A Phase IV Study of Thromboembolic and Bleeding Events Following Hip and Knee Arthroplasty Using Oral Factor Xa Inhibitor.

BACKGROUND: Multiple randomized controlled trials have documented the effectiveness of rivaroxaban in the prevention of venous thromboembolism up to 1-month following total joint arthroplasty. However, the effectiveness and safety of rivaroxaban in the real-world setting, outside of the strict protocols used by randomized clinical trials, are unknown. METHODS: This was a prospective, observational, noninterventional, phase IV study of 3914 consecutive patients who underwent total joint arthroplasty from June 2010 to December 2012. Patients were treated with rivaroxaban 10 mg by mouth daily starting postoperative day 1 and continued for 15 days. Participants were followed up in clinic at 6 weeks and contacted by telephone at 12 weeks. The primary outcome of interest was symptomatic venous thromboembolism; secondary outcomes included bleeding events, transfusion requirements, and death. RESULTS: The incidence of symptomatic deep venous thrombosis at 3 months was 0.5% (n = 18). Only 1 deep venous thrombosis event occurred within 7 days of surgery. The incidence of symptomatic pulmonary embolism (PE) at 3 months was 0.7% (n = 28). Thirteen PEs (46%) occurred within 7 days of surgery. The rate of major bleeding while on prophylaxis was 0.1%. Only 5% of patients received a blood transfusion. No deaths were attributed to thromboembolic events. CONCLUSION: This prospective, observational, phase IV study demonstrates that rivaroxaban appears to protect patients against symptomatic PE and is not associated with major bleeding events when used in a real-world setting as described.

Analysis of the Final DENALI Trial Data: A Prospective, Multicenter Study of the Denali Inferior Vena Cava Filter.

PURPOSE: To report the final 2-year data on the efficacy and safety of a nitinol retrievable inferior vena cava (IVC) filter for protection against pulmonary embolism (PE). MATERIALS AND METHODS: This was a prospective multicenter trial of 200 patients with temporary indications for caval filtration who underwent implantation of the Denali IVC filter. After filter placement, all patients were followed for 2 years after placement or 30 days after filter retrieval. The primary endpoints were technical success of filter implantation in the intended location and clinical success of filter placement and retrieval. Secondary endpoints were incidence of clinically symptomatic recurrent PE, new or propagating deep vein thrombosis (DVT), and filter-related complications including migration, fracture, penetration, and tilt. RESULTS: Filter placement was technically successful in 199 patients (99.5%). Filters were clinically successful in 190 patients (95%). The rate of PE was 3% (n = 6), with 5 patients having a small subsegmental PE and 1 having a lobar PE. New or worsening DVT was noted in 26 patients (13%). Filter retrieval was attempted 125 times in 124 patients and was technically successful in 121 patients (97.6%). The mean filter dwell time at retrieval was 200.8 days (range, 5-736 d). There were no instances of filter fracture, migration, or tilt greater than 15° at the time of filter retrieval or during follow-up. CONCLUSIONS: The Denali IVC filter exhibited high success rates for filter placement and retrieval while maintaining a low complication rate in this clinical trial.

The DENALI Trial: an interim analysis of a prospective, multicenter study of the Denali retrievable inferior vena cava filter.

