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 Fibrosis

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 Profiles

Fibrosis Absent

n=179

Fibrosis

Present

n=12 p value

% female 18.4 25 0.701

Age 52.9±15.0 54.4±9.1 0.722

BMI (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 0.927

MELD-XI (units) 14.6±4.4 13.7±2.9 0.487

INTERMACS Profile 0.827

Preimplant Laboratory ValuesFibrosis Absent

n=179

Fibrosis Present

n=12 p 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=12 p value

Right Atrial Pressure (mmHg) 10.2±6.1 10.3±6.1 0.956

Right Ventricle Systolic Pressure

(mmHg) 46.6±14.8 38.8±10.4 0.077

Right Ventricle Diastolic Pressure

(mmHg) 11.0±6.6 9.7±5.5 0.506

Mean Pulmonary Artery Pressure

(mmHg) 32.4±9.7 27.3±8.8 0.0779

Pulmonary Capillary Wedge

Pressure (mmHg) 22.6±8.2 19.7±6.4 0.229

Cardiac Output (Thermodilution)

(l/min) 4.8±1.4 5.2±1.3 0.352

Cardiac 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=12 p 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 value

Fibrosis 0.831 0.604 0.799

Biopsy 0.765 0.555 0.711

MELD-XI 0.998 0.033 0.951

INTERMACS 1.019 0.114 0.864

Age 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