Posterior Left pericardiotomy for the prevention of postoperative Atrial fibrillation after Cardiac Surgery (PALACS): study protocol for a randomized controlled trial

Ahmed A Abouarab, Jeremy R Leonard, Lucas B Ohmes, Christopher Lau, Lisa Q Rong, Natalia S Ivascu, Kane O Pryor, Monica Munjal, Filippo Crea, Massimo Massetti, Tommaso Sanna, Leonard N Girardi, Mario Gaudino, Ahmed A Abouarab, Jeremy R Leonard, Lucas B Ohmes, Christopher Lau, Lisa Q Rong, Natalia S Ivascu, Kane O Pryor, Monica Munjal, Filippo Crea, Massimo Massetti, Tommaso Sanna, Leonard N Girardi, Mario Gaudino

Abstract

Background: Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery. POAF is associated with increased morbidity and hospital costs. We herein describe the protocol for a randomized controlled trial to determine if performing a posterior left pericardiotomy prevents POAF after cardiac surgery.

Methods/design: All patients submitted to cardiac surgery at our institution will be screened for inclusion into the study. The study will consist of two parallel arms with random allocation between groups to either receive a posterior left pericardiotomy or serve as a control. Masking will be done in a single-blinded fashion to the patient. Patients will be continuously monitored postoperatively for the occurrence of atrial fibrillation until discharge. At the follow-up clinic visit (15-30 days after surgery), the primary endpoint (atrial fibrillation) and other secondary endpoints, such as pleural or pericardial effusion, will be assessed. A total sample size of 350 subjects will be recruited.

Discussion: POAF is associated with increased morbidity, prolonged hospital stay, and increased costs after cardiac surgery. Several strategies aimed at reducing the incidence of POAF have been investigated, including beta-blockers, amiodarone, and statins, all with suboptimal results. Posterior left pericardiotomy has been associated with a reduction of POAF in previous series. However, these studies had limited sample sizes and suboptimal methodology, so that the efficacy of posterior pericardiotomy in preventing POAF remains to be definitively proven. Our randomized trial aims to determine the effect of a posterior left pericardiotomy on the incidence of POAF.

Trial registration: ClinicalTrials.gov, ID: NCT02875405 , protocol record 1502015867. Registered on July 2016.

Keywords: Arrhythmia; Atrial fibrillation; Cardiac surgery; Postoperative arrhythmia; Postoperative atrial fibrillation.

Conflict of interest statement

Authors’ information

MG: Stephen and Suzanne Weiss Professor in Cardiothoracic Surgery (II), Director of Translational and Clinical Research

LBO: Research Fellow at the Department of Cardiothoracic Surgery, Weill Cornell Medicine and a general surgery resident at Rutgers University.

CL: Assistant Professor of Cardiothoracic Surgery at the Department of Cardiothoracic Surgery, Weill Cornell Medicine

TS: Professor at the Department of Cardiovascular Sciences, Catholic University, Rome, Italy

LNG: Chairman of Cardiothoracic Surgery, Weill Cornell Medicine

KOP: Associate Professor of Clinical Anesthesiology, Weill Cornell Medicine

NSI: Associate Professor of Clinical Anesthesiology, Weill Cornell Medicine

LQR: Assistant Professor of Clinical Anesthesiology, Weill Cornell Medicine

MM: Professor of Cardiothoracic Surgery, Catholic University, Rome, Italy

FC: Professor of Cardiology, Catholic University, Rome, Italy

MM: Research Biostatistician at the Department of Cardiothoracic Surgery, Weill Cornell Medicine

JRL: Research Fellow at the Department of Cardiothoracic Surgery, Weill Cornell Medicine and a general surgery resident.

AAA: Research Fellow at the Department of Cardiothoracic Surgery, Weill Cornell Medicine

Ethics approval and consent to participate

The study was approved by the Institutional Review Board on 26 May 2016; Protocol number 1502015867R001. Consent is required prior to individual patient enrollment according to institutional guidelines. Research will be performed according to the Declaration of Helsinki.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Figure
Fig. 2
Fig. 2
Participant timeline diagram: sequenced events of the trial modified from the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) Statement
Fig. 3
Fig. 3
Double function of the mediastinal chest tube in posterior pericardiotomy patients

