Cost Effectiveness of Endovascular Revascularisation vs. Exercise Therapy for Intermittent Claudication Due to Iliac Artery Obstruction.

OBJECTIVE: To compare cost effectiveness of endovascular revascularisation (ER) and supervised exercise therapy (SET) as primary treatment for patients with intermittent claudication (IC) due to iliac artery obstruction. METHODS: Cost utility analysis from a restricted societal perspective and time horizon of 12 months. Patients were included in a multicentre randomised controlled trial (SUPER study, NCT01385774, NTR2648) which compared effectiveness of ER and SET. Health status and health related quality of life (HRQOL) were measured using the Euroqol 5 dimensions 3 levels (EQ5D-3L) and VascuQol-25-NL. Incremental costs were determined per allocated treatment and use of healthcare during follow up. Effectiveness of treatment was determined in quality adjusted life years (QALYs). The difference between treatment groups was calculated by an incremental cost utility ratio (ICER). RESULTS: Some 240 patients were included, and complete follow up was available for 206 patients (ER 111 , SET 95). The mean costs for patients allocated to ER were €4 031 and €2 179 for SET, a mean difference of €1 852 (95% bias corrected and accelerated [bca] bootstrap confidence interval 1 185 - 2 646). The difference in QALYs during follow up was 0.09 (95% bcaCI 0.04 - 0.13) in favour of ER. The ICER per QALY was €20 805 (95% bcaCI 11 053 - 45 561). The difference in VascuQol sumscore was 0.64 (95% bcaCI 0.39 - 0.91), again in favour of ER. CONCLUSION: ER as a primary treatment, results in slightly better health outcome and higher QALYs and HRQOL during 12 months of follow up. Although these differences are statistically significant, clinical relevance must be discussed due to the small differences and relatively high cost of ER as primary treatment.

Editor's Choice - Randomised Clinical Trial of Supervised Exercise Therapy vs. Endovascular Revascularisation for Intermittent Claudication Caused by Iliac Artery Obstruction: The SUPER study.

OBJECTIVE: International guidelines recommend supervised exercise therapy (SET) as primary treatment for all patients with intermittent claudication (IC), yet primary endovascular revascularisation (ER) might be more effective in patients with iliac artery obstruction. METHODS: This was a multicentre RCT including patients with IC caused by iliac artery stenosis or occlusion (NCT01385774). Patients were allocated randomly to SET or ER stratified for maximum walking distance (MWD) and concomitant SFA disease. Primary endpoints were MWD on a treadmill (3.2 km/h, 10% incline) and disease specific quality of life (VascuQol) after one year. Additional interventions during a mean follow up of 5.5 years were recorded. RESULTS: Between November 2010 and May 2015, 114 patients were allocated to SET, and 126 to ER. The trial was terminated prematurely after 240 patients were included. Compliance with SET was 57/114 (50%) after six months. Ten patients allocated to ER (8%) did not receive this intervention. One year follow up was complete for 90/114 (79%) SET patients and for 104/126 (83%) ER patients. The mean MWD improved from 187 to 561 m in SET patients and from 196 to 574 m in ER patients (p = .69). VascuQol sumscore improved from 4.24 to 5.58 in SET patients, and from 4.28 to 5.88 in ER patients (p = .048). Some 33/114 (29%) SET patients had an ER within one year, and 2/114 (2%) surgical revascularisation (SR). Some 10/126 (8%) ER patients had additional ER within one year and 10/126 (8%) SR. After a mean of 5.5 years, 49% of SET patients and 27% of ER patients underwent an additional intervention for IC. CONCLUSION: Taking into account the many limitations of the SUPER study, both a strategy of primary SET and primary ER improve MWD on a treadmill and disease specific Qol of patients with IC caused by an iliac artery obstruction. It seems reasonable to start with SET in these patients and accept a 30% failure rate, which, of course, must be discussed with the patient. Patients continue to have interventions beyond one year.

