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Transjugular intrahepatic portosystemic stent shunt GOETZ M. RICHTER THOMAS ROEREN MARTIN ROESSLE JULIO C. PALMAZ
In 1967 Hanafee spurred interest in a non-surgical approach to the main vessels and ducts of the liver by utilizing a percutaneous right internal jugular vein access across the right atrium of the heart and into one of the major hepatic veins (Hanafee and Weiner, 1967). Two years later, Rosch and Hanafee described a method to create non-surgically a connection between the inferior vena cava and the portal circulation in dogs (Rosch et al, 1969). In the following decade, several comparable experimental models were presented which did not achieve definite clinical applicability for the treatment of portal hypertension (Koch et al, 1973; Reich et al, 1977; Burgener and Gutierrez, 1979). The clinical use of such a concept was not implemented until the early 1980s with Colapinto’s description of the first successful intrahepatic portosystemic shunt in the human using the transjugular approach (Colapinto et al, 1982). His technique was based on prolonged or repeated balloon dilation of a parenchymal track bridging hepatic and portal vein branches. However, clinical outcome and benefit in a series of patients were rather disappointing and patency of the shunts was maintained only in a small number of patients (Abecassis et al, 1985; Gordon et al, 1987). More durable portosystemic shunts were obtained by Palmaz et al (1985, 1986) by applying vascular metallic stents for the maintenance of shunt track patency in a dog model as early as 1985. Rosch used a modified version of the self-expanding Gianturco stent for the same purpose in pigs. His long-term results were, however, limited by progressive shunt occlusion as a result of intimal and parenchymal overgrowth within the shunt track. The question whether stent design problems or a peculiar response of swine liver were the reason for the unfavourable results could not be settled (Rosch et al, 1987). Palmaz achieved 50% long-term patency in a canine model without portal hypertension (Palmaz et al, 1985) and 100% patency when the animals had portal hypertension (Palmaz et al, 1986). This experience justified the search for a reproducible and reliable technique of transjugular intrahepatic portosystemic stent shunting to treat patients with severe portal hypertension. In 1987 the authors submitted to the Institutional Baillidre’s Clinical GastroenterologyVol. 6, No. 2, June 1992 ISBNO-702CL1623-3
403 Copyright @ 1992, by Baillitre All rights of reproduction in any form
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Revision Board of the University Hospital of Freiburg (Ethik-Kommittee) a pilot study application for first clinical use of transjugular intrahepatic portosystemic stent shunt (TIPSS). The first successful procedure was accomplished in January 1988 (Richter et al, 1989). From then on, the technique of TIPSS was developed and improved, drawing on experience gathered in 60 patients to date (Richter et al, 1990a,b, 1991). Initially, the study protocol restricted the use of the procedure to patients in whom conservative management with repeat sclerotherapy and vasoactive drugs failed to control bleeding and who were at prohibitive risk for surgical shunts. Subsequent accumulation of technical and clinical experience encouraged a wider and more deliberate use of TIPSS to include younger patients and milder stages of liver disease. HAEMODYNAMIC AND RHEOLOGICAL THE TIPSS CONCEPT
BACKGROUND
OF
The total blood supply of the normal liver is approximately 1500 ml/min of which two-thirds corresponds to portal inflow and the other third to arterial inflow. Liver cirrhosis is associated with a significant decrease of portal blood flow resulting from an up to tenfold increase of sinusoidal vascular resistance (Child and Turcott, 1964; Galambos, 1985; Rossle et al, 1990). Thus, the total liver perfusion is reduced with concomitant development of portal hypertension; while a flow volume of 500mVmin is considered borderline portal perfusion, 20% of all patients with portal hypertension show lower flow volumes (Child and Turcott, 1964; Galambos, 1985; Rossle et al, 1990). Particularly in patients with end-stage liver disease, the portal perfusion may drop to zero as a result of stagnant or reversed (portofugal) flow. Reversed portal flow is found in up to 10% of all patients with microscopically proven liver cirrhosis. Depending on the haemodynamic arrangement, portosystemic shunts may be non-selective or selective. Selectivity in this context refers to the selective deviation of the gastroepiploic portal blood to a systemic shunt (mainly the left renal vein) while portal liver perfusion from the mesenteric portal route is maintained. Non-selective shunts include end-to-end and side-to-side versions, and a host of different surgical techniques such as portocaval, mesocaval and various other H-interposition shunts. End-toside shunts are portocaval shunts with distal ligation of the portal vein. The concept of side-to-side shunts originated in the idea of maintaining portopetal flow while lowering the pressure which favours perfusion in the portosystemic pathways. However, this does not necessarily occur, as many research groups demonstrated reversal of portal flow after side-to-side shunts. An additional result of these shunts may be onset or increase of arterio-portal flow. Redeker et al (1958) reported arterio-portal flow volumes as high as 40-1100 ml/min in interposition shunts. It is well understood that the amount of such arterio-portal flow corresponds with the shunt size. Rypins et al (1984) and Sarfeh et al (1983, 1986) showed that arterioportal flow develops as soon as the shunt size reaches 50% of the diameter of
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the portal vein. Murray et al (1961) demonstrated that 70% of the arterial blood volume to the liver was lost via retrograde portal flow as soon as a large-calibre side-to-side portocaval shunt was created in a dog model. Such a portofugal steal effect is avoided when in portocaval shunts a hilar ligation of the portal vein is performed. In this case, the lack of portal perfusion is compensated by a net increase in arterial liver perfusion (Rector et al, 1988; Rossle et al, 1990). The typical selective shunt is the distal splenorenal shunt described by Warren et al (1982). In this shunt the pressure in the variceal collaterals is reduced by anastomosing the splenic vein to the left renal vein. Another important feature of this technique is careful ligation of the retropancreatic venous tributaries to the portal circulation as well as the ligation of gastroepiploic vein branches (Millikan et al, 1985). With this shunt partial but haemodynamically sufficient portal decompression should be assured while the integrity of mesoportal blood flow is believed to maintain adequate liver perfusion. However, recent duplex sonographic examinations revealed that flow reversal may develop in splenorenal shunts in a significant number of patients 1 year after surgery. This is contributed by the formation of new portosystemic pathways (Ohnishi et al, 1985; Lafortune et al, 1987; Bolondi et al, 1988; DeLacy et al, 1989). Portal flow reversal after shunt procedures may be accompanied by a significant alteration in liver function. This has been substantiated by a variety of publications (Foster et al, 1971; Ohnishi et al, 1985; Spina et al, 1988; DeLacy et al, 1989; Rossle et al, 1990). In three out of four randomized studies of distal splenorenal shunt versus side-by-side portocaval shunt, signficantly increased incidence of hepatic encephalopathy was found after H-interposition shunts (Reichle et al, 1979; Fischer and McCinley, 1985; Spina et al, 1988; Pagliaro et al, 1989). This was explained by onset of arterio-portal shunting. However, a new positive stimulus to side-to-side shunt techniques arose from reports on prosthetic small-calibre H-shunts. These shunts were believed to decrease the pressure within the portosystemic collateral pathways enough to prevent variceal bleeding while at the same time avoiding arterio-portal shunting by keeping the net pressure within the portal circulation sufficiently high. This was proved in a series of 50 patients by Johansen (1989). Rheologically and haemodynamically, the TIPSS procedure may be also categorized as a small-calibre interposition shunt, with two potential advantages: 1. 2.
