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Comparison of the Covered Self-Expandable Viatorr CX Stent with the Covered Balloon-Expandable BeGraft Peripheral Stent for Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation: a Single-Centre Retrospective Study in Patients with Variceal Bleeding

  • Clinical Investigation
  • TIPS
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Abstract

Purpose

This study compares the safety and efficacy of the ePTFE-covered self-expansible nitinol stent (VIATORR® Controlled Expansion, Gore, Flagstaff, USA) with the ePTFE-covered, balloon-expandable, metallic stent (BeGraft peripheral, Bentley, Hechingen, Germany) for the creation of the transjugular intrahepatic portosystemic shunt (TIPS).

Material and Methods

From September 2016 to December 2020, 72 consecutive patients receiving TIPS for acute variceal bleeding (rescue and early TIPS, n = 15) or for prophylaxis of variceal rebleeding (n = 57) were enrolled. The main contraindications were patients with vascular liver disease (portal vein thrombosis and Budd-Chiari syndrome). Forty patients (55.6%) received a Viatorr CX stent and 32 patients (44.4%) a BeGraft peripheral stent. Safety endpoints were technical and clinical adverse events and early deaths within 30 days after TIPS implantation. Efficacy endpoints were rebleeding rates, recurrence of large varices requiring endoscopic band ligation, or TIPS revision.

Results

Groups receiving the Viatorr CX or BeGraft peripheral stent were comparable in all respects except the TIPS indication for acute variceal bleeding (5% vs. 25%, p = 0.015). All patients had a successful intervention, and the physical variables of stent implantation (intervention and fluoroscopy time, reduction of the portosystemic pressure gradient) as well as adjunctive embolization of varices were similar in both groups. Severe clinical complications (Viatorr CX: 5% vs. BeGraft peripheral: 3.1%, p = 0.692), post-TIPS hepatic encephalopathy (12.5% vs. 18.8%, p = 0.743) and death (5% vs. 0%, p = 0.793) were not different between Viatorr CX and BeGraft peripheral groups. With respect to efficacy, freedom from rebleeding and from variceal band ligation during follow-up (100% vs. 100%, p = 1.0), as well as the need for shunt revision (10.5% vs. 18.8%, p = 0.327), was comparable.

Conclusion

Compared to the present gold standard, the Viatorr CX stent, the balloon-expandable BeGraft peripheral stent, showed similar results with respect to safety and efficacy.

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Abbreviations

BCS:

Budd-Chiari syndrome

EBL:

Endoscopic band ligation

FIPS:

Freiburg Index of Post-TIPS Survival

HE:

Hepatic encephalopathy

HR:

Hazard ratio

MELD:

Model of End-Stage Liver Disease

PSG:

Portosystemic pressure gradient

PTFE:

Polytetrafluoroethylene

TIPS:

Transjugular intrahepatic portosystemic shunt

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Funding

This study was not supported by any funding.

Author information

Author notes

  1. Michael Schultheiss and Dominik Bettinger have contributed equally to this work.

Authors and Affiliations

  1. Department of Medicine II, Faculty of Medicine, Medical Center University of Freiburg, University of Freiburg, Hugstetter Str. 55, 79106, Freiburg im Breisgau, Germany

    Michael Schultheiss, Dominik Bettinger, Lukas Sturm, Arthur Schmidt, Robert Thimme & Martin Rössle

  2. Berta-Ottenstein-Programme, Faculty of Medicine, University of Freiburg, Freiburg im Breisgau, Germany

    Dominik Bettinger & Lukas Sturm

  3. Department of Medicine I, Faculty of Medicine, Medical Center University of Ulm, University of Ulm, Albert-Einstein-Allee 23, 89081, Ulm, Germany

    Johanna Backhus

  4. Department of Medicine I, Faculty of Medicine, Medical Center University of Frankfurt, University of Frankfurt, Theodor-Stern-Kai 7, 60596, Frankfurt am Main, Germany

    Oliver Waidmann

  5. Klinik Für Innere Medizin I, Klinikum Saarbrücken, Saarbrücken, Germany

    Klaus Radecke & Daniel Grandt

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Contributions

MS and MR designed the study; MS, DB, LS, AS, JB, OW, KR, DG, MR were involved in acquisition of data and revision for important intellectual content; MS, DB, MR analysed the data and drafted the manuscript; DB and MR performed statistical analyses; and MS, DB, RT, MR were involved in interpretation of the data. All authors approved the final version of the article, including the authorship.

Corresponding author

Correspondence to Martin Rössle.

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Conflict of interest

MS has received speaker honorarium from Falk Foundation e.V., Roche Pharma AG, W. L. Gore & Associates and was a consultant for Bayer HealthCare. DB has received speaker honorarium form Falk Foundation e.V. and was consultant for Bayer HealthCare, Boston Scientific and Shionogi. RT was a consultant for Bayer Healthcare. MR was a consultant for Angiomed and Bentley. The other authors declare that they have no conflict of interest.

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For this type of study formal consent is not required.

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This study has obtained IRB approval from the ethics committee of the University Hospital Freiburg (no. 580/19) and was registered in the German Registry of Clinical Studies (DRKS00021157). The need for informed consent was waived due to the retrospective design of the study.

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Schultheiss, M., Bettinger, D., Sturm, L. et al. Comparison of the Covered Self-Expandable Viatorr CX Stent with the Covered Balloon-Expandable BeGraft Peripheral Stent for Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation: a Single-Centre Retrospective Study in Patients with Variceal Bleeding. Cardiovasc Intervent Radiol 45, 542–549 (2022). https://doi.org/10.1007/s00270-021-03040-8

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