Prevention of Post-Operative Cardiac Arrhythmias

Summary

Aim 1: Primary Prevention of Post-operative Cardiac Arrhythmias 1. To evaluate the efficacy of dexmedetomidine vs. the combination of Magnesium Sulfate and dexmedetomidine for the prevention of post-operative cardiac arrhythmias in children and young adults undergoing open heart surgical repair for congenital or acquired heart disease using cardiopulmonary bypass. Dexmedetomidine is currently being administered to almost all patients after coming off cardiopulmonary bypass and in the CICU. For this aim, the investigator will be comparing dexmedetomidine administered alone or in combination with Magnesium Sulfate. 2. To evaluate medication safety based on the frequency of Serious Adverse Events (SAEs) and Adverse Events (AEs) Aim 2: Secondary treatment of those Patients that develop a clinically significant arrhythmia despite having received either Dexmedetomidine alone or Magnesium Sulfate with Dexmedetomidine at the time of cardiac surgery 1. To evaluate the efficacy of intravenous (IV) Amiodarone vs. IV Procainamide for the control of postoperative cardiac arrhythmias developing after the failure of Stage 1, Preventative Trial. IV amiodarone and IV procainamide are standardly used treatment agents for the treatment of postoperative cardiac arrhythmias in this setting. The investigator will be assessing the comparative effectiveness of these agents in controlling post-operative cardiac arrhythmias. 2. To evaluate antiarrhythmic medication safety based on the frequency of SAEs and AEs

