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1. Temporal Trends in the Management Practices of Clinically Important Perioperative Atrial Fibrillation After Noncardiac Surgery

Author

Michael Ke Wang, MD, P.J. Devereaux, MD, PhD, Maura Marcucci, MD, MSc, Vladimir Lomivorotov, MD, PhD, Daniel I. Sessler, MD, Matthew T.V. Chan, MBBS, MMed, PhD, Flavia K. Borges, MD, PhD, Sandra N. Ofori, MBBS, PhD, Pilar Paniagua, MD, PhD, James D. Douketis, MD, Alben Sigamani, MD, Joel L. Parlow, MD, FRCPC, MSc, Chew Y. Wang, MBChB, Juan Carlos Villar, MD, PhD, Sadeesh K. Srinathan, MD, MSc, FRCSC, FRCS C-Th, Wojciech Szczeklik, MD, PhD, María José Martínez-Zapata, MD, PhD, German Malaga, MD, MSc, Soori Sivakumaran, MD, FRCPC, William F. McIntyre, MD, PhD, FRCPC, María-Virginia Rodríguez Funes, MD, MPH, FACS, Patricia Cruz, MD, PhD, Jesús Alvarez-Garcia, MD, PhD, Isabelle Greiss, B. Pharm, MD, FRCPC, Ekaterine Popova, MD, Martin E. Hemels, MD, PhD, FEHRA, FESC, Axel Brandes, MD, DMSc, Clara K. Chow, MD, PhD, Satish Prasad Barnawal, MD, Jeff S. Healey, MD, MSc, FRCPC, FHRS, and David Conen, MD, MPH

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: Clinically important perioperative atrial fibrillation (POAF) is a common cardiac complication after noncardiac surgery. Little is known about how patients with POAF are managed acutely and whether practices have changed over time. Methods: We conducted an observational substudy of patients who had POAF, were at elevated cardiovascular risk, and were enrolled in the PeriOperative Ischemic Evaluation (POISE)-1, 2 and 3 trials between 2002 and 2021. POAF was defined as new, clinically important atrial fibrillation occurring within 30 days after surgery. We assessed the use of rhythm-control and anticoagulation treatment in response to POAF, at hospital discharge and at 30 days after surgery. We assessed for temporal trends using multivariable logistic regression. Results: Of the 27,896 patients included, 545 (1.9%) developed clinically important POAF. Patients received rhythm-control treatment in 48.6% of cases. The level of use of rhythm-control treatment increased over the course of the trials (POISE-1 vs POISE-2 vs POISE-3; 40.9% vs 49.5% vs 59.1%). A later randomization date was associated independently with use of rhythm-control treatment (odds ratio, 1.05 per year; 95% confidence interval, 1.01-1.09). Anticoagulation treatment was prescribed in 21% of POAF cases. The level of anticoagulation treatement use was higher in POISE-3, compared to that in the 2 previous trials (POISE-1 vs POISE-2 vs POISE-3—16.4% vs 16.5% vs 33.6%). A later randomization date was associated independently with use of anticoagulation treatment (odds ratio, 1.06 per year; 95% confidence interval, 1.02-1.11). Conclusions: Despite the absence of randomized controlled trials, the level of use of rhythm-control and anticoagulation treatment for POAF is rising. High-quality trials are needed urgently to determine whether these interventions are safe and effective in this population. Résumé: Contexte: En chirurgie non cardiaque, la fibrillation auriculaire postopératoire (FAPO) d’importance clinique est une complication cardiaque fréquente. La prise en charge ponctuelle des patients présentant une FAPO est mal connue et on ne sait pas précisément si les pratiques ont évolué au fil du temps. Méthodologie: Nous avons mené une sous-étude d’observation auprès de patients ayant présenté une FAPO et dont le risque cardiovasculaire était élevé, et qui avaient participé aux études 1, 2 ou 3 du programme d’essais cliniques POISE (PeriOperative Ischemic Evaluation) entre 2002 et 2021. La FAPO était définie comme un nouvel épisode de fibrillation auriculaire (FA) d’importance clinique au cours des 30 jours suivant une intervention chirurgicale. Nous avons évalué l’utilisation d’un traitement visant à régulariser le rythme cardiaque et de l’anticoagulothérapie dans la prise en charge d’une FAPO, au moment du congé de l’hôpital, puis 30 jours après l’intervention chirurgicale. Nous avons procédé à l’évaluation des tendances temporelles par régression logistique multivariée. Résultats: Sur les 27 896 patients inclus dans l’analyse, 545 (1,9 %) ont présenté une FAPO d’importance clinique. Dans 48,6 % des cas, les patients ont reçu un traitement visant à régulariser le rythme cardiaque. Le taux d’utilisation d’un traitement visant à régulariser le rythme cardiaque a augmenté d’une étude à l’autre (étude POISE-1 vs étude POISE-2 vs étude POISE-3; 40,9 % vs 49,5 % vs 59,1 %, respectivement). Une date plus tardive de la répartition aléatoire était un facteur indépendant de l’utilisation d’un traitement visant à régulariser le rythme cardiaque (rapport de cotes = 1,05 par an; intervalle de confiance [IC] à 95 % : 1,01-1,09). Une anticoagulothérapie a été prescrite à 21 % des patients ayant présenté une FAPO. Le taux d’utilisation d’une anticoagulothérapie était plus élevé dans l’étude POISE-3, comparativement aux deux essais précédents (étude POISE-1 vs étude POISE-2 vs étude POISE-3; – 16,4 % vs 16,5 % vs 33,6 %, respectivement). Une date plus tardive de la répartition aléatoire était un facteur indépendant d’utilisation d’une anticoagulothérapie (rapport de cotes = 1,06 par an; IC à 95 % : 1,02-1,11). Conclusions: Malgré l’absence d’essais comparatifs avec répartition aléatoire, le taux d’utilisation d’un traitement visant à régulariser le rythme cardiaque ou d’une anticoagulothérapie chez les patients présentant une FAPO est en augmentation. Il existe un besoin urgent de réaliser des études cliniques de grande qualité afin de déterminer si ces interventions sont sûres et efficaces dans cette population de patients.

