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Epidural lipomatosis is most frequently seen in patients on chronic steroid treatment. Only twelve cases of idiopathic spinal epidural lipomatosis have been described. In this report we present an additional case of this condition in a middle-aged male presenting with neurogenic claudication.
The clinical description of intermittent claudication due to arterial occlusive disease was made by two French precursors: a veterinary surgeon, Jean-François Bouley, and a neurologist, Jean-Martin Charcot. The subsequent works clarified the aetiology, the investigations and the treatment of this trouble but did not add anything to the initial description.
OBJECTIVES: Reporting the long-term results of subintimal angioplasty (SA) in patients with intermittent claudication (IC). DESIGN: A prospective study. PATIENTS: One hundred and sixteen SA procedures were performed in 104 patients, from February 1997 to January 2000. METHODS: This is a prospective study of patients treated for IC with infrainguinal SA. Primary assisted patency rates were calculated, also on intention to treat basis. Univariate and multivariate Cox regression tests were used to assess whether patency was correlated with co-morbidities, run-off or occlusion length. RESULTS: There was no early mortality. Technical success was achieved in 101 cases (87%). Primary assisted patency rates on intention to treat basis (116 cases) at 6, 12, 36 and 60 months were 69, 62, 57 and 54%, respectively. For successfully recanalized patients (101 cases) these respective numbers are 79, 70, 66 and 64%. Length of occlusion, age and male gender were independent risk factors for reocclusion. CONCLUSIONS: The satisfactory results obtained in the present study are probably due to two main factors. First, the three participating radiologist are highly skilled and experienced. Secondly, a conscientious surveillance was adhered to, so that restenoses could be diagnosed and treated early. SA is a relevant alternative to bypass surgery in patients with disabling IC due to long femoro-popliteal occlusions. It is far less traumatic than conventional vascular reconstructions, complications are few and not serious. Very importantly, SA never interfered with later successful vascular surgery. Therefore, we have adopted SA as the primary treatment for patients with IC when medical treatment alone has not been satisfactory.
OBJECTIVES: To evaluate the sensitivity, specificity, positive and negative predictive value of contrast-enhanced (gadolinium) magnetic resonance imaging (CE-MRA) and colour duplex ultrasound (CDU) of lower limb arteries. DESIGN: Prospective, single centre study. MATERIAL AND METHODS: A consecutive series of 58 patients with intermittent claudication (IC) were examined with CE-MRA and CDU from the infrarenal aorta to the tibio-peroneal trunk with digital subtraction angiography (DSA) as reference. The arterial tree was divided into 15 segments, pooled into three regions; suprainguinal, thigh and knee. Sensitivity, specificity, positive and negative predictive values for significant obstructions were calculated. Cohen Kappa statistics was used to establish agreement between the three methods. RESULTS: The sensitivity (specificity in parentheses) for significant obstructions in the suprainguinal region were 96% (94%) for CE-MRA and 91% (96%) for CDU, in the thigh region 92% (95%) for CE-MRA and 76% (99%) for CDU, and in the knee region 93% (96%) for CE-MRA and 33% (98%) for CDU. CDU failed to visualize 10% of suprainguinal, 2% of thigh and 13% of knee-region arterial segments. CONCLUSIONS: Both CE-MRA and CDU are good alternatives to DSA in the suprainguinal- and thigh-region. In the knee region only CE-MRA can be relied upon as an alternative to DSA. Imaging by CDU is not suited to situations were evaluation of runoff vessels is important.
This article reports an observational study investigating the safety and effectiveness of a high-intensity interval exercise program for patients with peripheral arterial disease. Patients were asked to walk on a treadmill to maximal claudication pain six times in each exercise session, with 3-minute rests in between. Once a patient could walk continuously for 6 minutes without reaching maximal pain, speed and/or grade was increased. To account for the changes in speed and grade, patients' walking ability was measured as a rehabilitation score, calculated as the product of the two. A total of 47 patients were included in the study. Results showed overall improvement in the rehabilitation score with participation in the program, and specifically showed that participation in more exercise sessions led to greater improvement. Moreover, no adverse events occurred in the study patients, suggesting patients with peripheral arterial disease can safely tolerate high-intensity exercise programs.
