ABSTRACT
Background and Aim: Acute-on-chronic liver failure (ACLF) is a global health care challenge, with a 28-day mortality rate of 33.9% and 30-day readmission rate of 37%.1,2 Management of ACLF is often complicated by multiorgan involvement, need for intensive care support, sarcopenia/frailty, and lack of universally accepted diagnostic criteria.3,4 Health care resource utilization is high. Our aims were to assess the safety, efficacy, acceptability, and cost of LivR Well, a new model of intensive, multidisciplinary ambulatory care for patients with ACLF. Method(s): We conducted a prospective, single-arm, mixed-methods study at Monash Health, a large Victorian tertiary network. Adult patients were enrolled from the inpatient ward, emergency department, or outpatient clinic in the first 28 days after a formal diagnosis of ACLF. ACLF was defined using Asian Pacific Association for the Study of the Liver criteria (an acute hepatic insult manifesting as jaundice and coagulopathy, complicated by ascites and/or encephalopathy within 4 weeks).5 Study criteria and the LivR Well intervention are shown in Figure 1. Patients were admitted to hospital in the home and received nursing visits up to 3 times a week and a weekly clinic medical review. Patients accessed physiotherapy, pharmacy, dietetics, social work, addiction medicine, and neuropsychiatry if appropriate. Blood test results were monitored weekly, and patients were followed up for 12 weeks. Health-related quality of life (HRQoL) was measured using EQ-5D and the Chronic Liver Disease Questionnaire (CLDQ) at baseline and Week 6. A qualitative substudy was undertaken to assess acceptability, with interviews performed between Weeks 6 and 12. The primary outcome was safety. Secondary outcomes were readmission, liver disease severity, HRQoL, symptom burden (CLDQ), acceptability, and health care resource utilization. Result(s): Fifty-nine patients (median age, 51 years [IQR, 45-59];66% male) were enrolled between March 2021 and April 2022. Forty-four patients completed the 28-day program, with two deaths (at Days 16 and 27), one drop-out due to COVID-19 requiring isolation, eight patients discharged due to failure to attend, and four patients who remain active in the program. There were no reported adverse events. Alcohol misuse was the most frequent liver disease etiology (73%). There was a significant reduction in median Model for End-Stage Liver Disease-Sodium (MELDNa) score from 16 at baseline (IQR, 12-21) to 15 at Day 28 (IQR, 11-18;P < 0.001). Sarcopenia prevalence decreased from baseline to Day 28 but did not reach statistical significance (27% vs 19%, P = 0.48). HRQoL significantly improved from a median baseline CLDQ score of 4.34 (IQR, 3.37-5.08) to 4.75 (IQR, 3.97-5.81;P = 0.02), with specific improvement in the domains of activity (P = 0.04), fatigue (P = 0.02), and worry (P = 0.001). The qualitative study highlighted universal themes of high acceptability, improved health literacy/insight, and increased autonomy. The median self-reported health perception using a visual analog scale significantly improved from 64% (IQR, 42-77%) to 72% (IQR, 50-80%;P = 0.05). The 28-day mortality rate was 3%, and the 30-day readmission rate was 14%. The median LivRWell program cost was A$4947. The total 6-month median direct health care cost for each LivR Well patient improved from a median of A$30 913 before LivR Well (IQR, $11 201-$61 464) to $784 after LivR Well (IQR, $0-$18 117;P < 0.001). The total direct health care cost for this cohort was reduced by 71%, from $1.16 million before to $335 000 after LivR Well, largely driven by a 40% reduction in 30-day readmission. Conclusion(s): LivR Well is a world-first multidisciplinary ambulatory care program for patients with ACLF. Our feasibility study supported the safety, potential efficacy, and cost-effectiveness of such an intervention, with lower than expected 30-admission, 28-day mortality, and total health care cost for this complex cohort. There was a small, but significant improvement in MELD-Na score, HRQoL, and self-rep rted health perception. We are further evaluating the clinical and economic impact of LivR Well as part of a randomized controlled trial comparing it with standard ambulatory care.
ABSTRACT
Background and Aim: The coronavirus disease 2019 (COVID-19) pandemic has created challenges in how health care systems provide care for patients with refractory cirrhotic ascites. We aimed to investigate the safety and efficacy of a novel ambulatory care program developed with Hospital in the Home (HITH) to allow frequent low-volume ascitic drainage through a long-term, tunneled, intraperitoneal catheter (IPC;Rocket Medical) in patients with advanced cirrhosis. Methods: We conducted a prospective cohort study at a Victorian tertiary health care service from April to July 2020. Adult patients with refractory cirrhotic ascites requiring large-volume abdominal paracentesis twice in the past 8 weeks were recruited. We excluded patients otherwise eligible for transjugular intrahepatic portosystemic shunt (TIPS) insertion or liver transplantation and those with Child-Pugh C disease, prior spontaneous bacterial peritonitis, active infection, loculated ascites, or hepatic hydrothorax. All IPCs were inserted by an interventional radiologist and managed for 12 weeks by HITH in lieu of recurrent hospital admission for large-volume paracentesis. The drainage schedule was individualized, with 1-6 L drained by HITH nurses over 1-3 sessions per week, without human albumin infusions. All patients received antibiotic prophylaxis (norfloxacin 400 mg daily or trimethoprim-sulfamethoxazole 160-800 mg daily). The primary endpoint was safety (death related to IPC, rates of bleeding, peritonitis, and cellulitis), with secondary endpoints including symptom burden, IPC attrition rates, and quality of life (EuroQol 5 dimensions). Results: Five patients (median age, 60 years;IQR, 53-74;four male) underwent insertion of an IPC. All had Child-Pugh B disease, with a median Model for End-Stage Liver Disease score of 11 (IQR, 9-13). The etiology of liver disease was alcohol (n = 4) and hepatitis C (n = 1). All patients were ineligible for TIPS due to prior hepatic encephalopathy and ineligible for liver transplantation due to active alcohol use (n = 3), advanced age (n = 1), and underlying malignancy (n = 1). There were no deaths during the follow-up period and only one adverse event (cellulitis). IPC attrition rate over the 12-week program was 100%. The IPC was removed in one patient due to resolution of ascites at Week 11 and in a second patient due to non-compliance at Week 13. At 30 days after IPC insertion, the median self-reported health score on a vertical visual analog scale increased from a median of 50 (IQR, 50-70) to 78 (IQR, 50-85), attributable to a reduction in symptom burden. Conclusion: Long-term tunneled IPCs for the management of refractory cirrhotic ascites were safe. The IPC was associated with improved symptom control and patient perceptions of health, compared with baseline. The study is ongoing, and a larger sample size will allow further exploration of the safety and cost-effectiveness of this novel intervention in a vulnerable population during and after the COVID-19 pandemic.