S erratus anterior plane block alone, paravertebral block alone and their combination in video-assisted thoracoscopic surgery: the THORACOSOPIC double-blind, randomized trial.

OBJECTIVES: Serratus anterior plane block (SAPB) and paravertebral block (PVB) are well known to reduce pain levels after video-assisted thoracoscopic surgery (VATS). However, the relative efficacies of each block and a combination of the 2 have not been fully characterized. The objective of the present study was to assess the efficacy of PVB alone, SAPB alone and the combination of PVB and SAPB with regard to the occurrence and intensity of pain after VATS. METHODS: We conducted the THORACOSOPIC single-centre, double-blind, randomized trial in adult patients due to undergo elective VATS lung resection. The participants were randomized to PVB only, SAPB only and PVB + SAPB groups. The primary end-point was pain on coughing on admission to the postanaesthesia care unit. The secondary end-points were postoperative pain at rest and on coughing at other time points and the cumulative opioid consumption. Pain was scored on a visual analogue scale. RESULTS: One-hundred and fifty-six patients (52 in each group) were included. On admission to the postanaesthesia care unit, the 3 groups did not differ significantly with regard to the pain on coughing: the visual analogue scale score was 3 (0-6), 4 (0-8) and 2 (0-6) in the PVB, SAPB and PVB + SAPB groups, respectively (P = 0.204). During postoperative care, the overall pain score was significantly lower in the SABP + PVP group at rest and on cough. CONCLUSIONS: The combination of SABP + PVB could be beneficial for pain management in VATS in comparison to SABP or PVB alone.

Determinants of postoperative complications in high-risk noncardiac surgery patients optimized with hemodynamic treatment strategies: A post-hoc analysis of a randomized multicenter clinical trial.

STUDY OBJECTIVE: This post-hoc analysis of a randomized controlled trial was undertaken to establish the determinants of postoperative complications and acute kidney injury in high-risk noncardiac surgery patients supported with hemodynamic treatment strategies. DESIGN: We conducted a post-hoc analysis of patients enrolled in the OPtimization Hemodynamic Individualized by the respiratory QUotiEnt (OPHIQUE) trial. SETTING: Operating rooms in four university medical centers and one non-university hospital from December 26, 2018, to September 9, 2021. PATIENTS: We enrolled 350 patients with a high risk of postoperative complications undergoing high-risk noncardiac surgery lasting 2 h or longer under general anesthesia. INTERVENTIONS: All patients were treated according to hemodynamic treatment strategies which included cardiac output optimization by titration of fluid challenge and targeted systolic blood pressure to remain within ±10% of the reference value. MEASUREMENTS: We assessed the association between pre-operative and intra-operative exposure of interest with a composite primary outcome of major complications or death within seven days following surgery using a multivariable logistic regression model. We also assessed the association between these exposures of interest and acute kidney injury. MAIN RESULTS: The data of 341 patients were analyzed. In multivariate analysis, the factors independently associated with the primary outcome were age (OR = 1.04 (1.01-1.06), P = 0.002), preoperative hemoglobin concentration (OR = 0.85 (0.75-0.96), P = 0.012), non-vascular surgery (OR = 0.30 (0.17-0.53), P < 0.0001), and intraoperative surgical complications (OR = 2.08 (1.02-4.24), P = 0.046). The factors independently associated with postoperative acute kidney injury were age (OR = 1.04 (1.01-1.08), P = 0.008), preoperative creatinine concentration (OR = 1.01 (1.00-1.01), P = 0.049), non-vascular surgery (OR = 0.36 (0.20-0.66), P = 0.001), and intraoperative surgical complications (OR = 3.36 (1.50-7.55), P = 0.031). CONCLUSIONS: Surgical complications, a lower preoperative hemoglobin concentration, age, and vascular surgery were associated with postoperative complications in a high-risk noncardiac surgery population supported with hemodynamic treatment strategies.

Comparison of landiolol and amiodarone for the treatment of new-onset atrial fibrillation after cardiac surgery (FAAC) trial: study protocol for a randomized controlled trial.