The interposition is totally intrahepatic and centrally positioned, thus allowing unimpeded flow. Since the key element of TIPSS is the application of an expandable metallic stent, possible variation of Palmaz stent diameters by the use of different balloon sizes offer optimal adaptation of the shunt lumen to the haemodynamic needs of each individual patient. This also allows further increase of the shunt diameter whenever necessary. Other vascular stents that are currently on the market do not offer this perspective.
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ASPECTS OF TIPSS
Initial te-chnical problems The creation of a wide, central and more or less straight course of the intrahepatic shunt track was considered to be crucial for early and long-term success. Based on this premise, the puncture track should run from the proximal part of either the right or the middle hepatic vein to the upper wall of either one of the main portal vein branches. Therefore, exact knowledge of the anatomic relationship between the portal bifurcation and the hepatic vein radicles is mandatory. Initially, attempts were made to increase the accuracy of the puncture by establishing an additional transhepatic access to the portal circulation via a routine midaxillary approach (Rosch et al, 1987; Richter et al, 1989, 1990). For this purpose a small retrieval basket was placed within the portal bifurcation to serve as a target for the transjugular needle puncture. In the first successful 13 cases, the puncture was performed by using a 22-gauge Brockenborough needle through which a 0.014 in coronary wire was passed after portal access was gained. These preliminary attempts had an initial technical success of 70%. However, the average procedural time was near 7 hours as a result of a host of procedural problems; these included multiple and prolonged needle passes due to poor steerability of the needle as a result of its weak metal body. In addition, safe and stable portal access was difficult to achieve due to the flimsiness of the coronary wire. In some cases heavy-duty wires could be placed only after insertion of individually bent metal stiffeners. More importantly, lethal haemorrhagic complications resulted from the transhepatic access to the portal circulation. This happened in 2 of the first 16 patients in whom this technique was tried. These early technical problems are described in greater detail in the initial reports (Richter et al, 1989, 1990a,b). Development of better needles There is no single key element for improving the safety and efficacy of this procedure; rather, detailed improvement of many technical aspects has led to a safe and standardized procedure. It has been shortened significantly by the development and use of a more suitable needle with better torque control and a bigger inner lumen, allowing passage of larger and stiffer wires. Two needle types currently on the market seem to fulfil the requirements for safe and easy puncture. One of them is a 20-gauge coaxial needle, designed by the authors, with a 0.6-mm blunt tip obturator (Angiomed, Karlsruhe, Germany). It is advanced into the liver veins through an 8-FG multipurpose catheter, the distal body of which is scaffolded with wire mesh to prevent its perforation during needle insertion. For the puncture, the obturator is exchanged for a sharp, highly flexible inner mandril. The second needle is part of the Colapinto transjugular liver biopsy set (Cook, Bloomington, Ind., USA). It has a 16-gauge bevelled tip and is introduced through a 9-FG Teflon catheter. This needle allows primary passage of a 0.9-mm wire. Disadvantages with both needles should be overcome soon
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with the availability of 17-gauge and 19-gauge single piece, tapered tip needles that will be available with different curves allowing primary passage of heavy-duty wires. This is extremely helpful in avoiding the risk of large holes in the abdominal liver surface that may result from unsuccessful needle passes, an unfavourable feature of the short, bevelled 16-gauge Colapinto needle. Another aspect of an ideal puncture system is the guiding catheter, as mentioned above. This should not only protect the needle tip on its way from the patient’s neck to the liver veins but also function as a primary selective catheter for hepatic veins before needle insertion and after successful puncture for the portal vein. Such a system will significantly shorten and simplify the procedure. Predilation
of the shunt track
Once a stable portal access is gained, other crucial steps need to follow. Most important is predilation of the shunt track to 8mm, utilizing low-profile, 5-FG angioplasty catheters. Typically, upon initial inflation a balloon waist forms at the entry site of the puncture track into the portal wall. In most cases several minutes of inflation are needed for complete balloon expansion and effacement of the waist (Figure 1). Significant pain usually accompanies this process, which should be alleviated by appropriate intravenous analgesics under oximetry monitoring. Choice of stent To date, two different stent types offer promise for successful application in TIPSS: the balloon-expandable Palmaz iliac stent (Johnson & Johnson Interventional Systems, Warren, NJ, USA), and the self-expandable Wallstent (Schneider, Ziirich, Switzerland). Both stent types have advantages and disadvantages. In theory, the flexible Wallstent can stent more peripheral and curved shunt tracks, allowing a ‘take what you can’ policy after less than ideal transjugular punctures (Laberge et al, 1991a,b). With the use of the more rigid Palmaz stent a more central and straighter intrahepatic shunt course is mandatory, requiring a more accurate puncture. Nevertheless, the authors believe that a central, straight shunt track facilitates an undisturbed flow pattern, minimizing thrombus formation and intimal hyperplasia. This is important during shunt maturation and stented track healing, which so far has developed stenosis in less than 5% of cases. Most of the difficulties associated with punctures aimed centrally and medially towards the portal bifurcation have been almost completely eliminated by the use of direct ultrasound guidance in addition to fluoroscopy. Ultrasound guidance from an intercostal lateral view visualizes the portal bifurcation and a major portion of the portal vein. With this technique the target area is constantly kept visible during the needle pass while the intrahepatic advancement of the needle is conveniently monitored both fluoroscopically and sonographically (Figure 2). When a needle pass initially enters a more peripheral branch, the portal anatomy can be visualized thus allowing easy and quick reorientation of the needle more medially. In some cases a steeper
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Figure 2. Ultrasonographic aspect during transjugular puncture from a lateral intercostal view. The distal (3-4cm) part of the needle tip is easily recognized by its acoustic reflexion. Simultaneously, the right portal vein near the bifurcation is visualized (dark-grey structure pointing upwards perpendicular to the bottom). The needle tip is well inside the right portal branch. The dark area immediately above the needle tip represents flow signals (red in the original colourcoded image).
