Varizen Essay

Varizen Essay Early Use of TIPS in Patients with Cirrhosis and Variceal Bleeding — NEJM Varizen Essay


Varizen Essay

N Engl J Med ; Patients with cirrhosis in Child—Pugh class C or those in class B who have persistent bleeding at endoscopy are at high risk for treatment failure and a poor prognosis, even if they have undergone rescue treatment with a transjugular intrahepatic portosystemic shunt TIPS. This study evaluated the earlier use of TIPS in such patients.

Full Text of Background We randomly assigned, within 24 hours after admission, Varizen Essay, a total of 63 patients with cirrhosis and acute Geschwüre, Krampfadern Foto bleeding who had been treated with vasoactive drugs plus endoscopic therapy to treatment with a polytetrafluoroethylene-covered stent within 72 hours after randomization early-TIPS group, 32 patients or continuation of vasoactive-drug therapy, followed after 3 to 5 days by treatment with propranolol or Fliegen auf ein Flugzeug mit Krampfadern and long-term endoscopic band ligation EBLwith insertion of Varizen Essay TIPS if needed as rescue therapy pharmacotherapy—EBL group, 31 Varizen Essay. Full Text of Methods The number of days in the intensive care unit and the percentage of time in the hospital during follow-up were significantly higher in the pharmacotherapy—EBL group than in the early-TIPS group.

No significant differences were Varizen Essay between the two treatment groups with respect to serious adverse events. Full Text of Results In these patients with cirrhosis who were hospitalized for acute variceal bleeding and at high risk for treatment failure, the early use of TIPS was associated with significant reductions in treatment failure Varizen Essay in mortality.

Full Text of Discussion Variceal bleeding is Krampfadern der unteren Extremitäten Übung Venen severe complication of portal hypertension and a major cause of death in patients with cirrhosis. Advanced liver failure, failure to control variceal bleeding, Varizen Essay, early rebleeding, and marked elevations in portal pressure are associated with increased mortality.

In a study involving patients at high risk for treatment failure, Varizen Essay, as indicated by a hepatic venous pressure gradient of 20 mm Hg or more, 11 early treatment with TIPS improved the prognosis in comparison with medical treatment in a study by Monescillo et al. We conducted a study to determine whether early treatment with TIPS, with the use of a stent covered with extended polytetrafluoroethylene e-PTFEcan improve outcomes in patients with cirrhosis and variceal bleeding who are at high risk for treatment failure and death.

Eligible patients had cirrhosis with acute esophageal variceal bleeding that was being treated with a combination of vasoactive drugs, endoscopic treatment, and prophylactic antibiotics. Patients had Child—Pugh class C disease a score of 10 to 13 or they had class B disease a score of 7 to 9 but with active bleeding at diagnostic endoscopy. Patients with scores higher than 13 were excluded from the study. In the Child—Pugh classification of liver disease, class A [a score of 5 or 6] indicates the least severe disease, class B [7 to 9] moderately severe disease, and class C [10 to 15] the most severe disease.

Active variceal bleeding at endoscopy was defined on the basis of the Baveno criteria. Exclusion criteria were an age of more than 75 years, pregnancy, Varizen Essay, hepatocellular carcinoma that did not meet the Milano criteria for transplantation i.

All patients provided written informed consent. The study protocol was approved by the ethics committees of all participating hospitals and followed the Guidelines for Good Clinical Practice in clinical trials. Randomization was performed within 24 hours after admission.

The randomization sequence was generated by computer with the use of a concealed block size of four. The coded treatment assignments were kept at the coordinating center in sealed, consecutively numbered, opaque envelopes. Randomized assignments to the study groups were made by contacting the coordinating center available 24 hours a day by telephone or fax.

Treatment with vasoactive drugs was continued until patients were free of bleeding for at least 24 hours and preferably up to 5 days, at which point treatment with a nonselective beta-blocker either propranolol or nadolol was Varizen Essay. The dose was increased in a stepwise fashion every 2 to 3 days to the maximum tolerated dose or to a maximum of mg twice daily for propranolol and mg per day for nadolol.

After these doses were achieved, 10 mg of isosorbidemononitrate was initiated at bedtime, with a stepwise increase in the dose to a maximum of 20 mg twice a day or the maximum tolerated dose. In addition, Varizen Essay, within 7 to 14 days after the initial endoscopic treatment, the second, elective session of EBL was performed, Varizen Essay.

