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Digestive and Liver Disease xxx (2016) xxx–xxx

Contents lists available at ScienceDirect

Digestive and Liver Disease

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pecial Article

onsensus conference on TIPS management: Techniques, indications,ontraindications

tefano Fagiuoli a,∗, Raffaele Bruno b, Wilma Debernardi Venon c, Filippo Schepis d,rancesco Vizzutti e, Pierluigi Toniutto f, Marco Senzolo g, Paolo Caraceni h,rancesco Salerno i, Paolo Angeli j, Roberto Cioni k, Alessandro Vitale l,aurizio Grosso m, Andrea De Gasperi n, Gennaro D’Amico o, Alfredo Marzano c, for the

ISF TIPS Special Conference1

Gastroenterologia Epatologia e Trapiantologia, Papa Giovanni XXIII Hospital, Bergamo, ItalyDept. of Infectious Diseases, Hepatology Outpatients Unit, University of Pavia—Fondazione IRCCS Policlinico San Matteo, Pavia, ItalyGastroepatologia, AOU Città della Salute e della Scienza, Molinette Hospital, Torino, ItalyDepartment of Gastroenterology University of Modena and Reggio Emilia, ItalyDepartment of Experimental and Clinical Medicine, University of Florence, ItalyMedical Liver Transplant Section, Department of Medical Sciences Experimental and Clinical, Internal Medicine, University of Udine, ItalyUnità di Trapianto Multiviscerale, Gastroenterologia, Dipartimento di Scienze Chirurgiche e Gastroenterologiche, Università-Ospedale di Padova, ItalyDepartment of Medical and Surgical Sciences, University of Bologna, ItalyDepartment of Internal Medicine, Policlinico IRCCS San Donato, University of Milan, ItalyInternal Medicine and Hepatology Department of Medicine (DIMED), University of Padova, ItalyDipartimento di Radiologia Diagnostica e Interventistica, UO di Radiologia Interventistica, Azienda Ospedaliero Universitaria Pisana, Pisa, ItalyU.O.C. di Chirurgia Epatobiliare e del Trapianto Epatico, Azienda Ospedaliera Università di Padova, ItalyDepartment of Radiology S. Croce and Carle Hospital Cuneo, Italy2◦ Servizio Anestesia e Rianimazione–Ospedale Niguarda Ca Granda, Milan, ItalyUOC Gastroenterologia Ospedale V Cervello, Palermo, Italy

r t i c l e i n f o

rticle history:eceived 10 July 2016eceived in revised form7 September 2016ccepted 17 October 2016vailable online xxx

eywords:scitesirrhosisI bleeding

a b s t r a c t

The trans jugular intrahepatic Porto systemic shunt (TIPS) is no longer viewed as a salvage therapy ora bridge to liver transplantation and is currently indicated for a number of conditions related to portalhypertension with positive results in survival. Moreover, the availability of self-expandable polytetraflu-oroethylene (PTFE)-covered endoprostheses has dramatically improved the long-term patency of TIPS.However, since the last updated International guidelines have been published (year 2009) new evidencehave come, which have open the field to new indications and solved areas of uncertainty. On this basis, theItalian Association of the Study of the Liver (AISF), the Italian College of Interventional Radiology—ItalianSociety of Medical Radiology (ICIR-SIRM), and the Italian Society of Anesthesia, Analgesia and IntensiveCare (SIAARTI) promoted a Consensus Conference on TIPS. Under the auspices of the three scientific soci-eties, the consensus process started with the review of the literature by a scientific board of experts and

iver transplantationortal hypertensionIPS

ended with a formal consensus meeting in Bergamo on June 4th and 5th, 2015. The final statementspresented here were graded according to quality of evidence and strength of recommendations andwere approved by an independent jury. By highlighting strengths and weaknesses of current indicationsto TIPS, the recommendations of AISF-ICIR-SIRM-SIAARTI may represent the starting point for furtherstudies.

© 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: Fagiuoli S, et al. Consensus conferenceDig Liver Dis (2016), http://dx.doi.org/10.1016/j.dld.2016.10.011

∗ Corresponding author at: Division of Gastroenterology and Transplant Hep-tology, Hospital Papa Giovanni XXIII, Piazza OMS, 1, 24128 Bergamo, Italy.ax: +39 0352674964.

E-mail address: [email protected] (S. Fagiuoli).1 Supplementary materials – Appendix 5 – co-authors and collaborators.

ttp://dx.doi.org/10.1016/j.dld.2016.10.011590-8658/© 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All

Introduction

Portal hypertension (PH) is one of the major complications of cir-

on TIPS management: Techniques, indications, contraindications.

rhosis. The trans jugular intrahepatic porto systemic shunt (TIPS)has been an established procedure in the treatment of the com-plications of portal hypertension, including bleeding oesophageal

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arices, refractory ascites, hepatic hydrothorax, type-2 hepatorenalyndrome, and more recently, Budd–Chiari syndrome and veno-cclusive disease. However, despite these broad applications, manylinical aspects remain controversial. The multispecialistic con-ribute to patient selection and TIPS management have led thetalian hepatologic community to produce a consensus statementsimed to the reassessment of the technical and clinical aspects.

ethods

The goal of this document was to provide clinical guidelinesor the proper management of TIPS. Promoter of this “Consensusuidelines” was the Italian association for the Study of Liver (AISF).he Consensus was endorsed by: ICIR (Italian College of Inter-entional Radiology), SIRM (Italian Society of Medical Radiology)nd SIAARTI (Italian Society of Anesthesia, Analgesia and Intensiveare).

According to the PNLG (National Plan for GuideLines), the pro-oter identified a Scientific Board of Experts. The Scientific Board

efined methodology, goals and acted as developer and reviewer.The methodology chosen involved the following steps:

. The Promoters and the Scientific Board selected the main top-ics of interest: 1. Technique, contraindications, and untowardeffects of TIPS, 2. G.I bleeding, 3. Ascites, 4. Vascular disorders, 5.Liver transplantation, 6. Rare indications.

. For each topic a working party was identified by both the Pro-moters and the Scientific Board, and was composed by a groupof at least four experts guided by a chairman. The chairman,together with the promoters and the Scientific Board, selectedthe relevant clinical questions aiming at focusing on the clinicalpractice and controversial areas. The questions were circulatedwithin the working groups to refine the topics and to avoid dupli-cations. The members of the working parties were identified onthe basis of competence, role, expertise and publication/researchin the field of end stage liver diseases and liver transplantation.

. Each working group independently carried out a systematic lit-erature search and review, between October 2014 and May 2015,using Medline/Pub Med to support definitions and statements.Each recommendation was graded according with the Oxfordgrading system (Appendix 1 in Supplementary material).

. The working groups elaborated the proposed statements, gradedaccording with the selected grading system. They preparedthe statements together with the presentation of the literaturereview for each topic during phone conferences, group meet-ings and mailing exchange before the Consensus Conference(between February and May 2015).

. The jury members were nowhere involved in the selection,preparation and discussion of the topics and statements priorto the Consensus Conference.

. All the promoters, members of the Scientific board, workinggroups, and Jury invited to participate to the Consensus confer-ence were asked to declare any potential conflict of interests.

. On June 4th and 5th, 2015 a Consensus Meeting was heldin Bergamo. The consensus group consisted of a total of 102participants (promoters, Scientific Board, Working Groups, andJury). The jury was selected among Hepatologists, Radiologists,Surgeons, Methodologists, Intensive care physicians, epidemi-ologists, patient representatives and ethicists. During the firstsessions the chairman of each group presented the selected top-ics and the proposed statements. A general discussion was held


in order to refine the. At the end of the general session eachgroup met independently to re-elaborate the final statementsto be presented in the voting session according to the advicesreceived by the jury. The final general session consisted in the

PRESSr Disease xxx (2016) xxx–xxx

presentation of the statement by the chairman of each workinggroup, followed by a public vote from the jury. The agreementwas reached if over 73% of the voters agreed upon a two-levelsscore (Agree, Disagree).

8. The format of this document, drafted by the writing committee,includes the questions, the statements, the quality comments bythe working group chairmen, the percentage of agreement of thejury and the selected references.

SESSION 1—TIPS placement techniqueAlthough no clear definition of technical skills and relative learn-

ing curve exists, only a physician with elevated knowledge in bothhepatic and cardiopulmonary hemodynamic, should perform TIPSplacement [1–7].

