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Interim US multicenter results of Viatorr ePTFE TIPS Endoprosthesis trial


, : Interim US multicenter results of Viatorr ePTFE TIPS Endoprosthesis trial. Hepatology 38(4 Suppl 1): 293A, October

Purpose: To describe inrterim results associated ViatorrTM TIPS Endoprostheses in newly created transjugular intrahepatic portosystemic shunts (TIPS) on the interim cohort of patients enrolled in the US Randomized Clinical Trial. PATIENTS: Sixty-three TIPS were created in 63 patients (age: 54.2 years (r, 18-79)), gender: (15 F, 48 M) using ePTFE-lined ViatorrTM (W.L. Gore) TIPS endoprostheses(four 8mm diameter devices, 61 10mm, and 15 12mm) at 14 centers. Indications: 49% variceal bleeding, 48% ascites, 3% hepatic hydrothorax. Etiology: Hep B 8%, Hep C 44%, Alcoholic cirrhosis 73.0%, Cryptogenic 8% Other 8%; several patients had multiple etiologies. Initial Child-Pugh Class: A 12.7%, B 69.8%, C 15.9%. Patients were followed clinically at 1, 3, and 6 months. Patency was venographically assessed at 6 months defined as % residual stenosis <50% (independent core lab) and PSG<12mmHg. RESULTS: At protocol 6 month venography, 35 (80%) subjects maintained primary patency, 9 (20%) had patency failures (6 (14%) with PSG> 12mm Hg, 1 TIPS stenosis (2%), 1 PSG and stenosis failure, 1 reintervention due to unstented hepatic vein narrowing). Outcome. 7 deaths, 3 liver transplants. Portosystemic gradients decreased from 20 mmHg (+-7.1) to 7.8 (+-3.5) after TIPS. At the 6-month follow-up, mean PSG was 8.6 mmHg (+-3.3). Final and 6 month PSG were not significantly different (p=0.29). Mean % stenosis in 42 subjects was 14.0% (+-13.5%). CONCLUSION: This ePTFE TIPS stent graft is effective at maintaining, stable, unchanged portosystemic gradients with low instent stenosis rates at 6 month follow up.

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