Managing the expansion of TIPS stents supports optimal post TIPS gradient and reduces post TIPS HE

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1 Managing the expansion of TIPS stents supports optimal post TIPS gradient and reduces post TIPS HE Schepis Filippo, MD Hepatic Hemodynamic Laboratory Gastroenterology Unit University Hospital of Modena - Italy

2 Background Nitinol-based eptfe covered-stents PPG (VIATORR ) represent the standard option for TIPS creation in cirrhotic patients Unfortunately, development of hepatic encephalopathy (HE) makes hepatologists still cautious in indicating TIPS positioning HE is related to post-tips portosystemic pressure gradient (PPG) drop TIPS caliber (diameter) represents one of the hemodynamic factors determining post-tips PPG No definitive data exist on the VIATORR ability either to self-expand to nominal diameter or to maintain smaller calibers when under ballooned to avoid unwarranted PPG drop Riggio et al, 2006 (Modified from Casado et al., 1998)

3 Aims Primary Objectives To define the "behavior" of VIATORR in cirrhotic livers by answering the following questions: 1) Do VIATORR endoprosthesis self-expand to their nominal diameter? 2) Do they keep undersized? Secondary Objectives To define the relationship between VIATORR diameter and the achievement of clinically relevant endpoints by answering the following questions: 3) What s the relationship between VIATORR diameter and the post-tips PPG? 4) What s the relationship between VIATORR diameter and the post-tips incidence of portal hypertensive complications

4 Methods - Cohort retrospective study - Centralized image analysis 226 patients mm Ø 28 8mm Ø 56 from Modena 39 from Florence (Dr F. Vizzutti) 27 from Milan (Dr A. Rampoldi) 26 from Rome (Dr F. Fanelli) 25 from Bologna (Dr R. Golfieri) 20 from Bergamo (Dr R. Agazzi) 19 from Pavia (Dr P. Quaretti) 14 from Palermo (Dr A. Luca)

5 Methods - Single operator - Venous phase DIS - Double Oblique MPR - Blooming artifact correction - Larger diameter at each section - Average diameter calculated IPT PVW SVW

6 Distance from ND (%) Results 1) Do VIATORR endoprosthesis self-expand to their nominal diameter (ND)? Percent distance from ND of each implanted VIATORR Individual patients

7 Diameter (mm) Results 1) Do VIATORR endoprosthesis self-expand to their nominal diameter (ND)? Average diameter of different sections of VIATORR ballooned to their ND 10,0 9,5 9,0 8,5 N=34 8,0 7,5 7,0 N=11 10 mm 8 mm 6,5 6,0 5,5 5,0 PVW IPT SVW SVT CT section

8 Deviation from BD BD(%) 2) Do they keep undersized? Results mm BD 6 mm BD 30,0 17,5 12,5 0,0 27,5 15,0-2,5 42,5 10,0 0 0,5 1,0 1,5 2,0 2,5 3,0 3,5 4,0 25,0-5,0 40,0 12,5 22,5 37,5 7,5-7,5 20,0 35,0 10,0-10,0-12,5 17,5 32,5 7,5 30,0 2,5-15,0 12,5 27,5 0,0-17,5 25,0 2,5 10,0 22,5-2,5 0 0,5 1,0 1,5 2,0 2,5 3,0 3,5-20,0 20,0 0,0-22,5-5,0 7,5 17,5-2,5 5,0 0 0,5 1,0 1,5 2,0 2,5 3,0 3,5 4,0-25,0 15,0-7,5-5,0 2,5-27,5 12,5-10,0-30,0 10,0-7,5-2,5-12,5 7,5 0 0,5 1,0 1,5 2,0 2,5 3,0 3,5-32,5-10,0-5,0-35,0-12,5-15,0-7,5-37,5-10,0 0,0-15,0-17,5-40,0-2,5-12,5 0 0,5 1,0 1,5 2,0 2,5 3,0 3,5-20,0-42,5-17,5-5,0-15,0-7,5-17,5-20,0-22,5-45,0-10,0 Time (Log10 days) 10 mm 10 mm 10 8 mm mm Linear (10 mm) Linear (10 mm) Linear (8 mm) Linear (8 mm)

