TY - JOUR
T1 - Transjugular Intrahepatic Portosystemic Shunt Creation Using a Radiofrequency Wire
T2 - Prospective Clinical Safety and Feasibility Trial in Cirrhosis
AU - Farsad, Khashayar
AU - Narasimhan, Evan
AU - Russell, Lori
AU - Kaufman, John A.
N1 - Funding Information:
This study was supported by the Dotter Department of Interventional Radiology at Oregon Health and Science University. Radiofrequency wires and generator and IRB startup funds were provided by Baylis Medical (Montreal, Canada). Feasibility and Safety of Transjugular Intrahepatic Portosystemic Shunt [TIPS] Creation Using A Radiofrequency Guidewire; NCT03451149. The authors thank Asa DiCarlo for help in completion of case report forms. K.F. receives grants from Baylis Medical (Montreal, Quebec, Canada), personal fees from Cook Medical (Bloomington, IN), BTG (London, United Kingdom), Neuwave (Madison, Wisconsin), Genentech (South San Francisco, California), and Dova Pharmaceuticals (Durham, North Carolina), grants and personal fees from Guerbet (Villepinte, France) and Cook Medical, and holds a patent licensed to Auxetics (Portland, Oregon). E.N. and L.R. receive grants from Baylis Medical. J.A.K. receives grants from Baylis Medical, US National Institutes of Health (Bethesda, Maryland), and WL Gore (Newark, Delaware), grants and personal fees from Guerbet, Covidien (Dublin, Ireland), Delcath (Queensbury, New York), American Roentgen Ray Society/American Journal of Roentgenology (Leesburg, Virginia), and Biomet (Warsaw, Indiana), royalties from Elsevier (Amsterdam, The Netherlands), is an owner of Hatch Medical (Santa Rosa Beach, Florida), Vu Medi (Oakland, California), Endoshape (Boulder, Colorado), and Veniti (Fremont, California), owns stock in Javelin Medical (Yokneam Illit, Israel), AV Medical (Tel Aviv, Israel), and Bio2 Medical (San Antonio, Texas), and is a cofounder of and owns equity in Auxetics, Inc. None of the other authors have identified a conflict of interest.
Funding Information:
K.F. receives grants from Baylis Medical (Montreal, Quebec, Canada), personal fees from Cook Medical (Bloomington, IN), BTG (London, United Kingdom), Neuwave (Madison, Wisconsin), Genentech (South San Francisco, California), and Dova Pharmaceuticals (Durham, North Carolina), grants and personal fees from Guerbet (Villepinte, France) and Cook Medical, and holds a patent licensed to Auxetics (Portland, Oregon). E.N. and L.R. receive grants from Baylis Medical. J.A.K. receives grants from Baylis Medical, US National Institutes of Health (Bethesda, Maryland), and WL Gore (Newark, Delaware), grants and personal fees from Guerbet, Covidien (Dublin, Ireland), Delcath (Queensbury, New York), American Roentgen Ray Society/American Journal of Roentgenology (Leesburg, Virginia), and Biomet (Warsaw, Indiana), royalties from Elsevier (Amsterdam, The Netherlands), is an owner of Hatch Medical (Santa Rosa Beach, Florida), Vu Medi (Oakland, California), Endoshape (Boulder, Colorado), and Veniti (Fremont, California), owns stock in Javelin Medical (Yokneam Illit, Israel), AV Medical (Tel Aviv, Israel), and Bio2 Medical (San Antonio, Texas), and is a cofounder of and owns equity in Auxetics, Inc. None of the other authors have identified a conflict of interest.
Publisher Copyright:
© 2020 SIR
PY - 2020/9
Y1 - 2020/9
N2 - Purpose: To assess the safety and feasibility of using a radiofrequency (RF) wire for portosystemic shunt creation. Materials and Methods: Ten patients undergoing elective creation of a transjugular intrahepatic portosystemic shunt (TIPS) or a direct intrahepatic portosystemic shunt (DIPS) were prospectively enrolled. Primary outcomes were the safety and feasibility of RF wire used for the creation of TIPS and DIPS. Median age was 66.5 ± 6.1 years. Causes of liver disease included alcohol (n = 5), nonalcoholic steatohepatitis (n = 2), hepatitis C virus (n = 1), primary biliary cirrhosis (n = 1), autoimmune hepatitis (n = 1). The median score for model for end-stage liver disease was 11 ± 4.3. The Rosch-Uchida TIPS set was used with intravascular ultrasonography guidance in all cases. A 0.035-inch RF wire was used in lieu of the trocar needle through the 5-F TIPS set catheter to create a track between the hepatic vein and the portal vein. All shunts were created using stent grafts. Results: Technical success rate was 100%. In 7 of 10 patients, portal vein access was achieved with a single pass. A DIPS was created in 2 patients based on anatomic favorability. Median fluoroscopy time was 13.3 ± 3.8 min, and median total procedure time was 102 ± 19 min. The wire passed through parenchyma without subjective deflection. There was 1 case of extracapsular puncture with no clinical consequence. The RF wire was too stiff to curve into the main portal vein, requiring wire exchange in all but 1 case. Mean portosystemic gradient decreased from 13.9 ± 3.3 to 5.9 ± 2.1 mm Hg. No immediate complications were encountered. Shunt patency was 100% at 30 days. Conclusions: Creation of TIPS and DIPS using an RF wire was safe and feasible, enabling creation of an intrahepatic track without subjective deflection in cirrhotic patients.
AB - Purpose: To assess the safety and feasibility of using a radiofrequency (RF) wire for portosystemic shunt creation. Materials and Methods: Ten patients undergoing elective creation of a transjugular intrahepatic portosystemic shunt (TIPS) or a direct intrahepatic portosystemic shunt (DIPS) were prospectively enrolled. Primary outcomes were the safety and feasibility of RF wire used for the creation of TIPS and DIPS. Median age was 66.5 ± 6.1 years. Causes of liver disease included alcohol (n = 5), nonalcoholic steatohepatitis (n = 2), hepatitis C virus (n = 1), primary biliary cirrhosis (n = 1), autoimmune hepatitis (n = 1). The median score for model for end-stage liver disease was 11 ± 4.3. The Rosch-Uchida TIPS set was used with intravascular ultrasonography guidance in all cases. A 0.035-inch RF wire was used in lieu of the trocar needle through the 5-F TIPS set catheter to create a track between the hepatic vein and the portal vein. All shunts were created using stent grafts. Results: Technical success rate was 100%. In 7 of 10 patients, portal vein access was achieved with a single pass. A DIPS was created in 2 patients based on anatomic favorability. Median fluoroscopy time was 13.3 ± 3.8 min, and median total procedure time was 102 ± 19 min. The wire passed through parenchyma without subjective deflection. There was 1 case of extracapsular puncture with no clinical consequence. The RF wire was too stiff to curve into the main portal vein, requiring wire exchange in all but 1 case. Mean portosystemic gradient decreased from 13.9 ± 3.3 to 5.9 ± 2.1 mm Hg. No immediate complications were encountered. Shunt patency was 100% at 30 days. Conclusions: Creation of TIPS and DIPS using an RF wire was safe and feasible, enabling creation of an intrahepatic track without subjective deflection in cirrhotic patients.
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U2 - 10.1016/j.jvir.2020.05.025
DO - 10.1016/j.jvir.2020.05.025
M3 - Article
C2 - 32792278
AN - SCOPUS:85089258885
SN - 1051-0443
VL - 31
SP - 1401
EP - 1407
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
IS - 9
ER -