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Transjugular intrahepatic portosystemic shunting (TIPS) is not superior to endoscopic variceal band ligation (VBL) for prophylaxis of variceal rebleeding in cirrhotic patients - a randomized, controlled trial
HEPATOLOGYVol. 34, No. 4, Pt. 2, 2 0 0 1
533A
AASLD ABSTRACTS
1443
1444
TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNTING (TIPS) IS NOT SUPERIOR TO ENDOSCOPIC VARICEAL BAND LIGATION (VBL) FOR PROPHYLAXIS OF VARICEAL REBLEEDING IN CIRRI{OTIC PATIENTS - A RANDOMIZED, C O N T R O L L E D TRIAL. Veit G~lberg, University of Munich, M u n i c h Germany; Michael Schepke, University of Bonn, Bonn Germany; G u d r u n Geigenberger, Municipal Hospital Schwabing, Munich Germany; Joseph Holl, University of Munich, M u n i c h Germany; Karl A Brensing, University of Bonn, B o n n Germany; Tobias Waggershauser, Maximilian Reiser, University of Munich, M u n i c h Germany; Hans H Schild, Tilman Sauerbruch, University of Bonn, Bonn Germany; Alexander L Gerbes, University of Munich, Munich G e r m a n y
F O L L O W UP BANDING AFTER ACUTE VARICEAL BLEEDING: W H A T HAPPENS IN REAL W O R L D . Ravi Ravinuthala, Kimberly A Brown, Henry Ford Hospital, Detroit, MI
Background:Aim of the present study was to compare the transjugular intrahepatic pot tosystemic shunt with varicealband ligation for prophylaxis of varicealrebleeding in patients with cirrhosis of the liver. Methods: Fifty-fourcirrhotic patients (21 Child-Pugh class A, 27 class B, 6 class C) were randomized within two months after control of esophagealvaricealhemorrhage to TIPS (n= 28) or VBL(n=26). Assuminga one-year rebleeding rate of 35 % in the VBLgroup and 10 % in the TIPS group a sample size of 27 patients in each group was required to detect this differencewith a beta of 0.05 and a power of 80 % using a one-tailed test. Statistical analysis was performed on the intention to treat principle. Results: Mean follow-up was 2 years. Both groups were equally balanced with the exception of a slightly higher number of previous bleeding episodes in the TIPS group. Actuarial probability of remaining free from rebleeding is shown in figure 1. Mortality risk at one and two years of follow-up was 7.8 -+ 5.3 % and 19.9 -+ 8.8 % in the TIPS group and 16.5 ± 7.6 % and I6.5 -+ 7.6 % in the VBLgroup, respectively (n.s.). The rebleeding index (defined as ratio of months of follow-up over number of rebleeding episodes plus one according to the Baveno criteria) was not significantly different between TIPS and VBL patients (18.3 -+ 2.5 months vs. 17.7 -+ 2.1 months). TIPS was not feasible in two patients randomized to TIPS. Four patients randomized to VBL underwent TIPS, one of them as an emergency procedure, two for frequent rebleeding and one for VBLinduced complication prohibiting further endoscopic therapy. Hepatic encephalopathy within 1 month after randomization was observed in 2 patients in the TIPS group and 1 in the VBL group. Conclusion: TIPS was not superior m VBL for prevention of variceal rebleeding in our study. Furthermore, similar mortality rates in patients treated with TIPS or VBL argue against TIPS as prefered strategy for prevention of variceal rebleeding.