Estimation of Intraglomerular Pressure Using Invasive Renal Arterial Pressure and Flow Velocity Measurements in Humans.

BACKGROUND: Glomerular hyperfiltration resulting from an elevated intraglomerular pressure (Pglom) is an important cause of CKD, but there is no feasible method to directly assess Pglom in humans. We developed a model to estimate Pglom in patients from combined renal arterial pressure and flow measurements. METHODS: We performed hemodynamic measurements in 34 patients undergoing renal or cardiac angiography under baseline conditions and during hyperemia induced by intrarenal dopamine infusion (30 µg/kg). For each participant during baseline and hyperemia, we fitted an adapted three-element Windkessel model that consisted of characteristic impedance, compliance, afferent resistance, and Pglom. RESULTS: We successfully analyzed data from 28 (82%) patients. Median age was 58 years (IQR, 52-65), median eGFR was 95 ml/min per 1.73 m2 (IQR, 74-100) using the CKD-EPI formula, 30% had microalbuminuria, and 32% had diabetes. The model showed a mean Pglom of 48.0 mm Hg (SD=10.1) at baseline. Under hyperemia, flow increased by 88% (95% CI, 68% to 111%). This resulted in a 165% (95% CI, 79% to 294%) increase in afferent compliance and a 13.1-mm Hg (95% CI, 10.0 to 16.3) decrease in Pglom. In multiple linear regression analysis, diabetes (coefficient, 10.1; 95% CI, 5.1 to 15.1), BMI (0.99 per kg/m2; 95% CI, 0.38 to 1.59), and renal perfusion pressure (0.42 per mm Hg; 95% CI, 0.25 to 0.59) were significantly positively associated with baseline Pglom. CONCLUSIONS: We constructed a model on the basis of proximal renal arterial pressure and flow velocity measurements that provides an overall estimate of glomerular pressure and afferent and efferent resistance in humans. The model provides a novel research technique to evaluate the hemodynamics of CKD on the basis of direct pressure and flow measurements. CLINICAL TRIAL REGISTRY NAME AND REGISTRATION NUMBER: Functional HEmodynamics in patients with and without Renal Artery stenosis (HERA), NL40795.018.12 at the Dutch national trial registry (toetsingonline.nl).

Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 10-year outcomes from the randomized EMMY trial.

BACKGROUND: Since 1995 uterine artery embolization has been described as an alternative for hysterectomy in patients with symptomatic fibroids. Many studies including several randomized controlled trials established uterine artery embolization as a valuable treatment. These randomized controlled trials reported outcomes in terms of health-related quality of life, clinical outcomes, efficacy, and cost-effectiveness after 1, 2, and 5 years of follow-up. OBJECTIVE: The purpose of this study was to compare clinical outcome and health-related quality of life 10 years after uterine artery embolization or hysterectomy in the treatment of heavy menstrual bleeding caused by uterine fibroids in a randomized controlled trial. STUDY DESIGN: In all, 28 Dutch hospitals recruited patients with symptomatic uterine fibroids who were eligible for hysterectomy. Patients were 1:1 randomly assigned to uterine artery embolization or hysterectomy. The outcomes assessed at 10 years postintervention were reintervention rates, health-related quality of life, and patient satisfaction, which were obtained through validated questionnaires. Study outcomes were analyzed according to original treatment assignment (intention to treat). RESULTS: A total of 177 patients were randomized from 2002 through 2004. Eventually 81 uterine artery embolization and 75 hysterectomy patients underwent the allocated treatment shortly after randomization. The remaining patients withdrew from the trial. The 10-year questionnaire was mailed when the last included patient had been treated 10 years earlier. The mean duration of follow-up was 133 months (SD 8.58) accompanied by a mean age of 57 years (SD 4.53). Questionnaires were received from 131 of 156 patients (84%). Ten years after treatment, 5 patients underwent secondary hysterectomy resulting in a total of 28 of 81 (35%) (24/77 [31%] after successful uterine artery embolization). Secondary hysterectomies were performed for persisting symptoms in all cases but 1 (for prolapse). After the initial treatment health-related quality of life improved significantly. After 10 years, generic health-related quality of life remained stable, without differences between both groups. The urogenital distress inventory and the defecation distress inventory showed a decrease in both groups, probably related to increasing age, without significant differences between study arms. Satisfaction in both groups remained comparable. The majority of patients declared being (very) satisfied about the received treatment: 78% of the uterine artery embolization group vs 87% in the hysterectomy group. CONCLUSION: In about two thirds of uterine artery embolization-treated patients with symptomatic uterine fibroids a hysterectomy can be avoided. Health-related quality of life 10 years after uterine artery embolization or hysterectomy remained comparably stable. Uterine artery embolization is a well-documented and less invasive alternative to hysterectomy for symptomatic uterine fibroids on which eligible patients should be counseled.