tip angulation by manual bending is necessary. An example of such a process is portrayed in Figure 3. The radiopacity and expansion mechanism of the Palmaz stent allows precise positioning within the target area (Figures 3 and 4). Excessive intrusion of the stent inside portal venous or hepatic venous structures may be avoided. Conversely, the Wallstent substantially extends into both the portal and the hepatic veins because of its unpredictable deployment and site of foreshortening (Laberge et al, 1991a,b). It is not known if such protrusion of metallic stents inside portal or hepatic veins has adverse effects. Protrusion into the main stem of the portal vein, typically found with the Wallstent, may cause impaired flow to the portal branches with decrease of liver function or even may increase the risk of intimal hyperplasia. The use of the Palmaz stent allows adaptation of the shunt dimensions to the particular haemodynamic situation in each patient, because a range of diameters between 7 mm and 16 mm is obtained by choosing the appropriate size (Figures 3-5).
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Figure 3. Importance of central shunt course and demonstration of precise stent positioning. (a) The initial puncture with a 16-gauge Colapinto needle entering a peripheral branch. The portal bifurcation is 3 cm medial to this. (b) The next puncture enters the upper aspect of the right portal vein 0.5 cm distal to the bifurcation. A 5-FG cobra catheter is introduced. The umbilical vein is wide open. (c) Positioning of the Palmaz stent starting towards the portal vein. The distal lead marker of the catheter is flush with the distal part of the stent. The deployment site is fully monitored with millimetre accuracy.
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The relevance of the portosystemic gradient It is common knowledge that an absolute portal pressure greater than 20 mmHg or a portosystemic gradient greater than 15 mmHg increases the risk of variceal bleeding. This holds true both for spontaneously occurring bleeding episodes and for recurrent bleeding after surgical shunts. Conversely, a low portosystemic gradient accompanied by high-volume shunt flow may significantly increase the risk of hepatic encephalopathy. Therefore, the authors aim to keep the portosystemic gradient within the range lO15 mmHg (Figures 3 and 4). Whenever necessary, in the early postprocedural phase or during long-term follow-up after TIPSS, simple re-expansion of the stent shunt with bigger balloons allows the possibility of further lowering of the gradient (Figure 5). For this reason an initial gradient of 12-13mmHg is aimed for; the achievement of adequate portal decompression is confirmed by careful endoscopic re-evaluation of variceal filling thereafter. If no variceal reduction is observed over time the patient is rescheduled for shunt redilation (Figure 5). This proved necessary in 3 patients and was performed on an outpatient basis. In 6 of 60 patients to date, the shunt diameter was 8 mm, in 27 it was 9 mm, in 23 it was 10 mm and in 1 it was 11 mm. Variceal embolization The need for embolization of varices as an adjunct to a successful TIPSS procedure in an acutely bleeding patient is a major concern (Coldwell et al, 1991) and a somewhat unclear issue. In the authors’ opinion, simultaneous embolotherapy (by whatever means) and creation of a properly functioning shunt may be done on an emergency basis and can help to speed patient recovery. Usually, acutely bleeding patients in whom medical treatment has failed to control variceal haemorrhage present in a poor or critical clinical status, resulting from substantial intestinal blood loss and coagulopathy, possibly worsened by mass transfusion and hepatic encephalopathy. Failed intravenous vasopressive therapy and prolonged inflation times of gastrooesophageal tamponade balloons add to the life-threatening situation.
CLINICAL
RESULTS
Changes in study population and success rates To date, more than 4 years have elapsed since the authors’ first TIPSS (Richter et al, 1989). Initially, the procedure was carried out under a pilot study protocol requiring 100% ineligibility for surgical shunt procedures and failed medical treatment including repeat sclerotherapy for chronically recurring variceal bleeding. Therefore, initial patient selection for TIPSS displayed the worst case scenario in terms of liver disease. Nevertheless, with promising results emerging from the first year of clinical application (Richter et al, 1989, 1990a), TIPSS was expanded to include patients with
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Figure 4. Importance of monitoring the portosystemic gradient. (a) A cobra catheter inserted into the anterior descending branch of the right hepatic vein. A paper clip has been placed previously after sonographic identification of the portal bifurcation in AP projection. (b) After puncture with a tapered 20-gauge Richter needle. The needle tip enters the upper aspect of the right portal vein (same patient as in Figure 2). The bile ducts have been opacified by the preceding puncture. (c) Control during stent positioning shows very little overlap with the lumen of the right portal vein. (d) Deployment of two stents fully covering the shunt track with as little overlap with the adjacent vascular structures as possible. The shunt diameter is 9mm; the portosystemic gradient is 17 mmHg (2 mmHg in the right atrium and 19 mmHg in the portal vein). There is still high portopetal flow. (e) After shunt dilation up to 10 mm. The gradient now is 12 mmHg (3 mmHg in the right atrium and 15 mmHg in the portal vein). Portopetal flow is markedly decreased.