Steps required for proper TIPS placement

1. Creation of a vascular access by the puncture of the internal jugular vein,which must be performed under US guidance [2].

2. Catheterization of one of the hepatic veins, which can be also puncturedpercutaneously under real time US guidance when its ostium is noteasily accessible [3]. When hepatic veins are occluded (Budd-Chiarisyndrome), portal vein branches can be reached by direct puncture fromthe inferior vena cava [4–11].

3. Puncture through the liver parenchyma of one of the main branches ofportal vein with or without real time ultrasound guidance [12].

4. Measurement of the porto-systemic pressure gradient (PPG) by a digitalrecording system properly set-up for venous pressure [13,14]. Inferiorvena cava and not right atrium blood pressure should be subtracted toportal vein pressure to calculate the gradient [15].

5. Balloon dilatation of the parenchymal tract between the hepatic (orinferior vena cava) and portal veins.

6. Deployment of the stent within the parenchymal tract.7. Hemodynamic assessment of the resultant PPG reduction followed by

further balloon dilatation of the lumen to reach the desired target ofpressure gradient [14,16]. PPG measurement upon recovery from deepsedation should be considered at least in patients with variceal bleedingas an indication [14,17].

The use of bare metal stents to perform TIPS has been asso-ciated with high rates of dysfunction and recurrence of portalhypertension complications [14]. Stents covered with polyte-trafluoroethylene (PTFE—endoprostheses), have proven to warrantlong-term patency [18]. Dysfunctions occurring with the use of newgeneration TIPS sets (early thrombosis, later stenosis) appear tobe highly dependent upon the operative skills and the accuracy ofplacement technique [19–21]. Clinical and technical indications,success rates (>90%) and complications (<5%) of TIPS should bemonitored periodically in each Center [22,23].

Statements: technical coinsideration and patients selection

1.1. Where should a TIPS procedure be performed and who shoulddo it?

Statement 1.11.1a. TIPS should only be performed in tertiary care Centres by

interventional radiologists or specially trained physicians experiencedin: (a) portal vein catheterization either through a hepatic vein or theinferior vena cava; (b) assessment and interpretation of invasive hepaticand cardiopulmonary hemodynamic; (c) trans catheter embolization,and (d) management of procedural complications (5, D) [15,24–26].

1.1b. The decision to perform a TIPS should be reached by an expert teammade of one hepatologist (clinical indication) and an interventionalradiologist (technical feasibility); in high risk patients, the decision toplace a TIPS should be based on liver transplantation candidacy and atransplant surgeon should also be involved in the evaluation period (5,D) [24,27].


1.1c. Clinical and technical indications, success rates (>90%) andcomplications (<5%) of TIPS should be monitored periodically in eachCenter (5, D) [22,23].

Votation 1.1: Votes in Favour: 96%.

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Votation 1.11: Votes in Favour: 100%Comment: Patients undergoing TIPS placement often present with



1.2. Which imaging studies are needed prior to TIPS placement?

Statement 1.2Doppler ultrasonography (Doppler-US) and cross sectional liver imaging

by computed tomography (CT) or magnetic resonance (MR) areappropriate to identify anomalies in liver anatomy, to rule outintrahepatic masses, to assess both portal and hepatic vein anatomy andpatency and to plan the procedural approach (5, D) [22,24,25].

Votation 1.2: Votes in Favour: 100%.Comment: Before TIPS placement, a vascular and anatomical study

f the liver should be performed in order to assess both technical fea-ibility and anatomical contraindications to the creation of the shunt.o this end, there is no evidence to support the use of CT or MR ratherhan Doppler US [22,24,25].

1.3. Which are the techniques to access the portal vein for TIPSlacement?

Statement 1.31.3a. The internal jugular vein is the first-choice peripheral vascular access

for TIPS placement. For anatomical reasons, the right internal jugularvein is preferred (5, D) [2].

1.3b. US-guided puncture of the vessel is needed in order to decrease thecomplications (1a, A) [2].

1.3c. In case of unsuccessful trans jugular catheterization of the hepaticvein, a US-guided percutaneous puncture of the hepatic vein can beperformed (4, C) [3].

1.3d. In absence of available hepatic veins, a direct puncture from theinferior vena cava can be performed (4, C) [4–6].

1.3.e. The portal vein should be punctured under real time ultrasoundguide to reduce complications due to capsule perforation or accidentalpuncture of arteries, ectasic bile ducts and masses (cysts, haemangioma,tumours) along the parenchymal tract of TIPS (5,D) [7,9,10,12].

Votation 1.3: Votes in Favour: 100%.

1.4. Which is the technique for measuring the porto-systemic pres-ure gradient (PPG)?

Statement 1.41.4a. Baseline and post procedural porto-systemic pressure gradient (PPG)

should be calculated subtracting the inferior vena cava pressure(measured at the level of the hepatic vein and TIPS outflow level,respectively) to the portal vein pressure (2b, B) [14,15].

1.4b. Deep sedation with propofol and remifentanil adds substantialvariability and uncertainty to PPG measurements. This limitation needsto be considered whenever hemodynamic measurements are obtainedunder this condition (2b, B) [28].

1.4c. Reduction of PPG to less than 12 mmHg should be achieved when theindication is bleeding from oesophageal varices (1b, A) [14]. This is stillan uncertain hemodynamic target in patients with refractory ascites (5,D) [24,25].

Votation 1.4: Votes in Favour: 100%.Comment: PPG value after TIPS placement can be underestimated

n deep sedated patients: repetition of PPG measurement a few daysollowing the procedure is advisable in case of incomplete clinicalesponse particularly in bleeding patients. [14,28].

1.5. Which types of device are available for TIPS?

Statement 1.51.5. Dedicated ePTFE-covered stents should be preferred over bare stents

in order to reduce the risk of shunt dysfunction (1b, A) [18–20,29–31].

Votation 1.5: Votes in Favour: 100%.Comment: Two RCTS [32,33] and a meta-analysis [29] of six

tudies (one prospective and five retrospective) comparing TIPSlacement with PTFE-covered stents and bare stents for portalypertension related complications showed that the covered stentas superior in terms of shunt dysfunction (HR = 0.28; 95% CI

.20–0.35).


PRESSr Disease xxx (2016) xxx–xxx 3

1.6. Which is the proper stent diameter for TIPS?

Statement 1.61.6a. A step-wise procedure based on the progressive dilation of 10-mm

diameter covered stents by using balloon catheters of increasingdiameter might be used. The extent of dilation can be consideredacceptable when the target PPG is reached (in case of variceal bleeding)(1a, A) [14] or an adequate clinical response is obtained (in case ofrefractory/recidivant ascites) (4, C) [14,25,31,32].

1.6b There is not enough evidence to support the use of 10-mm rather than8-mm nominal diameter PTFE-covered stents aiming to achieve a bettercontrol of portal hypertension complications (5, D) [33,34].

Votation 1.6: Votes in Favour: 100%.Comment: A randomized, single centre, open label, active control

trial [33], which was aimed to demonstrate a potential benefit of 8-mm in comparison to 10-mm covered stents in reducing the risk ofpost-TIPS encephalopathy, was early interrupted after enrolling 39%of the calculated sample size (45 of 114 patients) due to the apparentworse control of ascites in patients treated with smaller stent grafts.Despite that, most operators perform TIPS using a 10 mm stent dilatedto 8 mm (with subsequent calibration up to 10 mm depending on post-procedure portocaval gradient) [3,33,34]. A step-wise procedure basedon the progressive dilatation of 10 mm diameter stents at TIPS posi-tioning or at delayed time points during follow up can be also appliedin ascitic patients with the goal to achieve a portal-pressure gradient<12 mmHg [14,25] and or an adequate clinical response [31,32].

1.7. Is there a need for US-Doppler follow-up immediately after TIPSplacement?

Statement 1.7Doppler-US follow up surveillance should not be routinely performed in

properly placed ePTFE-covered stents (4, C) [35–39].

Votation 1.7: Votes in Favour: 87%.Comment: A single evaluation within the first 7 days should be per-

formed when bare metal stents are implanted, technical difficultiesoccurred or in case of incomplete clinical response. The evaluation offlow direction in the intrahepatic portal vein branches is a reliablequalitative indicator of TIPS malfunction [35,36,38,39].

