GOODBYE HEPARIN. Sergio Bertoglio DEPT. OF SURGERY UNIVERSITY OF GENOA POLICLINICO SAN MARTINO- GENOA (ITALY)

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1 GOODBYE HEPARIN Sergio Bertoglio DEPT. OF SURGERY UNIVERSITY OF GENOA POLICLINICO SAN MARTINO- GENOA (ITALY)

2 Disclosure Lecturer and/or Consultancy agreements : Bard Baxter B.Braun Becton Dickinson BMR Brazil DEKRA P1Health

3 RATIONALE FOR LOCK VASCLUAR ACCESS DEVICES WITH HEPARINIZED SALINE SOLUTION Reduces platelet aggregation Prevents intraluminal catheter cloth No reduction of CR-DVT CERTAINLY TRUE ISSUES Prevents biofilm formation Decreases CRSBI incidence QUESTIONABLE ISSUES

4 CONTROVERSIES RELATED TO THE CHRONICAL USE OF HEPARINIZED SOLUTION Impact on coagulation laboratory values Drug incompatibility ( antibiotics, meperidine, prometazine) HIT mainly in oncological patients UFH short half-life (60-90 ) Possible risk of CR-BSI due to increased handling maneuvers Possible increased risk for medical-nursing errors In vitro induction of biofiim from S.Aureus Attributable Cost

5 Heparin may induce in vitro S. Aureus biofilm formation Shanks R.M. et al Consistent induction In vitro formation of S.aureus MZ 1000 biofilm on polystirene abiotic surfaces with or without heparin

6 Heparin may induce in vitro Staph. Aureus biofilm formation Shanks R.M. et al Consistent induction Epifluorescent microscopy of S.aureus MZ 1000 bacterial stain Syto 9 on abiotic surfaces

7 SIDE EFFECTS RELATED TO THE CHRONIC USE OF HEPARINIZED SOLUTION Chronical spillage from the catheter tip Bleeding Heparin Induced Thrombocytopenia (HIT) Medication errors

8 Spillage and fluid dynamics of lock procedures ASDIN POSITION : LIMITING HEPARIN CONCENTRATION TO 1000U/ML

9 HEPARIN INDUCED THROMBOCYTOPENIA (HIT) Production of immunoglobuline antibodies HIT-IgG that activates the clothing cascade from 5-10 days after exposure to 40 days after discontinuation Heparin dose independent side effect Incidence not well assessed but seems to be major in cancer patients

10 SIDE EFFECTS OF HEPARIN LOCK SOLUTIONS MEDICATION ERRORS Major bleding complications in wards and surgical settings Reported mortality due to medication errors especially in neonatology

11 SIDE EFFECTS OF HEPARIN LOCK SOLUTIONS STATE OF THE ART OF FLUSH AND LOCK PROCEDURES FOR PVAs Since the 90 there is a wide range of literature showing the non inferiority of normal saline vs heparinized solution for flush and lock solution Since last decades heparin has been eventually eliminated for peripheral catheters flush and lock procedures

12 A Meta-Analysis of Heparin Flush and Saline Flush : Quality and Cost Implications Goode C.J. Et al Nursing Research 40: ,1991 PVAs+ 2 CVCs Series HEPARINIZED vs NORMAL SALINE SOLUTION 15 RCT SAMPLE SIZE 3490 patients USD OCCLUSION.0573 THROMBOSIS/PHLEBITIS.0757 CATHETR s HALF-LIFE.0550 ESTIMAD SAVINGS FOR NS * 218,200,000 *USA / on annual basis THESE FIGURES WOULD BE MUCH HIGHER BY TODAY S STANDARDS

13 Efficacy of normal saline solution versus heparin solution for maintaining patency of peripheral intravenous catheters in children PVAs Series LeDuc K. R.N. J Emergenc Nursing 23: ,1997 Double blin RCT Heparinized vs Normal Saline ANY RESULT DIFFERENCE BETWEEN THE TWO REGIMENS Flebitis 1/0 Unpaired infusion 2/4 Withdrawal occlusion Occlusion 159/160 3/4 ATTRIBUTABLE COSTS HS 48,866 USD ATTRIBUTABLE COST NS 19,272 USD

