RESUMEN
Hepatic hydrothorax affects 5%-15% of decompensated cirrhosis patients, with up to 26% being refractory to standard treatments. For those ineligible for transjugular intrahepatic systemic shunts or liver transplants, alternatives to repeated thoracentesis are limited but can include the insertion of an indwelling pleural catheter. We present the first case of the use of an automatic low-flow ascites pump (alfapump) to manage nonmalignant pleural effusion in an elderly patient with cirrhosis.
RESUMEN
Standard of care for the treatment of ascites in cirrhosis is to administer a sodium-restricted diet and diuretic therapy. The progression of cirrhosis will eventually lead to the development of refractory ascites, at which point diuretics will no longer be able to control the ascites. Second-line therapies such as a transjugular intrahepatic portosystemic shunt (TIPS) placement or repeat large volume paracentesis are then required. There is some evidence that regular infusions of albumin may delay the onset of refractoriness and improve survival, especially if given at an early stage in the natural history of ascites and for a long enough duration. The use of TIPS can eliminate ascites, but its insertion is associated with complications, especially cardiac decompensation and worsening of hepatic encephalopathy. New information is now available regarding how to best select patients for TIPS, what type of cardiac investigations are needed and how under-dilating the TIPS at the time of insertion may help. The use of a non-absorbable antibiotics, such as rifaximin, starting in the pre-TIPS period may also reduce the likelihood of post-TIPS hepatic encephalopathy. In patients who are not suitable for TIPS, the use of an alfapump to remove the ascites via the bladder can improve quality of life without significantly altering survival. In the future it may be possible to use metabolomics to help refine the management of patients with ascites, e.g. to assess their response to non-selective beta-blockers or to predict the development of other complications such as acute kidney injury.
RESUMEN
Refractory ascites (RA) is a frequent and life-threatening complication of cirrhosis. In selected patients with RA, transjugular intrahepatic portosystemic shunt (TIPS) placement and liver transplantation (LT) are currently considered the best therapeutic alternatives to repeated large volume paracentesis. In patients with a contraindication to TIPS or LT, the alfapump® system (Sequana Medical, Ghent, Belgium) has been developed to reduce the need for iterative paracentesis, and consequently to improve the quality of life and nutritional status. We report here recent data on technical progress made since the first implantation, the efficacy and tolerance of the device, the position of the pump in the therapeutic arsenal for refractory ascites, and the grey areas that remain to be clarified regarding the optimal selection of patients who are potential candidates for this treatment.
RESUMEN
BACKGROUND AND AIMS: Patients with cirrhotic refractory ascites ineligible for transjugular intrahepatic shunt (TIPSS) have limited treatment options apart from repeated large volume paracentesis. The alfapump® is an implantable device mobilizing ascites from the peritoneal cavity to the bladder, from where it can be excreted. The aim of this observational cohort study was to prospectively investigate safety and efficacy of the device in a real-world cohort with cirrhotic refractory ascites and contraindications for TIPSS. METHODS: A total of 106 patients received an implant at 12 European centres and were followed up for up to 24 months. Complications, device deficiencies, frequency of paracentesis, clinical status and survival were recorded prospectively. RESULTS: Approximately half of the patients died on-study, about a quarter was withdrawn because of serious adverse events leading to explant, a sixth were withdrawn because of liver transplant or recovery, and nine completed follow-up. The most frequent causes of on-study death and complication-related explant were progression of liver disease and infection. The device reduced the requirement for large-volume paracentesis significantly, with more than half of patients not having required any post-implant. Survival benefits were not observed. Device-related reinterventions were predominantly caused by device deficiencies. A post-hoc comparison of the first 50 versus the last 50 patients enrolled revealed a decreased reintervention rate in the latter, mainly related to peritoneal catheter modifications. CONCLUSIONS: The device reduced paracentesis frequency in a real-world setting. Technical complications were successfully decreased by optimization of management and device modification (NCT01532427).
