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Biomedical subjects

J Weinberger

Publications and source records attributed to J Weinberger.

At least 19 recordsLinked to original sources
PubMed2006

Characterisation of a novel high-purity, double virus inactivated von Willebrand Factor and Factor VIII concentrate (Wilate).

This study summarises the biochemical and functional properties of a new generation plasma-derived, double virus inactivated von Willebrand Factor/Factor VIII (VWF/FVIII) concentrate, Wilate, targeted for the treatment of both von Willebrand disease (VWD) and haemophilia A. The manufacturing process comprises two chromatographic steps based on different performance principles, ensuring a high purity of the concentrate (mean specific activity in 15 consecutive production batches: 122 IU FVIII:C/mg total protein) and, thus, minimising the administered protein load to the patient (specification: < or = 15 mg total protein per 900 IU Wilate). The optimised solvent/detergent (S/D) treatment and prolonged terminal dry-heat (PermaHeat) treatment of the lyophilised product at a specified residual moisture (RM) provide two mechanistically independent, effective and robust virus inactivation procedures for enveloped viruses and one step for non-enveloped viruses. These process steps are aggressive enough to inactivate viruses efficiently, but yet gentle enough to maintain the structural integrity and function of the VWF and FVIII molecules, as proven by state-of-the-art assays covering the diverse features of importance. The VWF multimeric pattern is close to the one displayed by normal plasma, with a consistent content of more than 10 multimers, but a relatively lower portion of the very high multimers. The multimeric triplet structure is normal, underlining the gentle and effective manufacturing process, which does not require the addition of protein stabilisers at any step. The balanced activity ratio of VWF to FVIII is close to that of plasma from healthy subjects, rendering Wilate suitable also for the safe and effective treatment of patients with VWD.

Blood Proteins↗
PubMed2003

[The time-course of action of rapacuronium and mivacurium after early reversal following equally lasting relaxation].

This study was designed to compare the time course of action and the safety profile of Rapacuronium and Mivacurium in day case dental surgery. After Ethics Committee approval 61 healthy adult patients, scheduled for dental day case surgery, were randomised in an assessor-blinded manner to receive either 1.5 mg/kg Rapacuronium with and without 0.05 neostigmine 5 min later (19 patients each) or a total of 0.25 mg/kg Mivacurium (n = 16). Anaesthesia was induced using Propofol 2 - 5.1 mg/kg and Remifentanil 24 - 73 mcg/kg/h and maintained with Desflurane in N2O/O2 (2/1). Endotracheal intubation was performed when maximum blockade was achieved and scored by a blinded intubator. Neuromuscular block was monitored using the train-of-four response to supramaximal stimuli at the ulnar nerve every 15 seconds using acceleromyography (TOF Watch SX). Onset time, clinical duration (reappearance of the third twitch of a TOF-stimulation) and recovery to T4/T1 > 0.9 were recorded. Speed of recovery was evaluated by the time difference between reappearance of the third twitch and T4/T1 > 0.9. The intubating conditions at the time of maximum block revealed no statistically significant differences between the three groups. Changes in blood pressure, heart rate and airway pressure were not significant. Onset time in subjects who received Rapacuronium (99 +/- 29 s) was faster compared to the onset time in those who received Mivacurium (157 +/- 36 s). Also clinical duration was significantly shorter following Rapacuronium without reversal (12 +/- 4 min) as well as with reversal (9 +/- 1 min) compared with Mivacurium (21 +/- 5 min)). Patients treated with Rapacuronium and reversal recovered faster (14 +/- 8 min)) compared to the other two groups (Mivacurium: 20 +/- 6 min, Rapacuronium without reversal: 31 +/- 9 min). The fraction of clinical duration of the total duration was highest following Mivacurium (51 %) when compared with Rapacuronium/Neostigmine (43 %) and Rapacuronium (28 %).

Adolescent↗
PubMed2002

[Motor function during patient-controlled analgesia via a lumbar epidural catheter after major abdominal surgery. Ropivacaine-sufentanil vs. bupivacaine-sufentanil].