OBJECTIVE: Family history is an independent risk factor for premature acute myocardial infarction; in contrast, familial risk for peripheral arterial disease (PAD) has yet to be determined. Elevated levels of hemostatic proteins are consistently predictive for cardiovascular risk in "healthy" subjects, and may cluster with underlying insulin resistance. Atherothrombotic risk factor clustering occurs in first-degree relatives of subjects with coronary artery disease and type 2 diabetes. These may contribute to the enhanced cardiovascular risk in these subjects, and we hypothesised that familial clustering may occur in PAD. The objective of this study was to measure atherothrombotic risk factors in healthy male first-degree relatives of men with intermittent claudication, with emphasis on thrombotic risk. METHODS: One hundred sixty-five healthy male first-degree relatives were compared with control subjects matched for age, sex, and race (n = 165), free from a personal or family history of premature cardiovascular disease. Primary outcome measures were fibrinogen, von Willebrand factor, factor VII clotting activity (FVII:C), and factor XIII levels. Atherosclerotic risk factors were measured, and subjects were genotyped for common functional polymorphisms (factor VII r353q and fibrinogen B beta-455). RESULTS: Relatives had higher mean levels of fibrinogen (3.04 vs 2.89 g/L; P = .021), FVII:C (117% vs 104%; P = .000), factor XIII B subunit (1.11 vs 1.01 IU/mL; P = .000), and complex (A 2 B 2 ; 1.18 vs 1.11 IU/mL; P = .021). At multivariate analysis the association between relative status and fibrinogen, FVII:C, and factor XIII B subunit levels were independent of other variables. CONCLUSIONS: The healthy male relatives of men with PAD have elevated levels of fibrinogen, factor VII, and factor XIII. Our results support the existence of thrombotic risk factor clustering in this population at "high risk."
OBJECTIVE: To determine the perioperative mortality, myocardial infarction rate, and long-term survival of patients with critical limb ischemia (CLI) compared with those with intermittent claudication (IC) within a cohort selected for significant coronary artery disease, a secondary analysis was conducted of a prospective, randomized, multicenter trial of Coronary Artery Revascularization Prophylaxis (CARP) before peripheral vascular surgery. This multicenter trial was sponsored by the Cooperative Studies Program of the Department of Veterans Affairs. METHODS: Of the 510 patients enrolled in the CARP trial and randomized to coronary revascularization or no revascularization before elective vascular surgery, 143 had CLI and 164 had IC as an indication for lower limb revascularization; >95% of each group were men. The presence of coronary artery disease was determined by cardiac catheterization. Eligible patients had at least one treatable coronary lesion of > or =70%. Those with significant left main disease, ejection fraction of <20%, and aortic stenosis were excluded. Patients were randomized to coronary artery disease revascularization or no revascularization before vascular surgery and followed for mortality and morbidity perioperatively and for a median of 2.7 years postoperatively. Medical treatment of coronary artery disease was pursued aggressively. RESULTS: Patients with IC had a longer time from randomization to vascular surgery (p = .001) and more abdominal operations (p < .001). Patients with CLI had more urgent operations (p = .006), reoperations (p < .001), and limb loss (p = .008) as well as longer hospital stays (p < .001). The IC group had more perioperative myocardial infarctions (CLI, 8.4%; IC, 17.1%; p = .024), although perioperative mortality was similar (CLI, 3.5%; IC, 1.8%; p = .360). In follow-up, the IC group also had numerically more myocardial infarctions (CLI, 16.8%; IC, 25%; p = .079), but mortality was not different (CLI, 21%; IC, 22%; p = .825). Coronary artery revascularization did not lower perioperative or long-term mortality in either group. CONCLUSIONS: Our data indicate that patients with significant coronary artery disease and either CLI or IC can undergo vascular surgery with low mortality and morbidity, and these results are not improved by coronary artery revascularization before vascular surgery. Furthermore, when selected for the presence of symptomatically stable, severe coronary artery disease, there is no difference in long-term survival between patients with CLI and IC. Finally, the better-than-predicted outcomes for these patients with advanced systemic atherosclerosis may be due to aggressive medical management with beta-blockers, statins, and acetylsalicylic acid.