1.8–11. Sedation and patient monitoring

Statement 1.8Monitored anesthesia care (MAC) should be administered by an

anaesthesiologist (4, C) [40].

Votation 1.8: Votes in Favour: 100%

Statement 1.9Monitored anesthesia care (MAC) and moderate sedation should be

adopted as routine procedures during TIPS (4, C) [24].


Statement 1.10Propofol and remifentanil, which enable a fast recovery after sedation in

cirrhotic patients, represent the first choices for sedation or GA (2b, B)[41–44].


Statement 1.111.11a. All patients undergoing general Anesthesia or deep or moderate

sedation require continuous monitoring of vital parameters (level ofconsciousness, ventilation, oxygenation status, and hemodynamicvariables) (2a, B) [40].

1.11b. Patients who have received GA or MAC shall receive appropriatepost-Anesthesia care (2b,B) [45].

1.11c. Discharge of the patients should be upon anaesthesiologist care (4,


critical conditions (liver dysfunction, large amount of ascites, recent

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aemorrhagic shock) with a mental status that can indeed influencehe cooperation and the tolerance of the procedure. Moreover TIPSositioning can be an uncomfortable and prolonged procedure requir-

ng analgesics and sedatives administration, which could facilitate theransition to (GA) with or without intention, and could precipitatedverse physiological responses in particularly frail patients [45].

The choice between GA and MAC depends on the patient phys-cal conditions, mental state and ability to collaborate during therocedure. In the absence of randomized controlled trials, GA withndotracheal intubation represents the ideal option for critical patientsho are at risk for aspiration during the procedure [46–48]. Chronic

iver diseases are associated with variable and non-uniform reductionsn drug-metabolizing activities. These conditions make it difficult toefine the ideal dosages of drugs in cirrhotic patients. To avoid respira-ory depression and to reduce their hemodynamic impact, anaestheticnd analgesic drugs used during TIPS placement should be easily titrat-ble and/or rapidly antagonized [22,40]. The anaesthetist, dependingn the type, will define the frequency of monitoring and its invasivenessnd amount of medication administered, the length of the procedure,nd the general condition of the patient. Particular attention shoulde given to monitoring oxygenation, ventilation, circulation, level ofonsciousness and temperature [45,49].

1.12. Which are the contraindications to TIPS positioning?

Statements 1.121.12a. The absence of vascular accesses represents the only technical

contraindication to TIPS positioning (4, C) [3].1.12b. The presence of portal vein thrombosis resulting in a portal

cavernoma is not an absolute contraindication in presence of a “portal”landing zone with adequate flow and calibre to receive the device (4, C)*[9,10] *see statements on PVT

1.12c. Clinical contraindications to TIPS placement are:• Severe liver failure (Child-Pugh > 11, serum bilirubin > 5 mg/dl,

MELD > 18) (1a) [50].• Severe organic renal failure (serum creatinine > 3 mg/dl) (1a).• Heart failure (1a).• Severe porto-pulmonary hypertension (mPAP > 45 mmHg at RHC)(1a).• Recurrent or persistent overt hepatic encephalopathy grade ≥ 2

(West-Heaven scale) despite adequate treatment (1a).• Uncontrolled sepsis (1a).

Votation 1.12: Votes in Favour: a–b 87%, c 96%.Comment: Relative technical contraindications are anatomical

onditions associated with a reduction in technical success rate or withn increased risk of complications, such as liver tumours, the presencef multiple hepatic cysts. The clinical appropriateness of TIPS position-ng should be evaluated on a case-by-case basis according with theelevance of the indication and the presence of general contraindica-ions. Indeed, in the context of a life threatening condition such as acuteariceal bleeding (with a trickier assessment of liver failure), a broaderange can be adopted (Child C score <14).

1.13. How to prevent post-TIPS complications (contrast inducedephropathy—CIN)?

Statement 1.131.13a. Fluid hydration with normal saline should be considered in patients

at risk of renal impairment when undergoing TIPS placement (3, B)1.13b. The efficacy of NAC or other drugs in reducing the incidence of CIN

remains unproven and their use cannot be recommended (1a, A).

Votation 1.13: Votes in Favour 100%.Comment: Contrast-induced nephropathy (CIN) identifies an acute

enal failure developed after administration of radio contrast in thebsence of other identifiable cause. It is defined as an absolute increasef serum creatinine of 0.5 mg/d or of 25% from baseline. The rate ofIN is extremely low in patients with eGFR > 60 ml/min. It increases


n patients with pre-existing renal impairment, diabetes, many intra-rterial contrast procedures and eGFR < 45 ml/m [51,52]. A cautiousse of saline should be made in patients treated by TIPS for recurrent


ascites with covert diastolic dysfunction, due to the increased risk ofcardiac overload after the procedure.

1.14. Is antibiotic prophylaxis required for the prevention of TIPS-related infectious complications?

Statement 1.141.14a. Routine antibiotic prophylaxis should not be performed prior to

TIPS placement (4, C) [53].1.14b. If long or complex TIPS placement procedure is anticipated (portal

vein thrombosis, multiple stenting, trans parietal punctures, etc.),antibiotic prophylaxis (single dose of ceftriaxone orampicillin/sulbactam) should be considered (5,D) [54–57].

Votation 1.14: Votes in Favour: 100%.Comment: Early events: Bacteriemia after TIPS (defined by fever

>38.5 ◦C, or leucocytosis >15.0003 and positive blood cultures) rangesbetween 2–25% (54–56, 58) and in a prospective RCT was not influ-enced by antibiotic prophylaxis [53]. A longer duration of procedure,multiple stenting and the maintenance of a central venous line areassociated with a higher risk of infection after TIPS. In patients withuncomplicated procedure, the trans jugular venous access should beremoved at the end of the intervention [53,57]. A single dose oflong acting cephalosporin reduces the incidence of bacterial infec-tion (20–2.6%) justifying its use in anticipated complex procedures[54]. Late events: Endotipsitis is defined by the presence of sustainedbacteriemia associated with the evidence of thrombus or vegetationsinside the TIPS. This clinical condition is rare (1%). Early endotipsi-tis (<120 days of the procedure) is usually related to Gram-positiveorganisms and the antibiotic therapy must be long-lasting (at least3 months) to avoid recurrence [58]. In patients with uncontrolled orrecurrent infection liver transplant should be considered [59]. There isno evidence for adopting long-term prophylaxis for the prevention ofendotipsitis.

1.15. Are blood products routinely required during TIPS placement?

Statement 1.151.15a. Fresh frozen plasma, or pro-haemostatic agents are not required in

cirrhotic patients undergoing TIPS, irrespective of INR value (2a, C)[60,61].

1.15b. Although the threshold of platelet count needed to ensure normalprimary haemostasis in cirrhosis is not clearly defined, the 50 × 109/lcut-off can be utilized for platelets infusion before TIPS (4, C) [62].

Votation 1.15: Votes in Favour: 100%.Comment: A specific evaluation of the bleeding risk in patients

undergoing TIPS has never been reported. In cirrhotics, routine coag-ulation tests cannot define the coagulation status and the bleedingrisk. Several observational and randomized placebo-controlled studieshave shown that prothrombin time (PT) is a poor predictor of peri- orpost-operative bleeding in patients with cirrhosis [60,61,63]. In mostinvasive procedures, a 50 × 109/l platelets cut-off is utilized for definingthe need for blood product to correct preoperative laboratory values.However, the proper cut-off number for platelets has never been iden-tified (even though a number >60 × 109/l has been proven adequate,but in experimental models only [62,64]. Close monitoring for evidenceof bleeding during the procedure rather than a prophylactic attituderepresents the most adequate approach.

Cardiac dysfunction

1.16. Which is the role of pulmonary arterial hypertension (PAH)and how to perform a pre-TIPS cardiac assessment and?

Statement 1.161.16a. Doppler echocardiography (ECHO) is suggested IN ALL CANDIDATES


1.16b. A systolic pulmonary artery pressure (sPAP) > 50 mmHg at ECHO orhistory of congestive heart failure, tricuspid regurgitation andcardiomyopathy justify the execution of a right heart catheterization(RHC) to confirm and properly define pulmonary hypertension (PAH):

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Table 1Main risk factors for post-TIPS HE.

