Catheter‐associated deep vein thrombosis of the upper extremity in cancer patients: guidance from the SSC of the ISTH
2014; Elsevier BV; Volume: 12; Issue: 5 Linguagem: Inglês
10.1111/jth.12527
ISSN1538-7933
AutoresJeffrey I. Zwicker, Gregory C. Connolly, Marc Carrier, Pieter W. Kamphuisen, A.Y.Y. Lee,
Tópico(s)Diagnosis and Treatment of Venous Diseases
ResumoJournal of Thrombosis and HaemostasisVolume 12, Issue 5 p. 796-800 Recommendations and GuidelinesFree Access Catheter-associated deep vein thrombosis of the upper extremity in cancer patients: guidance from the SSC of the ISTH J. I. Zwicker, J. I. Zwicker Division of Hemostasis and Thrombosis, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USASearch for more papers by this authorG. Connolly, G. Connolly Division of Hematology and Oncology, Department of Medicine, University of Rochester, Rochester, NY, USASearch for more papers by this authorM. Carrier, M. Carrier Thrombosis Program, Division of Hematology, Department of Medicine, University of Ottawa, Ottawa, ON, CanadaSearch for more papers by this authorP. W. Kamphuisen, P. W. Kamphuisen Department of Vascular Medicine, University Medical Center Groningen, University of Groningen, Groningen, the NetherlandsSearch for more papers by this authorA. Y. Y. Lee, Corresponding Author A. Y. Y. Lee Division of Hematology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada Correspondence: Agnes Y. Lee, Division of Hematology, University of British Columbia, Diamond Health Care Center, 2775 Laurel Street 10th floor, Vancouver, BC V5Z 1M9, Canada. Tel.: +1 604 875 4952; fax: +1 604 875 4696. E-mail: alee14@bccancer.bc.caSearch for more papers by this author J. I. Zwicker, J. I. Zwicker Division of Hemostasis and Thrombosis, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USASearch for more papers by this authorG. Connolly, G. Connolly Division of Hematology and Oncology, Department of Medicine, University of Rochester, Rochester, NY, USASearch for more papers by this authorM. Carrier, M. Carrier Thrombosis Program, Division of Hematology, Department of Medicine, University of Ottawa, Ottawa, ON, CanadaSearch for more papers by this authorP. W. Kamphuisen, P. W. Kamphuisen Department of Vascular Medicine, University Medical Center Groningen, University of Groningen, Groningen, the NetherlandsSearch for more papers by this authorA. Y. Y. Lee, Corresponding Author A. Y. Y. Lee Division of Hematology, Department of Medicine, University of British Columbia, Vancouver, BC, Canada Correspondence: Agnes Y. Lee, Division of Hematology, University of British Columbia, Diamond Health Care Center, 2775 Laurel Street 10th floor, Vancouver, BC V5Z 1M9, Canada. Tel.: +1 604 875 4952; fax: +1 604 875 4696. E-mail: alee14@bccancer.bc.caSearch for more papers by this author First published: 18 February 2014 https://doi.org/10.1111/jth.12527Citations: 55 Manuscript handled by: S. Eichinger Final decision: F. R. Rosendaal, 12 February 2014 AboutSectionsPDF ToolsRequest permissionExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat Scope Upper extremity thrombi are frequently diagnosed in cancer patients with central venous catheters. A number of complications arise in the setting of a catheter-associated upper extremity thrombosis, including the development of pulmonary emboli, recurrent thrombosis, post-thrombotic syndrome and infection. As the management of catheter-associated thrombosis is often problematic, the ISTH Scientific Subcommittee on Hemostasis and Malignancy developed this guidance document in order to provide a concise review of current literature and to establish consensus guidance statements relevant to the diagnosis, treatment and prevention of catheter-associated thrombosis in the cancer population. The methodology and terminology included in this document are similar to prior guidance manuscripts (Supplementary file, Appendix A). Definition of terms Upper extremity deep vein thrombosis: deep veins of the upper extremity include brachial, axillary, subclavian, internal jugular and brachiocephalic veins. This excludes the distal, superficial veins of the upper limb, such as cephalic and basilica veins. Catheter-associated upper extremity deep vein thrombosis: deep venous thrombosis occurring in the clinical and anatomic setting of a central venous catheter, including tunneled catheters, subcutaneously implanted ports and peripherally inserted central catheters (PICC). Diagnosis of upper extremity thrombosis Typical symptoms associated with catheter-associated thrombosis include swelling, discomfort and erythema of the involved extremity 1. The