Published
2024
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2. Risk Factors for Hospital Readmission Following Noncardiac Surgery: International Cohort Study

Author

Michael H. McGillion, RN, PhD, Flavia K. Borges, MD, PhD, David Conen, MD, MPH, Daniel I. Sessler, MD, Brenda L. Coleman, RN, PhD, Maura Marcucci, MD, MSc, Carley Ouellette, RN, MSc, Marissa Bird, RN, PhD, Carly Whitmore, RN, PhD, Shaunattonie Henry, RN, PhD, Sandra Ofori, MD, MSc, Shirley M. Pettit, RN, Deborah M. Bedini, RN, MHS, Leslie P. Gauthier, MScT, Jennifer Lounsbury, RN(EC), MN, Nancy M. Carter, RN, PhD, Vikas Tandon, MD, Ameen Patel, MD, Teresa Cafaro, MD, MSc, Marko R. Simunovic, MD, John A. Harlock, MD, Diane Heels-Ansdell, MSc, Fadi Elias, MD, MS, Theodore Rapanos, MD, Shawn Forbes, MD, Elizabeth Peter, RN, PhD, Judy Watt-Watson, RN, PhD, Kelly Metcalfe, RN, PhD, Sandra L. Carroll, RN, PhD, and Philip J. Devereaux, MD, PhD

Subjects
Surgery, RD1-811
Abstract

Objective:. To determine timing and risk factors associated with readmission within 30 days of discharge following noncardiac surgery. Background:. Hospital readmission after noncardiac surgery is costly. Data on the drivers of readmission have largely been derived from single-center studies focused on a single surgical procedure with uncertainty regarding generalizability. Methods:. We undertook an international (28 centers, 14 countries) prospective cohort study of a representative sample of adults ≥45 years of age who underwent noncardiac surgery. Risk factors for readmission were assessed using Cox regression (ClinicalTrials.gov, NCT00512109). Results:. Of 36,657 eligible participants, 2744 (7.5%; 95% confidence interval [CI], 7.2–7.8) were readmitted within 30 days of discharge. Rates of readmission were highest in the first 7 days after discharge and declined over the follow-up period. Multivariable analyses demonstrated that 9 baseline characteristics (eg, cancer treatment in past 6 months; adjusted hazard ratio [HR], 1.44; 95% CI, 1.30–1.59), 5 baseline laboratory and physical measures (eg, estimated glomerular filtration rate or on dialysis; HR, 1.47; 95% CI, 1.24–1.75), 7 surgery types (eg, general surgery; HR, 1.86; 95% CI, 1.61–2.16), 5 index hospitalization events (eg, stroke; HR, 2.21; 95% CI, 1.24–3.94), and 3 other factors (eg, discharge to nursing home; HR, 1.61; 95% CI, 1.33–1.95) were associated with readmission. Conclusions:. Readmission following noncardiac surgery is common (1 in 13 patients). We identified perioperative risk factors associated with 30-day readmission that can help frontline clinicians identify which patients are at the highest risk of readmission and target them for preventive measures.

Published
2024
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3. Rationale and design of the PeriOperative ISchemic Evaluation-3 (POISE-3): a randomized controlled trial evaluating tranexamic acid and a strategy to minimize hypotension in noncardiac surgery

Author

Maura Marcucci, Thomas W. Painter, David Conen, Kate Leslie, Vladimir V. Lomivorotov, Daniel Sessler, Matthew T. V. Chan, Flavia K. Borges, Maria J. Martínez Zapata, C. Y. Wang, Denis Xavier, Sandra N. Ofori, Giovanni Landoni, Sergey Efremov, Ydo V. Kleinlugtenbelt, Wojciech Szczeklik, Denis Schmartz, Amit X. Garg, Timothy G. Short, Maria Wittmann, Christian S. Meyhoff, Mohammed Amir, David Torres, Ameen Patel, Emmanuelle Duceppe, Kurtz Ruetzler, Joel L. Parlow, Vikas Tandon, Michael K. Wang, Edith Fleischmann, Carisi A. Polanczyk, Raja Jayaram, Sergey V. Astrakov, Mangala Rao, Tomas VanHelder, William K. K. Wu, Chao Chia Cheong, Sabry Ayad, Marat Abubakirov, Mikhail Kirov, Keyur Bhatt, Miriam de Nadal, Valery Likhvantsev, Pilar Paniagua Iglesisas, Hector J. Aguado, Michael McGillion, Andre Lamy, Richard P. Whitlock, Pavel Roshanov, David Stillo, Ingrid Copland, Jessica Vincent, Kumar Balasubramanian, Shrikant I. Bangdiwala, Bruce Biccard, Andrea Kurz, Sadeesh Srinathan, Shirley Petit, John Eikelboom, Toby Richards, Peter L. Gross, Pascal Alfonsi, Gordon Guyatt, Emily Belley-Cote, Jessica Spence, William McIntyre, Salim Yusuf, and P. J. Devereaux

Subjects
Noncardiac surgery, Tranexamic acid, Perioperative bleeding, Perioperative hypotension, Cardiovascular complications, Randomized controlled trial, Medicine (General), R5-920
Abstract

