Impact of recipient functional status on 1-year liver transplant outcomes

Table 1 Karnofsky Performance Status scale and variable handling

Conditiona	%	Rating criteria
A (“None/Normal”) Able to carry on normal activity and to work; no special care needed	100	Normal, no complaints; no evidence of disease
	90	Able to carry on normal activity; minor signs or symptoms of disease
	80	Normal activity with effort; some signs or symptoms of disease
B (“Moderate”) Unable to work; able to live at home and care for most personal needs; varying amount of assistance needed	70	Cares for self; unable to carry on normal activity or to do active work
	60	Requires occasional assistance, but is able to care for most of his personal needs
	50	Requires considerable assistance and frequent medical care
C (“Severe”) Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly	40	Disabled; requires special care and assistance
	30	Severely disabled; hospital admission is indicated although death not imminent
	20	Very sick; hospital admission necessary; active supportive treatment necessary
	10	Moribund; fatal processes progressing rapidly
	0	Dead

^aAuthor-assigned variable labels in parentheses.

Table 2 Baseline characteristics^a by pre-transplant functional status, Scientific Registry of Transplant Recipients 2005-2014 (n = 38278)

Characteristicb	Functional impairment/disability
	A: None (n = 11674)	B: Moderate (n = 17530)	C: Severe (n = 9074)
Sociodemographics
Age in years
18-44	11.6	10.3	12.7
45-54	28.9	30.2	32.1
55-64	44.9	45.3	43.2
≥ 65	14.5	14.3	12.0
Women	26.8	32.1	33.4
Race/ethnicity
White	73.1	74.3	70.4
Hispanic/Latino	10.6	12.5	15.9
Black	8.9	8.4	9.1
Health insurance
Private	68.1	55.3	54.2
Medicare	18.5	26.5	24.6
Medicaid	8.8	14.0	17.0
Medical/Surgical History
Functional impairment at registration
None	74.6	33.4	22.4
Moderate	19.9	57.0	35.4
Severe	2.5	6.6	37.0
Primary cause of liver disease
Non-Cholestatic	56.2	64.7	75.8
Cholestatic	9.5	8.1	7.8
Malignancy	30.1	23.0	12.5
Hepatitis C	44.4	45.5	42.1
Diabetesc	23.2	25.8	25.3
Previous Abdominal Surgery	46.2	51.6	50.3

^aCharacteristics known at least 2 weeks prior to transplant;

^bColumn percentage;

^cDiabetes types 1, 2, or unspecified. All distributions varied significantly across categories of functional status (P < 0.001).

Table 3 Pre-transplant clinical characteristics by pre-transplant functional status, Scientific Registry of Transplant Recipients 2005-2014 (n = 38278)

Characteristica	Functional impairment/disability
	A: None (n = 11674)	B: Moderate (n = 17530)	C: Severe (n = 9074)
Waitlist time, mo	4.0 (1.3-10.2)	3.7 (1.1-10.3)	2.1 (0.4-8.4)
Weight loss ≥ 5%b	19.7	24.2	27.0
BMI, kg/m2
Underweight (< 18.5)	1.6	1.6	2.4
Normal (18.5-25)	28.3	27.5	27.1
Overweight (25-30)	37.0	36.0	34.0
Obese (≥ 30)	33.2	35.0	36.5
MELD
< 15	49.9	34.9	14.3
15-29	45.9	56.5	45.9
≥ 30	4.2	8.6	39.8
Total bilirubin	2.3 (1.2-4.4)	3.0 (1.6-6.1)	6.6 (2.9-17.2)
International normalized ratio	1.4 (1.2-1.7)	1.5 (1.3-1.9)	2.0 (1.5-2.6)
Serum creatinine	0.9 (0.7-1.2)	1.0 (0.8-1.3)	1.4 (0.9-2.3)
Serum sodium	137 (134-140)	136 (133-139)	135 (132-139)
Child Pugh score
A (Good)	23.8	11.8	4.1
B (Fair)	38.7	33.8	18.5
C (Poor)	37.5	54.4	77.4
Ascitesc
None	36.9	23.0	14.0
Mild/Moderate	48.4	52.4	43.5
Severe	14.8	24.6	42.6
Encephalopathyd
None	52.7	36.6	26.0
Grade 1-2	44.4	57.5	61.4
Grade 3-4	2.9	5.9	12.6
Albumin
> 3.5	26.7	19.3	22.8
2.8-3.5	41.7	41.2	39.0
< 2.8	31.6	39.6	38.2
Dialysise	0.9	1.6	10.9
Portal Vein Thrombosis	6.5	9.7	12.4

^aColumn percentage or median (interquartile range);

^bRelative to weight at time of waitlist registration;

^cMild/Moderate ascites: Diuretic-responsive; Severe ascites: Diuretic-refractory;

^dEncephalopathy grade 1-2 (or precipitant-induced); Grade 3-4 (or chronic);

^eDialyzed at least twice in prior week. All distributions varied significantly across categories of functional status (P < 0.001). BMI: Body mass index; MELD: Model for End-Stage Liver Disease.