.2i
- o.Xi 0
~2
24
ss
~,8
Introduction: Variceal bleeding is a catastrophic manifestation of portal hypertension. Acute variceal bleeding has a significant in hospital mortality and either endoscopic s d e r o t h e r a p y or b a n d ligation is utilized to achieve hemostasis. Secondary prophylaxis has been s h o w n to reduce rebleeding and possibly reduce mortality. O f the various techniques available, several clinical trials have s h o w n that variceal b a n d ligation is the most effective technique. E x c d lent follow up was achieved in the clinical trial setting a n d contributed to the positive results. However, in clinical practice follow u p rates are m u c h poorer. W h e t h e r secondary prophylaxis with b a n d ligation is efficacious outside clinical trial setting has not been tested. W e u n d e r t o o k this study to measure the follow up rates in an u r b a n tertiary care teaching hospital a n d identify potential areas for improvement. Effect of follow up rates on rebleeding a n d mortality were also examined. Methods: W e used the computerized gastroenterology endoscopy database to collect the data. Database search was performed for patients with endoscopic diagnosis of active variceal bleeding or varices with signs of recent hemorrhage. Both the database a n d other records of these patients were reviewed a n d follow u p endoscopies were recorded. Rebleeding a n d mortality rates were obtained. W h e n follow up endoscopy was not done, reason for the lack of follow u p was carefully recorded. W h e r e this information was not available from the hospital records, attempts were made to contact the patients b y telephone. Results: Of over 1000 u p p e r endoscopies done for u p p e r gastrointestinal bleeding between 1999 and 2000, 75 patients were found to have active variceal bleeding. Mean follow u p was 1.3 years. 23% died in the hospital a n d 8% h a d alternative definitive treatments. Of the people surviving the initial episode, only 27% had follow u p EGD and b a n d ligation. 73% were either lost to follow u p completely or did not have endoscopy despite follow up clinic visit. There were no significant differences between the two groups except for male p r e d o m i n a n c e in the endoscopy g r o u p and black race predominance in the no endoscopy group. Rebteeding (7% vs. 23%) and total mortality (0% vs. 45%) rates were significantly higher in the no endoscopy group. Noncompliance a n d lack of insurance were not significant factors affecting follow up rates. The single most important cause for lack of follow u p in this study was inadequate instructions about follow u p at the time of discharge. Conclusions: Follow u p rates after variceal bleeding are alarmingly low b u t seem to be remediable. Unless measures are taken to ensure return visits for b a n d ligation, secondary prophylaxis will be ineffective.
1445
1446
10 YEARS FOLLOW-UP OF 484 PATIENTS WITH TRANSJUGULAR INTI~A-HEPATIC PORTOSYSTEMIC STENT-SHUNT (TIPSS). Dhiraj Tripathi, Sherzad Balata, H o c k F Lui, Adrian J Stanley, Kim Macbeth, Ewan Forrest, Rajiv Jalan, Doris N Redhead, Peter C Hayes, Royal Infirmary of Edinburgh, E d i n b u r g h Uk
EVALUATION OF CHRONIC HEPATITIS C AND CIRRHOTIC PATIENTS THROUGH B L O O D F L O W VELOCITY IN PORTAL VEIN, Ashraf R AbulF u t u h MD, Mansoura International Hospital, Mansoura Egypt; Salwa M E1 Hadad, Ain Shams Universty Hosp Egypt, Cairo Egypt; Abdel Ghani M Solayman, Asiut Universty Hosp Egypt, Asiut Egypt
BACKGROUND AND AIMS: Since its introduction in 1989, TIPSS has improved the management of the complications of portal hypertension, and compares favourably with other treatment modalities. This study aims to report on the long-term follow-up of TIPSS at a single centre. METHODS: Data was collected prospectively on all patients who were referred for TIPSS during the period 7/1991 to 4/2001. The cohort included 484 patients who required TIPSS for complications secondary to portal hypertension. They were followed-up clinically (3 monthly) and radiographicany (6 monthly). Mean follow up was 43.6 -+ 29.6 months. RESULTS: I. Patients characteristics 65.6% were males, 39.4% females with a mean age of 47.4 -+ 21.1 years (range 4-84 yrs). Main aetiologies: alcoholic liver disease (66.8%), non-alcoholic (33.2%). Indications: oesophageal