Abstract Background For patients undergoing noncardiac surgery, bleeding and hypotension are frequent and associated with increased mortality and cardiovascular complications. Tranexamic acid (TXA) is an antifibrinolytic agent with the potential to reduce surgical bleeding; however, there is uncertainty about its efficacy and safety in noncardiac surgery. Although usual perioperative care is commonly consistent with a hypertension-avoidance strategy (i.e., most patients continue their antihypertensive medications throughout the perioperative period and intraoperative mean arterial pressures of 60 mmHg are commonly accepted), a hypotension-avoidance strategy may improve perioperative outcomes. Methods The PeriOperative Ischemic Evaluation (POISE)-3 Trial is a large international randomized controlled trial designed to determine if TXA is superior to placebo for the composite outcome of life-threatening, major, and critical organ bleeding, and non-inferior to placebo for the occurrence of major arterial and venous thrombotic events, at 30 days after randomization. Using a partial factorial design, POISE-3 will additionally determine the effect of a hypotension-avoidance strategy versus a hypertension-avoidance strategy on the risk of major cardiovascular events, at 30 days after randomization. The target sample size is 10,000 participants. Patients ≥45 years of age undergoing noncardiac surgery, with or at risk of cardiovascular and bleeding complications, are randomized to receive a TXA 1 g intravenous bolus or matching placebo at the start and at the end of surgery. Patients, health care providers, data collectors, outcome adjudicators, and investigators are blinded to the treatment allocation. Patients on ≥ 1 chronic antihypertensive medication are also randomized to either of the two blood pressure management strategies, which differ in the management of patient antihypertensive medications on the morning of surgery and on the first 2 days after surgery, and in the target mean arterial pressure during surgery. Outcome adjudicators are blinded to the blood pressure treatment allocation. Patients are followed up at 30 days and 1 year after randomization. Discussion Bleeding and hypotension in noncardiac surgery are common and have a substantial impact on patient prognosis. The POISE-3 trial will evaluate two interventions to determine their impact on bleeding, cardiovascular complications, and mortality. Trial registration ClinicalTrials.gov NCT03505723. Registered on 23 April 2018.

Published
2022
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4. Accuracy of Physicians in Differentiating Type 1 and Type 2 Myocardial Infarction Based on Clinical Information

Author

Flavia K. Borges, MD, PhD, Tej Sheth, MD, Ameen Patel, MD, Maura Marcucci, MD, MSc, Terence Yung, MD, Thomas Langer, MD, Carolina Alboim, MD, Carisi Anne Polanczyk, MD, ScD, Federico Germini, MD, Andre Ferreira Azeredo-da-Silva, MD, ScD, Erin Sloan, MD, Kendeep Kaila, MD, Ron Ree, MD, Alessandra Bertoletti, MD, Maria Cristina Vedovati, MD, Antonio Galzerano, MD, Jessica Spence, MD, and P.J. Devereaux, MD, PhD

Subjects
Diseases of the circulatory (Cardiovascular) system, RC666-701
Abstract

Background: Physicians commonly judge whether a myocardial infarction (MI) is type 1 (thrombotic) vs type 2 (supply/demand mismatch) based on clinical information. Little is known about the accuracy of physicians’ clinical judgement in this regard. We aimed to determine the accuracy of physicians’ judgement in the classification of type 1 vs type 2 MI in perioperative and nonoperative settings. Methods: We performed an online survey using cases from the Optical Coherence Tomographic Imaging of Thrombus (OPTIMUS) Study, which investigated the prevalence of a culprit lesion thrombus based on intracoronary optical coherence tomography (OCT) in patients experiencing MI. Four MI cases, 2 perioperative and 2 nonoperative, were selected randomly, stratified by etiology. Physicians were provided with the patient’s medical history, laboratory parameters, and electrocardiograms. Physicians did not have access to intracoronary OCT results. The primary outcome was the accuracy of physicians' judgement of MI etiology, measured as raw agreement between physicians and intracoronary OCT findings. Fleiss’ kappa and Gwet’s AC1 were calculated to correct for chance. Results: The response rate was 57% (308 of 536). Respondents were 62% male; median age was 45 years (standard deviation ± 11); 45% had been in practice for > 15 years. Respondents’ overall accuracy for MI etiology was 60% (95% confidence interval [CI] 57%-63%), including 63% (95% CI 60%-68%) for nonoperative cases, and 56% (95% CI 52%-60%) for perioperative cases. Overall chance-corrected agreement was poor (kappa = 0.05), consistent across specialties and clinical scenarios. Conclusions: Physician accuracy in determining MI etiology based on clinical information is poor. Physicians should consider results from other testing, such as invasive coronary angiography, when determining MI etiology. Résumé: Contexte: Les médecins déterminent généralement s’ils sont en présence d’un infarctus du myocarde (IM) de type 1 (thrombotique) ou de type 2 (demande accrue ou apport réduit en oxygène) sur la base des renseignements cliniques. On en sait cependant très peu au sujet de la justesse du jugement clinique des médecins à cet égard. Nous avons donc cherché à déterminer si les médecins réussissent à distinguer correctement les IM de type 1 et de type 2 dans les contextes périopératoire et non opératoire. Méthodologie: Nous avons mené une enquête en ligne en utilisant les cas de l’étude OPTIMUS (Optical Coherence Tomographic Imaging of Thrombus), qui avait évalué la prévalence des lésions causant un thrombus au moyen de la tomographie par cohérence optique (TCO) endocoronaire chez les patients subissant un IM. Nous avons choisi au hasard quatre cas d’IM stratifiés en fonction de leur cause : deux cas en contexte périopératoire et deux cas en contexte non opératoire. Les médecins avaient accès aux antécédents médicaux, aux résultats des analyses de laboratoire et aux électrocardiogrammes des patients, mais pas aux résultats de la TCO endocoronaire. Le principal paramètre d’évaluation était la justesse du jugement du médecin concernant la cause de l’IM, mesurée en fonction de la concordance approximative entre le jugement du médecin et les observations à la TCO endocoronaire. Les coefficients de concordance kappa de Fleiss et AC1 de Gwet ont servi à corriger pour le hasard. Résultats: Le taux de réponse était de 57 % (308 sur 536). Des participants, 62 % étaient des hommes et 45 % exerçaient depuis plus de 15 ans; l’âge médian était de 45 ans (écart-type : ± 11). La justesse globale avec laquelle les répondants ont déterminé la cause des IM était de 60 % (intervalle de confiance [IC] à 95 % : 57-63 %) : 63 % (IC à 95 % : 60-68 %) dans le cas des IM en contexte non opératoire et 56 % (IC à 95 % : 52-60 %) dans le cas des IM en contexte périopératoire. La concordance globale corrigée pour le hasard était faible (kappa = 0,05) et demeurait constante, sans égard au domaine de spécialité ou au scénario clinique. Conclusions: La justesse du jugement des médecins évaluant la cause d’un IM en fonction des renseignements cliniques est faible. Les médecins devraient envisager de recourir à des tests additionnels, y compris la coronarographie invasive, avant de déterminer la cause d’un IM.