PURPOSE: To assess safety and effectiveness of a nitinol retrievable inferior vena cava (IVC) filter in patients who require caval interruption to protect against pulmonary embolism (PE). MATERIALS AND METHODS: Two hundred patients with temporary indications for an IVC filter were enrolled in this prospective, multicenter clinical study. Patients undergoing filter implantation were to be followed for 2 years or for 30 days after filter retrieval. At the time of the present interim report, all 200 patients had been enrolled in the study, and 160 had undergone a retrieval attempt or been followed to 6 months with their filter in place. Primary study endpoints included technical and clinical success of filter placement and retrieval. Patients were also evaluated for recurrent PE, new or worsening deep vein thrombosis, and filter migration, fracture, penetration, and tilt. RESULTS: Clinical success of placement was achieved in 94.5% of patients (172 of 182), with a one-sided lower limit of the 95% confidence interval of 90.1%. Technical success rate of filter placement was 99.5%. Technical success rate of retrieval was 97.3%; 108 filters were retrieved in 111 attempts. In two cases, the filter apex could not be engaged with a snare, and one device was engaged but could not be removed. Filter retrievals occurred at a mean indwell time of 165 days (range, 5-632 d). There were no instances of filter fracture, migration, or tilt greater than 15° at the time of retrieval or 6-month follow-up. CONCLUSIONS: In this interim report, the nitinol retrievable IVC filter provided protection against pulmonary embolism, and the device could be retrieved with a low rate of complications.

[Experimental investigation of self-soluble cava-filter].

Pulmonary embolism accounts for sudden death of a third of patients. Endovascular catheter interventions including cava-filter implantation have the great promises for the prevention of pulmonary embolism and treatment of phlebothrombosis in inferior vena cava system. The aim of our research is creation of self-soluble cava-filter for prevention of pulmonary embolism and evaluation of opportunity of one-stage filter implantation. We conducted the series of experiments. We used 18 rabbits as experimental animals. The essence of experiment was to prove the possibility for application and to evaluate the extent of absorption of developed cava-filter in lumen of vena cava. It was revealed that copolymer rods implanted among gluteal muscles fibres and near ear vena completely dissolved after 40-50 days. Health of animals didn't change. The cava-filter dissolved partially. There were not toxic effects. The results suggest that there is need to continue research for developing of cava-filter of soluble copolymer.

Prevention of venous thromboembolism in patients with cancer.

Venous thromboembolism (VTE) is a major cause of both morbidity and mortality in patients with cancer. Venous thromboembolism, which includes both deep vein thrombosis and pulmonary embolism, affects a sizable portion of patients with malignancy and can have potentially life threatening complications. Accurate assessment of risk as well as diagnosis and treatment of this process is paramount to preventing death in this high risk population. Various risk models predictive of venous thromboembolism in patients with cancer have been developed, and knowledge of these rubrics is essential for the treating oncologist. Subgroups of particular interest are inpatients receiving chemotherapy, postoperative patients after surgical debulking, and patients undergoing radiotherapy. Numerous newer drugs have become available for the prevention of venous thromboembolism in patients with cancer who are at high risk of developing the disease. These include the class of drugs called direct oral anticoagulants, (DOACs) which do not require the same monitoring that other modalities have previously required and are taken by mouth, preventing the discomfort associated with subcutaneous strategies. The appropriate risk stratification and intervention to prevent venous thromboembolism are vital to the treatment of patients with cancer.

Secondary cement injection technique reduces pulmonary embolism in total hip arthroplasty.

PURPOSE: Cardio-pulmonary damage due to embolism is a feared complication of cemented hip arthroplasty and can be fatal. Embolic events result from an increased intramedullary pressure during cement and stem insertion and can lead to extrusion of bone-marrow elements into the circulation. To reduce embolism and at the same time achieve an ideal cement mantle, the cement injection stem has been designed. In contrast to conventional stems where cement applied before stem insertion (primary cementing technique), the cement injection stem is positioned first and only then is the cement injected via the stem in a volume- and pressure-controlled fashion (secondary cementing technique). METHODS: A randomised trial with 30 patients was performed to evaluate whether this technique is able to reduce embolic events. Patients either received a conventional cemented stem (primary cementing technique) or a cement injection stem (secondary cementing technique). Embolic events were recorded by transesophageal echocardiography at six specific points during the operation and classified from grade 0 to grade 3. RESULTS: Significantly fewer grade 2 and 3 embolic events were observed in patients receiving the cement injection stem using the secondary cementing technique. Moreover, in the conventional group all patients (100 %) had at least one grade 3 embolus whereas only 20 % with the secondary cementing technique had an embolic event of grade 3. CONCLUSION: Secondary cement insertion via the cement injection stem is able to reduce severe embolic events significantly. The technique offers a more gentle cementing technique and therefore appears especially beneficial for patients of advanced age and/or with pre-existing cardio-pulmonary comorbidities.