9 Diameter (mm) Diameter (mm) 2) Do they keep undersized? Results Average diameter for the main groups of patients (10 mm) 9,5 9,0 8,5 8,0 7,5 7,0 6,5 6,0 N=198 p=0,003 p=0,007 p=0,003 p=0,39 p=0,06 6mm 7mm 8mm 9mm 10mm Balloonng groups 7,6 7,4 7,2 7,0 6,8 6,6 6,4 6,2 6,0 Balloonng groups Average diameter for each ballooning group (Ø 8 mm) p=0,046 p=0,31 N=28 6mm 7mm 8mm Balloonng groups p=0,21

10 Proportion (%) Results 3) What s the relationship between VIATORR diameter and the post-tips HVPG? Ballooning and PPG targets N=95 (25 vs 70) ns 0,018 6 mm > 6 mm Ballooning groups <12 mmhg <10 mmhg

11 Patients free of HE Results 4) What s the relationship between VIATORR diameter and the post-tips incidence of HE or portal hypertensive complications? N=95 Ballooning Ballooning Remaining cases Time (days)

12 Patients free of paracentesis Results 4) What s the relationship between VIATORR diameter and the post-tips incidence of HE or portal hypertensive complications? N=58 Ballooning Ballooning Remaining cases Time (days)

13 Conclusions and Take Home message VIATORR do not reach their nominal diameter both in the intraparenchymal and suprahepatic tract even though properly ballooned When undersized, 10mm Ø VIATORR quite reliably keep dilatation at 7, 8 (and 9mm), while 8mm Ø VIATORR at 6 and 7mm. Overall, VIATORR ballooning at 6mm ensures the achievement of the primary hemodynamic target (PPG <12mm Hg) in about 50% of patients with a 20% risk of exceeding the secondary (PPG <10mm Hg) Pragmatic ballooning at 6mm significantly reduces the risk of post- TIPS hepatic encephalopathy without decreasing the control of portal hypertensive complications (ascites)

14

15 Acknowledgments Modena Firenze Careggi Milano Niguarda Pavia San Matteo Guido Marzocchi Cristian Caporali Stefano Colopi Mario De Santis Tommaso Di Maira Stefano Gitto Erica Villa Francesco Vizzutti Umberto Arena Luigi Rega Aldo Airoldi Antonio Rampoldi Luca Belli Pietro Quaretti Ilaria Fiorina Lorenzo Moramarco Raffaele Bruno Bologna Sant Orsola Bergamo HPG23 Palermo ISMETT Roma La Sapienza Rita Golfieri Cristina Mosconi Matteo Renzulli Roberto Agazzi Roberto Nani Stefano Fagiuoli Angelo Luca Roberto Miraglia Fabrizio Fanelli Alessandro Cannavale Oliviero Riggio

16 THANKS FOR THE ATTENTION

17 CT maximum diameter (mm) Diameter (mm) Methods CT protocol test on VIATORR phantom CT protocol test on VIATORR phantom Average diameter of VIATORR phantom 10, ,5 9 8,5 8 7, Serie1 Serie mm 10mm Ordered sections 0

18 PVW IPT SVW DIS

19 Patients free of HE Patients free of paracentesis Results 4) What s the relationship between VIATORR diameter and the post-tips incidence of HE? N=95 N=58 Remaining cases Time (days) Remaining cases Time (days)

20 Managing the expansion of TIPS stents supports optimal post TIPS gradient and reduces post TIPS HE Schepis Filippo, MD Hepatic Hemodynamic Laboratory Gastroenterology Unit University Hospital of Modena - Italy

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