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Adjunctive abciximab improves patency and functional outcome in endovascular treatment of femoropopliteal occlusions: initial experience.

PURPOSE: To prospectively evaluate the safety and effectiveness of adjunctive administration of abciximab observed within 30 days and at 6 months after randomization in patients undergoing endovascular revascularization of long-segment femoropopliteal occlusions. MATERIALS AND METHODS: The study was approved by the local ethical committee, and patients gave written informed consent. In a prospective, double-blind, placebo-controlled design, patients undergoing percutaneous treatment for long-segment (>5 cm) femoropopliteal occlusions were randomly assigned to receive abciximab or a placebo; all patients also received standard-dose heparin. Effectiveness and safety analyses were based on an intention-to-treat approach. Patency was calculated according to life-table analysis, and P values were derived from the log-rank statistic. The P values for dichotomous safety end points were calculated with the Fisher exact test. Odds ratios were calculated for subgroup analyses. Logistic regression modeling was used for analysis of the safety bleeding data. RESULTS: A total of 98 patients (103 limbs) were included: 47 patients received abciximab and 51 received a placebo. Patency with abciximab versus placebo was 95.7% versus 80.4% (relative risk, 0.21; 95% confidence interval: 0.05, 0.96; P = .02) at 30 days and was 61.7% versus 41.2% (relative risk, 0.57; 95% confidence interval: 0.32, 1.01; P = .03), coupled with a better clinical outcome according to the Rutherford score, at the end of follow-up (P = .03). Risk of major bleeding was not significantly increased, while access-site bleeding was significantly higher among patients receiving abciximab (odds ratio, 2.9; 95% confidence interval: 1.04, 8.2; P = .04). CONCLUSION: The data show that adjunctive administration of abciximab has a favorable effect on patency and clinical outcome in patients undergoing complex femoropopliteal catheter interventions not hampered by serious bleeding. Treatment effect of abciximab observed at 30 days was maintained at 6-month follow-up.

Abciximab↗

Is conservative management of prenatal and neonatal ovarian cysts justifiable?

OBJECTIVES: To evaluate conservative management of fetal and neonatal ovarian cysts. METHODS: We followed the progress of 11 fetal and 2 neonatal ovarian cysts. RESULTS: Ten fetal cysts were simple at recognition, but 8 silently became complex by birth, with ovarian loss in 6/11 cases (54%). In 2 cases where large simple cysts presented for the first time at birth, serious complications occurred, resulting in the death of 1 newborn. CONCLUSIONS: If a fetal ovarian cyst is already complex before birth it can be managed conservatively, albeit with loss of the ipsilateral ovary in the majority of cases. As simple fetal ovarian cysts frequently become complex before birth, intervention may be justifiable to preserve the ovary. But any intervention also has the potential for complications, and may be ineffective. Intervention also requires accurate differentiation of ovarian cysts from other abdominal cysts.

Female↗

Pathophysiology of acute ischaemic stroke: an analysis of common signalling mechanisms and identification of new molecular targets.

Stroke continues to be a major cause of death and disability. The currently available therapies have proven to be highly unsatisfactory (except thrombolysis) and attempts are being made to identify and characterize signalling proteins which could be exploited to design novel therapeutic modalities. The pathophysiology of stroke is a complex process. Delaying interventions from the first hours to days or even weeks following blood vessel occlusion may lead to worsening or impairment of recovery in later stages. The objective of this review is to critically evaluate the major mechanisms underlying stroke pathophysiology, especially the role of cell signalling in excitotoxicity, inflammation, apoptosis, neuroprotection and angiogenesis, and highlight potential novel targets for drug discovery.

Animals↗

Evidence-based practice in the management of vascular access devices for home parenteral nutrition therapy.

Catheter-related bloodstream infection and catheter occlusion are potential significant complications of parenteral nutrition therapy. The increased incidence and associated morbidity, mortality, increased costs, and quality-of-life issues experienced with these adverse events necessitate specialized management of vascular access devices. The host coagulation response to biomaterials and the associated development of biofilm on vascular devices are complex phenomena. Multiple interventions are required to prevent access of bacteria to both intraluminal and extraluminal catheter surfaces, and the occurrence of catheter occlusion. The discovery of the biofilm form of microbial life and the associated recalcitrance of biofilm bacteria to antimicrobials has provided insight into the failure of current prevention, diagnostic, and treatment protocols. Critical interventions are presented correlating current evidence with new discoveries in pathogenesis.