Published
2020
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5. Continuous Noninvasive Remote Automated Blood Pressure Monitoring With Novel Wearable Technology: A Preliminary Validation Study

Author

Michael H McGillion, Nazari Dvirnik, Stephen Yang, Emilie Belley-Côté, Andre Lamy, Richard Whitlock, Maura Marcucci, Flavia K Borges, Emmanuelle Duceppe, Carley Ouellette, Marissa Bird, Sandra L Carroll, David Conen, Jean-Eric Tarride, Prathiba Harsha, Ted Scott, Amber Good, Krysten Gregus, Karla Sanchez, Pamela Benoit, Julian Owen, Valerie Harvey, Elizabeth Peter, Jeremy Petch, Jessica Vincent, Michelle Graham, and P J Devereaux

Subjects
Information technology, T58.5-58.64, Public aspects of medicine, RA1-1270
Abstract

BackgroundWearable continuous monitoring biosensor technologies have the potential to transform postoperative care with early detection of impending clinical deterioration. ObjectiveOur aim was to validate the accuracy of Cloud DX Vitaliti continuous vital signs monitor (CVSM) continuous noninvasive blood pressure (cNIBP) measurements in postsurgical patients. A secondary aim was to examine user acceptance of the Vitaliti CVSM with respect to comfort, ease of application, sustainability of positioning, and aesthetics. MethodsIncluded participants were ≥18 years old and recovering from surgery in a cardiac intensive care unit (ICU). We targeted a maximum recruitment of 80 participants for verification and acceptance testing. We also oversampled to minimize the effect of unforeseen interruptions and other challenges to the study. Validation procedures were according to the International Standards Organization (ISO) 81060-2:2018 standards for wearable, cuffless blood pressure (BP) measuring devices. Baseline BP was determined from the gold-standard ICU arterial catheter. The Vitaliti CVSM was calibrated against the reference arterial catheter. In static (seated in bed) and supine positions, 3 cNIBP measurements, each 30 seconds, were taken for each patient with the Vitaliti CVSM and an invasive arterial catheter. At the conclusion of each test session, captured cNIBP measurements were extracted using MediCollector BEDSIDE data extraction software, and Vitaliti CVSM measurements were extracted to a secure laptop through a cable connection. The errors of these determinations were calculated. Participants were interviewed about device acceptability. ResultsThe validation analysis included data for 20 patients. The average times from calibration to first measurement in the static position and to first measurement in the supine position were 133.85 seconds (2 minutes 14 seconds) and 535.15 seconds (8 minutes 55 seconds), respectively. The overall mean errors of determination for the static position were –0.621 (SD 4.640) mm Hg for systolic blood pressure (SBP) and 0.457 (SD 1.675) mm Hg for diastolic blood pressure (DBP). Errors of determination were slightly higher for the supine position, at 2.722 (SD 5.207) mm Hg for SBP and 2.650 (SD 3.221) mm Hg for DBP. The majority rated the Vitaliti CVSM as comfortable. This study was limited to evaluation of the device during a very short validation period after calibration (ie, that commenced within 2 minutes after calibration and lasted for a short duration of time). ConclusionsWe found that the Cloud DX’s Vitaliti CVSM demonstrated cNIBP measurement in compliance with ISO 81060-2:2018 standards in the context of evaluation that commenced within 2 minutes of device calibration; this device was also well-received by patients in a postsurgical ICU setting. Future studies will examine the accuracy of the Vitaliti CVSM in ambulatory contexts, with attention to assessment over a longer duration and the impact of excessive patient motion on data artifacts and signal quality. Trial RegistrationClinicalTrials.gov NCT03493867; https://clinicaltrials.gov/ct2/show/NCT03493867

Published
2022
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6. Effect of a Perioperative Hypotension-Avoidance Strategy Versus a Hypertension-Avoidance Strategy on the Risk of Acute Kidney Injury: A Clinical Research Protocol for a Substudy of the POISE-3 Randomized Clinical Trial

Author

Amit X. Garg, Meaghan Cuerden, Hector Aguado, Mohammed Amir, Emilie P. Belley-Cote, Keyur Bhatt, Bruce M. Biccard, Flavia K. Borges, Matthew Chan, David Conen, Emmanuelle Duceppe, Sergey Efremov, John Eikelboom, Edith Fleischmann, Landoni Giovanni, Peter Gross, Raja Jayaram, Mikhail Kirov, Ydo Kleinlugtenbelt, Andrea Kurz, Andre Lamy, Kate Leslie, Valery Likhvantsev, Vladimir Lomivorotov, Maura Marcucci, Maria José Martínez-Zapata, Michael McGillion, William McIntyre, Christian Meyhoff, Sandra Ofori, Thomas Painter, Pilar Paniagua, Chirag Parikh, Joel Parlow, Ameen Patel, Carisi Polanczyk, Toby Richards, Pavel Roshanov, Denis Schmartz, Daniel Sessler, Tim Short, Jessica M. Sontrop, Jessica Spence, Sadeesh Srinathan, David Stillo, Wojciech Szczeklik, Vikas Tandon, David Torres, Thomas Van Helder, Jessica Vincent, C. Y. Wang, Michael Wang, Richard Whitlock, Maria Wittmann, Denis Xavier, and P. J. Devereaux

Subjects
Diseases of the genitourinary system. Urology, RC870-923
Abstract

Background: Most patients who take antihypertensive medications continue taking them on the morning of surgery and during the perioperative period. However, growing evidence suggests this practice may contribute to perioperative hypotension and a higher risk of complications. This protocol describes an acute kidney injury substudy of the Perioperative Ischemic Evaluation-3 (POISE-3) trial, which is testing the effect of a perioperative hypotension-avoidance strategy versus a hypertension-avoidance strategy in patients undergoing noncardiac surgery. Objective: To conduct a substudy of POISE-3 to determine whether a perioperative hypotension-avoidance strategy reduces the risk of acute kidney injury compared with a hypertension-avoidance strategy. Design: Randomized clinical trial with 1:1 randomization to the intervention (a perioperative hypotension-avoidance strategy) or control (a hypertension-avoidance strategy). Intervention: If the presurgery systolic blood pressure (SBP) is

