Spherical polyvinyl alcohol versus tris-acryl gelatin microspheres for uterine artery embolization for leiomyomas: results of a limited randomized comparative study

PURPOSE: To compare the outcomes of uterine artery embolization (UAE) for leiomyomas with use of tris-acryl gelatin microspheres (TAGM) versus spherical polyvinyl alcohol (PVA) particles. MATERIALS AND METHODS: Patients undergoing UAE were randomly assigned to receive TAGMs or PVA. Embolization was performed in a standardized manner. Outcome data were collected at 3 months after embolization, including assessment of clinical symptoms, scores from a fibroid tumor-specific symptom and quality of life (QOL) questionnaire, and findings on contrast material-enhanced magnetic resonance (MR) imaging, including the degree of tumor infarction and volume reduction. Data were analyzed with use of t tests, the Mann-Whitney U test, and chi2 tests as appropriate. RESULTS: Thirty-six patients were treated. There were no differences in the two treatment groups at baseline. Clinical follow-up was obtained in 35 patients. Among the clinical outcome measures, QOL score improvement was greater for UAE with TAGMs compared with PVA (49.0 vs 27.9; P = .02), but no other differences were noted. Of the 25 patients in whom 3-month MR imaging follow-up was completed, those treated with TAGM were significantly more likely to have complete infarction of all leiomyomas (six patients vs one patient; P = .02), were more likely to have at least 90% tumor infarction (eight patients vs four patients; P = .03), and had a lower mean percent of residual perfused fibroid tumor tissue (9.6% vs 44.3%; P = .004) compared with patients treated with PVA. Based on these differences between the embolic agents, enrollment in this study was terminated. CONCLUSION: The use of spherical PVA particles in the manner described herein results in an unacceptably high rate of failed tumor infarction in UAE.     

Recovery after uterine artery embolization for leiomyomas: a detailed analysis of its duration and severity

PURPOSE: To determine the duration and severity of recovery after uterine artery embolization (UAE) for leiomyomas. MATERIALS AND METHODS: As part of a study comparing different embolic materials used for UAE, detailed data on the severity of postprocedural recovery were gathered in 99 patients. These data included patient-controlled analgesia records, visual analogue scale (VAS) pain scores of daily peak pain levels for 7 days, medication use in the first week, and severity of constitutional symptoms experienced over the course of the first month after the procedure. The VAS scale assesses acute pain severity on a 10-cm linear scale and yields a continuous measure from 1 to 10. The constitutional symptoms were scored based on a questionnaire. The data were analyzed with use of summary statistics, and linear regression analysis was used to determine the impact of various baseline factors on the severity of recovery. RESULTS: The mean peak VAS score for the first 24 hours after UAE was 3.03 (SD, 0.26) and the mean maximum score in the first week was 4.89 (SD, 0.26). Only 11 patients had an in-hospital VAS score greater than 7, and 19 had a VAS score of greater than 7 on any of the first 7 days after discharge. The mean number of oral narcotic tablets used per patient was 10.8 in the first week. Although 33 patients had a temperature higher than normal sometime in the first postprocedural week, high temperature (>38.5 degrees C) occurred in only two patients. There were no differences detected in the measured parameters based on the type of embolic material used. CONCLUSION: Despite the reputation of UAE to the contrary, when current techniques are used, recovery after UAE for fibroids is relatively mild, with few instances of severe pain, high fever, or severe constitutional symptoms.     

Reliability of computer-automated hearing thresholds in cochlear-impaired listeners using ER-4B Canal Phone earphones

This paper describes the second phase of a study to determine test-retest reliability of hearing thresholds using a computer-automated technique with ER-4B Canal Phone insert earphones. The first phase documented reliable hearing thresholds in 20 normal-hearing individuals. For this second phase, 20 individuals with cochlear hearing loss completed the same testing protocol as for phase one. During each of two sessions, hearing thresholds were obtained in one-third octave steps at 500 Hz to 16,000 Hz. The octave frequencies were immediately retested, followed by ear-tip reinsertion and further retesting at octave frequencies. Both groups showed overall good threshold reliability, with observable differences between groups. First, repeated testing resulted in improved hearing thresholds for the normal-hearing group, but not for the cochlear-loss group. Second, the normal-hearing group showed overall better response reliability, both within and between sessions, than the cochlear-loss group. These differences were small but consistent.     