BACKGROUND: Postoperative atrial fibrillation (PoAF) after cardiac surgery has a high incidence of 30%, but its management is controversial. Two strategies are recommended without evidence of a superiority of one against the other: rate control with beta-blocker or rhythm control with amiodarone. Landiolol is a new-generation beta-blocker with fast onset and short half-life. One retrospective, single-center study compared landiolol to amiodarone for PoAF after cardiac surgery with a better hemodynamic stability and a higher rate of reduction to sinus rhythm with landiolol, justifying the need for a multicenter randomized controlled trial. Our aim is to compare landiolol to amiodarone in the setting of PoAF after cardiac surgery with the hypothesis of a higher rate of reduction to sinus rhythm with landiolol during the 48 h after the first episode of POAF. METHODS: The FAAC trial is a multicenter single-blind two parallel-arm randomized study, which planned to include 350 patients with a first episode of PoAF following cardiac surgery. The duration of the study is 2 years. The patients are randomized in two arms: a landiolol group and an amiodarone group. Randomization (Ennov Clinical®) is performed by the anesthesiologist in charge of the patient if PoAF is persistent for at least 30 min after correction of hypovolemia, dyskalemia, and absence of pericardial effusion on a transthoracic echocardiography done at bedside. Our hypothesis is an increase of the percentage of patients in sinus rhythm from 70 to 85% with landiolol in less than 48 h after onset of PoAF (alpha risk = 5%, power = 90%, bilateral test). DISCUSSION: The FAAC trial was approved by the Ethics Committee of EST III with approval number 19.05.08. The FAAC trial is the first randomized controlled trial comparing landiolol to amiodarone for PoAF after cardiac surgery. In case of higher rate of reduction with landiolol, this beta-blocker could be the drug of choice used in this context as to reduce the need for anticoagulant therapy and reduce the risk of complications of anticoagulant therapy for patients with a first episode of postoperative atrial fibrillation after cardiac surgery. TRIAL REGISTRATION: ClinicalTrials.gov NCT04223739. Registered on January 10, 2020.

Respiratory Exchange Ratio guided management in high-risk noncardiac surgery: The OPHIQUE multicentre randomised controlled trial.

BACKGROUND: There is a need to develop non-invasive markers to identify the occurrence of anaerobic metabolism in high-risk surgery. Our objective was to demonstrate that a goal-directed therapy algorithm incorporating the respiratory exchange ratio (ratio between CO2 production and O2 consumption) can reduce postoperative complications. METHODS: We conducted a randomized, multicenter, controlled clinical trial in four university medical centers and one non-university hospital from December 26, 2018, to September 9, 2021. 350 patients with a high risk of postoperative complications undergoing high-risk noncardiac surgery lasting 2 h or longer under general anesthesia were enrolled. The control group was treated according to current hemodynamic guidelines. The interventional group was treated according to an algorithm based on the measurement of the respiratory exchange ratio. The primary outcome was a composite of major complications or death within seven days of surgery. The secondary outcomes were the length of hospital stay, 30-day mortality, and the total intraoperative volume of fluids administered. RESULTS: The primary outcome occurred for 78 patients (45.6%) in the interventional group and 83 patients (48.8%) in the control group (relative risk: 0.93, 95% confidence interval [CI]: 0.75-1.17; p = 0.55). There were no clinically relevant differences between the two groups for secondary outcomes. CONCLUSIONS: In high-risk surgery, a goal-directed therapy algorithm integrating the measurement of the respiratory-exchange ratio did not reduce a composite outcome of major postoperative complications or death within seven days after surgery compared to routine care. TRIAL REGISTRATION: ClinicalTrials.gov, NCT03852147.

Assessment of fluid unresponsiveness guided by lung ultrasound in abdominal surgery: a prospective cohort study.

