Management of Bleeding and Hemolysis. Mauricio G. Cohen, MD, FACC, FSCAI Director, Cardiac Catheterization Lab Professor of

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1 Management of Bleeding and Hemolysis Mauricio G. Cohen, MD, FACC, FSCAI Director, Cardiac Catheterization Lab Professor of

2 Disclosure Statement of Financial Interest Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Grant/Research Support Company Abbott Vascular, Boston Scientific, Svelte Consulting Fees/Honoraria Abiomed / Terumo Medical / Medtronic / Merit Medical / AstraZeneca Major Stock Shareholder/Equity Royalty Income Ownership/Founder Intellectual Property Rights Other Financial Benefit Accumed None None None None

3 Liver failure DIC DAMPs: damage associated molecular patterns European Journal of Heart Failure (2015) 17,

4 Major or significant bleeding, 40.8% (26.8% to 56.6%) Ann Thorac Surg 2014;97:610 6

5 Bleeding requiring transfusion 4.2 Euroshock Uspella N=120 Early learning curve Impella 2.5 N=154 Early learning curve Impella Vascular Surgery Hemolysis Pericardiocentesis Lauten A et al. Circ Heart Fail. 2013;6:23-30 O Neill WW et al. J Interven Cardiol 2014;27:1 11

6 Groin hematoma TandemHeart Registry (n=117) Limb ischemia 29 Bleeding around cannula 0.8 Atrial perforation Sepsis Coagulopathy Transfusion GI Bleed J Am Coll Cardiol 2011;57:688 96

7 Cardiogenic Shock Patients High Bleeding Risk Large bore vascular access Percutaneous LVADs Traumatic insertion of urinary catheters Differential Hemolysis Multiple venipunctures Multiorgan dysfunction Shock liver GI stress ulcers Hemodialysis Antithrombotic therapies Anticoagulants Antiplatelets Coagulation abnormalities Coagulopathy due to shock liver Thrombocytopenia VWF loss of function

8 Critical Care Monitoring in Patients With CS Van Diepen S et al. Circulation. 2017;136:e232 e268

9 Patient Blood Management in the CICU Restrictive transfusion strategies Erythrocyte NO biology of stored blood can lead to vasoconstriction, platelet aggregation, and ineffective oxygen delivery, and contribute to inflammation Hemoglobin threshold <7 g/dl with target range of 7-9 g/dl Single-unit RBC transfusions Diagnostic blood draws for a patient can lead to up to 70 ml of blood loss on a daily basis Normal daily RBC production in a 70-kg healthy adult is around 17.5 ml Identify and manage hemolysis Stress GI ulcer prophylaxis has been recommended in high-risk patients Balance with increased risk of pneumonia and C difficile associated diarrhea Thrombocytopenia, coagulopathy and coagulation disorders Heparin-induced thrombocytopenia Shander A et al. Transfusion Medicine Reviews 31 (2017)

10 Preparedness for Recognition and Management of Vascular Complications Use of Covered Stents Coil Embolization Samal A and White CJ. CCI 2002;57:12 23

11 Hemolysis Passing of RBCs through heart pumps increases shear stress causing hemolysis Obstructions due to malpositioning can increase shear force and hemolysis; proper position includes inlet free from obstruction and outflow well above aortic valve leaflets Plasma free hemoglobin >27 mg/dl within 24 hours after Impella predictive of hemolysis with sensitivity 75% and specificity 94%

12 INTERMACS Hemolysis Definition Major Hemolysis: A plasma-free hemoglobin value greater than 20 mg/dl or a serum lactate dehydrogenase (LDH) level greater than two and onehalf times (2.5x) the upper limits of the normal range at the implanting center occurring after the first 72 hours post-implant and associated with clinical symptoms or findings of hemolysis or abnormal pump function. Major Hemolysis requires the presence of one or more of the following conditions: Hemoglobinuria ( tea-colored urine ) Anemia (decrease in hematocrit or hemoglobin level that is out of proportion to levels explainable by chronic illness or usual post-vad state) Hyperbilirubinemia (total bilirubin above 2 mg%, with predominately indirect component) Pump malfunction and/or abnormal pump parameters

