Rationale and design of the colchicine for the prevention of perioperative atrial fibrillation in patients undergoing major noncardiac thoracic surgery (COP-AF) trial.

BACKGROUND: Perioperative atrial fibrillation (AF) and myocardial injury after noncardiac surgery (MINS) are common complications after noncardiac surgery. Inflammation has been implicated in the pathogenesis of both disorders. The COP-AF trial tests the hypothesis that colchicine reduces the incidence of perioperative AF and MINS in patients undergoing major noncardiac thoracic surgery. METHODS AND RESULTS: The 'COlchicine for the Prevention of Perioperative Atrial Fibrillation' (COP-AF) trial is an international, blinded, randomized trial that compares colchicine to placebo in patients aged at least 55 years and undergoing major noncardiac thoracic surgery with general anesthesia. Exclusion criteria include a history of AF and a contraindication to colchicine (eg, severe renal dysfunction). Oral colchicine at a dose of 0.5 mg or matching placebo is given within 4 hours before surgery. Thereafter, patients receive colchicine 0.5 mg or placebo twice daily for a total of 10 days. The 2 independent co-primary outcomes are clinically important perioperative AF (including atrial flutter) and MINS during 14 days of follow-up. The main safety outcomes are sepsis or infection and non-infectious diarrhea. We aim to enroll 3,200 patients from approximately 40 sites across 11 countries to have at least 80% power for the independent evaluation of the 2 co-primary outcomes. The COP-AF main results are expected in 2023. CONCLUSIONS: COP-AF is a large randomized and blinded trial designed to determine whether colchicine reduces the risk of perioperative AF or MINS in patients who have major noncardiac thoracic surgery.

Myocardial Injury After Noncardiac Surgery: Incidence, Predictive Factors, and Outcome in High-Risk Patients Undergoing Thoracic Surgery: An Observational Study.

OBJECTIVE: The authors aimed to evaluate the incidence of myocardial injury after noncardiac surgery (MINS), its relationship with perioperative variables, and its prognostic implications for 30-day mortality in high-risk thoracic surgery patients. DESIGN: Observational study including cardiovascular high-risk patients undergoing routine postoperative troponin monitoring during the first 2 postoperative days. MINS was diagnosed based on at least 1 troponin I determination ≥0.04 ng/mL with no evidence of a nonischemic etiology. SETTING: Tertiary university hospital. PARTICIPANTS: Adult patients with cardiac risk factors, defined as patients ≥65 years old or patients <65 years old with known cardiovascular pathology (history of cardiac, cerebral, or peripheral vascular pathology) who underwent elective thoracic surgery. MEASUREMENT AND MAIN RESULTS: Forty-eight patients (27.3%) (95% confidence interval [CI] 20.8%-34.5%) of 177 had diagnostic criteria for MINS. On univariate analysis, an association was found between MINS and smoking (odds ratio [OR] 2.17, 95% CI 1.26-3.76), lobectomy (OR 1.30, 95% CI 1.03-1.66), pneumonectomy (OR 6.72, 95% CI 1.35-33.9), use of vasoactive drugs (OR 1.94, 95% CI 1.03-3.65), and pericardial incision (OR 6.72, 95% CI 1.35-33.9). On multivariate logistic regression analysis, only smoker status and type of surgery were independent risk factors for MINS. No association was found between MINS and 30-day mortality. CONCLUSIONS: Based on the findings, the elevated incidence of MINS after thoracic surgery, the independent relationship with the extent of lung resection, and the fact that MINS was not associated with greater mortality suggest that nonischemic causes may contribute to troponin elevation after thoracic surgeries.

Validation and cross-cultural adaptation of the postoperative quality of recovery 15 (QoR-15) questionnaire for Spanish-speaking patients: A prospective cohort study.