A fluid challenge can generate an infraclinical interstitial syndrome that may be detected by the appearance of B-lines by lung ultrasound. Our objective was to evaluate the appearance of B-lines as a diagnostic marker of preload unresponsiveness and postoperative complications in the operating theater. We conducted a prospective, bicentric, observational study. Adult patients undergoing abdominal surgery were included. Stroke volume (SV) was determined before and after a fluid challenge with 250 mL crystalloids (Delta-SV) using esophageal Doppler monitoring. Responders were defined by an increase of Delta-SV > 10% after fluid challenge. B-lines were collected at four bilateral predefined zones (right and left anterior and lateral). Delta-B-line was defined as the number of newly appearing B-lines after a fluid challenge. Postoperative pulmonary complications were prospectively recorded according to European guidelines. In total, 197 patients were analyzed. After a first fluid challenge, 67% of patients were responders and 33% were non-responders. Delta-B-line was significantly higher in non-responders than responders [4 (2-7) vs 1 (0-3), p < 0.0001]. Delta-B-line was able to diagnose fluid non-responders with an area under the curve of 0.74 (95% CI 0.67-0.80, p < 0.0001). The best threshold was two B-lines with a sensitivity of 80% and a specificity of 57%. The final Delta-B-line could predict postoperative pulmonary complications with an area under the curve of 0.74 (95% CI 0.67-0.80, p = 0.0004). Delta-B-line of two or more detected in four lung ultrasound zones can be considered to be a marker of preload unresponsiveness after a fluid challenge in abdominal surgery.The objectives and procedures of the study were registered at Clinicaltrials.gov (NCT03502460; Principal investigator: Stéphane BAR, date of registration: April 18, 2018).

Individualised or liberal red blood cell transfusion after cardiac surgery: a randomised controlled trial.

BACKGROUND: Current practice guidelines for red blood cell (RBC) transfusion in ICUs are based on haemoglobin threshold, without consideration of oxygen delivery or consumption. We aimed to evaluate an individual physiological threshold-guided by central venous oxygen saturation ScvO2. METHODS: In a randomised study in two French academic hospitals, 164 patients who were admitted to ICU after cardiac surgery with postoperative haemoglobin <9 g dl-1 were randomised to receive a transfusion with one unit of RBCs (haemoglobin group) or transfusion only if the ScvO2 was <70% (individualised group). The primary outcome was the number of subjects receiving at least one unit of RBCs. The secondary composite outcome was acute kidney injury, stroke, myocardial infarction, acute heart failure, mesenteric ischaemia, or in-hospital mortality. One- and 6-month mortality were evaluated during follow-up. RESULTS: The primary outcome was observed for 80 of 80 subjects (100%) in the haemoglobin group and in 61 of 77 patients (79%) in the individualised group (absolute risk -21% [-32.0; -14.0]; P<0.001). There was no significant difference in the secondary outcome between the two groups. Follow-up showed a non-significant difference in mortality at 1 and 6 months. CONCLUSIONS: An individualised strategy based on an central venous oxygen saturation threshold of 70% allows for a more restrictive red blood cell transfusion strategy with no incidence on postoperative morbidity or 6-month mortality. CLINICAL TRIAL REGISTRATION: NCT02963883.

Changes in Plasma Angiopoietin Levels After Transcatheter Aortic Valve Replacement and Surgical Aortic Valve Replacement: A Prospective Cohort Study.