14 Normal saline vs Heaprinized solutions for PVAs CONCLUSIONS OF BOTH STUDIES Quality of care can be enhanced by using saline as the flush solution, thereby eliminating problems with anticoagulant effect and drug incompatibilities. In addition estimated savings health care could be attained

15 Normal saline vs Heaprinized solutions for CVCs Until the last decade there has been a persistent fear to switch from heparinized solution to normal saline for flush and lock of any type of CVC and in particular for TIVADS

16 SINGLE INSTITUTION TRIALS ON TIVADS BERTOGLIO et al Cancer Nursing 2012 prospective study HEPARIN SOLUTION NORMAL SALINE GOOSSENS et al Annals of Oncology 2013 RCT HEPARIN SOLUTION NORMAL SALINE CATHETER OCCLUSION 6.7% 5.7% n.a. n.a. EASY INJECTION + WITHDRAWAL OCCLUSION n.a. n.a. 3.7% 3.9% DVT 2.2% 2.4% 3.3% 2.8% No statistically significant differences on occlusion between competitors

17 SISTEMATIC REVIEWS We conclude there is no evidence that heparin flushing of CVCs is better than flushing with sterile saline solution. As heparin is more expensive the findings of this review do not support its use except in futur eclinical trials

18 SISTEMATIC REVIEWS EFFECTIVENESS OF HEPARIN VERSUS 0.9% SALINE SOLUTION IN MAINTAINING TH EPERMEABILITY OF CENTRAL VENOUS CATHETERS: A SYSTEMMATIC REVIEW Ferreira Dos Santos EJ, et al Rev Esc Enferm USP 2015;49(6): 995

19 SISTEMATIC REVIEWS THIS META-ANALYSIS DID NOT DEMONSTRATED ANY SUPERIORITY OF HEPARIN LOCKED SALINE SOLUTIONS OVER NORMAL SALINE FOR THE MAINTENANCE OF CVC LUMEN PATENCY IN ADULT PATIENTS

20 GUIDELINES POSITION FAVOR THE USE OF NORMAL SALINE FOR FLUSH AND LOCK PURPOSES OF ANY TYPE OF NON DIALYSIS CVC

21 IS ANTICOAGULATION NECESSARY FOR FLUSH AND LOCK CVCs? J Vasc Access Nov 2;17(6):

22 PANEL POSITION Question 1 Q.1 - Is there a role for anticoagulant lock in the management of non-dialysis central venous access (NDCVA), as a method for prevention of lumen occlusion? PANEL RECOMENDATION 1. The role of anticoagulant lock is only marginally important in terms of prevention of lumen occlusion 1. Future assessmenf the role of citrate lock in NDCVA is desirable and considered of increasing importance. 2. The benefit on citrate might be more focused on its action against biofilm formation and against bacteria rather than on its anticoagulant effect

23 PANEL POSITION Question 2 Q.2 - Which drug (heparin; citrate; urokinasis; rtpa; etc.) may have a primary role in this kind of lock? PANEL RECOMENDATION 1. Heparin lock and citrate lock both guarantee an effective anticoagulant action, which is proven to be useful in DCVA rather than in NDCVA. 2. Thrombolytic/fibrinolytic drugs, as currently available, are neither safe nor cost effective for prevention of occlusion of NDCVA, while they have a definite role in the treatment oflumen occlusion due to blood clots.

24 PANEL POSITION Question 3 Q.3 - Is there evidence that lock with normal saline might be as appropriate as an anticoagulant lock, in terms of prevention of lumen occlusion? PANEL RECOMENDATION Saline lock is as appropriate as anticoagulant lock in prevention of occlusion of NDCVA

25 CONCLUSIONS ANTICOGULANTS AND IN PARTICULAR HEPARIN ARE NOT NEEDED TO PREVENT CATHETERS OCCLUSION EXCEPT FOR DIALYSIS CATHETERS OTHER ANTICOAGULANTS LIKE CITRATE AND EDTA RATHER THAN HEPARIN HAVE ATTITIONAL DESIRABLE EFFECTS ON BIOFILM FORMATION AND PREVENTION OF BACTERIAL CONTAMINATION GOODBYE HEPARIN!!!!!!!

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