The Balancing Act Bleeding and Thrombosis in MCS. Muhammad Adil Soofi

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1 The Balancing Act Bleeding and Thrombosis in MCS Muhammad Adil Soofi

2 Road Map Survival and complications with LVAD What is the Burden of thrombosis and bleeding Why Bleeding and Thrombosis happen When to suspect Thrombosis Where is the thrombosis How to deal with bleeding and thrombosis Speed Ramp test Take home message

3 >93% J Heart Lung Transplant 2017;36:

4 J Heart Lung Transplant 2017;36:

5 Early post-implant multisystem organ failure, right heart failure, and stroke pose the greatest risks for death. After the first 6 months, stroke remains the major cause of Bleeding is not one of the death out to 4 years. major cause of death J Heart Lung Transplant 2017;36:

6 What is the burden of thrombosis and bleeding? Bleeding and thrombosis are the most feared complications of MCS. Thrombosis thrombosis : EPPY Embolic events: EEPY Pump Thrombosis: EPPY Bleeding EPPY early phase: predominately surgical bleeding after the first 3 months: GI bleeding REMATCH, N Engl J Med 2001;345: J Am Coll Cardiol 2016;67:

7 What is the burden of bleeding and thrombosis? OMM 1 year LVAD 1 year OMM 2 year LVAD 2 year Bleeding (EPPY) Hemorrhagic stroke(eppy) Ischemic stroke (EPPY) Pump thrombosis (EPPY) ROADMAP 2 YEARS RESULT The Journal of Heart and Lung Transplantation, Vol 35, No 4S, April 2016

8 REMATCH, N Engl J Med 2001;345:

9 What is the burden of bleeding and thrombosis? Bleeding and thrombosis are major and serious adverse events. Bleeding is more common but less fatal. Thrombosis is less but more fatal.

10 Why bleeding and thrombosis happen Hemocompatability Interaction of prosthetic material with blood Result in prolong activation of endothelial and coagulation system, turbulent flow and hemolysis Improved by decreasing areas of stasis, retrograde flow, optimization of surface coating and promoting smooth flow Heart mate (electric vented) has textured interior surface and did not require systemic anticoagulation. Heart ware developed sentered inflow to reduce pump thrombosis

11 Sentered inflow to reduce pump thrombosis

12 Von Willebrand Factor Continuous flow instead of pulsatile flow Alteration in vwf multimers Loss of large vwf multimers Within first few days after implantation Impaired coagulation Promote angiodysplasia GI bleeding

13 Platelet activation Continuous flow leads to increase shear stress Increase platelet activation Increase platelet adhesion

14 Thrombosis Include CVA due to infarction, peripheral embolism and pump thrombosis CVA: 16% of 0.19/year Increase during early post op period Reduce by systemic anticoagulation Aggressive anticoagulation after CVA may result hemorrhagic transformation Lazar et al. REMATCH. Circulation. 2004;109:

15 Thrombosis Risk factors for thrombosis Inadequate anticoagulation Atrial fibrillation Hypercoagulable sates Coexistent infection

16 When to suspect pump thrombosis Hemolysis LHD > 1000 mg/dl (> 3.5 times UNL, excellent sensitivity and specificity) Plasma Free Hemoglobin >40 mg/dl Heart failure symptoms in absence of kinked inflow/outflow cannula Increase Power, Increase Flow Decrease Power, Decrease Flow Frequent aortic valve opening, Severe MR Increase right and left filling pressures on RHC Eckman & John. Circulation. 2012;125:

17 J Am Coll Cardiol October 30; 60(18)

18 HVAD Pump Performance Overview Waveforms are a tool to provide insight into the patient s condition and help with patient management Pump flow waveform depicts the rate of blood flowing through the pump The shape of the waveform varies with clinical changes

19 HVAD Pump Waveform Waveform Characteristics Flow Waveform: difference between afterload (AP) and preload (VP) Heart rate Beginning of diastole Pulsatility: Variation in pump flow relative to native systole and diastole Dependent on heart contractility and HVAD operating points Systole max HVAD flow Diastole min HVAD flow Waveform Trough: minimum value of the flow waveform Pulsatility Waveform Trough Beginning of systole Trough should be >2 L/min There should be >2 L/min of pulsatility

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21 Waveform Interpretation: What Do These Waveforms Represent? Normal Wave Form

22 Waveform Interpretation: What Do These Waveforms Represent? Low Pulsatility: Hypovolemia, Excessive pump speed, Hypotension

23 Flow Calculated value Low flow: Hypertension, Hypovolemia, Right sided failure, Cardiac tamponade, Inflow/outflow thrombosis Power Increase: Pump thrombosis

24 Inflow thrombosis Outflow thrombosis Outflow InPump thrombosis Inflow Inpump J Am Coll Cardiol 2016;67:

25 0.037 EPPY 0.1 EPPY EPPY J Am Coll Cardiol 2016;67:

26 Guideline regarding Anticoagulation Feldman et al ISHLT MCS Guidelines

27 GI Bleeding Thorough evaluation for source of GI bleeding including UGI endoscopy, LGI endoscopy, small bowel evaluation, RBC tag scan or angiography. Re initiation of ASA and warfarin after resolution of GI bleeding. Careful evaluation of patient and device when patient is not on anticoagulation. Feldman et al ISHLT MCS Guidelines

28 Thrombolysis is contraindicated During 6 months after surgery Active bleeding J Am Coll Cardiol 2016;67:

29 Speed Ramp Test Echocardiography monitored test, utilize for Speed optimization Device malfunction Recommendation for device speed adjustment MAP > 65mmHg Middle IVS position Improve RV function Intermittent Aortic valve opening Prevent or delay aortic regurgitation Pulsatile flow pattern No more than mild MR LV decompression J Am Coll Cardiol October 30; 60(18)

30 Contraindication for Ramp test J Am Coll Cardiol October 30; 60(18)

31 Protocol Increase RPM 400 every 2 minutes Record observation at each speed LVEDD: PSLAV LVESD: PSLAV AV valve opening: M-Mode, PSLAV, 10 sec AI/MR: PSLAV RVSP: Peak TR gradient Stop the test if Suction event occurred LVEDD less than 3 cm J Am Coll Cardiol October 30; 60(18)

32 Device thrombosis No change in LVEDD despite increasing Speed 52 ramp test in 39 patients 17 patients had suspected device thrombosis 7 had decrease in LVEDD and didn t show Hemolysis and remained well 10 had test with no change in LVEDD 9 developed hemolysis pump exchange(7), explant(1), transplant(1). 1 improve with increase anticoagulation. Aortic valve closure happened at a much higher speed and no suction event among patients with device thrombosis J Am Coll Cardiol October 30; 60(18)

33 Conclusion Bleeding events are more common than thrombotic events (early: Surgical, late: GI). Thrombotic events are less but more devastating. Stroke (Hemorrhagic or ischemic) is leading cause of death after 6 months. Dynamic management weighing the patient s risk of bleeding and thrombosis

34 Conclusion Elevated LDH (>750) has 100% sensitivity for pump thrombosis. Flow and power patterns are important and guide us to site of thrombosis. Speed Ramp test is highly sensitive and specific for device thrombosis

35 Thank You