variceal bleeding (OVB - 69.7%), gastric variceal bleeding (GVB - 11.8%), ascites (10.7%), portal hypertensive gastropathy (1.7%), ectopic variceal bleeding (1.7%), others (4.4%). The newer PTFE covered stems were used in 29 patients between 9/1999 to 4/2001 (23 at TIPSS creation and 6 at the time of re-stenting of insufficient "uncovered" stents) 2. Technical outcomes TIPSS insertion was successful in 95.6% and failed in 5.4% of referred cases. Functional success (defined as a post TIPSS portal pressure gradient (PPG) reduction to < 12mmHg or 20% drop in the pre TIPSS PPG) was achieved in 250 (82%). Procedure related mortaIity and complications were 0.8% and 3.2% respectively. 3. Clinical outcomes Variceal rebleeding occurred in 25 (5.5%) cases, with there being no difference in the rebleeding rate whether the indication was GVB or OVB. New or worsened encephalopathy was present in 68 (14.8%),and 45 (9.8%) respectively. In 16 cases of encephalopathy (14.2%) radiological intervention to block the shunt was necessary. TIPSS was a bridge to liver transplantation in 41 cases (9% of all successful cases), and was used in 2 patients following liver transplantation. Cumulative sur'dval at 30 days, 1, 2 & 5 years were 97.6%, 95.0%, 88.5% and 56.7% respectively. The 5 year survival for patients with OVB was 51.8% and for GVB 78.4% (p<0.05). 4. Natural history based on 302 patients with follow-up programme 169 patients (56.0%) developed shunt insufficiency (where the PPG was > 12 mmHg or there was a :>20% rise in the PPG from that of the immediate post TIPSS PPG). Shunt insufficiency rates at 6 months, 1 year, and 2 years were 29.8%, 43.4%, and 53.7% respectively. The overall assisted patency rate was 82.0%. CONCLUSIONS: TIPSS is an effective and safe treatment for the complications of portal hypertension. The majority of TIPSS shunts will remain patent with regular venography and interventions where indicated. Hepatic encephalopathy responds to medical treatments in mosl of the cases. The improved survival in the GVB group compared with the OVB group warrants further study. Longer follow up is required to fully evaluate the effectiveness of PTFE covered stents in reducing the incidence of shunt insufficiency.
Background: Changes in architecture of liver is k n o w n to cause increase in hepatic vascular resistance, dilation of the major t r u n k of portal vein as well as decrease in blood flow" velocity. Aim: This study aims to evaluate diagnostic value of the level of maximal a n d average velocity of blood flow in the major t r u n k of the portal vein depending on the diagnosis of the patient, activity rate of pathologic liver damage as well as compensation rate in patients with chronic liver disease a n d liver cirrhosis. Methods: 42 patients (23 males a n d 19 females) were included into the study, 25 of them suffering with liver cirrhosis (decompensated stage - 10 subjects, subcompensated - 15) a n d 17 patients with chronic hepatitis (moderate severity rate - 8, minimal activity rate - 9 subjects). Mean age 42 years, with 37 cases of HCV + v e and 5 cases with non-viral aetiology. The echo - Doppler examination was performed with EUB-515A application of the sector probe of 3.5Mhz frequency. The following parameters were taken into consideration: m a x i m u m velocity rate in portal vein (MV), average velocity rate in the portal vein (AV) as well as diameter of the portal vein (DV). Results of echo-Doppler examination in all groups of patients prescribed in the table. Conclusion : 1.Decrease in blood flow was diagnosed at early stages of the disease, i.e. at the point w h e n the diameter of the portal vein happened to stay within the normal range or slightly" dilated as compared to normvalues.2.Significant reduction in velocity of blood in portal vein was revealed in patients with liver cirrhosis a n d chronic hepatitis of moderate activity rate. Findings under study
Healthy subjects n=12
Chronic hepatitis Minimal activity rate n=9
MV
0.53 ± 0.035 0.47± 0.006
Chronic hepatitis
Liver cirrhosis
Liver cirrhosis
Average Subeompens Decompensat activity rate ationstage ion stage n=8 n=15 n=10 0.32± 0.03*
0,25 ± 0.0t8"
AV 0.43±0.037 0.35±0.03t 0.27±0,042* 0,2±0.01' DV 10.9±0.18 10.8±0.037 11.2±0,22 12.3±0.34" Note: * stands for significantdifferenceas comparedto Control(p<0,05).
