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European guidelines on perioperative venous thromboembolism prophylaxis: Inferior vena cava filters

Comes, Raquel, Ferrandis; Mismetti, Patrick; Afshari, Arashfor the ESA VTE Guidelines Task Force

European Journal of Anaesthesiology: February 2018 - Volume 35 - Issue 2 - p 108–111
doi: 10.1097/EJA.0000000000000730
Guidelines

The indications for the use of an inferior vena cava filter (IVCF) in the context of deep venous thrombosis to prevent pulmonary embolism remain controversial. Despite wide use in clinical practice, great variation exists in national and international guidelines in regard to the indications. In addition, clinical practice is based on poor-quality data from trauma and bariatric surgery with a high incidence of complications. It is often difficult to assess their efficacy and lack of filter retrieval appears to be a substantial issue compared with a potential benefit by insertion of these devices. Complications usually refer to increased risk of deep venous thrombosis, filter perforation, filter penetration, filter migration, inferior vena cava occlusion and subsequently failure in pulmonary embolism prevention. Evidence from low-quality studies or registries, with small numbers of patients and conflicting findings, does not allow for a strong recommendation for or against the use of IVCFs. IVCFs should only be considered in cases of very high risk of pulmonary embolism and in perioperative situations at very high risk of bleeding, resulting in a prolonged contra-indication to pharmacological prophylaxis.

From the Hospital Universitari i Politècnic La Fe, València, Spain (RFC), Unité de Recherche Clinique, Innovation et Pharmacologie, Centre Hospitalier Universitaire Saint-Etienne, Saint-Etienne, France (PM) and Department of Anesthesia, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark (AA)

Correspondence to Arash Afshari, MD, PhD, Department of Anesthesia, Juliane Marie Centre, Rigshospitalet, University of Copenhagen, 4013-4014, Blegdamsvej 9, 2100 Copenhagen, Denmark Tel: +45 35458749; e-mail: arash.afshari@regionh.dk

Published online 6 November 2017

This article is part of the European guidelines on perioperative venous thromboembolism prophylaxis. For details concerning background, methods and members of the ESA VTE Guidelines Task Force, please, refer to: Samama CM, Afshari A, for the ESA VTE Guidelines Task Force. European guidelines on perioperative venous thromboembolism prophylaxis. Eur J Anaesthesiol 2018; 35:73–76.

A synopsis of all recommendations can be found in the following accompanying article: Afshari A, Ageno W, Ahmed A, et al., for the ESA VTE Guidelines Task Force. European Guidelines on perioperative venous thromboembolism prophylaxis. Executive summary. Eur J Anaesthesiol 2018; 35:77–83.

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Introduction

Deep vein thrombosis (DVT) and pulmonary embolism remain a major challenge in the perioperative period, mainly in high-risk patients depending on the type of surgery and/or the associated risk factors. In general, the prevention of DVT/pulmonary embolism is usually achieved with the administration of an anticoagulant with or without mechanical methods as an adjunct. However, the risk of venous thromboembolism (VTE) should be put into context by assessment of the bleeding risk.

Among those patients in whom anticoagulation and the use of mechanical devices are contra-indicated or not possible, inferior vena cava filters (IVCFs) may be an alternative both for the prevention of the development of a pulmonary embolism from an established DVT or a ‘new’ VTE event.

IVCFs have been used for 50 years. Since the first transvenous IVCF in 1967, some important changes have been made. Currently, the vast majority of IVCFs are permanent/retrievable devices, although the success rate of retrieval decreases with time (from over 90% at 3 months to less than 40% at 12 months).1 Thus, they should be retrieved as soon as the filter has achieved its purpose. The retrieval devices have led to an increase in its use during the last decade. Nevertheless, there are outstanding differences in clinical practice from one hospital to another.2 Their indications remain controversial, as there are limited data on their efficacy and safety, but they are commonly advocated in acute pulmonary embolism or proximal central venous thrombosis with an absolute contra-indication to anticoagulation (as in major surgery), and with less clarity in trauma or a neurosurgical setting as a prophylactic measure.

