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19.3 Conclusions forClinical Practice
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reintervention, including for in-stent restenosis in 44 limbs, stent compression in 2 limbs, in-stent restenosis and stent compression in 48 limbs, and stent occlusion in 17 limbs. Use of a composite stent conguration of Wallstent and Z stent in patients requiring iliac vein stenting resulted in improved outcomes compared to published data from use of Wallstents alone. A composite stent conguration resulted in less need for contralateral iliac vein stenting and less contralateral deep vein thrombosis than the use of Wallstents alone.
Robertson etal. [25] evaluated the association between stent length and patency in patients treated for iliofemoral venous outow obstruction. A total of 108 patients (58.3% female) had had 6-month duplex ultrasound scans available for review. Their mean age was 55.6 +/− 17.2years. Overall, the 6-month patency was 89.9%. Of the 108 patients, 56 (51.9%) had had a total stented length of ≤100mm with a 6-month patency of 92.9%. The remaining 52 patients (48.1%) had had a total stented length>100mm with a 6-month patency of 86.5%. The rate of patency did not differ signicantly between the two groups (P=.222). Stent patency at 6months for patients with nonthrombotic iliac vein lesions (NIVLs) was 98% (40 of 41). Stent patency for patients with post-thrombotic venous stenoses (PTs) was 84% (32 of 38). Patency for patients with acute DVT who had undergone stenting after thrombectomy was 86% (25 of 29). Overall, 10 patients with thrombotic disease, including PT and acute DVT, had developed stent thrombosis. The total stented length was not predictive of the loss of patency. The ndings from the present study suggest that the length of stent coverage does not differ in the likelihood of stent thrombosis for patients with NIVLs and PTs. Interventionalists should treat affected venous segments identied on IVUS and effectively stent from normal to normal venous areas.
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19.3 Conclusions forClinical Practice
1. Patients with proximal DVT should be anticoagulated for at least 3-months.
2. In the absence of contraindications, DOACs should be preferred as rst-line
anticoagulant therapy in non-cancer patients with proximal DVT.
3. Catheter-directed thrombolysis (CDT) and pharmacomechanical catheter-
directed thrombolysis (PCDT), in experienced centers, may be considered in select patients with acute (≤14 days) symptomatic, extensive proximal DVT who have good functional capacity, ≥1-year life expectancy, and low expected bleeding risk.
4. Balloon angioplasty with or without stenting of underlying anatomic venous
lesions may be considered after CDT and PCDT as a means to prevent rethrom­bosis and subsequent PTS.
5. In patients with PTS, a composite stent conguration resulted in less need for
contralateral iliac vein stenting and less contralateral deep vein thrombosis than the use of Wallstents alone.
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19 Deep Vein Thrombosis oftheLower Limb andPost-Thrombotic Syndrome
6. A staged approach to iliofemoral stenting in patients with PTS and bilateral
symptoms focusing initially on the more symptomatic limb is suggested.
7. For patients with deep vein thrombosis treated by early thrombus removal, with
or without stenting, it is recommended that the duration of anticoagulation should be at least as long as if the patients were treated by anticoagulation alone and at the discretion of the treating physician.
References
1. Mazzolai L, Aboyans V, Ageno W, etal. Diagnosis and management of acute deep vein throm­bosis: a joint consensus document from the European Society of Cardiology working groups of aorta and peripheral vascular diseases and pulmonary circulation and right ventricular func­tion. Eur Heart J. 2018;39:4208–18.
2. Kahn SR, Comerota AJ, Cushman M, etal. American Heart Association Council on Peripheral Vascular Disease, Council on Clinical Cardiology, and Council on Cardiovascular and Stroke Nursing. The postthrombotic syndrome: evidence-based prevention, diagnosis, and treat­ment strategies: a scientic statement from the American Heart Association. Circulation. 2014;130:1636–61.
3. Stevens SM, Woller SC, Baumann Kreuziger L.Executive summary: antithrombotic therapy for VTE disease: second update of the CHEST guideline and expert panel report. Chest. 2021;160:2247–59.