13 Recognition of Hemolysis All patients who have an acute MCS device should have baseline LDH and pf-hb checked pre-implant of MCS. Check LDH and pf-hb q8-12hr for first 72hrs to assess DELTA pf-hb for a more accurate identification of hemolysis A few tips on traumatic foley insertions: A urinalysis can help Blood ++ / RBC ++ likely traumatic foley insertion Blood ++ / RBC (-) more concerning for hemolysis Spun urine can also help: Supernatent clear/red sediment likely traumatic foley insertion Supernatent pink/red sediment more concerning for hemolysis

14 Check Impella Positioning Initial insertion: To ensure the Impella is properly placed in the cath lab, and not caught in the mitral valve apparatus, it is recommended to cross the aortic valve with a pigtail catheter, rather than with the wire alone. CCU Impella Position Monitoring: Upon transfer to the CCU, obtain a TTE to ensure proper placement. Recheck Impella position with ECHO for position alarms or suction alarms Always re-position the Impella with real-time ECHO guidance

15 Impella Positioning Correct Position on TEE: Parasternal long axis transthoracic echocardiography is the preferred view to limit foreshortening The inlet area should be about 3.5 cm below the aortic valve Free from the anterior leaflet or the subannular structures If Re-positioning is required: Turn Impella to P-2 Support patient pharmacologically as needed Re-position Impella with real-time echo guidance Remove slack in drive-line Preferred view for TTE: Parasternal long axis view Resume prior performance level and ensure catheter hasn t migrated once flow increased

16 Impella Positioning Trouble-shooting Position: If proper position on echo is confirmed and not involved in the mitral subvalvular apparatus: Be cognizant that hemolysis can be an indication of incorrect Impella position even if position looks perfect Inflow cannula interaction with the anterior mitral valve leaflet can occur, even if perfect position on echo Recommend re-positioning, with trial of slight clock-wise rotation during repositioning under real-time echo guidance Optimize Performance Level: If patient can tolerate a small decrease in performance level, this may help. If patient cannot tolerate small decrease, consider increasing support level

17 Mosaic for Correct and Incorrect Position Correct Position Incorrect Position

18 Impella Positioning

19 Position Problem?

20 Conclusion Bleeding and hemolysis are relatively frequent complications of patients treated with MCS for AMICS A culture of vigilance is required in the CICU to recognize complications early and manage promptly AMICS patients are not forgiving Establish and implement protocols to prevent complications

21

22 70 yo Male Admitted with Cardiogenic Shock U/S guided access using micropuncture needle Placed 6 Fr sheath with intent to upsize for Impella access

23 Access Strategy (continued) Significant resistance is felt while advancing the sheath Angiographic assessment of iliac vessels showed

24 Clinical Course Patient develops further hypotension, the best immediate course of action is: 1. Apply pressure to the iliac fossa and refer the patient for CT scan 2. Call vascular surgery for open repair 3. Inflate PTA balloon in external iliac artery to prevent further bleeding 4. Fluid resuscitation 5. Central cannulation for LVAD

25 Clinical Course We inflated a ConQuest an 8mmX4cm PTA Balloon in the iliac artery Patient stabilized with pressors and fluids The best course of action now is?

26 Best Course of Action? Nothing. The perforation sealed with prolonged balloon inflation Place a self-expanding stent and seal the perforation Now is the time to take the patient to the OR for open vascular repair The patient is stable now. It is time to assess the blood loss with a CT scan

27 Best Course of Action? Nothing. The perforation sealed with prolonged balloon inflation Place a self-expanding stent and seal the perforation Now is the time to take the patient to the OR for open vascular repair The patient is stable now. It is time to assess the blood loss with a CT scan

28 Best Course of Action 10x40 mm Gore Viabahn covered self expanding stent deployed and then post-dilated with 9x60 mm Evercross balloon at 6 atm.

29

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