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Biomedical subjects

Erik Buskens

Publications and source records attributed to Erik Buskens.

At least 19 recordsLinked to original sources

Effectiveness of early switch from intravenous to oral antibiotics in severe community acquired pneumonia: multicentre randomised trial.

OBJECTIVES: To compare the effectiveness of an early switch to oral antibiotics with the standard 7 day course of intravenous antibiotics in severe community acquired pneumonia. DESIGN: Multicentre randomised controlled trial. SETTING: Five teaching hospitals and 2 university medical centres in the Netherlands. PARTICIPANTS: 302 patients in non-intensive care wards with severe community acquired pneumonia. 265 patients fulfilled the study requirements. INTERVENTION: Three days of treatment with intravenous antibiotics followed, when clinically stable, by oral antibiotics or by 7 days of intravenous antibiotics. MAIN OUTCOME MEASURES: Clinical cure and length of hospital stay. RESULTS: 302 patients were randomised (mean age 69.5 (standard deviation 14.0), mean pneumonia severity score 112.7 (26.0)). 37 patients were excluded from analysis because of early dropout before day 3, leaving 265 patients for intention to treat analysis. Mortality at day 28 was 4% in the intervention group and 6% in the control group (mean difference 2%, 95% confidence interval -3% to 8%). Clinical cure was 83% in the intervention group and 85% in the control group (2%, -7% to 10%). Duration of intravenous treatment and length of hospital stay were reduced in the intervention group, with mean differences of 3.4 days (3.6 (1.5) v 7.0 (2.0) days; 2.8 to 3.9) and 1.9 days (9.6 (5.0) v 11.5 (4.9) days; 0.6 to 3.2), respectively. CONCLUSIONS: Early switch from intravenous to oral antibiotics in patients with severe community acquired pneumonia is safe and decreases length of hospital stay by 2 days. TRIAL REGISTRATION: Clinical Trials NCT00273676 [ClinicalTrials.gov].

Administration, Oral↗

Alendronate or alfacalcidol in glucocorticoid-induced osteoporosis.

BACKGROUND: Treatment with glucocorticoids is associated with bone loss starting soon after therapy is initiated and an increased risk of fracture. METHODS: We performed a randomized, double-placebo, double-blind clinical trial of 18 months' duration among patients with a rheumatic disease who were starting glucocorticoids at a daily dose that was equivalent to at least 7.5 mg of prednisone. A total of 201 patients were assigned to receive either alendronate (10 mg) and a placebo capsule of alfacalcidol daily or alfacalcidol (1 microg) and a placebo tablet of alendronate daily. The primary outcome was the change in bone mineral density of the lumbar spine in 18 months; the secondary outcome was the incidence of morphometric vertebral deformities. RESULTS: A total of 100 patients received alendronate, and 101 received alfacalcidol; 163 patients completed the study. The bone mineral density of the lumbar spine increased by 2.1 percent in the alendronate group (95 percent confidence interval, 1.1 to 3.1 percent) and decreased by 1.9 percent in the alfacalcidol group (95 percent confidence interval, -3.1 to -0.7 percent). At 18 months, the mean difference of change in bone mineral density between the two groups was 4.0 percent (95 percent confidence interval, 2.4 to 5.5 percent). Three patients in the alendronate group had a new vertebral deformity, as compared with eight patients in the alfacalcidol group (of whom three had symptomatic vertebral fractures) (hazard ratio, 0.4; 95 percent confidence interval, 0.1 to 1.4). CONCLUSIONS: During this 18-month trial in patients with rheumatic diseases, alendronate was more effective in the prevention of glucocorticoid-induced bone loss than was alfacalcidol. (ClinicalTrials.gov number, NCT00138983 [ClinicalTrials.gov].).

Aged↗

UVB phototherapy in an outpatient setting or at home: a pragmatic randomised single-blind trial designed to settle the discussion. The PLUTO study.

