Bleeding Recurrence and Mortality Following Interventional Management of Spontaneous HCC Rupture: Results of a Multicenter European Study

International audienceBACKGROUND: The incidence of spontaneous rupture of hepatocellular carcinoma (HCC) is low in Europe, at less than 3%. HCC rupture remains a life-threatening complication, with mortality reported between 16 and 30%. The risk of bleeding recurrence has never been clearly evaluated in such clinical situation. The objectives of this study were to evaluate the current risk of mortality related to HCC rupture and to focus on the risk of bleeding recurrence following interventional management. METHODS: All patients admitted to 14 French-Italian surgical centers for spontaneous rupture of HCC between May 2000 and May 2012 were retrospectively included. Clinical data, imaging features, relevant laboratory data, treatment strategies, and prognoses were analyzed. RESULTS: Overall, 58 of the 138 included patients (42%) had cirrhosis. Thirty-five patients (25%) presented with hemorrhagic shock, and 19% with organ(s) dysfunction. Bleeding control was obtained by interventional hemostasis, emergency liver resection, and conservative medical management in 86 (62%), 24 (18%), and 21 (15%) patients, respectively. Best supportive care was chosen for 7 (5%) patients. The mortality rate following rupture was 24%. The bleeding recurrence rate was 22% with related mortality of 52%. In multivariate analysis, a bilirubin level \textgreater17 micromol/L (HR 3.768; p~=~0.006), bleeding recurrence (HR 5.400; p~\textless~0.0001), and ICU admission after initial management (HR 8.199; p~\textless~0.0001) were associated with in-hospital mortality. CONCLUSION: This European, multicenter, large-cohort study confirmed that the prognosis of ruptured HCC is poor with an overall mortality rate of 24%, despite important advances in endovascular techniques. Overall, the rate of bleeding recurrence was more than 20%, with a related high risk of mortality

Early eplerenone treatment in patients with acute ST-elevation myocardial infarction without heart failure: The Randomized Double-Blind Reminder Study

Aims: We aimed to assess the impact of eplerenone on cardiovascular (CV) outcomes in STEMI without known heart failure, when initiated within 24 h of symptom onset. Methods and results: In this randomized, placebo-controlled, double-blind trial, we assigned 1012 patients with acute STEMI and without a history of heart failure to receive either eplerenone (25–50 mg once daily) or placebo in addition to standard therapy. The primary endpoint was the composite of CV mortality, re-hospitalization, or, extended initial hospital stay, due to diagnosis of HF, sustained ventricular tachycardia or fibrillation, ejection fraction ≤40%, or elevated BNP/NT-proBNP at 1 month or more after randomization. BNP elevation was defined as BNP levels or values above 200 pg/mL or NT-proBNP values above 450 pg/mL (in patients aged below 50); above 900 pg/mL (age 50–75 years) or above 1800 pg/mL (patients older than 75). After a mean follow-up of 10.5 months, the primary endpoint occurred in 92 patients (18.2%) in the eplerenone group and in 149 patients (29.4%) in the placebo group [adjusted hazard ratio (HR), 0.58; 95% confidence interval (CI), 0.45–0.76; P < 0.0001]. The primary endpoint was driven by a high BNP/NT-proBNP level (adjusted HR, 0.60; 95% CI, 0.45–0.79; P < 0.0003). Adverse event rates were similar in both groups. Serum potassium levels exceeded 5.5 mmol/L in 5.6 vs. 3.2% (P = 0.09) and were below 3.5 mmol/L in 1.4 vs. 5.6% of patients (P = 0.0002), in the eplerenone and placebo groups, respectively. Conclusion: The addition of eplerenone during the acute phase of STEMI was safe and well tolerated. It reduced the primary endpoint over a mean 13 months follow-up mostly because of significantly lower BNP/NT-proBNP levels. Additional studies are needed to clarify the role of early use of MRAs in STEMI patients without heart failure

Impact of cirrhosis in patients undergoing laparoscopic liver resection in a nationwide multicentre survey

BACKGROUND: The aim was to analyse the impact of cirrhosis on short-term outcomes after laparoscopic liver resection (LLR) in a multicentre national cohort study. METHODS: This retrospective study included all patients undergoing LLR in 27 centres between 2000 and 2017. Cirrhosis was defined as F4 fibrosis on pathological examination. Short-term outcomes of patients with and without liver cirrhosis were compared after propensity score matching by centre volume, demographic and tumour characteristics, and extent of resection. RESULTS: Among 3150 patients included, LLR was performed in 774 patients with (24·6 per cent) and 2376 (75·4 per cent) without cirrhosis. Severe complication and mortality rates in patients with cirrhosis were 10·6 and 2·6 per cent respectively. Posthepatectomy liver failure (PHLF) developed in 3·6 per cent of patients with cirrhosis and was the major cause of death (11 of 20 patients). After matching, patients with cirrhosis tended to have higher rates of severe complications (odds ratio (OR) 1·74, 95 per cent c.i. 0·92 to 3·41; P = 0·096) and PHLF (OR 7·13, 0·91 to 323·10; P = 0·068) than those without cirrhosis. They also had a higher risk of death (OR 5·13, 1·08 to 48·61; P = 0·039). Rates of cardiorespiratory complications (P = 0·338), bile leakage (P = 0·286) and reoperation (P = 0·352) were similar in the two groups. Patients with cirrhosis had a longer hospital stay than those without (11 versus 8 days; P = 0·018). Centre expertise was an independent protective factor against PHLF in patients with cirrhosis (OR 0·33, 0·14 to 0·76; P = 0·010). CONCLUSION: Underlying cirrhosis remains an independent risk factor for impaired outcomes in patients undergoing LLR, even in expert centres

