Transjugular intrahepatic portosystemic shunt in cirrhosis: An exhaustive critical update

Table 1 Summary of the randomised controlled trials on early (preemptive) transjugular intrahepatic portosystemic shunt

Ref.	No. of pts (TIPS/control)	Primary inclusion criteria	Primary and secondary end-points	Rebleeding (%; TIPS/control)	1-yr survival (%; TIPS/control)	HE (%; TIPS/control)
Monescillo et al[13]	26/26	HVPG > 20 mmHg	Primary: sensivity and specificity of HVPG cutoff value (20 mmHg) in predicting TFS, and assessment of TFS as well as short- and long-term survival; secondary: transfusional needs, ICU stay, complications during the first week of treatment, and causes of death	12/50	62/35	31/35
Garcia-Pagán et al[14]	32/31	Child–Pugh class C disease (a score of 10 to 13) or class B disease but with active bleeding at diagnostic endoscopy	Primary: failure to control bleeding and failure to prevent clinically significant variceal rebleeding within 1 yr; secondary: mortality at 6 wk and at 1 yr, failure to control acute bleeding, early rebleeding, rate of rebleeding between 6 wk and 1 yr, other complications of portal hypertension, the number of days in the ICU, days spent in the hospital, and the use of alternative treatments	3/50	86/61	25/39
Lv et al[20]	84/45	Child–Pugh class C disease (a score of 10 to 13) or class B disease (with or without active bleeding at diagnostic endoscopy)	Primary: TFS; secondary: failure to control bleeding or rebleeding, new or worsening ascites, overt HE, and other complications of portal hypertension	11/34	62/35	35/36
Dunne et al[21]	29/29	Child–Pugh class C disease (a score of 10 to 13) or class B disease (with or without active bleeding at diagnostic endoscopy); inability to control bleeding at index endoscopy was considered an exclusion criteria	Primary: 1-yr survival; secondary: survival at 6 wk, early rebleeding (within 6 wk) and late rebleeding (between 6 wk and 1 yr), and the development of HE	24/34	79/76	41/17

HVPG: Hepatic venous pressure gradient; TFS: Transplant free survival; ICU: Intensive care unit; HE: Hepatic encephalopathy.

Table 2 Summary of the randomised controlled trials on transjugular intrahepatic portosystemic shunt in patients with ascites

