Andrew Civitello MD, FACC

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1 Timing the Transition from Short Term to Long Term Mechanical Circulatory Support Andrew Civitello MD, FACC Medical Director, Heart Transplant Program Director, Fellowship Co-Director, Baylor St. Luke's Medical Center / Texas Heart Institute

2 Kolte et al, J Am Heart Assoc 2014;13(1) AMI Cardiogenic Shock Mortality Remains High

3 Stretch et al, J Am Coll Cardiol 2014;64: Use of Short Term MCS is Increasing Rapidly

Cardiogenic Shock Management Pathway Resuscitation and Medical Therapy

Therapy R e c o v e r y Reperfusion (ACS Only) PCI CABG Fibrinolysis

VAD P a l l i a t i o n Destination VAD Transplant Adapted from the AHA

4 Cardiogenic Shock Management Pathway Resuscitation and Medical Therapy Inotropes / Vasopressors Mechanical Ventilation Etiology Specific Medical Therapy R e c o v e r y Reperfusion (ACS Only) PCI CABG Fibrinolysis Short Term MCS IABP Peripheral VAD Paracorporeal VAD Long Term (Durable) VAD P a l l i a t i o n Destination VAD Transplant Adapted from the AHA Scientific Statement: Contemporary Management of Cardiogenic Shock Circulation. 2017

5 Guiding Transition From Short to Long Term MCS Challenges: No randomized trials Case series and retrospective reviews - Small number of patients - Heterogeneous patient populations - Multiple devices used - Varying data points collected - None specifically address timing of transition

6 Guiding Transition From Short to Long Term MCS Practical recommendations Based on: - BSLMC THI experience with short term MCS - Limited literature - Extrapolation from durable (long term) LVAD risk studies

7 Survival by INTERMACS Profile % Survival Months post Implant Kirlin et al, J Heart Lung Transplant 2015;34:

Continuous Flow VAD Risk Scores Clinical Parameters Echocardiographic Parameters HeartMate II Risk

185 * BMI 20-25 - 0.019 * BMI >25 0.047 * BMI Right Ventricular Dysfunction Mild 0.099 Moderate 0.

504 MELD Score Cowger et al, Am Coll Cardiol;2013;61(3):313-21 Yang et al, J Heart Lung

8 Continuous Flow VAD Risk Scores Clinical Parameters Echocardiographic Parameters HeartMate II Risk Score Age * Creatinine * Total Bilirubin * Body Mass Index <20: * BMI * BMI > * BMI Right Ventricular Dysfunction Mild Moderate Severe Aortic Insufficiency Mild Moderate 0.36 Severe MELD Score Cowger et al, Am Coll Cardiol;2013;61(3): Yang et al, J Heart Lung Transplant;2012;31(6): Birati et al, J Am Heart Assoc. 2018;7:e Score < 6 Low Risk Score 6 < to 6.7 Medium Risk Score > 6.7 High Risk Penn Columbia Risk Score

9 Continuous Flow VAD Risk Scores Common Themes Marker of Renal Function HM II RS Serum creatinine MELD Serum creatinine Penn- Columbia Serum creatinine Marker of Hepatic Function HM II RS Albumin, INR MELD Serum bilirubin, INR Penn-Columbia Total bilirubin Cowger et al, Am Coll Cardiol;2013;61(3): Yang et al, J Heart Lung Transplant;2012;31(6): Birati et al, J Am Heart Assoc. 2018;7:e006408

48) Survival Estimates 90 d 1 yr 2 yr Low Risk 94% 83% 74% Med Risk

10 Survival by HeartMate II Risk Score Percent Survival Low Risk (HMRS < 1.58) Med Risk (HMRS ) High Risk (HMRS > 2.48) Survival Estimates 90 d 1 yr 2 yr Low Risk 94% 83% 74% Med Risk 86% 72% 61% High Risk 73% 58% 49% Time (years) Cowger et al, Am Coll Cardiol;2013;61(3):313-21

11 HeartMate II Risk Score HM II RS calculation formula: age albumin + creatine + INR + center volume* Cowger et al, Am Coll Cardiol;2013;61(3): (*1 if volume < 15, 0 if volume > 15)