OBJECTIVE: Angiopoietins (Angs) regulate endothelial permeability. Ang-1 and 2 (Ang-1 and Ang-2) are implied in endothelial stability through an antagonism effect. The objectives of the present study were to describe and compare changes in Ang levels after transcatheter aortic valve replacement (TAVR) and surgical aortic valve replacement (SAVR). DESIGN: A prospective, single-center study. PARTICIPANTS: Adult patients with aortic stenosis scheduled for SAVR or TAVR. INTERVENTIONS: None. MEASUREMENTS AND MAIN RESULTS: Ang-1 and Ang-2 were measured using an enzyme-linked immunosorbent assay right before surgery (T0), at the end of surgery (T1), and at day one (T2). Sixty consecutive patients (SAVR group [n = 30] and TAVR group [n = 30]) were included between January and June 2017. Ang-1 decreased significantly after both TAVR (T0: 3,663 [2,602-4,262]; T1: 1,611 [981-2,409]; T2: 1,082 [652-1,589] ng/mL; p < 0.0001) and SAVR (T0: 1,603 [975-2,849]; T1: 783 [547-1,024]; T2: 828 [460-1,227] ng/mL; p = 0.0001). Ang-2 increased significantly after SAVR (T0: 2,472 [1,502-3,622]; T1: 2,997 [1,759-3,839]; T2: 5,421 [3,557-7,087] ng/mL; p < 0.0001) but did not change markedly after TAVR (T0: 3,343 [2,661-6,272]; T1: 3,788 [2,574-5,016]; T2: 3,446 [3,029-6,313] ng/mL; p = 0.066). Among patients with paravalvular leakage, the changes in the plasma Ang-2 level and the Ang-2/Ang-1 ratio were greater. CONCLUSION: SAVR induces greater alterations of Ang homeostasis than TAVR, confirming a role for the use of cardiopulmonary bypass. Paravalvular leakage after TAVR is associated with Ang changes similar to those observed with SAVR.

Guidelines on enhanced recovery after pulmonary lobectomy

To establish recommendations for optimisation of the management of patients undergoing pulmonary lobectomy, particularly Enhanced Recovery After Surgery (ERAS). A consensus committee of 13 experts from the French Society of Anaesthesia and Intensive Care Medicine (Soci,t, franOaise d'anesth,sie et de r,animation, SFAR) and the French Society of Thoracic and Cardiovascular Surgery (Soci,t, franOaise de chirurgie thoracique et cardiovasculaire, SFCTCV) was convened. A formal conflict-of-interest policy was developed at the onset of the process and enforced throughout. The entire guidelines process was conducted independently of any industry funding. The authors were advised to follow the principles of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to guide assessment of quality of evidence. Five domains were defined: 1) patient pathway and patient information; 2) preoperative management and rehabilitation; 3) anaesthesia and analgesia for lobectomy; 4) surgical strategy for lobectomy; and 5) enhanced recovery after surgery. For each domain, the objective of the recommendations was to address a number of questions formulated according to the PICO model (Population, Intervention, Comparison, Outcome). An extensive literature search on these questions was carried out and analysed using the GRADE® methodology. Recommendations were formulated according to the GRADE® methodology, and were then voted by all experts according to the GRADE grid method. The SFAR/SFCTCV guideline panel provided 32 recommendations on the management of patients undergoing pulmonary lobectomy. After two voting rounds and several amendments, a strong consensus was reached for 31 of the 32 recommendations and a moderate consensus was reached for the last recommendation. Seven of these recommendations present a high level of evidence (GRADE 1+), 23 have a moderate level of evidence (18 GRADE 2+ and 5 GRADE 2-), and 2 correspond to expert opinions. Finally, no recommendation was provided for 2 of the questions. A strong consensus was expressed by the experts to provide recommendations to optimise the whole perioperative management of patients undergoing pulmonary lobectomy.

Guidelines on enhanced recovery after pulmonary lobectomy.

