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Anaemia and iron deficiency are frequent in patients scheduled for cardiac surgery. Perioperative patient blood management (PBM) is widely recommended in current practice guidelines. The aim of this protocol is to analyse the effect of a global perioperative PBM programme on the red blood cell (RBC) transfusion ratio, morbidities and rehabilitation score in elective cardiac surgery. This study is a prospective, single-centre trial with a 2-step protocol, A and B, as follows: A: non-drug intervention: the caregiver is given a blood management educational programme; B: drug intervention: systematic correction of perioperative iron, vitamin deficiencies, and anaemia. This study was designed to enrol 900 patients (500 in group A and 400 in group B) in a rolling period starting at anaesthesia consultation and ending 3 months after surgery. The primary objective was a 20% reduction in RBC transfusion after implementation of PBM programmes (protocol A + B) when compared to our previous transfusion ratio in the first half of 2018 (30.4% vs 38%). The secondary objectives were to evaluate the impact for each step of the study on the RBC transfusion rate, morbidity and the quality of postoperative rehabilitation. The strength of this study is its evaluation of the effect of a global PBM programme on RBC transfusion in cardiac surgery through a 2-step protocol. We aim to assess for the first time the impact of non-drug and drug interventions on RBC transfusion, comorbidities and delayed rehabilitation parameters. Trials registrations ClinicalTrials.gov, NCT04040023: registered 29 July 2019.

Coagulopathic bleeding is a serious complication of cardiac surgery. A very low preoperative plasma fibrinogen level (PFL) has been previously described as a risk factor for red blood cell (RBC) transfusion in the perioperative setting. Nevertheless, contradictory results have been published concerning preoperative fibrinogen infusion to decrease RBC transfusion. These results highlight the need for a better description of the relation between preoperative PFL and RBC transfusion. In this single-centre retrospective study, we showed that both high and low PFLs are associated with an increase in RBC transfusion. A pro-inflammatory preoperative status could be involved in the association between high PFL and the increase in RBC transfusion. This non-linear relation between PFL and RBC transfusion could explain the difficulty of decreasing postoperative bleeding using only an algorithm aimed at increasing preoperative PFL.

This study sought to compare perioperative outcomes and morbidities for open simple prostatectomy (OSP) and endoscopic green laser enucleation of the prostate (GreenLEP). In a single department, all consecutive patients who underwent OSP between January 2005 and December 2010 were retrospectively reviewed, and all consecutive patients undergoing GreenLEP between July 2013 and January 2017 were prospectively enrolled. Perioperative data, information regarding early postoperative complications for up to 6 months and outcomes were collected and retrospectively compared. Overall, 204 patients were enrolled in each group. The baseline characteristics of patients in both groups were comparable. Intraoperative time was significantly longer for the OSP group than for the GreenLEP group (67 versus 60 min; p

Introduction Fresh Frozen Plasma (FFP) is used to correct haemostatic function after cardiac surgery with cardio-pulmonary bypass (CPB). As a blood product, availability of FFP can be challenging. OctaplasLG®, a solvent/detergent (SD) treated and pooled human plasma, has been recently introduced in France. As a drug, it is delivered by hospital pharmacists. The main objective of this study was to describe the use of OctaplasLG® infusion in cardiac surgery patients. Feasibility, safety and drug tolerability of OctaplasLG® were assessed by monitoring Serious Adverse Events (SAEs) and Adverse Drug Reactions (ADRs) like allergic reaction, transfusion related acute lung injury (TRALI) events or transmitted transfusion diseases during 24 hours following each administration. Methods This observational and prospective study was conducted in 2 main French cardiac surgery centres from 27-Feb-2019 to 24-Feb-2020. All patients included in this study received OctaplasLG® because of abnormal peri-operative blood loss or haemostatic disorders in the peri-operative settings of cardio-vascular surgery. Data collected and analysed were demographic characteristic of patients, indications modalities, efficacy and safety outcomes of OctaplasLG® infusions. Results 99 adult patients were included, mean age 68.9 ± 11.6 years (67% male). OctaplasLG® indications were coagulopathy (70 %) and moderate haemorrhage (30%). OctaplasLG® was used 70% in the operating room and 30% in the intensive care unit (ICU). Cardiac surgery with CPB was performed in 83 patients. Infusion was done through a central venous line in 80% of patients. Emergency level of infusion was defined by physicians as immediate vital emergency, vital emergency, relative emergency and planned intervention for 24%, 38%, 32% and 5% respectively. Mean ± SD total dose of OctaplasLG® infused per patient was 2.9 ± 1.7 units (median 3 units of 200 ml). In addition to OctaplasLG®, patients received red blood cells (52%), platelets (37%) and fibrinogen concentrate (44%). No ADRs was reported during the 24h follow-up period. Six SAE were reported but not related to OctaplasLG®, 5 of which had a fatal outcome. OctaplasLG® infusion was evaluated as successful in 97 % of cases by investigators. Discussion Cardiac surgery is associated with a substantial risk of bleeding, frequently requiring the administration of FFP. In this descriptive study, the use of OctaplasLG®, a SD treated plasma, as a new drug for haemostatic disorders following cardio-vascular surgery seems feasible, readily available, safe and effective.

