TY - JOUR
T1 - Feasibility and Procedural Safety of alfapump System Implantation by IR
T2 - Experience from the MOSAIC Study, a Multicenter, Open-Label Prospective Study in Cirrhotic Patients with Refractory Ascites
AU - Bendel, Emily C.
AU - Sniderman, Kenneth
AU - Shaw, Cathryn
AU - Frederick, R. Todd
AU - Wong, Florence
AU - Sanyal, Arun
AU - Asrani, Sumeet K.
AU - Kamath, Patrick S.
AU - Capel, Jeroen
AU - Haskal, Ziv J.
N1 - Funding Information:
This study was sponsored by Sequana Medical NV, Ghent, Belgium. Sophia Y. Ly (Syntactx Europe, Herzele, Belgium) participated in the writing and technical editing of the manuscript. R.T.F. receives research support and is a paid consultant for Sequana Medical NV (Ghent, Belgium). F.W. receives grants and research support and is a paid consultant for Sequana Medical NV and Mallinckrodt Pharmaceuticals (Staines-upon-Thames, United Kingdom). A.S. is a paid employee of Sanyal Biotechnology (Norfolk, Virginia); receives grants and research support from BASF, Bristol-Myers Squibb, Conatus, Galectin, Gilead, Echosens-Sandhill, Immuron, Intercept, Mallinckrodt Pharmaceuticals, Novartis, Perspectum, Salix, Sequana Medical NV, and 89 Bio; is a paid consultant for Albireo, Amra, Ardelyx, Birdrock, Boehringer Ingelheim, Echosens-Sandhill, ENYO, General Electric, GenFit, Gilead, Hemoshear, Janssen, Eli Lilly and Company, Mallinckrodt Pharmaceuticals, Merck, Nimbus, Novartis, Novo Nordisk, Pfizer, Poxel, Salix, Sanofi, Second Genome, Servier, Takeda, Terns, Tiziana, and Zydus; and owns stock in Exhalenz, Sanyal Bio, Akarna, GenFit, Hemoshear, Durect, and Indalo. P.S.K. receives grants and research support from Sequana Medical NV. J.C. is employed by Sequana Medical AG (Zurich, Switzerland). Z.J.H. receives grants and research support from Sequana Medical NV and Siemens Healthcare (Erlangen, Germany); personal fees from Becton Dickinson and Company (Franklin Lakes, New Jersey), W.L. Gore & Associates (Flagstaff, Arizona), Medtronic (Minneapolis, Minnesota), Bend It Technologies Ltd. (Petach Tikva, Israel), and Boston Scientific (Marlborough, Massachusetts); and owns stock in Fluidx Medical Technology, LLC (Salt Lake City, Utah). None of the other authors have identified a conflict of interest.
Funding Information:
This study was sponsored by Sequana Medical NV, Ghent, Belgium. Sophia Y. Ly (Syntactx Europe, Herzele, Belgium) participated in the writing and technical editing of the manuscript.
Publisher Copyright:
© 2020 SIR
PY - 2020/8
Y1 - 2020/8
N2 - Purpose: To evaluate feasibility, procedural outcomes, and safety aspects of implantation of the alfapump system for management of refractory ascites by interventional radiology (IR) methods. Materials and Methods: The multicenter open-label prospective MOSAIC study included 29 patients (mean age 60.0 y ± 9.9; range, 32–72 y, 17 [56.7%] male) with cirrhotic refractory ascites who received an alfapump system implanted by IR. The fully subcutaneous alfapump system consists of a pump and 2 silicone catheters, whose distal ends are inserted in the peritoneum and the bladder, respectively. The device moves ascites from the peritoneum to the bladder, reducing the requirement of paracentesis. Pumped volume and speed can be customized as required. The implant procedure was performed under general or local anesthesia. Both catheters were placed under ultrasound guidance. The pump was inserted in a subcutaneous pocket on the upper abdomen. Incidence and severity of procedure-related serious adverse events up to 3 months after implantation were recorded. Results: Technical success was achieved in 29 (100%) IR implant procedures. The pump was usually implanted on the right abdomen (76.7%). In 5 patients, deviation from the Instructions for Use was required. Adverse events (requirement of additional incisions, postoperative bleed) occurred in 3 patients. At 3 months after implantation, 3 possibly procedure-related serious adverse events (ascites leakage, bacterial peritonitis, postoperative bleeding) had occurred. Two explantations (2/29; 6.8%) (cellulitis, pump pocket infection) and 4 reinterventions (pump or catheter replacement) were required, corresponding to an adverse event incidence rate of 9/29 (31.0%). Conclusions: Placement of the alfapump using IR methods is both feasible and technically successful.
AB - Purpose: To evaluate feasibility, procedural outcomes, and safety aspects of implantation of the alfapump system for management of refractory ascites by interventional radiology (IR) methods. Materials and Methods: The multicenter open-label prospective MOSAIC study included 29 patients (mean age 60.0 y ± 9.9; range, 32–72 y, 17 [56.7%] male) with cirrhotic refractory ascites who received an alfapump system implanted by IR. The fully subcutaneous alfapump system consists of a pump and 2 silicone catheters, whose distal ends are inserted in the peritoneum and the bladder, respectively. The device moves ascites from the peritoneum to the bladder, reducing the requirement of paracentesis. Pumped volume and speed can be customized as required. The implant procedure was performed under general or local anesthesia. Both catheters were placed under ultrasound guidance. The pump was inserted in a subcutaneous pocket on the upper abdomen. Incidence and severity of procedure-related serious adverse events up to 3 months after implantation were recorded. Results: Technical success was achieved in 29 (100%) IR implant procedures. The pump was usually implanted on the right abdomen (76.7%). In 5 patients, deviation from the Instructions for Use was required. Adverse events (requirement of additional incisions, postoperative bleed) occurred in 3 patients. At 3 months after implantation, 3 possibly procedure-related serious adverse events (ascites leakage, bacterial peritonitis, postoperative bleeding) had occurred. Two explantations (2/29; 6.8%) (cellulitis, pump pocket infection) and 4 reinterventions (pump or catheter replacement) were required, corresponding to an adverse event incidence rate of 9/29 (31.0%). Conclusions: Placement of the alfapump using IR methods is both feasible and technically successful.
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U2 - 10.1016/j.jvir.2020.02.005
DO - 10.1016/j.jvir.2020.02.005
M3 - Article
C2 - 32654961
AN - SCOPUS:85087796494
VL - 31
SP - 1256-1262.e3
JO - Journal of Vascular and Interventional Radiology
JF - Journal of Vascular and Interventional Radiology
SN - 1051-0443
IS - 8
ER -