4. De Maeseneer MG, Kakkos SK, Aherne T, et al. Editor's choice—European Society for Vascular Surgery (ESVS) 2022 clinical practice guidelines on the management of chronic venous disease of the lower limbs. Eur J Vasc Endovasc Surg. 2022;63:184–267.
5. Kakkos SK, Gohel M, Baekgaard N, etal. Editor's choice—European Society for Vascular Surgery (ESVS) 2021 clinical practice guidelines on the management of venous thrombosis. Eur J Vasc Endovasc Surg. 2021;61:9–82.
6. Broderick C, Watson L, Armon MP. Thrombolytic strategies versus standard antico­agulation for acute deep vein thrombosis of the lower limb. Cochrane Database Syst Rev. 2021;1:CD002783.
7. Javed A, Machin M, Gwozdz AM, Turner B, Onida S, Shalhoub J, Davies AH.Meta-analysis of lytic catheter-based intervention for acute proximal deep vein thrombosis in the reduction of post-thrombotic syndrome. J Vasc Surg Venous Lymphat Disord. 2023;11:866–75.
8. Li W, Zaid Al-Kaylani A, Zeebregts CJ, El Moumni M, de Vries JPM, van der Doef HPJ, Bokkers RPH.Effectiveness and safety of catheter-directed thrombolysis in conjunction with percutaneous mechanical thrombectomy for acute iliofemoral deep vein thrombosis: a meta­analysis. J Vasc Surg Venous Lymphat Disord. 2023;11:843–53.
9. Vedantham S, Goldhaber SZ, Julian JA, et al. ATTRACT Trial Investigators. Pharmacomechanical catheter-directed thrombolysis for deep-vein thrombosis. N Engl J Med. 2017;377:2240–52.
10. Yang X, Zhang X, Yin M, Wang R, Lu X, Ye K.Elastic compression stockings to prevent post­thrombotic syndrome in proximal deep venous thrombosis patients without thrombus removal. J Vasc Surg Venous Lymphat Disord. 2022;10:293–9.
11. Tang A, Lakhter V, Zack CJ, Comerota AJ, Shah N, Zhao H, Bashir R.Contemporary nation­wide trends and in-hospital outcomes of adjunctive stenting in patients undergoing catheter­directed thrombolysis for proximal deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2021;9:62–72.
References
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12. Brailovsky Y, Yeung HM, Lakhter V, Zack CJ, Zhao H, Bashir R. In-hospital outcomes of catheter-directed thrombolysis versus anticoagulation in cancer patients with proximal deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2020;8:538–44.
13. Pouncey AL, Gwozdz AM, Johnson OW, Silickas J, Saha P, Thulasidasan N, Karunanithy N, Cohen AT, Black SA.AngioJet pharmacomechanical thrombectomy and catheter directed thrombolysis vs. catheter directed thrombolysis alone for the treatment of iliofemoral deep vein thrombosis: a single centre retrospective cohort study. Eur J Vasc Endovasc Surg. 2020;60:578–85.
14. Jiang C, Zhao Y, Wang X, Liu H, Tan TW, Li F.Midterm outcome of pharmacomechanical catheter-directed thrombolysis combined with stenting for treatment of iliac vein compres­sion syndrome with acute iliofemoral deep venous thrombosis. J Vasc Surg Venous Lymphat Disord. 2020;8:24–30.
15. Avgerinos ED, Saadeddin Z, Abou Ali AN, Pandya Y, Hager E, Singh M, Al-Khoury G, Makaroun MS, Chaer RA. Outcomes and predictors of failure of iliac vein stenting after catheter-directed thrombolysis for acute iliofemoral thrombosis. J Vasc Surg Venous Lymphat Disord. 2019;7:153–61.
16. Turner BRH, Thapar A, Jasionowska S, Javed A, Machin M, Lawton R, Gwozdz AM, Davies AH.Systematic review and meta-analysis of the pooled rate of post-thrombotic syndrome after isolated distal deep venous thrombosis. Eur J Vasc Endovasc Surg. 2023;65:291–7.
