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 95th 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 FibrosisSinusoid(Portal Vein)

Central vein

Hepatic Cirrhosis

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

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 ProfilesFibrosis Absent n=179

Fibrosis Present

n=12p

value% female 18.4 25 0.701Age 52.9±15.0 54.4±9.1 0.722BMI (kg/m2) 28.1±8.1 27.8±5.9 0.898

Blood Pressure (systolic) 105.8±14.0 107.5±15.9 0.682

Blood Pressure (diastolic) 69.0±10.4 68.8±7.3 0.927MELD-XI (units) 14.6±4.4 13.7±2.9 0.487INTERMACS Profile     0.827

Preimplant Laboratory ValuesFibrosis

Absent n=179

Fibrosis Present

n=12p

value

Serum Sodium (mEq/l) 132.7±4.4 131.5±3.6 0.362

Serum Creatinine (mg/dl) 1.4±0.6 1.2±0.4 0.216

BUN (mg/dl) 25.7±17.7 32.6±25.6 0.211

Hematocrit (%) 32.7±5.0 32.8±4.6 0.975

Platelets (X103/μl) 189.6±70.2 221±82.6 0.139

Albumin (gm/dl) 3.2±0.5 3.3±0.4 0.436

AST (units/l) 42.5±40.2 29.8±7.9 0.274

ALT (units/l) 47.8±77.1 25.6±13.0 0.321

Total bilirubin (mg/dl) 1.5±0.7 1.6±0.4 0.597

Alkaline Phosphatase (units/l) 86.5±39.5 133.4±62.2 0.0002

Preimplant HemodynamicsFibrosis

Absent n=179

Fibrosis Present

n=12p

value

Right Atrial Pressure (mmHg) 10.2±6.1 10.3±6.1 0.956Right Ventricle Systolic Pressure (mmHg) 46.6±14.8 38.8±10.4 0.077Right Ventricle Diastolic Pressure (mmHg) 11.0±6.6 9.7±5.5 0.506Mean Pulmonary Artery Pressure (mmHg) 32.4±9.7 27.3±8.8 0.0779Pulmonary Capillary Wedge Pressure (mmHg) 22.6±8.2 19.7±6.4 0.229Cardiac Output (Thermodilution) (l/min) 4.8±1.4 5.2±1.3 0.352Cardiac Index (Thermodilution) (l/min/m2) 2.3±0.6 2.7±0.5 0.0664

Cardiac Output (Fick) (l/min) 4.4±1.3 4.6±1.8 0.613

Cardiac Index (Fick) (l/min/m2) 2.1±0.6 2.4±0.783 0.255

Heart Rate (beats/min) 88.6±17.1 91.6±16.7 0.56

Postoperative ResultsFibrosis Absent n=179

Fibrosis Present

n=12p

value

Post op hospital LOS (days) 24.8±16.2 16.1 0.296

ICU LOS (days) 9.6±10.7 11.2±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

Hazard Ratios for Survival

variable Hazard Ratio std error p valueFibrosis 0.831 0.604 0.799Biopsy 0.765 0.555 0.711MELD-XI 0.998 0.033 0.951INTERMACS 1.019 0.114 0.864Age 1.031 0.013 0.017

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