Lowering iodinated contrast concentration in infrainguinal endovascular interventions: a three-armed randomized controlled non-inferiority trial.

OBJECTIVES: To determine the influence of lowering iodinated contrast concentration on confidence of interventional radiologists in diagnosing and treating lesions during endovascular interventions in patients with symptomatic peripheral arterial disease (PAD). METHODS: A randomized controlled non-inferiority trial was performed in 60 patients. Intervention was performed with contrast concentrations (in mg of iodine per mL, mgI/mL) of 300 (standard), 240, or 140 mgI/mL. Primary outcome was confidence (score 0-100 %) of radiologists in diagnosing and treating arterial lesions. Secondary outcomes were procedural iodine load and image quality (i.e. non-diagnostic, limited, diagnostic, exemplary). RESULTS: Median confidence scores in diagnosing lesions were 100 % (range 81-100 %) for the 300 group (n = 21), 100 % (range 82-100 %) for the 240 group (n = 19), and 100 % (range 91-100 %) for the 140 group (n = 20) (both p = 1.00 compared to the 300 group). Median scores for treating lesions in the 240 and 140 groups, 100 % (range 79-100 %, p = 0.40), and 100 % (range 63-100 %, p = 0.25), respectively, were not lower compared to the 300 group (median 100 %, range 78-100 %). Procedural iodine load was lower in the 240 (24.3 ± 7.6 g, p = 0.022) and 140 groups (17.8 ± 5.6 g, p < 0.001) compared to the 300 group (29.7 ± 6.3 g). Image quality was diagnostic for all groups. CONCLUSION: Using iodine contrast of 140 mgI/mL for diagnosis and interventions in PAD patients significantly reduces administered iodine load without compromising image quality. Future use of lower iodine dose is recommended. KEY POINTS: • Lower iodinated contrast concentration during endovascular intervention does not decrease radiologist's confidence. • Image quality of standardized angiographies remains diagnostic using 140 mgI/mL iodinated contrast concentration. • Iodine load during intervention can be decreased by >40 % when using 140 mgI/mL. • Implementing the use of a lower iodinated contrast concentration will reduce the costs of the procedure.

Embolisation for caecal bleeding in a child with typhlitis.

A 16-year-old girl being treated for a relapse of promyelocytic leukaemia developed typhlitis of the caecum and ascending colon related to Klebsiella septicaemia during the neutropenic phase, 2 weeks after the start of induction treatment with chemotherapy. After 10 days of treatment with parenteral feeding and antibiotics, massive rectal blood loss occurred, causing haemodynamic instability. Contrast-enhanced abdominal CT showed contrast extravasation in the caecal lumen. This life-threatening situation prompted visceral angiography, which confirmed a contrast blush in the caecum. Subsequent embolisation resulted in haemodynamic stability.

Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial.

