Randomized, controlled clinical trial of the DIALIVE liver dialysis device versus standard of care in patients with acute-on- chronic liver failure.

BACKGROUND & AIMS: Acute-on-chronic liver failure (ACLF) is characterized by severe systemic inflammation, multi-organ failure and high mortality rates. Its treatment is an urgent unmet need. DIALIVE is a novel liver dialysis device that aims to exchange dysfunctional albumin and remove damage- and pathogen-associated molecular patterns. This first-in-man randomized-controlled trial was performed with the primary aim of assessing the safety of DIALIVE in patients with ACLF, with secondary aims of evaluating its clinical effects, device performance and effect on pathophysiologically relevant biomarkers. METHODS: Thirty-two patients with alcohol-related ACLF were included. Patients were treated with DIALIVE for up to 5 days and end points were assessed at Day 10. Safety was assessed in all patients (n = 32). The secondary aims were assessed in a pre-specified subgroup that had at least three treatment sessions with DIALIVE (n = 30). RESULTS: There were no significant differences in 28-day mortality or occurrence of serious adverse events between the groups. Significant reduction in the severity of endotoxemia and improvement in albumin function was observed in the DIALIVE group, which translated into a significant reduction in the CLIF-C (Chronic Liver Failure consortium) organ failure (p = 0.018) and CLIF-C ACLF scores (p = 0.042) at Day 10. Time to resolution of ACLF was significantly faster in DIALIVE group (p = 0.036). Biomarkers of systemic inflammation such as IL-8 (p = 0.006), cell death [cytokeratin-18: M30 (p = 0.005) and M65 (p = 0.029)], endothelial function [asymmetric dimethylarginine (p = 0.002)] and, ligands for Toll-like receptor 4 (p = 0.030) and inflammasome (p = 0.002) improved significantly in the DIALIVE group. CONCLUSIONS: These data indicate that DIALIVE appears to be safe and impacts positively on prognostic scores and pathophysiologically relevant biomarkers in patients with ACLF. Larger, adequately powered studies are warranted to further confirm its safety and efficacy. IMPACT AND IMPLICATIONS: This is the first-in-man clinical trial which tested DIALIVE, a novel liver dialysis device for the treatment of cirrhosis and acute-on-chronic liver failure, a condition associated with severe inflammation, organ failures and a high risk of death. The study met the primary endpoint, confirming the safety of the DIALIVE system. Additionally, DIALIVE reduced inflammation and improved clinical parameters. However, it did not reduce mortality in this small study and further larger clinical trials are required to re-confirm its safety and to evaluate efficacy. CLINICAL TRIAL NUMBER: NCT03065699.

Ultrasound-Guided Regional Anesthesia-Current Strategies for Enhanced Recovery after Cardiac Surgery.

With the advent of fast-track pathways after cardiac surgery, there has been a renewed interest in regional anesthesia due to its opioid-sparing effect. This paradigm shift, looking to improve resource allocation efficiency and hasten postoperative extubation and mobilization, has been pursued by nearly every specialty area in surgery. Safety concerns regarding the use of classical neuraxial techniques in anticoagulated patients have tempered the application of regional anesthesia in cardiac surgery. Recently described ultrasound-guided thoracic wall blocks have emerged as valuable alternatives to epidurals and landmark-driven paravertebral and intercostal blocks. These novel procedures enable safe, effective, opioid-free pain control. Although experience within this field is still at an early stage, available evidence indicates that their use is poised to grow and may become integral to enhanced recovery pathways for cardiac surgery patients.

Factors affecting the decision to undergo abortion in Romania: Experiences at our clinic.