Ref.	No. of pts (LVP/TIPS)	Definition of ascites for inclusion	Exclusion criteria	Primary and secondary outcomes and mean follow-up time (LVP/TIPS) in months	Improvement in ascites (%; LVP/TIPS)	HE (%; LVP/TIPS)	Survival (%; LVP/TIPS)
Lebrec et al[49]	12/13	Despite adequate diuretics and sodium restriction: (1) Weight loss < 200 g/d in 5 d or (2) > 2 episodes of tense ascites in 4 mth	Age > 70 yr, severe extra-hepatic diseases, HCC, pulmonary hypertension, HE, bacterial infection, severe alcoholic hepatitis, portal or hepatic vein obstruction or thrombosis, obstruction of biliary tract, obstruction of hepatic artery, serum creatinine >1.7 mg/dL	Primary: Recurrence of ascites; secondary: Overall survival, HE, hemodynamic, liver; and renal function; Follow-up: 12.4/7.5	0/38	6/15	60/29
Rossle et al[80]	31/29	Definition reported in 1996 by IAC (45% patients had recidivant ascites)	Overt HE, serum bilirubin > 5 mg/dL, serum creatinine > 3 mg/dL, PVT, hepatic hydrothorax, advanced cancer, failure of LVP (ascites persisting after LVP or need for LVP > once per week)	Primary: TFS; secondary: Recurrence of ascites, liver and renal function, HE; Follow-up: 44/45	43/84	13/23	32/58
Gines et al[81]	35/35	Definition reported in 1996 by IAC	Age > 18 or > 75 yr; serum bilirubin > 10 mg/dL; prothrombin time < 40% (INR 2.5); platelet count < than 40000/mm3; serum creatinine > 3 mg/dL, HCC, complete portal vein thrombosis; cardiac or respiratory failure; organic renal failure; bacterial infection; chronic HE	Primary: TFS; secondary: Recurrence of ascites, liver and renal function, HE, GI, bleeding, HRS; Follow-up: 10.8/9.5	17/51	34/60	30/26
Sanyal et al[82]	57/52	Definition reported in 1996 by IAC	Causes of ascites other than cirrhosis, advanced liver failure (serum bilirubin bilirubin > 5 mg/dL, PT INR > 2), incurable cancers or nonhepatic diseases that were likely to limit life expectancy to 1 yr, congestive heart failure, acute renal failure, parenchymal renal disease, PVT; bacterial infections, overt HE, florid alcoholic hepatitis, HCC, GI hemorrhage within 6 wk of randomisation	Primary: Recurrence of ascites and TFS; secondary: Overall survival, HE, GI bleeding, liver and renal function, quality of life; Follow-up: 38/41	16/58	21/38	33/35
Salerno et al[83]	33/33	Definition reported in 1996 by IAC (32% patients had recidivant ascites)	Age > 72 yr, recurrent overt HE, serum bilirubin > 6 mg/dL, serum creatinine > 3 mg/dL, CTP score> 11, complete PVT; HCC; GI bleeding within 15 d of randomisation, serious cardiac or pulmonary dysfunctions, bacterial infection, SAAG gradient < 11 g/L	Primary: TFS; secondary: Recurrence of ascites, HE, GI bleeding, liver and renal function, HRS; Follow-up: 15/21	42/79	39/61	29/59
Narahara et al[88]	30/30	Definition reported in 1996 by IAC	Age > 70 yr, chronic HE, HCC and other malignancies, complete portal vein thrombosis with cavernomatous transformation, bacterial infection, severe cardiac or pulmonary disease, organic renal disease	Primary: Overall survival; secondary: Recurrence of ascites, HE; Follow-up: 13/27	30/87	17/67	30/43
Bureau et al[92]	33/29	At least 2 LVPs within a minimum interval of 3 wk	Age < 18 and > 70 yrs, patients who had required > 6 LVPs within the previous 3 mo; patients on transplant waiting list, congestive heart failure, history or presence of pulmonary hypertension, complete PVT, recurrent overt HE, HCC, severe liver failure (prothrombin index < 35%, total bilirubin > 100 mmol/L or CTP score > 12), serum creatinine > 250 mmol/L, uncontrolled sepsis	Primary: 1-yr liver TFS; secondary: Ascites recurrence and treatment failure, overt HE, PHT-related complications, other complications of cirrhosis, and the number of days in hospital during a 1-yr period after inclusion; Follow-up: 10.4 /11.5	At 1-yr follow-up, total number of paracentesis in the TIPS and LVP group were 32 and 320, respectively	35/35	52/93

HCC: Hepatocellular carcinoma; HE: Hepatic encephalopathy; IAC: International ascites club; PVT: Portal vein thrombus; LVP: Large volume paracentesis; TFS: Transplant free survival; INR: International normalised ratio; HCC: Hepatocellular carcinoma; GI: Gastrointestinal; HRS: Hepatorenal syndrome; PVT: Portal vein thrombus; CTP: Child-Turcotte-Pugh; SAAG: Serum ascites albumin gradient; PHT: Portal hypertension; TIPS: Transjugular intrahepatic portosystemic shunt.

Table 3 Complications associated with transjugular intrahepatic portosystemic shunt placement and prevention or management strategies

Complication	Prevention/management
Carotid artery puncture during internal jugular vein access	Using ultrasound and fluoroscopic guidance for jugular venous access
Right atrial perforation	Avoid keeping the large 10-F sheath in the right atrium after the procedure
Capsular laceration during wedged hepatic venography	Using closed bag system for CO2 delivery/gentle injection of iodinated contrast
Hepatic capsular transgression or extrahepatic portal venous puncture	Using guidance for portal venous access
Non-target TIPS stent insertion into biliary tract or hepatic artery	Using guidance (USG/IVUS/CBCT) for portal venous access, confirm successful puncture with contrast injection
TIPS stent migration	Careful stent deployement and maintaining wire access across the stent until satisfactory, positioning is confirmed with portal venography, in case retrieval is needed
Early shunt occlusion	Positioning the proximal end of the stent till the hepatico-caval junction; thrombectomy, thrombolysis and restenting can be done for establishing flow
Hernia incarceration	Pre-TIPS hernia repair; alternatively, keeping a high index of suspicion after TIPS and prompt referral to a surgeon for management

CO₂: Carbondioxide; TIPS: transjugular intrahepatic portosystemic shunt; USG: Ultrasonography; IVUS: Intravascular ultrasound; CBCT: Cone beam computed tomography.