INTRODUCTION: The aim of the present study was to investigate postoperative motoric impairment during patient-controlled analgesia after major abdominal surgery with ropivacaine-sufentanil and bupivacaine-sufentanil via a lumbar epidural catheter. METHODS: After approval of the local ethics committee, 40 patients scheduled for major lower abdominal surgery were randomly allocated to receive bupivacaine 0.25 % or ropivacaine 0.2 %, both with sufentanil 2 microgram/ml in a double blind manner. General anaesthesia (midazolam, etomidate, fentanyl, vecuronium, and desflurane in N2O/O2) and postoperative management of the patients were standardised. Postoperatively, the motoric function and ability for active early mobilisation was examined clinically (application of the Bromage scale, ability to leave the bed and ability to walk). Reduction of muscular force of the legs was measured postoperatively using a scale and compared with preoperative baseline values. To ensure a similar level of analgesia, a 10-cm visual analogue scale was applied at rest and while coughing. RESULTS: The two groups did not differ with respect to the demographic data and postoperative levels of analgesia. Less reduction of motoric function at rest was observed in the ropivacaine group (p = 0,044). However, this did not lead to an increased ability to get up from bed (p = 0,57) or to walk around (p = 0,17). A high number of patients did not meet the requirements for early ambulation. Almost half of the patients of both groups were unable to leave their beds in the morning of the first postoperative day. On the second postoperative day about 25 - 30 % of the patients could not walk even when support was applied. Furthermore, median reduction (10th/90th percentile) of muscular strength was reduced to 50 % (37 %/76 %) in the ropivacaine group and to 48 % (31 %/61 %) in the bupivacaine group compared with preoperative values. DISCUSSION: While quality of analgesia was similar, mobility of the legs at rest is better preserved with ropivacaine 0.2 % than with bupivacaine 0.25 %. However, despite the fact that high dose sufentanil was added to both local anaesthetics, there was marked motoric impairment in both groups probably due to the lumbar site of the epidural catheter. This was associated with an unacceptable high incidence of patients unsuitable for early postoperative mobilisation.

Amides↗
PubMed2002

3D dosimetry study of 188Re liquid balloon for intravascular brachytherapy using bang polymer gel dosemeters.

It has been suggested that the combination of intravascular brachytherapy and coronary stent implantation may result in further reduction of restenosis after percutaneous balloon angioplasty. The use of an angioplasty balloon filled with a 188Re liquid beta source for intravascular brachytherapy provides the advantages of accurate source positioning and uniform dose distribution to the coronary vessel wall. The effect of source edge and stent on the dose distribution of the target tissue may be clinically important. In BANG gels, the absorbed radiation produces free-radical chain polymerisation of acrylic monomers that are initially dissolved in the gel. The number of polymer particles is proportional to the absorbed dose. In this study, 3D dose distributions are presented for 188Re balloons, with and without stents, using a prototype He-Ne laser CT scanner and the proprietary BANG polymer gel dosemeters.

Brachytherapy↗
PubMed2001

Encapsulation of isotope on novel beta-emitting poly(ethylene terephthalate) surfaces.

Recent data indicate that intravascular betaa-irradiation from centrally located sources at the time of balloon angioplasty or stenting reduces proliferation of smooth muscle cells, neointima formation, and restenosis. In an effort to simplify radiation delivery, a novel beta-radiation source was developed based on the adsorption of 32P (phosphoric acid) by pH-sensitive chitosan hydrogel on a poly(ethylene terephthalate) balloon surface. To prevent the 32P-isotope desorption in the patient's blood, the adsorbed phosphoric acid was precipitated as CaHPO4 on the surface by a saturated Ca(OH)2/5% CaCl2 solution. Various polyurethanes were applied to seal the radioactive surface by the dip-coating method. The isotope off-rate results were determined. Optimal results were obtained by serially coating with two polyurethane solutions. This approach holds promise for simplifying and improving the safety, and minimizing the cost of intravascular brachytherapy.

Adsorption↗
PubMed2001

Vertebral artery dissection in Turner's syndrome: diagnosis by magnetic resonance imaging.

Aortic artery dissection is a rare but well-recognized complication of Turner's syndrome. Isolated carotid or vertebral artery dissection has not previously been reported. The authors report the clinical and magnetic resonance imaging findings in a 30-year-old woman with Turner's syndrome who developed a high cervical spinal cord infarction with a Brown-Sequard syndrome owing to bilateral vertebral artery dissection. The diagnosis and management of the case is reviewed.