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(4 Figure 5. Importance of angiographic shunt control and possible redilation (in 3 out of 60 cases). (a) Transjugular portogram 5 months after TIPSS. Endoscopy had shown grade 2 variceal filling. Portography demonstrates significant intimal hyperplasia with a luminal decrease to 5mm at the narrowest part (previous shunt size was 9mm). The gradient is 19mmHg; moderate filling of the coronary vein is seen. (b) Redilation with a S-FG, 12-mm balloon administering a low pressure of 2.5 atm to avoid full expansion. (c) Portograph after dilation. Significant decrease of portosystemic gradient to 10 mmHg and decreased filling of the coronary vein. (d) Transfemoral portogram 12 months after TIPSS and 7 months after redilation. High shunt flow prevents visualization of the portal vein. However, no significant recurrence of stenosis is demonstrated, as reflected also by endoscopy, where grade 1 variceal filling was found.
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failed surgical shunts and patients refractory to medical treatment for severe ascites. The more liberal use of TIPSS favours its early application to patients waiting for liver transplantation. With the broadening of the inclusion criteria during this study, difficulties arise in the interpretation of clinical benefit and long-term success of the procedure. In the first 24 patients (Richter et al, 1990b), the technical success rate was 75%. Failures resulted from inability to puncture the portal circulation because of equipment problems, as detailed above. Since then, there has been only one further failure. At present, the total success rate is 92%. Procedural mortality The 30-day mortality rate in the first 13 (out of 18) successful cases was 15%. This was attributed to adult respiratory distress syndrome in 1 patient and lethal bleeding complications in 2 patients resulting from exsanguination from the percutaneous transhepatic track to the portal system. Among 42 patients receiving only transjugular liver puncture simultaneously under fluoroscopic and sonographic guidance only 1 early death occurred: this death resulted from pre-existing pulmonary disease. The procedural mortality rate has now dropped to 6.7% (4 out of 60 patients). In comparison, the mortality of emergency shunt operation for patients in stage C (Child’s classification) is being reported to be as high as 40-100% (Child and Turcott, 1964; Conn, 1981; Warren et al, 1982; Galambos, 1985; Millikan et al, 1985). The total number of patients is still too small to allow definite comparisons and conclusions on the basis of stage-related risk analysis. Control of variceal bleeding The rebleeding rate in the total study group is 6.7% (4 out of 60 patients). Two patients bled from severe ulcerative and erosive disease during the initial 30-day period after TIPSS. This was considered to result from extensive sclerotherapy trials of gastric varices accompanied by prolonged inflation times of the Senkstaken-Blakemore tube. The very first patient of the series had widespread mucosal bleeding 2 days after TIPSS, most probably due to disseminated intravascular coagulopathy from accelerated absorption of ascites with imbalance of fibrinolysis. This was easily controlled by blood transfusions and fresh frozen plasma. The fourth patient rebled 18 months after TIPSS from late shunt occlusion, and finally died. This was the only patient, to date, in whom late shunt occlusion occurred. Encephalopathy In addition to mortality and shunt occlusion, hepatic encephalopathy is one of the main problems of shunt surgery (Child and Turcott, 1964; Foster et al, 1971; Conn, 1977; Warren et al, 1982; Galambos, 1985; Millikan et al, 1985), and it is also a crucial issue in TIPSS. In non-selective shunts the postoperative rate of hepatic encephalopathy may rise to 50% (Galambos, 1985; Millikan et al, 1985; Spina et al, 1988). Even in selective shunts an incidence of hepatic encephalopathy as high as 20% is reported (Millikan et
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al, 1985; Spina et al, 1988). In the authors’ series, 3 patients developed de nave hepatic encephalopathy which was controlled by appropriate medical treatment. More importantly, none of the 21 stage-C patients who almost invariably presented with hepatic encephalopathy before TIPSS experienced worsening of symptoms after the procedure. Conversely, patients who had hepatic encephalopathy attributable to severe acute bleeding and significant intestinal protein uptake improved as soon as the shunt was functional. These findings are reflected more or less by variations in ammonia levels. In most of the patients with normal values before TIPSS these levels did not exceed the critical threshold during follow-up. In patients with increased values due to active bleeding, ammonia levels decreased after TIPSS in most cases. The study volume is still too small for firm conclusions to be drawn as to the risk of hepatic encephalopathy in TIPSS. The relatively low incidence of de lzovo hepatic encephalopathy is encouraging, favouring the concept of partial diversion of portal flow volume with small-calibre interposition shunting TIPSS. CONCLUSION Haemodynamically, TIPSS represents an intrahepatic small-calibre interposition shunt with partial portal decompression. Rypins et al (1984) and Johansen (1989) reported very favourable results with the surgical performance of this shunt type. Apart from its percutaneous character, TIPSS offers one major advantage, which is the possibility of adaptation of the shunt size to individual haemodynamic needs. The interposition is exclusively intrahepatic.The extrahepatic vascular trunks remain completely untouched which is a significant advantage if liver transplantation is being considered. Both the individual adaptation of the shunt size and the precise placement technique as a result of the use of the balloon-expandable Palmaz stent render this concept unique. In a 4-year period of clinical application the concept has been constantly refined. It has definitely proved its usefulness as a safe, non-invasive and efficient method for the treatment of variceal haemorrhage, even under desperate emergency situations. Moreover, it seems feasible to reduce the risk of lethal variceal bleeding in patients already on a waiting list for organ transplantation by performing TIPSS at an earlier stage of the underlying liver disease. With increased experience it appears that the optimum technique for the procedure is almost sufficiently defined. Refinement of puncture needles already in use will further improve the safety and efficacy of the method. A wider clinical application of TIPSS seems likely. Contraindications for TIPSS should include sepsis and right heart failure. REFERENCES Abecassis M, Gordon JD, Colapinto RF et al (1985) The transjugular intrahepatic portosystemic shunt (TIPS): an alternative for the management of life-threatening variceal hemorrhage. Hepatology 5: 1032A.
