Recombinant tissue plasminogen activator (alteplase) for restoration of flow in occluded central venous access devices: a double-blind placebo-controlled trial--the Cardiovascular Thrombolytic to Open Occluded Lines (COOL) efficacy trial.

PURPOSE: Central venous access devices (CVADs) are a mainstay of current medical therapy but often become occluded by thrombus. Tissue plasminogen activator (alteplase), at a dose of 2 mg per 2 mL, has been shown to be effective in restoring flow to catheters proven by radiographic contrast injection to be occluded by thrombus. The purpose of this double-blind placebo-controlled multicenter trial was to determine the efficacy of alteplase in occluded catheters without earlier contrast injections or radiographic examinations. MATERIALS AND METHODS: Patients were eligible for inclusion if blood could not be withdrawn from their catheter after a period of normal function of at least 48 hours. Single or multiple catheters, peripherally inserted central catheters, catheters with valves, and implanted ports were eligible; catheters used for hemodialysis were not included. Patients were randomly assigned to one of two groups. In one group, patients received a first dose of 2 mg alteplase followed, if needed, by a second dose of 2 mg alteplase and a third dose of placebo. The other group received placebo first followed by one 2-mg dose of alteplase and then a second, if needed. Each dose was allowed to dwell for 2 hours and ability to withdraw blood from the catheter was reassessed. The endpoint was restoration of the ability to withdraw and infuse through the catheter. One hundred forty-nine patients were randomized: 74 received placebo first, 75 received alteplase first. RESULTS: After the first 2-hour treatment, function was restored to 74% in the alteplase arm and 17% in the placebo arm (P <.0001 compared to placebo). After one or two treatments, function was restored in 90% of patients. There were no serious study-drug-related adverse events, no intracranial hemorrhage, no major hemorrhage, and no embolic events. CONCLUSION: Infusion of alteplase appeared to be safe and effective in restoring flow to occluded catheters without need for pretreatment radiographic evaluation.

Fallopian tube catheterization: modified fluoroscopic technique.

The authors describe a modification of previously described techniques for fallopian tube catheterization. Tubal catheterization was performed with standard techniques in nine patients. In nine patients tubal catheterization was achieved with a metal self-retaining uterine cannula and catheter set. The authors believe that the modified equipment offers several advantages over other available systems.

On the etiology and pathogenesis of porotic hyperostosis of the skull.

The 256 skulls and 66 skull fragments of the pre-Columbian Peruvian Indians in the Hrdlicka archeologic collection were examined for a porous bone lesion known as porotic hyperostosis. The age, sex, and geographic distribution, as well as the severity and pattern of involvement of the skull bones were noted in an attempt to define the etiology and the pathogenesis of the lesion. Porotic hyperostosis of the skull was present in 20% of the specimens and was probably caused by marrow expansion on the basis of iron deficiency. The lesion was more prevalent and severe among coastal dwellers; men and women were equally affected, and the parietal and occipital bones were the most frequently involved sites. Severe cases were observed only in infants and children, presumably because of limited marrow space and a special predilection for iron deficiency in infants, and of healing of the lesion in adults. Radiographic abnormalities included thinning of the outer table of the skull, diploic space widening, and a "hair-on-end" appearance. Sixty percent of all cases and 100% of severe cases demonstrated one or more of these findings.