Introduction
Patients and Methods
Rescue Portacaval Shunt
QOL Score
Direct Cost of Care
Statistical Analysis
Results
EPCS Versus EST—Outcome Data
EST with Rescue PCS Versus EPCS
Patient Characteristics
Primary EPCS (n = 105) | Rescue PCS (n = 50) | p value | |
---|---|---|---|
History | |||
Age (years) | |||
Mean/median | 49.9/47 | 47.7/44.5 | 0.27 |
Range | 28–82 | 30–75 | |
Male gender, n (%) | 81 (78) | 39 (78) | 1.0 |
Race, n (%) | 0.43 | ||
Caucasian | 58 (55) | 23 (46) | |
Hispanic | 39 (37) | 24 (48) | |
Other | 8 (8) | 3 (6) | |
Cause of cirrhosis, n (%) | 0.93 | ||
Alcoholism alone | 54 (51) | 27 (54) | |
Hepatitis B or C alone | 8 (8) | 4 (8) | |
Alcoholism and hepatitis | 33 (31) | 16 (32) | |
Other | 10 (10) | 3 (6) | |
Chronic alcoholism, n (%) | 87 (83) | 43 (86) | 0.82 |
Years of alcoholism median/range | 25/7–54 | 24/5–59 | 0.69 |
Recent alcohol ingestion ≤7 days, n (%) | 74 (70) | 33 (66) | 0.58 |
Past history, n (%) | |||
Jaundice | 58 (55) | 27 (54) | 1.00 |
Ascites | 48 (46) | 31 (62) | 0.062 |
Portal-systemic encephalopathy | 30 (29) | 7 (14) | 0.069 |
Physical examination, n (%) | |||
Jaundice | 38 (36) | 19 (38) | 0.86 |
Ascites | 54 (51) | 30 (60) | 0.39 |
Portal-systemic encephalopathy | 19 (18) | 8 (16) | 0.82 |
Severe muscle wasting (2+ or 3+ on 0–3+ scale) | 67 (64) | 25 (50) | 0.12 |
PSE index | |||
Median (interquartile range) | 0 (0–0.15) | 0 (0–0.9) | 0.066 |
Child’s risk class, n (%) | 0.58 | ||
A (5–8 points) | 26 (25) | 14 (28) | |
B (9–11 points) | 49 (47) | 26 (52) | |
C (12–15 points) | 30 (29) | 10 (20) | |
Child’s risk class points | |||
Mean/median | 10.0/10 | 9.8/9 | 0.37 |
Liver biopsy—cirrhosis | |||
n (%) | 105 (100) | 50 (100) | 1.0 |
Findings on endoscopy, n (%) | |||
Esophageal varices | 105 (100) | 50 (100) | 1.0 |
Size 2 + to 4 + (on scale of 0–4+) | 105 (100) | 49 (98) | 0.85 |
Active bleeding | 29 (28) | 24 (48) | 0.018a
|
Clot on varices | 51 (49) | 25 (50) | 1.0 |
Red color signs on varices | 66 (63) | 29 (58) | 0.60 |
Gastric varices on endoscopy | 17 (16) | 10 (20) | 0.65 |
Portal hypertensive gastropathy | 22 (21) | 12 (24) | 0.68 |
Gastritis/erosions | 14 (13) | 7 (14) | 1.0 |
Reason for not undergoing rescue PCS, n (%) | |||
BEV and death elsewhere, not at UCSD | 13 (42) | ||
Massive recurrent BEV and death | 11 (35) | ||
Refused rescue PCS | 2 (6) | ||
Died in hepatic coma with liver failure | 2 (6) | ||
Liver transplantation | 2 (6) | ||
Perforated esophagus with sepsis | 1(3) |
Hours | Primary EPCS (n = 105) | EST then Rescue PCS (n = 50) | p value | ||
---|---|---|---|---|---|
Median/mean | Range | Median/Mean | Range | ||
Onset bleeding to study entry | 16/19.5 | 0–95 | 10/17.5 | 0–144 | 0.038a
|
Onset bleeding to primary therapy | 19/24.0 | 2.6–100.3 | 13.4/21.6 | 3–146.5 | 0.010a
|
Study entry to primary therapy | 3.4/4.4 | 1.4–24.3 | 2.5/3.1 | 1.0–7.8 | <0.001a
|
>8 h, n (%) | 3 (2.9) | 0 (0) | |||
Transfer patients, n (%) | 80 (76) | 33 (66) | 0.61 | ||
Onset bleeding to entry in referring hospital | 3.8/9.9 | 0–83.6 | 4.5/11.2 | 0–127.4 | 0.76 |