17. Williams ZF, Dillavou ED.A systematic review of venous stents for iliac and venacaval occlu­sive disease. J Vasc Surg Venous Lymphat Disord. 2020;8:145–53.
18. Notten P, Ten Cate H, Ten Cate-Hoek AJ.Postinterventional antithrombotic management after venous stenting of the iliofemoral tract in acute and chronic thrombosis: a systematic review. J Thromb Haemost. 2021;19:753–96.
19. Garcia MJ, Sterling KM, Kahn SR, Comerota AJ, Jaff MR, Ouriel K, Weinberg I, ACCESS PTS Investigators. Ultrasound-accelerated thrombolysis and Venoplasty for the treatment of the postthrombotic syndrome: results of the ACCESS PTS Study. J Am Heart Assoc. 2020;9:e013398.
20. Espitia O, Douane F, Hersant J, Abbadie F, Sobocinski J, Heautot JF, Miossec A, Lapébie FX, Hartung O, Venous Stent Network Investigators. Predictive factors of stent patency in iliofem­oral venous diseases in a multicentre cohort study. Eur J Vasc Endovasc Surg. 2023;65:564–72.
21. David A, Thony F, Del Giudice C, Société Française d’Imagerie Cardiovasculaire Diagnostique et Interventionnelle. Short- and mid-term outcomes of endovascular stenting for the treatment of post-thrombotic syndrome due to iliofemoral and caval occlusive disease: a multi-centric study from the French Society of Diagnostic and Interventional Cardiovascular Imaging (SFICV). Cardiovasc Intervent Radiol. 2022;45:162–71.
22. Jayaraj A, Noel C, Raju S.Contralateral limb improvement after unilateral iliac vein stent­ing argues against simultaneous bilateral stenting. J Vasc Surg Venous Lymphat Disord. 2020;8:565–71.
23. Moeri L, Lichtenberg M, Gnanapiragasam S, Barco S, Sebastian T.Braided or laser-cut self­expanding nitinol stents for the common femoral vein in patients with post-thrombotic syn­drome. J Vasc Surg Venous Lymphat Disord. 2021;9:760–9.
24. Jayaraj A, Noel C, Kuykendall R, Raju S.Long-term outcomes following use of a compos­ite Wallstent-Z stent approach to iliofemoral venous stenting. J Vasc Surg Venous Lymphat Disord. 2021;9:393–400.
25. Robertson B, Shapiro J, Muck A, Fellner AN, Recht M, Kulwicki A, Broering M, Kuhn B, Muck P.Venous stent patency is independent of total stented length in nonthrombotic iliac vein and post-thrombotic venous stenoses. J Vasc Surg Venous Lymphat Disord. 2023;11:339–45.
26. Wells PS, Hirsh J, Anderson DR, Lensing AW, Foster G, Kearon C, Weitz J, D'Ovidio R, Cogo A, Prandoni P. Accuracy of clinical assessment of deep-vein thrombosis. Lancet. 1995;345(8961):1326–30.
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Chapter 20
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Vena Cava Filter
20.1 Guidelines
20.1.1 Society ofInterventional Radiology Clinical
Practice Guideline
The Society of Interventional Radiology developed in collaboration with other soci­eties clinical practice guidelines for the use of inferior vena cava (IVC) lters in the treatment of patients with or at substantial risk of venous thromboembolic disease [1]. They recommend:
20.1.1.1 Acute Pulmonary Embolism
• In patients with acute pulmonary embolism (PE) with a contraindication to anti-
coagulation therapy, we suggest an IVC lter be considered based on various clinical risk factors, as outlined in the rationale. (Strength of recommendation: limited)
Benets and Harms
The panel judged that the benets associated with IVC lter placement (reduction in short-term PE recurrence and possibly a reduction in mortality from acute PE) outweigh the potential harms (bleeding, vascular injury, device migration, and increased risk of recurrent DVT) in most patients.