• Advanced age (1a) [4,83,91]• High Child-Pugha and MELD score (1a) [4,81,85]• History of hepatic encephalopathy (1b) [31,81,82,84]• Baseline arterial hypotension (1a) [4,83]• High serum creatinine and hyponatriemia (Na < 130) (1a) [4,80,82]• Low serum albumin levels (1b) [80]

Statement 2.3Early TIPS (within 72 h, ideally ≤24 h from bleeding, and after initial

combined pharmacological and endoscopic therapy) is effective in



a) Severe PAH (mean pulmonary artery pressure, mPAP, >45 mmHg atRHC) represents an absolute contraindication to TIPS (5, D) [24,70–74].

b) Moderate PAH (mPAP between 35–45 mmHg) with elevated pulmonarycapillary wedge pressure (PCWP >15 mmHg) on right heartcatheterization is a relative contraindication and requires particularattention for the indication (only in patients with variceal bleedingrefractory to endoscopic/pharmacologic treatment), the procedure(small calibre TIPS) and the management (prevention of cardiacoverload) (5, D) [68,75–77].

c) Mild PAH (mPAP between 25–34 mmHg) does not represent acontraindication to TIPS (5,D) [68,75–77].

Votation 1.16. Votes in Favour: 100%.Comment: New-onset chronic cardiac dysfunction have been rec-

gnized in cirrhotic patients in the absence of known cardiac disease,rrespective of the aetiology of cirrhosis and related, at least in part,o the hyper dynamic circulation [68,75]. The disease is generallynapparent at rest and becomes manifest under pharmacogical orhysical stress as infection, haemorrhage, large volume paracente-is, and exercise. Left ventricular (diastolic) dysfunction may be aignificant factor in the development of ascites and hepatorenal syn-rome [65,66,68,77,78] as well as pulmonary arterial hypertensionPAH, defined as mPAP ≥25 mmHg). This condition is not infrequentn cirrhotic patients with portal hypertension (up to 16% in transplantandidates).

The incidence of cardiac dysfunction after TIPS is unknown and noeliable predictors are available at the individual patient level. Pul-onary oedema occurs in 10-12% of patients receiving TIPS for ascites

nd some cases of ascites recurrence after TIPS may be due to heartailure rather than portal hypertension [66,68,75,77,78].

From the haemodynamic stand point, liver transplantation sharesimilarities with TIPS. Data from liver transplantation indicate thatevere pulmonary arterial hypertension is an absolute contraindica-ion because of poor outcome [71–73]. In this setting, moderate orevere PAH is expected when sPAP by ECHO is >50 mmHg. Therefore,

sPAP greater than 50 mmHg at ECHO represents the cut-off point forxecuting a RHC. At RHC, a mPAP greater than 45 mmHg represents aontraindication to TIPS [24,70–74,79].

1.17. Is there a risk for hepatic encephalopathy after TIPS?

Statement 1.17TIPS is associated to an increased incidence of severe HE. (1a) Thus, the risk

factors for HE should be always considered before TIPS placement(A)(Table 1).

Votation 1.17: Votes in Favour: 100%.Comment: Hepatic encephalopathy (HE) is one of the major compli-

ations of TIPS. Notwithstanding, scarce are the studies directly aimingt the assessment of HE in relation to TIPS placement. Bearing in mindhese limitations, the incidence of overt episodic or recurrent HE post-IPS varies between 15 and 67% in a 2-year follow-up. The incidencef persistent overt HE is around 8% [80] and that of de-novo, covert HEround 35% [14,26,81–88].

1.18. Is there a need for routine prophylaxis of hepatic encephalopa-hy post TIPS placement?

Statement 1.181.18a. Prophylaxis of post-TIPS HE with either lactulose or rifaximin is not

routinely recommended (1b) [88].1.18b. Stent lumen reduction or occlusion is effective in case of persistent

overt post-TIPS HE (2b, B) [89,90].

Votation 1.18: Votes in Favour: 100%.Comment: The diagnosis and the treatment of post-TIPS overt

nd covert HE is not different from that of overt or covert HEccurring independently of the procedure and should be performedccording to the joint EASL/AASLD guidelines. Stent lumen reduc-


ion/occlusion should be performed only in case of persistent overt HE89–91].

• Bare vs. covered stent (2b) [85]• Very low porto-systemic pressure gradient after TIPS (<5 mmHg) (1a)

[25,78–83,87]a Child A risk of HE close to 0, in Child B up to 33%, in Child C up to 89%.

SESSION 2: TIPS for portal hypertension complications:portal hypertension-related bleeding in cirrhotic patients

The management of bleeding complications differs accordingto severity of the underlying liver disease and the stage of PH,ranging from primary prophylaxis of variceal bleeding to treat-ments aimed at controlling acute variceal bleeding or to preventrebleeding. HVPG measurements in these settings has clearly beenestablished as a clinically relevant diagnostic and prognostic tool[92]. The management of PH-related bleeding in cirrhotic patientsincludes endoscopic techniques, vasoactive drugs (somatostatinand vasopressin analogues), and TIPS.

2.1. Is TIPS indicated for primary prophylaxis of first variceal bleed-ing?

Statement 2.1.2.12 TIPS is not indicated for the prophylaxis of first variceal bleeding (1a,A)

Votation: 2.1 Votes in Favour 100%).Comment: The incidence of first bleeding in cirrhotic patients with

oesophageal varices (EV) ranges from 5% to 15% per year and the asso-ciated mortality is about 15–20%. A meta-analysis of shunt surgerytrials has conclusively shown an unacceptable burden of mortality andHE [93] in primary prophylaxis. Until RCTs are available for TIPS inthis setting, results from derivative surgery must be extrapolated topercutaneous shunting as primary prophylaxis [24].

2.2. How should acute bleeding treatment failure be managed?

Statement 2.22.2a. Persistent bleeding and rebleeding taking place within the first five

days from the index bleeding, despite appropriate combinedpharmacological and endoscopic treatments, should be managed bycovered-TIPS (2b,B).

Votation 2.2 Votes in Favour 91%.Comment: Variceal bleeding is unresponsive to initial combined

pharmacological and endoscopic treatments in 10–20% of cirrhoticpatients. If treatment failure leads to mild bleeding and the patient isstable, a further endoscopic haemostasis may be attempted. In case ofsevere bleeding, derivative treatment must be considered [92,94–97].Both TIPS and surgical shunts are extremely effective in controllingvariceal bleeding (control rate approaching 95%). TIPS represents thefirst choice due to the intolerable surgical risk in decompensated cir-rhotic patients [18,98]. Regrettably, following development of systemiccomplications or deterioration of liver function, mortality remains higheven when TIPS is applied as a rescue therapy. Prognostic scores arehelpful in the decision-making in order to accelerate TIPS referral inhigh-risk subjects [99] before a further deterioration of the patient’sclinical status occurs, affecting the outcome of derivative treatments. Inmore compromised cases it is advisable to perform TIPS in accordancewith the liver transplantation team.

2.3. Which is the role of “early TIPS” in acute bleeding high-riskpatients?


controlling bleeding from EV, GOV1* and 2 in patients at high risk oftreatment failure defined as:

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a) Child-Pugh class C (<14 points)b) Child-Pugh class B with active bleeding at index endoscopy (1b, A).

GOV1* and 2: gastro-oesophageal varices type 1 and 2.

Votation 2.3 Votes in Favour 100%.Comment: Available RCTs support the role of TIPS in patients with

high risk of treatment failure. Patients with HVPG levels >20 mmHgecorded within 24 h from bleeding [100] or in a Child-Pugh class C<14 points) or actively bleeding at index endoscopy and in Child-ugh class B [101] have been suggested to have a poor outcome. Inuch high-risk subjects [101] receiving TIPS within 72 h from bleeding,ailure to control bleeding or to prevent rebleeding and mortality wereignificantly lower (3% vs. 45% and 13% vs. 39% at 1 year, respectively)ithout an increased risk of HE [102–104]. However, in recent surveil-

ance studies, a survival benefit was not observed [102,105], althought approached statistical significance in one [101].

