BACKGROUND: Pulmonary emboli (PE), or blood clots in the lungs,can be potentially fatal. Anticoagulation is the first line therapy to prevent PE. In some instances anticoagulation fails to prevent more emboli, or cannot be given because the person has a high risk of bleeding. Inferior vena caval filters (VCFs) are metal alloy devices that mechanically trap fragmented emboli from the deep leg veins en route to the pulmonary circulation. Retrievable filters are designed to be introduced and removed percutaneously. Although their deployment seems of theoretical benefit, their clinical efficacy and adverse event profile is unclear. This is the third update of a Cochrane Review first published in 2007.
OBJECTIVES: To assess the evidence for the effectiveness and safety of vena caval filters (VCFs) in preventing pulmonary embolism (PE).
SEARCH METHODS: For this review update, the Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (last searched 10 September 2019) and the Cochrane Register of Controlled Trials (CENTRAL) (2019, Issue 8) via the Cochrane Register of Studies Online. The CIS also searched MEDLINE Ovid, EMBASE Ovid, CINAHL, and AMED (1 January 2017 to 10 September 2019) and trials registries to 10 September 2019.
SELECTION CRITERIA: We included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) that examined the efficacy of VCFs in preventing PE.
DATA COLLECTION AND ANALYSIS: For this update, studies were assessed and data extracted independently. We assessed study quality with Cochrane's 'Risk of bias' tool and used the GRADE approach to assess the overall certainty of the evidence. The outcomes of interest were PE, mortality, lower limb venous thrombosis, filter-related complications and major bleeding.
MAIN RESULTS: We identified four new studies for this update, bringing the total to six included studies involving 1388 participants. The six studies were clinically heterogeneous and we were unable to carry out meta-analysis. Only two studies were considered to be both applicable in current clinical settings and of good methodological quality. One was a randomised open-label trial studying the effect of a retrievable inferior vena caval filter plus anticoagulation versus anticoagulation alone on risk of recurrent pulmonary embolism (PE) in 399 participants over three months. There was no evidence of a difference in the rates of PE, death, lower extremity deep vein thrombosis (DVT), or bleeding at three and six months after the intervention (moderate-certainty evidence). A filter was inserted in 193 people, but could only be successfully retrieved from 153. Minor filter complications were noted at six months. The second clinically relevant study was a randomised open-label trial of 240 participants who had sustained multiple traumatic injuries, allocated to a filter or no filter, three days after injury, in conjunction with anticoagulation and intermittent pneumatic compression. Prophylactic anticoagulation was initiated in both groups when it was thought safe to do so. There was no evidence of a difference in symptomatic PE, death, or lower limb venous thrombosis rates (moderate-certainty evidence). The only major filter complication was that one person required surgical removal of the filter. We are unable to draw any conclusions from the remaining four included studies. One study showed an increased incidence of long-term lower extremity DVT at eight years. Three studies are no longer clinically applicable because they utilised permanent filters which are seldom used now, or they did not use routine prophylactic anticoagulation which is current standard practice. The fourth study compared two filter types and was terminated prematurely as one filter group had a higher rate of thrombosis compared to the other filter type.
AUTHORS' CONCLUSIONS: Two of the six identified studies were relevant for current clinical settings. One showed no evidence of a benefit of retrievable filters in acute PE for the outcomes of PE, death, DVT and bleeding during the initial three months in people who can receive anticoagulation (moderate-certainty evidence). The other study did not show any benefit for prophylactic filter insertion in people who sustained multiple traumatic injuries, with respect to symptomatic PE, mortality, or lower extremity venous thrombosis (moderate-certainty evidence). We can draw no firm conclusions regarding filter efficacy in the prevention of PE from the remaining four RCTs identified in this review. Further trials are needed to assess vena caval filter effectiveness and safety, and clinical differences between various filter types.