To analyse the accuracy of high preoperative PSA levels for predicting transitional zone incidental PCa (TZ-PCa) in men with very large prostates.Perioperative data from 375 consecutive patients who underwent endoscopic enucleation of the prostate (EEP) for benign prostatic obstruction between July 2013 and December 2018 were retrospectively reviewed. Patients were stratified into three groups according to the preoperative PSA level: low-PSA ( 4 ng/mL), intermediate-PSA (4 ≤ PSA 10 ng/mL) and high-PSA (≥ 10 ng/mL). Men in each group were propensity score matched by age, 5α-reductase inhibitor (5-ARI) use, prostate volume and mpMRI. The TZ-PCa incidence rate was retrospectively compared by preoperative PSA level in a propensity score model including all predetermined variables.Age, prostate volume, 5-ARI use were similar between patient groups. The median PSA levels in the low-, intermediate- and high-PSA groups were 3 [2.3; 3.4], 6.6 [5.3; 8.1] and 12.7 [11; 16.7] ng/mL, respectively. The median prostate volume was 100 grams in all groups (108, 105 and 120 cc, respectively). The T1a-Gleason 6 incidental TZ-PCa rate was statistically comparable between the three groups (3.4, 5.1 and 8.6% in the low-, intermediate- and high-PSA groups, respectively). The detection rate of clinically significant TZ-PCa was low for preoperative PSA levels 4 ng/mL (1.7%); with no difference between the intermediate- and high-PSA groups.In men with large glands, the clinically significant incidental TZ-PCa detection rate was similar regardless of the preoperative PSA level stratum. Such details may help with patient counselling during BPH surgical management.

OBJECTIVES To investigate the effect of surgical experience on the perioperative outcomes of endoscopic GreenLight™ (Boston Scientific Corporation, Marlborough, MA, USA) laser enucleation of the prostate (GreenLEP). SUBJECTS/PATIENTS AND METHODS A multicentre retrospective study of the first patients treated with GreenLEP by six surgeons was conducted. For each patient, surgical experience was coded as the total number of procedures performed by the surgeons before the patient's operation. The learning curve was analysed in terms of changes over time for the following variables: enucleation time, morcellation time, occurrence of intraoperative complications (IOCs), 3-month postoperative International Prostate Symptom Score (IPSS) reduction, and the rate of Pentafecta achievement. RESULTS In total, 922 patients were analysed. At multivariable regression analyses adjusted for case mix, surgical experience was associated with shorter enucleation and morcellation time (P