Adult↗
PubMed2000

Novel beta-emitting poly(ethylene terephthalate) surface modification.

Restenosis after percutaneous interventions in coronary and peripheral arteries leads to repeat procedures and surgery in a significant number of patients. We have previously demonstrated that irradiation of an arterial site using an endovascular source (brachytherapy) is highly effective in preventing the restenotic process. To this end, a novel beta radiation delivery system was developed, based on the adsorption of (32)P (o-phosphoric acid) by pH-sensitive chitosan hydrogel on a poly(ethylene terephthalate) (PET) balloon surface. The PET balloon surface was treated with oxygen plasma and coated with chitosan hydrogel. Covalent bonds, ionic bonds, and hydrogen bonds all contribute to the adhesion between chitosan hydrogel and PET. In the aqueous phosphoric acid (PA) solution, the -NH(2) groups of chitosan were protonated by PA and the adsorption of PA occurred at the same time. The effect of PA concentration and temperature on adsorption efficiency and kinetics were studied. More than 70% PA was adsorbed on the sample surface in 0.2 mM PA solution. The surface of samples was also investigated by attenuated total reflection-Fourier transform infrared spectroscopy and scanning electron microscopy. PET surface may be modified to carry high activity beta emitters; such materials may be useful in a therapeutic setting

Adsorption↗
PubMed2000

Natural history of aortic arch atherosclerotic plaque.

To define the natural history of aortic arch plaque, we used B-mode ultrasonography to perform sequential study of the aortic arch. Eighty-nine patients were studied for up to 18 months. There was no change in 67% of total plaques; 77% of simple plaque (<4 mm) and 48% of complex plaque (> or =4 mm) did not progress. Atherosclerosis of the aortic arch can be sequentially studied with B-mode ultrasonography, and most of these lesions remain unchanged after up to 18 months of observation.

Aged↗
PubMed2000

Plaque morphology correlates with cerebrovascular symptoms in patients with complex aortic arch plaque.

BACKGROUND: Studies of aortic arch plaques with transesophageal echocardiography have demonstrated that complex aortic arch plaques (CAPs) greater than or equal to 4 mm in thickness are associated with ischemic stroke. Recent studies have demonstrated that the morphological features of plaques may aid in the identification of aortic plaques that are more likely to be associated with embolic stroke. OBJECTIVE: To identify aortic plaques that are more likely to be associated with embolic stroke by means of their morphological features. METHODS: Transcutaneous B-mode ultrasonography was used to image aortic arch plaques in 500 consecutive patients. The criteria used to identify the morphological features of carotid artery plaques that are more likely to be associated with ischemic stroke (heterogeneous rather than homogeneous) were applied to aortic arch plaques. Statistical comparisons were made using the Fisher exact test. RESULTS: Ischemic symptoms (eg, stroke, transient ischemic attack, and amaurosis fugax) were present in 38% of 104 patients with CAP and in 34% of 391 patients without CAP. Nineteen (51%) of 37 patients with heterogeneous CAP were symptomatic. Twenty-one (31%) of 67 patients with homogeneous CAP were symptomatic (P = .04). CONCLUSION: Transcutaneous B-mode ultrasonography of the aortic arch can help to identify heterogeneous plaques that are more likely to be associated with ischemic stroke using morphological criteria derived from studies of carotid artery plaque.

Amaurosis Fugax↗
PubMed2000

William James and the unconscious: redressing a century-old misunderstanding.

Contrary to received wisdom in psychology, William James did not oppose postulating unconscious processes. This mistaken belief stems from a misreading of a passage in his Principles concerned with disproving the metaphysical notion that mental states are composed of elementary mental units. The term unconscious had been co-opted by individuals who supported this position. Unconscious did not mean then what it means now. Analysis of the rest of the Principles, his later works, and his reactions to the works of others reveals that James actually supported what we would now term unconscious processes. He even contributed to their study with his notions of the "fringe," "habit," and "subconscious incubation." Causes and effects of this misunderstanding are discussed.

History, 19th Century↗
PubMed1999

Antiphosphatidyl serine antibodies are independently associated with ischemic stroke.