OBJECTIVE: This study was conducted to detail the early experience after infrainguinal atherectomy using the Silverhawk plaque excision catheter for the treatment of symptomatic peripheral vascular disease. METHODS: A prospective database was established in August 2004 in which data for operations, outcomes, and follow-up were recorded for patients undergoing percutaneous plaque excision for peripheral arterial occlusive disease. Society for Vascular Surgery (SVS) ischemia scores and femoropopliteal TransAtlantic Inter-Society Consensus (TASC) criteria were assigned. A follow-up protocol included duplex ultrasound surveillance at 1, 3, and 6 months and then yearly thereafter. Standard statistical analyses were performed. RESULTS: During a 17-month period, 66 limbs of 60 patients (37 men [61.7%]) underwent 70 plaque excisions (four repeat procedures). Indications included tissue loss based on SVS ischemia at grades 5 and 6 (25/70), rest pain at grade 4 (22/70), and claudication at grades 2 to 3 (23/70). The mean lesion length was 8.8 +/- 0.7 cm. The technical success rate was 87.1% (61/70). Adjunctive treatment was required in 17 procedures (24.3%), consisting of 14 balloon angioplasties and three stents. Femoropopliteal TASC criteria included 5 TASC A lesions, 14 TASC B lesions, 32 TASC C lesions, and 19 TASC D lesions. Although 17 plaque excisions included a tibial vessel, no patient underwent isolated tibial atherectomy. The mean increase in ankle-brachial index was 0.27 +/- 0.04 and in toe pressure, 20.3 +/- 6.9 mm Hg. Mean duplex ultrasound follow-up was 5.2 months (range, 1 to 17 months). One-year primary, primary assisted, and secondary patency was 61.7%, 64.1%, and 76.4%, respectively. Restenosis or occlusion developed in 12 patients (16.7%) and was detected at a mean of 2.8 +/- 0.7 months. Restenosis or occlusion was significantly more common (P < .05) in patients with TASC C and D lesions compared with patients with TASC A and B lesions. Six (8.3%) of 12 patients underwent reintervention on the basis of duplex ultrasound surveillance results. Four (33.3%) of 12 patients experienced reocclusion during the same hospitalization, and amputation and open revascularization were required in two patients each. CONCLUSIONS: Percutaneous plaque excision is a viable treatment option for lower extremity revascularization. Outcomes are related to ischemia and lesion severity. Patency and limb salvage rates are equivalent to other endovascular modalities.
INTRODUCTION: We have developed an in vivo experimental model for evaluating peripheral arterial insufficiency and predicting the efficacy of drugs on intermittent claudication (IC). We found that rats that had been running normally on a treadmill developed a gait disturbance when a hindlimb artery was unilaterally occluded. We hypothesized that the distance run before gait disturbance developed (DGD) in rats with occlusion of a hindlimb artery might be an appropriate index of the severity of peripheral insufficiency, and that the model might serve as a test bed for evaluating drug efficacy. To prove this hypothesis, we examined whether DGD was determined by severity of hindlimb ischemia. Furthermore, we also examined whether cilostazol, which has been proved to have ameliorative effects in patients with IC, increased DGD. METHODS: To vary the severity of ischemia, either the superficial femoral artery, the distal portion of the iliac artery, or the proximal portion of iliac artery was unilaterally occluded. After a recovery period, these rats were subjected to a treadmill test (15 m/min and 15% incline) to determine DGD and examine the effect of cilostazol on DGD. RESULTS: DGD was the longest and shortest in rats with superficial femoral artery and proximal portion of iliac artery occlusion, respectively. Intermediate DGD was observed in rats with distal portion of iliac artery occlusion. These data suggest that DGD is correlated with the severity of hindlimb ischemia. Two weeks or longer administration of cilostazol 30 and 100 mg/kg twice a day evoked a significant increase in DGD. DISCUSSION: Peripheral arterial insufficiency and its modulation by drugs can be evaluated in rats with unilateral hindlimb artery occlusion, on a treadmill, by measuring DGD.
Intermittent claudication (IC), most often characterized by a reproducible, painful aching or cramping in muscle groups of the leg caused by walking and relieved by rest, is a common, lifestyle-limiting symptom of lower-extremity peripheral arterial occlusive disease. Because IC is usually indicative of systemic atherosclerosis, active investigation and treatment are recommended. Positive outcomes have been shown with a treatment regimen including risk-factor modification, particularly smoking cessation and control of diabetes, exercise, and pharmacotherapy. Pentoxifylline has been used since 1984 for the treatment of IC with indifferent results. Recently, clinical trials with cilostazol, a drug approved for use in the United States, have shown significant effectiveness in IC patients, generally doubling their maximal walking distance at 24 weeks of treatment. Cilostazol has also been shown to be significantly more effective than pentoxifylline in improving pain-free and maximal walking distance. Other classes of drugs, such as platelet antiaggregants, are being studied for the treatment of IC, but little efficacy has been shown. Arterial revascularization by endovascular or surgical methods is an additional option but must be considered on an individual basis depending on severity of symptoms and disability in each patient.