2.4. Which is the role of TIPS in failure of secondary prophylaxis ofariceal bleeding?

Statement 2.4In patients rebleeding despite an appropriate combined therapy

(pharmacological* + endoscopic treatment**):2.4a. Covered TIPS is the treatment of choice to prevent EV rebleeding

(2b,B).2.4b. TIPS may be used as a bridge treatment in patients eligible/listed for

liver transplantation (4,C).2.4c. TIPS is effective in the prevention of bleeding recurrence from GV and

should be considered in this setting (2b,B).2.4d. Balloon-Occluded Retrograde Trans venous Obliteration (BRTO) may

be employed for uncontrolled bleeding or rebleeding from gastricvarices (GV), in the presence of contraindication(s) to TIPS, and/or morecompromised liver function (5,D).

2.4e. TIPS can be considered in patients with transfusion-dependent PortalHypertensive Gastropathy (PHG), when NSBBs and/or endoscopictreatments fail (4,C).

2.4f. TIPS with or without embolization of the feeding vessel(s) may beemployed for uncontrolled bleeding or rebleeding from ectopic varices(4,C).

*NSBBs with or without 5-ISMN.**Oesophageal varices: endoscopic variceal ligation (EVL); Gastric varices:

glue injection

Votation 2.4 Votes in Favour 95%.Comment: Patients surviving a first variceal bleeding episode have

two-year rebleeding risk of over 60% [100,106]. First-line therapyFLT) is based on both NSBBs and EVL. RCT comparing TIPS to FLT, evenf inhomogeneous, agreed that TIPS is highly effective in preventingebleeding, although with a significantly burden of HE, but it did notmprove overall mortality [107–109].

The lack of survival benefit following TIPS may be dependent on clin-cal deterioration in patients with recurrent bleeding and sequentialreatments. Hemodynamic non-responders to secondary FLT shoulde considered earlier for TIPS. Preliminary, albeit uncontrolled, data

ndicate that allocation of these patients to TIPS reduces rebleedingate and bleeding-associated mortality [5,97,106,110–113].

Bleeding episodes from GV occur at lower HVPG levels and tendo be worse in respect to those occurring from EV and require signifi-antly more transfusions [114]. Although the available literature on GVleeding is not as robust as the one for EV, all studies comparing TIPSs. cyanoacrylate in bleeding GV demonstrated a significantly higheruccess rate in the TIPS group, with a greater burden of HE in derivedubjects [14,115–123]; In patients with large gastro renal shunts andontraindications to TIPS (e.g. elderly patients or patients with refrac-ory encephalopathy or more compromised liver function) BRTO maye considered for the treatment of GV bleeding [124–128].

PHG is mainly detected in patients with more advanced liver


isease and in those previously receiving endoscopic haemostaticreatment for EV and GV (prevalence 11–80%) [129,130]. Incidencef acute bleeding and related mortality are quite low (3% and 12.5%


at three years, respectively) [131–133]. Therefore, TIPS is unlikely tobe proposed to these subjects. Nonetheless, patients in whom PHGcauses both chronic and significant blood losses (requiring repeatedtransfusions), could be considered for TIPS [134,135].

GAVE is a rare finding in patients with PH (2%-3% incidence),which is not the leading pathogenic mechanism. Accordingly, GAVEis unresponsive to derivative treatment [135–137].

Ectopic varices account for only 2–5% of variceal bleeding in cir-rhosis. They bear a 4-fold increased bleeding risk compared to EVwith a mortality rate as high as 40% [138]. In case of uncommonbleeding sites (such as ectopic varices and stomas), local endoscopictreatment is often either impossible or ineffective. Several uncontrolledstudies have indicated that TIPS placement is effective in preventingrebleeding from ectopic varices [127,139–142]; it should be consid-ered that ectopic varices are known to rebleed despite a reductionof PCG below 12 mmHg following TIPS [127,139,141–143]. Therefore,TIPS also allows embolization of the feeding vessel(s) and facilitatesre-interventions in case of rebleeding. In this setting derivative surgerycould still play a crucial role if TIPS is not technically feasible (Supple-mentary materials—Appendix 4).

SESSION 3: TIPS for portal hypertension complications

3.1. Is TIPS more effective than conservative/medical treatment(large volume paracentesis plus albumin infusion ± diuretics) to treatrefractory ascites (defined according the International Club of Ascitescriteria) or recidivant ascites (3 episodes of tense ascites in 1 year)?

Statement 3.13.1a. TIPS is more effective than conservative/medical treatment to resolve

refractory/recidivant ascites, greatly reducing the need of paracentesis(1a, A).

3.1b. TIPS should be considered in all patients with refractory/recidivantascites (1a, A).

3.1c. In selected patients with refractory/recidivant ascites and withoutgeneral contraindications (*) TIPS improves transplant-free survival (1a,A).

3.1d. In patients who are eligible for liver transplant, TIPS should beplanned in agreement with a Transplant Centre (5,D).

3.1e. At present, in patients with ascites “early TIPS” is not indicated. Theconcept of “early TIPS” needs further definition (5,D)

*see statement 1.12.

Votation 3.1. Votes in Favour 100%.Comment: Efficacy: To date 6 RCTs performed with bare stents

and including 390 patients and a meta-analysis have been conductedto compare TIPS and large volume paracentesis in patients withrefractory/recurrent ascites [75,86,87,131,144–150]. In 2007 a meta-analysis of individual patient data has clearly demonstrated that therecurrence of tense ascites and the average number of paracentesiswere significantly lower in patients receiving bare-metal TIPS than inthose receiving paracentesis [83]. Survival: 6 RCTs provided differ-ent results on survival. While the unfavourable outcome showed bythe first study published in 1996 can be explained by technical dis-ability [144], the discrepancies among the other studies is likely due topatient selection and data analysis biases. Transplant-free survival wasindeed significantly improved in 3 RCTs [131,145,147] but not in othertwo RCTs [75,146]. When the individual data of included patients wereanalysed, improvement of both actuarial probability of transplant-free survival and 12-months survival was shown in TIPS patients[83,131,145,147]. These RCTs excluded patients with advanced liverdisease (as defined by serum bilirubin > 5–6 mg/dl, INR > 2, current orchronic HE > 2 by West-Heaven scale), and renal failure (as definedby serum creatinine >3 mg/dl) [86]. Moreover, they included patientswith recidivant non-refractory ascites [86].


Pre-OLT and early preventive TIPS. No study has assessed thepossible role of TIPS in reducing the pre-transplant mortality riskof OLT candidates in patients with non-recidivant/non refractoryascites.

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increased risk of complications [183,184]. In most cases, the indicationfor TIPS was not PVT “per se” but rather the complications of portal



3.2. Which is the role of TIPS in type-II hepatorenal syndrome (HRS)?

Statement 3.23.2a TIPS is effective to treat type-II HRS associated to refractory/recidivant

ascites (1b) [151].3.2b TIPS cannot be recommended in unselected patients with type-I HRS

(2b, B) [152–154].

Votation 3.2. Votes in Favour 100%.Comment: A total of 61 patients with HRS receiving TIPS have been

ncluded in small studies [26,151–154]. Most of them have shown anmprovement of renal function, with survival rates ranging from 20%or Type I and 70% in type II, while liver failure was the most frequentause of death following TIPS.

3.3. Which is the role of TIPS in refractory hydrothorax* (RH)?

Statement 3.33.3a TIPS can be considered in refractory hydrothorax aiming at resolution

of hydrothorax and reduction in number of thoracentesis (2b,B).3.3a The effect of TIPS on survival and the risk factors for poor outcome are

still not clearly defined in RH. Thus, the final decision to insert a TIPSshould be reached on an individual patient basis after amultidisciplinary clinical evaluation (5,D)

*Defined as: symptomatic hydrothorax not responsive to standard medicaltreatment (sodium restriction and maximal tolerable doses of diuretics)requiring repeated thoracentesis

Votation 3.3. Votes in Favour 100%.Comment: Refractory hydrothorax occurs in approximately 5-

0% of patients with advanced cirrhosis. TIPS has been investigateds a treatment option in 8 uncontrolled retrospective studies145,148,155–159] and several case reports. Overall 227 patientsere included. The reported complete and partial responses were

8.3–71.0% and 11.0–20.8%, respectively. An overall clinically relevantesponse (resolution of hydrothorax and reduction in thoracentesis)as shown in about 70% of patients. The average 30-days mortality

ate is 22%. A high creatinine level is the stronger prognostic factor forarly mortality. The 1-year survival ranges from 48 to 64%. Survival wasorrelated with response to TIPS, age <60 years and MELD score <15.