Prevention of Pulmonary Cement Embolism by Inferior Vena Cava Filter following Vertebroplasty-related Cement Intravasation.

A 77 year old woman with recent history of vertebroplasty for treatment of multiple osteoporotic lumbar vertebral body compression fractures presented for post-procedure care. A series of radiographs and cross-sectional imaging of the lumbar spine revealed an unexpected finding of cured bone cement within a small lumbar vertebral vein, the inferior vena cava and within the spokes of an inferior vena cava filter which had originally been placed two years earlier. Inferior vena cava filters have become the standard of care to prevent pulmonary embolism in the setting of deep venous thrombosis. However, cases of foreign materials becoming entrapped in filters are uncommon despite the documented frequency of intravasation of bone cement into the circulatory system following vertebroplasty procedures. This case is significant because it illustrates the rare occurrence of an inferior vena cava filter capturing intravasated bone cement and preventing its migration to the pulmonary circulation.

Prevention of cardiopulmonary embolization of polymethylmethacrylate cement fragment after kyphoplasty with insertion of inferior vena cava filter.

We report the case of a 51-year-old woman who underwent kyphoplasty with polymethylmethacrylate for painful compression fracture of the third lumbar vertebra. Infiltration of cement into the inferior vena cava, noted intraoperatively, was confirmed with postoperative CT scan. A Greenfield filter was placed to prevent cardiopulmonary embolization of the fragment. On follow-up x-rays, the cement fragment was found to have detached and embolized into the vena cava filter. Endovascular technique was used to retrieve it to the common femoral vein with subsequent successful removal of the crescent-like fragment with operative exploration. Patient was asymptomatic at four-week follow-up visit.

Cardiovascular changes after PMMA vertebroplasty in sheep: the effect of bone marrow removal using pulsed jet-lavage.

Clinically, the displacement of intravertebral fat into the circulation during vertebroplasty is reported to lead to problems in elderly patients and can represent a serious complication, especially when multiple levels have to be treated. An in vitro study has shown the feasibility of removing intravertebral fat by pulsed jet-lavage prior to vertebroplasty, potentially reducing the embolization of bone marrow fat from the vertebral bodies and alleviating the cardiovascular changes elicited by pulmonary fat embolism. In this in vivo study, percutaneous vertebroplasty using polymethylmethacrylate (PMMA) was performed in three lumbar vertebrae of 11 sheep. In six sheep (lavage group), pulsed jet-lavage was performed prior to injection of PMMA compared to the control group of five sheep receiving only PMMA vertebroplasty. Invasive recording of blood pressures was performed continuously until 60 min after the last injection. Cardiac output and arterial blood gas parameters were measured at selected time points. Post mortem, the injected cement volume was measured using CT and lung biopsies were processed for assessment of intravascular fat. Pulsed jet-lavage was feasible in the in vivo setting. In the control group, the injection of PMMA resulted in pulmonary fat embolism and a sudden and significant increase in mean pulmonary arterial pressure. Pulsed jet-lavage prevented any cardiovascular changes and significantly reduced the severity of bone marrow fat embolization. Even though significantly more cement had been injected into the lavaged vertebral bodies, significantly fewer intravascular fat emboli were identified in the lung tissue. Pulsed jet-lavage prevented the cardiovascular complications after PMMA vertebroplasty in sheep and alleviated the severity of pulmonary fat embolism.

[Bone resin based vertebral augmentation: form of anesthesia and systemic complications]. / Zementbasierte Augmentationsverfahren an der Wirbelsäule : Anästhesieverfahren und systemische Komplikationen.

