Renal function and clinical outcome of patients with cancer-associated venous thromboembolism randomized to receive apixaban or dalteparin. Results from the Caravaggio trial

The effect of renal impairment (RI) on risk of bleeding and recurrent thrombosis in cancer patients treated with direct oral anticoagulants for venous thromboembolism (VTE) is undefined. We ran a prespecified analysis of the randomized Caravaggio study to evaluate the role of RI as a risk factor for bleeding or recurrence in patients treated with dalteparin or apixaban for cancer-associated VTE. RI was graded as moderate (creatinine clearance between 30-59 mL/minute; 275 patients) and mild (between 60-89 mL/minute; 444 patients). In the 1142 patients included in this analysis, the incidence of major bleeding was similar in patients with moderate vs. no or mild RI (HR 1.06-95% CI: 0.53-2.11), with no difference in the relative safety of apixaban and dalteparin. Recurrent VTE was not different in moderate vs. no or mild RI (HR=0.67, 95% CI: 0.38-1.20); in moderate RI, apixaban reduced recurrent VTE compared to dalteparin (HR=0.27, 95% CI: 0.08-0.96; P for interaction 0.1085). At multivariate analysis, no association was found between variation of renal function over time and major bleeding or recurrent VTE. Advanced or metastatic cancer was the only independent predictor of major bleeding (HR=2.84, 95% CI: 1.20-6.71), with no effect of treatment with apixaban or dalteparin. In our study, in cancer patients treated with apixaban or dalteparin, moderate RI was not associated with major bleeding or recurrent VTE. In patients with moderate renal failure, the safety profile of apixaban was confirmed with the potential for improved efficacy in comparison to dalteparin. ClinicalTrials.gov identifier: {"type":"clinical-trial","attrs":{"text":"NCT03045406","term_id":"NCT03045406"}}NCT03045406.     

Cement,Asbestos, and Cement-Asbestos Pneumoconioses

The incidence and characteristics of cement-asbestos pneumoconiosis were compared with those of asbestosis and cement pneumoconiosis in three homogeneous samples of cases.

The clinical, functional, and radiological features of cement-asbestos pneumoconiosis are similar to those of classical asbestosis, but the observed changes are less common and occur after a longer exposure.     

Changes in bone mineral density, lean body mass and fat content as measured by dual energy x-ray absorptiometry in patients with prostate cancer without apparent bone metastases given androgen deprivation therapy

PURPOSE: We characterize the consequences of androgen deprivation therapy on body composition in elderly men. MATERIALS AND METHODS: Using a dual energy x-ray absorptiometry instrument, we determined the changes in bone mineral density, bone mineral content, fat body mass and lean body mass in 35 patients with prostate cancer without bone metastases who received luteinizing hormone releasing hormone analogue for 12 months. RESULTS: At baseline conditions 46% of cases were classified as osteopenic and 14% as osteoporotic at the lumbar spine and 40% were osteopenic and 4% osteoporotic at the hip. Androgen deprivation significantly decreased bone mineral density either at the lumbar spine (mean gm./cm.2 [SD] 1.00 [0.194], 0.986 [0.172] and 0.977 [0.182] at baseline, and 6 and 12 months, respectively, p <0.002) or the hip (0.929 [0.136], 0.926 [0.144] and 0.923 [0.138], p <0.03). A more than 2% decrease in bone mineral density was found at the lumbar spine in 19 men (54.3%) and at the hip in 15 (42.9%). Bone mineral content paralleled the bone mineral density pattern. Lean body mass decreased (mean gm. [SD] 50,287 [6,656], 49,296 [6,554] and 49,327 [6,345], p <0.003), whereas fat body mass consistently increased (18,115 [6,209], 20,724 [6,029] and 21,604 [5,923] p <0.001). CONCLUSIONS: Serial bone densitometry evaluation during androgen deprivation therapy may allow the detection of patients with prostate cancer at risk for osteoporotic fractures, that is those with osteopenia or osteoporosis at baseline and fast bone loss. The change in body composition may predispose patients to accidental falls, thus increasing the risk of bone fracture.     

Radiofrequency inferior turbinate reduction: An evaluation of olfactory and respiratory function

Objective

The aim of this study was to assess the outcomes after radiofrequency inferior turbinate reduction (RITR) on objective and subjective nasal function in patients with nasal obstruction caused by turbinate hypertrophy and to evaluate the possible effect on olfactory function.

Study Design

Case series with planned data collection.

Setting

ENT division, university hospital.

Subjects and Methods

Forty consecutive patients who underwent RITR for allergic or nonallergic chronic rhinitis with inferior turbinate hypertrophy were tested before and two months after the surgical procedure, using the Sniffin' Sticks test battery, anterior rhinomanometry, and the nasal obstruction symptom evaluation (NOSE) scale.

Results

The total basal nasal resistance at 150 Pa diminished significantly two months after surgery. Preoperative olfactory tests showed anosmia in five percent (n = 2) of the patients, hyposmia in 82 percent (n = 33), and normosmia in 12 percent (n = 5). At two months from the intervention, two percent (n = 1) were diagnosed as anosmic, 12 percent (n = 5) as hyposmic, and 85 percent (n = 34) as normosmic. The means of preoperative odor threshold (T), discrimination (D), identification (I), and the overall TDI score improved significantly postoperatively (P < 0.001). The NOSE score in the two-month follow-up improved in 97.5 percent (n = 39) of patients, with a mean difference in pre- vs. postintervention score of 40.12 (95% confidence interval 35.75-44.25; P < 0.001).

Conclusion

RITR may provide excellent outcomes in terms of improvement in olfactory function and nasal flow in patients affected by turbinate hypertrophy refractory to medical therapy.     

