Dataset Information

Improvement in Quality of Life and Decrease in Large-Volume Paracentesis Requirements With the Automated Low-Flow Ascites Pump.

ABSTRACT: The automated low-flow ascites pump (alfapump) is an implantable device that drains ascites directly into the urinary bladder. We studied its safety (absence of serious complications) and efficacy (decreased large-volume paracentesis [LVP] requirement and improved quality of life [QoL]) in the management of ascites in a cohort of North American patients with cirrhosis and recurrent ascites ineligible for transjugular intrahepatic portosystemic shunt (TIPS). QoL was measured by the Chronic Liver Disease Questionnaire (CLDQ) and Ascites Questionnaire (Ascites Q). Following alfapump implantation, patients were monitored for ascites control, laboratory abnormalities, QoL, adverse events, and survival at 12 months. A total of 30 patients (60.0 ± 9.9 years; 57% male; Model for End-Stage Liver Disease score, 11.4 ± 2.7) received an alfapump, mostly by an interventional radiology approach (97%), followed by longterm prophylactic antibiotics. The alfapump removed a mean ascites volume of 230.6 ± 148.9 L/patient at 12 months, dramatically reducing the mean LVP frequency from 2.4 ± 1.4/patient/month before pump implantation to 0.2 ± 0.4/patient/month after pump implantation. All surviving patients had improved QoL (baseline versus 3 months; CLDQ, 3.9 ± 1.21 versus 5.0 ± 1.0; Ascites Q, 51.7 ± 21.9 versus 26.7 ± 18.6; P < 0.001 for both) and a better biochemical index of nutritional status (prealbumin 87.8 ± 37.5 versus 102.9 ± 45.3 mg/L at 3 months; P = 0.04). Bacterial infections (15 events in 13 patients), electrolyte abnormalities (11 events in 6 patients), and renal complications (11 events in 9 patients) were the most common severe adverse events. By 12 months, 4 patients died from complications of cirrhosis. Alfapump insertion may be a definitive treatment for refractory ascites in cirrhosis, especially in patients who are not TIPS candidates.

SUBMITTER: Wong F

PROVIDER: S-EPMC7216956 | biostudies-literature | 2020 May

REPOSITORIES: biostudies-literature

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Improvement in Quality of Life and Decrease in Large-Volume Paracentesis Requirements With the Automated Low-Flow Ascites Pump.

Wong Florence F Bendel Emily E Sniderman Kenneth K Frederick Todd T Haskal Ziv J ZJ Sanyal Arun A Asrani Sumeet K SK Capel Jeroen J Kamath Patrick S PS

Liver transplantation : official publication of the American Association for the Study of Liver Diseases and the International Liver Transplantation Society 20200322 5

The automated low-flow ascites pump (alfapump) is an implantable device that drains ascites directly into the urinary bladder. We studied its safety (absence of serious complications) and efficacy (decreased large-volume paracentesis [LVP] requirement and improved quality of life [QoL]) in the management of ascites in a cohort of North American patients with cirrhosis and recurrent ascites ineligible for transjugular intrahepatic portosystemic shunt (TIPS). QoL was measured by the Chronic Liver ...[more]