Over the last few years bone resin based vertebral augmentation in the form of vertebro- and kyphoplasty has proved to be a safe therapeutic option in cases of vertebral compression fractures. Nevertheless, rare systemic complications have been seen, i.e., pulmonary embolisms ranging from harmless to lethal.The presence of an anesthesiologist can be especially useful in cases of systemic complications. Whether the form of anesthesia has any influence on the outcome of vertebro- or kyphoplasty is currently unknown. Local anesthesia supplemented by analgosedation is often used as an alternative to general anesthesia. The rationale for one or the other form of anesthesia can be factors like type of augmentation (vertebro- or kyphoplasty), number of vertebral levels to be treated as well as the patient's age, condition, and comorbidities.Single-shot epidural anesthesia is yet another anesthetic option that has been successfully used in our clinic for some years now. It combines the advantages of general and local anesthesia: excellent segmental analgesia even in multilevel cases in awake and responding patients.

Clinical investigations of polymethylmethacrylate cement viscosity during vertebroplasty and related in vitro measurements.

Percutaneous vertebroplasty, comprising an injection of polymethylmethacrylate (PMMA) into vertebral bodies, is a practical procedure for the stabilization of osteoporotic compression fractures as well as other weakening lesions. Cement leakage is considered to be one of the major and most severe complications during percutaneous vertebroplasty. The viscosity of the material plays a key role in this context. In order to enhance the safety for the patient, a rheometer system was developed to measure the cement viscosity intraoperatively. For this development, it is of great importance to know the proper viscosity to start the procedure determined by experienced surgeons and the relation between the time period when different injection devices are used and the cement viscosity. The purpose of the study was to investigate the viscosity ranges for different injection systems during conventional vertebroplasty. Clinically observed viscosity values and related time periods showed high scattering. In order to get a better understanding of the clinical observations, cement viscosity during hardening at different ambient temperatures and by simulation of the body temperature was investigated in vitro. It could be concluded, that the direct viscosity assessment with a rheometer during vertebroplasty can help clinicians to define a lower threshold viscosity and thereby decrease the risk of leakage and make adjustments to their injection technique in real time. Secondly, the acceleration in hardening of PMMA-based cements at body temperature can be useful in minimizing leakages by addressing them with a short injection break.

A prospective long-term study of 220 patients with a retrievable vena cava filter for secondary prevention of venous thromboembolism.

BACKGROUND: The immediate and long-term clinical events associated with the placement and removal of a retrievable filter (ALN filter; ALN Implants Chirurgicaux; Ghisonaccia, France) remain largely unknown. METHODS: This was a prospective cohort study with an 18-month follow-up. All consecutive patients scheduled for placement of an ALN filter between April 1999 and June 2005 in the Radiology Department of our hospital were included. RESULTS: During the study period, placement of an ALN filter was indicated in 220 patients (mean age, 70.8 years), who were followed up for a median duration of 338.5 days (range, 1 to 561 days); 148 patients (67.3%) completed the 18-month follow-up. No patients were unavailable for follow-up. All patients had an acute or past venous thromboembolism. Main indications were recurrent venous thromboembolism despite adequate anticoagulation therapy (10.9%), transient bleeding event (21.8%), definitive contraindication for anticoagulant therapy (26.8%), or obligation to stop anticoagulant therapy due to major surgery, major trauma, or invasive procedure (37.7%). Filter insertion was successful in 98.6% of patients and resulted in an immediate complication in 11.8%. The median duration of filter implantation was 166 days (first to third quartiles, 34 to 478 days). Meanwhile, 17.0% (37 of 217 patients) had at least one venous thromboembolic event. Filter retrieval was attempted in 25.3% of patients after a median of 51 days (range, 6 to 352 days); removal was successful at the first attempt in 92.7% of patients. CONCLUSIONS: The filter could be easily inserted and successfully removed up to 1 year after insertion. Its safety and efficacy in preventing pulmonary embolism should be properly assessed in a randomized study.

