A new era for transjugular intrahepatic portosystemic shunts

CIRRHOSIS affects approximately 300,000 adults in North America and causes more than 32,000 deaths annually (1). Most of the morbidity associated with cirrhosis results from the development of portal hypertension and its principal sequelae: variceal hemorrhage and ascites. Creation of a transjugular intrahepatic portosystemic shunt (TIPS) is a minimally invasive means of creating a portosystemic shunt that can markedly decrease portal hypertension and its complications. Like so many other great advances in medicine, TIPS was first conceived by serendipity. In 1969, Rosch and colleagues were attempting to perform transjugular cholangiography in animals by puncturing across the substance of the liver from the hepatic vein. They often entered the portal vein and quickly realized that they had discovered a new technique for creating an “intrahepatic” portosystemic shunt (2). Rosch and others subsequently went on to develop the TIPS procedure. In the early 1990s, large clinical trials proved the clinical utility of the TIPS procedure as a bridge to transplantation in patients with severe complications of portal hypertension (3–5). Since that time, a number of randomized trials that compared TIPS creation to a course of endoscopic therapy for the prevention of recurrent variceal bleeding have been completed (6–12). All these studies have shown essentially the same thing: that recurrent variceal bleeding is significantly less frequent after TIPS creation (in 10%–25% of patients) than after endoscopic therapy (in 35%–50%). However, TIPS creation is also associated with a higher rate of hepatic encephalopathy (approximately 30%, compared with 15% with endoscopic therapy). A significant difference in long-term survival has not been demonstrated. Because of these results, gastroenterologists and hepatologists generally consider TIPS creation a second-line therapy that is most useful as a bridge to transplantation. Moreover, the clinical utility of TIPS creation has always been limited by problems with recurrent stenosis and occlusion. Surveillance and multiple repeated interventions are required to maintain patency in more than 50% of patients within 1 year. This leads to added expense and increased clinical failure. In patients with high function and Child class A disease, selective surgical shunts are often preferable because of their durability and perceived lower associated encephalopathy rates. The role of TIPS relative to other available therapies is dramatically limited by poor patency, the cost of surveillance and repeat intervention, and concerns about hepatic encephalopathy. In 1995, our group began to explore the use of handmade stent-grafts for the creation of TIPS and demonstrated a marked improvement in patency relative to uncovered shunts, but only when expanded polytetrafluoroethylene (ePTFE) was used as the covering material (13). We went on to report the first small series of patients in 1997, in which a marked improvement in patency and clinical outcome was demonstrated (14); these results were later reproduced and confirmed by Haskal and associates (15,16). It is interesting to note how little interest there has been on the part of device manufacturers in the design and development of a device dedicated to TIPS since those initial reports. Unlike with endografts for aneurysms and stents of all types for other applications, it has taken a long time for a commercial stent-graft to be developed and tested for the TIPS application. It is a lesson in medical economics when one realizes that only one company (W.L. Gore & Associates, Flagstaff, AZ) has pursued development of a dedicated device. A relatively small, underinsured patient population does not attract great attention from large device manufacturers no matter how beneficial the advance might be medically. In this issue of the Journal of Vascular and Interventional Radiology, the study by Hausegger et al (17) adds substantially to a growing body of knowledge about the creation of TIPS with use of a commercial ePTFE-covered stent-graft that is designed for TIPS creation and revision. The question arises as to whether the results are substantially different than those with uncovered stents, and, if so, whether that will change the role of TIPS in the From the San Diego Vascular Institute, Diagnostic Imaging and Interventional Radiology, North County Radiology Medical Group, Tri-City Medical Center, 4002 Vista Way, Oceanside, California 92056. Received December 3, 2003; revision requested December 8; revision received and accepted December 11. Address correspondence to R.R.S.; E-mail: rsaxon5@cox.net