RATIONALE, AIMS, AND OBJECTIVES: It is estimated that 25% of pregnancies worldwide end in induced abortion. In Romania, the abortion situation shows a specific pattern. Following the fall of the communist regime, first-trimester abortions were legalized, and between 1990 and 1992, the country's abortion rate was the highest in the world, with 182 abortions per 1000 women of reproductive age. However, there are currently no statistically reliable data, as some abortions are not reported. The purpose of this study was to identify the main circumstances that determine the choice to undergo abortion with all related potential risks, rather than using contraception. METHOD: We conducted a prospective type 1 cohort study based on a Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement that included women who presented at Bucur Maternity, Saint John Hospital, Bucharest, for abortion during the first trimester, between July and December 2018. The patients were asked to complete a 21-item questionnaire based on psychosocial data. RESULTS: The study included 119 patients, with a mean age of 29.57 years. Their educational level was average (ie, 51.3%, 4.2%, and 8.4% had completed high school, elementary school, and college or university, respectively). Most women were married (46.2%), and 47.9% were unemployed. The main reason for deciding to undergo an abortion was poverty (P = .014), and guilt was correlated with this decision (P = .004). CONCLUSION: The profiles of the women who chose to undergo an abortion as a family planning method were as follows: in the third decade of life, resident of urban areas, married, unemployed, and with a low family income. The main reasons for abortion were financial status, advanced maternal age, incompatibility of pregnancy with future plans, and the desire to postpone conception.

Rapid Recovery of Liver Transplantation Recipients by Implementation of Fast-Track Care Steps: What Is Holding Us Back?

A body of scientific studies has shown that early extubation is safe and cost-effective in a large number of liver transplant (LT) recipients including pediatric patients. However, fast-track practices are not universally accepted, and debate still lingers about whether these interventions are safe and serve the patients' best interest. In this article, we focus on reasons why physicians still have a persistent, although diminishing, reluctance to adopt fast-track protocols. We stress the importance of collection/analysis of perioperative data, adoption of a consensus-based standardized protocol for perioperative care, and formation of LT anesthesia focused teams and leadership. We conclude that the practice of early extubation and fast-tracking after LT surgery could help improve anesthesia performance, safety, and cost-effectiveness.

Prothrombotic State in a Patient With Acute Liver Failure: The Question of Anticoagulation.

A 35-year-old male with acute liver failure due to acute hepatitis B virus infection was admitted to the intensive care unit with significant hepatocellular injury, cholestasis, abnormal standard coagulation tests, normal rotational thromboelastometry indices, and without signs of bleeding. He underwent emergency liver transplantation without requiring blood product transfusions or procoagulant treatments. The postoperative course was complicated by deep vein thrombosis and impending hepatic artery thrombosis treated with unfractionated heparin, aspirin, and intravenous prostacyclin. The patient survived and made a full neurological recovery. This case revealed the presence of a prothrombotic state due to a rebalanced coagulation system in a patient with liver dysfunction that was not identifiable by standard coagulation tests. This case emphasizes that identifying and treating coagulopathy is very difficult in liver failure patients and requires specific diagnostic and therapeutic strategies.

Obesity is associated with decreased lung compliance and hypercapnia during robotic assisted surgery.

Robotic assisted surgery (RAS) represents a great challenge for anesthesiology due to the increased intraabdomial pressures required for surgical optimal approach. The changes in lung physiology are difficult to predict and require fast decision making in order to prevent altered gas exchange. The aim of this study was to document the combined effect of patient physical status, medical history and intraoperative position during RAS on lung physiology and to determine perioperative risk factors for hypercapnia. We prospectively analyzed 62 patients who underwent elective RAS. Age, co-morbidities and body mass index (BMI) were recorded before surgery. Ventilatory parameters and arterial blood gas analysis were determined before induction of anesthesia, after tracheal intubation and on an hourly basis until the end of surgery. In RAS, the induction of pneumoperitoneum was associated with a significant decrease in lung compliance from a mean of 42.5-26.7 ml cm H2O-1 (p = 0.001) and an increase in plateau pressure from a mean of 16.1 mmHg to a mean of 23.6 mmHg (p = 0.001). Obesity, demonstrated by a BMI over 30, significantly correlates with a decrease in lung compliance after induction of anesthesia (p = 0.001). A significant higher increase in arterial CO2 tension was registered in patients undergoing RAS in steep Trendelenburg position (p = 0.05), but no significant changes in end-tidal CO2 were recorded. A higher arterial to end-tidal CO2 tension gradient was observed in patients with a BMI > 30 (p < 0.001). In conclusion, patients' physical status, especially obesity, represents the main risk factor for decreased lung compliance during RAS and patient positioning in either Trendelenburg or steep Trendelenburg during surgery has limited effects on respiratory physiology.