presence of both pain and swelling has been shown to be more predictive of a thrombus than either symptom in isolation 2. However, several studies examining prevalence of catheter-associated thrombosis by screening ultrasound suggest that a high percentage of patients with catheter-associated thrombosis are asymptomatic 3. Diagnostic imaging of venous structures in the upper extremities, where the vast majority of central venous catheters are placed in cancer patients, can be more challenging than in the lower extremities because the clavicle and other bone structures obscure direct visualization of upper extremity veins. There are limited studies with varied methodology specifically examining the accuracy of ultrasound imaging for diagnosis of upper extremity deep vein thrombosis. Two meta-analyses attempted to better characterize ultrasound test characteristics for upper extremity thrombosis 4, 5. The accuracy of different ultrasound techniques (compression, Doppler, and combined) did not differ significantly. The summary estimates of sensitivity and specificity were 97% (95% CI, 90–100) and 96% (95% CI, 87–100) for compression ultrasonography, 84% (95% CI, 72–97%) and 94% (95% CI, 86–100) for Doppler ultrasonography, and 91% (95% CI, 85–97) and 93% (95% CI, 80–100) for Doppler ultrasonography with compression, respectively 5. D-dimer can be useful to exclude thrombosis in non-cancer patients with low and intermediate clinical pre-test probability; however, in cancer patients D-dimer has poor specificity 6, 7. A clinical trial was recently completed in cancer and non-cancer patients to assess the diagnostic utility of an algorithm combining clinical decision score along with D-dimer/serial ultrasonography in suspected upper extremity thrombosis (NCT01324037). Until the safety of withholding anticoagulation in individuals with a low probability decision score and normal D-dimer level has been established, the routine measurement of D-dimer in suspected upper extremity thrombosis is not advocated. Ultrasound imaging has many advantages, including good sensitivity and specificity, low risk due to absence of radiation or contrast exposure, low cost and high accessibility. However, ultrasound is more limited in evaluating central vasculature and has a lower sensitivity in pediatric populations 8, 9. Contrast venography is the gold standard but has several limitations, including the invasive nature of the procedure along with risks associated with contrast administration and technical complexity of the procedure 10, 11. Other less invasive diagnostic tools such as magnetic resonance imaging (MRI) and computed tomography (CT) can be considered but data are limited regarding diagnostic accuracy for upper extremity thrombosis 12, 13. Guidance statements on diagnosis of catheter-associated upper extremity thrombosis in patients with cancer We recommend ultrasonography as the initial test of choice for the diagnosis of suspected upper extremity thrombosis. We recommend against the utilization of D-dimer to exclude the diagnosis of suspected catheter-associated upper extremity deep vein thrombosis. We suggest evaluation of deep vein thrombosis by standard contrast venography in cases of high clinical suspicion and negative (or non-diagnostic) ultrasound testing. Less invasive radiographic methods such as CT venography or MRI venography can be considered if contrast venography is not available or practical. Pharmacologic prevention of catheter-associated thrombosis in cancer patients Anticoagulation, either administered locally as catheter flushes or systemically, has been evaluated for the prevention catheter-associated thrombosis. There is limited evidence that heparin flushes reduce the incidence of catheter-associated thrombosis, with most studies either underpowered or poorly designed. In a double-blind, single institution study of 160 cancer patients with central venous catheters randomized to urokinase or normal saline catheter flushes, there was no difference in symptomatic, confirmed catheter-associated thrombosis (1.2% vs. 6.4%; RR, 2.22; 95% CI, 0.65–7.76) without increased bleeding complications 14. While thrombolytics have not been shown to be effective in the prevention of catheter-associated deep vein thrombosis, they are commonly used for the treatment of a malfunctioning catheter that is occluded due to formation of a fibrin sheath. The efficacy of systemic anticoagulant prophylaxis for prevention of catheter-associated thrombosis in the form of fixed-dose warfarin, adjusted-dose warfarin, low-molecular-weight heparin and unfractionated heparin has been