Radiopaque Resorbable Inferior Vena Cava Filter Infused with Gold Nanoparticles.

Failure to remove a retrievable inferior vena cava (IVC) filter can cause severe complications with high treatment costs. Polydioxanone (PPDO) has been shown to be a good candidate material for resorbable IVC filters. However, PPDO is radioluscent under conventional imaging modalities. Thus, the positioning and integrity of these PPDO filters cannot be monitored by computed tomography (CT) or x-ray. Here we report the development of radiopaque PPDO IVC filters based on gold nanoparticles (AuNPs). Commercially available PPDO sutures were infused with AuNPs. Scanning electron microscopy analysis confirmed the presence of AuNP on the surface of PPDO. Micro-CT and x-ray images of the AuNP-infused PPDO sutures showed significant signal enhancement compared to untreated PPDO sutures. Elemental analysis showed that gold loading exceeded 2000 ppm. Tensile strength and in vitro cytotoxicity showed no significant difference between AuNP-infused and untreated PPDO. In a 10-week stability study, neither the gold content nor the radiopacity of the infused PPDO sutures significantly changed in the first 6 weeks. The increased attenuation of AuNP-infused PPDO sutures indicates their major advantage as a radiopaque resorbable filter material, as the radiopacity allows monitoring of the position and integrity of the filter, thereby increasing its safety and efficacy.

Use of the ALN permanent/removable vena cava filter. A multi-centre experience.

AIM: Vena cava filters are used for the prevention of pulmonary embolism in cases of contraindication, failure or complications of the anticoagulant therapy. There are no certain data in the literature concerning the effectiveness of vena cava filters and, above all, the possible long-term complications are not known. For this reason increasing attention is paid to permanent/removable filters that permit exploitation of the short-term advantages of vena cava interruption, eliminating the possible long-term complications. We have reported the results of a multicentre experience concerning ALN permanent/removable vena cava filters in a total of 276 patients. METHODS: Vena cava filters were placed in 276 patients via the jugular, femoral and brachial vein. The filter was removed in 43 patients after 3 months and in 28 patients after 6 months. RESULTS: In 1 case, due to incomplete opening of the filter, immediate percutaneous removal was performed and another filter was positioned. In 5 cases it was not possible to remove the filter, in 1 case due to inexperience and in the remaining cases due to adhesion of the head or claws of the filter to the wall of the vein. No problems occurred in the other cases. CONCLUSIONS: The ALN vena cava filter is safe, easy to position and remove even a long time after placement. Currently permanent filters should be used only for patients with poor survival expectancy whereas in all other cases the use of removable filters is preferable.

In vitro evaluation of clot capture efficiency of an absorbable vena cava filter.

OBJECTIVE: The purpose of this study was to determine the in vitro clot capture efficiency (CCE) of an investigational absorbable inferior vena cava filter (IVCF) vs the Greenfield IVCF. METHODS: Investigational absorbable and Greenfield filters were challenged with polyacrylamide clot surrogates ranging from 3 × 5 to 10 × 24 mm (diameter × length) in a flow loop simulating the venous system. Filters were challenged with clots until CCE standard error of 5% or less was achieved under binomial statistics. Pressure gradients across the filters were measured for the largest size clot, enabling calculation of forces on the filter. RESULTS: The in vitro CCE of the absorbable IVCF was statistically similar to that of the Greenfield filter for all clot sizes apart from the 3 × 10-mm clot, for which there was statistically significant difference between filter CCEs (absorbable filter, 59%; Greenfield filter, 31%; P = .0001). CCE ranged from an average 32% for the 3 × 5-mm clot to 100% for 7 × 10-mm and larger clots for the absorbable IVCF. Pressure gradient across the absorbable filter with 10 × 24-mm clot averaged 0.14 mm Hg, corresponding to a net force on the filter of 2.1 × 10(-3) N, compared with 0.39 mm Hg or 5.8 × 10(-3) N (P < .001) for the Greenfield filter. CONCLUSIONS: CCE of the absorbable filter was statistically similar to or an improvement on that of the Greenfield stainless steel filter for all clot sizes tested. CCE of the Greenfield filter in this study aligned with data from previous studies. Given the efficacy of the Greenfield filter in attenuating the risk of pulmonary embolism, the current study suggests that the absorbable filter may be a viable candidate for subsequent human testing.