Asunto(s)
Trasplante de Hígado , Derivación Portosistémica Intrahepática Transyugular , Ascitis/etiología , Ascitis/terapia , Humanos , Cirrosis Hepática , Trasplante de Hígado/efectos adversos , Paracentesis/efectos adversos , Derivación Portosistémica Intrahepática Transyugular/efectos adversos , Derivación Portosistémica Intrahepática Transyugular/métodos , Sistema de RegistrosRESUMEN
BACKGROUND: The alfapump® is an implantable class III medical device that pumps ascitic fluid from the peritoneal space to the urinary bladder from where it is excreted. The pump reduces or abrogates the need for repeated paracentesis in patients with recurrent or refractory ascites. AIMS: To improve outcomes for alfapump® implantation and pre- and post-implant patient management in both clinical trial and real-world settings by development of consensus recommendations. METHODS: The alfapump® working group consisting of hepatologists and surgeons with extensive experience in implantation of the alfapump® and patient management met on two occasions: (1) to determine the key areas where recommendations should be made; and (2) to discuss the experiences of the working group within those areas and formulate draft statements. Developed statements were submitted to the group and consensus sought on relevance and wording through a collaborative iterative approach in order to consolidate the recommendations into consensus statements. Only recommendations agreed upon unanimously were included. RESULTS: Twenty-three consensus recommendations were developed in the areas of pre-implantation procedure, (three statements), surgical implant procedure (11 statements), immediate post-implant care (three statements) and long-term management (six statements). CONCLUSIONS: The consensus statements are a valuable reference resource for physicians managing patients with the alfapump® and for those considering management strategies for patients with refractory ascites.
Asunto(s)
Ascitis , Cirrosis Hepática , Ascitis/etiología , Ascitis/terapia , Humanos , Cirrosis Hepática/complicaciones , Cirrosis Hepática/cirugía , Paracentesis , Vejiga UrinariaRESUMEN
INTRODUCTION: The treatment of symptomatic hernia in cirrhotic patients with refractory ascites is critical but challenging. The objective of this study was to assess the feasibility and safety of the implantation of alfapump® combined with concomitant hernia repair in cirrhotic patients with refractory ascites. METHODS: Using data from six European centres, we retrospectively compared patients treated with alfapump® system implantation and concomitant hernia repair [the combined treatment group (CT group, n=12)] or with intermittent paracentesis hernia repair [the standard treatment group (ST group, n=26)]. Some patients of the ST group had hernia repair in an elective setting (STel group) and others in emergency (STem group). The endpoints were requirement of peritoneal drainage, the rate of infectious complications, the in-hospital mortality, the length of stay, paracentesis-free survival. RESULTS: Postoperatively, none of the patients in the CT group and 21 patients (80%) in the ST group underwent peritoneal drainage for the evacuation of ascites fluid (P<0.0001). The overall incidence of infectious complications was not different between groups but there were fewer infections in the CT group than in the STem group (33% vs. 81%; P=0.01). There was no difference for in-hospital mortality. The length of stay was shorter in the CT group (P=0.03). Paracentesis-free survival was significantly better (P=0.0003) in the CT group than in the ST group. CONCLUSION: Implantation of alfapump combined with concomitant hernia repair seems feasible and safe in cirrhotic patients; however, larger and randomized study are required.
Asunto(s)
Ascitis , Herniorrafia , Ascitis/etiología , Ascitis/terapia , Humanos , Cirrosis Hepática/complicaciones , Proyectos Piloto , Estudios RetrospectivosRESUMEN
INTRODUCTION: Ascites is a common complication of liver cirrhosis and represents the main cause of hospitalization among patients with cirrhosis. First-line therapy for those patients is the use of diuretics and dietary sodium restriction. However, 10 % of patients per year become therapy refractory to diuretic treatment with the need of repeated high-volume paracentesis or transjugular intrahepatic portosystemic shunt (TIPS). For these patients, an automated pump system (Alfapump/Sequana Medical) was developed. Here, we describe our single-center experience of ten consecutively implanted pump systems. PATIENTS AND METHODS: Between 08/13 and 11/14, ten Alfapump systems were implanted in patients with refractory ascites all suffering from liver cirrhosis. Those patients were treated as a bridge to transplant (4/10) or as an end-stage therapy (6/10). Median follow-up was 165 days (23-379 days). RESULTS: Postimplant, the need of paracentesis could be markedly reduced to a mean of 0.45 (0-4/month) per month. In eight patients, paracentesis was not needed after implantation of the pump system. The median daily output volume was 1000 ml/day (450-2000 ml/day). Prerenal insufficiency was a recurrent complication in the postoperative period. DISCUSSION: The Alfapump system is a useful system in the treatment of patients suffering from therapy refractory ascites. However, due to the high level of comorbidities, careful patient selection and postoperative monitoring are required.