3.4. Is there a role for TIPS in Hepatopulmonary syndrome?

Statement 3.4At present, there is no sufficient evidence to support the use of TIPS for the

treatment of hepatopulmonary syndrome [5].

Votation 3.4. Votes in Favour 95%.Comment: Few case reports described the successful treatment of

PS with TIPS placement [160]. In larger study on this topic [161] TIPSeither improved nor worsened gas exchange in patients with HPS.

ESSION 4: TIPS in vascular disorders

Sinusoidal occlusion syndrome (SOS*)Hepatic veno-occlusive syndrome (SOS) is characterized by hep-

tomegaly, ascites, weight gain and jaundice, due to the damage ofmall hepatic vessels affecting particularly the sinusoidal endothe-ium with a partial or complete occlusion of small hepatic veins. The

ost frequent causes are hematopoietic stem cell transplantationSCT) and alkaloid ingestion, but it is also observed after solid organransplantation [162]. (Supplementary material—Appendix 2).

*Defined as: damage to small hepatic vessels affecting particu-arly sinusoidal endothelium with a partial or complete occlusionf small hepatic veins.

4.1. Is there a role for TIPS in Sinusoidal Occlusion Syndrome (SOS)*?

Statement 4.14.1. TIPS is not indicated in Sinusoidal Occlusion Syndrome in Bone

Marrow Transplanted Patients (C4), but may be considered in individualbasis in Solid Organ Transplant Recipient as stand-alone treatment or as


bridge to liver transplantation in a setting of multidisciplinaryevaluation (4,C) [163,164].

Votation 4.1 Votes in favour 100%.


Comment: The incidence of SOS after SCT can be as high as 70%,depending on the specific diagnostic criteria, sample size and risk fac-tors, which are highly heterogeneous among different cohorts [162].In liver transplant recipients the largest series reported an incidence of1.9%, mainly related to the number and severity of rejection episodesand azathioprine use. A poor outcome of SOS after bone marrow trans-plantation is reported with 63% mortality, mainly related to liver failureand renal insufficiency secondary to portal hypertensive complica-tions. After liver transplantation only 7 patients with severe SOS havebeen treated with TIPS placement. Overall survival in this small cohortwas good [163,164].

Portal vein thrombosis

4.2. Is TIPS feasible in the presence of portal vein thrombosis (PVT)?

Statements 4.24.2a TIPS is feasible in patients with portal vein thrombosis with and

without cirrhosis, but it bears higher failure and complication rateswhen portal cavernoma, fibrous transformation of the main portal veinor intrahepatic branches thrombosis, are present (4,C).

4.2b Extension of the TIPS stent into the portal or superior mesenteric veinshould be considered when recanalization of PV/SMV is incomplete andthe patient is not a liver transplant candidate (5,D)

Votation 4.2: 100%.

4.3. Which are the indications to TIPS in portal vein thrombosis?

Statements 4.34.3a TIPS can be considered to treat PVT in both cirrhotic and non-cirrhotic

patients with progression of thrombosis despite adequate anticoagulanttreatment, or when there is an absolute contraindication toanticoagulation, or with no response after a maximum of 6 months ofanticoagulation treatment (3a, B).

Votation 4.3 Votes in favour 100%.Comment: The spontaneous recanalization rate of acute PVT in non-

cirrhotic patients is rare and response to anticoagulation therapy hasbeen described in about 50%. Therefore development of chronic por-tal vein thrombosis (20% portal cavernoma) and appearance of portalhypertensive complications eventually occur in about 50% of patients[165–167]. Moreover these patients bear an increased risk of splanch-nic venous system thrombosis and biliary complications. According tomultivariate analysis of clinical studies, prophylaxis of variceal bleed-ing is similar between cirrhotics and non cirrhotics [165–167], and,in selected patients, low mortality and re-bleeding rates have beenobserved after surgical porto systemic shunting [168]. However, theproportion of patients in which these shunts are feasible remainsunclear.

In cirrhotic patients, PVT is the most common thrombotic event,with an annual incidence up to 12% in absence of HCC [169,170].Despite a spontaneous recanalization has been described in up to 40% ofcases (mainly in partial PVT), progression of thrombosis has also beenreported in 48% up to 70% of patients at 2 years [171–173]. Data onthe efficacy of medical anticoagulation to treat PVT come from cohortstudies which included 163 anticoagulated patients with different regi-mens (LMWH or VKA). Repermeation rate ranged from 55% to 75% withmean interval time of about 6 months [173–180]. In patients withextension of the thrombus into the superior mesenteric vein the riskof intestinal infarction and associated mortality is higher [181]. TIPShave been performed in patients with PVT at different severity, mostlynon cirrhotic and even in presence of cavernomatous transformation ofthe portal vein [9,11,20,173] (Supplementary material—Appendix 3).The patency of intra-hepatic portal veins branches and partial throm-bosis of the main trunk are positive prognostic factors for technicalsuccess [182]. The thrombotic occlusion of the intrahepatic portal veinbranches compels the use of transcutaneous approach which bears an


hypertension. In liver transplant candidates with progressive portal

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ein thrombosis, early TIPS placement could be considered aiming atnsuring a patent portal vein during the transplant procedure.

Budd chiari syndrome (BCS)BCS results from blockage of exit of the blood from the liver

ither due to hepatic vein thrombosis or obstruction of the inferiorena cava [185,186].

4.4. Is TIPS indicated in hyper acute and chronic BCS?

Statements 4.44.4a In BCS patients, in a stepwise approach, TIPS with covered stent is

indicated in case of failure of anticoagulation (and angioplasty whenfeasible), represented by persistent ascites, renal failure or elevatedtransaminases (5, D).

4.4b Listing for liver transplantation should be considered in case of aprognostic index score greater than 7 in patients candidate to TIPS forBCS (2b, B) [183].

4.4c. When TIPS is attempted to treat hyper acute BCS with acute liverfailure presentation, the listing process for transplantation should notbe delayed (4,C).

Votation 4.4: Votes in favour 100%.Comment: In BCS, liver injury results from hepatic congestion,

nd side-to-side portocaval shunts were previously used for the man-gement of this disorder. At present, a wide array of options arevailable for patients with BCS, ranging from no intervention to liverransplantation. A validated model (based on encephalopathy, ascites,rothrombin time and bilirubin) has been developed which allows forhe prediction of survival of patients with BCS: only in patients withn intermediate prognosis, a side-to-side portocaval shunt showed aositive impact on survival [187]. There have been a number of caseeports and small series on the outcome of patients with BCS who haveeceived a TIPS showing worse results in patients with underlyingore advanced liver disease [19,188,189] and acute hepatic failure

190,191]. Patients with chronic disease did much better with relieff symptoms, improvement in liver function and a good intermediate2–4 years) survival [190,191]. In a retrospective report from Europen 221 patients with BCS, a lower than expected success rate (92%) and

higher than expected complication rate (18%) was observed, high-ighting the technical difficulties in positioning a TIPS in patients withepatic vein thrombosis [5]. One and ten year transplant free survivalere 88% and 69% respectively which are better than predicted by a

isk scoring system developed for BCS patients. TIPS dysfunction wasbserved significantly more often in those who received a bare as com-ared to a covered stent [5]. Positioning a TIPS in patient with BCS cane difficult when the hepatic veins are completely occluded: In this case

transcaval approach for TIPS may be performed but this procedurehould be reserved to highly experienced centres [192].

4.5. Is TIPS indicated for non-cirrhotic idiopathic portal hyperten-ion (INCPH)*?

Statement 4.54.5. TIPS can be considered in NCIPH, applying the same indications

utilized for the management of portal hypertensive complications (3b,B). Caution is needed in patients with refractory ascites, kidney failureand comorbidities (3b, B) [193].

*Defined as: an increased portal venous pressure gradient in the absence of aknown cause of liver disease and portal vein thrombosis.