OBJECTIVE: To determine whether elevated titers of antiphosphatidyl serine antibodies (aPS) are associated with an increased risk of ischemic stroke in a general stroke population. BACKGROUND: aPS are members of the family of antiphospholipid antibodies that has been associated with increased stroke risk. Although aPS have been demonstrated to occur in 18% of a group of young patients with cerebrovascular symptoms, their prevalence in the general stroke population is unknown, and no controlled study to assess the strength of their association with ischemic stroke has been undertaken previously. METHODS: A case-control study comparing 267 acute ischemic stroke patients and 653 community controls. Sera were obtained immediately after acute stroke in patients. Titers of IgG aPS >16 IgG phospholipid units or IgM aPS >22 IgM phospholipid units were considered positive. Odds ratios (ORs) were obtained by logistic regression, adjusting for age, gender, race/ethnicity, history of hypertension, diabetes mellitus, cardiovascular disease, and cigarette smoking. RESULTS: The adjusted OR was 5.6 (95% confidence interval [CI] 1.8, 18.0) for IgG aPS and 2.9 (95% CI 1.6, 5.3) for IgM aPS. The adjusted OR for either an elevated IgG or IgM aPS was 3.2 (95% CI 1.8, 5.5). CONCLUSIONS: This study demonstrates that elevated IgG and IgM antiphosphatidyl serine antibodies titers are associated with increased risk of ischemic stroke. The prevalence of these antibodies is lower, but the associated stroke risk is comparable with that of anticardiolipin antibodies.

Aged↗
PubMed1999

Patient preferences for heart failure treatment: utilities are valid measures of health-related quality of life in heart failure.

BACKGROUND: Current standards hold that cost-effectiveness analyses should incorporate measures of both quantity and quality of life, and that quality of life in this context is best measured by a utility. We sought to measure utility scores for patients with heart failure and to assess their validity as measures of health-related quality of life (HRQL). METHODS AND RESULTS: We studied 50 patients with heart failure. We measured utilities with the time trade-off technique, exercise capacity with a 6-minute walk test, and HRQL with the Minnesota Living With Heart Failure questionnaire, the Medical Outcomes Study Short Form-36 (SF-36) questionnaire, and a visual analogue score. Validity was assessed by establishing correlation between utilities and these other measures. Mean utility score was 0.77 +/- 0.28. There were significant (P < .05) curvilinear relationships between utility score and visual analogue score, the physical function summary scale of the SF-36, 6-minute walk distance, and the Living With Heart Failure score. Utility scores on retest at 1 week were unchanged in a subset of 12 patients. Utilities did not vary systematically with age, sex, or ethnicity. CONCLUSION: Utilities are valid measures of HRQL in patients with heart failure, and cost-effectiveness analyses of heart failure treatments incorporating utilities in the outcome measure can be meaningful.

Adult↗
PubMed1999

Gunshot wounds to the hand: management and economic impact.

Low-velocity firearms represent the majority of civilian gunshot wounds to the hand, yet much of the literature is based on high-velocity injuries. The authors reviewed their treatment regimen for civilian gunshot wounds to the hand and offer a treatment algorithm that emphasizes early debridement and fracture stabilization. They also address the economic impact on society. The authors reviewed 121 fractures in 90 patients with gunshot wounds to the hand treated at an urban trauma center during the last 5 years. All patients were managed with irrigation and debridement, elevation, intravenous antibiotics, and early fracture stabilization. Sixty fractures were managed with rigid internal or external fixation: Kirshner wires (26%), miniplates (16%), and external fixation (8%). Fifty-six fractures were managed with closed reduction. Five fractures required amputation. There was one subsequent infection and two late amputations. The cost of hospitalization and operative care was more than $1.7 million. For gunshot wounds to the hand the authors advocate immediate irrigation and debridement, intravenous antibiotics, early fracture stabilization, and a low threshold for internal fixation. This regimen is supported by their low infection and complication rates.

Algorithms↗
PubMed1999

Doppler pulse waveform analysis of carotid and middle cerebral artery flow in a patient with an intra-aortic balloon pump.

A 60-year-old man with intractable congestive heart failure (CHF) had an intra-aortic balloon pump placed to augment coronary artery perfusion. During the evaluation prior to heart transplant, carotid and transcranial Doppler ultrasonography (TCD) was performed. The authors report the findings of Doppler waveform analysis and the presence of balloon pump artifact which caused difficulty in distinguishing between internal and external carotid arteries. Higher blood flow velocity during diastole and diastolic runoff characteristically seen while insonating the internal carotid artery enabled that distinction.