Inferior vena cava filter (IVCF) use continues to increase in the United States (US) despite questionable clinical benefit and increasing concerns over long-term complications. For this review we comprehensively examine the randomized, prospective data on IVC filter efficacy, compare relative rates of IVCF placement in the US and Europe, compare commonly considered guidelines for IVCF indications, and the current data on IVCF complications. Searches of MEDLINE and Cochrane databases were conducted for randomized prospective IVCF studies. Only three randomized prospective studies for IVCFs were identified. Commonly cited IVCF guidelines were reviewed with attention to their evolution over time. No evidence has shown a survival benefit with IVCF use. Despite this, continued rising utilization, especially for primary prophylactic indications, is concerning, given increasing evidence of long-term filter-related complications. This is particularly noted in the US where IVCF placements for 2012 are projected to be 25 times that of an equivalent population in Europe (224,700 versus 9,070). Pending much-needed randomized controlled trials that also evaluate long-term safety, we support the more stringent American College of Chest Physicians (ACCP) guidelines for IVCF placement indications and advocate a close, structured follow-up of retrievable IVCFs to improve filter retrieval rates.
L'utilisation de la veine cave inférieure (VCI) des filtres pour empêcher une embolie pulmonaire (EP) chez les patients qui ont ou sont à risque de développer une thrombose veineuse profonde est en augmentation. Une revue systématique a été effectuée afin d'évaluer la fréquence des symptômes et des signes de syndrome post-thrombotique (STP) par rapport à IVC filtre de placement. Il a été également évalué si l'indication initiale pour IVC filtre de placement-prévention de la PE chez un patient sans thrombose veineuse connue (c.-à-la prévention primaire) par rapport à la prévention de la PE chez les patients atteints de thrombose veineuse connue (c.-à-la prévention secondaire) ou l'utilisation concomitante de bas anticoagulation ou de compression influencé ce taux. Onze articles décrivant 1.552 patients répondaient aux critères pour l'examen. À un suivi moyen de 4,5 ans, l'incidence de l'œdème pondérée en commun était de 42,9% (IC à 95%, 40,4% -45,4%), et que des changements chroniques de la peau (y compris les ulcères veineux) était de 12,0% (IC à 95%, 10,3% -13,7%). Parmi les patients qui ont eu IVC filtre à d'insertion pour la prévention secondaire, 51,2% (95% CI, 48,3%, 54,1%) avaient un œdème et 13,5% (95% CI, 11,5%, 15,5%) ont eu des changements de la peau lors du suivi-jusqu'à, par rapport avec les 20,2% (IC à 95%, 15,7%, 24,7%) et 8,3% (IC à 95%, 5,2% -11,4%), respectivement, chez les patients qui ont reçu un filtre IVC pour la prévention primaire. Une étude a rapporté aucune différence dans la fréquence des symptômes et des signes de PTS selon que l'anticoagulation a été lancé en plus de placement d'un filtre. Aucune étude fait état de taux de STP fonction de l'utilisation de bas de contention élastiques après placement d'un filtre. Les présents résultats soulèvent la possibilité que les filtres IVC pourrait être associée à l'élaboration de PTS, y compris les ulcères veineux, lorsqu'ils sont utilisés pour la prévention primaire ou secondaire de PE. Toutefois, en raison des limitations importantes des articles dans des revues, des recherches supplémentaires sont nécessaires pour aborder cette question directement.
OBJECTIF: Passer en revue les éléments de preuve pour l'utilisation de la veine cave inférieure (VCI) des filtres pour empêcher une embolie pulmonaire (EP) chez les patients à haut risque. Qualité des preuves: Ovid MEDLINE a été fouillé de 1966 et 2006 pour tous les journaux de langue anglaise sur les filtres IVC. Des preuves ont été classés selon le Système de classification des 3-niveau. La plupart des éléments de preuve trouvés était de niveau II. PRINCIPAL MESSAGE: filtres veine cave inférieure sont utilisées pour prévenir PE chez les patients présentant des contre, les complications de la, ou l'échec d'un traitement anticoagulant et les patients ayant une thrombose flottante ou thrombus résiduel à la suite PE massive. Les données actuelles indiquent que les filtres IVC sont largement effective; PE percée se produit dans seulement 0% à 6,2% des cas. Contre-indications à l'implantation de filtres IVC comprennent le manque d'accès veineux, occlusion cave, coagulopathie non corrigeable, et la septicémie. Les complications comprennent l'embolisation est égarée ou du filtre, une lésion vasculaire ou une thrombose, le pneumothorax, et embolie gazeuse. Récidive PE, thrombose IVC, la migration du filtre, la rupture du filtre, ou la pénétration de la paroi cave se produisent parfois à l'utilisation à long terme. CONCLUSION: Lorsqu'il est utilisé correctement, les filtres IVC sont une méthode sûre et efficace de prévenir PE. L'utilisation de filtres accessibles pourrait réduire les complications à long terme.