examined in several randomized studies. Caution must be taken when comparing these studies as the primary outcome measure varies between symptomatic and asymptomatic thrombosis and was assessed by various screening modalities at different time-points. The WARP trial, a multicenter open label randomized trial comparing no warfarin, fixed-dose warfarin (1 mg daily) and dose-adjusted warfarin (INR 1.5–2.0), included 1590 cancer patients with central venous catheters 15. Fixed-dose warfarin did not reduce the incidence of symptomatic radiographically confirmed catheter-associated thrombosis compared with no treatment (7% vs. 6%; P = 0.98), but dose-adjusted warfarin did significantly reduce the incidence of symptomatic catheter-associated thrombosis (2.7% vs. 7.2%; RR, 0.38; P = 0.002) at the expense of increased major bleeding complications (3.4% vs. 1.5%; P = 0.04). Although one early study suggested efficacy with fixed-dose warfarin 16, other randomized trials 16-18 and meta-analyses 19, 20 have failed to show a significant reduction in the incidence of symptomatic catheter-associated thrombosis with warfarin prophylaxis. Similarly, several randomized studies explored the efficacy of prophylactic-dose low-molecular-weight heparin 17, 21, 22. In one trial, 385 cancer patients were randomized to enoxaparin (40 mg daily) or placebo, and venography was performed 6 weeks later to determine the primary endpoint of asymptomatic upper extremity DVT 22. There was no significant difference detected between enoxaparin and placebo-treated groups in the incidence of asymptomatic DVT (14.1% vs. 18.0%; RR, 0.78; P = 0.38) or symptomatic DVT (1.0% vs. 3.0%; RR, 0.32; 95% CI, 0.07–1.66) 22. In a trial by Karthaus et al., cancer patients were randomized in a 2 : 1 ratio to dalteparin (5000 units once daily) or placebo and no difference in the incidence of catheter-related thrombosis was observed (3.7% vs. 3.4%; P = 0.88)23. Although low-molecular-weight heparin did not increase major bleeding complications compared with placebo, the overall major conclusion from these trials and several meta-analyses 19, 24 is that prophylactic low-molecular-weight heparin does not significantly reduce the incidence of symptomatic catheter-associated thrombosis in cancer patients. Guidance Statement on prophylaxis for catheter-associated upper extremity thrombosis in patients with cancer We recommend against the routine administration of pharmacologic prophylaxis to prevent catheter-associated deep vein thrombosis. We recommend against the routine administration of heparin flushes to prevent catheter-associated deep vein thrombosis. Short-term management of catheter-associated upper extremity thrombosis In the absence of randomized clinical trials to guide the management of upper extremity thrombosis, current treatment guidelines and recommendations are largely extrapolated from evidence derived from the treatment of deep vein thrombosis of the lower extremity 25, 26. The initial decisions governing the short-term management of a catheter-associated thrombosis of the upper extremity typically include whether or not to remove the catheter and/or initiate anticoagulation 27, 28. In a prospective study of 74 cancer patients with symptomatic catheter-associated upper extremity thrombosis treated with dalteparin (without catheter removal) followed by warfarin for 3 months, the majority (57%) of catheters remained functional and there was no reported recurrence of venous thromboembolic events, although there were three (5%) cases of major hemorrhage, including a hemorrhage-related death 27. Based on the available data, a common recommendation is to keep a functioning catheter as long as therapeutic anticoagulation is initiated 28. Several days of therapeutic anticoagulation prior to catheter removal can be considered in an effort to stabilize the thrombus prior to catheter removal, although the clinical utility of a delayed catheter removal approach is not known. The optimal management of incidental catheter-associated DVT is not known but, similar to the incidental VTE identified in the lungs or lower extremities, clinicians typically favor anticoagulation over no anticoagulation. There are limited data regarding the efficacy and safety of thrombolytic therapy for the management of upper extremity thrombosis in association with catheters, especially in the cancer population. Randomized trials have shown superior patency rates following thrombolysis in the acute management of patients with ileofemoral thrombosis 29, 30. However, malignancy is often associated with an increased risk of hemorrhage 