MagScrew TAH: an update

The MagScrew Total Artificial Heart (TAH) system is the result of a close collaboration among the Cleveland Clinic Foundation, Foster Miller Technologies, Wilson Greatbatch Ltd, and Whalen Biomedical Inc. The system components are the thoracic blood pumping unit with attached compliance chamber and refill port, implantable electronic control unit, implantable battery pack, transcutaneous energy transmission system, external battery pack, and a telemetry system for communication with the electronic control unit. System in vitro tests are underway for system characterization and durability demonstration, whereas in vivo tests were conducted to evaluate system performance and biocompatibility under physiologic conditions. The passively filling pump uses a left master alternate left and right ejection control mode and has a Starling law-like response to venous pressure. The in vitro tests documented excellent hydraulic pump performance with high device output of over 9 l/min at left atrial pressures below 12 mm Hg. Atrial balance was well maintained under all test conditions. The in vivo tests demonstrated good biocompatibility without use of anticoagulant therapy. Experimental durations have ranged between 0 and 92 days. Postexplant evaluation of tissue samples did not reveal any sign of thromboembolic events or tissue damage due to device operation.     

Increased 2',5'-oligoadenylate synthetase activity in blood mononuclear leukocytes from patients with advanced cutaneous T-cell lymphoma

The activity of the interferon-induced enzyme 2',5'-oligoadenylate synthetase (2',5' An synthetase) was found to be increased in the lysates of peripheral blood mononuclear leukocytes obtained from 10 of 25 (40%) patients with cutaneous T-cell lymphoma (mycosis fungoides and Sézary syndrome). A positive association was found between the level of mean total synthetase activity and extent of involvement (stage) of disease. However, the leukocytes from two patients with relatively high proportions of neoplastic T-cells in the blood (Sézary syndrome) had negligible enzyme activity. It is speculated that increased interferon production in vivo may account for the observed enzyme changes in normal blood leukocytes from these patients, and that the neoplastic T-cell population is the most likely source of the presumed interferon production. Possible mechanisms and biologic consequences of high levels of endogenous interferon in patients with cutaneous T-cell lymphoma are discussed.     

Rehabilitation of young craniopharyngioma patients

The course of rehabilitation in 11 young patients with craniopharyngeoma was investigated. With intelligence well-preserved, neuropsychological diagnosis revealed impairments in rate and persistence in virtually all patients; behaviour disorders were present in 8 of the 11 patients, with efforts to distinguish psychoorganic from psychoreactive causality however not always successful. The neuropsychological deficits and behavioural deviations mentioned, rather than complications of a medical nature (1 of 11), resulted in only 2 patients having been able to maintain their premorbid educational/vocational status. The rehabilitative outcomes obtained in patients with clear-cut indications of diencephalic lesion (among them variations in vigilance, polyphagia, adipsia) had been unsatisfactory, whereas, in the other behaviourally disordered patients, successful outcomes were achieved by a therapeutic approach tailored to the specific needs of the individual condition.     

Comparison of ABR stimuli for the early detection of ototoxicity: conventional clicks compared with high frequency clicks and single frequency tonebursts

Effective objective testing methodology is needed for early detection of the effects of ototoxicity on hearing in patients. The requirements for such testing include responses that are: 1) reliable across test sessions; 2) sensitive to ototoxic change ( > 8 kHz), and 3) recordable in a time-efficient manner. Auditory brainstem responses (ABR) appear well suited to this task however, conventional clicks stimulate primarily mid-frequencies (1-4 kHz) and high frequency tonebursts require too much time. We hypothesized that delivery of a band of high frequencies (a high frequency "click"), would elicit reliable and useful ABRs. In the current study, flat and sloped HF (high frequency) clicks with a bandwidth of 8-14 kHz were used. The purpose was to compare brainstem responses elicited by tonebursts, two HF clicks and conventional clicks. The results show that the reliability of responses to the HF clicks were comparable to the tonebursts and further, both HF clicks produced responses slightly larger than tonebursts.     

Missouri rural adolescent pregnancy project (MORAPP)

The purpose of this study was to investigate the pregnancy outcomes and services available to adolescent women in Missouri, comparing rural and urban residents. A secondary analysis of a large public use data set obtained from the Missouri Department of Health was done for the 5-year period 1992 to 1996. Data were collected by county, with each of the 114 counties of the state classified as rural or urban. The SAS program was used for analysis. Results demonstrated definite patterns of similarity and dissimilarity among the teen mothers based on residence, when age and race were controlled. There were over 54,000 births to adolescent mothers in the 5-year study period. Among the outcomes of pregnancy studied were: abortion rates, inadequate weight gain, intrauterine growth retardation, and low-birthweight (LBW) infants. Among the services available to the young mothers that were studied were fertility services, WIC (women, infants, and children supplemental nutrition) program, food stamps, and Medicaid coverage for pregnancy and infant care. The outcomes are probably generalizable to Midwestern, rural/urban states similar to Missouri.