CENTRAL VASCULAR ACCESS DEVICE INSERTION AND THE RISK OF COAGULOPATHY

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1 CENTRAL VASCULAR ACCESS DEVICE INSERTION AND THE RISK OF COAGULOPATHY LYNN HADAWAY, M.ED., RN-BC, CRNI THE CLINICAL QUESTION What is the reported risk of bleeding during insertion of any type of central vascular access device (CVAD)? Are there recommendations for coagulation-related lab values when a CVAD is inserted? What are the recommended values for coagulation-related lab test such as INR/PT, APPT, and platelets)? BACKGROUND The risk of bleeding from puncturing a vein with any size needle is a common thought especially when that puncture involves multiple steps leading to introduction of a plastic catheter of varying lengths and sizes. However, evidence shows this risk is minimal for both insertion and removal. An increased risk of bleeding, or coagulopathy, may be expected in patients with: Diagnoses of blood disorders (e.g., sickle cell disease, hemophilia, leukemia, thrombocytopenia) 1

2 Any type of anticoagulant (e.g., warfarin, heparin) or antiplatelet medication (eg., aspirin, clopidogrel, ticagrelor, glycoprotein IIB/IIIA inhibitors). Many factors increase the effect of these antiplatelet medications including: Medical diagnoses such as chronic renal failure, heart failure, and liver disease Other drugs including non-steroidal anti-inflammatory agents, cytotoxic medications, and selective serotonin reuptake inhibitors Food supplements such as ginkgo biloba, garlic, and St. John s wort. Patient assessment before any CVAD insertion should include all diagnoses and medications by any route. Risk added by medical diagnoses and drugs enhances the need for ultrasound guidance and insertion by highly skilled professionals to reduce the risk of bleeding. 1-3 Data on the incidence of bleeding during CVAD insertion is not reported in all studies. Three reports were found with general incidence rates: Self-limiting insertion site bleeding or hematoma is reported as the most common immediate complications with CVC insertion with rates from 1% to 3%. 4 Evidence-based CVAD guidelines from Sweden reported rates from 0.5% to 1.6% during insertion. Bleeding during removal is rare and not associated with low platelet counts or high PT/INR levels. 1 Analysis of a database of claims received by a large health insurance company reported major bleeding as an outcome of CVAD placement as 0.09 per 1000 catheter days in 5060 insertions. The report did not define major bleeding. 5 2

3 DEFINITIONS One challenge with assessing study data is a lack of objective definitions used to report outcomes with bleeding during CVAD insertion. Terms used include: Major bleeding Minor bleeding Hematoma The International Society on Thrombosis and Hemostasis published a definition of major bleeding in non-surgical patients and recommends this criteria: Fatal bleeding, and/or Symptomatic bleeding in critical organs (e.g., intracranial, intraspinal, pericardial) and/or Hemoglobin decrease of 20 g/l or more, requiring transfusion of 2 or more units of blood. 6 Three studies addressing bleeding risk with CVAD insertion used these definitions: Hemorrhagic adverse events o Minor oozing at puncture site and mild hematoma without the need for ablation or hemostasis surgery; o Minor oozing at puncture site requiring dressing change more than 2X per day and improving within 24 hours and not requiring hemostasis surgery; o Mild hematoma was a non-expanding and mild subcutaneous hematoma less than 5 cm in diameter without need for hemostasis surgery. o Major hemorrhage was subcutaneous bleeding more than 5 cm or minor hemorrhage not improving within 24 hour or bleeding that required ablation or surgical intervention. 7 Bleeding complications o Minor bleeding included superficial oozing or local non-expanding hematoma at insertion site outside the immediate procedure period. 3

4 o Major bleeding included hemoglobin loss of 20 g/l or more, the need for blood transfusion from loss related to insertion procedure, or need for surgical intervention to stop bleeding at insertion site. 8 Hemorrhagic outcomes o Minor bleeding was oozing from percutaneous insertion site or superficial hematoma within 24 hours of insertion. o Major bleeding included new post-procedural fluid collection in mediastinum, pleural cavity, or neck within 24 hrs confirmed by radiology OR catheter-related bleeding requiring blood or fluid replacement, vasopressors, or surgery. 9 Laboratory values are reported using the same measurements used in the study being discussed. Central vascular access device (CVAD) is used to encompass are types of catheters. Central venous catheter (CVC) indicates subclavian, jugular, or femoral insertion sites. Peripherally inserted central catheter (PICC) indicates a catheter inserted from the upper extremity. METHODS A literature search was conducted using Google Scholar and PubMed and the following terms: Bleeding and CVC Bleeding and PICC INR and PICC INR and CVC Platelets and PICC Platelets and CVC Coagulation lab values and PICC Coagulation lab values and CVC 4