Lower urinary tract symptoms related to benign prostatic obstruction (BPO) are frequent in men aged > 50 years. Based on the use of innovative medical devices, a number of transurethral ablative techniques have recently been developed for the surgical treatment of BPO. In recent years, GreenLight photoselective vaporization of the prostate (PVP) has been considered as a non-inferior alternative to transurethral resection of the prostate. The GreenLight PVP is usually considered as an interesting surgical option for patients treated via oral anticoagulants (OACs) with regard to its haemostatic properties. The aim of this study was to assess the impact of maintaining OAC treatment in patients undergoing PVP. This study is a multicentre, open-label, randomized controlled trial (RCT) designed to show the non-inferiority of PVP surgery in patients with BPO treated with OACs. This study is designed to enrol 386 OAC-treated patients (treated with vitamin K antagonists and direct oral anticoagulants) who are undergoing PVP for BPO. Patients will be randomized (1:1) to either maintain or stop OAC treatment during the perioperative course. The intervention group will maintain OAC treatment until the day before surgery and resume OAC treatment the day after surgery, whereas the control group will stop OAC treatment (with or without low-molecular-weight heparin bridging therapy) according to the anaesthesia guidelines. The primary outcome of interest to be assessed is the 30-day complications rate according to the Clavien-Dindo classification. The secondary endpoint will examine the 30-day rate of haemorrhagic and thrombotic events. This study will provide 80% power to show non-inferiority, defined as not worse than a 10% (non-inferiority margin) inferior change in the proportion of patients with good outcomes (Clavien-Dindo score

This study sought to compare the incidental prostate cancer (iPCa) detection rate between pathological specimens from green laser enucleation of the prostate (GreenLEP) and open simple prostatectomy (OSP). In two institutions, the charts of all consecutive patients who underwent OSP between January 2005 and December 2010 were retrospectively reviewed, and the data of all consecutive patients who underwent GreenLEP with tissue morcellation between July 2013 and January 2018 were also collected. Preoperative demographics and pathological findings were recorded. iPCa detection rate was retrospectively compared between the GreenLEP and OSP groups in a propensity score model, including all predetermined variables: Age, preoperative PSA level and prostate volume. Of 738 patients, 402 were included in the propensity-score matching analysis, and they were equally distributed among groups. The overall iPCa detection rates were similar in both groups (9.9% vs. 8.5%; p = 0.73), and there were no statistically significant differences in terms of tumour stage, Gleason score or the rate of clinically significant iPCa, although the number of cassettes analysed was significantly higher in the morcellation group than in the OSP group. No predictive factors for iPCa were identified. The results of the present study suggest that the mechanical morcellation of large glands had no influence on iPCa detection. Compared with a specimen from standard OSP, a large morcellated tissue sample allows adequate pathological evaluation and does not alter a pathologist’s ability to detect iPCa.

Background Live surgery remains controversial. Although it may improve surgical training and accelerate the dissemination of technical steps of surgical procedures, controversy exists regarding patient safety in live surgery. Objective To compare the perioperative outcomes of "en bloc" green laser enucleation of the prostate (GreenLEP) performed in workshops during live case demonstration (LCD) and in standard conditions (SCs). Design, setting, and participants Between June 2015 and January 2017, all consecutive patients who underwent GreenLEP for benign prostatic obstruction performed by a single surgeon were prospectively enrolled. Perioperative data and early postoperative complications according to Clavien–Dindo classification were collected. Workshop programmes started locally according to the European Association of Urology policy on live surgical events in June 2015 to enrol small groups of urologists in the GreenLEP technique. Intervention Endoscopic enucleation of the prostate using a GreenLight fibre. Outcome measurements and statistical analysis Outcomes were compared between the LCD and SC groups. Results and limitations Of the 126 performed procedures, 37 were performed live during 17 LCDs with a median attendee number of 3. The patients' baseline characteristics were similar in both groups. Intraoperative parameters were comparable: total energy of 62 [53; 77] versus 56kJ [44; 69] ( p =0.068), operative time of 61 [53; 71] versus 55min [45; 66] ( p =0.1), and morcellating time of 3 [3; 5] versus 4min [2; 6] ( p =0.82) in the LCD versus SC group. The catheterisation time (2d [1; 2]) and length of hospital stay (2d [2; 3]) were similar. The overall complication rate was comparable in the LCD (18.9%) and SC (24.7%) groups ( p =0.64). Preoperative parameters significantly improved from baseline without any significant differences between the two groups. Limitations included a small number of attendees/workshop, and case selections were made by the surgeon himself. Conclusions GreenLEP was safe and provided satisfactory functional outcomes in both conditions. From this preliminary study, it seems that LCD did not jeopardise the surgeon's skill or technique. Similar studies are required to further assess patient safety and outcomes associated with live surgical events. Patient summary According to the surgeon expertise, endoscopic enucleation of the prostate performed during live case demonstration provided similar functional outcomes to that performed in standard condition and could therefore be considered a safe potential educational tool.