Switzerland AG 2023 E. S. Debus, R. T. Grundmann, Evidence-based Therapy in Vascular Surgery,
https://doi.org/10.1007/978-3-031-47397-5_20
427© The Author(s), under exclusive license to Springer Nature
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20 Vena Cava Filter
20.1.1.2 Acute Deep Vein Thrombosis (DVT)
• In patients with acute DVT without PE and with a contraindication to anticoagu-
lation therapy, we suggest that an IVC lter be considered based on various clini­cal risk factors, as outlined in the rationale. (Strength of recommendation: consensus)
20.1.1.3 Anticoagulation forVenous Thromboembolism (VTE)
• In patients undergoing anticoagulation for acute VTE (DVT, PE) in whom a con-
traindication to anticoagulation develops, we suggest that an IVC lter be con­sidered in the setting of ongoing signicant clinical risk for PE. (Strength of recommendation: consensus statement)
• In patients receiving extended anticoagulation after acute treatment for VTE in
whom a contraindication to anticoagulation develops, we suggest that an IVC lter not be placed, with rare exceptions. (Strength of recommendation: consen­sus statement)
20.1.1.4 Recurrent Venous Thromboembolism
• In patients who are receiving therapeutic anticoagulation for VTE (DVT, PE)
who experience a recurrent VTE, we suggest that a lter not be placed, with few exceptions. Reasons for anticoagulation failure should always be addressed. (Strength of recommendation: consensus statement)
20.1.1.5 Routine IVC Filter Placement
• In patients with acute VTE (DVT, PE) who are being treated with therapeutic
anticoagulation, we recommend against routine placement of an IVC lter. (Strength of recommendation: moderate)
20.1.1.6 Trauma Patients without Known Venous Thromboembolism
• In trauma patients without known acute VTE, we recommend against the routine
placement of IVC lters for primary VTE prophylaxis. (Strength of recommen­dation: moderate)
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20.1.1.7 Major Surgery inPatients without Known VTE
• In patients without known acute VTE who are undergoing major surgery, we
suggest against routine placement of IVC lters. (Strength of recommendation: consensus statement)
20.1.1.8 Indwelling IVC Filters withno Anticoagulation Indication
• In patients who have indwelling IVC lters with no other indication for antico-
agulation, we cannot recommend for or against anticoagulation. (Strength of rec­ommendation: consensus statement)
20.1.1.9 Indwelling IVC Filters withMitigated PE Risk
• In patients with indwelling retrievable/convertible IVC lters whose risk of PE
has been mitigated or who are no longer at risk for PE, we suggest lters be rou­tinely removed/converted unless risk outweighs benet. (Strength of recommen­dation: consensus statement)
• In patients with indwelling permanent IVC lters whose risk of PE has been
mitigated or who are no longer at risk for PE, we suggest against routine removal of lters. (Strength of recommendation: consensus statement)
20.1.1.10 Complications andIndwelling IVC Filters
• In patients with complications attributed to indwelling IVC lters, we suggest
lter removal be considered after weighing lter- versus procedure-related risks and the likelihood that lter removal will alleviate the complications. (Strength of recommendation: consensus statement)
20.1.1.11 Structured Follow-Up
• In patients who have an IVC lter, we suggest the use of a structured follow-up
program to increase retrieval rates and detect complications. (Strength of recom­mendation: limited)
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20.1.1.12 Planned Filter Removal
• In patients who are having an IVC lter removed or converted, we suggest
against routine preprocedural imaging of the lter and the use of laboratory stud­ies except in select situations. (Strength of recommendation: consensus statement)
20.1.1.13 Filter Removal without Standard Snare Techniques
• In patients undergoing lter retrieval/conversion whose lter could not be
removed/converted by using standard techniques, we suggest attempted removal with advanced techniques, if appropriate and if the expertise is available, after reevaluation of risks and benets. (Strength of recommendation: consensus)
20.1.1.14 Filter Placement Technique
• In patients undergoing IVC lter placement, we cannot recommend for or against
any specic placement technique. (Strength of recommendation: consensus statement)
20 Vena Cava Filter
20.1.2 International Clinical Practice Guidelines
fortheTreatment andProphylaxis ofVenous Thromboembolism inPatients withCancer
These guidelines [2] comment on IVC lters:
• In the initial treatment of VTE, inferior vena cava lters may be considered when
anticoagulant treatment is contraindicated or, in the case of pulmonary embo­lism, when recurrence occurs under optimal anticoagulation. Periodic reassess­ment of contraindications for anticoagulation is recommended, and anticoagulation should be resumed when safe (guidance, based on evidence of very low quality and an unknown balance between desirable and undesirable effects).
