The authors report the first results of a new 6-F symmetrically designed permanent nitinol inferior vena cava (IVC) filter, the Cordis TrapEase, evaluated in a multicenter prospective study with 6-months of follow-up.
A total of 65 patients (29 men, 36 women) who ranged in age from 37 to 96 years (mean age, 68 years) and who were at high risk of pulmonary embolism (PE) were enrolled in 12 centers in Europe and Canada. The study was approved by the institutional review boards at all centers. Study objectives were to evaluate filter effectiveness, filter stability, and caval occlusion. Indications for filter placement were deep vein thrombosis with recurrent thromboembolism and/or free-floating thrombus with contraindication to anticoagulation in 37 patients, and complications in achieving adequate anticoagulation in 28 patients. Follow-up included clinical examination, plain film, Doppler ultrasound, CT scan, and nuclear medicine.
The analysis of the data revealed a technical success of 95.4% (three filter-system related implantations not at the intended site, no events of filter tilting) and a clinical success of 100% at 6 months (no cases of symptomatic PE), the study primary endpoint. There were no cases (0%) of filter migration, insertion site thrombosis, filter fracture, or vessel wall perforation. During the study period, there were two cases of filter thrombosis: one case of early symptomatic thrombosis that was successfully treated in the hospital, and one case of nonsymptomatic filter thrombosis detected at 1-month follow-up, with spontaneous recanalization at 3 months. In the latter patient, some residual thrombus was still detected at 6 months. Of the study population of 65 patients, there were 23 deaths. These deaths were not related to the device or the implantation procedure but to the underlying disease process.
This study demonstrates the new nitinol permanent IVC filter to be a safe and an effective device, with a low overall complication rate, for use in patients with thromboembolic disease at high risk of PE.
To summarize and evaluate the progress in the current practices of thromboprophylaxis (TP) in Danish surgical departments.
Summary of three questionnaire surveys in 1981, 1985 and 1990.
Hospital departments performing general, orthopaedic or gynaecological surgery in Denmark.
Development or routine employment of TP, standard instructions for TP, indications and methods for TP.
Replies were obtained from 85%-92%. During the period the overall use TP increased from 89% of the departments in 1981 to 93% in 1985 to 96% in 1990 (p = 0.03). The use of TP according to standard instructions increased from 50% over 54% to 68% (p = 0.001). Heparin is the drug of choice in 95% and graded compression stockings in 70% of the departments. Only 36% of the departments routinely use TP in emergency surgery.
The development in attitudes towards TP in Denmark complies with the scientific evolution. Methods and indications correspond with the recommendation of the literature and international consensus conferences. However, the low rate of TP in emergency surgery is unsatisfactory, and the use of acetylsalicylic acid as postoperative venous thromboprophylaxis should stop. The authors emphasize the introduction of firm standard instruction for TP in all surgical department. A continuous evaluation of the use of TP in Danish surgical department by means of quality assurance studies is recommended.
The post-operative mortality of 17,199 patients of whom approximately 20% were aged 70 years or more was studied. The primary mortality of patients aged 70 or more in major operations was 9.2%. In emergency operations, the mortality was 36.8%, in elective surgery 7.8%. Pulmonary embolism was the cause of death in 33%, cardiac collapse in 11%, and the primary illness in 9%. The mortality of patients with mental diseases was 45%, of diabetics 26%, and of cardiac patients 17%. 39% of cardiac patients died of pulmonary embolism. 26% of all deaths occurred during the first 3 post-operative days, and 35% between the 4th and 7th post-operative day. In operations lasting more than 2 h, the mortality was 36%, in those lasting less than 2 h, 7.5%. Macrodex (dextran 70) infusions during high-risk operations decreased the incidence of lethal pulmonary embolism.
The incidence of postoperative deep venous thrombosis in the lower limbs and of pulmonary embolism has been studied in 49 patients operated upon for gallbladder and gastric diseases. 125I fibrinogen test was performed preoperatively and usually five times postoperatively. Pulmonary scintigraphy was also performed preoperatively and usually twice after the operation. An attempt was made to evaluate the prophylactic effect of Dextran 40. Only one patient developed a deep vein thrombosis without clinical signs. Postoperative pulmonary embolism was found in 13 patients, all but one clinically silent. The second postoperative pulmonary scintigraphy showed that the emboli had disappeared or diminished in 6 patients. Because of the low number of patients with deep venous thrombosis the prophylactic effect of Dextran 40 could not be assessed. The present investigation showed that the incidence of deep venous thrombosis in the legs was low after operations in the upper part of the abdomen while the incidence of pulmonary embolism was high. No connection between leg vein thrombosis and pulmonary embolism could be demonstrated.