5 Studies from 2010 to March 2018 were included. EVIDENCE The evidence table includes 5 studies about placement of percutaneous and tunneled CVCs in adult patients with a wide variety of diagnoses including solid tumor and hematologic malignancy, renal failure, and sepsis/septic shock. Three studies used a retrospective method while one was a prospective observational study and one was a randomized controlled trial. Four studies were conducted using PICCs in children and adults. Three were retrospective and 1 was prospective observational study design. Major bleeding was reported in one septic patient that developed a hemothorax in the presence of normal lab values. 9 Six pediatric patients experienced major bleeding from PICC insertion, however blood or blood components were not required for treatment. 8 All authors concluded that major bleeding even in the presence of low platelets or high coagulation lab values is a very rare event. The majority of studies reported low occurrence of minor bleeding usually in the form of hematomas or oozing from the insertion site, however these rates were very low at ~5% or less. One study of pediatric patients reported minor bleeding rate of 29%, although the risk of bleeding was not correlated with abnormal lab values. Additionally, those with abnormal lab values receiving blood products before PICC insertion experienced higher rates of minor bleeding that those NOT receiving blood products. 8 Two studies reported an association between failed insertion procedures or repeated insertion attempts and minor bleeding events. 10, 11 Arterial puncture was associated with hematoma. 12 Statistical analysis in one study showed that failed access on the first attempt was associated with hemorrhagic events. 9 Ultrasound guidance is well documented to improve first attempt success and decrease bleeding risk by reducing vein trauma. 7, 10, 12 5

6 Haas, et.al. analyzed infection risk and overall survival of tunneled CVADs. There was no strong statistical difference in infection rates in patients with normal and abnormal lab values. Abnormal lab values did not alter total catheter survival time. 13 Although administration of blood products (e.g., plasma, platelets, cryoprecipitate) to address abnormal coagulation values and thrombocytopenia may be a common thought, there are multiple studies pointing to the higher risk associated these blood products. A Cochrane Review found insufficient evidence about administration of fresh frozen plasma prior to CVC insertion in patients with abnormal coagulation. 14 Bacterial contamination of platelets and other risk of platelets are a major concern. 15 Inventory of platelets is frequently inadequate to meet the needs of other clinical situations. Processing the transfusion requests can easily delay CVAD insertion and negatively affect patient care. Finally use of blood products adds to cost of care and produces little value for CVAD insertion procedures. 7, 8, 13 A commonly accepted rule of thumb is to require platelet counts above 50 X 10 9 /L 2, 8, 9 As shown in the 9 studies on the evidence table, platelet counts of less than 20 X 10 9 /L does not produce major bleeding episodes. All minor bleeding episodes were managed with minimal interventions such as prolonged pressure. Platelet transfusion was used in some patients with thrombocytopenia below 20 X 10 9 /L prior to CVAD insertion. 15 Avoiding CVAD insertion due to thrombocytopenia can negatively affect patient care. 9 Administration of medications to reverse coagulation lab values (e.g., vitamin K) or stopping anticoagulant and antiplatelet medications is also not recommended by these studies. An elevated INR or PT does not predict bleeding during CVAD insertion. 9, 13 Potet demonstrated that patient receiving a variety of aspirin doses, aspirin and clopidogrel and rivaroxaban did not have an increased risk of bleeding complications with PICC insertion and did not require stopping these medications. 11 6

