An Automated Continual Water Removal System in Patients With Advanced Diuretic Resistant Heart Failure

Who can take part

• ≥ 21 years of age; Life expectancy > 6 months; HF, NYHA class II-IV; > 1 HF related admissions in the last 12 months; Fluid congestion (2 signs of pitting oedema, jugular distention, BW elevation, nocturnal dyspnoea score, respiration rate, pulmonary congestion and/or pleural effusion per chest x-ray, ascites); Failure to achieve effective diuresis and congestion relief despite appropriate or escalating diuretic doses or combination of diuretics (eg. Furosemide and Metolazone); Eligible for general anaesthesia and laparoscopic procedure; Able to give written informed consent; Ability to comply with study procedures and ability to operate the device; Women of childbearing potential should use adequate contraception for as long as the device is implanted

Who cannot take part

• • Any non-cardiac disease with life expectancy < 1 year; Any patient listed for solid organ transplantation; Patients with history, or with indication for, mechanical circulatory support; iv inotropes required in last 3 months (INTERMACS Score ≤3); Immunocompromised (e.g. chronic steroid treatment, HIV, etc.); Insulin dependent diabetes; Severe hyponatraemia as defined by a serum Sodium < 120 mmol/l; Serum Albumin < 2.5 g/dL; eGFR < 25 ml/min/1.73m2 by MDRD method; Previous significant intraabdominal surgery, severe abdominal adhesions, intra-abdominal foreign body (except for small inguinal mesh); Large diaphragmatic hernia, or surgically irreparable, complex or recurring hernia; 6 minutes' walk test of less than 100 meter; History (>6 months) of diaphragmatic hernia, inflammatory or ischemic bowel disease and frequent episodes of diverticulitis; Gastrointestinal haemorrhage within the last 4 months; Bacterial peritonitis episode within the last 24 months; > 2 systemic or local infections, such as urinary tract infection or abdominal skin infection within the last 6 months; Liver cirrhosis; BMI > 40 presenting a risk for surgery; Patients with contraindications for general anaesthesia or laparoscopic surgery; Unsuitability for self-maintenance of the experimental home set-up; Presence of any current cancer; Presence of any active implantable or body-worn devices that cannot be removed excluding ICD / pacemaker; Pregnancy; Patients being in another therapeutic clinical study