Controlled underdilation using novel VIATORR® controlled expansion stents improves survival after transjugular intrahepatic portosystemic shunt implantation

Michael Praktiknjo, Jasmin Abu-Omar, Johannes Chang, Daniel Thomas, Christian Jansen, Patrick Kupczyk, Filippo Schepis, Juan Carlos Garcia-Pagan, Manuela Merli, Carsten Meyer, Christian P Strassburg, Claus C Pieper, Jonel Trebicka, Michael Praktiknjo, Jasmin Abu-Omar, Johannes Chang, Daniel Thomas, Christian Jansen, Patrick Kupczyk, Filippo Schepis, Juan Carlos Garcia-Pagan, Manuela Merli, Carsten Meyer, Christian P Strassburg, Claus C Pieper, Jonel Trebicka

Abstract

Background & aims: Smaller 8-mm diameter transjugular intrahepatic portosystemic shunts (TIPS) appear to be more beneficial than larger 10-mm TIPS stent-grafts, but lack the ability for secondary dilation in cases of clinical ineffectiveness. Underdilated VIATORR® TIPS stent grafts (VTS) expand passively, whereas novel VIATORR Controlled Expansion (VCX) stent grafts do not. This study evaluated the impact on survival of underdilated VCX compared with VTS in patients with decompensated cirrhosis.

Methods: This was a prospective case-control study including patients with cirrhosis receiving TIPS using 10-mm VCX underdilated to 8 mm. Patients with cirrhosis receiving 10-mm VTS underdilated to 8 mm were matched for age, sex, indication for TIPS, and liver function.

Results: A total of 114 patients (47 VCX, 47 VTS, and 20 fully dilated VCX/VTS) were included. After TIPS implantation, underdilated VCX diameter was 8.0 (7.8-9.2) mm at a median time of 359 (87-450) days, compared with VTS at 9.9 (9.7-10.0) mm (p <0.001). The portosystemic pressure gradient immediately after TIPS procedure and after 7 days did not change significantly in VCX [mean 9.4 (± 0.8) vs. 10.4 (± 0.7) mmHg, p = 0.115). Hospital readmission rates for hepatic encephalopathy were 23% (n = 11) vs 51% (n = 24) for VCX and VTS (p <0.001), respectively. Patients with VCX had significantly lower rates of large-volume paracentesis (n = 5 [11%] vs. n = 10 [21%], p = 0.017) and heart failure (n = 1 [2%] vs. n = 7 [15%], p = 0.015). One-year mortality for underdilated VCX and VTS was 15% (n = 7) and 30% (n = 14) and, for fully dilated VCX/VTS, was 45% (n = 9) (log-rank p = 0.008), respectively.

Conclusions: This study demonstrated that VCX stent grafts underdilated to 8 mm do not passively expand to nominal diameter and suggests reduced hospital readmissions because of hepatic encephalopathy, uncontrolled ascites, and heart failure, and improved 1-year survival compared with underdilated VTS.

Lay summary: Transjugular intrahepatic portosystemic shunt (TIPS) improves survival in selected patients with liver cirrhosis and acute variceal bleeding or refractory ascites. Smaller 8-mm diameter TIPS stent grafts appear to improve patient outcome compared with larger 10-mm diameter stent grafts. Novel VIATORR® Controlled Expansion (VCX) stent grafts facilitate safe and stable underdilation to 8 mm of large 10-mm diameter stent grafts with improved patient outcome (survival, hepatic encephalopathy, ascites and heart failure) compared with legacy VIATORR TIPS stent graft (VTS). Thus, the use of underdilated VCX could preserve heart function.

Clinical trials registration: The study is registered at Clinicaltrials.govNCT03628807.