7 PRACTICE RECOMMENDATIONS Several guidelines are available however many authors question the quality of studies used to create these guidelines. Old studies using less rigorous methods or consensus of opinions are reasons for these questions. 13 All clinical questions have not been addressed in studies. For instance, Potet advised not to stop antiplatelet medications before PICC insertion, however no studies have examined this question for other CVC insertion sites. 11 Additionally, 6 of 9 studies in this report were retrospective analysis. Many aspects of care could not be assessed when facility policy called for decisions to be made by providers based on their discretion. Examples include use of blood products before CVAD insertion and experience level of the inserter. 13 Low numbers in prospective studies and addressing only a single factor such as thrombocytopenia and not other coagulation values are other identified limitations. 7 The following documents are the most recent ones that address thrombocytopenia and abnormal coagulation values with CVAD insertion. Each type of CVAD is not included in each document. For instance, the Society of Interventional Radiologists does not address insertion of nontunneled, percutaneous CVC insertions through the subclavian, jugular, or femoral sites. Statements on reversal of abnormal lab values are in conflict on several documents (eg., clopidogrel). All documents rely on platelet counts of 50,000 or less although studies in this review show that bleeding is not associated with this level of platelets. The Society of Interventional Radiology Guidelines recommends: Low risk procedures include PICC insertion and CVC removal o Lab values INR of greater than 2 should be corrected to 2 or less APTT no consensus Hematocrit is not recommended 16 o Platelet transfusion not recommended unless count is less than 50, o Medications 7

8 Hold clopidogrel for 5 days before procedure Do not hold aspirin Hold low molecular weight heparin for 1 dose before procedure 17 Moderate risk procedures include tunneled CVC and subcutaneous port placement o Lab values INR corrected to 1.5 or less APTT corrected to 1.5 X control or less Hematocrit not recommended 16 o Platelet transfusion if 50,000 or less 16 o Medications Hold clopidogrel for 5 days before procedure Do not hold aspirin Hold low molecular weight heparin for 1 dose before procedure 17 Cardiovascular and Interventional Radiological Society guidelines (United Kingdom) Category 1 low risk includes PICC insertion but no other types of CVADs o Lab values INR for patients on warfarin or with liver disease, correct if greater than 2 APTT on unfractionated heparin, no consensus on correction Platelet count not routinely recommended, transfusion if less than 50,000 Hemoglobin not recommended, no recommended threshold 18 Swedish Society of Anaesthesiology and Intensive Care Medicine Structured assessment of bleeding diathesis including heredity, medical history, previous complications for surgery, drugs affecting coagulation Patients with suspected coagulation disorder o Use an easily compressible vein o Experienced inserter using optimal techniques 8

9 o Do not routinely reverse coagulation disorders with blood products or medications; consider pharmacological reversal for selected patients o Non-tunneled CVADs platelet count below 50 X 10 9 /L associated with prolonged bleeding o APTT Up to 1.3 times upper reference interval in absence of other coagulation disorders do not increase risk of bleeding; high value indicates increased risk of bleeding in hemophilia o PT-INR at or below 1.8 not reported to have higher risk of bleeding 1 CONCLUSION There are a few sets of guidelines that address these issues, however they do not appear to be using the most recent evidence. Platelet count lower than 20,000 is used in many recent studies. Therapeutic INR could be maintained as high as 3.5 and much higher values have not produced an increased risk of bleeding. Studies from the past 8 years indicate that major bleeding episodes are extremely rare, while minor episodes occur in very small numbers. These medical studies describe minor episodes in terms indicating the absence of a clinical problem. While minor bleeding episodes do not pose an immediate serious risk to the patient, there are ongoing challenges from a nursing care perspective. Blood under a CVAD dressing is a problem because it produces a wet, dirty, or non-occlusive dressing. These conditions increase the risk of infection indicating a need for immediate change of dressing, yet excessively frequent dressing changes may also increase the risk of infection and catheter dislodgment. Thus, maintaining dressing integrity drives the need to reduce or prevent all bleeding from the insertion site. To appropriately prevent and manage bleeding from the insertion site, follow these recommendations: 9

10 1. Perform a pre-insertion thorough patient assessment of all medical and nursing diagnoses, medications by all routes, and herbal or nutritional supplements in use to identify those patients with a potentially increased risk. 2. Assess the most recent lab values, however ordering blood testing immediately before CVAD insertion is not routinely required. 3. Patients with medical diagnoses associated with bleeding, presence of thrombocytopenia and/or abnormal coagulation lab values require personnel with the highest level of skill. Do not allow personnel learning CVAD insertion to practice on these patients. 4. Use ultrasound guidance for insertion of all CVADs to increase first attempt success and decrease risk of arterial puncture and the need for subsequent attempts. 5. Prepare to use a hemostatic dressing if minor bleeding occurs. Follow manufacturers instructions for use regarding the length of time for the hemostatic product to remain on the site. 6. Apply external compression as needed to achieve hemostasis. 7. Use skin protective barrier solution to ensure integrity of the dressing. 10

