Continuous low flow ascites drainage through the urinary bladder via the Alfapump system in palliative patients with malignant ascites

Abstract

Background: Malignant Ascites (MA) is a therapeutic dilemma significantly impairing patients' quality of life (QoL). The Sequana Medical alfapump System (AP), a subcutaneous, externally rechargeable, implantable device, continually draining ascites via the urinary bladder, has been well established in liver cirrhosis, but not yet in MA. The AP-system was evaluated in cancer patients in reducing the need for large volume paracentesis (LVP).

Methods: A retrospective multicentre evaluation of all eligible patients who received an AP for MA-palliation was performed. AP was evaluated for its ability to reduce LVP and cross-correlated with adverse events (AE), survival and retrospective physician-reported QoL.

Results: Seventeen patients with median age of 63 years (range: 18-81), 70.6% female, across 7 primary tumour types were analysed. Median duration of AP-implantation was 60 min (range: 30-270) and median post-implantation hospital stay: 4 days (range: 2-24). Twelve protocol-defined AE occurred in 5 patients (29.4%): 4 kidney failures, 4 pump/catheter-related blockages, 3 infections/peritonitis and 1 wound dehiscence. Median ascitic volume (AV) pumped daily was 303.6 ml/day (range:5.6-989.3) and median total AV drained was 28 L (range: 1-638.6). Median patient post-AP-survival was 111 days (range:10-715) and median pump survival was 89 days (range: 0-715). Median number of paracenteses was 4 (range: 1-15) per patient pre-implant versus 1 (range: 0-1) post-implant (p = 0.005). 71% of patients were reported to have an improvement of at least one physician reported QoL-parameters.

Conclusions: AP appears to be effective in palliating patients with MA by an acceptable morbidity profile. Its broader implementation in oncology services should be further explored.

Trial registration: NCT03200106; June 27, 2017.

Keywords: Ascites; Carcinomatosis; Palliative care; Pathologic processes; Quality of life; Retrospective studies.

Conflict of interest statement

All authors were compensated for the conduct of the study. Prof. Fotopoulou reports grants and personal fees from Sequana Medical to design study and write the paper, during the conduct of the study; advisory board of Roche, Ethicon, Tesaro, Pharmacokinesis, Olympus and Astra Zeneca, outside the submitted work. Prof. Berg reports grants and personal fees from Sequana Medical. Dr. Hausen reports speaker fees from Sequana Medical. Prof. Jalan received a grant from Thaurus, is a consultant for Takeda, board member for JHEP, a speaker for Grifols, outside the submitted work. Dr. Hennig, Prof. Malago and Prof. De Gottardi report no other conflicts of interest. Mr. Capel is an employee of Sequana Medical. Dr. Stirnimann reports being a consultant and speaker for Sequana Medical.

Figures

Fig. 1

Patient and Pump Survival Kaplan-Meier