Pulmonary emboli (PE), or blood clots in the lungs,can be potentially fatal. Anticoagulation is the first line therapy to prevent PE. In some instances anticoagulation fails to prevent more emboli, or cannot be given because the person has a high risk of bleeding. Inferior vena caval filters (VCFs) are metal alloy devices that mechanically trap fragmented emboli from the deep leg veins en route to the pulmonary circulation. Retrievable filters are designed to be introduced and removed percutaneously. Although their deployment seems of theoretical benefit, their clinical efficacy and adverse event profile is unclear. This is the third update of a Cochrane Review first published in 2007.
OBJECTIVES:
To assess the evidence for the effectiveness and safety of vena caval filters (VCFs) in preventing pulmonary embolism (PE).
SEARCH METHODS:
For this review update, the Cochrane Vascular Information Specialist (CIS) searched the Specialised Register (last searched 10 September 2019) and the Cochrane Register of Controlled Trials (CENTRAL) (2019, Issue 8) via the Cochrane Register of Studies Online. The CIS also searched MEDLINE Ovid, EMBASE Ovid, CINAHL, and AMED (1 January 2017 to 10 September 2019) and trials registries to 10 September 2019.
SELECTION CRITERIA:
We included randomised controlled trials (RCTs) and controlled clinical trials (CCTs) that examined the efficacy of VCFs in preventing PE.
DATA COLLECTION AND ANALYSIS:
For this update, studies were assessed and data extracted independently. We assessed study quality with Cochrane's 'Risk of bias' tool and used the GRADE approach to assess the overall certainty of the evidence. The outcomes of interest were PE, mortality, lower limb venous thrombosis, filter-related complications and major bleeding.
MAIN RESULTS:
We identified four new studies for this update, bringing the total to six included studies involving 1388 participants. The six studies were clinically heterogeneous and we were unable to carry out meta-analysis. Only two studies were considered to be both applicable in current clinical settings and of good methodological quality. One was a randomised open-label trial studying the effect of a retrievable inferior vena caval filter plus anticoagulation versus anticoagulation alone on risk of recurrent pulmonary embolism (PE) in 399 participants over three months. There was no evidence of a difference in the rates of PE, death, lower extremity deep vein thrombosis (DVT), or bleeding at three and six months after the intervention (moderate-certainty evidence). A filter was inserted in 193 people, but could only be successfully retrieved from 153. Minor filter complications were noted at six months. The second clinically relevant study was a randomised open-label trial of 240 participants who had sustained multiple traumatic injuries, allocated to a filter or no filter, three days after injury, in conjunction with anticoagulation and intermittent pneumatic compression. Prophylactic anticoagulation was initiated in both groups when it was thought safe to do so. There was no evidence of a difference in symptomatic PE, death, or lower limb venous thrombosis rates (moderate-certainty evidence). The only major filter complication was that one person required surgical removal of the filter. We are unable to draw any conclusions from the remaining four included studies. One study showed an increased incidence of long-term lower extremity DVT at eight years. Three studies are no longer clinically applicable because they utilised permanent filters which are seldom used now, or they did not use routine prophylactic anticoagulation which is current standard practice. The fourth study compared two filter types and was terminated prematurely as one filter group had a higher rate of thrombosis compared to the other filter type.
AUTHORS' CONCLUSIONS:
Two of the six identified studies were relevant for current clinical settings. One showed no evidence of a benefit of retrievable filters in acute PE for the outcomes of PE, death, DVT and bleeding during the initial three months in people who can receive anticoagulation (moderate-certainty evidence). The other study did not show any benefit for prophylactic filter insertion in people who sustained multiple traumatic injuries, with respect to symptomatic PE, mortality, or lower extremity venous thrombosis (moderate-certainty evidence). We can draw no firm conclusions regarding filter efficacy in the prevention of PE from the remaining four RCTs identified in this review. Further trials are needed to assess vena caval filter effectiveness and safety, and clinical differences between various filter types.
