Endovascular repair of acute uncomplicated aortic type B dissection promotes aortic remodelling: 1 year results of the ADSORB trial.

OBJECTIVES: Uncomplicated acute type B aortic dissection (AD) treated conservatively has a 10% 30-day mortality and up to 25% need intervention within 4 years. In complicated AD, stent grafts have been encouraging. The aim of the present prospective randomised trial was to compare best medical treatment (BMT) with BMT and Gore TAG stent graft in patients with uncomplicated AD. The primary endpoint was a combination of incomplete/no false lumen thrombosis, aortic dilatation, or aortic rupture at 1 year. METHODS: The AD history had to be less than 14 days, and exclusion criteria were rupture, impending rupture, malperfusion. Of the 61 patients randomised, 80% were DeBakey type IIIB. RESULTS: Thirty-one patients were randomised to the BMT group and 30 to the BMT+TAG group. Mean age was 63 years for both groups. The left subclavian artery was completely covered in 47% and in part in 17% of the cases. During the first 30 days, no deaths occurred in either group, but there were three crossovers from the BMT to the BMT+TAG group, all due to progression of disease within 1 week. There were two withdrawals from the BMT+TAG group. At the 1-year follow up there had been another two failures in the BMT group: one malperfusion and one aneurysm formation (p = .056 for all). One death occurred in the BMT+TAG group. For the overall endpoint BMT+TAG was significantly different from BMT only (p < .001). Incomplete false lumen thrombosis, was found in 13 (43%) of the TAG+BMT group and 30 (97%) of the BMT group (p < .001). The false lumen reduced in size in the BMT+TAG group (p < .001) whereas in the BMT group it increased. The true lumen increased in the BMT+TAG (p < .001) whereas in the BMT group it remained unchanged. The overall transverse diameter was the same at the beginning and after 1 year in the BMT group (42.1 mm), but in the BMT+TAG it decreased (38.8 mm; p = .062). CONCLUSIONS: Uncomplicated AD can be safely treated with the Gore TAG device. Remodelling with thrombosis of the false lumen and reduction of its diameter is induced by the stent graft, but long term results are needed.

Simultaneous determination of terbinafine (Lamisil) and five metabolites in human plasma and urine by high-performance liquid chromatography using on-line solid-phase extraction.

The antimycotic agent terbinafine (Lamisil) and five of its main metabolites were determined simultaneously in human plasma and urine samples by an isocratic HPLC method. The compounds were separated on a phenyl column following on-line solid-phase sample clean-up with a column-switching device. Terbinafine and its metabolites were detected by monitoring the column effluent with UV light at a wavelength of 224 nm. The linear range in plasma was assessed between 0 and 2500 ng/ml for the parent drug and metabolites V, IV and I. The linear response of metabolites III and II was assessed between 0 and 1250 ng/ml. In urine, linearity was assessed between 0 and 10,000 ng/ml for metabolites V, IV, III, II and between 0 and 1000 ng/ml for the parent drug and metabolite I. Quantification limits based on a C.V. < or = 20% and a bias < or = +/- 20% ranged from 20 to 500 ng/ml depending on the compound and the matrix. Inter-day and intra-day variations were similar indicating the ruggedness of the two methods. Due to the considerable differences in hydrophobicity between the compounds, extraction efficiencies ranged from 55 to 100%. Both methods were found to be reproducible and sufficiently sensitive for the evaluation of metabolite pharmacokinetics.

Determination of terbinafine and its desmethyl metabolite in human plasma by high-performance liquid chromatography.

A reliable reversed-phase high-performance liquid chromatographic method has been developed for the determination of terbinafine (Terb) and its desmethyl metabolite (DMT) in human plasma. The analytes and the internal standard (I.S.) are extracted by a liquid-liquid technique followed by an aqueous back-extraction, allowing injection of an aqueous solvent in the HPLC system. The mobile phase is acetonitrile + 0.012 M triethylamine -0.020 M orthophosphoric acid (50:50, v/v) and the UV detection is at 224 nm. The inter-assay precision over the concentration range 2-1000 ng/ml is between 2.9 and 9.8% for both compounds. The limit of quantification, 2 ng/ml for both compounds, is sufficient for investigating the pharmacokinetics of Lamisil in human studies. With an additional preparation step, this method can be used for assaying Terb in tissues such as nail, sebum and stratum corneum.

[Does the thoracic outlet syndrome exist?]. / Gibt es das Thoracic Outlet Syndrom (TOS)?