Votation 4.5: votes in favour 100%.Comment: In contrast to the high prevalence of this disorder in

ndia, INCPH is a rare disease in the Western world. Associated riskactors for INCPH are chronic infections, exposure to medication oroxins, thrombophilia, immunological disorders, and genetic disorders.

ultifactorial aetiology can also be encountered. Chronic abdominalnfection the most important etiological factor among Eastern patients,

hether thrombophilia is relevant for Western patients. The majorityf patients with INCPH initially present with signs or complications


f portal hypertension (mainly variceal bleeding and splenomegaly).hese patients usually have preserved liver function. Liver functionmpairment occurs mainly in the context of intercurrent conditions


[194]. In 69 biopsy proven cases of INCPH with a mean follow-up of6.7 ± 4.6 years, all had evidence of portal hypertension at diagnosis,and 42% were symptomatic [195]. Amongst 41 patients with NCIPHtreated with TIPS for portal hypertensive complications 11 died: serumcreatinine, ascites as indication for TIPS and the presence of significantcomorbidities at the time of the procedure emerged as death-relatedrisk factors [193].

SESSION 5: TIPS in liver transplant setting

Patients on the waiting list for liver transplantation (LT) oftenrequire treatment of complications related to portal hypertensionsuch as gastrointestinal bleeding, refractory ascites or vascularthrombosis. Besides medical or endoscopic treatments, reductionof portal hypertension by trans jugular intrahepatic Porto systemicshunt (TIPS) may be required if other measures fail, in order topreserve their candidacy for LT [196].

5.1. Which are the indications and contraindications to TIPS place-ment in patients listed for LT?

Statement 5.15.1a. The indications and contraindications to TIPS in patients listed for LT ar

identical to those recommended for non waitlisted patients (2b, B) [123].5.1b. A specific indication to TIPS in patients listed for LT is to maintain paten

of portal vein if at risk of occlusion (2b, B) [11,196].5.1c. In the absence of priority for liver transplantation, TIPS should be

considered for patients with low MELD scores or MELD exceptions (2b, B) [1

Votation 5.1. Votes in Favour: 95%.Comment: TIPS has been shown to be effective in managing

complications of portal hypertension also in patients listed for LT[25,196,197,201]. However, TIPS placement in patients on the wait-ing list for LT may influence several clinical aspects not only relatedto the outcome of primary complication of liver disease (i.e. gas-trointestinal bleeding or refractory ascites), but also related to thepatient’s priority in the waiting list due to MELD score modifications[10,11,196,197,199,201–203].

5.2. Can TIPS placement have an impact on transplant surgeryand/or intra-operative management?

Statements 5.25.2a The choice of adequate stent length, positioning, and extension from

the portal to the hepatic vein, is paramount to avoid hampering vascularcross-clamping at the time of surgery (4,C) [115,196,199,202,203,207].

Votation 5.2 Votes in Favour 100%.Comment: The presence of TIPS on the one hand may reduce

the intraoperative blood loss following portal decompression but onthe other it may enhance the difficulty of the transplant procedure.In about 28% of LT patients TIPS had migrated, increasing the timespent on by pass and complexity of transplant operation. The pres-ence of TIPS however does not have any influence on intra-operativeblood requirements, length of hospital stay or early survival after LT[115,196,199,202,203,207]. No significant advantage in performingTIPS before living donor liver transplantation has been observed [125].

5.3. Which is the role of TIPS in post-LT patients?

Statement 5.35.3. TIPS after LT is indicated to treat portal hypertension-related

complications secondary to recurrent liver disease* (2b,B) and venouscomplications** (2b,C) [132,163,164].

*Refractory ascites, gastrointestinal bleedin**Portal vein thrombosis (PVT), Sinusoidal obstruction syndrome (SOS),

Hepatic vein outflow obstruction (HVOO), Small for size syndrome (SSS)

Votation 5.3. Votes in Favour: 100%.


may evolve because of allograft dysfunction/rejection, biliary compli-cations, and recurrent disease [163,164,198,200,204–210]. Peculiarindications to TIPS in liver transplanted patients refer to treatment of

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everal vascular complications. These complications accounted for PVT,OS, and HVOO [163,164]. The use of TIPS in treatment of PVT afterT has been associated with a reduced risk of bleeding and technicalomplications in comparison with trans hepatic puncture for portalein interventional procedures [204,205] Although no randomizedrials evaluated the efficacy and safety of TIPS in treating SOS, someuthors have suggested that TIPS placement can be tried in carefullyelected patients with SOS after LT, particularly if retransplantations not an option [164,192] Despite HVOO after LT is uncommon, its a life-threatening complication if untreated. Because of the smallample size behind the current data on TIPS in patients with HVOO204], TIPS placement for treating HVOO cannot be routinely recom-

ended, but considered in a individual patient basis, potentially as aridge to retransplantation [205]. SSS, which develops in a graft with

suboptimal parenchymal mass, is more frequent in LT performedith partial grafts. Until now, the treatment options for SSS focused

o reduce the portal flow via the embolization of a portion of spleen.ome reports showed the efficacy in treating SSS with TIPS placement.ecause the number of treated patients is still very limited, TIPS place-ent for SSS should be considered in selected cases, when no other

reatment options are available [163,164].

5.4. Are there specific technical issues and feasibility of TIPS place-ent after LT?

Statement 5.45.4a. Knowledge of portal and hepatic venous anatomy and surgical

anastomoses is paramount to appropriate TIPS positioning after LT(conventional technique vs. latero-lateral or termino-lateral piggybackanastomoses and partial grafts) (2c, B) [198,204,210].

5.4.b TIPS feasibility in whole-size LT does not differ from what reported innon-transplant patients (2b) [200,204–206,208,210].

A 5.4c TIPS feasibility rates in partial graft and in kinked piggyback


anastomoses are lower (4) [206].

Votation 5.4. Votes in Favour: 100%.Comment: TIPS placement can be difficult after LT

198,204–206,208,210] particularly in split grafts, particularly

Box 1 Tips indications in marginal clinical settings to controlSome clinical scenarios may pose concerns about the appropriatene

of procedure-related complications and/or a worst outcome. Notabnegatively affected by underlying comorbidity. The following box isby chronic kidney diseases (CKD), haemophilia, myeloid metaplasia amainly based on few case reports or small series of patients. Therefobasis.

CKDThe available data suggest considering TIPS placement to prevent

in end-stage renal disease requiring renal-replacement therapy [223,rapid dialysis after TIPS creation, to avoid the development of fluid overight atrial pressure afterload. However, the risk of marked encephalodisease is high. Therefore it appears reasonable to reserve TIPS to pa

HaemophiliaThe available data suggest considering TIPS placement in haemoph

logical and endoscopic treatment. With peri-procedural factor VIII supthe outcomes appear to be comparable to those in patients without h

PregnancyTreatment of bleeding EV occurring during pregnancy is a rare but

are associated with significant increases in both mortality and compliin portal hypertension occurs during the last stages of the second trimhypertension related bleeding in the later stages of pregnancy [229–2in pregnant patients who bleed or rebleed despite an optimal pharmandatory, TIPS could prophylactically decompress abdominal wall v

Hepatic myeloid metaplasia in IMExtra medullary haematopoiesis in the liver can lead to portal hyperte

sis of the hepatic or splenoportal veins. Hepatic myeloid metaplasia mTreatment of the complications of PHT might not differ from that ofrescue treatment to control portal hypertension complications (varice

*CKD, chronic kidney disease; IM, idiopathic myelofibrosis.


for those derived from left liver lobe. This is related to the fact thatalmost all interventional radiologists are accustomed to performingthe TIPS from a right or middle hepatic vein approach while targetingthe right portal vein. Real time ultrasound guidance or gun-sitetechnique may be useful to place the TIPS in the left hepatic vein [210].

5.5. Which are the complication rates of TIPS placement after LT?

Statement 5.5The incidence of TIPS obstruction, infections and development of hepatic

encephalopathy are similar between LT and non-LT patients (2b,B)[198,204,210].

Votation 5.5 Votes in Favour 100%.Comment: It must be noted that more recent data concerning the

rates of TIPS obstruction, infection and the development of hepaticencephalopathy after LT compared to native livers, derived from stud-ies involving the use of covered stents [204]. This observation mayexplain why in the past, when bare stents were used, rates of complica-tions after TIPS placement in LT patients were observed more frequentlythan in native livers [198,204,208,210].

5.6. Which are the clinical response rates and the outcome of TIPSplacement after LT?

Statement 5.65.6.a. The overall clinical response rates to TIPS in LT patients is lower than

in pre-transplant patients, mainly in the case of refractory ascites (2b)[209,210].

