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Becton, Dickinson and — Technical Presentation (April 2020)
76 slides from Becton, Dickinson and's technical presentation, April 2020
Slide 1: Presenter views disclaimer
These presentations were developed by the respective presenter(s), and the findings, interpretations, and conclusions contained or expressed with them do not necessarily reflect the views of BD. To the extent these presentations relate to specific products, such products should always be used in acc
Slide 2: Thrombosis – causative factors and preventative measures
Thrombosis – causative factors and preventative measures Fulvio Pinelli, MD Careggi University Hospital Florence, Italy
Slide 3: Catheter-related thrombosis: definition
Catheter-related thrombosis Definition CRT = Appearance of a thrombus on the vascular wall, most frequently where the endothelium is damaged by the catheter introduction site and/or where the contact between vein wall and catheter is maximal.
Slide 4: Catheter-related thrombosis: definition
Catheter-related thrombosis Definition Baskin et al. Lancet. 2009 July 11; 374(9684): 159
Slide 5: Intraluminal clot is not CRT
Catheter-related thrombosis Definition Intraluminal clot Intraluminal clot is not CRT Baskin et al. Lancet. 2009 July 11; 374(9684): 159
Slide 6: Fibroblastic sleeve is not CRT
Catheter-related thrombosis Definition Fibroblastic sleeve Fibroblastic sleeve is not CRT Baskin et al. Lancet. 2009 July 11; 374(9684): 159
Slide 7: Mural and venous thrombosis are CRT
Catheter-related thrombosis Definition Mural and venous thrombosis are CRT Baskin et al. Lancet. 2009 July 11; 374(9684): 159
Slide 8: Pathophysiology: the Virchow's Triade
Pathophysiology: the Virchow’s Triade ENDOTHELIAL DAMAGE Catheter insertion Rudolf Virchow (1821-1902) HYPERCOAGULABILITY BLOOD STASIS Sepsis Presence of the catheter itself Malignancies Infusion fluids: CHT, viscous drugs, TPN, etc. Inflammation Immobilization Thrombophilia Virchow R. Thrombose und
Slide 9: Pathophysiology
Pathophysiology Endovascular foreign body Acute Chronic Endothelial Blood stasis Endothelial Damage Damage Coagulation Pathways Activation Thrombosis
Slide 10: Natural history of CRT
Majority of CRT precocious (within 2 weeks from implantation) Approximately 1/4 symptomatic events Natural history of CRT Approximately 3/4 Uncommon Long-term asymptomatic events sequelae without treatment
Slide 11: Which are the risk factors for CRT?
Which are the risk factors for CRT ? - Choice of the device - Patients’ predisposing factors - Technique of insertion - Catheter/vein ratio - Magnitude of the trauma to the vein wall - Position of the tip
Slide 12: Choice of the Device
Choice Of The Device Is there any clinical evidence that some type of central venous approach (CICC vs. PICC vs. FICC) may actually reduce the risk of CRT ?
Slide 13: Are FICC particularly at risk of CRT?
Are FICC particularly at risk of CRT ? • Yes • Much evidence shows that Femorally Inserted Central Catheters are at increased risk of CRT (5-15% in adult patients) • Lower limb CRT is also associated with a four fold increase of risk of pulmonary embolism (Minet 2015)
Slide 14: Are CICC particularly at risk of CRT?
Are CICC particularly at risk of CRT ? • It depends on the caliber, the route and the technique of insertion: • Larger catheters (dialysis) = more risk • Supraclavicular route = more risk • Ultrasound guided puncture = less risk • No hard data about the actual incidence, probably less than 3-5% • Ri
Slide 15: Are PICC particularly at risk of CRT?