EBL sessions were then scheduled every 10 to 14 days until variceal eradication was achieved i. Varizen Essay received proton-pump inhibitors until variceal eradication was accomplished. After eradication, endoscopic monitoring was performed at 1-month, 6-month, and month intervals and then annually.

If varices Varizen Essay, further EBL sessions were initiated. Treatment failure was defined as one severe rebleeding episode i. TIPS was performed Varizen Essay 72 hours after diagnostic endoscopy or, when possible, within the first 24 hoursVarizen Essay, and vasoactive drugs were administered until then, Varizen Essay.

If the portal-pressure gradient the difference between portal-vein pressure and inferior vena caval pressure did not decrease to below 12 mm Hg, the stent was dilated to 10 mm, Varizen Essay.

Follow-up visits were scheduled at 1 month, at 3 months, and every 3 months thereafter, Varizen Essay. Doppler ultrasonography was performed at the first visit, at 6 months, and every 6 months thereafter.

Patients were followed until death or liver transplantation up to a maximum Creme von der Website von Krampfadern 2 years of follow-up or until the end Rezepte mit Krampfadern an den Beinen the study September The primary end point of the study was a composite outcome of failure to control acute Varizen Essay or failure to prevent clinically significant variceal rebleeding within 1 year after enrollment.

Secondary end points were mortality at 6 weeks and at 1 year, failure to control acute bleeding, Varizen Essay, early rebleeding rate of rebleeding at 5 days and at 6 weeksrate of rebleeding between 6 weeks and 1 year, the development of other complications related Varizen Essay portal hypertension on follow-up, the number of days in the intensive care unit, the percentage of follow-up days spent in the hospital, and the use of alternative treatments.

In a study by Villanueva et al. Because the only rationale for early use of TIPS would be evidence that this approach is better than the current standard treatment, the sample size was calculated with the use of a one-sided test. All data analyses were performed on an intention-to-treat basis according to a preestablished analysis plan. Dichotomous variables were compared by means of Fisher's exact test, Varizen Essay, and continuous variables were compared by means of the nonparametric Mann—Whitney rank-sum test.

The probabilities of reaching the primary end point and of survival were estimated by the Kaplan—Meier method and were compared by means of the log-rank test. A P value of less than 0. The statistical software packages used for the analysis were SPSS version We screened patients with acute variceal bleeding who were admitted to the participating hospitals for study eligibility.

There were no significant differences in baseline characteristics between the two groups at the time of entry into the study Table 1 Table 1 Baseline Characteristics of the Patients. A total of 7 patients 3 in the pharmacotherapy—EBL group and 4 in the early-TIPS group were lost to follow-up after a median of 8 months range, 0. A total of 6 patients 2 in the pharmacotherapy—EBL group and 4 in the early-TIPS group underwent liver transplantation during follow-up.

In the pharmacotherapy—EBL group, Varizen Essay, 22 Abstracts Krampfadern Krankheit received propranolol median dose, 55 mg [range, Varizen Essay, 10 to ]and only 3 received nadolol.

In the remaining 6 patients, nonselective beta-blocker therapy was not initiated because of failure to control bleeding, early rebleeding, or death. In 12 patients, isosorbidemononitrate was added to the nonselective beta-blocker median dose, 25 mg [range, 10 to 40]Varizen Essay, but it was not added in 13 patients because of arterial hypotension, the treating physician's preference, or early death. Variceal eradication was achieved in 12 patients after a median of 2 EBL sessions range, 1 to 7 without rebleeding; in 4 patients, eradication was achieved after treatment of a rebleeding episode with additional EBL sessions, Varizen Essay.

In the remaining 15 patients, eradication was not achieved in 12 because the primary end point was reached [resulting in rescue TIPS in 7 and death in Varizen Essay, in 2 who were lost to follow-up, and in 1 despite eight EBL sessions.

In the early-TIPS group, all but 1 patient, who withdrew consent, underwent early shunt placement. There were no technical failures or major complications of the TIPS procedure. Paroxysmal supraventricular tachycardia occurred in 1 patient and was controlled medically. A Die Behandlung von Krampfadern Strumpfhosen of 27 patients required one stent, and 4 required two stents, Varizen Essay.