Anti-Bacterial Agents↗

Ethical issues concerning participants in community surveys of child and adolescent mental disorders.

OBJECTIVE: Considering that a literature review yielded limited information on ethical issues concerning participants in child and adolescent mental health community surveys, the authors identify and discuss some of these issues. METHOD: First, the authors present the ethical principles set forth by the National Council on Bioethics in Human Research (NCBHR) and evoked by the 1998 Tri-Council Policy Statement, underscoring their importance as guidelines for establishing ethical standards for research with children. Second, they describe the general objectives and currently preferred methods of child psychiatric surveys. Third, they discuss issues pertaining to the validity and innocuousness of structured interview guides, the limitations of parental authorization and children's assent, and the complexity of clinical interventions based on ethical grounds. CONCLUSIONS: The authors emphasize the importance of developing empirical knowledge regarding the questions raised and bringing the social stakeholders concerned into the debate.

Adolescent↗

Strengthening individual and community capacity to prevent disease and promote health: in search of relevant theories and principles.

The dominant theoretical models used in health education today are based in social psychology. While these theories have increasingly acknowledged the role of larger social and cultural influences in health behavior, they have many limitations. Theories seek to explain the causes of health problems, whereas principles of practice, which are derived from practical experience, assist intervenors to achieve their objectives. By elucidating the relationships between theory and practice principles, it may be possible to develop more coherent and effective interventions. The key research agenda for health education is to link theories at different levels of analysis and to create theory-driven models that can be used to plan more effective interventions in the complex environments in which health educators work.

Community Health Services↗

Factors influencing the evaluation of telehealth interventions: preliminary results from a qualitative study of evaluation projects in the UK.

We have carried out a qualitative study of factors that influence the evaluation of telehealth. The study concerned six telehealth projects that are being tracked over two years. In the first 12 months of the study we carried out semistructured interviews and made observations of the participants in the projects. Each case study involved 5-15 subjects, many of whom were interviewed several times. The results indicate that important issues affecting telehealth evaluation include developing and maintaining the technology, reorganization of clinical and administrative duties, professional dynamics, and the difficulty of integrating service provision and evaluation. The findings suggest that the evaluation of telehealth interventions is highly complex, and that this complexity is often underestimated in the design and conduct of evaluation studies.

Computer Communication Networks↗

Volumetric computerized tomography as a measurement of periprosthetic acetabular osteolysis and its correlation with wear.

Osteolysis, which is considered to be a major source of morbidity following total hip joint replacement, has been notoriously difficult to measure accurately, particularly in the acetabular area. In order to study periacetabular osteolysis, specialized software for computerized tomography (CT) scan image analysis has been developed. This software (3D-CT) eliminates metal artifacts, allows three-dimensional segmentation of the CT image, and reconstructs the segmented image to provide an accurate representation and measurement of volume for osteolytic lesions. In the present study, 20 patients underwent periacetabular osteolytic volume determination using 3D-CT, functional assessment (using the Harris Hip Scale, the Western Ontario and McMaster University Osteoarthritis Index, and the short form 36 questionnaire), and two-dimensional analysis of volumetic polyethylene wear using digitalized plain films. Periacetabular osteolysis correlated directly with the polyethylene wear rate (relative risk [RR] = 0.494, P = 0.027). If one patient with an acetabular revision, one patient with recurrent dislocation, and one patient with a Biomet prosthesis are excluded, then the correlation between wear and osteolysis is improved (RR = 0.685, P = 0.002). In summary, the current study demonstrates both the feasibility of CT imaging of periacetabular osteolysis and the correlation between polyethylene wear and osteolytic volume, providing a potential outcome measure for clinical trials that are designed to examine interventions in this complex disease process.

Acetabulum↗

The pitfalls of planning for demographic change.

As we begin to understand the biology of aging, it will be ever more tempting to try to plan for the social consequences of the coming biomedical interventions in this arena. However, this will remain a daunting task, because the larger consequences of the arrival of antiaging interventions will greatly depend on the relative character and timing of the specific procedures that emerge. Three basic classes of interventions are likely: ones that slow aging in adults, ones that reverse aging in adults, and embryonic interventions that modify the overall trajectory of human aging. The consequences of each will differ significantly in the time required before noticeable demographic shifts begin to manifest in the human population, and in the social and political changes the interventions evoke. The specific societal consequences generally will arrive long before the demographic ones, and will hinge on the technical details of the interventions themselves--their complexity, physiological targets, modes of delivery, costs, unpleasantness, and the character and frequency of side effects.