Keywords: Acute decompensation; Ascites; CT, computed tomography; Cirrhosis; HE, hepatic encephalopathy; HF, heart failure; Hepatic encephalopathy; LV, left ventricular; LV-GLS, LV global longitudinal strain; LVP, large-volume paracentesis; Liver; MELD, model of end-stage liver disease; NEPTUN, Non-invasive Evaluation Program for TIPS and follow Up Network; PSPG, portosystemic pressure gradient; PTFE, polytetrafluorethylene; RA, recurrent/refractory ascites; RAAS, renin-angiotensin-aldosterone system; SPSS, spontaneous portosystemic shunt; TIPS; TIPS, transjugular intrahepatic portosystemic shunt; TTE, transthoracic echocardiography; Transjugular intrahepatic portosystemic shunt; VB, variceal bleeding; VCX, VIATORR controlled expansion; VTS, VIATORR TIPS stent.

Conflict of interest statement

M.P. received funding from the 10.13039/501100008436Ernst und Berta Grimmke Foundation (Germany) (Lfd.Nr.5/19), BONFOR research program of the University of Bonn, Germany (2020-2A-07). J.T. received funding from the 10.13039/100010661European Union’s Horizon 2020 research and innovation program’s GALAXY study (No. 668031), LIVERHOPE (No. 731875), MICROB-PREDICT (No. 825694), the 10.13039/100008050Cellex Foundation, and W.L. Gore & Associates Medical. Please refer to the accompanying ICMJE disclosure forms for further details.

© 2021 The Author(s).

Figures

Graphical abstract
Graphical abstract
Fig. 1
Fig. 1
Flow chart of patient cohorts included in the study. VCX, VIATORR controlled expansion; VTS, first generation VIATORR stent-graft.
Fig. 2
Fig. 2
One-year survival analysis. (A) Kaplan-Meier survival curve for 1-year survival stratified by stent type. VCX underdilated to 8 mm (green), VTS underdilated to 8 mm (yellow), VCX and VTS stent grafts fully dilated to 10 mm (red). p by log-rank. Crosses are censor events. X-axis shows time between TIPS and death in months. Y-axis shows 1-cumulative incidence. (B) Univariate Cox regression analysis for 1-year survival. Plot shows HR and 95% CI. (C) Multivariate Cox regression analysis for 1-year survival. Plot shows HR and 95% CI. HR, hazard ratio; MELD, model of end-stage liver disease; VCX, VIATORR controlled expansion, underdilated 8 mm; VTS, first-generation VIATORR stent-graft, underdilated 8 mm; WBC, white blood cell count.
Fig. 3
Fig. 3
Evolution of median stent diameter measured by computed tomography reconstruction at last follow-up. X-axes show time of measurement. (A) VCX (n = 47). Y-axis shows diameter in mm. (B) VTS (n = 30). Y-axis shows diameter in mm. (C) Evolution of PSPG of patients with a VCX immediately after TIPS implantation and 7 days post implantation (n = 21). Y-axis shows PSPG in mmHg. PSPG, portosystemic pressure gradient; VCX, VIATORR controlled expansion; VTS, first-generation VIATORR stent graft.
Fig. 4
Fig. 4
Time-to-event analysis for hospitalisation for (A) hepatic encephalopathy, (B) large-volume paracentesis and (C) heart failure. X-axes show time between TIPS and hospitalisation in months. Y-axes show cumulative incidence. p by log-rank. Blue indicates patients with a VCX implanted; red indicates patients with a VTS implanted. TIPS, transjugular intrahepatic portosystemic shunt; VCX, VIATORR controlled expansion; VTS, first-generation VIATORR stent graft.
Fig. 5
Fig. 5
Evolution of cardiac function. (A) Fraction of patients with normal LV-GLS by speckle-tracking echocardiography before and after TIPS. Blue indicates patients with a VCX implanted; red indicates patients with a VTS implanted. Y-axis shows the fraction of patients. p by paired non-parametric testing. Evolution of LV-GLS before and 6 weeks after TIPS implantation in patients receiving (B) VCX or (C) VTS. Y-axes show LV-GLS in percent. LV-GLS, left ventricular global longitudinal strain; TIPS, transjugular intrahepatic portosystemic shunt; VCX, VIATORR controlled expansion; VTS, first-generation VIATORR stent graft.

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