However, the use of retrievable IVCFs is usually not recommended for VTE treatment when adequate anti-coagulation can be prescribed as no additional benefit is to be expected.3,4 Thus, IVCF is to be considered in VTE patients with formal contra-indications to anti-coagulants.3,4

Taking into account the above existing recommendations, and the potential risk of serious adverse events (perforation, penetration, migration) associated with IVCFs compared with the effectiveness of pharmacological prophylactic methods [low molecular weight heparins (LMWH), fondaparinux, direct oral anticoagulants], IVCFs should be considered only in cases of very high risk of pulmonary embolism and in perioperative situations at very high risk of bleeding resulting in prolonged contra-indication to pharmacological prophylaxis such as a temporary contra-indication to pharmacological prophylaxis according to the patient's bleeding risk observed in some trauma patients or in neurosurgery, and in patients with very recent proximal DVT and/or pulmonary embolism requiring full doses of anticoagulants but unable to be treated given the bleeding risk of the surgical procedure.

However, in all the above situations, the use of IVCFs is supported by prospective and mainly retrospective cohorts and no randomised comparisons with pharmacological prophylaxis are available.

When considering the low quality of evidence in support of IVCFs,5 one has to reflect on the numerous reports of adverse events associated with IVCFs such as filter thrombosis (2 to 30%), filter migration (2 to 10%), filter penetration, perforation (0 to 50%), increased risk of DVT (estimated incidence of 5%) and failure from protection from pulmonary embolism (2%) and inferior vena cava occlusion.5,6

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Different clinical settings

In most clinical settings of relevance, the thromboembolic risk remains temporary, whereas IVCFs are often considered because of their presumed advantage of being retrievable. On this basis, numerous publications have demonstrated a potential feasibility and safety for a retrieval procedure (more than 95% success).7 On the contrary, in daily clinical practice, retrieval is not systematically attempted and up to 25% of the IVCFs become permanent.8 This is particularly frequent when there is a lack of standard operative procedures regarding the use of IVCFs and especially their retrieval. Thus, IVCFs should be considered only with experienced teams.

In trauma, a high risk of bleeding is often accompanied by a high risk of VTE. Without thromboprophylaxis, VTE can occur in up to 58% of patients, with 18% being proximal DVTs. The incidence of pulmonary embolism in historical controls differs widely in the literature (1 to 6%),9 but when a computed tomography scan is performed, figures as high as 24% have been found for asymptomatic pulmonary embolism.10 The risk factors described for pulmonary embolism and DVT are increasing age, duration of mechanical ventilation more than 3 days, severe chest, lower extremities or spine injury, pelvic fractures and shock.10,11 Moreover, in certain patients, such as those with traumatic brain injury, solid organ injury or with ongoing bleeding, the use of LMWH is often contra-indicated because of the life-threatening bleeding risk. In such patients, mechanical devices or IVCFs may be advocated. However, this prophylactic indication remains controversial, due to lack of convincing evidence. Very few small controlled studies (only one randomised) have been published assessing the incidence of pulmonary embolism with and without IVCFs.12–19 They compare their findings on the use of IVCFs with historical controls, suffer from a high risk of bias due to design shortcomings, and the majority of them reported a significant decrease in the pulmonary embolism incidence when inserting IVCFs. However, a recent meta-analysis of eight non-randomised studies showed a significant effect on pulmonary embolism risk without any effect on overall mortality, but the number needed to treat was between 109 and 662, depending on the assumed pulmonary embolism risk.20

More importantly, IVCFs were shown to be associated with a significant increase in DVT risk in a large survey of 39 459 trauma patients.21

In bariatric surgery, despite the use of preventive measures to reduce VTE complications, the reported global rates of VTE are 0.3 to 2.2%, with pulmonary embolism rates of around 1%, and an important cause of postoperative mortality.22–24

Others have examined the specific risk factors in bariatric surgery, to adjust the prophylactic methods.25 Age, male sex, higher patient weight, previous VTE and smoking history have been attributed to this condition. Procedure-related risk factors such as open surgery, duration of surgery exceeding 3 h, postoperative anastomotic leak and specific surgical procedures may add to this risk. The appropriate method, including mechanical and pharmacological approaches, is yet to be defined. There are no randomised controlled trials evaluating the efficacy and safety of IVCFs, whereas the few existing observational studies on the use of IVCFs for VTE prophylaxis in bariatric surgery26–31 have failed to show a decrease in pulmonary embolism when an IVCF is inserted, and some even found higher rates of DVT.