OBJECTIVE: To establish recommendations for optimisation of the management of patients undergoing pulmonary lobectomy, particularly Enhanced Recovery After Surgery (ERAS). DESIGN: A consensus committee of 13 experts from the French Society of Anaesthesia and Intensive Care Medicine (Soci,t, franOaise d'anesth,sie et de r,animation, SFAR) and the French Society of Thoracic and Cardiovascular Surgery (Soci,t, franOaise de chirurgie thoracique et cardiovasculaire, SFCTCV) was convened. A formal conflict-of-interest policy was developed at the onset of the process and enforced throughout. The entire guidelines process was conducted independently of any industry funding. The authors were advised to follow the principles of the Grading of Recommendations Assessment, Development and Evaluation (GRADE) system to guide assessment of quality of evidence. METHODS: Five domains were defined: 1) patient pathway and patient information; 2) preoperative management and rehabilitation; 3) anaesthesia and analgesia for lobectomy; 4) surgical strategy for lobectomy; and 5) enhanced recovery after surgery. For each domain, the objective of the recommendations was to address a number of questions formulated according to the PICO model (Population, Intervention, Comparison, Outcome). An extensive literature search on these questions was carried out and analysed using the GRADE® methodology. Recommendations were formulated according to the GRADE® methodology, and were then voted by all experts according to the GRADE grid method. RESULTS: The SFAR/SFCTCV guideline panel provided 32 recommendations on the management of patients undergoing pulmonary lobectomy. After two voting rounds and several amendments, a strong consensus was reached for 31 of the 32 recommendations and a moderate consensus was reached for the last recommendation. Seven of these recommendations present a high level of evidence (GRADE 1+), 23 have a moderate level of evidence (18 GRADE 2+ and 5 GRADE 2-), and 2 correspond to expert opinions. Finally, no recommendation was provided for 2 of the questions. CONCLUSIONS: A strong consensus was expressed by the experts to provide recommendations to optimise the whole perioperative management of patients undergoing pulmonary lobectomy.

Predictive value of the respiratory exchange ratio for the occurrence of postoperative complications in laparoscopic surgery: a prospective and observational study.

Indirect measurement of the respiratory exchange ratio (RER) has been shown to predict the occurrence of postoperative complications after major open non-cardiac surgery. Our main objective was to demonstrate the ability of the RER, indirectly measured by the anaesthesia respirator, to predict the occurrence of postoperative complications following laparoscopic surgery. We performed an observational, prospective and monocentric study. Haemodynamic and respiratory parameters were collected at several timepoints to calculate the RER by a non-volumetric method: RER = (FetCO2-FiCO2)/(FiO2-FetO2). Fifty patients were prospectively included. Nine patients (18%) had at least one postoperative complication. The mean RER was significantly higher for the subgroup of patients with complications than the subgroup without (1.04 ± 0.27 vs 0.88 ± 0.13, p < 0.05). The RER could predict the occurrence of post-operative complications with an area under the ROC curve of 0.73 (95% CI 0.59-0.85, p = 0.021). The best cut off was 0.98, with a sensitivity of 56% and a specificity of 88%. One hour after insufflation, the FiO2-FetO2 difference was significantly lower and the RER was significantly higher in the complications subgroup than in the subgroup without complications (4.4/- 1.6% vs 5.8/- 1.2%, p = 0.001 and 0.95 [0.85-1.04] vs 0.83 [0.75-0.92], p = 0.04, respectively). The RER measured during laparoscopic surgery can predict the occurrence of postoperative complications.Trial registration The objectives and procedures of the study was registered at Clinicaltrials.gov (NCT03751579); date: November 23, 2018.

Individualized hemodynamic optimization guided by indirect measurement of the respiratory exchange ratio in major surgery: study protocol for a randomized controlled trial (the OPHIQUE study).

BACKGROUND: Observational studies have suggested that a high respiratory exchange ratio (RER) is associated with the occurrence of postoperative complications. The study's primary objective is to demonstrate that the incidence of postoperative complications is lower in an interventional group (patients monitored using a hemodynamic algorithm that incorporates the RER) than in a control group (treated according to standard practice). METHODS: We shall perform a prospective, multicenter, randomized, open-label, superiority trial of consecutive patients undergoing major noncardiac surgery (i.e., abdominal, vascular, and orthopedic surgery). The control group will be treated according to the current guidelines on standard hemodynamic care. The interventional group will be treated according to an algorithm based on the RER. The primary outcome will be the occurrence of at least one complication in the 7 days following surgery. The secondary outcomes will be the length of hospital stay, the total number of complications per patient, the 30-day mortality, the total intraoperative volume of fluids administered, and the Sequential [sepsis-related] Organ Failure Assessment (SOFA) score and laboratory data measured on postoperative days 1, 2, and 7. A total of 350 patients will be included. DISCUSSION: In the operating theater, the RER is potentially a continuously available, easy-to-read, indirect marker of tissue hypoperfusion and postoperative complications. If the RER does predict the occurrence of tissue hypoperfusion, it will help the physician to provide personalized hemodynamic management and limit the side effects associated with excessive hemodynamic optimization (volume overload, vasoconstriction, etc.). TRIAL REGISTRATION: ClinicalTrials.gov NCT03852147 . Registered on February 25, 2019.