Entry in referring hospital to study entry | 8.4/11.6 | 0–53 | 7/11.3 | 1.5–43 | 0.33 |
Last observation of bleeding to study entry | 0/3.1 | 0–30 | 0/3.4 | 0–32 | 0.95 |
≤4 h, n (%) | 88 (84) | 41 (82) | |||
>4 h, n (%) | 17 (16) | 9 (18) | 0.82 |
Control of Bleeding
Primary EPCS (n = 105) | Primary EST then Rescue PCS (n = 50) | p value | |
---|---|---|---|
Success of primary therapy, n (%) | |||
Indeterminate—non-bleeding death ≤14 days | 11 (10) | 0 (0) | 0.017a
|
Indeterminate—non-bleeding death ≤30 days | 15 (14) | 2 (4) | 0.060 |
Successful control by primary therapy | |||
Excluding indeterminates for at least 14 days | 94 (100) | 0 (0) | <0.001a
|
Excluding indeterminates for at least 30 days | 90 (100) | 0 (0) | <0.001a
|
>30 days | 89 (100) | 0 (0) | <0.001a
|
Reason in EST group for declaration of primary therapy failure, n (%) | |||
Required ≥6 U PRBC in first 7 days | – | 15 (19) | |
Required ≥8 U PRBC in any 12 months | – | 47 (58) | |
Recurrent variceal bleeding after variceal obliteration was declared | – | 27 (34) | |
More than one criterion for failure | – | 8 (10) | |
Successful control of bleeding by rescue PCS | |||
n (%) | – | 50 (100) | |
PRBC transfusion—units PRBC, mean/median (range) | |||
Index hospitalization | |||
Before primary treatment | 5.78/5 (2–17) | 4.48/4 (2–10) | 0.005a
|
During primary treatment | 6.31/3 (0–68) | 0.62/0 (0–6) | <0.001a
|
Catch-up after primary treatment | 1.17/0 (0–21) | 0.26/0 (0–4) | 0.14 |
Post-therapy bleeding | |||
Variceal | 0/0 (0–0) | 6.92/2 (0–35) | <0.001a
|
Non-variceal | 1.75/0 (0–29) | 0.38/0 (0–5) | 0.30 |
Total PRBC units | 14.99/10 (2–81) | 12.66/7 (2–44) | 0.16 |
Readmission for bleeding | |||
Variceal bleeding | 0.36/0 (0–26) | 10.58/9 (0–60) | <0.001a
|
Non-variceal bleeding | 3.45/0 (0–33) | 5.19/0 (0–36) | 0.93 |
Total PRBC units | 3.81/0 (0–33) | 15.77/10 (0–60) | <0.001a
|
Grand total PRBC units | |||
Variceal bleeding | 13.56/10 (2–73) | 22.44/19 (7–64) | <0.001a
|
Variceal and non-variceal bleeding | 17.83/14 (2–81) | 27.80/23 (7–64) | <0.001a
|
Survival
Survival data | Primary EPCS (n = 105) | Primary EST then Rescue PCS (n = 50) | p value |
---|---|---|---|
Overall survival—Pr (95% CI) | |||
30 days | 0.86 (0.79–0.93) | 0.96 (0.91–1.00) | 0.073 |
1 year | 0.80 (0.73–0.88) | 0.80 (0.70–0.92) | 1.0 |
5 years | 0.72 (0.64–0.82) | 0.22 (0.13–0.37) | <0.001a
|
10 years | 0.46 (0.37–0.56) | 0.16 (0.08–0.30) | <0.001a
|
15 years | 0.36 (0.27–0.47) | NA (NA, NA) | |
Median survival, years (95% CI) | 6.15 (5.58–10.43) | 3.00 (1.51–4.33) | <0.001a
|
Hazard ratio of death (95% CI) | 1 | 2.24 (1.50–3.35) | |
Survival by Child’s risk class—Pr (95% CI) | |||
5 years | |||
Class A, n (26 EPCS, 14 rescue) | 0.89 (0.77–1.00) | 0.36 (0.18–0.72) | 0.001a
|
Class B, n (49 EPCS, 26 rescue) | 0.76 (0.64–0.89) | 0.15 (0.06–0.38) | <0.001a
|
Class C, n (30 EPCS, 10 rescue) | 0.53 (0.38–0.75) | 0.20 (0.06–0.69) | 0.058 |
10 years | |||
Class A | 0.62 (0.45–0.83) | 0.29 (0.13–0.65) | 0.010a
|
Class B | 0.47 (0.35–0.63) | 0.12 (0.04–0.33) | 0.005a
|
Class C | 0.30 (0.17–0.52) | 0.10 (0.02–0.64) | 0.29 |
