In vitro particulate and in vivo drug retention study of a novel polyethylene oxide formulation for drug-coated balloons.

OBJECTIVE: The purpose of this study was to investigate the newly developed drug-coated balloon (DCB) using polyethylene oxide (PEO) as a platform and to compare it directly with a commercially available DCB in a preclinical experimental setting. METHODS: The PEO balloon was characterized for coating morphology and degree of paclitaxel (PAT) crystallinity. PAT tissue levels were then measured up to 30 days in a healthy porcine model (10 swine, 20 vessels) after treatment with either a PEO balloon or a commercially available DCB. An in vitro bench-top model was used to compare the particulates released from the PEO balloon and commercially available DCB. RESULTS: The coating on the PEO balloon was smooth and homogeneous with PAT in its amorphous state. From the porcine survival study, the PAT tissue levels were comparable between PEO balloon and commercially available DCB after 7 days of treatment. Both the PEO balloon and the commercially available DCB retained therapeutic drug up to 30 days. During the simulated in vitro model, the PEO balloon shed significantly fewer particulates that were smaller than those of the commercially available DCB. Most important, the PEO balloon shed 25 times fewer large particulates than the commercially available DCB. CONCLUSIONS: The amorphous PAT in the PEO balloon provided comparable drug tissue retention levels to those of the commercially available DCB and fewer particulates. Thus prepared PEO balloon proved to be safe and effective in the preclinical experimental setting. The clinical outcomes of these findings need further investigation.

Shear accumulation as a means for evaluating risk of thromboembolic events in novel endovascular stent graft designs.

OBJECTIVE: This study proposes to establish a simulation-based technique for evaluating shear accumulation in stent grafts and to use the technique to assess the performance of a novel branched stent graft system. METHODS: Computational fluid dynamics models, with transient boundary conditions, particle injection, and rigid walls, simplifying assumptions were developed and used to evaluate the shear accumulation in various stent graft configurations with a healthy aorta as comparison. RESULTS: Shear streamlines are presented for the various configurations. Shear accumulation was also calculated for each configuration. The number of particles with shear accumulations >3.5 Pa-s for each configuration was compared with the shear accumulation values of commercially available mechanical aortic valves from the literature. CONCLUSIONS: The stent graft configuration with the diaphragm does have particles with shear accumulation >3.5 Pa-s. However, the percentage of particles with shear accumulation above 3.5 Pa-s is less than the two commercially available mechanical aortic valves, and more surprisingly, is smaller than in the healthy aorta.

Burning Tongue as Initial Presentation of Celiac Disease in an Elderly Woman: A Case Report.

There are few reports in the literature where celiac disease presents with tongue manifestations, although atypical presentations of celiac disease are not uncommon. This case report highlights an atypical presentation of celiac disease in an elderly female. Our patient presented to clinic with complaints of a burning tongue for the past two years as well as occasional loose stools and fatigue. Work-up revealed iron deficiency anemia, zinc deficiency and an abnormal celiac panel. Complete symptom improvement was noted by 10 weeks into the initiation of a gluten free diet. Celiac disease can present at any age and should be considered as a differential in findings of malabsorption and gastrointestinal symptoms.

Stigmatizing experiences of parents of children with a new diagnosis of ADHD.

OBJECTIVE: The experiences of parents of a child who received an initial diagnosis of attention-deficit hyperactivity disorder (ADHD) were examined to determine the ways in which they may have encountered stigmatizing situations. METHODS: Forty-eight parents of children aged six to 18 years were interviewed about their experiences leading up to their child's ADHD diagnosis, including their decisions to seek treatment. All interviews were recorded, transcribed, and analyzed using grounded theory methods. Codes were identified using a constant comparative approach, which led to theoretically defined thematic constructs of stigma. RESULTS: Stigmatizing experiences were noted by 77% of the sample. Nearly half (N=21, 44%) were concerned about how society would label their child, 40% (N=19) felt social isolation and rejection, and 21% (N=10) perceived health care professionals and school personnel as being dismissive of their concerns. Parents' own attitudes about ADHD treatment were shaped by their exposure to negative media (N=10, 21%), their mistrust of medical assessments (N=8, 17%), and the influence of general public views (N=3, 6%). These stigmatizing views were related to parental concerns about the impact that diagnosis and treatment would have on their child's self-esteem and opportunities for future success. CONCLUSIONS: The range of ways in which parents in the study experienced stigma highlights the need for multiple perspectives for community outreach and public health programs that are aimed at addressing and eliminating mental health stigma. Even though stigma is a well-established barrier to mental health service use, the anticipated benefits of treatment may outweigh parents' experiences with stigma.