Risk factors and mortality of patients undergoing hip fracture surgery: a one-year follow-up study.

Hip fracture (HF) remains a main issue in the elderly patient. About 1.6 million patients a year worldwide are victims of a HF. Their incidence is expected to rise with the aging of the world's population. Identifying risk factors is mandatory in order to reduce mortality and morbidity. The aim of the study was to identify risk factors of 1-year mortality after HF surgery. We performed an observational, prospective, single-center study at Amiens University Hospital (Amiens, France). After ethical approval, we consecutively included all patients with a HF who underwent surgery between June 2016 and June 2017. Perioperative data were collected from medical charts and by interviews. Mortality rate at 12 months was recorded. Univariate analysis was performed and mortality risk factors were investigated using a Cox model. 309 patients were analyzed during this follow-up. Mortality at 1 year was 23.9%. Time to surgery over 48 hours involved 181 patients (58.6%) while 128 patients (41.4%) had surgery within the 48 hours following the hospital admission. Independent factors associated with 1-year mortality were: age (HR at 1.059 (95%CI [1.005-1.116], p = 0,032), Lee score ≥ 3 (HR at 1,52 (95% CI [1,052-2,198], p = 0.026) and time to surgery over 48 hours (HR of 1.057 (95% CI [1.007-1.108], p = 0.024). Age, delayed surgical (over 48 hours) management and medical history are important risk factors of 1-year mortality in this French cohort.

Individualized Fluid Management Using the Pleth Variability Index: A Randomized Clinical Trial.

BACKGROUND: The present trial was designed to assess whether individualized strategies of fluid administration using a noninvasive plethysmographic variability index could reduce the postoperative hospital length of stay and morbidity after intermediate-risk surgery. METHODS: This was a multicenter, randomized, nonblinded parallel-group clinical trial conducted in five hospitals. Adult patients in sinus rhythm having elective orthopedic surgery (knee or hip arthroplasty) under general anesthesia were enrolled. Individualized hemodynamic management aimed to achieve a plethysmographic variability index under 13%, and the standard management strategy aimed to maintain a mean arterial pressure above 65 mmHg during general anesthesia. The primary outcome was the postoperative hospital length of stay decided by surgeons blinded to the group allocation of the patient. RESULTS: In total, 447 patients were randomized, and 438 were included in the analysis. The mean hospital length of stay ± SD was 6 ± 3 days for the plethysmographic variability index group and 6 ± 3 days for the control group (adjusted difference, 0.0 days; 95% CI, -0.6 to 0.5; P = 0.860); the theoretical postoperative hospital length of stay was 4 ± 2 days for the plethysmographic variability index group and 4 ± 1 days for the control group (P = 0.238). In the plethysmographic variability index and control groups, serious postoperative cardiac complications occurred in 3 of 217 (1%) and 2 of 224 (1%) patients (P = 0.681), acute postoperative renal failure occurred in 9 (4%) and 8 (4%) patients (P = 0.808), the troponin Ic concentration was more than 0.06 µg/l within 5 days postoperatively for 6 (3%) and 5 (2%) patients (P = 0.768), and the postoperative arterial lactate measurements were 1.44 ± 1.01 and 1.43 ± 0.95 mmol/l (P = 0.974), respectively. CONCLUSIONS: Among intermediate-risk patients having orthopedic surgery with general anesthesia, fluid administration guided by the plethysmographic variability index did not shorten the duration of hospitalization or reduce complications.