OBJECTIVE: Randomized comparison of endovascular repair (EVAR) with open repair (OR) in patients with a ruptured abdominal aortic aneurysm (RAAA). BACKGROUND: Despite advances in operative technique and perioperative management RAAA remains fraught with a high rate of death and complications. Outcome may improve with a minimally invasive surgical technique: EVAR. METHODS: All patients with a RAAA in the larger Amsterdam area were identified. Logistics for RAAA patients was changed with centralization of care in 3 trial centers. Patients both fit for EVAR and for OR were randomized to either of the treatments. Nonrandomized patients were followed in a prospective cohort. Primary endpoint of the study was the composite of death and severe complications at 30 days. RESULTS: Between April 2004 and February 2011, we identified 520 patients with a RAAA of which 116 could be randomized. The primary endpoint rate for EVAR was 42% and for OR was 47% [absolute risk reduction (ARR) = 5.4%; 95% confidence interval (CI): -13% to +23%]. The 30-day mortality was 21% in patients assigned to EVAR compared with 25% for OR (ARR = 4.4% 95% CI: -11% to +20%). The mortality of all surgically treated patients in the nonrandomized cohort was 30% (95% CI: 26%-35%) and 26% (95% CI: 20% to 32%) in patients with unfavorable anatomy for EVAR, treated by OR at trial centers. CONCLUSIONS: This trial did not show a significant difference in combined death and severe complications between EVAR and OR. Mortality for OR both in randomized patients and in cohort patients was lower than anticipated, which may be explained by optimization of logistics, preoperative CT imaging, and centralization of care in centers of expertise.

The relationship of walking distances estimated by the patient, on the corridor and on a treadmill, and the Walking Impairment Questionnaire in intermittent claudication.

OBJECTIVE: Physicians and patients consider the limited walking distance and perceived disability when they make decisions regarding (invasive) treatment of intermittent claudication (IC). We investigated the relationship between walking distances estimated by the patient, on the corridor and on a treadmill, and the Walking Impairment Questionnaire (WIQ) in patients with IC due to peripheral arterial disease. METHODS: This was a single-center, prospective observational cohort study at a vascular laboratory in a university hospital in the Netherlands. The study consisted of 60 patients (41 male) with a median age of 64 years (range, 44-86 years) with IC and a walking distance ≤ 250 m on a standardized treadmill test. Main outcome measures were differences and Spearman rank correlations between pain-free walking distance, maximum walking distance (MWD) estimated by the patient, on the corridor and on a standardized treadmill test, and their correlation with the WIQ. RESULTS: The median patients' estimated, corridor, and treadmill MWD were 200, 200, and 123, respectively (P < .05). Although the median patients' estimated and corridor MWD were not significantly different, there was a difference on an individual basis. The correlation between the patients' estimated and corridor MWD was moderate (r = 0.61; 95% confidence interval [CI], 0.42-0.75). The correlation between patients' estimated and treadmill MWD was weak (r = 0.39; 95%, CI 0.15-0.58). Respective correlations for the pain-free walking distance were comparable. The patients' estimated MWD was moderately correlated with WIQ total score (r = 0.63; 95%, CI 0.45-0.76) and strongly correlated with WIQ distance score (r = 0.81; 95% CI, 0.69-0.88). The correlation between the corridor MWD and WIQ distance score was moderate (r = 0.59; 95% CI, 0.40-0.74). CONCLUSIONS: Patients' estimated walking distances and on a treadmill do not reflect walking distances in daily life. Instruments that take into account the perceived walking impairment, such as the WIQ, may help to better guide and evaluate treatment decisions.

Changes in functional status after treatment of critical limb ischemia.