Published
2022
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7. High-sensitivity cardiac troponin I thresholds to identify -myocardial injury after noncardiac surgery : a cohort study

Author

Emmanuelle Duceppe, Flavia K. Borges, Maria Tiboni, Rupert Pearse, Matthew T.V. Chan, Sadeesh Srinathan, Peter A. Kavsak, Amit X. Garg, Daniel I. Sessler, Robert Sapsford, Diane Heels-Ansdell, Shirley Pettit, Javiera Vasquez, Christian Mueller, Micheal Walsh, Wojciech Szczeklik, Reitze Rodseth, Manoj Lalu, Lehana Thabane, Gordon Guyatt, and P.J. Devereaux

Subjects
Cardiology and Cardiovascular Medicine
Published
2023

8. Tranexamic Acid in Patients Undergoing Noncardiac Surgery

Author

P J, Devereaux, Maura, Marcucci, Thomas W, Painter, David, Conen, Vladimir, Lomivorotov, Daniel I, Sessler, Matthew T V, Chan, Flavia K, Borges, María J, Martínez-Zapata, Chew Yin, Wang, Denis, Xavier, Sandra N, Ofori, Michael K, Wang, Sergey, Efremov, Giovanni, Landoni, Ydo V, Kleinlugtenbelt, Wojciech, Szczeklik, Denis, Schmartz, Amit X, Garg, Timothy G, Short, Maria, Wittmann, Christian S, Meyhoff, Mohammed, Amir, David, Torres, Ameen, Patel, Emmanuelle, Duceppe, Kurt, Ruetzler, Joel L, Parlow, Vikas, Tandon, Edith, Fleischmann, Carisi A, Polanczyk, Andre, Lamy, Sergey V, Astrakov, Mangala, Rao, William K K, Wu, Keyur, Bhatt, Miriam, de Nadal, Valery V, Likhvantsev, Pilar, Paniagua, Hector J, Aguado, Richard P, Whitlock, Michael H, McGillion, Michael, Prystajecky, Jessica, Vincent, John, Eikelboom, Ingrid, Copland, Kumar, Balasubramanian, Alparslan, Turan, Shrikant I, Bangdiwala, David, Stillo, Peter L, Gross, Teresa, Cafaro, Pascal, Alfonsi, Pavel S, Roshanov, Emilie P, Belley-Côté, Jessica, Spence, Toby, Richards, Tomas, VanHelder, William, McIntyre, Gordon, Guyatt, Salim, Yusuf, Kate, Leslie, Erin, Hittesdorf, UCL - SSS/IREC/CARD - Pôle de recherche cardiovasculaire, Devereaux, P J, Marcucci, Maura, Painter, Thomas W, Conen, David, Lomivorotov, Vladimir, Sessler, Daniel I, Chan, Matthew T V, Borges, Flavia K, Martínez-Zapata, María J, Wang, Chew-Yin, Xavier, Deni, Ofori, Sandra N, Wang, Michael K, Efremov, Sergey, Landoni, Giovanni, Kleinlugtenbelt, Ydo V, Szczeklik, Wojciech, Schmartz, Deni, Garg, Amit X, Short, Timothy G, Wittmann, Maria, Meyhoff, Christian S, Amir, Mohammed, Torres, David, Patel, Ameen, Duceppe, Emmanuelle, Ruetzler, Kurt, Parlow, Joel L, Tandon, Vika, Fleischmann, Edith, Polanczyk, Carisi A, Lamy, Andre, Astrakov, Sergey V, Rao, Mangala, Wu, William K K, Bhatt, Keyur, de Nadal, Miriam, Likhvantsev, Valery V, Paniagua, Pilar, Aguado, Hector J, Whitlock, Richard P, Mcgillion, Michael H, Prystajecky, Michael, Vincent, Jessica, Eikelboom, John, Copland, Ingrid, Balasubramanian, Kumar, Turan, Alparslan, Bangdiwala, Shrikant I, Stillo, David, Gross, Peter L, Cafaro, Teresa, Alfonsi, Pascal, Roshanov, Pavel S, Belley-Côté, Emilie P, Spence, Jessica, Richards, Toby, Vanhelder, Toma, Mcintyre, William, Guyatt, Gordon, Yusuf, Salim, Leslie, Kate, and Anesthesiology

Subjects
BLOOD-TRANSFUSION, HEMORRHAGE, Canada, Tranexamic Acid, MORTALITY, Surgical Procedures, Operative, BIMS, Humans, Hemorrhage, Thrombosis, General Medicine, Antifibrinolytic Agents
Abstract

BACKGROUND Perioperative bleeding is common in patients undergoing noncardiac surgery. Tranexamic acid is an antifibrinolytic drug that may safely decrease such bleeding. METHODS We conducted a trial involving patients undergoing noncardiac surgery. Patients were randomly assigned to receive tranexamic acid (1-g intravenous bolus) or placebo at the start and end of surgery (reported here) and, with the use of a partial factorial design, a hypotension-avoidance or hypertension-avoidance strategy (not reported here). The primary efficacy outcome was life-threatening bleeding, major bleeding, or bleeding into a critical organ (composite bleeding outcome) at 30 days. The pri- mary safety outcome was myocardial injury after noncardiac surgery, nonhemor- rhagic stroke, peripheral arterial thrombosis, or symptomatic proximal venous thromboembolism (composite cardiovascular outcome) at 30 days. To establish the noninferiority of tranexamic acid to placebo for the composite cardiovascular out- come, the upper boundary of the one-sided 97.5% confidence interval for the hazard ratio had to be below 1.125, and the one-sided P value had to be less than 0.025. RESULTS A total of 9535 patients underwent randomization. A composite bleeding outcome event occurred in 433 of 4757 patients (9.1%) in the tranexamic acid group and in 561 of 4778 patients (11.7%) in the placebo group (hazard ratio, 0.76; 95% confi- dence interval [CI], 0.67 to 0.87; absolute difference, −2.6 percentage points; 95% CI, −3.8 to −1.4; two-sided P