0.23 ± 0.0096* 0,19±0008" t4.3±0.65"
533A
AASLD ABSTRACTS
1443
1444
TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNTING (TIPS) IS NOT SUPERIOR TO ENDOSCOPIC VARICEAL BAND LIGATION (VBL) FOR PROPHYLAXIS OF VARICEAL REBLEEDING IN CIRRI{OTIC PATIENTS - A RANDOMIZED, C O N T R O L L E D TRIAL. Veit G~lberg, University of Munich, M u n i c h Germany; Michael Schepke, University of Bonn, Bonn Germany; G u d r u n Geigenberger, Municipal Hospital Schwabing, Munich Germany; Joseph Holl, University of Munich, M u n i c h Germany; Karl A Brensing, University of Bonn, B o n n Germany; Tobias Waggershauser, Maximilian Reiser, University of Munich, M u n i c h Germany; Hans H Schild, Tilman Sauerbruch, University of Bonn, Bonn Germany; Alexander L Gerbes, University of Munich, Munich G e r m a n y
F O L L O W UP BANDING AFTER ACUTE VARICEAL BLEEDING: W H A T HAPPENS IN REAL W O R L D . Ravi Ravinuthala, Kimberly A Brown, Henry Ford Hospital, Detroit, MI
Background:Aim of the present study was to compare the transjugular intrahepatic pot tosystemic shunt with varicealband ligation for prophylaxis of varicealrebleeding in patients with cirrhosis of the liver. Methods: Fifty-fourcirrhotic patients (21 Child-Pugh class A, 27 class B, 6 class C) were randomized within two months after control of esophagealvaricealhemorrhage to TIPS (n= 28) or VBL(n=26). Assuminga one-year rebleeding rate of 35 % in the VBLgroup and 10 % in the TIPS group a sample size of 27 patients in each group was required to detect this differencewith a beta of 0.05 and a power of 80 % using a one-tailed test. Statistical analysis was performed on the intention to treat principle. Results: Mean follow-up was 2 years. Both groups were equally balanced with the exception of a slightly higher number of previous bleeding episodes in the TIPS group. Actuarial probability of remaining free from rebleeding is shown in figure 1. Mortality risk at one and two years of follow-up was 7.8 -+ 5.3 % and 19.9 -+ 8.8 % in the TIPS group and 16.5 ± 7.6 % and I6.5 -+ 7.6 % in the VBLgroup, respectively (n.s.). The rebleeding index (defined as ratio of months of follow-up over number of rebleeding episodes plus one according to the Baveno criteria) was not significantly different between TIPS and VBL patients (18.3 -+ 2.5 months vs. 17.7 -+ 2.1 months). TIPS was not feasible in two patients randomized to TIPS. Four patients randomized to VBL underwent TIPS, one of them as an emergency procedure, two for frequent rebleeding and one for VBLinduced complication prohibiting further endoscopic therapy. Hepatic encephalopathy within 1 month after randomization was observed in 2 patients in the TIPS group and 1 in the VBL group. Conclusion: TIPS was not superior m VBL for prevention of variceal rebleeding in our study. Furthermore, similar mortality rates in patients treated with TIPS or VBL argue against TIPS as prefered strategy for prevention of variceal rebleeding.
