Home Predictors of Shunt Dysfunction and Overall Survival in Patients with Variceal Bleeding Treated with Transjugular Portosystemic Shunt Creation Using the Fluency Stent Graft
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Predictors of Shunt Dysfunction and Overall Survival in Patients with Variceal Bleeding Treated with Transjugular Portosystemic Shunt Creation Using the Fluency Stent Graft

Rationale and Objectives

Transjugular intrahepatic portosystemic shunt (TIPS) is an established method for portal hypertension. This study was to investigate the long-term safety, technical success, and patency of TIPS, and to determine the risk factors and clinical impacts of shunt dysfunction.

Materials and Methods

A total of 154 consecutive patients undergoing embolotherapy of gastric coronary vein and/or short gastric vein and TIPS creation were prospectively studied. Follow-up data included technical success, patency and revision of TIPS, and overall survival of patients.

Results

During the study, the primary and secondary technical success rates were 98.7% and 100%, respectively. Sixty-three patients developed shunt dysfunction, 30 with shunt stenosis and 33 with shunt occlusion. The cumulative 60-month primary, primary assisted, and secondary patency rates were 19.6%, 43.0%, and 93.4%, respectively. The cumulative 60-month overall survival rates were similar between the TIPS dysfunction group and the TIPS non-dysfunction group (68.6% vs. 58.6%, P = .096). Baseline portal vein thrombosis ( P < .001), use of bare stents ( P = .018), and portal pressure gradient (PPG) ( P = .020) were independent predictors for shunt dysfunction, hepatocellular carcinoma ( P < .001), and ascites ( P = .003) for overall survival. The accuracy of PPG for shunt dysfunction was statistically significant ( P < .001), and a cutoff value of 8.5 had 77.8% sensitivity and 64.8% specificity.

Conclusions

The long-term safety, technical success, and patency of TIPS were good; baseline portal vein thrombosis, use of bare stents, and PPG were significantly associated with shunt dysfunction; shunt dysfunction has little impact on patients’ long-term survival because of high secondary patency rates.

Introduction

Transjugular intrahepatic portosystemic shunt (TIPS) is an established method to manage sequelae of portal hypertension, that is, variceal hemorrhage and refractory ascites . Initially, TIPS was created by using bare metal stents that led to high rates of shunt dysfunction, often above 50% at 1 year . Shunt dysfunction is associated with recurrence of ascites and variceal hemorrhage , which requires sometimes repeated revisions that bear additional procedural risks and expenses . After the advent of expanded polytetrafluoroethylene (ePTFE)-covered stent grafts, numerous studies have demonstrated that ePTFE-covered stent grafts are better than bare metal stents in long-term patency .

However, shunt dysfunction remains a major concern of TIPS creation with ePTFE-covered stent grafts in the long run. Weber et al. reported that shunt patency rates gradually decreased, mortality rates continued to increase, and the chance of recurrent ascites or bleeding remained present beyond 2 years after TIPS creation with ePTFE-covered stent grafts. Except the type of stent used, there are limited data regarding the risk factors for shunt dysfunction and its impact on clinical outcomes in patients who underwent TIPS creation to prevent variceal rebleeding with ePTFE-covered stent grafts .

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Materials and Methods

Patients

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TIPS Procedure

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Figure 1, Venogram shows embolization of coronary vein ( arrow , a ) and short gastric vein ( arrowhead , a ), and deployment of a covered fluency stent (8 mm × 60 mm; arrow , b ).

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Follow-up Protocol

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Shunt Dysfunction and TIPS Revisions

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Figure 2, Venogram shows thrombosis and stenosis of a covered fluency stent (8 mm × 60 mm) close to the portal side ( arrows , a ), revision by balloon angioplasty ( arrow , b ); peripheral puncture of hepatic vein resulted in kink, thrombosis, and occlusion of a covered fluency stent (8 mm × 80 mm) at hepatic side of shunt ( arrow , c ), insertion of a bare stent (8 mm × 80 mm) at the hepatic end ( arrow , d); kink, thrombosis and occlusion of a covered fluency stent (8 mm × 60 mm) at the portal side ( arrow , e ), deployment of a bare stent (8 mm × 40 mm) at the portal end ( arrow , f ) and another bare stent (8 mm × 60 mm) at the hepatic end ( arrowhead , f ).