11 EVIDENCE TABLE AUTHOR/YEAR PURPOSE/POPULATION INTERVENTION N REPORTED LAB VALUES OUTCOME Centrally inserted venous catheters (CVC) Cavanna, Prospective, observational study in adult oncology patients US guided; single and dual lumen catheters inserted into internal jugular vein with Seldinger technique 1978 catheters in 1660 patients; 580 with hematologic malignancies, 1398 with solid tumors Platelet count in mm3 236,000 median 116 patients (6.99%) below 50, patients (4.22%) below 20,000 No major bleeding 4 (0.2%) self-limiting hematomas at insertion site, all associated with arterial puncture, no medical intervention reported. 38 patients (2.29%) below 10,000 Haas, Retrospective review of large-bore TCVC used for infusion, pheresis, and hemodialysis to assess bleeding rate in patients Radiology inserted TCVCs Fr size over a 7 year period Data collected on platelet count 3170 TCVC insertions in 2514 patients Platelet counts range - from 3 to 49 X 1000/dL 27 complications in entire population; 0.85% rate 11

12 AUTHOR/YEAR PURPOSE/POPULATION INTERVENTION N REPORTED LAB VALUES OUTCOME with disorders of hemostasis and INR at time of insertion and those receiving blood products to correct coagulation Hematologic malignancy most frequent diagnosis 626 TCVCs placed in 567 patients with platelet counts less than 50,000 and INR 1.5 or greater INR range from 1.5 to bleeding related events including oozing at exit site requiring treatment, hemothorax and hematoma No bleeding complications in group with low platelet count or high INR 43/626 with platelet count less than 25,000 43/626 with INR greater than 2 No significant rates of infection in patients with coagulopathy or thrombocytopenia Zeidler, Retrospective review leukemia adults with CVC insertions over a 6- year period. Nontunneled multiple lumen CVCs with antimicrobial coating inserted 193 patients with 604 CVC insertions Mean platelet count at insertion = 48 X 10 9 /L Bleeding occurred in 190/604 (32%) insertions 12

13 AUTHOR/YEAR PURPOSE/POPULATION INTERVENTION N REPORTED LAB VALUES OUTCOME via subclavian jugular using MST the and veins All bleeding events occurred with platelet counts above 20 X 10 9 /L No change in hemoglobin levels before insertion or at 24 and 48 hours after insertion Grade 1, mild, no intervention required (e.g. local hematoma) = 182, 96% Grade 2, mild requiring intervention such as prolonged compression = 8, 4% Grade 3, transfusion or operative interventions required = none Grade 4 lifethreatening events, urgent interventions required = none Platelet count below 20 X 109/L had statistically significant risk of bleeding, although all episodes were minor 13

14 AUTHOR/YEAR PURPOSE/POPULATION INTERVENTION N REPORTED LAB VALUES OUTCOME Vinson, Retrospective review of adult patients receiving CVC in ED Data from 21 EDs included over 28 month period 7 to 8.5 Fr Triple lumen CVC inserted for early goal directed therapy for sepsis or septic shock with platelet count less than 100,000/dL, INR at least 3, and APTT at last 35 seconds 2612 patients with sepsis/septic shock 936 insertions in 934 patients meeting lab criteria 732 with 1 lab abnormality Lowest platelet count = 4000/dL Highest INR = /936 (95.9%) no hemorrhagic complications Major bleeding causing hemothorax in 1 patient with normal lab values and refractory septic shock 204 with 2 or more lab abnormalities 20 patients received preinsertion blood products Minor hemorrhage in 37 patients 23 with superficial hematoma, with and without oozing 14 with oozing alone 23 patients received vitamin K during ED stay 8/37 required treatment of line removal, suture, or blood products No statistical difference based on 14

