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4. Risk Factors Associated With Bleeding in Children With Cardiac Disease Receiving Extracorporeal Membrane Oxygenation: A Multi-Center Data Linkage Analysis

Author

Ankola, Ashish A, Bailly, David K, Reeder, Ron W, Cashen, Katherine, Dalton, Heidi J, Dolgner, Stephen J, Federman, Myke, Ghassemzadeh, Rod, Himebauch, Adam S, Kamerkar, Asavari, Koch, Josh, Kohne, Joseph, Lewen, Margaret, Srivastava, Neeraj, Willett, Renee, and Alexander, Peta MA

Subjects
Biomedical and Clinical Sciences, Cardiovascular Medicine and Haematology, Clinical Sciences, Hematology, Lung, Clinical Research, Cardiovascular, Heart Disease, Pediatric, extracorporeal membrane oxygenation, bleeding, pediatric, cardiac, anticoagulation, Cardiovascular medicine and haematology
Abstract

Background: Bleeding is a common complication of extracorporeal membrane oxygenation (ECMO) for pediatric cardiac patients. We aimed to identify anticoagulation practices, cardiac diagnoses, and surgical variables associated with bleeding during pediatric cardiac ECMO by combining two established databases, the Collaborative Pediatric Critical Care Research Network (CPCCRN) Bleeding and Thrombosis in ECMO (BATE) and the Extracorporeal Life Support Organization (ELSO) Registry. Methods: All children (80 ml/kg on any ECMO day. Bleeding odds were assessed on ECMO Day 1 and from ECMO Day 2 onwards with multivariable logistic regression. Results: There were 187 children with 114 (61%) bleeding events in the study cohort. Biventricular congenital heart disease (94/187, 50%) and cardiac medical diagnoses (75/187, 40%) were most common, and 48 (26%) patients were cannulated directly from cardiopulmonary bypass (CPB). Bleeding events were not associated with achieving pre-specified therapeutic ranges of activated clotting time (ACT) or platelet levels. In multivariable analysis, elevated INR and fibrinogen were associated with bleeding events (OR 1.1, CI 1.0-1.3, p = 0.02; OR 0.77, CI 0.6-0.9, p = 0.004). Bleeding events were also associated with clinical site (OR 4.8, CI 2.0-11.1, p < 0.001) and central cannulation (OR 1.75, CI 1.0-3.1, p = 0.05) but not with cardiac diagnosis, surgical complexity, or cannulation from CPB. Bleeding odds on ECMO day 1 were increased in patients with central cannulation (OR 2.82, 95% CI 1.15-7.08, p = 0.023) and those cannulated directly from CPB (OR 3.32, 95% CI 1.02-11.61, p = 0.047). Conclusions: Bleeding events in children with cardiac diagnoses supported on ECMO were associated with central cannulation strategy and coagulopathy, but were not modulated by achieving pre-specified therapeutic ranges of monitoring assays.

Published
2022

6. Outcomes of Extracorporeal Cardiopulmonary Resuscitation for In-Hospital Cardiac Arrest Among Children With Noncardiac Illness Categories*

Author

Loaec, Morgann, Himebauch, Adam S., Reeder, Ron, Alvey, Jessica S., Race, Jonathan A., Su, Lillian, Lasa, Javier J., Slovis, Julia C., Raymond, Tia T., Coleman, Ryan, Barney, Bradley J., Kilbaugh, Todd J., Topjian, Alexis A., Sutton, Robert M., Morgan, Ryan W., Guerguerian, Anne-Marie, O’Brien, Caitlin E., Fink, Ericka L., Lasa, Javier J., Roberts, Joan S., Su, Lillian, Brown, Linda L., Dewan, Maya, Bembea, Melania M., Kleinman, Monica, Ali, Noorjahan, Gupta, Punkaj, Sutton, Robert M., Reeder, Ron, and Sweberg, Todd

Published
2024
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11. Outcomes and characteristics of cardiac arrest in children with pulmonary hypertension: A secondary analysis of the ICU-RESUS clinical trial