BACKGROUND: Home ultraviolet B (UVB) treatment is a much-debated treatment, especially with regard to effectiveness, safety and side effects. However, it is increasingly being prescribed, especially in the Netherlands. Despite ongoing discussions, no randomised research has been performed, and only two studies actually compare two groups of patients. Thus, firm evidence to support or discourage the use of home UVB phototherapy has not yet been obtained. This is the goal of the present study, the PLUTO study (Dutch acronym for "national trial on home UVB phototherapy for psoriasis"). METHODS: We designed a pragmatic randomised single-blind multi-centre trial. This trial is designed to evaluate the impact of home UVB treatment versus UVB phototherapy in a hospital outpatient clinic as to effectiveness, quality of life and cost-effectiveness. In total 196 patients with psoriasis who were clinically eligible for UVB phototherapy were included. Normally 85% of the patients treated with UVB show a relevant clinical response. With a power of 80% and a 0.05 significance level it will be possible to detect a reduction in effectiveness of 15%. Effectiveness will be determined by calculating differences in the Psoriasis Area and Severity Index (PASI) and the Self Administered PASI (SAPASI) scores. Quality of life is measured using several validated generic questionnaires and a disease-specific questionnaire. Other outcome measures include costs, side effects, dosimetry, concomitant use of medication and patient satisfaction. Patients are followed throughout the therapy and for 12 months thereafter. The study is no longer recruiting patients, and is expected to report in 2006. DISCUSSION: In the field of home UVB phototherapy this trial is the first randomised parallel group study. As such, this trial addresses the weaknesses encountered in previous studies. The pragmatic design ensures that the results can be well generalised to the target population. Because, in addition to effectiveness, aspects such as quality of life and cost-effectiveness are also taken into consideration, this study will produce valuable evidence to either support or discourage prescription of home UVB phototherapy. TRIAL REGISTRATION: Current controlled trials/Nederlands Trial register: ISRCTN83025173. Clinicaltrials.gov: NCT00150930.

Adult↗

Determinants and prognostic significance of collaterals in patients undergoing coronary revascularization.

There is evidence that coronary collaterals improve the prognosis in patients with acute myocardial infarction (MI). However, there is limited clinical information on the protective role of collaterals in patients with stable coronary artery disease. This information may help risk stratification and the development of novel therapies, such as arteriogenesis and angiogenesis. The relation between collaterals and cardiac death or MI at 1 year after coronary revascularization was studied in 561 patients who were enrolled in a randomized study that compared stent implantation with bypass grafting. Collaterals were assessed on an angiogram using Rentrop's classification and considered present with a Rentrop grade >1. Unadjusted and adjusted odds ratios for cardiac death or MI at 1 year were calculated using univariate and multivariate regression analyses. In addition, determinants of collaterals were assessed using univariate and multivariate analyses. Collaterals were present in 176 patients (31%). The adjusted odds ratio of cardiac death or infarction was 0.18 (95% confidence interval 0.04 to 0.78) in the presence of collaterals. Independent determinants of collaterals were age (odds ratio 0.97, 95% confidence interval 0.95 to 0.99), multivessel disease (odds ratio 1.60, 95% confidence interval 1.02 to 2.51), impaired ventricular function (odds ratio 1.85, 95% confidence interval 1.04 to 3.29), type C lesion (odds ratio 3.72, 95% confidence interval 2.33 to 5.95), and stenosis severity >90% (odds ratio 9.08, 95% confidence interval 4.65 to 17.73). In conclusion, in patients with a low risk profile, the presence of collaterals protects against cardiac death and MI at 1 year after coronary revascularization. Variables that reflect the duration and severity of the atherosclerotic and ischemic burden determine their presence.

Angioplasty, Balloon, Coronary↗

The prevalence and incidence of pressure ulcers in hospitalised patients in the Netherlands: a prospective inception cohort study.

BACKGROUND: Pressure ulcers frequently occur in hospitalised patients. The prevalence of pressure ulcers grade 2 or worse varies from 3% to 12% in hospitalised patients. Incidence figures are not frequently reported. While incidence and prevalence are both measures of disease frequency, they provide different perspectives on pressure ulcers. OBJECTIVES: To describe the incidence rate and prevalence of pressure ulcers in hospitalised patients. DESIGN: Prospective inception cohort study. SETTING: Two large hospitals, one general (530-beds) and one teaching (1042-beds), in The Netherlands. PARTICIPANTS: A non-selected, though not strictly random, sample of 1536 patients was eligible for inclusion in the study. One thousand four hundred and thirty one patients (93.2%) consented to participate. Eventually, 1229 patients (80%) had a complete follow-up. The sample consisted of patients admitted to the surgical, internal, neurological and geriatric wards for more than 5 days between January 1999 and June 2000. METHODS: Follow-up once a week until pressure ulcer occurrence, discharge or length of stay over 12 weeks. MAIN OUTCOME MEASURES: Occurrence of a pressure ulcer grade 2 or worse during admission to hospital, according to the classification of the European Pressure Ulcer Advisory Panel. RESULTS: One hundred and thirty four patients developed 172 pressure ulcers during follow-up. The overall weekly incidence rate was 0.06 per week (95% confidence interval 0.05-0.07 per week). Highest rates were observed for surgical patients and lowest for geriatric and neurologic patients (0.08 and 0.02, respectively). The week specific prevalence varied between 12.8% and 20.3%. CONCLUSIONS: Among patients hospitalised for more than 5 days overall one may expect 6% per week to develop pressure ulcers. It would appear that any preventive measures can only be effective if taken timely. Accordingly, preventive measures should be considered early, because pressure ulcers were observed already within the first week of admission.