Published
2022
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9. Accelerated surgery versus standard care in hip fracture (HIP ATTACK-1) : a kidney substudy of a randomized clinical trial

Author

Flavia K. Borges, P.J. Devereaux, Meaghan Cuerden, Jessica M. Sontrop, Mohit Bhandari, Ernesto Guerra-Farfán, Ameen Patel, Alben Sigamani, Masood Umer, John Neary, Maria Tiboni, Vikas Tandon, Mmampapatla Thomas Ramokgopa, Parag Sancheti, Abdel-Rahman Lawendy, Mariano Balaguer-Castro, Richard Jenkinson, Paweł Ślęczka, Aamer Nabi Nur, Gavin C.A. Wood, Robert J. Feibel, John Stephen McMahon, Bruce M. Biccard, Alessandro Ortalda, Wojciech Szczeklik, Chew Yin Wang, Jordi Tomás-Hernández, Jessica Vincent, Valerie Harvey, Shirley Pettit, Kumar Balasubramanian, Gerard Slobogean, Amit X. Garg, Laurent Veevaete, Bernard le Polain de Waroux, Patricia Lavand'homme, Olivier Cornu, Karim Tribak, Jean C. Yombi, Nassim Touil, Jigme T. Bhutia, Carol Clinckaert, Dirk De Clippeleir, Maike Reu, Leslie P. Gauthier, Victoria RA. Avram, Mitchell Winemaker, Daniel M. Tushinski, Justin de Beer, Andrew Worster, Diane L. Simpson, Kim A. Alvarado, Krysten K. Gregus, Kelly H. Lawrence, Darryl P. Leong, Philip G. Joseph, Patrick Magloire, Benjamin Deheshi, Stuart Bisland, Thomas J. Wood, David AJ. Wilson, Sandra N. Ofori, Jessica Spence, Emmanuelle Duceppe, Maria E. Tiboni, John D. Neary, Anthony Adili, David D. Cowan, Vickas Khanna, Amna Zaki, Janet C. Farrell, Anne Marie MacDonald, David Conen, Steven CW. Wong, Arsha Karbassi, Douglas S. Wright, Harsha Shanthanna, Javier Ganame, Andrew Cheung, Ryan Coughlin, Moin Khan, Spencer Wikkerink, Faraaz A. Quraishi, Waleed Kishta, Emil Schemitsch, Timothy Carey, Mark D. Macleod, David W. Sanders, Edward Vasarhelyi, Debra Bartley, George K. Dresser, Christina Tieszer, Richard J. Jenkinson, Steven Shadowitz, Jacques S. Lee, Stephen Choi, Hans J. Kreder, Markku Nousiainen, Monica R. Kunz, Ravianne Tuazon, Mopina Shrikumar, Bheeshma Ravi, David Wasserstein, David J.G. Stephen, Diane Nam, Patrick D.G. Henry, Gavin CA. Wood, Stephen M. Mann, Melanie T. Jaeger, Marco LA. Sivilotti, Christopher A. Smith, Christopher C. Frank, Heather Grant, Leone Ploeg, Jeff D. Yach, Mark M. Harrison, Aaron R. Campbell, Ryan T. Bicknell, Davide D. Bardana, Katie McIlquham, Catherine Gallant, Samantha Halman, Venkatesh Thiruganasambandamoorth, Sara Ruggiero, William J. Hadden, Brian PJ. Chen, Stephanie A. Coupal, Stephen J. McMahon, Lisa M. McLean, Hemant R. Shirali, Syed Y. Haider, Crystal A. Smith, Evan Watts, David J. Santone, Kevin Koo, Allan J. Yee, Ademilola N. Oyenubi, Aaron Nauth, Emil H. Schemitsch, Timothy R. Daniels, Sarah E. Ward, Jeremy A. Hall, Henry Ahn, Daniel B. Whelan, Amit Atrey, Amir Khoshbin, David Puskas, Kurt Droll, Claude Cullinan, Jubin Payendeh, Tina Lefrancois, Lise Mozzon, Travis Marion, Michael J. Jacka, James Greene, Matthew Menon, Robert Stiegelmahr, Derek Dillane, Marleen Irwin, Lauren Beaupre, Chad P. Coles, Kelly Trask, Shelley MacDonald, J.A.I. Trenholm, William Oxner, C.G. Richardson, Niloofar Dehghan, Mehdi Sadoughi, Achal Sharma, Neil J. White, Loretta Olivieri, Stephen B. Hunt, Thomas R. Turgeon, Eric R. Bohm, Sarah Tran, Stephen M. Giilck, Tom Hupel, Pierre Guy, Peter J. O'Brien, Andrew W. Duncan, Gordon A. Crawford, Junlin Zhou, Yanrui Zhao, Yang Liu, Lei Shan, Anshi Wu, Juan M. Muñoz, Philippe Chaudier, Marion Douplat, Michel Henri Fessy, Vincent Piriou, Lucie Louboutin, Jean Stephane David, Arnaud Friggeri, Anthony Viste, Charles Hervé Vacheron, Frankie Ka Li Leung, Christian Xinshuo Fang, Dennis King Hang Yee, Parag K. Sancheti, Chetan V. Pradhan, Atul A. Patil, Chetan P. Puram, Madhav P. Borate, Kiran B. Kudrimoti, Bharati A. Adhye, Himanshu V. Dongre, Bobby John, Valsamma Abraham, Ritesh A. Pandey, Arti Rajkumar, Preetha E. George, Manesh Stephen, Nitheesh Chandran, Mohammed Ashraf, A.M. Georgekutty, Ahamad S. Sulthan, S. Adinarayanan, Deep Sharma, Satish P. Barnawal, Srinivasan Swaminathan, Prasanna U. Bidkar, Sandeep K. Mishra, Jagdish Menon, M. Niranjan, Z.K. Varghese, Santosh A. Hiremath, N.C. Madhusudhan, Abhijit Jawali, Kingsly R. Gnanadurai, Carolin E. George, Tatarao Maddipati, K.P. Mary, Vijay Sharma, Kamran Farooque, Rajesh Malhotra, Samarth Mittal, Chavi Sawhney, Babita Gupta, Purva Mathur, Shivanand Gamangati, Vijaylaxmi Tripathy, Prem H. Menon, Mandeep S. Dhillon, Devendra K. Chouhan, Sharanu Patil, Ravi Narayan, Purushotham