Median survival—years (95% CI) | |||
Class A | 10.43 (5.58 to >10.68) | 4.33 (1.46, >10.82) | 0.031a
|
Class B | 6.24 (5.44 to >11.02) | 2.71 (1.48–4.51) | <0.001a
|
Class C | 5.17 (0.04 to 10.16) | 1.37 (0.12 to >11.72) | 0.35 |
Postoperative survival years—Pr (95% CI) | 6.18 (5.61, 10.38) | 1.99 (1.34–3.73) | <0.001a
|
Portal Systemic Encephalopathy
PSE data | Primary PCS (n = 88) | Primary EST then rescue PCS (n = 47) | p value |
---|---|---|---|
Incidence of recurrent PSE, n (%) | 13 (15) | 20 (43) | <0.001a
|
Length of survival | <0.001a
| ||
Total days | 269,927 | 69,060 | |
Total years | 739.0 | 189.1 | |
Total days/patient | 3,067.4 | 1,469.4 | |
Total years/patient | 8.40 | 4.02 | |
Recurrent PSE episodes | <0.001a
| ||
Total episodes, n
| 94 | 118 | |
Episodes/patient | 1.07 | 2.51 | |
Episodes/year of follow-up | 0.13 | 0.62 | |
Interval between episodes (in years) | 7.86 | 1.60 | |
Hospital readmissions for recurrent PSE | 0.001a
| ||
Total readmissions, n
| 87 | 91 | |
Readmissions/patient | 0.99 | 1.94 | |
Readmissions/year of follow-up | 0.12 | 0.48 | |
Interval between episodes (years) | 8.49 | 2.08 | |
Cause of recurrent PSE episodes, n (%) | <0.001a
| ||
Dietary protein indiscretion | 60 (61) | 61 (50) | |
UGI bleeding | 8 (8) | 28 (23) | |
Infection | 12 (12) | 4 (3) | |
Alcoholism | 4 (4) | 22 (18) | |
Uncontrolled diabetes | 11 (11) | 2 (2) | |
Hepatic failure | 0 (0) | 3 (2) | |
Other | 3 (3) | 2 (2) | |
Relationship of PSE to survival | |||
Median (95% CI, in years) | |||
Patients with recurrent PSE | |||
Overall survival | 5.18 (1.26, Inf) | 3.44 (1.81–7.04) | |
Survival after first PSE | 4.15 (1.17, Inf) | 2.01 (1.08–4.54) | |
Patients free of recurrent PSE | |||
Overall survival | 10.43 (6.24, Inf) | 2.45 (1.46–4.42) | |
p value (recurrent versus no PSE) | <0.001a
| 0.62 | |
High PSE index, n (%) | |||
Patients with PSE index ≥0.33 | 12 (14) | 10 (22) | 0.23 |
Patients with PSE index ≥0.33 who had recurrent PSE clinically | 4 (33) | 10 (100) | 0.002a
|
Change in Liver Function
Years after study entry | Changes in Child’s classes—A, B, and C combined | Primary EPCS | Primary EST, then rescue PCS | p value |
---|---|---|---|---|
1 |
n
| 89 | 45 | 0.008a
|
Improved, n (%) | 53 (60) | 17 (38) | ||
Unchanged, n (%) | 26 (29) | 16 (36) | ||
Worse, n (%) | 10 (11) | 12 (27) | ||
2 |
n
| 82 | 39 | <0.001a
|
Improved, n (%) | 50 (61) | 12 (31) | ||
Unchanged, n (%) | 24 (29) | 14 (36) | ||
Worse, n (%) | 8 (10) | 13 (33) | ||
3 |
n
| 77 | 28 | 0.054 |
Improved, n (%) | 44 (65) | 11 (57) | ||
Unchanged, n (%) | 25 (27) | 10 (32) | ||
Worse, n (%) | 8 (8) | 7 (10) | ||
4 |
n
| 75 | 24 | <0.001a
|
Improved, n (%) | 45 (60) | 6 (25) | ||
Unchanged, n (%) | 24 (32) | 7 (29) | ||
Worse, n (%) | 6 (8) | 11 (46) | ||
5 |
n
| 76 | 16 | <0.001a
|
Improved, n (%) | 45 (59) | 3 (19) | ||
Unchanged, n (%) | 25 (33) | 6 (38) | ||
Worse, n (%) | 6 (8) | 7 (44) | ||
1–5-year average |
n
| 89 | 45 | <0.001a
|
Improved (%) | 59 | 32 | ||
Unchanged (%) | 31 | 35 | ||
Worse (%) | 10 | 33 |
Quality of Life Score