The long-term safety and efficacy of adenoviral delivery of growth factors in patients with peripheral arterial disease (PAD) is unknown. CI-1023 (Ad(GV)VEGF(121.10)) is a replication-deficient adenovirus encoding human vascular endothelial growth factor isoform 121. In this phase I trial, we investigated the safety and efficacy of CI-1023 in subjects with advanced claudication symptoms secondary to infra-inguinal disease. Eighteen subjects >35 years of age with a median ankle brachial index (ABI) at rest of 0.525 (interquartile range 0.4) and angiographic disease involving the infra-inguinal vessels underwent intramuscular injection of CI-1023 (4 x10(8) to 4 x10(10) particle units, n = 15) or placebo (n = 3). Eleven of 15 patients (73%) who received CI-1023 and 1 of 3 subjects (33%) who received placebo, completed 1 year of follow-up. Edema and rash were the most common early adverse event. One infra-inguinal bypass procedure occurred in each of the placebo and CI-1023 groups at days 29 and 104, respectively. One death (day 160) and 1 malignancy (day 274) occurred in the CI-1023 group. Conclusions on efficacy could not be made due to the small number of patients. However, there were encouraging trends in ABI at rest and peak walking time at follow-up.
A double-blind, dose titration study was designed to assess the efficacy of propionyl-L-carnitine in intermittent claudication. The effect on walking capacity was described in a previous article. This study reports on the effect on quality of life, assessed by the McMaster Health Index Questionnaire (MHIQ). After 24 weeks of treatment, the global MHIQ score did not show any difference from baseline in patients randomized to placebo (n = 102). Conversely, it increased from 0.59 +/- 0.12 to 0.64 +/- 0.12 in those taking propionyl-L-carnitine (n = 85). Analysis of variance showed a significant difference between treatments (p = 0.018). Stepwise multiple regression analysis identified baseline maximal walking capacity (cutoff point 250 m) as a predictor of treatment outcome. In patients walking < 250 m, propionyl-L-carnitine significantly improved physical function (p = 0.027), emotional function (p = 0.002), and global MHIQ score (p = 0.002) compared with placebo. Also, for maximal walking capacity, group difference significantly favored propionyl-L-carnitine (p = 0.009). In patients with baseline maximal walking capacity > or = 250 m, propionyl-L-carnitine did not affect the MHIQ scores, nor improve walking performance. These data indicate that propionyl-L-carnitine exerts beneficial effects on quality of life and walking performance in patients with more severely limited walking capacity.
PURPOSE: We performed a long-term, multicenter, randomized, double-blind trial to evaluate the efficacy and tolerability of low-dose, subcutaneous calcium-heparin (12,500 IU/day) in comparison with placebo in patients with stable peripheral arterial disease of the lower extremities. PATIENTS AND METHODS: At the end of a 2-week washout period, during which aspirin placebo was given, 201 patients were randomly assigned to receive either subcutaneous calcium-heparin or placebo for two 3-month treatment periods, each of which was followed by a 6-month period of observation. All of the patients were given low-dose aspirin (50 mg/day) throughout the 18-month study. The main efficacy variables were pain-free and maximum walking time (by standard treadmill test). Patients answered a questionnaire about pain and the limitation of daily activities. Results were analyzed by intention-to-treat. RESULTS: At the end of the study, the estimated increase in pain-free walking time was 39% in the heparin group and 23% in the placebo group (P = 0.09). The estimated increase in maximum walking time was 40% in the heparin group and 16% in the placebo group (P = 0.05). Patients treated with heparin also reported that they had to stop walking because of leg pain, or had daily activities limited by leg pain, less frequently than the placebo group (P <0.01). CONCLUSIONS: Treatment with low-dose subcutaneous calcium-heparin is safe and effective in improving walking performance and reducing physical disability in patients with stable peripheral arterial disease and claudication.
A 56-year-old woman with a chief complaint of left lower-extremity numbness was referred by her gynecologist to the physical medicine clinic for workup of presumed lumbosacral radiculopathy. She had no history of low back pain, and her symptoms were elicited only with exercise. Results of her neurologic examination and lumbosacral radiographs were normal. Her medical history was significant for advanced cervical cancer, successfully treated with local surgery followed by high-dose pelvic radiation and chemotherapy 2 years before the current onset of symptoms. Subsequent workup with Doppler and arteriogram studies discovered a 3-cm area of diffuse stenosis of the left external iliac artery for which she was successfully treated with balloon angioplasty. This case presents an unusual cause of left leg claudication secondary to left iliac artery stenosis 2 years after pelvic radiation for cervical cancer and shows the necessity for a detailed evaluation of patients' medical histories.
