Ibero-American Society of Interventionism (SIDI) and the Spanish Society of Vascular and Interventional Radiology (SERVEI) Standard of Practice (SOP) for the management of inferior Vena Cava filters in the treatment of acute venous Thromboembolism

Objectives: to present an interventional radiology standard of practice on the use of inferior vena cava filters (IVCFs) in patients with or at risk to develop venous thromboembolism (VTE) from the Iberoamerican Interventional Society (SIDI) and Spanish Vascular and Interventional Radiology Society (SERVEI). Methods: a group of twenty-two interventional radiologist experts, from the SIDI and SERVEI societies, attended online meetings to develop a current clinical practice guideline on the proper indication for the placement and retrieval of IVCFs. A broad review was undertaken to determine the participation of interventional radiologists in the current guidelines and a consensus on inferior vena cava filters. Twenty-two experts from both societies worked on a common draft and received a questionnaire where they had to assess, for IVCF placement, the absolute, relative, and prophylactic indications. The experts voted on the different indications and reasoned their decision. Results: a total of two-hundred-thirty-three articles were reviewed. Interventional radiologists participated in the development of just two of the eight guidelines. The threshold for inclusion was 100% agreement. Three absolute and four relative indications for the IVCF placement were identified. No indications for the prophylactic filter placement reached the threshold. Conclusion: interventional radiologists are highly involved in the management of IVCFs but have limited participation in the development of multidisciplinary clinical practice guidelines

Ibero-American Society of Interventionism (SIDI) and the Spanish Society of Vascular and Interventional Radiology (SERVEI) Standard of Practice (SOP) for the Management of Inferior Vena Cava Filters in the Treatment of Acute Venous Thromboembolism

Vena cava filtersFiltres de vena cavaFiltros de vena cavaObjectives: to present an interventional radiology standard of practice on the use of inferior vena cava filters (IVCFs) in patients with or at risk to develop venous thromboembolism (VTE) from the Iberoamerican Interventional Society (SIDI) and Spanish Vascular and Interventional Radiology Society (SERVEI). Methods: a group of twenty-two interventional radiologist experts, from the SIDI and SERVEI societies, attended online meetings to develop a current clinical practice guideline on the proper indication for the placement and retrieval of IVCFs. A broad review was undertaken to determine the participation of interventional radiologists in the current guidelines and a consensus on inferior vena cava filters. Twenty-two experts from both societies worked on a common draft and received a questionnaire where they had to assess, for IVCF placement, the absolute, relative, and prophylactic indications. The experts voted on the different indications and reasoned their decision. Results: a total of two-hundred-thirty-three articles were reviewed. Interventional radiologists participated in the development of just two of the eight guidelines. The threshold for inclusion was 100% agreement. Three absolute and four relative indications for the IVCF placement were identified. No indications for the prophylactic filter placement reached the threshold. Conclusion: interventional radiologists are highly involved in the management of IVCFs but have limited participation in the development of multidisciplinary clinical practice guidelines

Filtros de veia cava inferior em pacientes com câncer: experiência em 50 casos

OBJECTIVE: To study the immediate and late results obtained from the implantation of vena cava filters in cancer patients with deep vein thrombosis concomitant with neoplasia. METHODS: This was a retrospective evaluation of 50 patients with an association of cancer and deep venous thrombosis who underwent interruption of the inferior vena cava and the insertion of permanent vena cava filters. The indications for the procedure, filter implantation technique, early and late complications related to the operation, and the clinical evolution were evaluated. RESULTS: The most frequent indication for filter implantation was the contraindication for full anticoagulant treatment (80%). The femoral vein was the preferred access route (86% of the patients). There were no complications related to the surgical procedure. During the follow-up, the following complications were observed: 1 episode of nonfatal pulmonary thromboembolism, 2 cases of occlusion of the inferior vena cava, and 1 case of thrombus retained in the device. Twenty patients (40%) died due to progression of the neoplasm. CONCLUSIONS: Interruption of the inferior cava vein using an endoluminal filter is a procedure with a low rate of complications. It is a safe and efficient measure for preventing pulmonary embolism in cancer patients who have deep vein thrombosis of the lower limbs.OBJETIVO: Estudar os resultados imediatos e tardios obtidos com a implantação de filtros de veia cava inferior em pacientes com trombose venosa profunda concomitante a neoplasia. MÉTODOS: Avaliamos retrospectivamente 50 pacientes com câncer e trombose venosa profunda associada submetidos a interrupção de veia cava inferior com filtros intraluminais definitivos. Foram estudados aspectos referentes à indicação do procedimento, à técnica de implante dos dispositivos, complicações precoces e tardias relacionadas à operação e à evolução dos pacientes. RESULTADOS: A indicação mais freqüente para o procedimento foi a impossibilidade de anticoagulação plena (80% ) e a via de acesso preferencial foi a punção da veia femoral, realizada em 86% dos pacientes. Não houve complicações relativas ao implante dos filtros. Durante a evolução ocorreram: um episódio de tromboembolia pulmonar não fatal e dois casos de oclusão da veia cava inferior; em um paciente foi demonstrada a presença de coágulo retido no dispositivo. Vinte pacientes (40%) faleceram devido à neoplasia. CONCLUSÃO: A interrupção da veia cava inferior com filtro endoluminal é um procedimento com baixo índice de complicações e eficaz na prevenção da embolia pulmonar nos pacientes com tromobose venosa profunda de membros inferiores portadores de câncer

