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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
% female
Age
BMI (kg/m2)
Fibrosis Absent
n=179
18.4
52.9±15.0
28.1±8.1
Fibrosis
Present
n=12
25
54.4±9.1
27.8±5.9
p value
0.701
0.722
0.898
Blood Pressure (systolic)
105.8±14.0
107.5±15.9
0.682
Blood Pressure (diastolic)
MELD-XI (units)
INTERMACS Profile
69.0±10.4
14.6±4.4
68.8±7.3
13.7±2.9
0.927
0.487
0.827
Preimplant Laboratory Values
Fibrosis Absent
n=179
Serum Sodium (mEq/l)
Fibrosis Present
n=12
p value
132.7±4.4
131.5±3.6
0.362
1.4±0.6
1.2±0.4
0.216
25.7±17.7
32.6±25.6
0.211
32.7±5.0
32.8±4.6
0.975
189.6±70.2
221±82.6
0.139
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
1.5±0.7
1.6±0.4
0.597
86.5±39.5
133.4±62.2
0.0002
Serum Creatinine (mg/dl)
BUN (mg/dl)
Hematocrit (%)
Platelets (X103/μl)
Albumin (gm/dl)
Total bilirubin (mg/dl)
Alkaline Phosphatase (units/l)
Preimplant Hemodynamics
Fibrosis Absent
n=179
Right Atrial Pressure (mmHg)
Right Ventricle Systolic Pressure
(mmHg)
Right Ventricle Diastolic Pressure
(mmHg)
Mean Pulmonary Artery Pressure
(mmHg)
Pulmonary Capillary Wedge
Pressure (mmHg)
Cardiac Output (Thermodilution)
(l/min)
Cardiac Index (Thermodilution)
(l/min/m2)
Fibrosis Present
n=12
p value
10.2±6.1
10.3±6.1
0.956
46.6±14.8
38.8±10.4
0.077
11.0±6.6
9.7±5.5
0.506
32.4±9.7
27.3±8.8
0.0779
22.6±8.2
19.7±6.4
0.229
4.8±1.4
5.2±1.3
0.352
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
88.6±17.1
91.6±16.7
0.56
Heart Rate (beats/min)
Postoperative Results
Fibrosis Absent Fibrosis Present
n=179
n=12
Post op hospital LOS (days)
p value
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
30 (16.8%)
5 (41.7%)
0.047
Gastrointestinal bleeding w/in 1 yr (n)
Hazard Ratios for Survival
variable
Fibrosis
Biopsy
MELD-XI
INTERMACS
Age
Hazard Ratio
0.831
0.765
0.998
1.019
1.031
std error
0.604
0.555
0.033
0.114
0.013
p value
0.799
0.711
0.951
0.864
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