Cohort Studies↗

Minimally invasive 'step-up approach' versus maximal necrosectomy in patients with acute necrotising pancreatitis (PANTER trial): design and rationale of a randomised controlled multicenter trial [ISRCTN13975868].

BACKGROUND: The initial treatment of acute necrotizing pancreatitis is conservative. Intervention is indicated in patients with (suspected) infected necrotizing pancreatitis. In the Netherlands, the standard intervention is necrosectomy by laparotomy followed by continuous postoperative lavage (CPL). In recent years several minimally invasive strategies have been introduced. So far, these strategies have never been compared in a randomised controlled trial. The PANTER study (PAncreatitis, Necrosectomy versus sTEp up appRoach) was conceived to yield the evidence needed for a considered policy decision. METHODS/DESIGN: 88 patients with (suspected) infected necrotizing pancreatitis will be randomly allocated to either group A) minimally invasive 'step-up approach' starting with drainage followed, if necessary, by videoscopic assisted retroperitoneal debridement (VARD) or group B) maximal necrosectomy by laparotomy. Both procedures are followed by CPL. Patients will be recruited from 20 hospitals, including all Dutch university medical centres, over a 3-year period. The primary endpoint is the proportion of patients suffering from postoperative major morbidity and mortality. Secondary endpoints are complications, new onset sepsis, length of hospital and intensive care stay, quality of life and total (direct and indirect) costs. To demonstrate that the 'step-up approach' can reduce the major morbidity and mortality rate from 45 to 16%, with 80% power at 5% alpha, a total sample size of 88 patients was calculated. DISCUSSION: The PANTER-study is a randomised controlled trial that will provide evidence on the merits of a minimally invasive 'step-up approach' in patients with (suspected) infected necrotizing pancreatitis.

Drainage↗

Direct costs of surgical clipping and endovascular coiling of unruptured intracranial aneurysms.

BACKGROUND: Unruptured intracranial aneurysms can be preventively treated by surgical clipping or endovascular coiling. We determined in detail the costs of these treatments. METHODS: We included patients who were treated for an unruptured aneurysm between 1997 and 2003. Patients coiled in this period were matched with clipped patients according to the year of treatment, age and gender. Considering clipping and coiling, we compared all pre-admission costs of diagnostic procedures, all costs of treatment, and costs during follow-up including standard angiographic control examinations at 6 and 18 months after coiling. Costs were calculated as the product of the used resources and the costs of these resources. RESULTS: The mean price for clipping was EUR 8,865.42 and that for coiling EUR 10,370.29. The difference was mainly determined by the higher material costs of coiling (EUR 5,300) compared with clipping (EUR 690). Costs of clipping were mainly determined by the need for intensive care facilities (1.2 days after clipping and 0 days after coiling) and the length of hospital stay (10.5 days after clipping and 3.4 days after coiling). After bootstrapping the data, costs of coiling were on average EUR 1,553 (95% confidence interval: EUR 1,539-1,569) higher than those of clipping. CONCLUSIONS: For unruptured intracranial aneurysms, direct in-hospital costs of coiling are on average higher than those of clipping, mostly because of the more expensive coils.

Adult↗

Comparison of the SF-6D and the EQ-5D in patients with coronary heart disease.

