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 determine the prevalence of and risk indicators for Chlamydia trachomatis cervical infection among women presenting for a periodic medical examination.
Centre local de services communautaires (CLSC) Saint-Louis du Parc, Montreal.
All women presenting for a routine gynecologic examination from May 1985 to July 1986. Of the 773 (99%) who agreed to participate 56 were excluded because of inadequate diagnostic tests (34), antibiotic intake in the preceding 6 weeks (19) or loss to follow-up after the initial visit (3).
Culture was the diagnostic standard, but rapid diagnostic tests were also used. From the identified cases logistic regression analysis was used to evaluate the following risk indicators: age, place of residence, use of oral contraceptives, sexual partners and frequency, history of sexually transmitted disease (STD) and abnormalities found on genital examination.
Fifty-one of the women were found to have C. trachomatis infection, for a prevalence rate of 7.1%; 32 (63%) were completely asymptomatic. Three independent indicators were found: age of 25 years or less (odds ratio [OR] 3.2, 95% confidence limits [CL] 1.8 and 5.9), cervical erythema, contact bleeding or mucopurulent exudate (OR 2.5, 95% CL 1.4 and 4.5) and residency in the CLSC area (OR 2.3, 95% CL 1.1 and 5.1). A history of STD or vaginitis had a significant protective effect in women 30 years of age or more (OR 0.2).
Case-finding for chlamydial infection could be an effective public health measure among women 25 years of age or less and among those with signs of cervicitis when they present for a Papanicolaou test.
Cites: Sex Transm Dis. 1978 Apr-Jun;5(2):51-610328031