31, 32 and thus cancer patients are commonly excluded in such clinical trials. In a retrospective analysis of 61 cancer patients with deep vein thrombosis treated with catheter-directed thrombolysis (including 28 patients with brachiosubclavian thrombosis), patency was observed in 67% of patients, with a 5% incidence of hemorrhage; event rates that were similar to the non-cancer population 33. There is an absence of data to guide the management of catheter-associated upper extremity thrombosis in the setting of thrombocytopenia. As the reported rates of pulmonary embolism following catheter removal without anticoagulation are low, this management approach should be considered for individuals with severe thrombocytopenia (< 25 × 109 L−1). In cases of less severe thrombocytopenia, anticoagulation dose reduction is an option, as outlined in the SSC/ISTH guidance on the anticoagulation management of thrombocytopenic patients 34. Guidance statements for the acute treatment of a catheter-associated upper extremity deep vein thrombosis in cancer patients We suggest anticoagulation with low-molecular-weight heparin without removal of the catheter if the central venous catheter is functional and required for ongoing therapy. We recommend removal of a non-functional, infected or incorrectly positioned catheter and suggest anticoagulation with low-molecular-weight heparin. We suggest a short duration of anticoagulation (3–5 days), if clinically practical, prior to removal of a central venous catheter. We suggest removal of a central venous catheter without anticoagulation if therapeutic anticoagulation cannot be safely administered due to the active risk of hemorrhage. We suggest anticoagulation over no anticoagulation for an incidental catheter-associated DVT. Alternative strategies such as serial ultrasound and/or catheter removal can be considered. We recommend anticoagulation over thrombolysis for the acute management of catheter-associated thrombosis. Consideration of clot-directed thrombolysis should be reserved for cases of massive clot burden and/or refractory thrombosis. In cases of thrombocytopenia without bleeding, the decision to anticoagulate or withhold anticoagulation should be made on an individual basis. Long-term management Optimal long-term management of catheter-associated upper extremity thrombosis has not been established. In prospective studies, oral anticoagulation is typically administered for 3–6 months with favorable outcomes 27, 35. In the absence of randomized clinical trials, anticoagulant recommendations are extrapolated from efficacy data for the management of deep vein thrombosis of the lower extremity. Accordingly, we favor the long-term administration of low-molecular-weight heparin based on evidence demonstrating superiority over warfarin in the treatment of VTE in cancer 25, 26. Longer term anticoagulation (beyond 3–6 months) should be considered if the underlying catheter remains in place. Newer oral anticoagulants have not been studied in the treatment of catheter-associated thrombosis and are thus discouraged. Guidance statements for the long-term treatment of a catheter-associated upper extremity deep vein thrombosis in cancer patients We suggest 3–6 months of anticoagulation for a symptomatic, catheter-associated upper extremity deep vein thrombosis. We suggest the long-term administration of low-molecular-weight heparin over warfarin in cancer patients. We suggest anticoagulation for the duration the catheter remains in place for individuals with ongoing risk factors, such as persistent central venous catheter. Addendum All authors discussed and developed guidance statements. J. Zwicker and G. Connolly authored the background summaries. A. Lee, M. Carrier and P. Kamphuisen provided critical revisions and final approval for publication. Acknowledgements The authors received no funding support for this manuscript. We thank G. Johnson and the SSC Guidance Committee of the ISTH for editorial review. The authors acknowledge receiving past research support from LeoPharma (A. Lee, M. Carrier and P. Kamphuisen) and Sanofi (J. Zwicker). Disclosure of Conflict of Interests The authors state that they have no conflict of interests. Supporting Information Filename Description jth12527-sup-0001-Appendix.docWord document, 38.5 KB Appendix A. Methodology. Please note: The publisher is not responsible for the content or functionality of any supporting information supplied by the authors. Any queries (other than missing content) should be directed to the corresponding author for the article. 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