BACKGROUND: The SF-6D was derived from the SF-36. A single summary score is obtained allegedly preserving the descriptive richness and sensitivity to change of the SF-36 into utility measurement. We compared the SF-6D and EQ-5D on domain content, scoring distribution, pre-treatment and change scores. METHODS: The SF-6D and the EQ-5D were completed prior to intervention and 1, 3, 6 and 12 months post-intervention in a study enrolling 561 patients with symptomatic coronary stenosis. Patients were randomized to off-pump coronary artery bypass surgery (CABG), standard on-pump CABG, or percutaneous transluminal coronary angioplasty (PTCA). Baseline and change over time scores were compared using parametric and non-parametric tests. RESULTS: The relative contribution of similar domains measuring daily functioning to the utility scores differed substantially. SF-6D focused more on social functioning, while EQ-5D gave more weight to physical functioning. Pain and mental health had similar contributions. The scoring range of the EQ-5D was twice the range of the SF-6D. Before treatment, EQ-5D and SF-6D mean scores appeared similar (0.64 versus 0.63, p = 0.09). Median scores, however, differed substantially (0.69 versus 0.60), a difference exceeding the minimal important difference of both instruments. Agreement was low, with an intra-class correlation of 0.45.Finally, we found large differences in measuring change over time. The SF-6D recorded greater intra-subject change in the PTCA-group. Only the EQ-5D recorded significant change in the CABG-groups. In the latter groups changes in SF-6D domains cancelled each other out. CONCLUSION: Although both instruments appear to measure similar constructs, the EQ-5D and SF-6D are quite different. The low agreement and the differences in median values, scoring range and sensitivity to change after intervention show that the EQ-5D and SF-6D yield incomparable scores in patients with coronary heart disease.

Aged↗

Endograft treatment of ruptured abdominal aortic aneurysms using the Talent aortouniiliac system: an international multicenter study.

OBJECTIVE: To understand the potential of endovascular aneurysm repair (EVAR) in patients presenting with a ruptured abdominal aortic aneurysm (rAAA), the proportion in whom this procedure was applicable was assessed. Mortality and morbidity was also determined in patients treated with emergency EVAR (eEVAR) when anatomic and hemodynamic conditions allowed (ie, in the entire cohort with patients receiving endovascular and open repair combined). In addition, a comparison was made between the treatment group with eEVAR and open repair. METHODS: Between February 2003 and September 2004, 10 participating institutions enrolled a representative sample of 100 consecutive patients in whom eEVAR was considered. Patients in the New Endograft treatment in Ruptured abdominal aortic Aneurysm (ERA) trial were offered eEVAR or open repair in accordance with their clinical condition or anatomic configuration. Written informed consent was obtained from all patients or their legal representatives. The study included patients who were treated by stent-graft technique or by open surgery in the case of adverse anatomy for endoluminal stent-grafting or severe hemodynamic instability, or both. Data were collated in a centralized database for analysis. The study was sponsored and supported by Medtronic, and eEVAR was uniquely performed with a Talent aortouniiliac (AUI) system in all patients. Crude and adjusted 30-day or in-hospital and 3-month mortality rates were assessed for the entire group as a whole and the EVAR and open repair category separately. Complication rates were also assessed. RESULTS: Stent-graft repair was performed in 49 patients and open surgery in 51. No significant differences were observed between these treatment groups with regard to comorbidity at presentation, hemodynamic instability, and the proportion of patients who could be assessed by preoperative computed tomography scanning. Patients with eEVAR more frequently demonstrated a suitable infrarenal neck for endovascular repair, a longer infrarenal neck, and suitable iliac arteries for access than patients with open repair. The primary reason to perform open aneurysm repair was an unfavorable configuration of the neck in 80% of the patients. In patients undergoing eEVAR, operative blood loss was less, intensive care admission time was shorter, and the duration of mechanical ventilation was shorter (P < or = .02, all comparisons). The 30-day or in-hospital mortality was 35% in the eEVAR category, 39% in patients with open repair, and 37% overall. There was no statistically significant difference between the treatment groups with regard to crude mortality rates or rates adjusted for age, gender, hemodynamic shock, and pre-existent pulmonary disease. The cumulative 3-month all-cause mortality was 40% in the eEVAR group and 42% in the open repair group (no significant differences at crude and adjusted comparisons). The 3-month primary complication rate in the two treatment groups was similar at 59%. CONCLUSIONS: In approximately half the rAAA patients, eEVAR appeared viable. An unsuitable infrarenal neck was the most frequent cause to select open repair. In dedicated centers using a Talent AUI system, eEVAR appeared to be a feasible method for treatment of a rAAA. The overall first-month mortality did not differ across treatment groups (patients with endovascular and open repair combined), yet was somewhat lower than observed in a recent meta-analysis reporting on open repair.