We reviewed fourteen patients suffering from thoracic outlet syndrome (TOS). This allowed a critical analysis of the diagnostic tools, especially the Adson and Allen tests, currently used. The value of arthrography and phlebography are discussed in relation to the supposed pathophysiology of the disease. The decision to operate on those patients has to be considered in relation to the possible mishaps related to the surgical procedure. Particular attention has to be paid to post-operative perineural fibrosis, a possible cause of definite disability. The psychological components seem to remain mostly underestimated, a fact that has to be stressed and which we were able to demonstrate in our small sample. However, pre-operative evaluation remains difficult. No definite objective sign enables the surgeon to assert the presence of a thoracic outlet syndrome. Therefore not only the decision making but also the analysis of the results remains debatable. In all cases, even in the presence of clear narrowing of the vessels, indication to operation should be restrictive.

Cyclosporin A: correlation between HPLC and RIA serum levels.

Serum levels of cyclosporin A were analysed in parallel with an HPLC and a RIA method for six patients who received repeated intramuscular and oral doses of this immunosuppressive drug after bone marrow transplantation. A good correlation was found between both methods with a similar time course of the serum curves. Due to cross-reacting metabolites, the values from the RIA assay were on average 30 to 100% higher than with the HPLC assay which is specific for the parent drug.

[Infusion therapy after vaginal hysterectomy (author's transl)]. / Infusionstherapie bei vaginaler Hysterektomie.

The applicability of a complete solution containing amino acids, electrolytes and calories for post-operative infusion therapy after vaginal hysterectomy was investigated. In the 16 patients examined it was found that using this solution it is possible to maintain a smooth nitrogen balance to a large extent. In a control group of 6 patients who only received an infusion of electrolytes and calories, the nitrogen balance was clearly noncompensated. As even with the complete solution compensation of the nitrogen balance is not achieved until the second day, it is recommended that for patients at risk the infusion treatment should be commenced on the day prior to operation.

[Various metabolic effects in total parenteral feeding using a carbohydrate combination and amino-acid solution in the pre- and postoperative phase]. / Einige Stoffwechselwirkungen bei totaler parenteraler Ernährung mit einer Kohlenhydratkombinations- und Aminosäurenlösung in der prä- und postoperativen Phase.

Ten metabolically healthy patients who had undergone gastric resection were fed intravenously from the preoperative to the 5th postoperative day. After the 24-hour preoperative infusion period the concentration of cholesterol, free fatty acids and alkaline phosphatase dropped significantly. So did the concentration of uric acid. During the postoperative period cholesterol and uric acid continued to fall. The concentration of free fatty acids remained low all the postoperative days. From the second postoperative day on the triglycerides rose continuously. Serum glutamic oxalacetic transaminase and serum lactic dehydrogenase reached their highest level on the first postoperative day. On the same day the alkaline phosphatase dropped to the lowest level. Five patients had a rise of total bilirubin up to 1.1 mg/100 at the end of the infusion period.

[Metabolic behavior in pre, intra, and postoperative total parenteral feeding with a carbohydrate combination and amino acid solution]. / Stoffwechselverhalten bei prä-, intra- und postoperativer totaler parenteraler Ernährung mit einer Kohlenhydratkombinations- und Aminosäurenlösung.

Ten metabolically healthy patients who had undergone gastric resection were fed intravenously from the preoperative to the 5th postoperative day. No metabolic alternations were observed by using a low dosis of 0.12 mg/kg.h of glucose, fructose and xylitol in combination with amino acids. We were able to limit the so-called postaggressive syndrome by eliminating the fasting state. These results were proven by evaluating the most important metabolic parameters like triglycerides, free fatty acids, lactate and by measuring the carbohydrate-nitrogen balances.

[A study of the carbohydrate and electrolyte balance of 10 surgical patients during 7-days' infusion therapy (author's transl)]. / Kohlenhydrat- und Elektrolytbilanz während einer 7tägigen Infusionsperiode bei 10 Patienten in der operativen Medizin.

For postoperative parenteral feeding fructose proved preferable to glucose and xylitol. Although the infusions were started pre-operatively sodium deficiency and a fall in serum osmolarity developed during the postoperative stage. Administration of potassium to normalize lowered serum potassium levels was needed only on the first and second postoperative day. Serum calcium levels fell during the 7-days' period of observation but remained within the limits of normal. If parenteral feeding is to be continued for longer periods determination of the phosphorus balance is advisable to avoid excessive depletion of the endogenous phosphorus stores. Estimations of urinary osmolarity and urine volume indicated that fluid uptake was adequate.

[Changes in several important metabolic parameters and insulin level during a 7-day total parenteral nutrition under pre- and postoperative conditions]. / Das Verhalten einiger wichtiger Stoffwechselparameter und des Insulinspiegels bei 7tägiger totaler parenteraler Ernährung unter prä- und postoperativen Bedingungen.