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Warren WD, Millikan WJ Jr, Henderson JM et al (1982) Ten years portal hypertensive surgery at Emory: results and new perspectives. Annals of Surgery 195: 530-542.
Transjugular intrahepatic portosystemic stent shunt GOETZ M. RICHTER THOMAS ROEREN MARTIN ROESSLE JULIO C. PALMAZ
In 1967 Hanafee spurred interest in a non-surgical approach to the main vessels and ducts of the liver by utilizing a percutaneous right internal jugular vein access across the right atrium of the heart and into one of the major hepatic veins (Hanafee and Weiner, 1967). Two years later, Rosch and Hanafee described a method to create non-surgically a connection between the inferior vena cava and the portal circulation in dogs (Rosch et al, 1969). In the following decade, several comparable experimental models were presented which did not achieve definite clinical applicability for the treatment of portal hypertension (Koch et al, 1973; Reich et al, 1977; Burgener and Gutierrez, 1979). The clinical use of such a concept was not implemented until the early 1980s with Colapinto’s description of the first successful intrahepatic portosystemic shunt in the human using the transjugular approach (Colapinto et al, 1982). His technique was based on prolonged or repeated balloon dilation of a parenchymal track bridging hepatic and portal vein branches. However, clinical outcome and benefit in a series of patients were rather disappointing and patency of the shunts was maintained only in a small number of patients (Abecassis et al, 1985; Gordon et al, 1987). More durable portosystemic shunts were obtained by Palmaz et al (1985, 1986) by applying vascular metallic stents for the maintenance of shunt track patency in a dog model as early as 1985. Rosch used a modified version of the self-expanding Gianturco stent for the same purpose in pigs. His long-term results were, however, limited by progressive shunt occlusion as a result of intimal and parenchymal overgrowth within the shunt track. The question whether stent design problems or a peculiar response of swine liver were the reason for the unfavourable results could not be settled (Rosch et al, 1987). Palmaz achieved 50% long-term patency in a canine model without portal hypertension (Palmaz et al, 1985) and 100% patency when the animals had portal hypertension (Palmaz et al, 1986). This experience justified the search for a reproducible and reliable technique of transjugular intrahepatic portosystemic stent shunting to treat patients with severe portal hypertension. In 1987 the authors submitted to the Institutional Baillidre’s Clinical GastroenterologyVol. 6, No. 2, June 1992 ISBNO-702CL1623-3
403 Copyright @ 1992, by Baillitre All rights of reproduction in any form
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Revision Board of the University Hospital of Freiburg (Ethik-Kommittee) a pilot study application for first clinical use of transjugular intrahepatic portosystemic stent shunt (TIPSS). The first successful procedure was accomplished in January 1988 (Richter et al, 1989). From then on, the technique of TIPSS was developed and improved, drawing on experience gathered in 60 patients to date (Richter et al, 1990a,b, 1991). Initially, the study protocol restricted the use of the procedure to patients in whom conservative management with repeat sclerotherapy and vasoactive drugs failed to control bleeding and who were at prohibitive risk for surgical shunts. Subsequent accumulation of technical and clinical experience encouraged a wider and more deliberate use of TIPSS to include younger patients and milder stages of liver disease. HAEMODYNAMIC AND RHEOLOGICAL THE TIPSS CONCEPT
BACKGROUND
OF
The total blood supply of the normal liver is approximately 1500 ml/min of which two-thirds corresponds to portal inflow and the other third to arterial inflow. Liver cirrhosis is associated with a significant decrease of portal blood flow resulting from an up to tenfold increase of sinusoidal vascular resistance (Child and Turcott, 1964; Galambos, 1985; Rossle et al, 1990). Thus, the total liver perfusion is reduced with concomitant development of portal hypertension; while a flow volume of 500mVmin is considered borderline portal perfusion, 20% of all patients with portal hypertension show lower flow volumes (Child and Turcott, 1964; Galambos, 1985; Rossle et al, 1990). Particularly in patients with end-stage liver disease, the portal perfusion may drop to zero as a result of stagnant or reversed (portofugal) flow. Reversed portal flow is found in up to 10% of all patients with microscopically proven liver cirrhosis. Depending on the haemodynamic arrangement, portosystemic shunts may be non-selective or selective. Selectivity in this context refers to the selective deviation of the gastroepiploic portal blood to a systemic shunt (mainly the left renal vein) while portal liver perfusion from the mesenteric portal route is maintained. Non-selective shunts include end-to-end and side-to-side versions, and a host of different surgical techniques such as portocaval, mesocaval and various other H-interposition shunts. End-toside shunts are portocaval shunts with distal ligation of the portal vein. The concept of side-to-side shunts originated in the idea of maintaining portopetal flow while lowering the pressure which favours perfusion in the portosystemic pathways. However, this does not necessarily occur, as many research groups demonstrated reversal of portal flow after side-to-side shunts. An additional result of these shunts may be onset or increase of arterio-portal flow. Redeker et al (1958) reported arterio-portal flow volumes as high as 40-1100 ml/min in interposition shunts. It is well understood that the amount of such arterio-portal flow corresponds with the shunt size. Rypins et al (1984) and Sarfeh et al (1983, 1986) showed that arterioportal flow develops as soon as the shunt size reaches 50% of the diameter of
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the portal vein. Murray et al (1961) demonstrated that 70% of the arterial blood volume to the liver was lost via retrograde portal flow as soon as a large-calibre side-to-side portocaval shunt was created in a dog model. Such a portofugal steal effect is avoided when in portocaval shunts a hilar ligation of the portal vein is performed. In this case, the lack of portal perfusion is compensated by a net increase in arterial liver perfusion (Rector et al, 1988; Rossle et al, 1990). The typical selective shunt is the distal splenorenal shunt described by Warren et al (1982). In this shunt the pressure in the variceal collaterals is reduced by anastomosing the splenic vein to the left renal vein. Another important feature of this technique is careful ligation of the retropancreatic venous tributaries to the portal circulation as well as the ligation of gastroepiploic vein branches (Millikan et al, 1985). With this shunt partial but haemodynamically sufficient portal decompression should be assured while the integrity of mesoportal blood flow is believed to maintain adequate liver perfusion. However, recent duplex sonographic examinations revealed that flow reversal may develop in splenorenal shunts in a significant number of patients 1 year after surgery. This is contributed by the formation of new portosystemic pathways (Ohnishi et al, 1985; Lafortune et al, 1987; Bolondi et al, 1988; DeLacy et al, 1989). Portal flow reversal after shunt procedures may be accompanied by a significant alteration in liver function. This has been substantiated by a variety of publications (Foster et al, 1971; Ohnishi et al, 1985; Spina et al, 1988; DeLacy et al, 1989; Rossle et al, 1990). In three out of four randomized studies of distal splenorenal shunt versus side-by-side portocaval shunt, signficantly increased incidence of hepatic encephalopathy was found after H-interposition shunts (Reichle et al, 1979; Fischer and McCinley, 1985; Spina et al, 1988; Pagliaro et al, 1989). This was explained by onset of arterio-portal shunting. However, a new positive stimulus to side-to-side shunt techniques arose from reports on prosthetic small-calibre H-shunts. These shunts were believed to decrease the pressure within the portosystemic collateral pathways enough to prevent variceal bleeding while at the same time avoiding arterio-portal shunting by keeping the net pressure within the portal circulation sufficiently high. This was proved in a series of 50 patients by Johansen (1989). Rheologically and haemodynamically, the TIPSS procedure may be also categorized as a small-calibre interposition shunt, with two potential advantages: 1. 2.