The Clinical Rationale for the Sentry Bioconvertible Inferior Vena Cava Filter for the Prevention of Pulmonary Embolism

The Sentry inferior vena cava (IVC) filter is designed to provide temporary protection against pulmonary embolism (PE) during transient high-risk periods and then to bioconvert after 60 days after implantation. At the time of bioconversion, the device's nitinol arms retract from the filtering position into the caval wall. Subsequently, the stable stent-like nitinol frame is endothelialized. The Sentry bioconvertible IVC filter has been evaluated in a multicenter investigational-device-exemption pivotal trial (NCT01975090) of 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, and with contraindications to anticoagulation. Successful filter conversion was observed in 95.7% of patients at 6 months (110/115) and 96.4% at 12 months (106/110). Through 12 months, there were no cases of symptomatic PE. The rationale for development of the Sentry bioconvertible device includes the following considerations: (1) the period of highest risk of PE for the vast majority of patients occurs within the first 60 days after an index event, with most of the PEs occurring in the first 30 days; (2) the design of retrievable IVC filters to support their removal after a transitory high-PE-risk period has, in practice, been associated with insecure filter dynamics and time-dependent complications including tilting, fracture, embolization, migration, and IVC perforation; (3) most retrievable IVC filters are placed for temporary protection, but for a variety of reasons they are not removed in any more than half of implanted patients, and when removal is attempted, the procedure is not always successful even with advanced techniques; and (4) analysis of Medicare hospital data suggests that payment for the retrieval procedure does not routinely compensate for expense. The Sentry device is not intended for removal after bioconversion. In initial clinical use, complications have been limited. Long-term results for the Sentry bioconvertible IVC filter are anticipated soon

VENA CAVA FILTER UTILIZATION AND RETRIEVAL: A QUALITY OF CARE ISSUE

Vena cava filters (VCFs) are mechanical devices implanted in the inferior vena cava to trap thrombi from travelling to the pulmonary circulation, resulting in pulmonary embolism. VCFs are available as permanent or non-permanent, retrievable devices and are generally indicated for use in patients unable to receive systemic anticoagulation or at exceedingly high risk for pulmonary embolism (PE). Retrievable devices allow for removal of the VCF once the contraindication to anticoagulation or high risk of PE has abated. Since the introduction of retrievable VCFs in the early 2000’s, use of VCFs has increased three-fold, with \u3e85% of all VCFs placed being retrievable. Complications due to indwelling VCFs are time-dependent and the FDA-recommended time periods for retrieval fall within 50-70 days post-implantation. However, retrieval rates are low. Generally around 30% of all VCFs are retrieved in eligible patients, with the remainder becoming permanent despite no indication for the VCF to remain in place. These studies sought to quantify the epidemiology of VCF use, and retrieval in Kentucky and nationally, and to inform future clinical interventions to increase retrieval rates. The following objectives were achieved: 1) describe treatment patterns for patients hospitalized with PE or other venous thromboembolism including VCF utilization and anticoagulation, 2) characterize patients who do and do not receive VCFs, 3) evaluate retrieval rates among subgroups of patients and identify factors associated with retrieval, and 4) evaluate a minimal intervention performed in the University of Kentucky hospital aimed at increasing VCF retrieval rates. Finally, a review of the literature was conducted to identify interventions that have increased retrieval rates at individual hospitals. All these data will be useful in developing a future institutional-level intervention to increase retrieval rates to better improve the quality of patient care

Early Placement of Optional Vena Cava Filter in High-Risk Patients with Traumatic Brain Injury

Objectives:: Patients sustaining severe trauma are at high risk for the development of venous thromboembolic events (VTE). Pharmacologic VTE prophylaxis may be contraindicated early after trauma due to potential bleeding complications. The purpose of this study was to evaluate safety and feasibility of early prophylactic vena cava filter (VCF) placement and subsequent retrieval in multiple injured patients with traumatic brain injury (TBI). Methods:: Analysis of single-institution case series of consecutive patients who received a prophylactic VCF after severe TBI (Abbreviated Injury Scale, AiS ≥ 3) between August 2003 and October 2006. Results:: A total of 34 optional VCF were prophylactically placed with a median delay of 1 day after trauma (range, 0-7 days). All patients had sustained multiple injuries (median Injury Severity Score 41, range, 18-59) with severe TBI (median AiS 4, range 3-5). Median age was 41 years (range, 17-67 years). Two patients had succumbed before potential filter retrieval. Of the remaining patients, 27 (84%) had their filters uneventfully retrieved between 11 and 32 days (median, 18 days) after placement with no retrieval-related morbidity. Five VCF (16%) were left permanently. In one patient (3%) early inferior vena cava occlusion and deep venous thrombosis occurred 14 days after VCF placement. Symptomatic pulmonary embolism was observed in one patient (3%) 5 days after VCF retrieval. Overall trauma-related mortality was 9%. Conclusions:: Early VCF placement may be of benefit for multiple injured patients with TBI when pharmacologic VTE prophylaxis is contraindicated. VCF retrieval is safe and feasible. Filter placement- and retrieval-related morbidity is lo