12 BSLMC / THI Short Term MCS Program 2017 Volume THI Percutaneous MCS Algorithm 101 VA ECMO 139 Impella 23 Tandem Heart 420 IABP Idelchik et al, J Heart and Lung Transplant 2008;27:106-11

13 THI Cohort - Short Term MCS as Bridge to Long Term MCS Severe refractory cardiogenic shock SBP < 90 mmhg Cardiac index < 2.0 Despite 2 or more vasopressors and IABP support TandemHeart support Mean duration 4.7 days Idelchik et al, J Heart and Lung Transplant 2008;27:106-11

14 Temporary MCS Can Improve Markers of Adverse Outcomes Idelchik et al, J Heart and Lung Transplant 2008;27:106-11

15 HeartMate II Risk Score HeartMate II Risk Score HeartMate II Risk Score Age :48 years Creatinine :2.0 mg/dl Albumin :3.8 mm g/dl INR :2.78 Center LVAD vol :>15 Temporary MCS Age :48 years Creatinine :1.5 mg/dl Albumin :2.78 mm g/dl INR :1.23 Center LVAD vol :>15 HMRS: 3.21 High Risk Group 90-day survival: 73% 1-year Survival: 58% 2-year survival: 49% HMRS: 1.08 Low Risk Group 90-day survival: 94% 1-year Survival: 83% 2-year survival: 74% Calculations based on data from Cowger et al, Am Coll Cardiol;2013;61(3):313-21

16 Actual vs Survival Predicted by HMRS THI Cohort Percent Survival Low HMRS Mid HMRS High HMRS Predicted 1-year survival 58% before short term MCS Time (years) Adamo et al, JACC Heart Fail;2015;3 (4):

17 THI Cohort - Survival Predicted by HMRS Percent Survival Low HMRS Mid HMRS High HMRS Predicted 1-year survival Improved to 83% with short term MCS Time (years) Adamo et al, JACC Heart Fail;2015;3 (4):

18 Practical Recommendations - Temporary MCS, inotropes, diuretics +/- CRRT as needed - Invasive hemodynamic monitoring - Target filling pressures and cardiac output as close to normal as possible - Extubate - Target normal end-organ function - Mentation - Renal function - Hepatic function

19 Balancing Potential Benefit and Harm Consider accelerating progression to durable MCS, palliation or explant for recovery if: Bleeding Thromboembolism Infection Limb ischemia Hemolysis

20 Balancing Potential Benefit and Harm If patient develops refractory right heart failure with short term MCS, consider alternative strategies, including: - Urgent heart transplant listing - Durable biventricular MCS - Total artificial heart - Palliative care

Algorithm For Short-Term MCS Management Short Term Mechanical Circulatory

Recovery NO Neurological Recovery Myocardial Recovery End Organ Recovery

of Short Term MCS Blood Group O BSA > 2 m 2 PRA > 10% Contraindication to

Other Blood Group BSA < 2 m 2 PRA <10% Contraindication to VAD Severe RV

21 Algorithm For Short-Term MCS Management Short Term Mechanical Circulatory Support End Organ Recovery Neurological Recovery Myocardial Recovery End Organ Recovery NO Neurological Recovery Myocardial Recovery End Organ Recovery Neurological Recovery NO Myocardial Recovery MCS Wean to Recovery Withdrawal of Short Term MCS Blood Group O BSA > 2 m 2 PRA > 10% Contraindication to transplant PVR > 4 WU, etc. Other Blood Group BSA < 2 m 2 PRA <10% Contraindication to VAD Severe RV failure, etc. Normalize End Organ Function as Possible Urgent Wait List for Transplant Mohite el al, Artificial Organs 2014;38(4): Long Term VAD

22 Questions?

Update on Mechanical Circulatory Support. AATS May 5, 2010 Toronto, ON Canada

Update on Mechanical Circulatory Support AATS May 5, 2010 Toronto, ON Canada Disclosures NONE Emergency Circulatory Support ECMO Tandem Heart Impella Assessment Cardiac Function Pulmonary function Valvular