OBJECTIVE: This study evaluated changes in functional status with the Academic Medical Center Linear Disability Score (ALDS) and in quality of life with the Vascular Quality of Life Questionnaire (VascuQol) in patients treated for critical limb ischemia (CLI). METHODS: We conducted a prospective observational cohort study in a single academic center that included consecutive patients with CLI who presented between May 2007 and May 2010. The ALDS and VascuQol questionnaires were administered before treatment (baseline) and after treatment at 6 and 12 months of follow-up. Changes in functional status (ALDS) and quality of life (VascuQol) scores after 6 and 12 months, compared with baseline, were tested with the appropriate statistical tests, with significance set at P < .05. RESULTS: The study included 150 patients, 96 (64%) were men, and mean (± standard deviation) age was 68.1 (± 12.4) years. The primary treatment was endovascular in 98 (65.3%), surgical in 36 (24%), conservative in 11 (7.3%), or a major amputation in five (3.3%). The ALDS was completed by 112 patients after 12 months. At that time, the median ALDS score had increased by 10 points (median, 83; range, 12-89; P = .001) in patients who achieved limb salvage, which corresponds with more difficult outdoor and indoor activities. In patients with a major amputation, the median ALDS score decreased by 14 points (median, 55; range, 16-89; P = .117) after 12 months, which corresponds with domestic activities only. VascuQol scores improved significantly in all separate domains for the limb salvage group (P < .001). All VascuQol scores, except for the activity and social domains, increased significantly after amputation. CONCLUSIONS: Our study confirms the clinical validity of the ALDS in patients treated for CLI and shows that it is a valuable and sophisticated instrument to measure changes in functional status in these patients.

Diagnostic performance of computed tomography angiography and contrast-enhanced magnetic resonance angiography in patients with critical limb ischaemia and intermittent claudication: systematic review and meta-analysis.

OBJECTIVE: To evaluate the diagnostic performance of computed tomography angiography (CTA) and contrast-enhanced magnetic resonance angiography (CE-MRA) in detecting haemodynamically significant arterial stenosis or occlusion in patients with critical limb ischaemia (CLI) or intermittent claudication (IC). METHODS: Medline and Embase were searched for studies comparing CTA or CE-MRA with digital subtraction angiography as a reference standard, including patients with CLI or IC. Outcome measures were aortotibial arterial stenosis of more than 50 % or occlusion. Methodological quality of studies was assessed using QUADAS. RESULTS: Out of 5,693 articles, 12 CTA and 30 CE-MRA studies were included, respectively evaluating 673 and 1,404 participants. Summary estimates of sensitivity and specificity were respectively 96 % (95 % CI, 93-98 %) and 95 % (95 % CI, 92-97 %) for CTA, and 93 % (95 % CI, 91-95 %) and 94 % (95 % CI, 93-96 %) for CE-MRA. Regression analysis showed that the prevalence of CLI in individual studies was not an independent predictor of sensitivity and specificity for either technique. Methodological quality of studies was moderate to good. CONCLUSION: CTA and CE-MRA are accurate techniques for evaluating disease severity of aortotibial arteries in patients with CLI or IC. No significant differences in the diagnostic performance of the two techniques between patients with CLI and IC were found. KEY POINTS: • Computed tomography and contrast-enhanced magnetic resonance angiography can both demonstrate arterial disease. • CTA and CE-MRA can both accurately evaluate arteries in peripheral arterial disease. • Diagnostic performances of critical limb ischaemia and intermittent claudication are not different. • Separate imaging technique of tibial arteries by CE-MRA is preferred. • CTA and CE-MRA can distinguish confidently between high-grade stenoses and occlusions.

Uterine artery embolization versus surgery in the treatment of symptomatic fibroids: a systematic review and metaanalysis.

OBJECTIVE: To summarize the evidence on short-, mid-, and long-term results up to 5 years of uterine artery embolization in comparison to surgery. STUDY DESIGN: We searched the CENTRAL, MEDLINE and EMBASE databases for randomized clinical trials comparing uterine artery embolization with hysterectomy/myomectomy in premenopausal women with heavy menstrual bleeding caused by symptomatic uterine fibroids, written from September 1995 to November 2010. Two reviewers independently assessed methodologic quality and extracted data from included trials. RESULTS: Four randomized controlled trials with a total of 515 patients were included. On the short-term, uterine artery embolization showed fewer blood loss, shorter hospital stay, and quicker resumption of work. Mid- and long-term results showed comparable health-related quality of life results and a higher reintervention rate in the uterine artery embolization group, whereas both groups were equally satisfied. CONCLUSION: Uterine artery embolization has short-term advantages over surgery. On the mid- and long-term the benefits were similar, except for a higher reintervention rate after uterine artery embolization.