BACKGROUND: The postoperative QoR-15 questionnaire may improve the detection of postoperative complications on an early basis and contribute to optimize treatment and recovery. No validated Spanish QoR-15 questionnaire has been available to date. METHODS: The Spanish QoR-15 questionnaire (QoR-15E), carried out by official bilingual translators, was administered to 242 adult patients undergoing elective surgery before and 24 h after surgery. Patients were asked about their perceived quality of general recovery using a visual analogue scale (VAS). A random subgroup of 36 patients completed a third questionnaire 30-60 min after having completed the first one, and under the same conditions. RESULTS: The Pearson correlation coefficient between QoR-15E and the VAS score was 0.759. Cronbach's alpha was 0.856 in the postoperative period. Reliability by the split-half method was 0.781. Test-retest correlation coefficient was 0.998. Cohen's d was 0.94. The mean time to complete the preoperative questionnaire was 2.9 ± 0.5 min. CONCLUSIONS: The QoR-15E is valid and reliable for assessing postoperative quality of recovery in Spanish-speaking patients, with psychometric and interpretative features similar to those of the original instrument.

Effect of Colchicine on the Risk of Perioperative Acute Kidney Injury: Clinical Protocol of a Substudy of the Colchicine for the Prevention of Perioperative Atrial Fibrillation Randomized Clinical Trial.

Background: Inflammation during and after surgery can lead to organ damage including acute kidney injury. Colchicine, an established inexpensive anti-inflammatory medication, may help to protect the organs from pro-inflammatory damage. This protocol describes a kidney substudy of the colchicine for the prevention of perioperative atrial fibrillation (COP-AF) study, which is testing the effect of colchicine versus placebo on the risk of atrial fibrillation and myocardial injury among patients undergoing thoracic surgery. Objective: Our kidney substudy of COP-AF will determine whether colchicine reduces the risk of perioperative acute kidney injury compared with a placebo. We will also examine whether colchicine has a larger absolute benefit in patients with pre-existing chronic kidney disease, the most prominent risk factor for acute kidney injury. Design and Setting: Randomized, superiority clinical trial conducted in 40 centers in 11 countries from 2018 to 2023. Patients: Patients (~3200) aged 55 years and older having major thoracic surgery. Intervention: Patients are randomized 1:1 to receive oral colchicine (0.5 mg tablet) or a matching placebo, given twice daily starting 2 to 4 hours before surgery for a total of 10 days. Patients, health care providers, data collectors, and outcome adjudicators will be blinded to the randomized treatment allocation. Methods: Serum creatinine concentrations will be measured before surgery and on postoperative days 1, 2, and 3 (or until hospital discharge). The primary outcome of the substudy is perioperative acute kidney injury, defined as an increase (from the prerandomization value) in serum creatinine concentration of either ≥26.5 µmol/L (≥0.3 mg/dL) within 48 hours of surgery or ≥50% within 7 days of surgery. The primary analysis (intention-to-treat) will examine the relative risk of acute kidney injury in patients allocated to receive colchicine versus placebo. We will repeat the primary analysis using alternative definitions of acute kidney injury and examine effect modification by pre-existing chronic kidney disease, defined as a prerandomization estimated glomerular filtration rate (eGFR) <60 mL/min per 1.73 m2. Limitations: The substudy will be underpowered to detect small effects on more severe forms of acute kidney injury treated with dialysis. Results: Substudy results will be reported in 2024. Conclusions: This substudy will estimate the effect of colchicine on the risk of perioperative acute kidney injury in older adults undergoing major thoracic surgery. Clinical trial registration number: NCT03310125.