Which osteotomy for a valgus knee?

A valgus knee is a disabling condition that can affect patients of all ages. Antivalgus osteotomy of the knee is the treatment of choice to correct the valgus, to eliminate pain in the young or middle age patient, and to avoid or delay a total knee replacement. A distal femoral lateral opening wedge procedure appears to be one of the choices for medium or large corrections and is particularly easy and precise if compared to the medial femoral closing wedge osteotomy. However, if the deformity is minimal, a tibial medial closing wedge osteotomy can be done with a faster healing and a short recovery time.     

Treatment of band erosion: feasibility and safety of endoscopic band removal

Background  

Band erosion is reported with a highly variable incidence (0.3–14%) after laparoscopic adjustable gastric banding. Removal of the band is mandatory because the patient regains weight and may become symptomatic, but no consensus exists about the best method, surgical or endoscopic, for this purpose. This study aimed to evaluate the feasibility and effectiveness of endoscopic management of band erosion.     

Estrogen deficiency increases osteoclastogenesis up-regulating T cells activity: a key mechanism in osteoporosis

Compelling evidences suggest that increased production of osteoclastogenic cytokines by activated T cells plays a relevant role in the bone loss induced by estrogen deficiency in the mouse. However, little information is available on the role of T cells in post-menopausal bone loss in humans. To investigate this issue we have assessed the production of cytokines involved in osteoclastogenesis (RANKL, TNFalpha and OPG), in vitro osteoclast (OC) formation in pre and post-menopausal women, the latter with or without osteoporosis. We evaluated also OC precursors in peripheral blood and the ability of peripheral blood mononuclear cells to produce TNFalpha in both basal and stimulated condition by flow cytometry in these subjects. Our data demonstrate that estrogen deficiency enhances the production of the pro-osteoclastogenetic cytokines TNFalpha and RANKL and increases the number of circulating OC precursors. Furthermore, we show that T cells and monocytes from women with osteoporosis exhibit a higher production of TNFalpha than those from the other two groups. Our findings suggest that estrogen deficiency stimulates OC formation both by increasing the production of TNFalpha and RANKL and increasing the number of OC precursors. Women with post-menopausal osteoporosis have a higher T cell activity than healthy post-menopausal subjects; T cells thus contribute to the bone loss induced by estrogen deficiency in humans as they do in the mouse.     

Laparoscopic Treatment of Gastric <Emphasis Type="SmallCaps">Gist</Emphasis>: Report of 21 Cases and Literature’s Review

Background Although the feasibility of laparoscopic resection of gastric gastrointestinal stromal tumors (GISTs) has been established, various aspects are debated. This paper describes the problems of minimally invasive resection of gastric GISTs and compares this experience with an extensive literature review. Study Design Between August 2001 and December 2006, 21 consecutive patients undergoing laparoscopic resection of gastric GISTs were enrolled in a prospective study. A literature review of laparoscopic treatment was performed on Pubmed using keywords GIST and surgery. A comparison with authors’ experience with open wedge-segmental resection of GISTs (25 cases from November 1995 to December 2000) was also carried out. Statistical analysis was based on chi-squared test and t Student evaluation. Results Twenty-one patients, mean age 50.1 years (range, 34–68 years), were submitted to laparoscopic wedge- segmental gastric resections. Mean tumor size was 4.5 cm (range, 2.0–8.5 cm). Mean operative time was 151 min (range, 52–310 min), the mean blood loss was 101 mL (range, 10–250 mL), and the mean hospital stay was 4.8 days (range 3–7 days). There were no major operative complications or mortalities. All lesions had negative resection margins. At a mean follow-up of 35 months, all patients were disease-free. Morbidity, mortality, length of stay, and oncologic outcomes were comparable to the open surgery retrospective evaluation (p = not significant). Conclusions As found also in the literature review, the laparoscopic resection is safe and effective in treating gastric GISTs. Given these findings as well as the advantages afforded by laparoscopic surgery, a minimally invasive approach should be the preferred surgical treatment in patients with small- and medium-sized gastric GISTs.     

Gallbladder injury

The Authors report on a rare case of blunt traumatic injury of the gallbladder. A careful clinical examination, an abdominal ultrasonography and a contrast material-enhanced computed tomography have a primary importance for a correct diagnosis. Laparoscopic surgery has an important diagnostic and, in selected cases, therapeutic role. In all traumatic gallbladder ruptures, after an accurate search of eventual associated injuries of other abdominal organs, cholecystectomy is considered the treatment of choice.     

Surgical treatment of Basedow's disease: our experience with 424 operations

From February 2002 to December 2005, 424 operations for thyroid disease were performed in our institute. Twenty-two patients were suffering from Basedow's disease, 14 female and 8 male, mean age 36 years (range: 23 to 53 years). In each patient the diagnosis of Basedow's disease was made according to common clinical and laboratory criteria, by evaluation of the thyroid hormones, TSH and TRAB. Before operation all patients were rendered euthyroid with antithyroid drug treatment. Fourteen total thyroidectomies (64%) and 8 near-total thyroidectomies (36%) were performed. Postoperative thyroid function status was evaluated before, 3-4 weeks after the operation and then 3, 6,12 and 24 months postoperatively. The patients were classified as euthyroid (FT3-FT4 and TSH normal), hypothyroid (FT3 and/or FT4 reduced and TSH increased), or hyperthyroid (FT3-FT4 increased). In expert hands, surgical treatment appears to be capable of curing the hyperthyroidism of Basedow's disease effectively, with a very low and largely acceptable risk of complications. Among the different types of surgery, total thyroidectomy and near-total thyroidectomy are equally appropriate to ensure there is no risk of recurrence of hyperthyroidism.