Aged↗

Describing computed tomography findings in acute necrotizing pancreatitis with the Atlanta classification: an interobserver agreement study.

OBJECTIVES: The 1992 Atlanta classification is a clinically based classification system that defines the severity and complications of acute pancreatitis. A study was undertaken to assess the interobserver agreement of categorizing peripancreatic collections on computed tomography (CT) using the Atlanta classification. METHODS: Preoperative contrast-enhanced CTs from 70 consecutive patients (49 men; median age, 59 years; range, 29-79 years) operated for acute necrotizing pancreatitis (2000-2003) in 11 hospitals were reviewed. Five abdominal radiologists independently categorized the peripancreatic collections according to the Atlanta classification. Radiologists were aware of the timing of the CT and the clinical condition of the patient. Interobserver agreement was determined. RESULTS: Interobserver agreement among the radiologists was poor (kappa, 0.144; SD, 0.095). In 3 (4%) of 70 cases, the same Atlanta definition was chosen. In 13 (19%) of 70 cases, 4 radiologists agreed, and in 42 (60%) of 70 cases, 3 radiologists agreed on the definition. In 21 cases (30%), 1 or more of the radiologists classified a collection as "pancreatic abscess," whereas 1 or more radiologist used another Atlanta definition. CONCLUSION: The interobserver agreement of the Atlanta classification for categorizing peripancreatic collections in acute pancreatitis on CT is poor. The Atlanta classification should not be used to describe complications of acute pancreatitis on CT.

Adult↗

Costs and benefits of bacterial culturing and pathogen reduction in the Netherlands.

BACKGROUND: Bacterial contamination is a life-threatening risk of blood transfusion, especially with platelet (PLT) transfusions. Bacterial culturing (BCU) of PLTs as well as pathogen reduction (PRT) reduce the likelihood of such contamination. The cost-effectiveness (CE) of these interventions was analyzed after the introduction of the diversion pouch during blood collection. STUDY DESIGN AND METHODS: The balance between costs and benefits of preventing adverse events due to PLT transfusion was assessed with a mathematical decision model and Monte Carlo simulations. Model parameters were obtained from the literature and from Dutch Sanquin blood banks. The balance between costs and benefits is assessed in terms of costs per quality-adjusted life-year (QALY). RESULTS: The costs per 100,000 PLT concentrates in the Netherlands are estimated at $3,277,032 (euro2,520,794) for BCU and at $18,582,844 (euro14,294,495) for PRT. In comparison to the situation without BCU and PRT, costs per QALY are estimated at $90,697 (euro69,767) for BCU (95% confidence interval [CI], $18,149-$2,088,854) and at $496,674 (euro382,057) for PRT (95% CI, $143,950-$8,171,133). The ratio of differences in costs and QALYs between BCU and PRT (the relative CE) is estimated at $3,596,256 (euro2,766,351; 95% CI, $1,100,630-$24,756,615). Large uncertainty in sepsis complication rates and PLT recipient survival exist, causing large uncertainties in the absolute CE for both interventions. CONCLUSIONS: As a result of the unknown probability of sepsis complications and PLT recipient survival, the CE ratios of BCU and PRT in the Dutch setting are highly uncertain. Despite these large uncertainties, it can be concluded that BCU is without doubt more cost-effective than PRT.

Bacteriological Techniques↗

Clinical effectiveness of first and repeat influenza vaccination in adult and elderly diabetic patients.