.2i
- o.Xi 0
~2
24
ss
~,8
Introduction: Variceal bleeding is a catastrophic manifestation of portal hypertension. Acute variceal bleeding has a significant in hospital mortality and either endoscopic s d e r o t h e r a p y or b a n d ligation is utilized to achieve hemostasis. Secondary prophylaxis has been s h o w n to reduce rebleeding and possibly reduce mortality. O f the various techniques available, several clinical trials have s h o w n that variceal b a n d ligation is the most effective technique. E x c d lent follow up was achieved in the clinical trial setting a n d contributed to the positive results. However, in clinical practice follow u p rates are m u c h poorer. W h e t h e r secondary prophylaxis with b a n d ligation is efficacious outside clinical trial setting has not been tested. W e u n d e r t o o k this study to measure the follow up rates in an u r b a n tertiary care teaching hospital a n d identify potential areas for improvement. Effect of follow up rates on rebleeding a n d mortality were also examined. Methods: W e used the computerized gastroenterology endoscopy database to collect the data. Database search was performed for patients with endoscopic diagnosis of active variceal bleeding or varices with signs of recent hemorrhage. Both the database a n d other records of these patients were reviewed a n d follow u p endoscopies were recorded. Rebleeding a n d mortality rates were obtained. W h e n follow up endoscopy was not done, reason for the lack of follow u p was carefully recorded. W h e r e this information was not available from the hospital records, attempts were made to contact the patients b y telephone. Results: Of over 1000 u p p e r endoscopies done for u p p e r gastrointestinal bleeding between 1999 and 2000, 75 patients were found to have active variceal bleeding. Mean follow u p was 1.3 years. 23% died in the hospital a n d 8% h a d alternative definitive treatments. Of the people surviving the initial episode, only 27% had follow u p EGD and b a n d ligation. 73% were either lost to follow u p completely or did not have endoscopy despite follow up clinic visit. There were no significant differences between the two groups except for male p r e d o m i n a n c e in the endoscopy g r o u p and black race predominance in the no endoscopy group. Rebteeding (7% vs. 23%) and total mortality (0% vs. 45%) rates were significantly higher in the no endoscopy group. Noncompliance a n d lack of insurance were not significant factors affecting follow up rates. The single most important cause for lack of follow u p in this study was inadequate instructions about follow u p at the time of discharge. Conclusions: Follow u p rates after variceal bleeding are alarmingly low b u t seem to be remediable. Unless measures are taken to ensure return visits for b a n d ligation, secondary prophylaxis will be ineffective.
1445
1446
10 YEARS FOLLOW-UP OF 484 PATIENTS WITH TRANSJUGULAR INTI~A-HEPATIC PORTOSYSTEMIC STENT-SHUNT (TIPSS). Dhiraj Tripathi, Sherzad Balata, H o c k F Lui, Adrian J Stanley, Kim Macbeth, Ewan Forrest, Rajiv Jalan, Doris N Redhead, Peter C Hayes, Royal Infirmary of Edinburgh, E d i n b u r g h Uk
EVALUATION OF CHRONIC HEPATITIS C AND CIRRHOTIC PATIENTS THROUGH B L O O D F L O W VELOCITY IN PORTAL VEIN, Ashraf R AbulF u t u h MD, Mansoura International Hospital, Mansoura Egypt; Salwa M E1 Hadad, Ain Shams Universty Hosp Egypt, Cairo Egypt; Abdel Ghani M Solayman, Asiut Universty Hosp Egypt, Asiut Egypt
BACKGROUND AND AIMS: Since its introduction in 1989, TIPSS has improved the management of the complications of portal hypertension, and compares favourably with other treatment modalities. This study aims to report on the long-term follow-up of TIPSS at a single centre. METHODS: Data was collected prospectively on all patients who were referred for TIPSS during the period 7/1991 to 4/2001. The cohort included 484 patients who required TIPSS for complications secondary to portal hypertension. They were followed-up clinically (3 monthly) and radiographicany (6 monthly). Mean follow up was 43.6 -+ 29.6 months. RESULTS: I. Patients characteristics 65.6% were males, 39.4% females with a mean age of 47.4 -+ 21.1 years (range 4-84 yrs). Main aetiologies: alcoholic liver disease (66.8%), non-alcoholic (33.2%). Indications: oesophageal variceal bleeding (OVB - 69.7%), gastric variceal bleeding (GVB - 11.8%), ascites (10.7%), portal hypertensive gastropathy (1.7%), ectopic variceal bleeding (1.7%), others (4.4%). The newer PTFE covered stems were used in 29 patients between 9/1999 to 4/2001 (23 at TIPSS creation and 6 at the time of re-stenting of insufficient "uncovered" stents) 2. Technical outcomes TIPSS insertion was successful in 95.6% and failed in 5.4% of referred cases. Functional success (defined as a post TIPSS portal pressure gradient (PPG) reduction to < 12mmHg or 20% drop in the pre TIPSS PPG) was achieved in 250 (82%). Procedure related mortaIity and complications were 0.8% and 3.2% respectively. 3. Clinical outcomes Variceal rebleeding occurred in 25 (5.5%) cases, with there being no difference in the rebleeding rate whether the indication was GVB or OVB. New or worsened encephalopathy was present in 68 (14.8%),and 45 (9.8%) respectively. In 16 cases of encephalopathy (14.2%) radiological intervention to block the shunt was necessary. TIPSS was a bridge to liver transplantation in 41 cases (9% of all successful cases), and was used in 2 patients following liver transplantation. Cumulative sur'dval at 30 days, 1, 2 & 5 years were 97.6%, 95.0%, 88.5% and 56.7% respectively. The 5 year survival for patients with OVB was 51.8% and for GVB 78.4% (p<0.05). 4. Natural history based on 302 patients with follow-up programme 169 patients (56.0%) developed shunt insufficiency (where the PPG was > 12 mmHg or there was a :>20% rise in the PPG from that of the immediate post TIPSS PPG). Shunt insufficiency rates at 6 months, 1 year, and 2 years were 29.8%, 43.4%, and 53.7% respectively. The overall assisted patency rate was 82.0%. CONCLUSIONS: TIPSS is an effective and safe treatment for the complications of portal hypertension. The majority of TIPSS shunts will remain patent with regular venography and interventions where indicated. Hepatic encephalopathy responds to medical treatments in mosl of the cases. The improved survival in the GVB group compared with the OVB group warrants further study. Longer follow up is required to fully evaluate the effectiveness of PTFE covered stents in reducing the incidence of shunt insufficiency.
Background: Changes in architecture of liver is k n o w n to cause increase in hepatic vascular resistance, dilation of the major t r u n k of portal vein as well as decrease in blood flow" velocity. Aim: This study aims to evaluate diagnostic value of the level of maximal a n d average velocity of blood flow in the major t r u n k of the portal vein depending on the diagnosis of the patient, activity rate of pathologic liver damage as well as compensation rate in patients with chronic liver disease a n d liver cirrhosis. Methods: 42 patients (23 males a n d 19 females) were included into the study, 25 of them suffering with liver cirrhosis (decompensated stage - 10 subjects, subcompensated - 15) a n d 17 patients with chronic hepatitis (moderate severity rate - 8, minimal activity rate - 9 subjects). Mean age 42 years, with 37 cases of HCV + v e and 5 cases with non-viral aetiology. The echo - Doppler examination was performed with EUB-515A application of the sector probe of 3.5Mhz frequency. The following parameters were taken into consideration: m a x i m u m velocity rate in portal vein (MV), average velocity rate in the portal vein (AV) as well as diameter of the portal vein (DV). Results of echo-Doppler examination in all groups of patients prescribed in the table. Conclusion : 1.Decrease in blood flow was diagnosed at early stages of the disease, i.e. at the point w h e n the diameter of the portal vein happened to stay within the normal range or slightly" dilated as compared to normvalues.2.Significant reduction in velocity of blood in portal vein was revealed in patients with liver cirrhosis a n d chronic hepatitis of moderate activity rate. Findings under study
Healthy subjects n=12
Chronic hepatitis Minimal activity rate n=9
MV
0.53 ± 0.035 0.47± 0.006
Chronic hepatitis
Liver cirrhosis
Liver cirrhosis
Average Subeompens Decompensat activity rate ationstage ion stage n=8 n=15 n=10 0.32± 0.03*
0,25 ± 0.0t8"
AV 0.43±0.037 0.35±0.03t 0.27±0,042* 0,2±0.01' DV 10.9±0.18 10.8±0.037 11.2±0,22 12.3±0.34" Note: * stands for significantdifferenceas comparedto Control(p<0,05).
0.23 ± 0.0096* 0,19±0008" t4.3±0.65"