The mid-term efficacy and safety of a permanent nitinol IVC filter(TrapEase).

OBJECTIVE: 1) To evaluate the mid-term efficacy and safety of a permanent nitinol inferior vena cava (IVC) filter; 2) to evaluate filter effectiveness, filter stability and caval occlusion. MATERIALS AND METHODS: A prospective evaluation of the TrapEase IVC filter was performed on 42 patients (eight men, 34 women) ranging in age from 22 to 78 years (mean age 66 years). All patients were ill with a high risk of pulmonary embolism (PE). Indications for filter placement were: 1) deep vein thrombosis with recurrent thromboembolism; 2) and/or free-floating thrombus with contraindication to anticoagulation; and 3) complications in achieving adequate anticoagulation. Follow-up evaluations (mean: 15.4 months, range: 2 to 28 months) were performed at 6- and 12-month intervals after the procedure and included clinical histories, chart reviews, plain film, Doppler ultrasounds, and contrasted abdominal CT scans. RESULTS: In follow-up evaluations, the data analysis revealed no cases of symptomatic PE. There were no cases of filter migration, insertion site thrombosis, filter fracture, or vessel wall perforation. During the study, there was one case of filter thrombosis; early symptomatic thrombosis that was successfully treated in the hospital. Of the 42 subjects, eight died. These deaths were not related to the filter device or the implantation procedure, but to the underlying disease. CONCLUSION: This study demonstrates that the TrapEase permanent IVC filter is a safe and an effective device with low complication rates and is best used in patients with thromboembolic disease with a high risk of PE.

Comparison of the oral direct thrombin inhibitor ximelagatran with enoxaparin as prophylaxis against venous thromboembolism after total knee replacement: a phase 2 dose-finding study.

BACKGROUND: Up to one third of patients who undergo total knee replacement develop deep vein thrombosis after surgery despite receiving low-molecular-weight heparin prophylaxis. Ximelagatran is a novel direct inhibitor of free and clot-bound thrombin. METHODS: We performed a randomized, parallel, dose-finding study of 600 adults undergoing elective total knee replacement at 68 North American hospitals to determine the optimum dose of ximelagatran to use as prophylaxis against venous thromboembolism after total knee replacement. Patients received either ximelagatran twice daily by mouth in blinded fixed doses of 8, 12, 18, or 24 mg or open-label enoxaparin sodium, 30 mg, subcutaneously twice daily, starting 12 to 24 hours after surgery and continuing for 6 to 12 days. We measured the 6- to 12-day cumulative incidence of symptomatic or venographic deep vein thrombosis, symptomatic pulmonary embolism, and bleeding. RESULTS: A total of 594 patients received at least 1 dose of the study drug; 443 patients were evaluable for efficacy. Rates of overall venous thromboembolism (and proximal deep vein thrombosis or pulmonary embolism) for the 8-, 12-, 18-, and 24-mg doses of ximelagatran were 27% (6.6%), 19.8% (2.0%), 28.7% (5.8%), and 15.8% (3.2%), respectively. Rates of overall venous thromboembolism (22.7%) and proximal deep vein thrombosis or pulmonary embolism (3.1%) for enoxaparin did not differ significantly compared with 24-mg ximelagatran (overall difference, -6.9%; 95% confidence interval, -18.0% to 4.2%; P=.3). There was no major bleeding with administration of 24 mg of ximelagatran twice daily. CONCLUSION: Fixed-dose, unmonitored ximelagatran, 24 mg twice daily, given after surgery appears to be safe and effective oral prophylaxis against venous thromboembolism after total knee replacement.