OBJECTIVE: Influenza vaccine uptake remains low among the high-risk group of patients with diabetes, partly because of conflicting evidence regarding its potential benefits. We assessed the clinical effectiveness of influenza vaccination in adults with diabetes and specifically examined potential modification of effect by age and prior influenza vaccine uptake. RESEARCH DESIGN AND METHODS: The study was part of the Prevention of Influenza, Surveillance and Management (PRISMA) study, a nested case-control study conducted during the 1999-2000 influenza A epidemic, among 75,235 patients from primary care of any age recommended for vaccination. Among 9,238 adult patients with diabetes, 131 cases arose who were either hospitalized for diabetes dysregulation, acute respiratory disease, or cardiovascular disease and 61 cases who died, and we compared them with 1,561 control subjects. We evaluated the effect of (prior) influenza vaccination by means of logistic regression analysis controlling for age, sex, health insurance coverage, prior health care use, medication use, and comorbid conditions. RESULTS: Vaccination was associated with a 56% reduction in any complication (95% CI 36-70%), a 54% reduction in hospitalizations (26-71%), and 58% reduction in deaths (13-80%). Among study subjects aged 18-64 years, we observed somewhat higher reductions in the occurrence of any complication than among those aged >65 years (72 vs. 39%). In first-time vaccinated subjects, the primary end point was reduced by 47% (0.2-72%), and in those who received vaccination in the year before, the reduction was 58% (4-81%). CONCLUSIONS: Adults with type 2 diabetes, like other individuals from recognized risk groups, benefit considerably from influenza vaccination, and no difference in vaccine effectiveness was observed between first-time and repeat vaccination.

Adolescent↗

Optimal peak systolic velocity threshold at duplex us for determining the need for carotid endarterectomy: a decision analytic approach.

PURPOSE: To determine the optimal peak systolic velocity (PSV) threshold at duplex ultrasonography (US) required to establish the need for carotid endarterectomy in symptomatic patients on the basis of the long-term cost-effectiveness outcomes of diagnostic testing and subsequent treatment. MATERIALS AND METHODS: From January 1997 through January 2000, a prospective medical ethics committee-approved multicenter study was conducted. After giving informed consent, patients with amaurosis fugax, transient ischemic attack, or minor stroke who underwent duplex US and digital subtraction angiography were included in the study. Selective ipsilateral carotid angiograms were obtained in at least three planes. Arteries that were nearly or totally occluded at duplex US were excluded because the PSV cannot be reliably measured in these vessels. Receiver operating characteristic (ROC) curves were constructed for the diagnoses of 70%-99% and 50%-99% stenoses. Optimal likelihood ratios were calculated on the basis of lifetime costs and quality-adjusted life-years derived at cost-effectiveness analysis and the prevalence of disease. The associated optimal sensitivities, specificities, and PSV thresholds were derived from the ROC curves. RESULTS: In this clinical study, 350 patients were included. The nonoccluded arteries in a total of 236 patients were assessable for ROC analysis. For the diagnosis of 70%-99% stenosis, the optimal likelihood ratio was 0.21, which was associated with a PSV threshold of 220 cm/sec, a sensitivity of 97% (127 of 131 patients; 95% confidence interval [CI]: 94%, 100%), and a specificity of 48% (50 of 105 patients; 95% CI: 38%, 57%). For the diagnosis of 50%-99% stenosis, the optimal likelihood ratio was 0.38, which was associated with a PSV threshold of 180 cm/sec, a sensitivity of 95% (182 of 191 patients; 95% CI: 92%, 98%), and a specificity of 69% (31 of 45 patients; 95% CI: 55%, 82%). CONCLUSION: On the basis of the lifetime outcomes of diagnostic testing and subsequent treatment, the optimal PSV thresholds for the diagnosis of 70%-99% and 50%-99% carotid artery stenoses in patients with amaurosis fugax, transient ischemic attack, or minor stroke were 220 cm/sec and 180 cm/sec, respectively.

Adult↗

Dutch iliac stent trial: long-term results in patients randomized for primary or selective stent placement.

PURPOSE: To determine long-term results of the prospective Dutch Iliac Stent Trial. MATERIALS AND METHODS: The study protocol was approved by local institutional review boards. All patients gave written informed consent. Two hundred seventy-nine patients (201 men, 78 women; mean age, 58 years) with iliac artery disease were randomly assigned to undergo primary stent placement (143 patients) or percutaneous transluminal angioplasty (PTA) with selective stent placement in cases in which the residual mean pressure gradient was greater than 10 mm Hg across the treated site (136 patients). Before and at 3, 12, and 24 months and 5-8 years after treatment, all patients underwent assessment, which included duplex ultrasonography (US), ankle-brachial index (ABI) measurement, Fontaine classification of symptoms, and completion of the Rand 36-Item Health survey for quality-of-life assessment. Treatment was considered successful for symptoms if symptoms increased at least one Fontaine grade, for ABI if ABI increased more than 0.10, for patency if peak systolic velocity ratio at duplex US was less than 2.5, and for quality of life if the RAND 36-Item Health Survey score increased more than 15 points. Effects of both treatments on symptoms, quality of life, patency, and ABI were compared by using survival analyses. RESULTS: Patients who underwent PTA and selective stent placement had better improvement of symptoms (hazard ratio [HR], 0.8; 95% confidence limits [CLs]: 0.6, 1.0) than did patients treated with primary stent placement, whereas ABI (HR, 0.9; 95% CLs: 0.7, 1.3), iliac patency (HR, 1.3; 95% CLs: 0.8, 2.1), and score for quality of life for nine survey dimensions did not support a difference between treatment groups. CONCLUSION: Patients treated with PTA and selective stent placement in the iliac artery had a better outcome for symptomatic success compared with patients treated with primary stent placement, whereas data about iliac patency, ABI, and quality of life did not support a difference between groups.