Years after study entry | QOL score | Primary EPCS | Primary EST, then rescue EPCS | p value |
---|---|---|---|---|
1 | Number of patients | 75–105 | 40–49 | <0.001a
|
Total points | 1810 | 2002 | ||
Mean points | 20.73 | 45.62 | ||
2 | Number of patients | 71–97 | 29–43 | <0.001a
|
Total points | 1279 | 1004 | ||
Mean points | 15.51 | 27.72 | ||
3 | Number of patients | 69–88 | 26–32 | <0.001a
|
Total points | 1034 | 473 | ||
Mean points | 13.18 | 16.96 | ||
4 | Number of patients | 67–83 | 19–29 | <0.001a
|
Total points | 774 | 403 | ||
Mean points | 10.08 | 17.35 | ||
5 | Number of patients | 66–80 | 11–22 | <0.001a
|
Total points | 666 | 212 | ||
Mean points | 8.81 | 13.63 | ||
0–5 | Number of patients | 348–453 | 125–175 | <0.001a
|
Total points | 5,563 | 4,094 | ||
Mean points | 13.89 | 27.89 |
Total charges and charges per day or per year in $1,000 | Primary EPCS | Primary EST, then Rescue PCS | p value | ||||
---|---|---|---|---|---|---|---|
n
| Mean and (SD) | Range |
n
| Mean and (SD) | Range | ||
Index admission | 105 | 50 | |||||
1. Total hospital charges | 69.1 (56.1) | 23.1–352.6 | 67.6 (65.6) | 7.5–433.9 | 0.34 | ||
Hospital charges per day | 5.60 (5.85) | 1.98–52.06 | 4.19 (2.62) | 0.83–16.98 | 0.024a
| ||
2. Total physician charges | 11.1 (5.4) | 3.3–34.8 | 9.1 (8.6) | 1.6–50.4 | <0.001a
| ||
Physician charges per day | 1.05 (1.21) | 0.16–7.28 | 0.61 (0.48) | 0.18–3.15 | <0.001a
| ||
3. Total overall charges | 80.2 (60.0) | 33.7–380.5 | 76.7 (70.9) | 9.4–458.5 | 0.20 | ||
Overall charges per day | 6.65 (6.83) | 2.41–58.11 | 4.80 (2.81) | 1.04–17.70 | 0.009a
| ||
Readmission post-index | 88 | 47 | |||||
1. Total hospital charges | 56.6 (71.3) | 0–262.0 | 150.2 (183.9) | 0–911.4 | <0.001a
| ||
Hospital charges per year | 20.4 (48.2) | 0–262.3 | 124.6 (273.4) | 0–1642.0 | <0.001a
| ||
2. Total physician charges | 8.6 (10.5) | 0–49.2 | 19.7 (18.8) | 0–89.0 | <0.001a
| ||
Physician charges per year | 2.6 (5.6) | 0–35.8 | 17.0 (35.5) | 0–180.6 | <0.001a
| ||
3. Total overall charges | 65.2 (80.6) | 0–284.2 | 169.8 (195.0) | 0–926.1 | <0.001a
| ||
Overall charges per year | 23.0 (53.6) | 0–298.1 | 141.5 (306.8) | 0–1823.0 | <0.001a
| ||
Outpatient post-index | 88 | 47 | |||||
1. Total hospital charges | 8.4 (4.9) | 0–27.7 | 16.4 (40.3) | 0–267.3 | 0.49 | ||
Hospital charges per year | 1.3 (1.2) | 0–7.5 | 4.4 (7.5) | 0–34.3 | <0.001a
| ||
2. Physician charges | 6.3 (3.6) | 0–12.8 | 6.4 (6.1) | 0–19.7 | 0.35 | ||
Physician charges per year | 0.8 (0.5) | 0–2.7 | 2.1 (2.6) | 0–14.7 | <0.001a
| ||
3. Total overall charges | 14.7 (7.6) | 0–33.2 | 22.8 (44.0) | 0–286.9 | 0.36 | ||
Overall charges per year | 2.1 (1.5) | 0–9.5 | 6.6 (9.6) | 0–48.4 | <0.001a
| ||
Total post-index charges | 88 | 79.9 (79.8) | 0–302.0 | 47 | 192.6 (198.5) | 11.2–958.4 | <0.001a
|
Total post-index charges per year | 25.1 (54.0) | 0–302.1 | 47 | 148.1 (308.4) | 1.5–1824.0 | <0.001a
| |
Grand total charges | 88 | 150.4 (100.8) | 41.4–682.5 | 47 | 263.6 (192.9) | 27.5–982.8 | <0.001a
|
Grand total charges per year | 39.2 (70.5) | 2.6–374.5 | 47 | 216.7 (397.1) | 8.0–1954.0 | <0.001a
|