After the 24 hours preoperative infusion period 0.37% glucose, 0.05% fructose and 1.28% xylitol of the infused amount were excreted in the urine. Postoperatively fructose was the best metabolized energy donator before xylitol and glucose. As a sign of an undisturbed hepatic synthesis of lipoproteins the triglycerides rose up to the 5th postoperative day. During the parenteral nutrition and the additional surgical intervention the cholesterol fell from 192.3 to 128.5 mg/100 ml on the first postoperative day. The infusion solutions caused a rise of the insulin concentration from 23.2 to 46.3 U/l on the operation day. There is a positive nitrogen balance of 3.5 g/24 h on the operation day. The slight negative balance of - 1.15 g/24 h on the first postoperative day is reduced to - 0.61 g/24 h on the postoperative day. The changes of the enzymes LDH, GOT and AP were at normal range. The postoperative changes were due to the surgical intervention. Without a simultaneous change of enzymes, 5 patients had a rise of bilirubin up to 1.1 mg/100 ml. To avoid a too great loose of phosphate during a long-term parenteral nutrition period, it is important to put up a balance.

[Modification of urea-N and creatinine levels using need-adapted amino acids during parenteral nutrition in patients under intensive care]. / Beeinflussung von Harnstoff-N und Kreatinin durch bedarfsadaptierte Aminosäuren während parenteraler Ernährung in der Intensivtherapie.

The present retrospective study concerns two sub-groups of patients having normal serum creatinine levels, adequate 24-hour urine volumes and no pathological changes in the serum or urine osmolarity. There are differences in the initial values of the serum urea nitrogen, the higher (with almost 60 mg%) being already in the azotemia range. Both sub-groups received 100 g of an amino acid mixture adapted to requirements in addition to comparable parenteral nutrition. This did not lead to non-physiological changes in urea nitrogen or any of the other parameters measured in either of the groups. The findings obtained allow the following conclusions to be drawn: Parenteral administration of a quantity of essential and non-essential amino acids adapted to requirements did not bring about a rise in urea nitrogen in either the patients with normal or raised urea nitrogen values. Hence there are not grounds for assuming that in the post-operative or post-traumatic phase the use of a mixture of essential amino acids is necessary to reduce potentially occurring azotemia.

[Postoperative total parenteral feeding with a carbohydrate mixture (autor's transl)]. / Postoperative totale parenterale Ernährung unter Verwendung einer Kohlenhydratmischung

After gastric operations, patients were fed completely by the parenteral route. Aminoacids, caloric nutrients and electrolytes were infused simultaneously and continuously 24 hours daily until the fourth postoperative day. The daily supply of aminoacids amounted to 80 g. Glucose, fructose and xylite in equal proportions were used to supply calories. The total daily amount was 605 g. The important electrolytes were contained in the infusion solutions in amounts corresponding to basic requirement. The results of the investigation confirmed that patients can be successfully nourished parenterally after extensive operations with the combined daily additives we have selected.

[The effect of various electrolyte solutions on the water and electrolyte balance during the postoperative phase]. / Die Wirksamkeit verschiedener Elektrolytlösungen auf den Wasser- und Elektrolythaushalt in der postoperativen Phase

Investigations with 3 electrolyte solutions having different qualitative and quantitative compositions were carried out to see their effect on the physiological equilibrium in the pre, intra- and postoperative phases in patients who had to undergo moderately severe surgery. On the basis of electrolyte and osmolarity determinations in serum and 24-hour urine, blood gas analyses, determinations of hemoglobin and hematocrit, 24-hour volume and specific weight of the urine, it was possible to establish an electrolyte administration adapted to the pre-, intra- and postoperative condition of the patients. By the infusion of a solution with this electrolyte content it was possible to keep the measured parameters within the normal range throughout the entire period of measurement before, during and after the operation.

[Metabolic behavior in total parenteral nutrition during the postoperative phase]. / Stoffwechselverhalten bei totaler parenteraler Ernährung in der postoperativen Phase

In patients who had undergone gastric operation, total postoperative parenteral nutrition was effected using a combination of two infusion solutions having complementary constituents. 80 g L-amino acids and about 2,500 kcal in the form of a glucose-levulose-xylitol mixture together with electrolytes and trace elements were infused daily. Metabolic parameters, serum levels and the concentrations of the most important administered substances excreted in the urine were determined every day at the same time. The 1:1:1 glucose-levulose-xylitol ratio of the caloric carrier proved to be a favourable combination with respect to metabolic behaviour and the necessary daily supply of calories. The basic electrolyte requirement of the patients was to a large extent met by the quantities contained in the solutions.