Uterine artery embolization vs hysterectomy in the treatment of symptomatic uterine fibroids: 5-year outcome from the randomized EMMY trial.

OBJECTIVE: The purpose of this study was to compare clinical outcome and health related quality of life (HRQOL) 5 years after uterine artery embolization (UAE) or hysterectomy in the treatment of menorrhagia caused by uterine fibroids. STUDY DESIGN: Patients with symptomatic uterine fibroids who were eligible for hysterectomy were assigned randomly 1:1 to hysterectomy or UAE. Endpoints after 5 years were reintervention rates, menorrhagia, and HRQOL measures that were assessed by validated questionnaires. RESULTS: Patients were assigned randomly to UAE (n = 88) or hysterectomy (n = 89). Five years after treatment 23 of 81 UAE patients (28.4%) had undergone a hysterectomy because of insufficient improvement of complaints (24.7% after successful UAE). HRQOL measures improved significantly and remained stable until the 5-year follow-up evaluation, with no differences between the groups. UAE had a positive effect both on urinary and defecation function. CONCLUSION: UAE is a well-established alternative to hysterectomy about which patients should be counseled.

Stent placement in patients with atherosclerotic renal artery stenosis and impaired renal function: a randomized trial.

BACKGROUND: Little is known about the efficacy and safety of renal artery stenting in patients with atherosclerotic renal artery stenosis (ARAS) and impaired renal function. OBJECTIVE: To determine the efficacy and safety of stent placement in patients with ARAS and impaired renal function. DESIGN: Randomized clinical trial. Randomization was centralized and computer generated, and allocation was assigned by e-mail. Patients, providers, and persons who assessed outcomes were not blinded to treatment assignment. SETTING: 10 European medical centers. PARTICIPANTS: 140 patients with creatinine clearance less than 80 mL/min per 1.73 m(2) and ARAS of 50% or greater. INTERVENTION: Stent placement and medical treatment (64 patients) or medical treatment only (76 patients). Medical treatment consisted of antihypertensive treatment, a statin, and aspirin. MEASUREMENTS: The primary end point was a 20% or greater decrease in creatinine clearance. Secondary end points included safety and cardiovascular morbidity and mortality. RESULTS: Forty-six of 64 patients assigned to stent placement had the procedure. Ten of the 64 patients (16%) in the stent placement group and 16 patients (22%) in the medication group reached the primary end point (hazard ratio, 0.73 [95% CI, 0.33 to 1.61]). Serious complications occurred in the stent group, including 2 procedure-related deaths (3%), 1 late death secondary to an infected hematoma, and 1 patient who required dialysis secondary to cholesterol embolism. The groups did not differ for other secondary end points. LIMITATION: Many patients were falsely identified as having renal artery stenosis greater than 50% by noninvasive imaging and did not ultimately require stenting. CONCLUSION: Stent placement with medical treatment had no clear effect on progression of impaired renal function but led to a small number of significant procedure-related complications. The study findings favor a conservative approach to patients with ARAS, focused on cardiovascular risk factor management and avoiding stenting.

Effect of Endovascular Treatment With Medical Management vs Standard Care on Severe Cerebral Venous Thrombosis: The TO-ACT Randomized Clinical Trial.