The interposition is totally intrahepatic and centrally positioned, thus allowing unimpeded flow. Since the key element of TIPSS is the application of an expandable metallic stent, possible variation of Palmaz stent diameters by the use of different balloon sizes offer optimal adaptation of the shunt lumen to the haemodynamic needs of each individual patient. This also allows further increase of the shunt diameter whenever necessary. Other vascular stents that are currently on the market do not offer this perspective.
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ASPECTS OF TIPSS
Initial te-chnical problems The creation of a wide, central and more or less straight course of the intrahepatic shunt track was considered to be crucial for early and long-term success. Based on this premise, the puncture track should run from the proximal part of either the right or the middle hepatic vein to the upper wall of either one of the main portal vein branches. Therefore, exact knowledge of the anatomic relationship between the portal bifurcation and the hepatic vein radicles is mandatory. Initially, attempts were made to increase the accuracy of the puncture by establishing an additional transhepatic access to the portal circulation via a routine midaxillary approach (Rosch et al, 1987; Richter et al, 1989, 1990). For this purpose a small retrieval basket was placed within the portal bifurcation to serve as a target for the transjugular needle puncture. In the first successful 13 cases, the puncture was performed by using a 22-gauge Brockenborough needle through which a 0.014 in coronary wire was passed after portal access was gained. These preliminary attempts had an initial technical success of 70%. However, the average procedural time was near 7 hours as a result of a host of procedural problems; these included multiple and prolonged needle passes due to poor steerability of the needle as a result of its weak metal body. In addition, safe and stable portal access was difficult to achieve due to the flimsiness of the coronary wire. In some cases heavy-duty wires could be placed only after insertion of individually bent metal stiffeners. More importantly, lethal haemorrhagic complications resulted from the transhepatic access to the portal circulation. This happened in 2 of the first 16 patients in whom this technique was tried. These early technical problems are described in greater detail in the initial reports (Richter et al, 1989, 1990a,b). Development of better needles There is no single key element for improving the safety and efficacy of this procedure; rather, detailed improvement of many technical aspects has led to a safe and standardized procedure. It has been shortened significantly by the development and use of a more suitable needle with better torque control and a bigger inner lumen, allowing passage of larger and stiffer wires. Two needle types currently on the market seem to fulfil the requirements for safe and easy puncture. One of them is a 20-gauge coaxial needle, designed by the authors, with a 0.6-mm blunt tip obturator (Angiomed, Karlsruhe, Germany). It is advanced into the liver veins through an 8-FG multipurpose catheter, the distal body of which is scaffolded with wire mesh to prevent its perforation during needle insertion. For the puncture, the obturator is exchanged for a sharp, highly flexible inner mandril. The second needle is part of the Colapinto transjugular liver biopsy set (Cook, Bloomington, Ind., USA). It has a 16-gauge bevelled tip and is introduced through a 9-FG Teflon catheter. This needle allows primary passage of a 0.9-mm wire. Disadvantages with both needles should be overcome soon
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with the availability of 17-gauge and 19-gauge single piece, tapered tip needles that will be available with different curves allowing primary passage of heavy-duty wires. This is extremely helpful in avoiding the risk of large holes in the abdominal liver surface that may result from unsuccessful needle passes, an unfavourable feature of the short, bevelled 16-gauge Colapinto needle. Another aspect of an ideal puncture system is the guiding catheter, as mentioned above. This should not only protect the needle tip on its way from the patient’s neck to the liver veins but also function as a primary selective catheter for hepatic veins before needle insertion and after successful puncture for the portal vein. Such a system will significantly shorten and simplify the procedure. Predilation
of the shunt track
Once a stable portal access is gained, other crucial steps need to follow. Most important is predilation of the shunt track to 8mm, utilizing low-profile, 5-FG angioplasty catheters. Typically, upon initial inflation a balloon waist forms at the entry site of the puncture track into the portal wall. In most cases several minutes of inflation are needed for complete balloon expansion and effacement of the waist (Figure 1). Significant pain usually accompanies this process, which should be alleviated by appropriate intravenous analgesics under oximetry monitoring. Choice of stent To date, two different stent types offer promise for successful application in TIPSS: the balloon-expandable Palmaz iliac stent (Johnson & Johnson Interventional Systems, Warren, NJ, USA), and the self-expandable Wallstent (Schneider, Ziirich, Switzerland). Both stent types have advantages and disadvantages. In theory, the flexible Wallstent can stent more peripheral and curved shunt tracks, allowing a ‘take what you can’ policy after less than ideal transjugular punctures (Laberge et al, 1991a,b). With the use of the more rigid Palmaz stent a more central and straighter intrahepatic shunt course is mandatory, requiring a more accurate puncture. Nevertheless, the authors believe that a central, straight shunt track facilitates an undisturbed flow pattern, minimizing thrombus formation and intimal hyperplasia. This is important during shunt maturation and stented track healing, which so far has developed stenosis in less than 5% of cases. Most of the difficulties associated with punctures aimed centrally and medially towards the portal bifurcation have been almost completely eliminated by the use of direct ultrasound guidance in addition to fluoroscopy. Ultrasound guidance from an intercostal lateral view visualizes the portal bifurcation and a major portion of the portal vein. With this technique the target area is constantly kept visible during the needle pass while the intrahepatic advancement of the needle is conveniently monitored both fluoroscopically and sonographically (Figure 2). When a needle pass initially enters a more peripheral branch, the portal anatomy can be visualized thus allowing easy and quick reorientation of the needle more medially. In some cases a steeper
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Figure 2. Ultrasonographic aspect during transjugular puncture from a lateral intercostal view. The distal (3-4cm) part of the needle tip is easily recognized by its acoustic reflexion. Simultaneously, the right portal vein near the bifurcation is visualized (dark-grey structure pointing upwards perpendicular to the bottom). The needle tip is well inside the right portal branch. The dark area immediately above the needle tip represents flow signals (red in the original colourcoded image).