15 AUTHOR/YEAR PURPOSE/POPULATION INTERVENTION N REPORTED LAB VALUES OUTCOME mild or moderate-tosevere lab abnormalities Parienti, RCT in adult ICU patients in 10 French hospitals to compare catheterrelated complications of subclavian, jugular and femoral insertion sites Seldinger technique with anatomical landmark or US guidance for insertion of central venous catheter Jugular = 845 Femoral = 844 Subclavian = 843 No lab values reported Patients receiving anticoagulant therapy: Jugular 257 (30.4%) No major bleeding reported Hematoma Jugular 8 Femoral 0 Femoral 259 (30.7%) Subclavian- 2 Subclavian 249 (29.9%) Peripherally Inserted Central Catheters (PICC) 15

16 AUTHOR/YEAR PURPOSE/POPULATION INTERVENTION N REPORTED LAB VALUES OUTCOME Pittiruit, Retrospective review of all power-injectable PICCs in adults and children in ICU over a 12- month period Multiple brands of single, dual, and triple lumen, power-injectable PICCs from 4 to 6 Fr size; all US guided using MST inserted into upper mid-arm 89 PICCs inserted 65 in adults 24 in pediatrics None reported No major bleeding Local hematoma in 3 cases (3.4%) Potet, Prospective, observational study of PICC insertion in oncology patients with profound thrombocytopenia 5 Fr, single lumen power-injectable PICCs inserted by 4 interventional radiologists using US fluoroscopic guidance. 143 PICCs in 101 patients from 16 to 86 years old. APTT, PT and platelet counts performed within 4 hr of procedure 50 patients with platelet counts less than 20 x 10 9 /L with 1 having minor oozing No hemorrhage Minor hemorrhage major solid tumor patients 1/8 (12%) hematology patients - 7/135 (5%) Minor oozing in 6 (4.2%) 16

17 AUTHOR/YEAR PURPOSE/POPULATION INTERVENTION N REPORTED LAB VALUES OUTCOME Mild hematoma in 2 (1.4%) (see authors definitions above) No patients given blood or blood components before insertion Only 1 patient with alteration in secondary hemostasis. No recommendations regarding elevated PT or APTT. Woodley-Cook, Retrospective review of pediatric patients to determine value of preprocedure coagulation tests 3, 4, and 5 Fr single and dual lumen PICC with US and fluoroscopy guidance; single external suture used 1441 hospitalized children from birth to 18 years old; 2 cohorts Normal lab values: Cohort A Platelets> 50 X 10 9 ml APTT < 55 seconds Major bleeding = 6/832 (0.7%); none required blood or blood components Minor bleeding = 242/832 (29%) 17

18 AUTHOR/YEAR PURPOSE/POPULATION INTERVENTION N REPORTED LAB VALUES OUTCOME All inserted in Radiology Dept A- age 0-3 months INR < 1.30 (definitions above) listed B ->3 months to 18 years 832 met inclusion criteria Included those with pre-picc insertion coagulation tests and hemoglobin up to 48 hr post insertion Excluded were those with known bleeding disorder, malignancy, and/or other invasive procedure Cohort B Platelets > 50 X 10 9 ml APTT <36 seconds INR <1.30 3/1441 required CVC insertion in internal jugular due to failed PICC insertion, but no bleeding in any of these patients Cohort A 32% with Minor bleeding and normal lab values 27% minor bleeding with abnormal lab values Patients with abnormal lab values not given blood product before PICC insertion and those with normal lab values had no difference in bleeding complications. 18

19 AUTHOR/YEAR PURPOSE/POPULATION INTERVENTION N REPORTED LAB VALUES OUTCOME before insertion PICC Minor bleeding caused statistically significant difference in Hemoglobin but not clinically relevant. Cohort B Major bleeding in 6 patients (1%); hemoglobin drop without clinical symptoms; only 1 of these 6 had abnormal lab values before insertion Minor bleeding = 174 or 29% Those with normal lab values had same rate as those with abnormal lab values Those with abnormal values receiving 19