A meta-analysis of six studies (102 767 patients) found IVCFs to be associated with a significant increase in DVT risk [relative risk (RR) 2.81, 95% confidence interval (CI) 1.33 to 5.97, P = 0.007] without any effect on either pulmonary embolism risk (RR 1.02, 95% CI 0.31 to 3.37, P = 0.9) or overall mortality (RR 3.27, 95% CI 0.78 to 13.6, P = 0.10).32

Taking all the above into account, the available evidence does not support the routine placement of IVCFs as an adjunctive method of prophylaxis in the case of bariatric surgery.32–34 Moreover, given the marked decrease of VTE risk observed with laparoscopic surgery, ‘classic’ evidence might not be easily applicable to actual bariatric surgery practice.

Prophylactic IVCFs have been evaluated in cancer patients35,36 and in neurosurgery without any apparent efficacy.37

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Guidelines and expert opinions

In light of the sparse evidence, other guidelines or expert opinion must be highlighted.3,38–43 Only the British Committee for Standards in Haematology recommends IVCF use preoperatively in cases of recent acute VTE (less than 30 days) and when therapeutic anticoagulation must be interrupted for surgery (grade C, level IV).39 Without referring to the perioperative setting, the 2012 American College of Chest Physicians (ACCP) guidelines recommend the placement of IVCFs in patients with acute proximal lower extremity DVT when anti-coagulation is contra-indicated (grade 1B).43 Not so uniform are the prophylactic recommendations. In 2002 (with no update), the Eastern Association for the Surgery of Trauma recommended the use of prophylactic IVCFs in very high-risk VTE trauma patients with a contra-indication for thromboprophylaxis (class III evidence).38 The Society of Interventional Radiology also recommends considering IVCFs when pharmacological prophylaxis is contra-indicated.40 However, the 2012 ACCP guidelines recommend against the use of prophylactic IVCFs in trauma patients (grade 2C).43 There is also a recommendation against the use of IVCFs for primary prevention in general, abdominal-pelvic or major orthopaedic surgery patients in the ACCP guideline (grade 2C).43

There is currently no clear evidence on the efficacy and safety of IVCFs in patients with a contra-indication for pharmacological and mechanical thromboprophylaxis undergoing high thrombotic risk surgery or procedures. Moreover, evidence for patients developing acute pulmonary embolism or DVT despite accurate prophylaxis, (e.g. during pregnancy), or in patients with previous pulmonary embolism or DVT needing non-deferrable surgery, remains poor and often only from cases reports. Therefore, it is not possible to recommend for or against the use of IVCFs in such clinical scenarios.

To conclude, evidence from low-quality studies or registries, with small numbers of patients and conflicting findings, does not allow a strong recommendation for or against the use of IVCFs. Therefore, as this lack of compelling evidence results in an unclear balance between benefits and potential harm, the recommendations for IVCFs remains inconclusive. IVCFs should be considered only in patients at very high risk of pulmonary embolism, such as a recent history of VTE, and in perioperative situations with a very high bleeding risk resulting in a prolonged contra-indication to pharmacological prophylaxis. This use should be discussed with experienced teams.

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Recommendations

  • There is currently no clear evidence on the efficacy and safety of IVCFs in patients with a contra-indication to pharmacological and mechanical thromboprophylaxis undergoing high thrombotic risk surgery or procedures (Grade B).
  • IVCF-associated complications often seem to outweigh any potential benefit (Grade B).
  • We suggest considering temporary IVCF placement in patients at high VTE risk when pharmacological and mechanical thromboprophylaxis are fully contra-indicated (Grade 2C).
  • We suggest considering temporary IVCF placement in patients with documented recent DVT, and with an absolute contra-indication for full anticoagulation and planned non-deferrable major surgery (Grade 2C).
  • We suggest not systematically using IVCFs to prevent pulmonary embolism in the perioperative setting (Grade 2B).
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Acknowledgements relating to this article

Assistance with the guideline chapter: none.

Financial support and sponsorship: expenses for two meetings of the VTE Task Force (Brussels and Berlin) were covered by the ESA for the ESA members.

Conflicts of interest: RF has received honoraria from Rovi.

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