Lal, Prashanth N. Bilchod, Surya U. Singh, Uttam V. Gattu, Ravi P. Dashputra, Prashant V. Rahate, Maurizio Turiel, Riccardo Accetta, Paolo Perazzo, Daniele Stella, Marika Bonadies, Chiara Colombo, Giuseppe De Blasio, Stefania Fozzato, Fabio Pino, Ilaria Morelli, Francesco De Donato, Eleonora Colnaghi, Vincenzo Salini, Giacomo Placella, Giuseppe Giardina, Gaetano Lombardi, Anna Marcato, Luca Guzzetti, Ilaria Rivetti, Massimiliano Greco, H.M. Khor, Hou Yee Lai, C.S. Kumar, K.H. Chee, P.S. Loh, Kit Mun Tan, Simmrat Singh, Li Lian Foo, Komella Prakasam, Sook Hui Chaw, Meng-Li Lee, Joanne HL. Ngim, Huck Wee Boon, Im Im Chin, Ydo V. Kleinlugtenbelt, Ellie BM. Landman, Elvira R. Flikweert, Herbert W. Roerdink, Roy BG. Brokelman, Hannie F. Elskamp-Meijerman, Bas Staffhorst, Jan-Hein MG. Cobben, Dilshad Begum, Anila Anjum, Pervaiz M. Hashmi, Tashfeen Ahmed, Haroon U. Rashid, Mujahid J. Khattak, Rizwan H. Rashid, Riaz H. Lakdawala, Shahryar Noordin, Naveed M. Juman, Robyna I. Khan, Muhammad M. Riaz, Syedah S. Bokhari, Ayesha Almas, Hussain Wahab, Arif Ali, Hammad N. Khan, Eraj K. Khan, Kholood A. Janjua, Sajjad H. Orakzai, Abdus S. Khan, Khawaja J. Mustafa, Mian A. Sohail, Muhammad Umar, Siddra A. Khan, Muhammad Ashraf, Muhammad K. Khan, Muhammad Shiraz, Ahmad Furgan, Piotr Dąbek, Adam Kumoń, Wojciech Satora, Wojciech Ambroży, Mariusz Święch, Jacek Rycombel, Adrian Grzelak, Ilona Nowak-Kózka, Jaroslaw Gucwa, Waldemar Machala, Mmampapatla T. Ramokgopa, Gregory B. Firth, Mwalimu Karera, Maria Fourtounas, Virsen Singh, Anna Biscardi, Muhammad N. Iqbal, Ryan J. Campbell, Matimba L. Maluleke, Carien Moller, Lerato Nhlapo, Sithombo Maqungo, Margot Flint, Marcin B. Nejthardt, Sean Chetty, Stephen Venter, Ernesto Guerra-Farfan, Jordi Tomas-Hernandez, Yaiza Garcia-Sanchez, Miriam Garrido Clua, Vicente Molero-Garcia, Jordi Teixidor-Serra, Maria del Mar Villar-Casares, Jordi Selga Marsa, Juan A. Porcel-Vazquez, Jose-Vicente Andres- Peiro, Jaume Mestre-Torres, Patricia Guilabert, M Luisa Paños Gozalo, Luis Abarca, Nuria Martin, Gemma Usua, Pilar Lalueza-Broto, Judith Sanchez-Raya, Jorge Nuñez Camarena, Antoni Fraguas-Castany, Carlos Piedra Calle, Diego Soza Leiva, Maria Garcia Carrasco, Montsant Jornet-Gibert, Montserrat Monfort-Mira, Alfons Gasset-Teixidor, Francesc Antoni Marcano-Fernández, Isabel Simó- Sánchez, Begoña Mari-Alfonso, Christian Yela-Verdú, Raúl Pellejero-García, Júlia Casas-Codina, Ruben Iglesias- Sanjuan, Pau Balcells-Nolla, Oriol Vila-Sánchez, Mercè Bertrana de Bustos, Pablo Castillón, Martí Bernaus, Saioa Quintas, Olga Gómez, Jordi Salvador, Javier Abarca, Cristina Estrada, Marga Novellas, Francesc Anglès, Alfred Dealbert, Oscar Macho, Alexia Ivanov, Esther Valldosera, Marta Arroyo, Borja Pey, Antoni Yuste, Llorenç Mateo, Julio De Caso, Rafael Anaya, J.L. Higa-Sansone, Angelica Millan, Victoria Baños, Sergio Herrera-Mateo, Hector J. Aguado, Virginia García-Virto, Clarisa Simón-Pérez, Sergio Chavez, María Bragado, María Plata, Enrique Guerado, Encarnacion Cruz, Juan R. Cano, Jose M. Bogallo, Paphon Sa-ngasoongsong, Noratep Kulachote, Norachart Sirisreetreerux, Nachapan Pengrung, Theerawat Chalacheewa, Vanlapa Arnuntasupakul, Teerapat Yingchoncharoen, Bundit Naratreekoon, Miriam A. Kadry, Surendini Thayaparan, Victor Babu, Arash Aframian, Souad Bentoumi, Amrinder Sayan, Ihab Abdlaziz, Marcela P. Vizcaychipi, Patricia Correia, Shashank Patil, Kevin Haire, Amy SE. Mayor, Sally Dillingham, Laura Nicholson, Ben T. Brooke, Joby John, Shashi K. Nanjayan, Martyn J. Parker, Susan O'Sullivan, Meir T. Marmor, Amir Matityahu, Robert T. McClellan, Curt Comstock, Anthony Ding, Paul Toogood, Robert O’Toole, Marcus Sciadini, Jason Nascone, Nathan O’Hara, Scott P. Ryan, Molly E. Clark, Charles Cassidy, Konstantin Balonov, Tristan Weaver, Laura S. Phieffer, Sergio D. Bergese, Andrew J. Marcantonio, Shrikant I. Bangdiwala, Michael H. McGillion, Sanela Dragic-Taylor, Chelsea Maxwell, Sarah Molnar, Jennifer R. Wells, Patrice Forget, Paul Landais, Giovanni Landoni, Ekaterine Popova, Iain K. Moppett, Robin Roberts, null Chairperson, Finlay McAlister, David Sackett, James Wright, UCL - SSS/IONS/CEMO - Pôle Cellulaire et moléculaire, UCL - SSS/IREC/NMSK - Neuro-musculo-skeletal Lab, UCL - SSS/IREC/SLUC - Pôle St.-Luc, UCL - (SLuc) Service d'anesthésiologie, UCL - (SLuc) Service d'orthopédie et de traumatologie de l'appareil locomoteur, and UCL - (SLuc) Service de médecine interne générale