Are PICC particularly at risk of CRT ? Lancet 2013
Slide 16: Cancer 6.7%, ICU 14%
Chopra V et Al. Risk of venous thromboembolism associated with peripherally inserted central catheters: a systematic review and meta- analysis. Lancet. 2013;382:311-25 CANCER: 6.7% ICU: 14%
Slide 17: 64 studies included, only 9 considered
Chopra V et Al. Risk of venous thromboembolism associated with peripherally inserted central catheters: a systematic review and meta-analysis. Lancet. 2013;382:311-25 64 studies included, only 9 to be taken into consideration - Many studies considered asymptomatic CRT - Some were performed without t
Slide 18: Chopra 2015: Michigan Appropriateness Guide
Annals of Internal Medicine SUPPLEMENT The Michigan Appropriateness Guide for Intravenous Catheters (MAGIC): Results From a Multispecialty Panel Using the RAND/UCLA Appropriateness Method Vineet Chopra, MD, MSc; Scott A. Flanders, MD; Sanjay Saint, MD, MPH; Scott C. Woller, MD; Naomi P. O'Grady, MD;
Slide 19: INS 2016 Infusion Therapy Standards
Infusion Therapy Standards of Practice =) INS 2016 Use a PICC with caution in patients who have cancer or are critically ill d ill due to venous thrombo- sis and infection risk.!”° (III) 19. Chopra V, Anand §S, Hickner A, et al. Risk of venous thromboem- bolism associated with peripherally inserted
Slide 20: JVA 2019 studies 2010-2018
JVA 2019 • 2010-2018 • 15 studies
Slide 21: PICC-related thrombosis rate in modern vascular access era
PICC-related thrombosis rate in modern vascular access era: when insertion Risk of venous thromboembolism associated with @Qk® peripherally inserted central catheters: a systematic review and meta-analysis technique matters. A systematic review and meta-analysis Vineet Chepr, Sarah Anand, Andy Hickn
Slide 22: % DVT meta-analysis forest plot
% DVT Total Author ES (95% Cl) Weight events PICCs Oncology 4 Bertoglio 2016 ' Sa 0.117 (0.085, 0.159) 4.04 34 291 Cotogni 2015 0.011 (0.004, 0.032) 10.45 3 269 Kang 2017 0.019 (0.010, 0.035) 10.57 9 477 Liu 2018 0.019 (0.005, 0.067) 6.11 2 104 Pittiruti 2014 0.006 (0.001, 0.031) 11.031 180 Tian 201
Slide 23: Incidence of CRT for PICCs around 2.4%
So, incidence of CRT for PICCs is around 2.4%. What about other VADs in cancer patients? CRT in cancer patients with ports: 3.8 % (Decousus 2018) 2.3 % (Hong 2018)
Slide 24: Risk of Thrombosis
Risk of Thrombosis There is no clear evidence-based difference between CICCs and PICCs. Though, PICC have a higher risk of thrombosis: • In ICU hematologic patients (leukemia) • When PICCs are inserted in veins which are too small for the ideal catheter/vein ratio • When PICCs are inserted without a
Slide 25: Are PICC particularly at risk of CRT?
Are PICC particularly at risk of CRT ? • Current evidence shows that if PICCs are inserted respecting the proper indications/contraindications and paying attention to the catheter/vein caliber and to the tip position, the expected rate of CRT is 3% or less in both oncologic and non-oncologic patient
Slide 26: CRT risk vs. PICC advantages
CRT risk vs. PICC advantages • Even in populations with the highest thrombotic risk (hematology pts), the benefits of PICCs outnumber the risk of CRT • No insertion-related complications • Safe insertion even in severe coagulopathy • Safe insertion in severe cardiorespiratory disease • Low risk of C
Slide 27: CICC, PICC or FICC?
CICC, PICC or FICC ? • Estimated risk of symptomatic CRT • CICC 0-2 % low risk of pulmonary embolism • PICC 0-5 % no risk of pulmonary embolism • FICC 5-15 % high risk of pulmonary embolism In terms of prevention of thrombosis-related morbidity/mortality, the use of PICCs should be recommended over
Slide 28: Choice of the Material
Choice of the Material Silicone and II and III generation PUR catheters are less thrombogenic than polyethylene or PVC ones. ➢ short peripheral cannulas (PFTE>PUR) ➢ long peripheral cannulas (PE>PUR) ➢ Midlines, PICC, CICC: PUR = silicone
Slide 29: Choice of The Material
Choice of The Material Is there any evidence that any material treated with specific substances may reduce thrombotic risk? NO.
Slide 30: PICC with treated PUR
PICC with treated PUR • PICC with Endexo technology – effect on CRT: n.s. • Kleidon (RCT, pediatrics, 2018) • PICC with CHG treatment – effect on CRT: none • PICC with CHG treatment – effect on fibroblastic sleeve • Sylvia 2018 (ovine model)
Slide 31: Patient's Predisposing Factors
Patient’s Predisposing Factors
Slide 32: Is there anything we can do about patients' predisposing factors?
Is there anything we can do about patients’ predisposing factors?
Slide 33: Which are the patients' risk factors?
GAVeCeLT Consensus JAVA 2007 Q4 Which are the patients’ risk factors? Neoplastic disease and chemotherapy are recognised risk factors for development of deep vein thrombosis in patients bearing a central venous catheter. Pathophysiology is known, it includes direct release of thrombogenic factors by
Slide 34: Many antitumour drugs
Many antitumour drugs Decrease of antithrombotic natural factors
Slide 35: Not all cancer patients have the same risk
Not all cancer patients have the same risk Khorana et al. Blood 2008
Slide 36: Pharmacological prophylaxis in oncologic patients with VAD?
