Recombinant coagulation factor VIIa in major liver resection: a randomized, placebo-controlled, double-blind clinical trial

BACKGROUND: Prevention of bleeding episodes in noncirrhotic patients undergoing partial hepatectomy remains unsatisfactory in spite of improved surgical techniques. The authors conducted a randomized, placebo-controlled, double-blind trial to evaluate the hemostatic effect and safety of recombinant factor VIIa (rFVIIa) in major partial hepatectomy. METHODS: Two hundred four noncirrhotic patients were equally randomized to receive either 20 or 80 microg/kg rFVIIa or placebo. Partial hepatectomy was performed according to local practice at the participating centers. Patients were monitored for 7 days after surgery. Key efficacy parameters were perioperative erythrocyte requirements (using hematocrit as the transfusion trigger) and blood loss. Safety assessments included monitoring of coagulation-related parameters and Doppler examination of hepatic vessels and lower extremities. RESULTS: The proportion of patients who required perioperative red blood cell transfusion (the primary endpoint) was 37% (23 of 63) in the placebo group, 41% (26 of 63) in the 20-microg/kg group, and 25% (15 of 59) in the 80-microg/kg dose group (logistic regression model; P = 0.09). Mean erythrocyte requirements for patients receiving erythrocytes were 1,024 ml with placebo, 1,354 ml with 20 microg/kg rFVIIa, and 1,036 ml with 80 microg/kg rFVIIa (P = 0.78). Mean intraoperative blood loss was 1,422 ml with placebo, 1,372 ml with 20 microg/kg rFVIIa, and 1,073 ml with 80 microg/kg rFVIIa (P = 0.07). The reduction in hematocrit during surgery was smallest in the 80-microg/kg group, with a significant overall effect of treatment (P = 0.04). CONCLUSIONS: Recombinant factor VIIa dosing did not result in a statistically significant reduction in either the number of patients transfused or the volume of blood products administered. No safety issues were identified.     

Carcinosarcoma of the biliary tract: two case reports and a review of the literature

Carcinosarcoma of the biliary tract is extremely rare. Little is known about the natural course of these tumours, or the best available treatment. We present two cases of carcinosarcoma of the biliary tract, one of the gall bladder and one of the common bile duct, followed by a review of the literature.     

Cerebral small vessel diseases: cerebral microangiopathies

PURPOSE OF REVIEW: Small vessel diseases of the brain are still clinically underrecognized whereas their burden is increasing steeply. The most frequent is acquired degenerative small vessel disease. Many hereditary or idiopathic small vessel diseases have also been identified, of which cerebral autosomal-dominant arteriopathy with stroke and ischaemic leukoencephalopathy (CADASIL) is the most prominent. In this review, we will highlight current evidence on pathophysiology and genetics, new imaging tools, and treatment options. RECENT FINDINGS: Recent imaging studies have stressed the disruption of white matter connections in the pathogenesis of cognitive impairment in acquired small vessel disease. Clinical trials suggest a therapeutic benefit of acetylcholinesterase inhibitors. CADASIL is caused by mutations in the Notch3 gene. Current basic research has identified Notch genes to be important for endothelial and smooth muscle cells to form arteries and veins. Diagnosis can now be made reliably by magnetic resonance brain imaging, skin biopsy, or genetic testing. The so-called retinocerebral vasculopathies share the involvement of both retinal, cerebral and cochlear arterioles (e.g. Susac's syndrome). Cerebral amyloid angiopathy, occurring either sporadically or as a cause of various gene mutations, predisposes to lobar haemorrhages caused by rupture of affected small cortical vessels. Other rare cerebral microangiopathies, such as mitochondrial cytopathies, Fabry's disease and toxemic vasculopathy, offer established or new therapeutic options. SUMMARY: Cerebral small vessel diseases are highly variable in their aetiopathogenesis and clinical course. Current pathophysiological insights will help develop better treatment modalities; new imaging tools will provide surrogate markers for monitoring disease progression and treatment effects.     

Surgical management of complications after hearing aid fitting

OBJECTIVES: Standard procedures for hearing aid fitting performed in accordance with established guidelines are well tolerated, safe, and effective. In this article, we present unusual complications after hearing aid fitting that required surgical management. METHODS: Four otologists at a major university center with a combined 65 years of experience performed a retrospective analysis of their surgical practice. Six patients were identified that had encountered severe complications from improper earmold fitting that required surgical intervention. RESULTS: One patient had a perforation of the tympanic membrane with earmold material found to have migrated into the middle ear cleft. The tympanic membrane healed spontaneously, resulting in persistent otalgia and a maximum air-bone gap. The earmold cast was successfully removed by means of a tympanomastoidectomy. Two patients with presbycusis and normal ear canals developed eardrum perforations and conductive hearing deficits. In both patients, earmold material was found partially occupying the middle ear cleft and removed by way of a transcanal approach. Three patients with prior canal wall down mastoidectomy defects and narrow external ear canals required microtoscopy under general anesthesia or canaloplasty for removal of impacted material. CONCLUSION: Proper fitting of hearing aids performed by well-trained medical professionals results in a very low incidence of significant complications. Perforation of the tympanic membrane with impaction of earmold material in the middle ear or mastoid bowl may occur and can be successfully managed by standard otologic surgical techniques.     