20 AUTHOR/YEAR PURPOSE/POPULATION INTERVENTION N REPORTED LAB VALUES OUTCOME blood product before PICC insertion had higher rate of minor bleeding than those NOT given blood product Potet, Retrospective review of adult patients with hemostasis disorders and PICC placement 4 and 5 Fr power injectable, single and dual lumen PICCs inserted by 4 radiologists using US and fluoroscopic guidance 378 PICC placed in 271 patients, age range from 18 to 93 years 89/378 receiving antiplatelet therapy 269 (71%) with thrombocytopenia 42 (11.1%) with prolonged APTT and INR No hemorrhagic complications 14 insertions had blood oozing and mild hematoma APTT- activated partial thromboplastin time; ED- emergency department; Fr- French; ICU- intensive care unit; INRinternational normalized ratio; MST- modified seldinger technique; PT-prothrombin time; US- ultrasound 20

21 REFERENCES 1. Frykholm P, Pikwer A, Hammarskjöld F, et al. Clinical guidelines on central venous catheterisation. Acta Anaesthesiologica Scandinavica. 2014;58(5): Bishop L, Dougherty L, Bodenham A, et al. Guidelines on the insertion and management of central venous access devices in adults. International journal of laboratory hematology. 2007;29(4): Parienti J-J, Mongardon N, Mégarbane B, et al. Intravascular complications of central venous catheterization by insertion site. New England Journal of Medicine. 2015;373(13): Lee KA, Ramaswamy RS. Intravascular access devices from an interventional radiology perspective: indications, implantation techniques, and optimizing patency. Transfusion. 2018;58(S1): Napalkov P, Felici DM, Chu LK, Jacobs JR, Begelman SM. Incidence of catheter-related complications in patients with central venous or hemodialysis catheters: a health care claims database analysis. BMC cardiovascular disorders. 2013;13(1): Schulman S, Kearon C. Definition of major bleeding in clinical investigations of antihemostatic medicinal products in non surgical patients. Journal of Thrombosis and Haemostasis. 2005;3(4): Potet J, Thome A, Curis E, et al. Peripherally inserted central catheter placement in cancer patients with profound thrombocytopaenia: a prospective analysis. European radiology. 2013;23(7): Woodley-Cook J, Amaral J, Connolly B, Brandão LR. Do children without a known bleeding tendency undergoing PICC placement require coagulation laboratory testing? Pediatric radiology. 2015;45(5): Vinson DR, Ballard DW, Hance LG, et al. Bleeding complications of central venous catheterization in septic patients with abnormal hemostasis. The American journal of emergency medicine. 2014;32(7):

22 10. Pittiruti M, Brutti A, Celentano D, et al. Clinical experience with powerinjectable PICCs in intensive care patients. critical care. 2012;16(1):R Potet J, Arnaud F-X, Thome A, et al. Peripherally inserted central catheter placement in patients with coagulation disorders: A retrospective analysis. Diagnostic and interventional imaging. 2015;96(11): Cavanna L, Civardi G, Vallisa D, et al. Ultrasound-guided central venous catheterization in cancer patients improves the success rate of cannulation and reduces mechanical complications: a prospective observational study of 1,978 consecutive catheterizations. World journal of surgical oncology. 2010;8(1): Haas B, Chittams JL, Trerotola SO. Large-bore tunneled central venous catheter insertion in patients with coagulopathy. Journal of vascular and interventional radiology. 2010;21(2): Hall DP, Estcourt LJ, Doree C, Hopewell S, Trivella M, Walsh TS. Plasma transfusions prior to insertion of central lines for people with abnormal coagulation. The Cochrane Library Zeidler K, Arn K, Senn O, Schanz U, Stussi G. Optimal preprocedural platelet transfusion threshold for central venous catheter insertions in patients with thrombocytopenia. Transfusion. 2011;51(11): Taslakian B. Appendix 2 Society of Interventional Radiology Guidelines for Preprocedural Coagulation Parameter Surveillance Based on the Procedural Risk for Bleeding. Procedural Dictations in Image-Guided Intervention: Springer; 2016: Patel IJ, Davidson JC, Nikolic B, et al. Consensus guidelines for periprocedural management of coagulation status and hemostasis risk in percutaneous image-guided interventions. Journal of vascular and interventional radiology. 2012;23(6): Kyaw Tun J, Khwaja S, Flanagan S, Fotheringham T, Low D. Current practice of periprocedural haematological management for patients undergoing imageguided procedures. The British journal of radiology. 2015;88(1047):