Contexte: L'inflammation pendant et après une intervention chirurgicale peut causer des lésions aux organes, notamment de l'insuffisance rénale aiguë (IRA). La colchicine, un médicament anti-inflammatoire reconnu et bon marché, peut contribuer à protéger les organes contre les lésions pro-inflammatoires. Le présent protocole décrit une sous-étude rénale de l'essai Colchicine for the Prevention of Perioperative atrial fibrillation (COP-AF), qui examine l'effet de la colchicine, par rapport à un placebo, sur le risque de fibrillation auriculaire et de lésion myocardique chez les patients qui subissent une chirurgie thoracique. Objectif: Notre sous-étude rénale de l'essai COP-AF permettra de vérifier si la colchicine réduit le risque d'IRA périopératoire par rapport à un placebo. Nous tenterons également de déterminer si la colchicine présente un plus grand bénéfice absolu pour les patients atteints d'une insuffisance rénale chronique préexistante, laquelle constitue le plus important facteur de risque pour l'IRA. Cadre et type d'étude: Essai clinique à répartition aléatoire visant à démontrer une supériorité. L'étude, qui s'étend de 2018 à 2023, est menée dans 40 centers situés dans 11 pays. Sujets: Des patients (~3200) âgés de 55 ans et plus subissant une chirurgie thoracique majeure. Interventions: Les patients sont répartis 1:1 de façon aléatoire pour recevoir de la colchicine par voie orale (comprimé de 0.5 mg), ou un placebo correspondant, deux fois par jour à partir de 2 à 4 heures avant l'intervention chirurgicale, pour un total de 10 jours. Les patients, les prestataires de soins de santé, les personnes qui collectent les données et celles qui évaluent les résultats ne seront pas informés de l'attribution du traitement. Méthodologie: Les concentrations sériques de créatinine seront mesurées avant l'intervention et aux jours postopératoires 1, 2, et 3 (ou jusqu'au congé de l'hôpital). Le principal critère d'évaluation de cette sous-étude est une IRA périopératoires définie par une hausse (par rapport à la valeur mesurée avant la répartition aléatoire) d'au moins 26.5 µmol/L (≥0.3 mg/dL) de la créatinine sérique dans les 48 heures suivant l'intervention ou d'au moins 50% dans les 7 jours suivants. L'analyze primaire (intention de traiter) examinera le risque relatif d'IRA chez les patients recevant de la colchicine par rapport au placebo. L'analyze primaire sera répétée en utilisant d'autres définitions de l'IRA et nous examinerons la modification de l'effet en présence d'une insuffisance rénale préexistante, définie par un débit de filtration glomérulaire estimé (DFGe) inférieur à 60 mL/min/1.73 m2 avant la répartition aléatoire. Limites: Cette sous-étude ne sera pas assez puissante pour détecter de petits effets sur les formes plus graves d'insuffisance rénale aiguë traitées par dialyze. Résultats: Les résultats de cette sous-étude feront l'objet d'un rapport en 2024. Conclusion: Cette sous-étude permettra d'estimer l'effet de la colchicine sur le risque d'insuffisance rénale aiguë périopératoire chez les adultes âgés qui subissent une chirurgie thoracique majeure. Numéro d'enregistrement de l'essai clinique: NCT03310125.

Robotic-assisted lobectomy after bilateral lung transplantation.

A 67-year-old woman diagnosed with a lung nodule on the left upper lobe was referred for surgical treatment. She had undergone a bilateral lung transplant in 2014. A robotic-assisted lobectomy with mediastinal lymph node dissection was performed. Final pathology revealed a pT3N0M0 Micropapillary Adenocarcinoma. The patient is alive and disease-free 13 months after the operation. This case report and video illustrate the safety and feasibility of a robotic-assisted lobectomy in a lung transplant recipient.

Study protocol for an observational cohort evaluating incidence and clinical relevance of perioperative elevation of high-sensitivity troponin I and N-terminal pro-brain natriuretic peptide in patients undergoing lung resection.