Author

Morgan, Ryan W, Reeder, Ron W, Ahmed, Tageldin, Bell, Michael J, Berger, John T, Bishop, Robert, Bochkoris, Matthew, Burns, Candice, Carcillo, Joseph A, Carpenter, Todd C, Dean, J Michael, Diddle, J Wesley, Federman, Myke, Fernandez, Richard, Fink, Ericka L, Franzon, Deborah, Frazier, Aisha H, Friess, Stuart H, Graham, Kathryn, Hall, Mark, Hehir, David A, Himebauch, Adam S, Horvat, Christopher M, Huard, Leanna L, Maa, Tensing, Manga, Arushi, McQuillen, Patrick S, Meert, Kathleen L, Mourani, Peter M, Nadkarni, Vinay M, Naim, Maryam Y, Notterman, Daniel, Page, Kent, Pollack, Murray M, Sapru, Anil, Schneiter, Carleen, Sharron, Matthew P, Srivastava, Neeraj, Tabbutt, Sarah, Tilford, Bradley, Viteri, Shirley, Wessel, David, Wolfe, Heather A, Yates, Andrew R, Zuppa, Athena F, Berg, Robert A, and Sutton, Robert M

Published
2023
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15. Definitions of adverse events associated with extracorporeal membrane oxygenation in children: results of an international Delphi process from the ECMO-CENTRAL ARC

Author

Alexander, Peta M A, Di Nardo, Matteo, Combes, Alain, Vogel, Adam M, Antonini, Marta Velia, Barrett, Nicholas, Benedetti, Giulia M, Bettencourt, Amanda, Brodie, Daniel, Gómez-Gutiérrez, René, Gorga, Stephen M, Hodgson, Carol, Kapoor, Poonam Malhotra, Le, Jennifer, MacLaren, Graeme, O’Neil, Erika R, Ostermann, Marlies, Paden, Matthew L, Patel, Neil, Rojas-Peña, Alvaro, Said, Ahmed S, Sperotto, Francesca, Willems, Ariane, Vercaemst, Leen, Yoganathan, Ajit P, Lorts, Angela, del Nido, Pedro J, Barbaro, Ryan P, Abecasis, Francisco, Al Foudri, Huda, Anders, Marc M., Angus, Derek C., Annich, Gail M., Arachchillage, Deepa J., Akcan-Arikan, Ayse, Armstrong, Aimee K., Balcells, Joan, Barrett, Meredith, Bartlett, Robert H., Belda-Hofheinz, Sylvia, Bembea, Melania M., Best, Derek J., Bonadonna, Desiree, Boonstra, Philip S., Brogan, Thomas V, Brown, Katherine L, Butragueño-Laiseca, Laura, Butt, Warwick W., Camporota, Luigi, Cardenas, Barbara, Cascarano, Maria T., Caspi, Joseph, Chen, Eric, Chiletti, Roberto, Colombo, Giovanna G., Conte, Marisa L., Crowe, Liz, Cvetkovic, Mirjana, Dalton, Heidi J., Daverio, Marco, Davidson, Mark G., Davis, Carl, DiGeronimo, Robert J., Egbunine, Ariel, Ellis, W. Cory, Fan, Eddy, Foster, Claire C, Fraser, John F., Friedman, Matthew L., Furlong-Dillard, Jamie, Fynn-Thompson, Francis, Garcia, Alejandro V., Geppert, Jeffery, Gillette, Nicole, Grazioli, Lorenzo, Greene, Christina L, Guerguerian, Anne-Marie, Guilliams, Kristin P., Haji Fortis, Jumana Y., Hao, Jianming, Heinsar, Silver, Hejduk, Mark W., Himebauch, Adam S., Horvat, Christopher M., Hoskote, Aparna, Hou, Xiaotong, Hyslop, Robert W., Ibrahim, Nicole, Ito, Takuya, Karagiannidis, Christian, Karam, Oliver, Kaushik, Shubhi, Kilbaugh, Todd J., Kim-Campbell, Nahmah, Kirsch, Roxanne E, Kormos, Robert L., Kornberger, Angela, Krucoff, Mitchell W., Lakshminrusimha, Satyan, LaRovere, Kerri L, Leger, Pierre-Louis, Levy, Philip T., Lorusso, Roberto, Lyster, Haifa, Malone, Matthew P., McMullan, D. Michael, Mečířová, Soña, Mehran, Roxana, Merz, Scott I., Mochizuki, Shuichi, Moler, Frank W., Molla, Kalkidan, Monagle, Paul, Morgan, Gareth J., Morgan, Catherine, Morice, Marie-Claude, Muszynski, Jennifer A., Najaf, Tasnim A., Nellis, Marianne E., Newburger, Jane W., O'Rourke, P. Pearl, Ostadal, Petr, Ozment, Caroline P., Pagani, Francis D., Peek, Giles J., Polito, Angelo, Priest, John R., Raman, Lakshmi, Rintoul, Natalie E., Roy, Nathalie, Rubin, Juli, Rumford, Martha, Rycus, Peter, Ryerson, Lindsay M., Sakamoto, Wakako, Segura-Matute, Susana, Shekar, Kiran, Spinella, Philip C., Spitzer, Ernest, Starr, Joanne P., Stead, Christine, Steffen, Katherine, Steiner, Marie E., Tan, Lucy, Tasker, Robert C., Taylor, J. Michael, Thiagarajan, Ravi R., Tonna, Joseph E., Ubertini, Gina M., van Leeuwen, Grace, Vang, Eric, Ventetuolo, Corey E., Venugopal, Prem S., Weinberg, Allison, Westrope, Claire, Wu, Changfu, Wylie, Gillian, Zeymer, Uwe, Zivick, Elizabeth E., and Zochios, Vasileios

