1. Periportal Fibrosis Without Cirrhosis Does Not Affect Outcomes Following Continuous Flow Ventricular Assist Device Implantation Jonathon E. Sargent, BS, Todd F. Dardas, MD, MS, Jason W. Smith, MD, Jay D. Pal, MD, PhD, Richard K. Cheng, MD, S. Carolina Masri, MD, Kent R. Shively, BS, Lauren M. Colyer, BS, Claudius Mahr, DO, Nahush A. Mokadam, MD University of Washington, Seattle WA American Association for Thoracic Surgery 95 th Annual Meeting April 28, 2015

2. Background Heart Failure epidemic continues to grow More than 5 million people affected in US Heart Transplant remains donor limited Increasing use of VADs for both BTT and DT

3. Background Advanced liver disease generally considered a contraindication to advanced heart failure therapy Risk models (Child-Turcotte-Pugh, MELD) are difficult to apply to HF patients

4. Objective Determine the effect of periportal fibrosis without cirrhosis on outcomes following VAD implantation

5. Hepatic Fibrosis Central vein

6. Hepatic Cirrhosis

7. Methods Retrospective review of Quality Improvement Database from 2005-2013 IRB waiver obtained Statistical analysis using STATA – Fischer Exact Test – categorical variables – Student t-test and ANOVA - continuous variables – Cox proportional hazards regression -overall survival – Poisson regression - length of stay – Kaplan-Meier – survival

8. Comparisons Demographics Preimplant hemodynamics MELD-XI Score – Eliminates INR for patients on warfarin INTERMACS profile Postoperative outcomes Survival

9. Results 191 Patients implanted with continuous flow VAD during the time period (HM2=182, HW=9) 14 patients underwent clinically indicated liver biopsy 12 patients found to have fibrosis without cirrhosis, 2 with negative biopsy Comparison of 179 patients vs. 12 patients

10. Patient Profiles Fibrosis Absent n=179 Fibrosis Present n=12p value % female18.4250.701 Age 52.9±15.054.4±9.1 0.722 BMI (kg/m2) 28.1±8.127.8±5.9 0.898 Blood Pressure (systolic) 105.8±14.0107.5±15.9 0.682 Blood Pressure (diastolic) 69.0±10.468.8±7.3 0.927 MELD-XI (units) 14.6±4.413.7±2.9 0.487 INTERMACS Profile 0.827

11. Preimplant Laboratory Values Fibrosis Absent n=179 Fibrosis Present n=12p value Serum Sodium (mEq/l) 132.7±4.4131.5±3.6 0.362 Serum Creatinine (mg/dl) 1.4±0.61.2±0.4 0.216 BUN (mg/dl) 25.7±17.732.6±25.6 0.211 Hematocrit (%) 32.7±5.032.8±4.6 0.975 Platelets (X10 3 /μl) 189.6±70.2221±82.6 0.139 Albumin (gm/dl) 3.2±0.53.3±0.4 0.436 AST (units/l) 42.5±40.229.8±7.9 0.274 ALT (units/l) 47.8±77.125.6±13.0 0.321 Total bilirubin (mg/dl) 1.5±0.71.6±0.4 0.597 Alkaline Phosphatase (units/l)86.5±39.5133.4±62.20.0002

12. Preimplant Hemodynamics Fibrosis Absent n=179 Fibrosis Present n=12p value Right Atrial Pressure (mmHg) 10.2±6.110.3±6.1 0.956 Right Ventricle Systolic Pressure (mmHg) 46.6±14.838.8±10.4 0.077 Right Ventricle Diastolic Pressure (mmHg) 11.0±6.69.7±5.5 0.506 Mean Pulmonary Artery Pressure (mmHg) 32.4±9.727.3±8.8 0.0779 Pulmonary Capillary Wedge Pressure (mmHg) 22.6±8.219.7±6.4 0.229 Cardiac Output (Thermodilution) (l/min) 4.8±1.45.2±1.3 0.352 Cardiac Index (Thermodilution) (l/min/m 2 ) 2.3±0.62.7±0.5 0.0664 Cardiac Output (Fick) (l/min) 4.4±1.34.6±1.8 0.613 Cardiac Index (Fick) (l/min/m 2 ) 2.1±0.62.4±0.783 0.255 Heart Rate (beats/min)88.6±17.191.6±16.70.56

13. Postoperative Results Fibrosis Absent n=179 Fibrosis Present n=12p value Post op hospital LOS (days) 24.8±16.2 16.10.296 ICU LOS (days) 9.6±10.711.2±9.6 0.629 RVAD (n)2 (1.1%)0 (0%)1 Reintubated (n)23 (13.6%)2 (16.7%0.673 Renal Failure (n)15 (8.9%)2 (16.7%)0.313 Dialysis (new) (n)5 (3.0%)1 (8.3%)0.341 VAD infection w/in 1 yr (n)52 (29.1%)2 (16.7%)0.515 Driveline infection (n)37 (21.4%)2 (16.7%)1 Pump pocket infection (n)18 (10.1%)0 (0%)0.608 Gastrointestinal bleeding w/in 1 yr (n)30 (16.8%)5 (41.7%)0.047

14. Hazard Ratios for Survival variableHazard Ratiostd errorp value Fibrosis0.8310.6040.799 Biopsy0.7650.5550.711 MELD-XI0.9980.0330.951 INTERMACS1.0190.1140.864 Age1.0310.0130.017

16. Limitations Small sample size Retrospective study Patients with cirrhosis were not implanted, and therefore were not available for comparison Patients without biopsy may have had fibrosis and/or cirrhosis creating a biased comparison

17. Conclusions Age was only prognostic risk factor MELD-XI Score was not predictive Higher rate of GI bleeding in fibrosis group No obvious adverse association between hepatic fibrosis and overall outcomes following VAD implantation