Table 4 Donor characteristics by pre-transplant functional status, Scientific Registry of Transplant Recipients 2005-2014 (n = 38278)

Characteristica	Functional impairment/disability			P value
	A: None (n = 11674)	B: Moderate (n = 17530)	C: Severe (n = 9074)
Transplant type: Living donor	5.5	5.0	2.3	< 0.001
Donor Risk Indexb	1.6 (1.3-1.9)	1.6 (1.3-1.9)	1.5 (1.2-1.9)	< 0.001
Age in years
18-39	37.3	37.1	39.9
40-49	19.7	19.7	19.7
50-59	19.8	20.4	20.7
60-69	11.7	12.7	10.8
≥ 70	5.5	4.9	3.9	< 0.001
Women	40.5	41.4	40.9	0.35
Race/ethnicity
White	68.2	68.1	65.6
Black	17.2	17.9	17.5
Other	14.6	14.0	16.9	< 0.001
BMI, kg/m2
Underweight (< 18.5)	2.9	2.9	2.6
Normal (18.5-25)	36.5	35.9	36.2
Overweight (25-30)	33.5	34.2	33.4
Obese (≥ 30)	27.1	27.0	27.9	0.43
Cause of death
Trauma	34.3	34.1	34.1
Anoxia	21.5	22.5	24
Cardiovascular accident	41.4	40.9	39.4	< 0.01
Donation after cardiac death	12.6	13.2	12.1	0.04
Split/Partial liver	1.5	1.4	1.3	0.38
Allocation type
Regional	17.8	19.9	23.3
National	6.6	5.0	3.8	< 0.001
Cold ischemia time ≥ 8 h	30.9	28.9	27.9	< 0.001

^aColumn percentage or median (interquartile range);

^bDonor risk index as described by Feng et al[35], 2006. BMI: Body mass index.

Table 5 Association between pre-transplant functional status and 1-year (all-cause) post-transplant mortality, Scientific Registry of Transplant Recipients 2005–2014 (n = 38278^a)

Functional impairment/disability	Hazard Ratio (95%CI)
	1-Yr		Day 0-30c		Day 31-365d
	Unadjusted	Adjustedb	Unadjusted	Adjustedb	Unadjusted	Adjustedb
Severe	1.94 (1.77-2.13)	1.73 (1.56-1.91)	2.40 (1.99-2.89)	2.10 (1.71-2.59)	1.82 (1.64-2.02)	1.62 (1.45-1.82)
Moderate	1.38 (1.27-1.51)	1.32 (1.21-1.44)	1.60 (1.34-1.92)	1.53 (1.27-1.83)	1.33 (1.20-1.46)	1.26 (1.15-1.40)
None	Referent		Referent		Referent

^aAdjusted model n = 380762 [missing albumin (n = 1) or donor body mass index (n = 200)];

^bAdjusted for recipient age, sex, race, insurance, body mass index (BMI), diabetes, previous abdominal surgery, liver disease, MELD, albumin, portal vein thrombosis, dialysis; donor age, race, BMI, donor type (living or deceased) and cause of death, donation after cardiac death, allocation type, cold ischemia time ≥ 8 hours; interactions: recipient BMI and diabetes, recipient hepatitis C and portal vein thrombosis, recipient hepatitis C and donor age;

^cPostoperative day 0-30: n = 38,278; 881 deaths;

^dPostoperative day 31-365: n = 37352; 2714 deaths. BMI: Body mass index; CI: Confidence interval; MELD: Model for End-Stage Liver Disease.

Table 6 Association between pre-transplant functional status and 1-year graft failure, Scientific Registry of Transplant Recipients 2005-2014 (n = 38278)

Functional impairment/disability	Events, na	Hazard Ratio (95%CI)
		Unadjusted	Adjustedb
Severe	527	1.10 (0.98-1.23)	1.16 (1.02-1.31)
Moderate	1051	1.12 (1.01-1.23)	1.13 (1.02-1.24)
None	636	Referent	Referent

^aNumber of graft failures within 1 year of liver transplantation;

^bAdjusted for recipient age, sex, race, body mass index (BMI), primary diagnosis of liver disease, MELD, portal vein thrombosis; donor age, race, BMI, donor type (living or deceased) and cause of death, donation after cardiac death, cold ischemia time ≥ 8 h; interactions: recipient hepatitis C and portal vein thrombosis, recipient hepatitis C and donor age. BMI: Body mass index; CI: Confidence interval; MELD: Model for End-Stage Liver Disease.