tip angulation by manual bending is necessary. An example of such a process is portrayed in Figure 3. The radiopacity and expansion mechanism of the Palmaz stent allows precise positioning within the target area (Figures 3 and 4). Excessive intrusion of the stent inside portal venous or hepatic venous structures may be avoided. Conversely, the Wallstent substantially extends into both the portal and the hepatic veins because of its unpredictable deployment and site of foreshortening (Laberge et al, 1991a,b). It is not known if such protrusion of metallic stents inside portal or hepatic veins has adverse effects. Protrusion into the main stem of the portal vein, typically found with the Wallstent, may cause impaired flow to the portal branches with decrease of liver function or even may increase the risk of intimal hyperplasia. The use of the Palmaz stent allows adaptation of the shunt dimensions to the particular haemodynamic situation in each patient, because a range of diameters between 7 mm and 16 mm is obtained by choosing the appropriate size (Figures 3-5).
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Figure 3. Importance of central shunt course and demonstration of precise stent positioning. (a) The initial puncture with a 16-gauge Colapinto needle entering a peripheral branch. The portal bifurcation is 3 cm medial to this. (b) The next puncture enters the upper aspect of the right portal vein 0.5 cm distal to the bifurcation. A 5-FG cobra catheter is introduced. The umbilical vein is wide open. (c) Positioning of the Palmaz stent starting towards the portal vein. The distal lead marker of the catheter is flush with the distal part of the stent. The deployment site is fully monitored with millimetre accuracy.
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The relevance of the portosystemic gradient It is common knowledge that an absolute portal pressure greater than 20 mmHg or a portosystemic gradient greater than 15 mmHg increases the risk of variceal bleeding. This holds true both for spontaneously occurring bleeding episodes and for recurrent bleeding after surgical shunts. Conversely, a low portosystemic gradient accompanied by high-volume shunt flow may significantly increase the risk of hepatic encephalopathy. Therefore, the authors aim to keep the portosystemic gradient within the range lO15 mmHg (Figures 3 and 4). Whenever necessary, in the early postprocedural phase or during long-term follow-up after TIPSS, simple re-expansion of the stent shunt with bigger balloons allows the possibility of further lowering of the gradient (Figure 5). For this reason an initial gradient of 12-13mmHg is aimed for; the achievement of adequate portal decompression is confirmed by careful endoscopic re-evaluation of variceal filling thereafter. If no variceal reduction is observed over time the patient is rescheduled for shunt redilation (Figure 5). This proved necessary in 3 patients and was performed on an outpatient basis. In 6 of 60 patients to date, the shunt diameter was 8 mm, in 27 it was 9 mm, in 23 it was 10 mm and in 1 it was 11 mm. Variceal embolization The need for embolization of varices as an adjunct to a successful TIPSS procedure in an acutely bleeding patient is a major concern (Coldwell et al, 1991) and a somewhat unclear issue. In the authors’ opinion, simultaneous embolotherapy (by whatever means) and creation of a properly functioning shunt may be done on an emergency basis and can help to speed patient recovery. Usually, acutely bleeding patients in whom medical treatment has failed to control variceal haemorrhage present in a poor or critical clinical status, resulting from substantial intestinal blood loss and coagulopathy, possibly worsened by mass transfusion and hepatic encephalopathy. Failed intravenous vasopressive therapy and prolonged inflation times of gastrooesophageal tamponade balloons add to the life-threatening situation.
CLINICAL
RESULTS
Changes in study population and success rates To date, more than 4 years have elapsed since the authors’ first TIPSS (Richter et al, 1989). Initially, the procedure was carried out under a pilot study protocol requiring 100% ineligibility for surgical shunt procedures and failed medical treatment including repeat sclerotherapy for chronically recurring variceal bleeding. Therefore, initial patient selection for TIPSS displayed the worst case scenario in terms of liver disease. Nevertheless, with promising results emerging from the first year of clinical application (Richter et al, 1989, 1990a), TIPSS was expanded to include patients with
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Figure 4. Importance of monitoring the portosystemic gradient. (a) A cobra catheter inserted into the anterior descending branch of the right hepatic vein. A paper clip has been placed previously after sonographic identification of the portal bifurcation in AP projection. (b) After puncture with a tapered 20-gauge Richter needle. The needle tip enters the upper aspect of the right portal vein (same patient as in Figure 2). The bile ducts have been opacified by the preceding puncture. (c) Control during stent positioning shows very little overlap with the lumen of the right portal vein. (d) Deployment of two stents fully covering the shunt track with as little overlap with the adjacent vascular structures as possible. The shunt diameter is 9mm; the portosystemic gradient is 17 mmHg (2 mmHg in the right atrium and 19 mmHg in the portal vein). There is still high portopetal flow. (e) After shunt dilation up to 10 mm. The gradient now is 12 mmHg (3 mmHg in the right atrium and 15 mmHg in the portal vein). Portopetal flow is markedly decreased.