Timeline

Start

2023-01

Primary completion

2023-04

Completion

2023-08

Publications

• Background Rekawek J, Kansy A, Miszczak-Knecht M, Manowska M, Bieganowska K, Brzezinska-Paszke M, Szymaniak E, Turska-Kmiec A, Maruszewski P, Burczynski P, Kawalec W. Risk factors for cardiac arrhythmias in children with congenital heart disease after surgical intervention in the early postoperative period. J Thorac Cardiovasc Surg. 2007 Apr;133(4):900-4. doi: 10.1016/j.jtcvs.2006.12.011.
• Background Hoffman TM, Bush DM, Wernovsky G, Cohen MI, Wieand TS, Gaynor JW, Spray TL, Rhodes LA. Postoperative junctional ectopic tachycardia in children: incidence, risk factors, and treatment. Ann Thorac Surg. 2002 Nov;74(5):1607-11. doi: 10.1016/s0003-4975(02)04014-6.
• Background Dodge-Khatami A, Miller OI, Anderson RH, Goldman AP, Gil-Jaurena JM, Elliott MJ, Tsang VT, De Leval MR. Surgical substrates of postoperative junctional ectopic tachycardia in congenital heart defects. J Thorac Cardiovasc Surg. 2002 Apr;123(4):624-30. doi: 10.1067/mtc.2002.121046.
• Background Cecchin F, Johnsrude CL, Perry JC, Friedman RA. Effect of age and surgical technique on symptomatic arrhythmias after the Fontan procedure. Am J Cardiol. 1995 Aug 15;76(5):386-91. doi: 10.1016/s0002-9149(99)80106-4.
• Background Pfammatter JP, Wagner B, Berdat P, Bachmann DC, Pavlovic M, Pfenninger J, Carrel T. Procedural factors associated with early postoperative arrhythmias after repair of congenital heart defects. J Thorac Cardiovasc Surg. 2002 Feb;123(2):258-62. doi: 10.1067/mtc.2002.119701.
• Background Moak JP, Arias P, Kaltman JR, Cheng Y, McCarter R, Hanumanthaiah S, Martin GR, Jonas RA. Postoperative junctional ectopic tachycardia: risk factors for occurrence in the modern surgical era. Pacing Clin Electrophysiol. 2013 Sep;36(9):1156-68. doi: 10.1111/pace.12163. Epub 2013 May 10.
• Background He D, Aggarwal N, Zurakowski D, Jonas RA, Berul CI, Hanumanthaiah S, Moak JP. Lower risk of postoperative arrhythmias in congenital heart surgery following intraoperative administration of magnesium. J Thorac Cardiovasc Surg. 2018 Aug;156(2):763-770.e1. doi: 10.1016/j.jtcvs.2018.04.044. Epub 2018 Apr 18.
• Background He D, Sznycer-Taub N, Cheng Y, McCarter R, Jonas RA, Hanumanthaiah S, Moak JP. Magnesium Lowers the Incidence of Postoperative Junctional Ectopic Tachycardia in Congenital Heart Surgical Patients: Is There a Relationship to Surgical Procedure Complexity? Pediatr Cardiol. 2015 Aug;36(6):1179-85. doi: 10.1007/s00246-015-1141-5. Epub 2015 Mar 12.
• Background Lapsa J, Clark B, Chen YI, Moak JP. Incidence and risk factors for development of post-operative bradyarrhythmias following congenital and acquired cardiac disease repair in pediatric patients. Poster at APS, Baltimore, MD, 2019.
• Background El Amrousy DM, Elshmaa NS, El-Kashlan M, Hassan S, Elsanosy M, Hablas N, Elrifaey S, El-Feky W. Efficacy of Prophylactic Dexmedetomidine in Preventing Postoperative Junctional Ectopic Tachycardia After Pediatric Cardiac Surgery. J Am Heart Assoc. 2017 Mar 1;6(3):e004780. doi: 10.1161/JAHA.116.004780.
• Background Chrysostomou C, Sanchez-de-Toledo J, Wearden P, Jooste EH, Lichtenstein SE, Callahan PM, Suresh T, O'Malley E, Shiderly D, Haney J, Yoshida M, Orr R, Munoz R, Morell VO. Perioperative use of dexmedetomidine is associated with decreased incidence of ventricular and supraventricular tachyarrhythmias after congenital cardiac operations. Ann Thorac Surg. 2011 Sep;92(3):964-72; discussion 972. doi: 10.1016/j.athoracsur.2011.04.099.
• Background Chang PM, Silka MJ, Moromisato DY, Bar-Cohen Y. Amiodarone versus procainamide for the acute treatment of recurrent supraventricular tachycardia in pediatric patients. Circ Arrhythm Electrophysiol. 2010 Apr;3(2):134-40. doi: 10.1161/CIRCEP.109.901629. Epub 2010 Mar 1.
• Background Jian W, Su L, Yiwu L. The effects of magnesium prime solution on magnesium levels and potassium loss in open heart surgery. Anesth Analg. 2003 Jun;96(6):1617-1620. doi: 10.1213/01.ANE.0000065444.21593.23.
• Background Manrique AM, Arroyo M, Lin Y, El Khoudary SR, Colvin E, Lichtenstein S, Chrysostomou C, Orr R, Jooste E, Davis P, Wearden P, Morell V, Munoz R. Magnesium supplementation during cardiopulmonary bypass to prevent junctional ectopic tachycardia after pediatric cardiac surgery: a randomized controlled study. J Thorac Cardiovasc Surg. 2010 Jan;139(1):162-169.e2. doi: 10.1016/j.jtcvs.2009.07.064. Epub 2009 Oct 12.
• Background Dittrich S, Germanakis J, Dahnert I, Stiller B, Dittrich H, Vogel M, Lange PE. Randomised trial on the influence of continuous magnesium infusion on arrhythmias following cardiopulmonary bypass surgery for congenital heart disease. Intensive Care Med. 2003 Jul;29(7):1141-4. doi: 10.1007/s00134-003-1802-3. Epub 2003 May 28.
• Background Lee HY, Ghimire S, Kim EY. Magnesium supplementation reduces postoperative arrhythmias after cardiopulmonary bypass in pediatrics: a metaanalysis of randomized controlled trials. Pediatr Cardiol. 2013 Aug;34(6):1396-403. doi: 10.1007/s00246-013-0658-8. Epub 2013 Feb 27.
• Background Dorman BH, Sade RM, Burnette JS, Wiles HB, Pinosky ML, Reeves ST, Bond BR, Spinale FG. Magnesium supplementation in the prevention of arrhythmias in pediatric patients undergoing surgery for congenital heart defects. Am Heart J. 2000 Mar;139(3):522-8. doi: 10.1016/s0002-8703(00)90097-8.
• Background Verma YS, Chauhan S, Gharde P, Lakshmy R, Kiran U. Role of magnesium in the prevention of postoperative arrhythmias in neonates and infants undergoing arterial switch operation. Interact Cardiovasc Thorac Surg. 2010 Nov;11(5):573-6. doi: 10.1510/icvts.2010.239830. Epub 2010 Aug 5.
• Background Fairley JL, Zhang L, Glassford NJ, Bellomo R. Magnesium status and magnesium therapy in cardiac surgery: A systematic review and meta-analysis focusing on arrhythmia prevention. J Crit Care. 2017 Dec;42:69-77. doi: 10.1016/j.jcrc.2017.05.038. Epub 2017 Jun 21.
• Background Li X, Zhang C, Dai D, Liu H, Ge S. Efficacy of dexmedetomidine in prevention of junctional ectopic tachycardia and acute kidney injury after pediatric cardiac surgery: A meta-analysis. Congenit Heart Dis. 2018 Sep;13(5):799-807. doi: 10.1111/chd.12674. Epub 2018 Sep 27.
• Background Gautam NK, Turiy Y, Srinivasan C. Preincision Initiation of Dexmedetomidine Maximally Reduces the Risk of Junctional Ectopic Tachycardia in Children Undergoing Ventricular Septal Defect Repairs. J Cardiothorac Vasc Anesth. 2017 Dec;31(6):1960-1965. doi: 10.1053/j.jvca.2017.04.010. Epub 2017 Apr 10.
• Background Mahmoud AB, Tantawy AE, Kouatli AA, Baslaim GM. Propranolol: a new indication for an old drug in preventing postoperative junctional ectopic tachycardia after surgical repair of tetralogy of Fallot. Interact Cardiovasc Thorac Surg. 2008 Apr;7(2):184-7. doi: 10.1510/icvts.2007.160945. Epub 2007 Dec 18.
• Background Shuplock JM, Smith AH, Owen J, Van Driest SL, Marshall M, Saville B, Xu M, Radbill AE, Fish FA, Kannankeril PJ. Association between perioperative dexmedetomidine and arrhythmias after surgery for congenital heart disease. Circ Arrhythm Electrophysiol. 2015 Jun;8(3):643-50. doi: 10.1161/CIRCEP.114.002301. Epub 2015 Apr 15.
• Background Amrousy DE, Elshehaby W, Feky WE, Elshmaa NS. Safety and Efficacy of Prophylactic Amiodarone in Preventing Early Junctional Ectopic Tachycardia (JET) in Children After Cardiac Surgery and Determination of Its Risk Factor. Pediatr Cardiol. 2016 Apr;37(4):734-9. doi: 10.1007/s00246-016-1343-5. Epub 2016 Jan 27.
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