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

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

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

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

Hepatic Fibrosis Central vein

Hepatic Cirrhosis

Methods Retrospective review of Quality Improvement Database from 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

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

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

Patient Profiles Fibrosis Absent n=179 Fibrosis Present n=12p value % female Age 52.9± ± BMI (kg/m2) 28.1± ± Blood Pressure (systolic) 105.8± ± Blood Pressure (diastolic) 69.0± ± MELD-XI (units) 14.6± ± INTERMACS Profile 0.827

Preimplant Laboratory Values Fibrosis Absent n=179 Fibrosis Present n=12p value Serum Sodium (mEq/l) 132.7± ± Serum Creatinine (mg/dl) 1.4±0.61.2± BUN (mg/dl) 25.7± ± Hematocrit (%) 32.7± ± Platelets (X10 3 /μl) 189.6± ± Albumin (gm/dl) 3.2±0.53.3± AST (units/l) 42.5± ± ALT (units/l) 47.8± ± Total bilirubin (mg/dl) 1.5±0.71.6± Alkaline Phosphatase (units/l)86.5± ±

Preimplant Hemodynamics Fibrosis Absent n=179 Fibrosis Present n=12p value Right Atrial Pressure (mmHg) 10.2± ± Right Ventricle Systolic Pressure (mmHg) 46.6± ± Right Ventricle Diastolic Pressure (mmHg) 11.0±6.69.7± Mean Pulmonary Artery Pressure (mmHg) 32.4± ± Pulmonary Capillary Wedge Pressure (mmHg) 22.6± ± Cardiac Output (Thermodilution) (l/min) 4.8±1.45.2± Cardiac Index (Thermodilution) (l/min/m 2 ) 2.3±0.62.7± Cardiac Output (Fick) (l/min) 4.4±1.34.6± Cardiac Index (Fick) (l/min/m 2 ) 2.1±0.62.4± Heart Rate (beats/min)88.6± ±

Postoperative Results Fibrosis Absent n=179 Fibrosis Present n=12p value Post op hospital LOS (days) 24.8± ICU LOS (days) 9.6± ± 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

Hazard Ratios for Survival variableHazard Ratiostd errorp value Fibrosis Biopsy MELD-XI INTERMACS Age

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

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