Improved clinical outcome using polytetrafluoroethylene-coated stents for TIPS: results of a randomized study.
OBJECTIVE
A 50% dysfunction rate at 1 year is one of the main drawbacks of the transjugular intrahepatic portosystemic shunt procedure. Preliminary experimental and clinical studies suggest that the use of stents covered with polytetrafluoroethylene could tremendously decrease this risk.


METHODS
Eighty patients with cirrhosis and uncontrolled bleeding (n = 23), recurrent bleeding (n = 25), or refractory ascites (n = 32) were randomized to be treated by transjugular intrahepatic portosystemic shunts with either a polytetrafluoroethylene-covered stent (group 1; 39 patients) or a usual uncovered prosthesis (group 2; 41 patients). Follow-up Doppler ultrasound was scheduled at day 7, at 1 month, and then every 3 months for 2 years. Angiography and portosystemic pressure gradient measurements were performed 6, 12, and 24 months after the transjugular intrahepatic portosystemic shunt procedure and whenever dysfunction was suspected. Dysfunction was defined as a >50% reduction of the lumen of the shunt at angiography or a portosystemic pressure gradient >12 mm Hg.


RESULTS
After a median follow-up of 300 days, 5 patients (13%) in group 1 and 18 (44%) in group 2 experienced shunt dysfunction (P < 0.001). Clinical relapse occurred in 3 patients (8%) in group 1 and 12 (29%) in group 2 (P < 0.05). Actuarial rates of encephalopathy were 21% in group 1 and 41% in group 2 at 1 year (not significant). Estimated probabilities of survival were 71% and 60% at 1 year and 65% and 41% at 2 years in groups 1 and 2, respectively (not significant).


CONCLUSIONS
The use of polytetrafluoroethylene-covered prostheses improves transjugular intrahepatic portosystemic shunt patency and decreases the number of clinical relapses and reinterventions without increasing the risk of encephalopathy.
Bureau
Christophe
C
Service d'Hépato-Gastro-Entérologie, Fédération Digestive, Centre Hospitalier Universitaire Purpan et U531 Institut National de la Santé et de la Recherche Médicale, Toulouse, France. bureau.c@chu-toulouse.fr
Garcia-Pagan
Juan Carlos
JC
Otal
Philippe
P
Pomier-Layrargues
Gilles
G
Chabbert
Valérie
V
Cortez
Carlos
C
Perreault
Pierre
P
Péron
Jean Marie
JM
Abraldes
Juan G
JG
Bouchard
Louis
L
Bilbao
José Ignacio
JI
Bosch
Jaume
J
Rousseau
Hervé
H
Vinel
Jean Pierre
JP
D000328:Adult; D000368:Aged; D020099:Coated Materials, Biocompatible; D006471:Gastrointestinal Hemorrhage / Q000209:etiology* / Q000601:surgery*; D006501:Hepatic Encephalopathy / Q000453:epidemiology / Q000209:etiology; D006801:Humans; D015994:Incidence; D008103:Liver Cirrhosis / Q000150:complications; D008875:Middle Aged; D011138:Polytetrafluoroethylene; D019168:Portasystemic Shunt, Transjugular Intrahepatic / Q000295:instrumentation / Q000401:mortality; D011475:Prosthesis Failure; D015607:Stents / Q000009:adverse effects; D016019:Survival Analysis; D016896:Treatment Outcome; D014648:Varicose Veins / Q000150:complications*
D020099:Coated Materials, Biocompatible; D011138:Polytetrafluoroethylene