Slide 1: Updates on MOSAIC Study: The Toronto Experience
Updates on MOSAIC Study The Toronto Experience Florence Wong University of Toronto October 4, 2019 10/2/2019 1
Slide 2: Poor Survival After Ascites Development
Poor Survival After Ascites Development (Bruno et al, Am J Gastro 2013)
Slide 3: Management of Refractory Ascites
Management of Refractory Ascites OR Large volume paracentesis TIPS
Slide 4: What About Patients Unsuitable for TIPS
What About Patients Unsuitable for TIPS • The >65 years of age • Patients with prior spontaneous hepatic encephalopathy • MELD >18 • Portal vein thrombosis • Pulmonary hypertension • Heart failure
Slide 5: Possible Solution: The alfapump System
Possible Solution The alfapump® System Automatically & continually moves ascites from the abdominal cavity to the bladder, where it is excreted naturally from the body. 10/2/2019 5
Slide 6: ALFA pump provides continuous small volume ascites drainage
ALFA pump provides continuous small volume ascites drainage
Slide 7: The MOSAIC Study
The MOSAIC Study • First North American prospective, open label, feasibility study • Assessed the use of alfapump in the management of recurrent or refractory ascites • Enrolled 30 patients not suitable for TIPS as treatment for ascites from April 2015 to January 2017 • Alfapump inserted by interven
Slide 8: Patient Disposition
Patient Disposition 36 subjects screened * 2 deaths (sepsis, upper Gl bleed) * 2 eligibility criteria (para. Frequency) * 2 AE (multiple AEs, pericardial effusion) 14 death . Progression of underlying disease * 2 explants : cellulitis 2 withdrawals *pump pocket infection * Hepatorenal syndrome 2deat
Slide 9: Control of Ascites
Control of Ascites • Pump is set to work from 0800-2200 hours • Average volume per pump cycle: ~6ml • Average time between pump cycles: 5-6 minutes • Total ascites removed in 12 months: 317.9±121.9 litres/patient (=53 large volume paracenteses of 5 litres each) • Average daily ascites volume removed
Slide 10: Control of Ascites with alfapump
Control of Ascites with alfapump a) Number of LVPs b) Paracentesis Count
Slide 11: Quality of Life Changes
Quality of Life Changes a CLDQ Score b ) )
Slide 12: Nutritional Status
Nutritional Status n= 30 27 21 18 17
Slide 13: Complications
Complications 3 months 12 months Related # of events # of events # of events # of patients (%) Total: 12 10/30 (33.3%) 27 13/30 (43.3%) Post-operative bleeding 1 1/30 (3.3%) 1 1/30 (3.3%) Leakage of ascites into pump 2 2/30 (6.7%) 2 2/30 (6.7%) pocket Wound dehiscence 1 1/30 (3.3%) 1 1/30 (3.3%) Pum
Slide 14: Vasoconstrictor activities post-pump insertion
Vasoconstrictor activities post-pump insertion Plasma renin activity Norepinephrine Continued monitoring of renal function and intermittent albumin infusions may be required (Sola E, et al, Liver Transplantation 2017)
Slide 15: Survival post-pump insertion
Survival post-pump insertion
Slide 16: The Toronto Experience
The Toronto Experience Characteristic Value n 15 Age (years) 64±7 M:F 10:5 Etiology of cirrhosis alcohol 9 alcohol + viral hepatitis 2 viral hepatitis 1 NASH 1 NASH + viral hepatitis 1 NASH + alcohol 1 Duration of alfapump in situ 23±17 months (Range 4-54 months) Number of pump(s)/patient Range : 1-
Slide 17: The Toronto Experience
The Toronto Experience Characteristic Value n 15 Mean daily pump volume* 650ml (Range: 200-1100ml) # pumps explanted 7 Reasons for Explant total clearance of ascites 3 worsening of renal function 1 development of HCC 1 Infection 2 Albumin used* 825gm (Range: 0-8750gm) Total volume of ascites* 239.7L
Slide 18: Laboratory Parameters
Laboratory Parameters Serum Na Serum Creatinine p=N.S. faust t-—— 2507 p=N.S. 200- I | 150-5 1005 50- Baseline Final Baseline Final
Slide 19: Parameters of Liver Function
Parameters of Liver Function n=15
Slide 20: Major Infections
Major Infections 10/15 patients had major infections 8 7 6 5 4 3 2 1 0 SBP UTI Pneumonia Cellulitis Bacteremia Endocarditis
Slide 21: Summary
Summary • Overall experience is positive, especially from patient perspective • No significant changes in liver or renal function • May need individualized albumin support • Bacterial infections, whether related or not related to alfapump are still present in significant number of patients • Careful