Transforming personal care through ritual.

The philosophical and theoretical framework of transforming personal care through ritual is based on 5 assumptions: 1) routinization is not necessarily a good thing; 2) individuals who are deprived of "other ways" of knowing, of experiencing the everyday, will have a felt sense of helplessness and hopelessness; 3) personhood relies on memory and on the frames we construct to interpret and explain the world; 4) having a sense of purpose affects health and well-being; and 5) caregiver self-care increases productivity and well-being. The approach discussed in this article suggests that the opportunity for other ways of "doing" should be injected into the daily routine of care giving and care receiving. In fact, the American Nurses Association Code of Ethics for Nurses holds that a nurse is as morally obligated to care for his or her self as for others; this would certainly apply as well to the personal care staff in assisted living. This article discusses the key concepts that support the introduction of ritual into long-term care practice, champions, a ritual "toolkit," self-care rituals, and 2 rituals for assisted living residents: moving into their new homes/rooms and relinquishing their driver's licenses.

Cervical carcinosarcoma: a case report.

BACKGROUND: Carcinosarcomas are rare neoplasms of the female genital tract. They tend to be highly aggressive and are generally associated with a poor prognosis. Carcinosarcomas of the uterine cervix are extremely rare, with only approximately 35 cases previously reported in English. CASE: A 68-year-old woman presented with cervical carcinosarcoma. She remained without evidence of recurrent disease for 18 months after surgical resection and pelvic radiation treatment. CONCLUSION: In a review of all cases reported in the literature, it appears that cervical carcinosarcomas tend to present at an earlier stage than carcinosarcomas of the uterine corpus, therefore allowing early diagnosis and treatment. They may therefore be associated with a better overall prognosis than their counterparts in the corpus. Some studies have shown improved survival of patients of carcinosarcoma of the uterine corpus whose treatment included postoperative radiation and chemotherapy. Due to the better prognosis of cervical carcinosarcomas, we suggest studies to evaluate the role of aggressive, multimodal therapy, with the intent of obtaining a cure of cervical carcinosarcomas.

Bioterrorism and Emergency Preparedness in Aging (BTEPA): HRSA-funded GEC collaboration for curricula and training.

Frail elders living alone or in long-term care settings are particularly vulnerable to bioterrorism and other emergencies due to their complex physical, social and psychological needs. This paper provides an overview of the recent literature on bioterrorism and emergency preparedness in aging (BTEPA); discusses federal initiatives by the health resources and services administration (HRSA) to address BTEPA; describes the collaborative efforts of six HRSA-funded geriatric education centers (GECS) to develop BTEPA geriatric curricula and training; and offers recommendations for BTEPA education and training, clinical practices, policy, and research. The GEC/BTEPA collaboration has produced model curricula, including emergency planning for diverse groups of older persons; enhanced networking among stakeholders in a fast paced environment of information sharing and changing policies; and developed interdisciplinary educational resources and approaches to address emergency preparedness for various settings in the elder care continuum.

Impact of transplanted fibroblasts on rabbit skin wounds.

OBJECTIVES: To determine the effect of injected fibroblasts on full-thickness cutaneous wounds and to distinguish between the properties of fetal vs adult fibroblasts. DESIGN: Full-thickness cutaneous wounds were created by incision in the skin of adult New Zealand white rabbits and treated with fluorescently labeled autogenic, allogenic, and xenogenic fetal and adult fibroblasts. Wound healing was evaluated by histologic analysis and tensiometry over time. SUBJECTS: A total of 9 New Zealand white rabbits with 24 wounds per animal were examined in this study. Groups of 3 animals were treated with different fibroblasts and euthanized at 7, 14, and 28 days after manipulation. INTERVENTION: Fibroblasts were labeled with a fluorescent dye (CM-DiI) and suspended in a hyaluronic acid gel. The cell-gel mix was used to treat full-thickness incisional wounds in rabbit skin. Imaging of CM-DiI determined the quantity and the migratory patterns of the transplanted fibroblasts present in the wounds. Tensiometry characterized the mechanical properties of the healed connective tissue. RESULTS: Transplanted fibroblasts exhibited good survival and migration patterns. Cell therapy increased the tensile strength of the wounds. Allogenic fetal and autogenic adult fibroblasts achieved similar effects. CONCLUSIONS: Cell therapy is a viable approach to significantly affect the course of normal cutaneous wound healing, and cell lines from genetically unrelated donors do not appear to be disadvantaged by a host immune response compared with autogenic cell lines.