Artifacts↗
PubMed1999

Elevated anticardiolipin antibody titer is a stroke risk factor in a multiethnic population independent of isotype or degree of positivity.

BACKGROUND AND PURPOSE: Previous studies have produced conflicting results regarding the putative association between anticardiolipin antibodies (aCL) and infarction in the general stroke population. These inconsistencies may be a function of sample size and methodological differences among the studies. The purpose of the present study, the largest case-control study of this issue to date, was to assess aCL status as an independent risk factor for ischemic stroke in a multiethnic, urban population. METHODS: We obtained aCL titers in 524 hospitalized acute stroke patients and 1020 community controls enrolled in the Minorities Risk Factors and Stroke Study. The results were interpreted as negative (</=22.9 IgG phospholipid [GPL] or 10.9 IgM phospholipid [MPL] units), low positive (22.9 to 30.0 GPL or 10.9 to 15.0 MPL units), or high positive (>30.0 GPL or 15.0 MPL units). Odds ratios (ORs) were adjusted for age, sex, race/ethnicity, history of diabetes, hypertension, atrial fibrillation, coronary artery disease, and current cigarette smoking. RESULTS: A positive aCL titer was present in 11% (111/1020) of controls and 34% (180/524) of cases. The adjusted OR for any positive aCL titer was 4.0 (95% CI, 3.0 to 5.5). For any positive IgG aCL titer this value was 3.9 (95% CI, 2.8 to 5.5), and for any positive IgM aCL titer it was 3.4 (95% CI, 2.1 to 5.5). There were no significant differences in ORs associated with high- or low-positive IgG or IgM aCL titers. CONCLUSIONS: In the largest study of its kind to date, aCL antibodies were demonstrated to be independent stroke risk factors across the 3 ethnic groups studied, conferring a 4-fold increased risk of ischemic stroke. IgG and for the first time IgM aCL were each shown to be associated with increased stroke risk. The prevalence of these antibodies and the stroke risk associated appear greater than previously reported.

Acute Disease↗
PubMed1998

Intracoronary radiation for prevention of restenosis: dose perturbations caused by stents.

BACKGROUND: Intravascular irradiation with beta-emitters has been proposed for inhibition of restenosis in coronary arteries after balloon angioplasty or stent implantation. Previous studies have shown the effectiveness of gamma-radiation to prevent recurrent restenosis, even in the presence of an implanted stent. The limited range of beta-particles compared with gamma-radiation, however, opens the question of whether absorption and scattering of beta-particles by stent struts will cause significant perturbations in the uniformity and magnitude of the radiation dose, which may in turn compromise treatment. METHODS AND RESULTS: Nine different stents were deployed with a balloon filled with a beta-emitting radioactive liquid. Dose distributions were measured with Gafchromic film. Stents varied significantly in their absorption of beta-particles. Some stents, constructed of fine meshed wires, produced minimal dose perturbations. Others, with thicker, high-atomic-number struts, induced cold spots in the dose distribution adjacent to the wires of </=35%. Average dose reduction varied from 4% to 14% in the presence of various stents. CONCLUSIONS: Radiation strategy may have to be tailored to stent design. Stents that minimally perturb the dose distribution may be deployed before irradiation. Those that significantly alter the radiation dose might be better deployed after irradiation. Dose prescriptions may require modification if such perturbations prove clinically significant. Observed dose perturbations, however, decreased rapidly with increasing distance from the stent, which may mitigate the clinical impact of these findings. This, as well as the effects of stents on gamma-dose distributions, requires further investigation.

Angioplasty, Balloon, Coronary↗
PubMed1998

Intracoronary radiation using radioisotope solution-filled balloons.

A substantial body of experimental evidence suggests that local application of radiation at sites of angioplasty or stent implantation prevents neointima formation. Recent initial clinical studies report a significant reduction in clinical restenosis rates when gamma emitting radiation sources are used to treat the site of coronary intervention. Because of the energy of therapeutic gamma sources and the shielding requirements, it would be far preferable to deliver ionizing radiation using a local beta emitter. This report discusses a number of the physical, biological, and technical parameters involved in radiation from a balloon angioplasty catheter filled with a beta emitting radioisotope solution.

Angioplasty, Balloon, Coronary↗