One-Year Analysis of the Prospective Multicenter SENTRY Clinical Trial: Safety and Effectiveness of the Novate Sentry Bioconvertible Inferior Vena Cava Filter

Purpose To prospectively assess the Sentry bioconvertible inferior vena cava (IVC) filter in patients requiring temporary protection against pulmonary embolism (PE). Materials and Methods At 23 sites, 129 patients with documented deep vein thrombosis (DVT) or PE, or at temporary risk of developing DVT or PE, unable to use anticoagulation were enrolled. The primary end point was clinical success, including successful filter deployment, freedom from new symptomatic PE through 60 days before filter bioconversion, and 6-month freedom from filter-related complications. Patients were monitored by means of radiography, computerized tomography (CT), and CT venography to assess filtering configuration through 60 days, filter bioconversion, and incidence of PE and filter-related complications through 12 months. Results Clinical success was achieved in 111 of 114 evaluable patients (97.4%, 95% confidence interval [CI] 92.5%–99.1%). The rate of freedom from new symptomatic PE through 60 days was 100% (n = 129, 95% CI 97.1%–100.0%), and there were no cases of PE through 12 months for either therapeutic or prophylactic indications. Two patients (1.6%) developed symptomatic caval thrombosis during the first month; neither experienced recurrence after successful interventions. There was no filter tilting, migration, embolization, fracture, or caval perforation by the filter, and no filter-related death through 12 months. Filter bioconversion was successful for 95.7% (110/115) at 6 months and for 96.4% (106/110) at 12 months. Conclusions The Sentry IVC filter provided safe and effective protection against PE, with a high rate of intended bioconversion and a low rate of device-related complications, through 12 months of imaging-intense follow-up

Navigating inferior vena cava filters in invasive cardiology procedures: A systematic review

BACKGROUND: Transfemoral venous access (TFV) is the cornerstone of minimally invasive cardiac procedures. Although the presence of inferior vena cava filters (IVCFs) was considered a relative contraindication to TFV procedures, small experiences have suggested safety. We conducted a systematic review of the available literature on cardiac procedural success of TFV with IVCF in-situ. METHODS: Two independent reviewers searched PubMed, EMBASE, SCOPUS, and Google Scholar from inception to October 2020 for studies that reported outcomes in patients with IVCFs undergoing TFV for invasive cardiac procedures. We investigated a primary outcome of acute procedural success and reviewed the pooled data for patient demographics, procedural complications, types of IVCF, IVCF dwell time, and procedural specifics. RESULTS: Of the 120 studies initially screened, 8 studies were used in the final analysis with a total of 100 patients who underwent 110 procedures. The most common IVCF was the Greenfield Filter (36%), 60% of patients were males and the mean age was 67.8 years. The overall pooled incidence of acute procedural success was 95.45% (95% confidence interval 89.54. - 98.1) with no heterogeneity (I2 = 0%, p = 1) and there were no reported filter related complications. CONCLUSION: This systematic review is the largest study of its kind to demonstrate the safety and feasibility of TFV access in a variety of cardiac procedures in the presence of IVCF

Tempofilter II implantation in patients with lower extremity fractures and proximal deep vein thrombosis

PURPOSEWe aimed to examine the efficacy and safety of Tempofilter II (B. Braun, Melsungen, Germany) implantation to prevent pulmonary embolism in patients with lower-extremity fractures and proximal deep vein thrombosis (DVT).MATERIALS AND METHODSThe records of patients with lower limb fractures and proximal DVT who were implanted with Tempofilter II devices from May 2004 to August 2009 were reviewed. Data collected included success rate, occurrence of pulmonary embolism, retrieval rate, and complications.RESULTSA total of 176 eligible patients, including 129 males (73.3%) and 47 females (26.7%) with a median age of 42.0 years (interquartile range [IQR], 34.0–52.0 years) were included in the study. Filters were successfully implanted in 174 patients (98.9%). One patient experienced a pulmonary embolism after implantation and died. Filters were removed without complications in all other patients. Median filter implantation time was 27 days (IQR, 25.0–29.0 days). Visible organized thrombi were present on the surface of 144 (82.8%) of filters after removal, and the diameter of most thrombi (n=124) ranged from 0.5 to 1.0 cm. Filters migrated <2 cm in 104 patients (59.8%) and ≥2 cm in five patients (2.9%). In these five cases, three filters migrated into the right atrium and two migrated to the orifice of the renal veins.CONCLUSIONTempofilter II is safe and may be useful in cases of lower extremity fracture with proximal DVT for the prevention of pulmonary embolism. The filter is easily placed and retrieved, and associated with minimal complications