Should we use paharmacological prophilaxis in oncologic patients with VAD?
Slide 37: Routine pharmacological prophylaxis in some patients with VAD?
Should we use routine pharmacological prophylaxis in some patients with VAD ? GAVeCeLT Consensus JAVA 2007
Slide 38: Current recommendations
Current recommendations • Pharmacological prevention – Only with LMWH (100 U/kg/24h) – Only in high-risk patients • Hereditary anomalies associated with thrombophilia • Previous catheter-related venous thrombosis • Previous DVT related to the neoplastic disease GAVeCeLT 2007, ACCP 2008, Debordeau 20
Slide 39: Risk is increased in ICU patients
Patient’s predisposing Factors Risk is increased in ICU patients
Slide 40: ICU risk factors
In particular: • Sedated and ventilated patients • Sepsis • Vasopressors • FICC • VAD inserted in emergency
Slide 41: GAVeCeLT Consensus: patients' risk factors
GAVeCeLT Consensus Catheter-Related Central Venous JAVA 2007 Thrombosis: The Development of a Nationwide Consensus Paper in Italy Costantino Campisi, MD, Roberto Biffi, MD, and Mauro Pittiruti, MD Q 4 on behalf of the GAVeCeLT Committee for the Consensus Which are the patients’ risk factors? In pros
Slide 42: Is it useful to quantify the patient's risk of CRT?
May be clinically useful to quantify the patient’s risk of CRT ? NO.
Slide 43: Example: Michigan Risk Score
Example: Michigan Risk Score
Slide 44: Example: Michigan Risk Score
Example: Michigan Risk Score
Slide 45: Michigan Risk Score: worst scenario
Example: Michigan Risk Score •Worst scenario: • Patient has already a central line • WBC > 12,000 • We need a 3-lumen PICC • History of VTE in the last 30 days • History of active cancer
Slide 46: Michigan Risk Score: 4.7% risk
Example: Michigan Risk Score •Worst scenario: • Patient has already a central line • WBC > 12,000 • We need a 3-lumen PICC • History of VTE in the last 30 days • History of active cancer 10 points = Class IV = 4.7% risk of CRT
Slide 47: Example: Michigan Risk Score
Example: Michigan Risk Score • Now we know that the risk of PICC related thrombosis is 4.7 %
Slide 48: And now?
Example: Michigan Risk Score • Now we know that the risk of PICC related thrombosis is 4.7 % •And now?
Slide 49: And now?
Example: Michigan Risk Score • Now we know that the risk of PICC related thrombosis is 4.7 % •And now? • If the patient needs a central line and there are no technical contraindication to a PICC, I will insert a PICC anyway
Slide 50: And now?
Example: Michigan Risk Score • Now we know that the risk of PICC related thrombosis is 4.7 % •And now? • If the patient needs a central line and there are no technical contraindication to a PICC, i will insert a PICC anyway • Remember: PICC-related thrombosis is a low cost complication with low morb
Slide 51: Role of technique insertion
Role of technique insertion
Slide 52: The best prevention: a proper technique of VAD insertion
The best prevention: a proper technique of VAD insertion 1. Consider the catheter/vein ratio 2. Minimize the vein trauma 3. Assess a proper position of the tip 4. Stabilize the catheter i.e: USE an INSERTION BUNDLE FOR CRT PREVENTION (ex. GAVeCeLT bundle)
Slide 53: The GAVeCeLT insertion bundle for preventing CRT
The GAVeCeLT insertion bundle for preventing CRT 1. Appropriate choice of the vein 2. Appropriate technique of venipuncture 3. Adequate position of the tip 4. Proper securement
Slide 54: Appropriate choice of the vein
1. Appropriate choice of the vein - Easier and Safest Vein to be punctured - For PICCs: avoid broken or paralyzed limbs - Avoid to puncture already thrombosed vein - Exit site - Catheter - vein ratio
Slide 55: Catheter to vein ratio
Maybe the most important factor: catheter to vein ratio
Slide 56: Match the VAD caliber with the vein caliber
Match the VAD caliber with the vein caliber: - Inner vein diameter should be at least three times the catheter diameter - 3Fr PICC = vein of 3 mm or larger - 4 Fr PICC = vein of 4 mm or larger - 5 Fr PICC = vein of 5 mm or larger - 6 Fr PICC = vein of 6 mm or larger WoCOVA-GAVeCeLT-WINFOCUS CONSENSU
Slide 57: Particularly for PICCs, dimensions do matter
Particularly for PICCs, dimensions do matter Mermis 2014 (non-oncological pts) 5-6 Fr PICCs 7.6 % 4 Fr PICCs 0% McAuliffe 2016 (leukemia) 5-6 Fr PICCs 14.5 % Koo 2017 (retrospective, 3020 PICCs) proven relationship between CRT (4 %) and cath. size Menendez 2016 (265 PICCs in children) proven relatio
Slide 58: GAVeCeLT consensus: catheter diameter
Catheter-Related Central Venous 38 AVA Vol 2 No 1 2007 Thrombosis: The Development of a Nationwide Consensus Paper in Italy isi, MD. Roberto Biff, MD. and Mauro Pittiruti, MD AVeCeLT the C Q3 Is there any device or material which may intrinsically reduce the risk? ¢ A lower diameter of the catheter
Slide 59: Appropriate technique of venipuncture
2 – Appropriate technique of venipuncture US guided venipuncture
Slide 60: Use ultrasound!
