Expanding consensus in portal hypertension: Report of the Baveno VI Consensus Workshop: Stratifying risk and individualizing care for portal hypertension (original) (raw)
See Editorial, pages 543-545 Portal hypertension is the haemodynamic abnormality associated with the most severe complications of cirrhosis, including ascites, hepatic encephalopathy and bleeding from gastroesophageal varices. Variceal bleeding is a medical emergency associated with a mortality that, in spite of recent progress, is still in the order of 10-20% at 6 weeks. The evaluation of diagnostic tools and the design and conduct of good clinical trials for the treatment of portal hypertension have always been difficult. Awareness of these difficulties has led to the organisation of a series of consensus meetings. The first one was organised again in Baveno in 2005 (Baveno IV) [9,10], in Atlanta in 2007 [11], and again in Stresa in 2010 (Baveno V) [12,13]. The aims of these meetings were to develop definitions of key events in portal hypertension and variceal bleeding, to review the existing evidence on the natural history, the diagnosis and the therapeutic modalities of portal hypertension, and to issue evidence based recommendations for the conduct of clinical trials and the management of patients. All these meetings were successful and produced consensus statements on some important points, although several issues remained unsettled. To continue the work of the previous meetings, a Baveno VI workshop was held on April 10-11, 2015. The workshop was attended by many of the experts responsible for most of the major achievements of the last years in this field. Many of them had attended the previous meetings as well. A concept that has gained wide acceptance over the past few years is the fact that patients in different stages of cirrhosis have different risks of developing complications and of dying. Accordingly, the Baveno VI workshop was entitled ''Stratifying risk and individualizing care for portal hypertension''. The main fields of discussion were the use of invasive and non-invasive methods for the screening and surveillance of gastroesophageal varices and of portal hypertension, the impact of aetiological therapy for cirrhosis, the primary prevention of decompensation, the management of the acute bleeding episode, the prevention of recurrent haemorrhage and other decompensating events, and vascular diseases of the liver in cirrhotic and non-cirrhotic patients. For each of these topics, a series of consensus statements were discussed and agreed upon. Whenever applicable, the level of existing evidence was evaluated and the recommendations were ranked according to the Oxford System [14] (i.e., level of evidence from 1 = highest to 5 = lowest; grade of recommendation from A = strongest, to D = weakest). The presentations given during the workshop are reported 'in extenso' in the Baveno VI proceedings [15]. A summary of the most important conclusions is reported here. Whenever relevant, the changes from previous consensus statements are outlined. The areas where major new recommendations were made are: screening and surveillance, the importance of obesity, comorbidities and malnutrition, the use of beta blockers in patients with refractory ascites/end-stage liver disease, and anticoagulation and portal vein thrombosis in liver cirrhosis. Definitions of key events regarding the bleeding episode (changed from Baveno V) Six-week mortality should be the primary endpoint for studies for treatment of acute variceal bleeding (5;D). 5 day treatment failure is defined using Baveno IV/V criteria without ABRI (adjusted blood requirement index) and with a clear definition of hypovolemic shock (1b;A). Baveno IV/V criteria correlate with 6-week mortality (1b;A) and should be included in future studies as a secondary endpoint to allow further validation (5;D). Additional endpoints should be reported including: need for salvage therapy (tamponade, additional endoscopic therapy, transjugular intrahepatic portosystemic shunt [TIPS], surgery etc.); blood transfusion requirements and days of ICU/hospital stay (5;D).