Subjects
Hip Fractures, Nephrology, Humans, Pelvic Bones, Kidney
Abstract

To the Editor: Acute kidney injury (AKI) is a lesser-known complication of hip fracture that may come about owing to decreased kidney perfusion and heightened inflammation from trauma, pain, bleeding, and fasting. Approximately 15%-20% of patients undergoing surgery for a hip fracture develop AKI, with 0.5%-1.8% receiving dialysis. [...]

Published
2022

10. High-Sensitivity Troponin I after Cardiac Surgery and 30-Day Mortality

Author

P J, Devereaux, Andre, Lamy, Matthew T V, Chan, René V, Allard, Vladimir V, Lomivorotov, Giovanni, Landoni, Hong, Zheng, Domenico, Paparella, Michael H, McGillion, Emilie P, Belley-Côté, Joel L, Parlow, Malcolm J, Underwood, Chew Yin, Wang, Nazari, Dvirnik, Marat, Abubakirov, Evgeny, Fominskiy, Stephen, Choi, Stephen, Fremes, Fabrizio, Monaco, Gerard, Urrútia, Marialuz, Maestre, Ludhmila A, Hajjar, Graham S, Hillis, Nicholas L, Mills, Vito, Margari, Joseph D, Mills, J Stephen, Billing, Emily, Methangkool, Carisi A, Polanczyk, Roberto, Sant'Anna, Dmitry, Shukevich, David, Conen, Peter A, Kavsak, Matthew J, McQueen, Katheryn, Brady, Jessica, Spence, Yannick, Le Manach, Rajibul, Mian, Shun Fu, Lee, Shrikant I, Bangdiwala, Sara, Hussain, Flavia K, Borges, Shirley, Pettit, Jessica, Vincent, Gordon H, Guyatt, Salim, Yusuf, Joseph S, Alpert, Harvey D, White, Richard P, Whitlock, Allison, Serra, Devereaux, P. J., Lamy, A., Chan, M. T. V., Allard, R. V., Lomivorotov, V. V., Landoni, G., Zheng, H., Paparella, D., Mcgillion, M. H., Belley-Cote, E. P., Parlow, J. L., Underwood, M. J., Wang, C. Y., Dvirnik, N., Abubakirov, M., Fominskiy, E., Choi, S., Fremes, S., Monaco, F., Urrutia, G., Maestre, M., Hajjar, L. A., Hillis, G. S., Mills, N. L., Margari, V., Mills, J. D., Billing, J. S., Methangkool, E., Polanczyk, C. A., Sant'Anna, R., Shukevich, D., Conen, D., Kavsak, P. A., Mcqueen, M. J., Brady, K., Spence, J., Le Manach, Y., Mian, R., Lee, S. F., Bangdiwala, S. I., Hussain, S., Borges, F. K., Pettit, S., Vincent, J., Guyatt, G. H., Yusuf, S., Alpert, J. S., White, H. D., and Whitlock, R. P.

Subjects
Male, heart infarction, adverse event, Myocardial Infarction, surgery, Postoperative Complications, blood, coronary artery bypass graft, Reference Values, Humans, postoperative complication, human, Prospective Studies, Cardiac Surgical Procedures, Coronary Artery Bypass, Aged, Troponin I, reference value, clinical trial, General Medicine, Middle Aged, biological marker, mortality, heart surgery, multicenter study, Aortic Valve, Female, Biomarkers, prospective study
Abstract

BACKGROUND Consensus recommendations regarding the threshold levels of cardiac troponin elevations for the definition of perioperative myocardial infarction and clinically important periprocedural myocardial injury in patients undergoing cardiac surgery range widely (from >10 times to >= 70 times the upper reference limit for the assay). Limited evidence is available to support these recommendations. METHODS We undertook an international prospective cohort study involving patients 18 years of age or older who underwent cardiac surgery. High-sensitivity cardiac troponin I measurements (upper reference limit, 26 ng per liter) were obtained 3 to 12 hours after surgery and on days 1, 2, and 3 after surgery. We performed Cox analyses using a regression spline that explored the relationship between peak troponin measurements and 30-day mortality, adjusting for scores on the European System for Cardiac Operative Risk Evaluation II (which estimates the risk of death after cardiac surgery on the basis of 18 variables, including age and sex). RESULTS Of 13,862 patients included in the study, 296 (2.1%) died within 30 days after surgery. Among patients who underwent isolated coronary-artery bypass grafting or aortic-valve replacement or repair, the threshold troponin level, measured within 1 day after surgery, that was associated with an adjusted hazard ratio of more than 1.00 for death within 30 days was 5670 ng per liter (95% confidence interval [CI], 1045 to 8260), a level 218 times the upper reference limit. Among patients who underwent other cardiac surgery, the corresponding threshold troponin level was 12,981 ng per liter (95% CI, 2673 to 16,591), a level 499 times the upper reference limit. CONCLUSIONS The levels of high-sensitivity troponin I after cardiac surgery that were associated with an increased risk of death within 30 days were substantially higher than levels currently recommended to define clinically important periprocedural myocardial injury. (Funded by the Canadian Institutes of Health Research and others; VISION Cardiac Surgery ClinicalTrials.gov number, NCT01842568.)

Published
2022
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