Aging↗

Endovascular management of acute symptomatic intracranial arterial occlusion.

OBJECTIVE: Acute ischemic stroke has reached epidemic proportions in the United States, affecting approximately 700,000 people annually. With the recent technological advancements in endovascular devices, clinicians now have tools capable of recanalizing acute intracranial occlusions. The combination of pharmacological thrombolysis and mechanical clot perturbation may result in increased rates of angiographic recanalization, which may lead to improvement in patient outcomes after acute stroke. METHODS: In this article, the various intra-arterial pharmacological and mechanical therapies used by interventionists to treat acute stroke are described. Strategies for using combinations of these therapies are discussed, as are preliminary radiographic and clinical outcomes. Techniques for complex mechanical stroke interventions are discussed in detail. RESULTS: Several advances in endovascular stroke technologies are becoming increasingly available. CONCLUSION: With proper patient selection, these therapies may lead to increased recanalization rates and better patient outcomes.

Acute Disease↗

A new device for the treatment of female stress urinary incontinence.

Treatment for stress urinary incontinence (SUI) comprises a broad range of possible interventions. Non-surgical options include absorbent pads, vaginal weights and cones, biofeedback and minimally invasive techniques such as urethral bulking agents (UBAs). Surgical interventions range in complexity from sling surgery and suspension techniques to more major surgeries such as burch colposuspension. Each option has its challenges and limitations. This paper will focus on UBAs, which are implantable materials whose purpose is to augment urethral tissue function and restore continence. The characteristics required of such materials, and the challenges to be overcome when incorporating them in a successful product design, will be described and discussed. Particular attention will be given to the latest developments in the administration of polydimethylsiloxane elastomer UBA.

Biocompatible Materials↗

Prenatal intervention for urinary obstruction and myelomeningocele.

Widespread use of ultrasonography has resulted in an increase in the recognition of fetal hydronephrosis. The enthusiasm that accompanied early interventions has been tempered by the experience and results obtained over the past 2 decades. The goal has remained the same: to identify patients with serious prenatal obstruction and to identify those which may benefit from intervention. Myelomeningocele remains a devastating congenital anomaly. Fetal and experimental studies suggested that patients with myelomeningocele could benefit from prenatal intervention. Advances in technology and perinatal management have made intervention for more complex malformations such as myelomeningocele possible. This article will review current knowledge and will detail rational management for the management of prenatal hydronephrosis. The current state of antenatal myelomeningocele repair and the urologic implications will be described as well.

Adult↗

Incidence, patterns, and clinical relevance of variant portal vein anatomy.

OBJECTIVE: The purpose of this study was to determine the incidence of variant intrahepatic portal vein anatomy detected on CT portography and to discuss surgical implications. CONCLUSION: Variant portal vein anatomy is nearly as common as variant hepatic artery anatomy. The complexity of hepatic interventions now performed by interventional radiologists and surgeons, including portal vein embolization, anatomic resection, and transplantation, make recognition and understanding of normal and variant portal vein anatomy increasingly important.

Female↗

[Estimation of operator dose by dose area product meter].

Because of the more advanced and more complex procedures in interventional radiology (IVR), longer treatment times have become necessary. Therefore, it is important to determine the exposure doses received by operators and patients. Operator doses arising from the use of X-rays are mainly due to scattered radiation. The purpose of this study was to assess the feasibility of estimating operator dose by dose area product (DAP), which shows the total X-ray output from the collimator. DAP showed a strong correlation with the space dose from the fundamental examination. In clinical practice, we measured the exposure doses of the neck, left shoulder, left hand, and right finger using a thermoluminescence dosimeter (TLD). These then were compared with the DAP. The results indicated that the dose equivalents (H70 microm) of the neck and left shoulder were strongly correlated with DAP (r=0.85, 0.86), whereas the H70 microm of the left hand and right finger were less closely correlated (r=0.40, 0.48). In comparison with the fluoroscopic time, the dose equivalents showed a better correlation with DAP in all the evaluated parts. The effective doses for the operator were strongly correlated with DAP (r=0.87). When measurements are not available, dose equivalents and operator effective doses can be estimated by the DAP, as indicated by the strong correlations recognized in this study.