Importance: To date, only uncontrolled studies have evaluated the efficacy and safety of endovascular treatment (EVT) in patients with cerebral venous thrombosis (CVT), leading to the lack of recommendations on EVT for CVT. Objective: To evaluate the efficacy and safety of EVT in patients with a severe form of CVT. Design, Setting, and Participants: TO-ACT (Thrombolysis or Anticoagulation for Cerebral Venous Thrombosis) was a multicenter, open-label, blinded end point, randomized clinical trial conducted in 8 hospitals in 3 countries (the Netherlands, China, and Portugal). Patients were recruited from September 2011 to October 2016, and follow-up began in March 2012 and was completed in December 2017. Adult patients with radiologically confirmed CVT who had at least 1 risk factor for a poor outcome (mental status disorder, coma state, intracerebral hemorrhage, or thrombosis of the deep venous system) were included. Data were analyzed according to the intention-to-treat principle from March 2018 to February 2019. The trial was halted after the first interim analysis for reasons of futility. Interventions: Patients were randomized to receive either EVT with standard medical care (intervention group) or guideline-based standard medical care only (control group). The EVT consisted of mechanical thrombectomy, local intrasinus application of alteplase or urokinase, or a combination of both strategies. Patients in the intervention group underwent EVT as soon as possible but no later than 24 hours after randomization. Main Outcomes and Measures: Primary end point was the proportion of patients with a good outcome at 12 months (recovered without a disability; modified Rankin Scale [mRS] score of 0-1). Secondary end points were the proportion of patients with an mRS score of 0 to 1 at 6 months and an mRS score of 0 to 2 at 6 and 12 months, outcome on the mRS across the ordinal continuum at 12 months, recanalization rate, and surgical interventions in relation to CVT. Safety end points included symptomatic intracranial hemorrhage. Results: Of the 67 patients enrolled and randomized, 33 (49%) were randomized to the intervention group and 34 (51%) were randomized to the control group. Patients in the intervention group vs those in the control group were slightly older (median [interquartile range (IQR)] age, 43 [33-50] years vs 38 [23-48] years) and comprised fewer women (23 women [70%] vs 27 women [79%]). The median (IQR) baseline National Institutes of Health Stroke Scale score was 12 (7-20) in the EVT group and 12 (5-20) in the standard care group. At the 12-month follow-up, 22 intervention patients (67%) had an mRS score of 0 to 1 compared with 23 control patients (68%) (relative risk ratio, 0.99; 95% CI, 0.71-1.38). Mortality was not statistically significantly higher in the EVT group (12% [n = 4] vs 3% [n = 1]; P = .20). The frequency of symptomatic intracerebral hemorrhage was not statistically significantly lower in the intervention group (3% [n = 1] vs 9% [n = 3]; P = .61). Conclusions and Relevance: The TO-ACT trial showed that EVT with standard medical care did not appear to improve functional outcome of patients with CVT. Given the small sample size, the possibility exists that future studies will demonstrate better recovery rates after EVT for this patient population. Trial Registration: ClinicalTrials.gov Identifier: NCT01204333.

Locally applied recombinant plasmin results in effective thrombolysis in a porcine model of arteriovenous graft thrombosis.

PURPOSE: Arteriovenous (AV) graft thrombosis is a frequent complication in patients undergoing hemodialysis. Thrombolytic therapy with tissue plasminogen activator (TPA) is hampered by the risk of bleeding complications. Locally delivered plasmin may have similar thrombolytic efficacy with a superior safety profile, so herein it was compared with TPA in a porcine model of AV graft thrombosis. MATERIALS AND METHODS: AV grafts were created bilaterally between the carotid artery and jugular vein. Graft thrombosis was induced by clamping the grafts for 1 hour. On day 3, one graft was treated with a 2-mL local recombinant plasmin injection (10 mg; n = 10) with the contralateral graft being infused with TPA (10 mg, n = 8) or saline solution (n = 2). Thrombolytic efficacy was assessed by weighing the residual clot and released clot fragments. RESULTS: After saline solution injection, the mean residual clot weight in the graft was 618 mg. Local administration of TPA showed the least residual clot in the graft (69 mg +/- 26), with large clot particles reaching the venous outflow (241 mg +/- 23). Plasmin treatment significantly reduced the released clot mass versus TPA (52 mg +/- 23; P < .05), whereas residual clot weight was greater compared with TPA treatment (140 mg +/- 22; P < .05). Overall thrombolytic activity of plasmin (ie, residual clot plus released clot) was significantly better than that of TPA (193 mg +/- 25 vs 310 mg +/- 35; P < .05). CONCLUSIONS: The thrombolytic efficacy of recombinant plasmin was shown to be superior to that of TPA in this study.