The mean portal-pressure gradient dropped from Despite dilation to 10 mm, the portal-pressure gradient after TIPS remained above 12 mm Hg in 2 patients. Collateral embolization was performed in 2 patients one of whom had a portal-pressure gradient above 12 mm Hg after TIPS. The probability of remaining free from uncontrolled variceal bleeding or variceal rebleeding is shown in Panel A, and the probability of survival is shown in Panel B. In these patients, the Model for End-Stage Liver Disease MELD score which ranges from 6 to 40, with higher scores indicating more severe disease increased from a mean of In 7 of these patients, TIPS with an e-PTFE—covered stent was used as rescue therapy; although bleeding was controlled, Varizen Essay, 4 of these patients died within 36 days range, 1 to In 5 patients, no further treatment was considered because of severe liver failure, and all died.

In Varizen Essay 9 patients who died, the mean MELD score was The remaining 2 patients who reached the Varizen Essay end point underwent additional EBL sessions and were alive at the end of the follow-up period. An additional 4 patients 3 in the pharmacotherapy—EBL group and 1 in the early-TIPS group had a rebleeding episode that was not clinically significant i. Causes of death are summarized in Table 2.

In the pharmacotherapy—EBL group, 12 patients had a total of 17 episodes of hepatic encephalopathy, whereas in the early-TIPS group, Varizen Essay, 8 patients had a total of 10 episodes Table 3 Table 3 Adverse Events.

Most of these episodes occurred during the index bleeding. A total of 3 patients in the pharmacotherapy—EBL group and 2 in the early-TIPS group had Varizen Essay III hepatic encephalopathy, and 1 patient in each group had mild, recurrent hepatic encephalopathy. Spontaneous bacterial peritonitis developed during the index bleeding in 2 patients in the pharmacotherapy—EBL group, both of whom died. In addition, the hepatorenal syndrome developed during the index bleeding in 7 patients: As shown in Table 3 Varizen Essay, there were no significant between-group differences in the numbers of patients who had adverse effects.

In the study by Monescillo et al. Therefore, it is difficult to extrapolate the results of this study for application to clinical practice. Our study was specifically designed Varizen Essay show whether an early decision to use TIPS, with e-PTFE—covered stents and based on clinical criteria, can improve the prognosis for patients with variceal bleeding who are at high risk.

We found that in patients treated early with TIPS, the risks of failure to control bleeding and of variceal rebleeding were reduced. In addition, and even more important, Varizen Essay, the early use of TIPS was associated with a reduction in mortality.

This beneficial effect on survival was observed even though rescue TIPS was used in patients in whom medical treatment failed. Mortality was very high among the patients who underwent rescue TIPS after treatment failure, Varizen Essay, a result that is consistent with the findings in previous studies.

Previous studies evaluating the role of TIPS in the prevention of recurrent variceal bleeding clearly showed that TIPS reduces the rebleeding rate but increases hepatic encephalopathy without improving survival. It should be noted that previous studies of TIPS differed from our study in that they used bare stents Varizen Essay did not limit enrollment to patients at high risk for treatment failure.

In the study by Escorsell et al, Varizen Essay. Therefore, the study design precluded the possibility of demonstrating a benefit of TIPS in these high-risk patients. In high-risk patients, the potentially deleterious effects of e-PTFE—covered TIPS appear to be counterbalanced by Varizen Essay high efficacy in controlling bleeding and thus preventing further clinical deterioration.

In contrast, Varizen Essay, TIPS should not be used as the initial treatment in patients with Child—Pugh class A disease, since the rates of medical-treatment failure and mortality are low among such patients.

Although the risks of treatment failure and death were higher in patients with Child—Pugh class C disease than in those with class B disease, our trial was not powered to conduct appropriate subgroup analyses. Therefore, further evaluation will be needed to determine whether the early use of TIPS equally benefits these two subgroups of patients.

The early use of TIPS was not associated with an increase in the number or severity of episodes of hepatic encephalopathy.

In conclusion, in patients with Child—Pugh class C disease or class B disease with active bleeding who were admitted for acute variceal bleeding, the early use of TIPS with an wobei Varizen kann stent was associated with significant reductions in the failure to control bleeding, in rebleeding, and in mortality, Varizen Essay, with no increase in the risk of hepatic encephalopathy.

Lalemanand an educational grant from Gore. Caca, Varizen Essay, receiving lecture fees and reimbursement for travel expenses from Gore; and Dr.


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