PMID: 31999044

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Project description:BackgroundCritically ill patients with cirrhosis and ascites are at high risk for intra-abdominal hypertension (IAH) which increases mortality. Clinical guidelines recommend maintaining intra-abdominal pressure (IAP) below 16 mmHg; nonetheless, more than three quarters of critically ill patients with cirrhosis develop IAH during their first week of ICU stay. Standard-of-care intermittent large-volume paracentesis (LVP) relieves abdominal wall tension, reduces IAP, optimizes abdominal perfusion pressure, and is associated with short-term improvement in renal and pulmonary dysfunction. However, there is no evidence of the superiority of different paracentesis strategies in the prevention and treatment of IAH in critically ill patients with cirrhosis. This trial aims to compare the outcomes of continuous passive paracentesis versus LVP in the prevention and treatment of IAH in patients with cirrhosis and ascites.MethodsAn investigator-initiated, open label, randomized controlled trial, set in a general ICU specialized in liver disease, was initiated in August 2022, with an expected duration of 36 months. Seventy patients with cirrhosis and ascites will be randomly assigned, in a 1:1 ratio, to receive one of two methods of therapeutic paracentesis. A stratified randomization method, with maximum creatinine and IAP values as strata, will homogenize patient baseline characteristics before trial group allocation, within 24 h of admission. In the control group, LVP will be performed intermittently according to clinical practice, with a maximum duration of 8 h, while, in the intervention group, continuous passive paracentesis will drain ascitic fluid for up to 7 days. The primary endpoint is serum creatinine concentration, and secondary endpoints include IAP, measured creatinine clearance, daily urine output, stage 3 acute kidney injury and multiorgan dysfunction assessed at day 7 after enrollment, as well as 28-day mortality rate and renal replacement therapy-free days, and length-of-stay. Prespecified values will be used in case of renal replacement therapy or, beforehand ICU discharge, liver transplant and death. Safety analysis will include paracentesis-related complication rate and harm. Data will be analyzed with an intention-to-treat approach.DiscussionThis is the first trial to compare the impact of different therapeutic paracentesis strategies on organ dysfunction and outcomes in the prevention and treatment of IAH in critically ill patients with cirrhosis and ascites.Trial registrationClinicalTrials.gov NCT04322201 . Registered on 20 December 2019.

Project description:BACKGROUND:We observed that increasing fresh gas flow (FGF) decreased exhaled tidal volume (VT) during pressure control ventilation (PCV). A literature search produced no such description whereby unintended VT changes occur with FGF changes during PCV. METHODS:To model an infant's lungs, 1 lung of a mechanical lung model (Dual Adult TTL 1600; Michigan Instruments, Inc, Grand Rapids, MI) was set at a compliance of 0.0068 L/cm H2O. An Rp50 resistor (27.2 cm H2O/L/s at 15 L/min) simulated normal bronchial resistance. The simulated lung was connected to a pediatric breathing circuit via a 3.5-mm cuffed endotracheal tube. A ventilator with PCV capability (Model 7900; Aestiva, GE Healthcare, Madison, WI) measured exhaled VT, and a flow monitor (NICO; Respironics, Murraysville, PA) measured peak inspiratory flow, positive end-expiratory pressure (PEEP), and peak inspiratory pressure. In PCV mode, exhaled VT displayed by the ventilator at FGF rates of 1, 6, 10, and 15 L/min was manually recorded across multiple ventilator settings. This protocol was repeated for the Avance CS2 anesthesia machine (GE Healthcare). RESULTS:For the Aestiva, higher FGF rates in PCV mode decreased exhaled VT. Exhaled VT for FGFs of 1, 6, 10, and 15 L/min were on average 48, 34.9, 16.5, and 10 mL, respectively, at ventilator settings of inspiratory pressure of 10 cm H2O, PEEP of 0 cm H2O, and respiratory rate of 20 breaths/min. This is a decrease by up to 27%, 65.6%, and 79.2% when FGFs of 6, 10, and 15 L/min are compared with a FGF of 1 L/min, respectively. In the GE Avance CS2 at the same ventilator settings, VT for FGF rates of 1, 6, 10, and 15 L/min were on average 46, 43, 40.4, and 39.7 mL, respectively. The FGF effect on VT was not as pronounced with the GE Avance CS2 as with the GE Aestiva. CONCLUSIONS:FGF has a significant effect on VT during PCV in the Aestiva bellows ventilator, suggesting caution when changing FGF during PCV in infants. Our hypothesis is that at higher FGF rates, an inadvertent PEEP is developed by the flow resistance of the ventilator relief valve that is not recognized by the ventilator. In turn, less change in pressure is needed to reach the set inspiratory pressure, resulting in lower VT delivery at higher FGF rates. This underappreciated FGF-VT interaction during PCV with a bellows ventilator may be clinically significant in pediatric patients; prospective data collection in patients is needed for further evaluation.

Dataset Information

Improvement in Quality of Life and Decrease in Large-Volume Paracentesis Requirements With the Automated Low-Flow Ascites Pump.

Publications

Improvement in Quality of Life and Decrease in Large-Volume Paracentesis Requirements With the Automated Low-Flow Ascites Pump.

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