The Angelchik antireflux device: a 5-year experience.

A total of 44 patients had an Angelchik antireflux prosthesis inserted over a 5-year period. Of these, 41 were available for review and were assessed by interview using a modified Visick grading. Of the 23 patients followed up for a minimum of 3 years 74% had an excellent or satisfactory outcome; 92% of patients with symptoms of reflux obtained relief, but less than 50% of those patients presenting with dysphagia had a satisfactory outcome. The incidence of mild postoperative dysphagia increased the longer the period of follow-up. The main cause of a Visick 3 or 4 result was prosthesis migration. We have modified our technique of insertion to reduce these complications, and in a more recent series have achieved a Visick Grade 1 or 2 in up to 92% of patients. We conclude that dysphagia is a relative contraindication to the insertion of the Angelchik prosthesis. Our recent results encourage the use of the prosthesis provided steps are taken to reduce the incidence of migration and pericapsular fibrous tissue formation.     

Fibrin glue-antibiotic suspension in the prevention of prosthetic graft infection

The following study was done to assess whether fibrin glue-antibiotic suspension (FGAS) can prevent infection of a PTFE vascular graft in a contaminated wound. METHODS: FGAS was made by combining cryoprecipitate with a mixture of bovine thrombin, aminocaproic acid, and tobramycin (5 mg/cc thrombus). Antibiotic activity was documented by in vitro kinetics which revealed initial elutions to be greater than 8,000 mu gm/cc and elutions at 4 days to be greater than 2 mcg/cc. Twelve dogs had a 1-cm section of infrarenal aorta replaced with a PTFE graft that had been bathed in a 2-cc solution of E. coli 3 x 10(8) CFU/ml and S. aureus 3 x 10(8) CFU/ml. Both organisms were sensitive to tobramycin and cefonicid. Dogs were divided into three groups of four. Group I had a contaminated PTFE graft placed and no further therapy. Group II had a contaminated PTFE graft placed and sealed with fibrin glue. Group III had a contaminated PTFE graft placed and sealed with FGAS. All three groups received daily IV cefonicid. RESULTS: Group I: Four of four dogs were reoperated on the fourth day for suspected sepsis and all four had pseudoaneurysms (one ruptured). Three of four were culture positive for S. aureus and two of four positive for E. coli. Group II: Four of four died of anastomotic disruption by the third day. Four of four were culture positive for S. aureus and E. coli. Group III: All four dogs survived and were sacrificed on Day 17: all anastomoses were normal. Animal survival was significantly associated with the treatment given (p = 0.0025). Three of four tissue cultures of the grafts were weakly positive for S. aureus and one of four for E. coli and Pseudomonas. Serum tobramycin levels were negligible at 12, 24, 72, and 96 hours. CONCLUSIONS: The data show that FGAS was associated with a reduction in vascular graft infection and pseudoaneurysm formation after exposure to a standardized bacterial inoculum. Whether complete eradication of all organisms can be achieved with higher doses of tobramycin is as yet undetermined.     

Impact of mandibular condyle preservation on patterns of failure in head and neck cancer.

OBJECTIVE: To determine the role of native condyle preservation in local recurrence after segmental mandibulectomy in patients with head and neck squamous cell carcinoma. METHODS: Retrospective chart review with main outcome measuring local control of cancer. RESULTS: Between 1994 and 2003, 72 patients (48 men, 24 women) with an average age of 73.5 years without previous treatment underwent segmental mandibulectomy. Fifty-four cases (n = 54) involved the mandible posterior to the mental foramen and are the subject of this review. In 36 patients, the condyle was preserved and mandibular continuity was restored. In 18 patients, condyle and ramus were resected without mandibular reconstruction. Reconstructive modalities included primary closure (3), split-thickness skin graft (3), pedicle flap (19), and free tissue reconstructions (29). Overall local-regional recurrence rate was 22 percent (12 of 54); no recurrences were identified in patients who underwent condylar resection. Recurrences were observed in patients with mandibular reconstruction by both plate and pedicle flap (5 of 9) or (osteo) myocutaneous free flap (7 of 27). CONCLUSION: Condylar preservation may predispose patients to local recurrence after segmental mandibulectomy. This does not translate into overall reduction in survival.     

Deterioration in quality of life and depressive symptoms during radiation therapy for head and neck cancer.

OBJECTIVE: The aim of this study was to assess the quality of life and psychologic profile during radiation therapy for head and neck cancer. STUDY DESIGN AND SETTING: The University of Washington QoL instrument and the Hospital Anxiety and Depression Scale were administered to 202 patients at two or three time points during radiation therapy. RESULTS: A total of 118 (54.6%) patients completed the questionnaires at the beginning and at the end of the study. A mid-treatment dataset was also available for 67 (31.0%) patients. There was a statistically significant deterioration in composite QoL scores (P < 0.000) and a statistically significant increase in depression (P < 0.000). There was no difference in anxiety levels (P = 0.276). CONCLUSION: Patients undergoing radiation are increasingly depressed as treatment progresses, with worsening QoL during the treatment. SIGNIFICANCE: This study underlines the need for good psychologic support during radiation therapy in head and neck cancer.     

