HONOLULU – Early use of a transjugular intrahepatic portosystemic shunt (TIPS) is associated with substantial reductions in mortality, according to an analysis of a national inpatient database.
Based on this study, “early use of TIPS, together with patient and physician education on current guidelines and protocols, should continue to be a priority to improve patient outcomes” in patients with hepatic cirrhosis and risk of recurrent esophageal variceal bleeds, reported Dr. Basile Njei, a gastroenterology fellow at Yale University, New Haven, Conn.
In this study, the Nationwide Inpatient Sample database was queried by ICD-9 codes to identify patients with esophageal variceal bleeding treated between the years 2000 and 2010. The goal was to compare early use of TIPS, defined as TIPS administered within 72 hours of the bleeding, relative to rescue TIPS, defined as TIPS after two or more episodes of bleeding or one bleeding episode followed by another endoscopic intervention, such as balloon tamponade or surgery.
Over the period of study, a Poisson regression analysis used to control for multiple variables associated any TIPS utilization with an inverse association with overall mortality, producing a relative risk of 0.88 (95% confidence interval, 0.83-0.92). In the context of timing of TIPS, in-hospital mortality fell from 5.6% for those who received rescue TIPS to 1.5% in those who underwent early TIPS.
On multivariate analysis, an advantage was observed for early TIPS relative to rescue TIPS for in-hospital mortality (RR, 0.85; P less than .01), in-hospital rebleeding (RR, 0.57; P less than .01), and length of hospital stay (RR, 0.87; P less than .01). Rates of sepsis (RR, 0.83; P = .32) and hepatic encephalopathy (RR, 0.87; P = .22) were not significantly lower in the early TIPS group, but they were also not increased. For early TIPS versus no TIPS, the advantages on multivariate analysis were similar for both in-hospital deaths (RR, 0.87; P less than .01) and in-hospital rebleeding (RR, 0.57; P less than .01), but no advantage was seen for length of stay for TIPS versus no TIPS (RR, 0.99; P = .18).
Overall, there was a steady decline in mortality associated with esophageal variceal bleeding over the period of evaluation, falling incrementally over time from 656 deaths per 100,000 hospitalizations in 2000 to 412 deaths per 100,000 in 2010. This 37.2% reduction was statistically significant (P less than .01). The reduction in mortality was inversely associated with an increasing use of TIPS over the study period.
The data from this analysis are consistent with a multicenter randomized trial conducted several years ago in Europe (N Engl J Med. 2010;362:2370-9). In that study 63 patients with hepatic cirrhosis and acute variceal bleeding who had been treated with vasoactive drugs plus endoscopic therapy were randomized to early TIPS or rescue TIPS. At 1 year, 86% of those in the early TIPS group were alive versus 61% (P = .01) of those randomized to receive TIPS as a rescue strategy.
Relative to the previous study, the key finding of this study is that early TIPS “is associated with significant short-term reductions in rebleeding and mortality without a significant increase in encephalopathy in real world U.S. clinical practice,” according to Dr. Njei. It substantiates the European study and encourages a protocol that emphasizes early TIPS, particularly in those with a high risk of repeat esophageal variceal bleeding.
In the discussion that followed the presentation of these results at the annual meeting of the American College of Gastroenterology, the moderator, Dr. Paul Y. Kwo, medical director of liver transplantation, Indiana University, Indianapolis, pointed out, that some of those in the rescue TIPS group might simply have been poor candidates for this intervention. Although he praised the methodology of this study, which won the 2015 ACG Fellows-In-Training Award, he questioned whether rescue TIPS was a last resort salvage therapy in those initially considered poor risks for TIPS. Dr. Njei responded that the multivariate analysis was specifically designed to control for variables such as risk status to diminish this potential bias. Indeed, he said he believes TIPS is underemployed.
“The relatively small percentage of eligible cases receiving early TIPS suggests that there is room for further improvement in the treatment of patients with decompensated cirrhosis and esophageal variceal bleeding,” Dr. Njei concluded.
Dr. Njei reported that he had no relevant financial relationships to disclose.