Angioplasty, Balloon↗

Diagnostic performance of duplex ultrasound in patients suspected of carotid artery disease: the ipsilateral versus contralateral artery.

BACKGROUND AND PURPOSE: To evaluate duplex ultrasonographic thresholds for the determination of 70% to 99% stenosis of the ipsilateral and contralateral internal carotid artery in patients with symptoms of amaurosis fugax, transient ischemic attack (TIA), or minor stroke based on 2 criteria: maximizing accuracy and optimizing cost-effectiveness and to compare these with current recommendations. METHODS: From January 1997 to January 2000, a prospective multicenter study was conducted including 350 consecutive patients with symptoms of amaurosis fugax, TIA, or minor stroke who underwent bilateral duplex ultrasonography and digital subtraction angiography. A linear regression analysis was performed to estimate the degree of angiographic stenosis as a function of the peak systolic velocity (PSV). PSV thresholds were calculated for the ipsilateral and contralateral carotid arteries based on maximizing accuracy and optimizing cost-effectiveness. RESULTS: The PSV measurements significantly overestimated the angiographic stenosis in the contralateral artery (9.5%; 95% CI, 6.3% to 12.7%) compared with the ipsilateral carotid artery. The recommended PSV threshold for the diagnosis of 70% to 99% stenosis is 230 cm/s. Maximizing accuracy, the optimal PSV threshold for the ipsilateral artery was 280 cm/s, and for the contralateral artery, 370 cm/s for diagnosing a 70% to 99% stenosis. Optimizing cost-effectiveness, the optimal PSV threshold was 220 cm/s for ipsilateral and 290 cm/s for contralateral carotid arteries. CONCLUSIONS: PSV measurements overestimate the degree of angiographic stenosis in the contralateral carotid artery in patients with symptoms of amaurosis fugax, TIA, or minor stroke. Separate PSV thresholds should be used for the ipsilateral and contralateral carotid artery. PSV thresholds that optimize cost-effectiveness differ from the recommended thresholds and from thresholds that maximize accuracy.

Adult↗

Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms.

BACKGROUND: Two randomized trials have shown better outcomes with elective endovascular repair of abdominal aortic aneurysms than with conventional open repair in the first month after the procedure. We investigated whether this advantage is sustained beyond the perioperative period. METHODS: We conducted a multicenter, randomized trial comparing open repair with endovascular repair in 351 patients who had received a diagnosis of abdominal aortic aneurysm of at least 5 cm in diameter and who were considered suitable candidates for both techniques. Survival after randomization was calculated with the use of Kaplan-Meier analysis and compared with the use of the log-rank test on an intention-to-treat-basis. RESULTS: Two years after randomization, the cumulative survival rates were 89.6 percent for open repair and 89.7 percent for endovascular repair (difference, -0.1 percentage point; 95 percent confidence interval, -6.8 to 6.7 percentage points). The cumulative rates of aneurysm-related death were 5.7 percent for open repair and 2.1 percent for endovascular repair (difference, 3.7 percentage points; 95 percent confidence interval, -0.5 to 7.9 percentage points). This advantage of endovascular repair over open repair was entirely accounted for by events occurring in the perioperative period, with no significant difference in subsequent aneurysm-related mortality. The rate of survival free of moderate or severe complications was also similar in the two groups at two years (at 65.9 percent for open repair and 65.6 percent for endovascular repair; difference, 0.3 percentage point; 95 percent confidence interval, -10.0 to 10.6 percentage points). CONCLUSIONS: The perioperative survival advantage with endovascular repair as compared with open repair is not sustained after the first postoperative year.

Aged↗