5.6b. In LT recipients with a MELD score >15 and in those with refractoryascites secondary to HCV recurrence with a MELD score >12, TIPS hasbeen associated with greater failure rates in the pre-direct antiviralagents (DAA) era: thus, it should be considered with caution if no DAAoption is available (2b,B).

Votation 5.9 Votes in Favour: 100% and 85%.Comment: Most recent studies report that TIPS appears to be less


clinically effective in LT compared with not liver transplanted patients[205,208–210]. Moreover, TIPS for treating ascites after LT is likelyto have a poor clinical response [209]. Although this difference in

bleeding or to prevent rebleeding.ss of TIPS procedure, mainly due to the potential higher incidencely, the outcome of portal hypertension complications could bean attempt to clarify the feasibility of TIPS in patients affectednd in pregnancy. Please note that these lines of information are

re, indication to TIPS must be evaluated on an individual patient

rebleeding or control bleeding in patients affected by CKD, even224]. Patients can be “rebalanced” to a new euvolemic state byrload, pulmonary oedema and TIPS dysfunction due to elevated

pathy in subjects with haemodialysis-dependent end-stage renaltients suitable for combined liver/kidney transplantation.

ilic patients who bleed or rebleed despite an optimal pharmaco-plementation, TIPS have been placed without complications andaemophilia [225–228].

relevant clinical dilemma. Complications of portal hypertensioncations during pregnancy or in the post-partum period. Increaseester of pregnancy and is associated with increased risk of portal31]. The available literature suggest considering TIPS placementmacological and endoscopic treatment. If caesarean section isarices if they provide high operative risk [232–234].

nsion and related complications even in the absence of thrombo-ay cause both sinusoidal and presinusoidal portal hypertension.

patients with cirrhosis. Indeed, available data support TIPS as aal bleeding and ascites) [235–237].

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he outcomes seem to be consistent among the studies it should beointed out that they differ from each other in the definition of clinicaluccess for ascites response and in the retransplant thresholds. Onlyew studies evaluated the clinical response to TIPS after LT in rela-ionship to the combination of MELD score and the indication to TIPS200,201,204,209]. Most Authors agree that transplant free survivals poorer and MELD threshold predicting poor survival is lower thanhose of patients with native livers [201,209,210]. The availability ofhe new DAAs is expected to modify the outcome of post-LT TIPS inCV positive recipients. At present, there are no data to differentiateost-TIPS PPG target between LT and non-LT patients.

ESSION 6: unusual inications to tips placement

lease note that these lines of information are mainly based on few caseeports or small series of patients. Therefore, indication to TIPS must bevaluated on an individual patient basison-cirrhotic portal hypertension (NCPH) in HIVon-cirrhotic portal hypertension (NCPH) has been reported as a liver disease

n Human Immunodeficiency Virus (HIV)-infected patients underntiretroviral therapy (ART) [211] Combination of non-exclusive mechanismsas been described: primary endothelial damage of terminal portal veins

nduced by HIV or immunologic disorders, mitochondrial toxicity byidanosine and prothrombotic state [212]. It is characterized byeterogeneous liver histological findings, frequently identified as nodularegenerative hyperplasia and clinical manifestations of portal hypertensionith well-preserved liver function [213,214].

he key issues in the management of patients with idiopathic noncirrhoticortal hypertension are related mainly to treatment and prevention of varicealaemorrhage. While data are limited in this population regarding the bestpproach, patients are typically managed in the same manner as those withortal hypertension due to cirrhosis (2,C).eneral surgeryhe risk of surgery should be considered individually depending upon thelinical setting: the presence of cirrhosis and the type of procedure: cirrhoticatients who present for elective and emergent surgery pose a formidablehallenge for the surgeon because of the high reported morbidity andortality. The Child-Turcotte-Pugh (CTP) score has been used for decades to

valuate preoperative severity of liver dysfunction and to predictostoperative outcome. The MELD score has been shown to predict accuratelyhe 3-month mortality for cirrhotic patients after TIPS placement. Surgery isenerally well-tolerated by cirrhotic patients in Child-Turcotte-Pugh class A orith a MELD <10 [215]. Surgery is generally permissible in patients in

hild-Turcotte-Pugh class B or with a MELD 10–15 (except those undergoingxtensive hepatic resection or cardiac surgery) who have undergone thoroughreoperative preparation) [216]. Patients with portal hypertension bear an

ncreased risk of bleeding during intraabdominal surgery. Therefore, it haseen suggested that preoperative TIPS placement may improve the prognosisf cirrhotic patients submitted to abdominal surgery [217].ontraindications for TIPS placement are identical whether or not the patient

s a potential candidate for abdominal surgery. Portal decompression witheoadjuvant TIPS placement might reduce the risk of intraoperative bleedingnd perioperative complications in patients with cirrhosis undergoing surgery,ut experience is limited, and a case-by case multidisciplinary-based decisionhould be made (4,D).ardiac surgeryardiac surgery is associated with increased mortality in patients withirrhosis compared to other surgical procedures. A number of risk factors forepatic decompensation following cardiac surgery have been identified

ncluding the total time of cardiopulmonary bypass, use of non-pulsatile aspposed to pulsatile cardiopulmonary bypass, and need for perioperativeressor support [218]. Cardiopulmonary by-pass can exacerbate underlyingoagulopathy by inducing platelet dysfunction, fibrinolysis, andypocalcaemia. Thus, the least invasive options, such as angioplasty,alvuloplasty, or minimally invasive revascularization techniques, should beonsidered in patients with advanced cirrhosis who require invasiventervention for cardiac disease [219].


IPS might be considered before cardiac surgery in selected patients withortal hypertension. However, the role of preoperative TIPS has not been welltudied in this context, where TIPS placement is strongly affected by the heartonditions: a careful multidisciplinary evaluation is warranted before optingor TIPS (5;D) [218,219].


Paediatric patientsPortal hypertension (PH) in children differs from adults in two main aspects:(1) Cirrhotic disease has usually an early onset and a rapid progression, leadingto transplantation in the first two years of life (i.e. biliary atresia).Consequently, the length of the follow-up of children with severe cirrhotic PHis short. (2) Non-cirrhotic causes of portal hypertension instead are verycommon and long-standing, representing the main group of patients in thefollow up for PH [220]. These patients usually have extra hepatic portal veinobstruction (EHPVO) and conditions characterized by the wide spectrum ofthe liver ductal plate malformation. Very commonly they develop severebleeding episodes unresponsive to medical and endoscopic treatment, as wellas hypersplenism, but do not progress to end-stage liver disease, and thereforehave no indication for liver transplantation. In this setting porto-systemicshunting has become an important tool in the armamentarium available tocontrol severe PH, especially in non-cirrhotic conditions [168]. When coveredstents were not yet available, TIPS in children has been used both in cirrhoticand non-cirrhotic patients with a moderate success [221]. A recent studyshowed that children with severe portal hypertension could be managed verysuccessfully with covered TIPS, with no significant complications and a goodcontrol of bleeding in the mid-term [222]. In another study, TIPS wassuccessfully placed in 11 of 13 (85%) children weighing more than 10 kg,including cirrhotic, non-cirrhotic and transplanted patients. Following TIPS,the Porto systemic gradient decreased to below 10 mmHg, portal hypertensioncomplications resolved in 10 of 11, no clinically apparent encephalopathydeveloped; TIPS revision was necessary in 3 patients. Shunts were patent atfollow-up (0.2–67 months) in 7 children without transplant and in 4 children(1.5–33 months) with transplant [220].Feasibility and safety:TIPS has been shown to be technically feasible and safe in children weighingmore than 10 kg of body weight (4,C).Efficacy: TIPS as been effective in children with cirrhotic and non-cirrhotic PH,as well in liver transplant complications. However, further studies are stronglyadvocated to support the routine use of TIPS out of expert centres, in childrenwith PH unresponsive to medical and endoscopic treatment (4,D).

Areas requiring investigation in TIPS positioning and patient assessmentThe possible future studies regarding the TIPS should include the management

of most frequent side effects, which are strictly correlated with the diameterof the shunt. Indeed, a variable diameter of TIPS may change the volume ofporto systemic shunting remotely controlled to tune for varyingrequirement.

Conflict of interestNone declared.

Appendix A. Supplementary data

Supplementary data associated with this article can be found, inthe online version, at http://dx.doi.org/10.1016/j.dld.2016.10.011.

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