Cryoablation treatment of benign breast lesions with 12-month follow-up

OBJECTIVE: Eighty percent of all breast biopsies reveal benign findings. The most common benign tumor is a fibroadenoma. Despite their benign nature, many women eventually choose to have their bothersome lumps surgically removed. We report the use of cryoablation to treat these benign breast lesions with minimum 12-month follow-up. METHODS: After receiving Institutional Review Board approval, a prospective nonrandomized trial was initiated in June 2000. Ultrasound-guided cryoablation of core biopsy-proven benign fibroadenomas, other benign breast nodules, or nodular fibrocystic change was performed on 78 lesions in 63 patients. Eighty-five percent of lesions treated were benign fibroadenomas. The cryoablation procedure consisted of a double freeze-thaw cycle that lasted between 6 and 30 minutes and was performed most often in an office setting. Each patient was serially evaluated for treatment efficacy, complications, and patient satisfaction. RESULTS: Sixty-four of 78 lesions (mean size 2.0 cm [range 0.8 to 4.2]) were followed-up for at least 12 months after cryoablation per protocol, which included 53 fibroadenomas. At 1 year, ultrasound tumor volume resorption was 88.3% overall (87.3% for fibroadenomas), and 73% of the entire group became nonpalpable to both clinician and patient (75% for fibroadenomas). Two of the fibroadenoma patients had their palpable residual nodule excised, both revealing necrotic debris and no viable tumor in the treated volume. Serial mammograms showed resorption of the lesion leaving minimal residual density without calcifications. Cosmesis was excellent with only a small scar remaining at the probe insertion site. There was no report of visual or palpable volumetric deficit. Patient satisfaction was good to excellent in 92% of cases. CONCLUSIONS: Cryoablation was successful in treating core biopsy-proven benign breast lesions in 63 patients. At 12 months, we found gradual resorption of treated tissue with no cosmetic deficit. Ultrasound-guided cryoablation is an effective and safe treatment for benign breast lesions, as seen at 12-month follow-up, and offers an office-based, minimally invasive alternative to surgical excision.     

Computerized tomography with 3-dimensional reconstruction for the evaluation of renal size and arterial anatomy in the living kidney donor

PURPOSE: Computerized tomography (CT) with 3-dimensional (3-D) reconstruction has gained acceptance as an imaging study to evaluate living renal donors. We report our experience with this technique in 199 consecutive patients to validate its predictions of arterial anatomy and kidney volumes. MATERIALS AND METHODS: Between January 1997 and March 2002, 199 living donor nephrectomies were performed at our institution using an open technique. During the operation arterial anatomy was recorded as well as kidney weight in 98 patients and displacement volume in 27. Each donor had been evaluated preoperatively by CT angiography with 3-D reconstruction. Arterial anatomy described by a staff radiologist was compared with intraoperative findings. CT estimated volumes were reported. Linear correlation graphs were generated to assess the reliability of CT volume predictions. RESULTS: The accuracy of CT angiography for predicting arterial anatomy was 90.5%. However, as the number of renal arteries increased, predictive accuracy decreased. The ability of CT to predict multiple arteries remained high with a positive predictive value of 95.2%. Calculated CT volume and kidney weight significantly correlated (0.654). However, the coefficient of variation index (how much average CT volume differed from measured intraoperative volume) was 17.8%. CONCLUSIONS: CT angiography with 3-D reconstruction accurately predicts arterial vasculature in more than 90% of patients and it can be used to compare renal volumes. However, accuracy decreases with multiple renal arteries and volume comparisons may be inaccurate when the difference in kidney volumes is within 17.8%.     

A simple scoring system to evaluate the effects of cold ischemia on marginal liver donors

BACKGROUND: Exactly what constitutes a marginal donor remains ill defined. The authors set out to create a scoring system that objectively classifies a donor as marginal or nonmarginal and to define what the maximum acceptable preservation period is for the marginal liver to minimize early graft dysfunction. METHODS: The authors performed an analysis on data collected prospectively of 397 cadaveric liver transplants. Both univariate and multivariate analyses were performed on donor, recipient, and perioperative factors with relation to early allograft dysfunction. A score was developed that classified donors into marginal and nonmarginal populations, and the influence of cold ischemia was determined for each group. RESULTS: Multivariate analysis-determined donor age and steatosis (moderate to severe) were independent predictors of deranged function. This enabled the authors to produce a scoring system to differentiate marginal donors with respect to risk of early allograft dysfunction as follows: Formula=(20.06xsteatosis)+(0.44xdonor age), cutoff 23.1. In the marginal group, the cutoff value of cold ischemia time was 12.6 hr. CONCLUSIONS: The authors developed a scoring system that classified an organ as marginal or nonmarginal depending on the donor age and degree of steatosis. Marginal livers have a strong risk of developing early allograft dysfunction with increasing cold ischemia times and should be transplanted within 12 hr. Cold ischemia time was not found to be an important factor in the development of early allograft dysfunction in nonmarginal donors.     

Effects of toltrazuril and ponazuril on<Emphasis Type="Italic"> Hammondia heydorni</Emphasis> (syn.<Emphasis Type="Italic"> Neospora caninum</Emphasis>) infections in mice

Mice infected with tachyzoites of Neospora caninum (syn.: Hammondia heydorni) must be pretreated with cortisone in order to show disease symptoms. This indicates the status of an opportunistic agent of disease. Toltrazuril was an effective curative agent.