Abstract

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). 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 30days after TIPS implantation. Efficacy endpoints were rebleeding rates, recurrence of large varices requiring endoscopic band ligation, or TIPS revision. 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. 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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