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(4 Figure 5. Importance of angiographic shunt control and possible redilation (in 3 out of 60 cases). (a) Transjugular portogram 5 months after TIPSS. Endoscopy had shown grade 2 variceal filling. Portography demonstrates significant intimal hyperplasia with a luminal decrease to 5mm at the narrowest part (previous shunt size was 9mm). The gradient is 19mmHg; moderate filling of the coronary vein is seen. (b) Redilation with a S-FG, 12-mm balloon administering a low pressure of 2.5 atm to avoid full expansion. (c) Portograph after dilation. Significant decrease of portosystemic gradient to 10 mmHg and decreased filling of the coronary vein. (d) Transfemoral portogram 12 months after TIPSS and 7 months after redilation. High shunt flow prevents visualization of the portal vein. However, no significant recurrence of stenosis is demonstrated, as reflected also by endoscopy, where grade 1 variceal filling was found.
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failed surgical shunts and patients refractory to medical treatment for severe ascites. The more liberal use of TIPSS favours its early application to patients waiting for liver transplantation. With the broadening of the inclusion criteria during this study, difficulties arise in the interpretation of clinical benefit and long-term success of the procedure. In the first 24 patients (Richter et al, 1990b), the technical success rate was 75%. Failures resulted from inability to puncture the portal circulation because of equipment problems, as detailed above. Since then, there has been only one further failure. At present, the total success rate is 92%. Procedural mortality The 30-day mortality rate in the first 13 (out of 18) successful cases was 15%. This was attributed to adult respiratory distress syndrome in 1 patient and lethal bleeding complications in 2 patients resulting from exsanguination from the percutaneous transhepatic track to the portal system. Among 42 patients receiving only transjugular liver puncture simultaneously under fluoroscopic and sonographic guidance only 1 early death occurred: this death resulted from pre-existing pulmonary disease. The procedural mortality rate has now dropped to 6.7% (4 out of 60 patients). In comparison, the mortality of emergency shunt operation for patients in stage C (Child’s classification) is being reported to be as high as 40-100% (Child and Turcott, 1964; Conn, 1981; Warren et al, 1982; Galambos, 1985; Millikan et al, 1985). The total number of patients is still too small to allow definite comparisons and conclusions on the basis of stage-related risk analysis. Control of variceal bleeding The rebleeding rate in the total study group is 6.7% (4 out of 60 patients). Two patients bled from severe ulcerative and erosive disease during the initial 30-day period after TIPSS. This was considered to result from extensive sclerotherapy trials of gastric varices accompanied by prolonged inflation times of the Senkstaken-Blakemore tube. The very first patient of the series had widespread mucosal bleeding 2 days after TIPSS, most probably due to disseminated intravascular coagulopathy from accelerated absorption of ascites with imbalance of fibrinolysis. This was easily controlled by blood transfusions and fresh frozen plasma. The fourth patient rebled 18 months after TIPSS from late shunt occlusion, and finally died. This was the only patient, to date, in whom late shunt occlusion occurred. Encephalopathy In addition to mortality and shunt occlusion, hepatic encephalopathy is one of the main problems of shunt surgery (Child and Turcott, 1964; Foster et al, 1971; Conn, 1977; Warren et al, 1982; Galambos, 1985; Millikan et al, 1985), and it is also a crucial issue in TIPSS. In non-selective shunts the postoperative rate of hepatic encephalopathy may rise to 50% (Galambos, 1985; Millikan et al, 1985; Spina et al, 1988). Even in selective shunts an incidence of hepatic encephalopathy as high as 20% is reported (Millikan et
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al, 1985; Spina et al, 1988). In the authors’ series, 3 patients developed de nave hepatic encephalopathy which was controlled by appropriate medical treatment. More importantly, none of the 21 stage-C patients who almost invariably presented with hepatic encephalopathy before TIPSS experienced worsening of symptoms after the procedure. Conversely, patients who had hepatic encephalopathy attributable to severe acute bleeding and significant intestinal protein uptake improved as soon as the shunt was functional. These findings are reflected more or less by variations in ammonia levels. In most of the patients with normal values before TIPSS these levels did not exceed the critical threshold during follow-up. In patients with increased values due to active bleeding, ammonia levels decreased after TIPSS in most cases. The study volume is still too small for firm conclusions to be drawn as to the risk of hepatic encephalopathy in TIPSS. The relatively low incidence of de lzovo hepatic encephalopathy is encouraging, favouring the concept of partial diversion of portal flow volume with small-calibre interposition shunting TIPSS. CONCLUSION Haemodynamically, TIPSS represents an intrahepatic small-calibre interposition shunt with partial portal decompression. Rypins et al (1984) and Johansen (1989) reported very favourable results with the surgical performance of this shunt type. Apart from its percutaneous character, TIPSS offers one major advantage, which is the possibility of adaptation of the shunt size to individual haemodynamic needs. The interposition is exclusively intrahepatic.The extrahepatic vascular trunks remain completely untouched which is a significant advantage if liver transplantation is being considered. Both the individual adaptation of the shunt size and the precise placement technique as a result of the use of the balloon-expandable Palmaz stent render this concept unique. In a 4-year period of clinical application the concept has been constantly refined. It has definitely proved its usefulness as a safe, non-invasive and efficient method for the treatment of variceal haemorrhage, even under desperate emergency situations. Moreover, it seems feasible to reduce the risk of lethal variceal bleeding in patients already on a waiting list for organ transplantation by performing TIPSS at an earlier stage of the underlying liver disease. With increased experience it appears that the optimum technique for the procedure is almost sufficiently defined. Refinement of puncture needles already in use will further improve the safety and efficacy of the method. A wider clinical application of TIPSS seems likely. Contraindications for TIPSS should include sepsis and right heart failure. REFERENCES Abecassis M, Gordon JD, Colapinto RF et al (1985) The transjugular intrahepatic portosystemic shunt (TIPS): an alternative for the management of life-threatening variceal hemorrhage. Hepatology 5: 1032A.
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