- 77.40 vs $22.45 +/- 12.45, P = .05). Ninety-eight patients underwent open revascularization, with the following outcomes in LI and HI patients respectively: primary assisted patency (78% vs 86%, P = NS) and 12-month cost-per-day of patency ($319.43 +/- 225.44 vs $40.47 +/- 4.63, P = .07). Of the 77 patients with critical limb ischemia, 19 underwent eventual amputation. Multivariate analysis demonstrated that income above 100% of the federal poverty line was protective against limb loss (odds ratio 0.06, 95% confidence interval 0.01-0.51, P < .001). CONCLUSION: Income level correlates with advanced presentation, advanced age, and lack of statin use. Although primary assisted patency rate is not affected by income status, an increased cost-per-day of patency and inferior limb salvage is found in lower income patients.

Are drug-eluting stents the future of SFA treatment?

Drug-eluting stent (DES) technology was developed to prevent early thrombosis and late luminal loss to potentially improve long-term patency rates. Although favorable DES results have recently become available with the Zilver PTX and STRIDES studies, the high price of DES is a major drawback for this technology to become the golden standard for peripheral endovascular therapy in de novo femoro-popliteal (FP) lesions. Nevertheless, DES has the potential to make the difference and to establish itself as an important treatment option in patients presenting with TASC C&D FP lesions who are at high-risk for surgery and for the treatment of in-stent restenosis, where until now, no valuable treatment option has proven to be beneficial.

Are bio-absorbable stents the future of SFA treatment?

Several limitations inherent to the implantation of a metallic device, such as the occurrence of in-stent re-stenosis, in an arterial lumen intuitively explain the interest for developing bio-absorbable stents. Two main types of bio-absorbable stents currently exist: polymer stents and metallic stents. To date, no studies with bio-absorbable stents have been conducted in the superficial femoral artery (SFA). Because of their strut thickness and lack of radial force, polymer stents are no good candidates for endovascular use. Absorbable metal stents (AMS) do have the potential to perform well for artery treatment, although current evidence from in-human coronary and infrapopliteal studies yield unsatisfactory results. Drastic technological improvements are mandatory before AMS can be considered for every day practice. Yet, it is our belief that further development of other metal and non-metal bio-absorbable stents, with or without drug-coating, may lead to the creation of the ultimate SFA stent.

[Intravascular brachytherapy for peripheral arterial occlusive disease: systematic review of medical efficacy and health economic modelling]. / Intravaskuläre Brachytherapie bei peripherer arterieller Verschlusskrankheit: Systematische Ubersicht zur medizinischen Wirksamkeit und gesundheitsökonomische Modellierung.

CONTEXT: Percutaneous transluminal angioplasties (PTA) using balloon dilatation with or without stenting are performed to treat peripheral arterial occlusive disease (PAOD). Intravascular brachytherapy (IB) after PTA promises to reduce the restenosis rates. The present article addresses questions concerning medical efficacy and cost-effectiveness of IB in PAOD patients. METHODS: A systematic literature search for randomized controlled studies evaluating IB in PAOD was conducted in August 2007. Information synthesis was conducted using meta-analysis. Health economic modelling was performed on the basis of clinical assumptions derived from the meta-analysis and economical assumptions derived from the German Diagnosis Related Groups (G-DRG) 2007. RESULTS: Twelve publications covering seven studies about IB vs. no IB were included in the evaluation. IB after successful balloon dilatation showed a significant reduction in the rate of restenosis at six and/or twelve months (relative risk 0.62; 95% confidence interval: 0.46 to 0.84) and a significant delay in the time to recurrence of restenosis (17.5 vs. 7.4 months, p < 0.01). IB after stenting did not lead to significant results regarding the restenosis rates, but was more often associated with early and late occlusive thromboses. The incremental cost-effectiveness ratio per restenosis avoided for IB vs. no IB after successful balloon dilatation was--depending on the G-DRG used-Euro 8,484 and Euro 9,058, respectively. In the comparison of IB vs. no IB after stenting IB was demonstrated to be inferior to no IB. CONCLUSIONS: IB after successful balloon dilatation in PAOD can be recommended from a medical point of view. From the health economic perspective the answer is not yet clear. IB after stenting in PAOD cannot be recommended.

Tibial angioplasty for limb salvage in high-risk patients and cost analysis.