The AMC linear disability score (ALDS): a cross-sectional study with a new generic instrument to measure disability applied to patients with peripheral arterial disease.

BACKGROUND: The AMC Linear Disability Score (ALDS) is a calibrated generic itembank to measure the level of physical disability in patients with chronic diseases. The ALDS has already been validated in different patient populations suffering from chronic diseases. The aim of this study was to assess the clinimetric properties of the ALDS in patients with peripheral arterial disease. METHODS: Patients with intermittent claudication (IC) and critical limb ischemia (CLI) presenting from January 2007 through November 2007 were included. Risk factors for atherosclerosis, ankle/brachial index and toe pressure, the Vascular Quality of Life Questionnaire (VascuQol), and the ALDS were recorded. To compare ALDS and VascuQol scores between the two patient groups, an unpaired t-test was used. Correlations were determined between VascuQol, ALDS and pressure measurements. RESULTS: Sixty-two patients were included (44 male, mean +/- sd age was 68 +/- 11 years) with IC (n = 26) and CLI (n = 36). The average ALDS was significantly higher in patients with IC (80, +/- 10) compared to patients with CLI (64, +/- 18). Internal reliability consistency of the ALDS expressed as Cronbach's alpha coefficient was excellent (alpha > 0.90). There was a strong convergent correlation between the ALDS and the disability related Activity domain of the VascuQol (r = 0.64). CONCLUSION: The ALDS is a promising clinimetric instrument to measure disability in patients with various stages of peripheral arterial disease.

Diagnostic performance of computed tomography angiography in peripheral arterial disease: a systematic review and meta-analysis.

CONTEXT: Computed tomography angiography (CTA) is an increasingly attractive imaging modality for assessing lower extremity peripheral arterial disease (PAD). OBJECTIVE: To determine the accuracy of CTA compared with intra-arterial digital subtraction angiography (DSA) in differentiating extent of disease in patients with PAD. DATA SOURCES AND STUDY SELECTION: Search of MEDLINE (January 1966-August 2008), EMBASE (January 1980-August 2008), and the Database of Abstracts of Reviews of Effectiveness for studies comparing CTA with intra-arterial DSA for PAD. Eligible studies compared multidetector CTA with intra-arterial DSA, included at least 10 patients with intermittent claudication or critical limb ischemia, aimed to detect more than 50% stenosis or arterial occlusion, and presented either 2 x 2 or 3 x 3 contingency tables (< or = 50% stenosis vs > 50% stenosis or occlusion), or provided data allowing their construction. DATA EXTRACTION: Two reviewers screened potential studies for inclusion and independently extracted study data. Methodological quality was assessed by using the QUADAS instrument. DATA SYNTHESIS: Of 909 studies identified, 20 (2.2%) met the inclusion criteria. These 20 studies had a median sample size of 33 (range, 16-279) and included 957 patients, predominantly with intermittent claudication (68%). Methodological quality was moderate. Overall, the sensitivity of CTA for detecting more than 50% stenosis or occlusion was 95% (95% confidence interval [CI], 92%-97%) and specificity was 96% (95% CI, 93%-97%). Computed tomography angiography correctly identified occlusions in 94% of segments, the presence of more than 50% stenosis in 87% of segments, and absence of significant stenosis in 96% of segments. Overstaging occurred in 8% of segments and understaging in 15%. CONCLUSION: Computed tomography angiography is an accurate modality to assess presence and extent of PAD in patients with intermittent claudication; however, methodological weaknesses of examined studies prevent definitive conclusions from these data.