INTRODUCTION: Myocardial injury after non-cardiac surgery has been defined as myocardial injury due to ischaemia, with or without additional symptoms or ECG changes occurring during or within 30 days after non-cardiac surgery and mainly diagnosed based on elevated postoperative cardiac troponin (cTn) values. In patients undergoing thoracic surgery for lung resection, only postoperative cTn elevations are seemingly not enough as an independent predictor of cardiovascular complications. After lung resection, troponin elevations may be regulated by mechanisms other than myocardial ischaemia. The combination of perioperative natriuretic peptide measurement together with high-sensitivity cTns may help to identify changes in ventricular function during thoracic surgery. Integrating both cardiac biomarkers may improve the predictive value for cardiovascular complications after lung resection. We designed our cohort study to evaluate perioperative elevation of both high-sensitivity troponin I (hs-TnI) and N-terminal pro-brain natriuretic peptide (NT-proBNP) in patients undergoing lung resection and to establish a risk score for major cardiovascular postoperative complications. METHODS AND ANALYSIS: We will conduct a prospective, multicentre, observational cohort study, including 345 patients undergoing elective thoracic surgery for lung resection. Cardiac biomarkers such as hs-TnI and NT-proBNP will be measured preoperatively and at postoperatively on days 1 and 2. We will calculate a risk score for major cardiovascular postoperative complications based on both biomarkers' perioperative changes. All patients will be followed up for 30 days after surgery. ETHICS AND DISSEMINATION: All participating centres were approved by the Ethics Research Committee. Written informed consent is required for all patients before inclusion. Results will be disseminated through publication in peer-reviewed journals and presentations at national or international conference meetings. TRIAL REGISTRATION NUMBER: NCT04749212.

Pre-operative prevalence of asymptomatic carriers of COVID-19 in hospitals in Catalonia during the first wave after the resumption of surgical activity.

INTRODUCTION: The COVID-19 pandemic led to the cancellation of non-essential surgical procedures in March 2020. With the resumption of surgical activity, patients undergoing surgery were one of the first population groups to be systematically tested for PCR. The aim of this study was to determine the prevalence of asymptomatic SARS-CoV-2 carriers after the resumption of non-essential surgical activity. METHODS: Retrospective multicenter observational study of patients scheduled for surgery or undergoing emergency surgery in Catalonia between 20 April and 31 May 2020. The microbiological results of preoperative PCR tests and clinical records were reviewed, and an epidemiological survey was conducted on patients with positive PCR for SARS-CoV-2. RESULTS: A total of 10,838 patients scheduled for surgery or who underwent emergency surgery were screened for COVID-19. One hundred and eighteen patients (1.09%) were positive for SARS-CoV-2 in the 72 h prior to surgery. The prevalence of asymptomatic carriers was 0.7% (IC95%: 0.6%-0.9%). The first week of the study presented the highest prevalence of asymptomatic carriers [1.9% (CI95%:1.1%-3.2%)]. CONCLUSIONS: The low levels of asymptomatic carriers of COVID-19 infection obtained in the surgical population of hospitals in Catalonia after the resumption of surgical activity, shows that most patients were able to undergo surgical procedures without the risks of COVID-19 associated complications in the perioperative period.

Pre-operative prevalence of asymptomatic carriers of COVID-19 in hospitals in Catalonia during the first wave after the resumption of surgical activity. / Prevalencia preoperatoria de portadores asintomáticos de COVID-19 en hospitales de Cataluña durante la primera ola tras el reinicio de la actividad quirúrgica.

INTRODUCTION: The COVID-19 pandemic led to the cancellation of non-essential surgical procedures in March 2020. With the resumption of surgical activity, patients undergoing surgery were one of the first population groups to be systematically tested for PCR. The aim of this study was to determine the prevalence of asymptomatic SARS-CoV-2 carriers after the resumption of non-essential surgical activity. METHODS: Retrospective multicenter observational study of patients scheduled for surgery or undergoing emergency surgery in Catalonia between 20 April and 31 May 2020. The microbiological results of preoperative PCR tests and clinical records were reviewed, and an epidemiological survey was conducted on patients with positive PCR for SARS-CoV-2. RESULTS: A total of 10,838 patients scheduled for surgery or who underwent emergency surgery were screened for COVID-19. One hundred and eighteen patients (1.09%) were positive for SARS-CoV-2 in the 72hours prior to surgery. The prevalence of asymptomatic carriers was 0.7% (95%CI: 0.6% - 0.9%). The first week of the study presented the highest prevalence of asymptomatic carriers [1.9% (95%CI: 1.1%-3.2%)]. CONCLUSIONS: The low levels of asymptomatic carriers of COVID-19 infection obtained in the surgical population of hospitals in Catalonia after the resumption of surgical activity, shows that most patients were able to undergo surgical procedures without the risks of COVID-19 associated complications in the perioperative period.