Computer Systems↗

Anal carcinoma arising from condyloma acuminata.

Condyloma acuminata is a common anorectal condition that frequently requires surgical evaluation and treatment. We have noted an increased incidence of anal carcinoma in patients with condyloma acuminata. The purpose of this study is to review the incidence of malignant transformation of condyloma in our recent experience. We conducted a 5-year retrospective review of patients with condyloma acuminata treated at a university medical center that serves as a major referral center for the state. From May 1994 through May 1999 257 patients were treated for anal condyloma. During the same time period 74 patients were diagnosed with squamous cell carcinoma of the anus; nine of these patients also had condyloma acuminata (12.2% of patients with anal carcinoma). All nine were immunosuppressed by illness and/or medication. The extent of carcinoma at diagnosis ranged from stage 0 (carcinoma in situ) to stage IVb. Overall 3.5 per cent of patients with condyloma acuminata also had squamous cell carcinoma of the anus. One patient with stage IVb disease died shortly after initial evaluation. Two patients with advanced disease required extensive surgical intervention and had complex postoperative courses. Malignant transformation of condyloma acuminata may be increasing in incidence. This disease progression can be insidious and may be fatal. Screening of high-risk patients might be of value, and more aggressive early management of condyloma may prevent the development of malignancy.

Adult↗

Expanding access to early HIV care: new challenges for federal health policy.

Advances in biomedical research have resulted in new standards for HIV treatment that involve earlier intervention with more complex combination antiretroviral therapy. This article examines the implications of these treatments for federally funded programs that provide HIV care and discusses mechanisms for making Medicaid and the AIDS Drug Assistance Program (ADAP) consistent with the treatment standards. The article provides a rationale for expanding access by expanding entitlement programs (Medicaid) rather than discretionary programs (ADAP). A potential legislative approach to Medicaid expansion is described. Cost projections suggest that this approach is feasible and would constitute a significant step toward increasing access to HIV care.

Adolescent↗

Muscle retraining in the ICU patients.

One of the most common causes of an ICU admission is a severe episode of acute respiratory failure due either to an exacerbation of chronic pulmonary disease or its ex-novo development after a surgical procedure, trauma or medical complications. These patients usually report, at admission to the ICU, a sedentary life before the acute episode, because the evolution of the disease is characterized by a progressive decline not only in respiratory function (e.g. FEV1), but also in the functional status, due to the effects of lack of exercise, drug administration, malnutrition and, later on, gas exchange abnormalities. Together with specific vital organ support, such as mechanical ventilation, patients admitted to an ICU may require other complex and integrated interventions in order to maintain the spared function and to prevent further damage. These interventions include nutritional and psychological support, counselling, nursing, prevention (e.g. to preserve skin integrity) and in particular a complete physiotherapic program, that may range from simple help to maintain a correct posture to complete recovery of walking autonomy.

Clinical Trials as Topic↗

Evaluating a mental health assessment for older people with depressive symptoms in general practice: a randomised controlled trial.

BACKGROUND: There is a lack of evidence on the most effective primary care management of older people with minor depression. AIM: To evaluate a follow-up assessment by the community mental health team (CMHT) for older people with depressive symptoms identified by practice nurses at a health check for people over the age of 75 years. DESIGN OF STUDY: A pragmatic randomised controlled trial. SETTING: A single large general practice in Leicestershire. METHOD: Patients receiving a health check administered by a practice nurse and scoring 5 or more on the 15-item Geriatric Depression Scale (GDS15) were randomised to either follow-up by the CMHT or routine general practitioner (GP) care. The GDS15 score was measured at the subsequent health check 18 months later. RESULTS: Forty-seven patients were randomised to CMHT assessment and 46 to routine GP care. Uptake of the intervention was 72% (n = 34). At the follow-up health check a greater proportion of the control group had improved GDS15 scores (P = 0.08). Following assessment, the CMHT recommended their further involvement in the care of 12 patients and this was authorised by patients' GPs in six cases. CONCLUSIONS: A follow-up mental health assessment by a member of the local CMHT was not effective in improving outcomes for mildly depressed older people. Other than random error possible reasons for this include the length of follow-up and a failure to meet raised expectations among the intervention group. If complex referral procedures do not improve outcomes for this group, then specialist community services should play a more prominent part in the training of practice staff to care for their depressed older patients.

Aged↗