Abstract

Extracorporeal membrane oxygenation (ECMO) is a high-risk and low-volume life support with increasing clinical study. However, heterogenous outcome definitions impede data assimilation into evidence to guide practice. The Academic Research Consortium (ARC), an international collaborative forum committed to facilitating the creation of stakeholder-driven consensus nomenclature and outcomes for clinical trials of medical devices, supported the ECMO Core Elements Needed for Trials Regulation And quality of Life (ECMO-CENTRAL) ARC. The ECMO-CENTRAL ARC was assembled to develop definitions of paediatric ECMO adverse events for use in clinical trials and regulatory device evaluation. An initial candidate list of ECMO adverse events derived from the mechanical circulatory support ARC was supplemented with a review of ECMO-relevant adverse event definitions collated from literature published between Jan 1, 1988, and Feb 20, 2023. Distinct teams of international topic experts drafted separate adverse event definitions that were harmonised to existing literature when appropriate. Draft definitions were revised for paediatric ECMO relevance with input from patients, families, and an international expert panel of trialists, clinicians, statisticians, biomedical engineers, device developers, and regulatory agencies. ECMO-CENTRAL ARC was revised and disseminated across research societies and professional organisations. Up to three rounds of internet-based anonymous surveys were planned as a modified Delphi process. The expert panel defined 13 adverse event definitions: neurological, bleeding, device malfunction, acute kidney injury, haemolysis, infection, vascular access-associated injury, non-CNS thrombosis, hepatic dysfunction, right heart failure, left ventricular overload, lactic acidaemia, and hypoxaemia. Definitional structure varied. Among 165 expert panel members, 114 were eligible to vote and 111 voted. Consensus was achieved for all proposed definitions. Agreement ranged from 82% to 95%. ECMO-CENTRAL ARC paired rigorous development with methodical stakeholder involvement and dissemination to define paediatric ECMO adverse events. These definitions will facilitate new research and the assimilation of data across clinical trials and ECMO device evaluation in children.

Published
2024
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17. Executive Summary: The Pediatric Extracorporeal Membrane Oxygenation Anticoagulation CollaborativE (PEACE) Consensus Conference.

Author

Alexander, Peta M. A., Bembea, Melania M., Cashen, Katherine, Cheifetz, Ira M., Dalton, Heidi J., Himebauch, Adam S., Karam, Oliver, Moynihan, Katie M., Nellis, Marianne E., Ozment, Caroline, Raman, Lakshmi, Rintoul, Natalie E., Said, Ahmed S., Saini, Arun, Steiner, Marie E., Thiagarajan, Ravi R., Watt, Kevin, Willems, Ariane, Zantek, Nicole D., and Barbaro, Ryan P.

Published
2024
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20. Venovenous Extracorporeal Membrane Oxygenation Initiation for Pediatric Acute Respiratory Distress Syndrome With Cardiovascular Instability is Associated With an Immediate and Sustained Decrease in Vasoactive-Inotropic Scores

Author

Chilcote, Daniel, primary, Sriram, Anant, additional, Slovis, Julia, additional, Morgan, Ryan W., additional, Schaubel, Douglas E., additional, Connelly, James, additional, Berg, Robert A., additional, Keim, Garrett, additional, Yehya, Nadir, additional, Kilbaugh, Todd, additional, and Himebauch, Adam S., additional

