First Results of the Transatlantic BD Liverty TIPS Stent Graft trial; The Small Shunt Era, A New Paradigm

To report the safety and efficacy of the Liverty TIPS device for creating TIPS from 6-10mm for treatment of ascites, hydrothorax, and variceal hemorrhage, and validate the Tailored Expansion Procedure (TEP) step-up approach to small caliber TIPS creation.

Materials and Methods:

177 patients (mean age 58.5y (r, 28-88); 59.3% M /40.7% F) at 26 centers in the US, France, and Germany underwent successful TIPS creation with Liverty™ TIPS Stent Graft (BDPI, Tempe, AZ). Primary indications included ascites 68.4%; esophageal 24.3% & gastric 2.8% variceal bleeding; and hepatic hydrothorax 4.5%.  40.7% of shunts were 6 and 7 mm diameter at final size (if TEP performed); 83.1% of TIPS were 6-8mm diameter.

Results:

Technical success for shunt creation was 100%. Mean baseline PSG of 17.8mm Hg (r, 7-33) was reduced to 7.8mm Hg (r, 2-13). 90.4% of TIPS were patent and free from shunt dysfunction at 6-month (p=0.0002) (Primary Endpoint).  Re: safety, there were no causal nor probable device related major complications(CEC adjudicated). Freedom from major complications through 30-days was 85.8% (p=.4341)(Primary Endpoint).  West-Haven Grade 1 & 2 hepatic encephalopathy (HE) events resolved with medical therapy; proportion of patients free from major complications was 94.3% (p < 0.0001); probability of freedom of ≥ grade 3 HE was 95% (0% for 6,7 mm TIPS). Overall clinical success: ascites 78.8 %; esophagogastric variceal bleeding (VB) 96.7%; hydrothorax 71.4%. Clinical success for 6,7 mm TIPS patients: ascites 84.8%; VB 91.7%; HE 80% were unimpaired at 6 months (compared to 69.2% in 'large' (8-10mm) shunts). Transplant-free survival at 6 months was 81.4%. Mean HRQoL metrics were essentially stable (w/some improvement in social participation, pain).

Conclusion:

 The Liverty TIPS stent graft proved effective for durable control of variceal bleeding, refractory ascites and hydrothorax related to portal hypertension. Post-hoc analysis corroborated safety when West-Haven Grades 1&2 resolved with medical therapy and not included as major complications. Novel smaller 6 and 7mm diameter TIPS resulted in lower incidence and severity of HE at all time points compared to 'traditional' shunt diameters of 8-10 mm. This prospective multicenter trial shows the utility, safety, and efficacy of smaller caliber (6,7 mm) TIPS in patients as initial therapy and the 'step-up' TEP approach to shunt diameter as the recommended new norm and strategy for TIPS creation.