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Diagnosis and Definitions

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Statistical Analysis

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Results

Patient Characteristics

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Table 1

Baseline Characteristics

Variables Results Patients ( n = 154) Sex: male, n (%) 101 (65.6) Age 52.1 ± 10.8 Etiology, n (%) Hepatitis B virus 74 (48.1) Hepatitis C virus 26 (16.9) Alcohol 14 (9.1) Autoimmune liver disease 10 (6.5) Cryptogenic 30 (19.5) Spleen surgery, n (%) Splenectomy 5 (3.2) Partial splenic embolization 2 (1.3) Thrombosis within the portal venous system, n (%) 53 (34.4) Comorbidity, n (%) Diabetes mellitus 38 (24.7) Hypertension 5 (3.2) Hepatocellular carcinoma 17 (11.0) Endoscopic varices, n (%) Gastroesophageal varices 113 (72.9) Esophageal varices 41 (26.6) Ascites, n (%) None 88 (57.1) Mild 35 (22.7) Moderate to severe 31 (20.1) White blood cell count (3.5–9.5 × 10 9 /L) 2.71 (IQR: 2.08–3.78) Hemoglobulin (female:115–150 g/L; male:130–175 g/L) 87.7 ± 18.9 Platelet count (125–350 × 10 9 /L) 56.0 (IQR: 48.0–77.0) Prothrombin time (10.0-16.0 s) 19.6 ± 3.7 International normalized ratio 1.64 ± 0.33 Albumin (35–50 g/L) 28.9 ± 4.9 Alanine aminotransferase (5–40 U/L) 25.5 (IQR: 18.0–41.0) Aspartate aminotransferase (8–40 U/L) 42.5 (IQR: 31.0–60.0) Total bilirubin (3.4–20.5 µmol/L) 29.4 (IQR: 19.6–39.5) direct bilirubin (0.0–6.8 µmol/L) 12.9 (IQR: 8.8–17.9) Creatinine (53–97 µmol/L) 68.0 (IQR: 59.0–78.0) Child-Turcotte-Pugh score 8.0 (IQR: 7.0–9.0) Child class, n (%) A 32 (20.8) B 96 (62.3) C 26 (16.9) Model for end stage liver disease score 10.5 ± 4.3 Stent site, n (%) From middle hepatic vein to left portal branch 94 (61.0) From right hepatic vein to right portal branch 42 (27.3) From inferior vena cava to the portal vein 18 (11.7) Stent number, n (%) One stent 105 (68.2) Two stents 47 (30.5) Three stents 2 (1.3) ePTFE-covered stent, n (%) 8 mm × 40 mm 19 (12.3) 8 mm × 60 mm 103 (66.9) 8 mm × 80 mm 32 (20.8) Bare stent, n (%) 8 mm × 40 mm 5 (3.2) 8 mm × 60 mm 32 (20.8) 8 mm × 80 mm 7 (4.5) Baseline portal pressure (mm Hg) 28.0 (IQR: 25.0–32.0) Postoperative portal pressure (mm Hg) 19.0 (IQR: 15.0–22.0) Intrashunt pressure (mm Hg) 10.5 (IQR: 9.0–12.0) Right atrial pressure (mm Hg) 7.0 (IQR: 5.0–9.3) Portal pressure reduction (mm Hg) 8.0 (IQR: 6.0–12.0) Portosystemic venous collaterals, n (%) Short gastric vein 21 (13.6) Coronary gastric vein 66 (42.9) Both short gastric and coronary vein 67 (43.5) Spontaneous shunts, n (%) Splenorenal shunt 12 (7.8) Intrahepatic arteriovenous fistula 4 (2.6) Gastrorenal shunt 1 (0.6)

ePTFE, expanded polytetrafluoroethylene.

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TIPS Procedure and Complications

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Shunt Dysfunction, Primary Patency Rate, and Risk Factors

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Figure 3, Kaplan-Meier curves. Cumulative rates of primary patency ( a ), primary assisted patency ( b ), and secondary patency ( c ) in all patients. Cumulative rates of overall survival in patients with and without shunt dysfunction ( P = .096, by log-rank test) ( d ) and in patients without shunt dysfunction, with shunt stenosis, and with shunt occlusion ( P = .207, by log-rank test) ( e ).

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Table 2

Univariate and multivariate analysis for the factors predictive of shunt dysfunction

Baseline factors Univariate analysis Multivariate analysis HR 95%CI_P_ Value HR 95%CI_P_ Value Baseline PVT 3.561 2.151–5.895 .000 4.544 2.643–7.810 .000 Bare stent use \* 0.356 0.215–0.589 .000 0.377 0.167–0.848 .018 PPR 0.870 0.809–0.936 .000 0.913 0.846–0.986 .020 Stent number 1.720 1.145–2.585 .009 Bare stent type § 1.347 1.056–1.718 .017 Postoperative portal pressure 1.077 1.027–1.129 .002

CI, confidence interval; HR, Hazard ratio; PPR, portal pressure reduction before and after TIPS creation; PVT, thrombosis at any site of the portal venous system.

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Figure 4, Receiver operating characteristic curves of the portal pressure gradient ( a ) and the postoperative portal pressure ( b ) for the diagnosis of shunt dysfunction.

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Shunt Occlusion, Primary Assisted Patency Rate, and Risk Factors

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Shunt Revision and Secondary Patency Rate

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Impacts of Shunt Dysfunction on Overall Survival

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Table 3

Univariate and Multivariate Analysis for the Factors Predictive of Overall Survival

Baseline Factors Univariate Analysis Multivariate Analysis HR 95%CI_P_ Value HR 95%CI_P_ Value HCC 9.234 4.229–20.164 .000 6.615 2.863–15.283 .000 Ascites \* 1.788 1.148–2.784 .010 2.166 1.298–3.615 .003 Right atrium pressure 1.117 1.002–1.244 .045 Age 1.048 1.016–1.081 .003 WBC 0.659 0.481–0.904 .010

CI, confidence interval; HCC, hepatocellular carcinoma; HR, hazard ratio; WBC, white blood cell count.

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Discussion

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Conclusions

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Supplementary Data

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Appendix S1

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