• Prophylaxis of VTE in patients with cancer who have undergone surgery: infe-
rior vena cava lters are not recommended for routine prophylaxis. (Grade 1 A recommendation).
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20.1.3 NICE (National Institute forHealth
andCare Excellence)
The NICE guidelines for venous thromboembolic disease recommend [3]:
• Do not offer an inferior vena caval (IVC) lter to people with proximal DVT or
PE unless:
– It is part of a prospective clinical trial or – anticoagulation is contraindicated or a PE has occurred during anticoagula-
tion treatment.
• Consider an IVC lter for people with proximal DVT or PE when anticoagula-
tion treatment is contraindicated. Remove the IVC lter when anticoagulation treatment is no longer contraindicated and has been established.
• Consider an IVC lter for people with proximal DVT or PE who have a PE while
taking anticoagulation treatment only after taking the steps outlined in the rec­ommendation on treatment failure.
• Before tting an IVC lter, ensure that there is a strategy in place for it to be
removed at the earliest possible opportunity. Document the strategy and review it if the clinical situation changes.
20.1.4 European Society ofCardiology (ESC) Guidelines
fortheDiagnosis andManagement ofAcute Pulmonary Embolism [4]
20.1.4.1 Recommendations forVena Cava Filter
• IVC lters should be considered in patients with acute pulmonary embolism and
absolute contraindications to anticoagulation. (Recommendation class IIa / Level of evidence C)
• IVC lters should be considered in cases of pulmonary embolism recurrence
despite therapeutic anticoagulation. (Recommendation class IIa/Level of evidence C)
• Routine use of IVC lters is not recommended. (Recommendation class III/
Level of evidence A)
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20 Vena Cava Filter
20.2 Results
20.2.1 Meta-Analyses andSystematic Reviews
A Cochrane review assessed the evidence for the effectiveness and safety of vena caval lters (VCFs) in preventing pulmonary embolism (PE) [5]. Six studies involv­ing 1388 participants were included. The six studies were clinically heterogeneous and the authors were unable to carry out meta-analysis. Two of the six identied studies were relevant for current clinical settings. One showed no evidence of a benet of retrievable lters in acute PE for the outcomes of PE, death, DVT and bleeding during the initial 3 months in people who can receive anticoagulation (moderate-certainty evidence). The other study did not show any benet for prophy­lactic lter insertion in people who sustained multiple traumatic injuries, with respect to symptomatic PE, mortality, or lower extremity venous thrombosis (moderate- certainty evidence). No rm conclusions regarding lter efcacy in the prevention of PE could be drawn from the remaining four RCTs identied in this review. With the paucity of evidence for groups of people for whom lters are potentially benecial and for the use of retrievable lters data suggest the current accepted indication for lters is a contraindication to anticoagulation.
Liu etal. [6] performed a meta-analysis of randomized trials to investigate the effect of IVC lters on PE-related mortality and complications. Seven articles with 1274 patients were included. They found no signicant difference in mortality related to PE between the IVC lter and control groups within 3months (P=.11) nor during the entire follow-up period with low heterogeneity. However, the use of IVC lters decreased the new occurrence of PE without increasing deep vein throm­bosis or major bleeding.