BACKGROUND: We examined the efficacy and cost of tibial angioplasty in patients with critical limb ischemia (CLI) at high operative risk. METHODS: A retrospective analysis of all consecutive patients who underwent tibial angioplasty with critical ischemia Rutherford class 4 and 5 from January 2001 to April 2007 was performed. Demographic information, presentation, and angiographic characteristics of the lesions were analyzed. The primary end point was freedom from major amputation. Secondary end points were overall survival and recurrence. Cost comparison was performed between the endovascular group and a matched group of high-risk patients submitted to femoral tibial bypass in the same period. RESULTS: Forty-five patients, with mean age of 69.6 years and a 2.5:1 (male:female) ratio, had 49 limbs treated. The mean follow-up was 7.7 months (range 1-61.5). Eighty percent of the patients were Rutherford class 5. Incidence rates were as follows: diabetes 90%, chronic renal failure 73%, end-stage renal disease (ESRD) on hemodialysis 45%, and coronary disease 69%. Single vessel run-off to the foot was present in 57% of patients and complete occlusion of all tibial vessels in 12%. Only the tibial vessels were angioplastied in 55% of patients. Angiographic success rate was 84%. Thirty-day mortality was 2% and major complications occurred in 6.1%. A poor angiographic result was a statistically significant predictor (p = 0.009) of symptomatic recurrence (43%) (worsening of preexisting symptoms and/or signs or new ones). Cardiac disease was the major cause of mortality beyond 30 days (12.5%). Freedom from major amputation in the entire group was 75.5%, with no difference between tibial and diffuse infrainguinal angioplasty (p = 0.61). Recurrence, especially early recurrence, was a significant predictor of amputation (p = 0.04 and p = 0.0008, respectively). There was a trend toward presence of ESRD and recurrence (p = 0.06). Both average hospital cost ($2,910.60 vs. $17,703.50) and length-of-stay (LOS) (<1 vs. 9 days) were significantly reduced in the angioplasty group (p < 0.0001). CONCLUSION: Tibial angioplasty has acceptable rates of limb salvage in patients with CLI considered to be at high risk for surgery, despite high recurrence rates. The presence of diabetes or ESRD did not reduce the rate of success in this series, although ESRD seemed to predict recurrence. The procedure has low morbidity and mortality with lower cost and LOS compared with open revascularization. Aggressive angioplasty should be an option to patients who otherwise would face primary amputation.

Characterizing structural uncertainty in decision analytic models: a review and application of methods.

BACKGROUND: The characterization of uncertainty is critical in cost-effectiveness analysis, particularly when considering whether additional evidence is needed. In addition to parameter and methodological uncertainty, there are other sources of uncertainty which include simplifications and scientific judgments that have to be made when constructing and interpreting a model of any sort. These have been classified in a number of different ways but can be referred to collectively as structural uncertainties. MATERIALS AND METHODS: Separate reviews were undertaken to identify what forms these other sources of uncertainty take and what other forms of potential methods to explicitly characterize these types of uncertainties in decision analytic models. These methods were demonstrated through application to four decision models each representing one of the four types of uncertainty. RESULTS: These sources of uncertainty fall into four general themes: 1) inclusion of relevant comparators; 2) inclusion of relevant events; 3) alternative statistical estimation methods; and 4) clinical uncertainty.Two methods to explicitly characterize such uncertainties were identified: model selection and model averaging. In addition, an alternative approach, adding uncertain parameters to represent the source of uncertainty was also considered.The applications demonstrate that cost-effectiveness may be sensitive to these uncertainties and the methods used to characterize them. The value of research was particularly sensitive to these uncertainties and the methods used to characterize it. It is therefore important, for decision-making purposes, to incorporate such uncertainties into the modeling process. CONCLUSION: Only parameterizing the uncertainty directly in the model can inform the decision to conduct further research to resolve this source of uncertainty.

[Fast track in vascular surgery]. / Fast Track in der Gefässchirurgie.

Vascular comorbidities are common in vascular surgery, being associated with perioperative complications. Since it was demonstrated that the postoperative course could be optimized by introduction of the fast track concept in general surgery, application to vascular surgery may also be of benefit. The fast track concept was introduced in our institution on May 1st 2008 with special adjustments for vascular surgery. The authors describe the development and implementation of a clinical pathway, which proved to be of value in vascular surgery.

Nonoperative active management of critical limb ischemia: initial experience using a sequential compression biomechanical device for limb salvage.