Use ultrasound ! Prospective studies suggest a relationship between minimal insertion damage to vein wall and low rate of thrombosis. Strength C Recommendation
Slide 61: Use ultrasound!
Use ultrasound ! Ultrasound guidance, by reducing puncture attempts, technical failure rates and mechanical complications, has to be preferred because of a reduced incidence of catheter-related thrombosis
Slide 62: Use ultrasound!
Use ultrasound ! “,.. adoption of ultrasound guidance may have a significant favourable impact on the risk of catheter contamination and catheter related infection and on the risk of catheter related venous thrombosis” (from SOR guidelines, 2008)
Slide 63: Use microintroducers!
2 – Appropriate technique of venipuncture Use microintroducers ! Minimize vessel trauma
Slide 64: Adequate position of the tip
3. Adequate position of the tip All the new guidelines agree that an incorrect tip position is a risk factor for "central" CRT
Slide 65: Tip location and CRT rate
January 2008 October 2008 August 2010 Tip location Vein/Catheter ratio % CRT 6 4.2 1.6 Meyer BM et al. JAVA2011, 16: 144-147
Slide 66: Adequate position of the tip: IC-ECG
3. Adequate position of the tip • IC-ECG is the method of choice for checking the position of the tip; • It is an economic, effective, simple and safe methodology for a real-time assessment of the position of the tip of the catheter during the procedure itself; • The intra-procedural assessment of t
Slide 67: Stabilize the catheter
4 – Stabilize the catheter A ‘mobile’ VAD is more prone to exert mechanical trauma on the vein wall at the puncture site.
Slide 68: Stabilize the catheter: multimodal strategy
4 – Stabilize the catheter Multimodal strategy 1. Proper choice of the exit site (mid-arm, infra-clavicular) 2. Cyanoacrylate glue at the exit site 3. Sutureless device (SAS to be preferred in patients at high risk of catheter displacement) 4. Exit site protection with semipermeable transparent memb
Slide 69: Mid-arm = excellent exit site
4 – Stabilize the catheter Mid-arm = excellent exit site
Slide 70: Stabilize the catheter
4 – Stabilize the catheter
Slide 71: Stabilize the catheter
4 – Stabilize the catheter
Slide 72: Stabilize the catheter
4 — Stabilize the catheter _— Fo ate
Slide 73: Take home messages (1)
TAKE HOME MESSAGES (1) • CRT is a pathophysiological phenomenon, quite inevitable during any venous access procedure • The magnitude (and clinical relevance) of CRT is related to factors that are largely out of our control • We can control only few factors, mainly related to the technique of inserti
Slide 74: Take home messages (2)
TAKE HOME MESSAGES (2) • CRT may occur after PICC, or CICC, or FICC insertion • The risk of thrombosis is certainly higher with FICCs • There is no convincing data comparing PICC vs. CICC in terms of risk of thrombosis • Though, in terms of morbidity and mortality, PICC- related thrombosis is far le
Slide 75: Take home messages (3)
TAKE HOME MESSAGES (3) Use a bundle for CRT prevention: 1) Cath/vein size according to the 33% rule 2) Ultrasound venipuncture and micro-introducer kits 3) Tip location with intraprocedural, accurate methods (IC-ECG or echocardio) 4) Proper stabilization of the catheter
Slide 76: Thank you
Thank you Fulvio Pinelli, MD Careggi University Hospital Florence, Italy
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