Cilostazol, a novel oral phosphodiesterase inhibitor, has shown consistent improvement in exercise tolerance in patients with intermittent claudication (IC). In addition to this effect, cilostazol has previously been shown to have beneficial effects on the dyslipidemia, i.e., combination of high triglycerides with low high-density-lipoprotein cholesterol (HDL-C) levels. Interleukin-6 (IL-6) suppresses the activity of lipoprotein lipase, which modulates the metabolism of triglycerides and HDL-C. To determine whether a reduction of IL-6 contributes to the improvement of lipid profiles, we prospectively investigated the effect of cilostazol (n=16, 100 mg, twice daily) on the changes of lipid profiles and on the association with the changes of IL-6 compared with those of pentoxifylline (n=16, 400 mg, bid) in patients with IC. After eight weeks of administration of cilostazol to patients with IC, walking distances were increased, associated with a 29% decrease in plasma triglycerides and a 13% increase in HDL-C. No significant changes of lipid profiles in the pentoxifylline and placebo groups were observed although a similar improvement in walking distances was achieved in the pentoxifylline group. IL-6 levels were significantly reduced in patients receiving cilostazol as compared with those receiving placebo or pentoxifylline. The cilostazol-induced changes in the IL-6 were positively related to those of triglycerides in the cilostazol group (r=0.63, P<0.05) and negatively related to those of HDL-C (r=-0.55, P<0.05). These findings suggest that in addition to consistent improvement of exercise tolerance, cilostazol may improve lipid profiles by reducing IL-6 release. However, pentoxifylline did not affect lipid profiles although a similar improvement of maximal walking distance (MWD) was achieved.
Normovolaemic haemodilution down to a packed-cell volume of 35% was done in 10 patients with stable intermittent claudication. For a mean reducation in the packed-cell volume of 21.5% there was a 170% increase in peak calf blood-flow and a 111% increase in haemoglobin delivery. 7 of the 10 patients reported an increased walking distance. Normovolaemic haemodilution may be of use in the management of some patients with peripheral vascular disease.
The effects of ketanserin, a serotonin antagonist, were studied in 37 patients with intermittent claudication in a double-blind placebo-controlled, trial done in London and Leuven. 40 mg ketanserin taken orally three times a day for 4 months was associated with a clear-cut inhibition of serotonin-induced platelet aggregation but no changes were observed in pain-free and maximum walking distance on a treadmill, in ankle/arm Doppler systolic blood pressure ratio, or in reactive hyperaemia after 3 min of ischaemia. In contrast, the placebo group had increases in both pain-free and maximum walking distance (p less than 0.05).
OBJECTIVE: The purpose of this study was the prospective comparison of functional outcomes after lower extremity bypass grafting surgery, angioplasty, or medical management of intermittent claudication. METHODS: The study was designed as a prospective cohort study to compare functional outcomes for patients with interventional management to medical management, including a matched (younger, with more disability) subgroup, followed for a mean of 19 months. Sixteen Chicago-area vascular surgery clinics participated in the study. The subjects were consecutively enrolled patients with an abnormal ankle-brachial blood pressure index (ABI), without signs of rest pain, ulcer, or gangrene, and without prior lower extremity revascularization procedures. The main outcome measures were changes in physical functioning, community walking distance, bodily pain, leg symptoms, and ABI. RESULTS: Of the 526 study patients, 20% underwent revascularization procedures (60 surgical bypass grafting and 44 angioplasty only). The mean ABI improved significantly for the patients who underwent bypass grafting surgery (0.20; P <.001) and modestly for the patients who underwent angioplasty (0.09; P <. 05). Patients undergoing bypass grafting and angioplasty maintained highly significant (P <.001) improvements in mean physical functioning, (17%, 14%), bodily pain (18%, 13%), and walking distance (28%, 27%) scores and reported greater leg symptom improvement. The results were far superior for the patients with greater improvement in ABI. The conditions of the 277 unmatched patients who underwent medical management declined on all outcome measures, and the conditions of the 145 matched patients who underwent medical management improved 5% (P <.001) on walking distance score. Eighteen percent of the study patients failed to complete the full study follow-up period. CONCLUSION: Most of the functional improvement achieved by patients who underwent interventional management appears to be related to improved patency rather than to selection bias or placebo effects. The functional gains were approximately half those often reported for patients for hip arthroplasty and similar to patients who undergo elective coronary angioplasty.