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Case report: Successful management of a patient with alcoholic cirrhosis and intractable ascites with a novel device - the alfapump® system D. Adebayo, M. Malago, R. Jalan Institute for Liver and Digestive Health Royal Free Hospital Pond Street, London NW3 2QG Email address: [email protected] Introduction Ascites is defined as the pathological accumulation of fluid within the peritoneal cavity. It is a common manifestation of cirrhosis with approximately 50% of patients with cirrhosis developing ascites within 10 years of diagnosis1. The development of ascites in a cirrhotic patient is an important landmark for a number of reasons: (1) it is associated with a poor quality of life and an increased 1-year mortality; (2) it functions as a risk stratification marker for orthotopic liver transplantation; (3) it is a common complication and thus associated with high contingent costs2,3. The initial management of ascites is diuretics and sodium restriction. Despite this, up to 10% of ascitic patients develop diuretic-refractory or diuretic intractable ascites per annum4. Ascites is classified as diuretic refractory when there is a lack of response to high doses of diuretics (400mg spironolactone per day plus 160mg of furosemide per day) or diuretic-intractable when the development of side effects prevent the use of diuretics in a patient5. The first-line therapy strategy for diuretic-refractory/intractable ascites is large volume paracentesis (LVP) with the concomitant administration of intravenous albumin. However, some patients treated with regular LVP may develop post-paracentesis circulatory dysfunction. In addition, there are cost considerations associated with the need for repeated LVP. An alternative treatment strategy involves the insertion of a Transjugular Intrahepatic Porto-systemic Shunt (TIPS). Although TIPS is effective in controlling ascites in up to 66% of patients, approximately half of these patients are at risk of developing hepatic encephalopathy. In addition, its use is contraindicated in patients with severe liver disease4. In selected patients, who are suitable candidates, orthotropic liver transplantation is the definitive treatment strategy. We report a case of 48-year-old male, with diureticintractable ascites, who was the first patient in our centre to be treated with a novel therapeutic devicethe alfapump® system (Automated Low-Flow Ascites Pump System, Sequana Medical, Zurich, Switzerland). This device is a fully implantable battery-powered pump that transports ascites from the peritoneal cavity into the bladder so it can be eliminated by micturition. Case Report A 48- year old man with alcoholic cirrhosis and ascites diagnosed 3 years ago was referred to our centre for consideration of a liver transplant. He had been abstinent from alcohol since his diagnosis with liver disease. At presentation, he was requiring paracentesis about every two weeks with on average 8-litres of ascites being drained. He had no history of spontaneous bacterial peritonitis. He had a medical history of hepatic encephalopathy, systemic arterial hypertension, renal impairment and two previous deep vein thromboses in the right calf. Medications included Bisoprolol, Citalopram, Amitriptyline, Omeprazole, Spironolactone and vitamins. Physical examination revealed reduced muscle mass and a distended abdomen in keeping with grade 3 ascites. Blood tests at the initial visit revealed: haemoglobin of 12.8g/dl, platelet count of 153x10 9/L, INR 1.2, sodium 142, urea 7.3 mmol/L, creatinine 119 umol/L, bilirubin 8 umol/L, ALT 16 u/L, AST 26 u/L, ALP 75 u/L, gamma-GT 37 u/L, albumin 39 g/L giving a MELD score of 11 and UKELD score of 48. He had a complete transplant work-up and it was felt that in view of his relatively well-preserved liver function, he was too early to be considered for a liver transplant. In view of his previous episode of hepatic encephalopathy, it was felt he would be high risk for TIPS. As our centre was in the process of recruiting patients for a large, multi-centre, randomised control trial of the alfapump system, we offered the patient an opportunity to participate in the trial. The patient consented to be involved in the trial and was randomised to receive the alfapump. A surgeon performed the procedure under general anaesthesia and the implantation took approximately 45 mins. Peri-operative prophylactic antibiotics, Ceftazidime and Teicoplanin were administered at the time of the procedure and 12-hours afterwards. The alfapump was turned on the day after the operation and programmed to drain 500 ml/day. Day 2 post implantation, the patient developed a stage-1 acute kidney injury with a rise in creatinine (see Table 1). This was managed with intravenous volume replacement using Human Albumin solution and settled by day 5. Day 5 post implantation, a rise in inflammatory markers was noted despite the patient being clinically well (CRP 203mg/L, WCC 18.80x109/L). A septic screen yielded no positive results and the blood test results improved after 48 hours. Antibiotic therapy was not required. The patient was discharged at day 7 post implantation with the pump set to drain 1 litre/day. Approximately 6 weeks post implantation, the patient complained of difficulty with micturition. Ultrasound demonstrated evidence of urinary retention. Subsequent urodynamic studies suggested the presence of a urethral stricture. The patient underwent a cystoscopy and urethral dilatation. In that period, the pump volume was turned down from 1 litre to 500 ml/day. The patient recovered within days of the procedure and the pump setting was readjusted to drain 1litre/ day. The patient encountered no further adverse events. which are likely to be related to surgery rather than the device. It is possible that the urethral stricture was long-standing and only aggravated when the urinary tract was challenged with the increased amount of ascites. Nevertheless, we now routinely carry out a detailed urological survey on all our patients before implantation. The alfapump system should be considered as a treatment option for refractory ascites in selected patients. At 8-months post pump insertion, he had drained approximately 100 litres of ascites and an abdominal ultrasound revealed less than 100 mls of ascites in the peritoneal cavity. His nutritional status improved significantly and he reported an “excellent” quality of life. To date (more than 12 months post implantation), he has not required paracentesis or hospital admission. His laboratory results have remained improved (Table 1) giving a current MELD of 10 and UKELD of 43. 1. Gines, P., et al. Compensated cirrhosis: natural history and prognostic factors. Hepatology 7, 122-128 (1987). 2. Planas, R., et al. Natural history of patients hospitalized for management of cirrhotic ascites. Clinical gastroenterology Summary Liver international : official journal of the International Association for the Study of the Liver 30, 937-947 (2010). 5. Moore, K.P., et al. The management of ascites in cirrhosis: This case report describes our first experience in managing a patient with the new alfapump system. In the initial post-operative period, the patient experienced stage-1 acute kidney injury and showed evidence of a systemic inflammatory response both of References: and hepatology : the official clinical practice journal of the American Gastroenterological Association 4, 1385-1394 (2006). 3. Moore, C.M. & Van Thiel, D.H. Cirrhotic ascites review: Pathophysiology, diagnosis and management. World journal of hepatology 5, 251-263 (2013). 4. Salerno, F., et al. Refractory ascites: pathogenesis, definition and therapy of a severe complication in patients with cirrhosis. report on the consensus conference of the International Ascites Club. Hepatology 38, 258-266 (2003) . TABLE 1 PARAMETER Haemoglobin (g/dL) White blood count (x109/L) Platelet count (x109/L) INR AST (u/L) ALT (u/L) Alkaline phosphatase (u/L) Gamma glutamyl transferase (u/L) Total bilirubin (μmol/L) Creatinine (μmol/L) Urea (mmol/L) Serum albumin (g/L) Sodium (mmol/L) Potassium (mmol/L) C-Reactive Protein (mg/L) 1 DAY pre-implantation 12.5 9.23 143 1.3 30 21 74 42 25 116 8.3 44 142 4.6 8 2 DAYS post-implantation 11.0 16.72 99 1.4 22 12 51 27 24 184 10.5 46 136 4.4 14 360 DAYS post-implantation 14.3 9.54 125 1.1 26 16 66 47 8 111 6.5 48 147 4.3 6