Pilot in vivo study of an absorbable polydioxanone vena cava filter.

OBJECTIVE: The objectives of this study were to evaluate tensile strength retention of polydioxanone as a function of time in a swine venous system and to assess the feasibility of an absorbable inferior vena cava (IVC) filter made from polydioxanone in a pilot swine study. METHODS: Twenty strands (60 cm each) of size 1 polydioxanone absorbable suture (Ethicon, Somerville, NJ) were placed in the central venous system of domestic swine. Strands were harvested at weekly intervals during 10 weeks for tensile strength testing. Results were compared with control samples obtained from an in vitro engineered circulation system containing sodium phosphate buffer solution. Three IVC filters braided from polydioxanone suture were also catheter deployed in three swine to assess absorbable IVC filter feasibility. RESULTS: Polydioxanone retained 82% tensile strength in vitro vs 79% in vivo at 35 days (P > .22), the desired prophylactic duration. For IVC filters made from polydioxanone, technical success of placement was achieved in all three filters deployed (100%). Autologous thrombus deployed inferior to the filter remained trapped in the filter until thrombus resorption, with no evidence of pulmonary emboli on follow-up computed tomography. There were no instances of caval penetration, filter-induced IVC thrombosis, filter migration, or tilt >15 degrees with imaging and clinical follow-up carried out to 32 weeks. CONCLUSIONS: Strength retention of polydioxanone suture placed in the venous system of swine is similar to earlier in vitro studies out to 10 weeks (P > .06 for all weeks) and is more than sufficient (8.20 ± 0.37 kg mean load at break for size 1) to trap thrombus. Pilot animal study suggests that an absorbable polydioxanone IVC filter can be catheter deployed to capture and to hold iatrogenically administered autologous thrombus through resorption.

A new device for the prevention of pulmonary embolism in critically ill patients: Results of the European Angel Catheter Registry.

BACKGROUND: Pulmonary embolism (PE) is a potentially life-threatening complication of critical illness. In trauma and neurosurgical patients with contraindications to anticoagulation, inferior vena cava (IVC) filters have been used to prevent PE, but their associated long-term complication rates and difficulties associated with filter removal have limited their use. The Angel catheter is a temporary device, which combined an IVC filter with a triple-lumen central venous catheter (IVC filter-catheter) and is intended for bedside placement and removal when no longer indicated. METHODS: This study presents data from a European Registry of 60 critically ill patients in whom the IVC filter-catheter was used to prevent PE. The patients were all at high risk of PE development or recurrence and had contraindications to anticoagulation. The primary end points of this study were to evaluate the safety (in particular, the presence of infectious or thrombotic events) and effectiveness (the numbers of PEs and averted PEs) of the IVC filter-catheter. RESULTS: The main diagnosis before catheter insertion was major trauma in 33 patients (55%), intracerebral hemorrhage or stroke in 9 (15%), a venous thromboembolic event in 9 (15%), and active bleeding in 6 (10%). The IVC filter-catheter was placed as prophylaxis in 51 patients (85%) and as treatment in the 9 patients (15%) with venous thromboembolic event. The devices were inserted at the bedside without fluoroscopic guidance in 54 patients (90%) and within a median of 4 days after hospital admission. They were left in place for a mean of 6 days (4-8 days). One patient developed a PE, without hemodynamic compromise; two PEs were averted. No serious adverse events were reported. CONCLUSION: Early bedside placement of an IVC filter-catheter is possible, and our results suggest that this is a safe, effective alternative to short-term PE prophylaxis for high-risk patients with contraindications to anticoagulation. LEVEL OF EVIDENCE: Therapeutic study, level V.