Published
2023
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32. Primary graft dysfunction grade 3 following pediatric lung transplantation is associated with chronic lung allograft dysfunction

Author

Wong, Wai, primary, Johnson, Brandy, additional, Cheng, Pi Chun, additional, Josephson, Maureen B., additional, Maeda, Katsuhide, additional, Berg, Robert A., additional, Kawut, Steven M., additional, Harhay, Michael O., additional, Goldfarb, Samuel B., additional, Yehya, Nadir, additional, and Himebauch, Adam S., additional

Published
2022
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39. Risk Factors Associated With Bleeding in Children With Cardiac Disease Receiving Extracorporeal Membrane Oxygenation: A Multi-Center Data Linkage Analysis

Author

Ankola, Ashish A., primary, Bailly, David K., additional, Reeder, Ron W., additional, Cashen, Katherine, additional, Dalton, Heidi J., additional, Dolgner, Stephen J., additional, Federman, Myke, additional, Ghassemzadeh, Rod, additional, Himebauch, Adam S., additional, Kamerkar, Asavari, additional, Koch, Josh, additional, Kohne, Joseph, additional, Lewen, Margaret, additional, Srivastava, Neeraj, additional, Willett, Renee, additional, and Alexander, Peta M. A., additional

Published
2022
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47. Risk Factors Associated With Bleeding in Children With Cardiac Disease Receiving Extracorporeal Membrane Oxygenation: A Multi-Center Data Linkage Analysis.

Author

Ankola, Ashish A, Ankola, Ashish A, Bailly, David K, Reeder, Ron W, Cashen, Katherine, Dalton, Heidi J, Dolgner, Stephen J, Federman, Myke, Ghassemzadeh, Rod, Himebauch, Adam S, Kamerkar, Asavari, Koch, Josh, Kohne, Joseph, Lewen, Margaret, Srivastava, Neeraj, Willett, Renee, Alexander, Peta MA, Ankola, Ashish A, Ankola, Ashish A, Bailly, David K, Reeder, Ron W, Cashen, Katherine, Dalton, Heidi J, Dolgner, Stephen J, Federman, Myke, Ghassemzadeh, Rod, Himebauch, Adam S, Kamerkar, Asavari, Koch, Josh, Kohne, Joseph, Lewen, Margaret, Srivastava, Neeraj, Willett, Renee, and Alexander, Peta MA

Abstract

Background: Bleeding is a common complication of extracorporeal membrane oxygenation (ECMO) for pediatric cardiac patients. We aimed to identify anticoagulation practices, cardiac diagnoses, and surgical variables associated with bleeding during pediatric cardiac ECMO by combining two established databases, the Collaborative Pediatric Critical Care Research Network (CPCCRN) Bleeding and Thrombosis in ECMO (BATE) and the Extracorporeal Life Support Organization (ELSO) Registry. Methods: All children (<19 years) with a primary cardiac diagnosis managed on ECMO included in BATE from six centers were analyzed. ELSO Registry criteria for bleeding events included pulmonary or intracranial bleeding, or red blood cell transfusion >80 ml/kg on any ECMO day. Bleeding odds were assessed on ECMO Day 1 and from ECMO Day 2 onwards with multivariable logistic regression. Results: There were 187 children with 114 (61%) bleeding events in the study cohort. Biventricular congenital heart disease (94/187, 50%) and cardiac medical diagnoses (75/187, 40%) were most common, and 48 (26%) patients were cannulated directly from cardiopulmonary bypass (CPB). Bleeding events were not associated with achieving pre-specified therapeutic ranges of activated clotting time (ACT) or platelet levels. In multivariable analysis, elevated INR and fibrinogen were associated with bleeding events (OR 1.1, CI 1.0-1.3, p = 0.02; OR 0.77, CI 0.6-0.9, p = 0.004). Bleeding events were also associated with clinical site (OR 4.8, CI 2.0-11.1, p < 0.001) and central cannulation (OR 1.75, CI 1.0-3.1, p = 0.05) but not with cardiac diagnosis, surgical complexity, or cannulation from CPB. Bleeding odds on ECMO day 1 were increased in patients with central cannulation (OR 2.82, 95% CI 1.15-7.08, p = 0.023) and those cannulated directly from CPB (OR 3.32, 95% CI 1.02-11.61, p = 0.047). Conclusions: Bleeding events in children with cardiac diagnoses supported on ECMO were associated with central cannulation st

Published
2021

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