Benchmark performance of laparoscopic left lateral sectionectomy and right hepatectomy in expert centers

International audienceHerein, we aimed to establish benchmark values - based on a composite indicator of healthcare quality - for the performance of laparoscopic left lateral sectionectomy (LLLS) and laparoscopic right hepatectomy (LRH) using data from expert centers

Benchmark performance of laparoscopic left lateral sectionectomy and right hepatectomy in expert centers

Background &amp; Aims: Herein, we aimed to establish benchmark values – based on a composite indicator of healthcare quality – for the performance of laparoscopic left lateral sectionectomy (LLLS) and laparoscopic right hepatectomy (LRH) using data from expert centers. Methods: Data from a nationwide multicenter survey including all patients undergoing LLLS and LRH between 2000 and 2017 were analyzed. Textbook outcome (TO) completion was considered in patients fulfilling all 6 of the following characteristics: negative margins, no transfusion, no complication, no prolonged hospital stay, no readmission and no mortality. For each procedure, a cut-off laparoscopic liver resection (LLR) volume by center was associated with TO on multivariable analysis. These cut-offs defined the expert centers. The benchmark values were set at the 75th percentile of median outcomes among these expert centers. Results: Among 4,400 LLRs performed in 29 centers, 855 patients who underwent LLLS and 488 who underwent LRH were identified. The overall incidences of TO after LLLS and LRH were 43.7% and 23.8%, respectively. LLR volume cut-offs of 25 LLR/year (odds ratio [OR] 2.45; bootstrap 95% CI 1.65–3.69; p = 0.001) and 35 LLR/year (OR 2.55; bootstrap 95% CI 1.34–5.63; p = 0.003) were independently associated with completion of TO after LLLS and LRH, respectively. Eight centers for LLLS and 6 centers for LRH, including 516 and 346 patients undergoing LLLS/LRH respectively, reached these cut-offs and were identified as expert centers. After LLLS, benchmark values of severe complication, mortality and TO completion were defined as ≤5.3%, ≤1.2% and ≥46.6%, respectively. After LRH, benchmark values of severe complication, mortality and TO completion were ≤20.4%, ≤2.8% and ≥24.2%, respectively. Conclusions: This study provides an up-to-date reference on the benchmark performance of LLLS and LRH in expert centers. Lay summary: In a nationwide French survey of laparoscopic liver resection, expert centers were defined according to the completion of a textbook outcome, which is a composite indicator of healthcare quality. Benchmark values regarding intra-operative details and outcomes were established using data from 516 patients with laparoscopic left lateral sectionectiomy and 346 patients with laparoscopic right hepatectomy from expert centers. These values should be used as a reference point to improve the quality of laparoscopic resections

Thrombin-receptor antagonist vorapaxar in acute coronary syndromes

BACKGROUND Vorapaxar is a new oral protease-activated–receptor 1 (PAR-1) antagonist that inhibits thrombin-induced platelet activation. METHODS In this multinational, double-blind, randomized trial, we compared vorapaxar with placebo in 12,944 patients who had acute coronary syndromes without ST-segment elevation. The primary end point was a composite of death from cardiovascular causes, myocardial infarction, stroke, recurrent ischemia with rehospitalization, or urgent coronary revascularization. RESULTS Follow-up in the trial was terminated early after a safety review. After a median follow-up of 502 days (interquartile range, 349 to 667), the primary end point occurred in 1031 of 6473 patients receiving vorapaxar versus 1102 of 6471 patients receiving placebo (Kaplan–Meier 2-year rate, 18.5% vs. 19.9%; hazard ratio, 0.92; 95% confidence interval [CI], 0.85 to 1.01; P = 0.07). A composite of death from cardiovascular causes, myocardial infarction, or stroke occurred in 822 patients in the vorapaxar group versus 910 in the placebo group (14.7% and 16.4%, respectively; hazard ratio, 0.89; 95% CI, 0.81 to 0.98; P = 0.02). Rates of moderate and severe bleeding were 7.2% in the vorapaxar group and 5.2% in the placebo group (hazard ratio, 1.35; 95% CI, 1.16 to 1.58; P<0.001). Intracranial hemorrhage rates were 1.1% and 0.2%, respectively (hazard ratio, 3.39; 95% CI, 1.78 to 6.45; P<0.001). Rates of nonhemorrhagic adverse events were similar in the two groups. CONCLUSIONS In patients with acute coronary syndromes, the addition of vorapaxar to standard therapy did not significantly reduce the primary composite end point but significantly increased the risk of major bleeding, including intracranial hemorrhage

Cardiovascular Efficacy and Safety of Bococizumab in High-Risk Patients

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