Critical limb ischemia (CLI) patients are at high risk of primary amputation. Using a sequential compression biomechanical device (SCBD) represents a nonoperative option in threatened limbs. We aimed to determine the outcome of using SCBD in amputation-bound nonreconstructable CLI patients regarding limb salvage and 90-day mortality. Thirty-five patients with 39 critically ischemic limbs (rest pain = 12, tissue loss = 27) presented over 24 months. Thirty patients had nonreconstructable arterial outflow vessels, and five were inoperable owing to severe comorbidity scores. All were Rutherford classification 4 or 5 with multilevel disease. All underwent a 12-week treatment protocol and received the best medical treatment. The mean follow-up was 10 months (SD +/- 6 months). There were four amputations, with an 18-month cumulative limb salvage rate of 88% (standard error [SE] +/- 7.62%). Ninety-day mortality was zero. Mean toe pressures increased from 38.2 to 67 mm Hg (SD +/- 33.7, 95% confidence interval [CI] 55-79). Popliteal artery flow velocity increased from 45 to 47.9 cm/s (95% CI 35.9-59.7). Cumulative survival at 12 months was 81.2% (SE +/- 11.1) for SCBD, compared with 69.2% in the control group (SE +/- 12.8%) (p = .4, hazards ratio = 0.58, 95% CI 0.15-2.32). The mean total cost of primary amputation per patient is euro29,815 ($44,000) in comparison with euro13,900 ($20,515) for SCBD patients. SCBD enhances limb salvage and reduces length of hospital stay, nonoperatively, in patients with nonreconstructable vessels.

Treatment for peripheral arterial obstructive disease: An appraisal of the economic outcome of complications.

OBJECTIVE: This study determined the average estimated total costs after treatment for peripheral arterial occlusive disease (PAOD) and evaluated the effect of postoperative complications and their consequences for the total costs. METHODS: Cost data on all admissions involving treatment for PAOD from January 2007 until July 2007 were collected. A prospective analysis was made using the patient-related risk factor and comorbidity (Society for Vascular Surgery/International Society of Cardiovascular Surgeons) classification, primary and secondary treatment, and prospectively registered complications. At admission, patients without complications were placed in group A, and those with complications were in group B. Prospectively registered complications were divided into patient management (I), surgical technique (II), patient's disease (III), and outside surgical department (IV). The consequences of these were divided into minor complication, no long-term consequence (1A), additional medication or transfusion (1B), surgical reoperation (2A), prolonged hospital stay (2B), irreversible physical damage (3), and death (4). The main outcome measures were total costs of patients and costs per patient (PP), with or without the presence of complications, cost of complications and costs per complication (PC), and the costs of their consequences calculated in euros (euro). RESULTS: Ninety patients (mean age, 71.4 years; 59% men) were included. Group B patients had a significantly higher American Society of Anesthesiologists (4) and Fontaine (3) classification and more secondary procedures. Total costs were euro 1,716,852: group A, euro 512,811 (PP euro 12,820); and group B, euro 1,204,042 (PP euro 24,081). The costs of the 115 complications were euro 568,500 (PC euro 4943). Split by the cause of the complication, costs were I, euro 95,924 (PC euro 2998); II, euro 163,137 (PC euro 8157); III, euro 289,578 (PC euro 5171); and IV, euro 19,861 (PC euro 2837). The increase of costs in group B was mainly caused by additional medication or transfusion (1B) euro 348,293 (61.3%), a surgical reoperation (2A) euro 118,054 (20.8%), or prolonged hospital stay (2B) euro 60,451 (10.6%). Patients who died caused 23% of the total costs. CONCLUSION: Complications cause an increase of the average estimated total costs in the treatment for peripheral arterial occlusive disease and are responsible for 33% of these total costs. The most expensive complications were errors in surgical technique and patient's disease, resulting in surgical reoperation or additional medication, or both, or transfusion, the two most expensive consequences.

Endovascular treatment of iliac occlusive disease: review and update.

Use of endovascular interventions for arterial occlusive lesions continues to increase. With the evolution of the technology supporting these therapeutic measures, the results of these interventions continue to improve. In general, a comparison of techniques for revascularization of iliac occlusive diseases shows similar initial technical success rates for open versus percutaneous transluminal angioplasty. Angioplasty is often associated with lower periprocedural morbidity and mortality rates. Conversely, surgery frequently provides greater long-term patency, although late failure of percutaneous therapies may occur but still can be treated successfully with reintervention. The perpetual buildup of experience with angioplasty and stenting will eventually characterize its role in the management of occlusive disease. This review outlines the current consensus and applicability of endovascular management of iliac occlusive diseases.