Neuropsychological, psychosocial and vocational correlates of the Glasgow Outcome Scale at 6 months post injury: a study of moderate to severe traumatic brain injury patients

Traumatic brain injury (TBI) subjects at Glasgow Outcome Scale levels 3 (severe disability), 4 (moderate disability), 5 (good recovery), and an other injury control group (OIC) were compared in terms of neuropsychological, psychosocial, and vocational functioning 6 months after injury. Subjects were a sample of 100 patients with a moderate to severe traumatic brain injury (TBI) and a matched sample of 30 other injury control subjects (OIC) enrolled in the UCLA Brain Injury Research Center study of TBI outcome. Overall, the results showed a systematic decrease in mean neuropsychological test performance as a function of increasing GOS severity, as well as an increased prevalence of symptoms of depression and lower ratings on measures assessing employability and capacity for self care. TBI patients in the 'severe' and 'moderate disability' groups were distinctly inferior to the 'good recovery' and 'OIC' groups, who were quite similar to each other in terms of cognitive, psychosocial, and vocational outcomes. The results demonstrate overall support for the predictive and concurrent validity of the GOS 6 months post injury. Despite these results, which strengthen the utility and appeal of the GOS for multicentre studies, concerns still remain regarding GOS category 4 (moderate disability), which was shown to lack sufficient discriminability in this study.     

Prevalent vertebral deformities: Relationship to bone mineral density and spinal osteophytosis in elderly men and women

The aims of this study were to ascertain vertebral deformity prevalence in elderly men and women and to describe the association between bone mineral density (BMD) at the lumbar spine and femoral neck, severity of spinal degenerative disease and vertebral deformity prevalence. We performed standardized spinal radiographs in a random sample of 300 elderly men and women participating in the Dubbo Osteoporosis Epidemiology Study, a population-based study of fracture risk factors. Radiographs were read independently by masked observers for the prevalence of vertebral deformity and severity of osteophytosis. BMD was measured by dual-energy X-ray absorptiometry. The prevalence of vertebral deformities was critically dependent on the criterion used. The less strict criteria seemed to overestimate deformities at either end of the spine region analysed. However, irrespective of the criterion used, prevalence of deformity was higher in men than in women (25% vs 20% for the 3 SD criterion, 17% vs 12% for the 4 SD criterion and 27% vs 25% for the 25% criterion). Femoral neck BMD was more strongly associated with vertebral deformities than spinal BMD for the 25% criterion (OR/SD change in BMD 1.39 (p=0.02) vs 1.20 (p=0.19)), 3 SD criterion (OR/SD change in BMD 1.45 (p=0.01) vs 1.10 (p=0.34)) and 4 SD criterion (OR/SD change in BMD 1.98 (p=0.0002) vs 1.68 (p=0.008)). BMD was also more strongly associated with biconcave deformities than either wedge or crush deformities and more so in men than in women. Severity of spinal osteophytosis was not associated with vertebral deformity. In conclusion, femoral neck BMD is at least equivalent to the lumbar spine BMD in strength of association with prevalent vertebral fractures. Spinal osteophytosis falsely elevates BMD without a concomitant decrease in fracture risk, indicating that any interpretation of spinal BMD needs to be adjusted for osteophytosis. These findings support the use of femoral neck bone densitometry in older men and women. Moreover, these data indicate that current criteria for radiological assessment of vertebral deformity are sufficiently loose to include a substantial proportion of non-fractures in the elderly, with important implications for the design of clinical trials. However, irrespective of the criterion used, vertebral deformities in men are at least as common, if not more so, than in women, suggesting that vertebral osteoporotic fractures are overlooked in men.     

Pseudotumoral appearance of small bowel strictureplasty for Crohn's disease

In two patients with Crohn's disease, strictureplasties had been marked operatively by a metal clip, so that definitive location on subsequent small bowel examination was possible. Each stricture-plasty presented radiologically as a short annular constriction with apparently shouldered edges and parallel lumen. Similar radiological features were found in five other patients with strictureplasties, suggesting that a pseudotumoral appearance is characteristic of strictureplasty. Attention is drawn to this finding to avoid confusion with malignancy.     

Effect of Renal Impairment on the Pharmacokinetics and Tolerability of Tiagabine

Summary: Purpose: We wished to determine the effect of renal impairment on the pharmacokinetics and tolerability of the new antiepileptic drug tiagabine (TGB).
Methods: We assessed TGB pharmacokinetics and tolerability in 25 subjects with various degrees of renal function (based on creatinine clearance, n = 4–6 per group) from healthy (group I) to requiring hemodialysis (group V) in a single and multiple dose (every 12h), one-period (groups I-IV) or a single dose, two-period (group V) study (4-mg oral doses of TGB · HCl). Blood samples were collected after the first dose (both periods for group V) and after the last dose on day 5 (groups I-IV). TGB plasma concentrations and plasma protein binding were determined by high-performance liquid chromatography (HPLC) and ultrafiltration, respectively.
Results: TGB was well tolerated by all study subjects. The pharmacokinetics of TGB were similar in all subjects; no pharmacokinetic parameter (based on either total or unbound concentrations) was statistically correlated with creatinine clearance. For total TGB in plasma, single-dose mean values of the maximum plasma concentration, clearance, and half-life (t1/2) ranged from 52 to 108 ng/ml, from 7.14 to 11.02 I/h, and from 6.4 to 8.4 h, respectively.
Conclusions: TGB pharmacokinetics and tolerability were independent of renal function; therefore, dosage adjustment is unnecessary for epilepsy patients with renal impairment.