In a meta-analysis of 10 studies (two of which were randomized controlled tri­als), Shariff et al. [7] investigated the prophylactic IVC lter placement among patients with major trauma. The use of prophylactic IVC lters was associated with a reduced risk of symptomatic PE among subjects with major trauma (RR: 0.27, CI
0.12–0.58, P value <0.05), the evidence was further reinforced by a trial sequential analysis. However, the use of IVC lters was not associated with a decreased risk of fatal PE among subjects with major trauma.
20.2.2 Randomized Trials
Data from the French multicentre randomised PREPIC (Prévention du Risque d’Embolie Pulmonaire par Interruption Cave) trial were rst published by Decousus etal. [8]. In this trial, 400 patients with proximal deep-vein thrombosis who were at risk for pulmonary embolism were assigned to receive a vena caval lter (200 patients) or no lter (200 patients), and to receive low-molecular-weight heparin (enoxaparin, 195 patients) or unfractionated heparin (205 patients). At day 12, two
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433
patients assigned to receive lters (1.1%), as compared with nine patients assigned to receive no lters (4.8%), had had symptomatic or asymptomatic pulmonary embolism (odds ratio, 0.22; 95% condence interval, 0.05–0.90). At 2 years, 37 patients assigned to the lter group (20.8%), as compared with 21 patients assigned to the no-lter group (11.6%), had had recurrent deep-vein thrombosis. The initial benecial effect of vena caval lters for the prevention of pulmonary embolism was counterbalanced by an excess of recurrent deep-vein thrombosis, without any dif­ference in mortality. An 8-year follow-up was performed to assess the very long­term effect [9]. At 8years, vena cava lters reduced the risk of pulmonary embolism but increased that of deep-vein thrombosis and had no effect on survival. Although their use may be benecial in patients at high risk of pulmonary embolism, system­atic use in the general population with venous thromboembolism was not recommended.
In the PREPIC2-study [10], the efcacy and safety of retrievable vena cava lters plus anticoagulation vs anticoagulation alone for preventing pulmonary embolism recurrence in patients presenting with acute pulmonary embolism and a high risk of recurrence was evaluated. In the lter group, the lter was successfully inserted in 193 patients and was retrieved as planned in 153 of the 164 patients in whom retrieval was attempted. By 3months, recurrent pulmonary embolism had occurred in 6 patients (3.0%; all fatal) in the lter group and in 3 patients (1.5%; 2 fatal) in the control group (relative risk with lter, 2.00 [95% CI, 0.51–7.89]; P = .50). Results were similar at 6months. No difference was observed between the 2 groups regarding the other outcomes. Filter thrombosis occurred in 3 patients. These nd­ings do not support the use of this type of lter in patients who can be treated with anticoagulation.
In a multicenter, randomized, controlled trial, Ho etal. [11] assessed whether insertion of a retrievable vena cava lter within 72hours after admission for trauma would result in a lower incidence of pulmonary embolism than no lter in patients, who had a contraindication to anticoagulant agents. 240 patients were enrolled and underwent randomization. Of the 122 patients assigned to the vena cava lter group, 89% had the lter inserted within 24h after enrollment. Early placement of a vena cava lter did not result in a signicantly lower incidence of symptomatic pulmo­nary embolism or death than no placement of a lter (13.9% in the vena cava lter group and 14.4% in the control group; P=0.98). Among the 46 patients in the vena cava lter group and the 34 patients in the control group who did not receive pro­phylactic anticoagulation within 7days after injury, pulmonary embolism devel­oped in none of those in the vena cava lter group and in 5 (14.7%) in the control group, including 1 patient who died (relative risk of pulmonary embolism, 0; 95% CI, 0.00 to 0.55). Except in the case of one patient, all lters were removed before day 232. An entrapped thrombus was found in the lter in 6 patients. In conclusion, early placement of a vena cava lter after major trauma did not result in a lower incidence of symptomatic pulmonary embolism or death at 90days (the primary composite end point) than no placement of a lter.