References

    1. Redle JD, Khurana S, Marzan R, McCullough PA, Stewart JR, et al. Prophylactic oral amiodarone compared with placebo for prevention of atrial fibrillation after coronary artery bypass surgery. Am Heart J. 1999;138(1):144–150. doi: 10.1016/S0002-8703(99)70260-7.
    1. Aranki SF, Shaw DP, Adams DH, Rizzo RJ, Couper GS, et al. Predictors of atrial fibrillation after coronary artery surgery. Circulation. 1996;94(3):390–397. doi: 10.1161/01.CIR.94.3.390.
    1. Abdel-Salam Z, Nammas W. Atrial fibrillation after coronary artery bypass surgery: can ivabradine reduce its occurrence? J Cardiovasc Electrophysiol. 2016;27(6):670–676. doi: 10.1111/jce.12974.
    1. Onk OA, Erkut B. Is the preoperative administration of amiodarone or metoprolol more effective in reducing atrial fibrillation: after coronary bypass surgery? Medicine (Baltimore) 2015;94(41):e1576. doi: 10.1097/MD.0000000000001576.
    1. Abaci O, Kocas C, Oktay V, Yildiz CE, Kilickesmez KO, et al. Comparison of rosuvastatin versus atorvastatin for preventing postoperative atrial fibrillation. Heart Surg Forum. 2013;16(3):E158–E161. doi: 10.1532/HSF98.20121061.
    1. Kaleda VI, McCormack DJ, Shipolini AR. Does posterior pericardiotomy reduce the incidence of atrial fibrillation after coronary artery bypass grafting surgery? Interact Cardiovasc Thorac Surg. 2012;14(4):384–389. doi: 10.1093/icvts/ivr099.
    1. Kuralay E, Ozal E, Demirkili U, Tatar H. Effect of posterior pericardiotomy on postoperative supraventricular arrhythmias and late pericardial effusion (posterior pericardiotomy) J Thorac Cardiovasc Surg. 1999;118(3):492–495. doi: 10.1016/S0022-5223(99)70187-X.
    1. Ekim H, Kutay V, Hazar A, Akbayrak H, Başel H, Tuncer M. Effects of posterior pericardiotomy on the incidence of pericardial effusion and atrial fibrillation after coronary revascularization. Med Sci Monit. 2006;12(10):CR431–CR434.
    1. Mulay A, Kirk AJ, Angelini GD, Wisheart JD, Hutter JA. Posterior pericardiotomy reduces the incidence of supra-ventricular arrhythmias following coronary artery bypass surgery. Eur J Cardio-Thorac Surg off J Eur Assoc Cardio-Thorac Surg. 1995;9(3):150–152. doi: 10.1016/S1010-7940(05)80063-6.
    1. Biancari F, Mahar MAA. Meta-analysis of randomized trials on the efficacy of posterior pericardiotomy in preventing atrial fibrillation after coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2010;139(5):1158–1161. doi: 10.1016/j.jtcvs.2009.07.012.
    1. Chua S-K, Shyu K-G, Lu M-J, Lien L-M, Lin C-H, et al. Clinical utility of CHADS2 and CHA2DS2-VASc scoring systems for predicting postoperative atrial fibrillation after cardiac surgery. J Thorac Cardiovasc Surg. 2013;146(4):919–926.e1. doi: 10.1016/j.jtcvs.2013.03.040.
    1. Ashes CM, Yu M, Meineri M, Katznelson R, Carroll J, et al. Diastolic dysfunction, cardiopulmonary bypass, and atrial fibrillation after coronary artery bypass graft surgery. Br J Anaesth. 2014;113(5):815–821. doi: 10.1093/bja/aeu208.
    1. Nagueh SF, Appleton CP, Gillebert TC, Marino PN, Oh JK, et al. Recommendations for the evaluation of left ventricular diastolic function by echocardiography. Eur J Echocardiogr. 2009;10(2):165–193. doi: 10.1093/ejechocard/jep007.
    1. Hahn RT, Abraham T, Adams MS, Bruce CJ, Glas KE, et al. Guidelines for performing a comprehensive transesophageal echocardiographic examination: recommendations from the American Society of Echocardiography and the Society of Cardiovascular Anesthesiologists. J Am Soc Echocardiogr. 2013;26(9):921–964. doi: 10.1016/j.echo.2013.07.009.
    1. International Committee of Medical Journal Editors. Defining the roles of authors and contributors. Available from: . Accessed 19 Sept 2017.
    1. Rostagno C, La Meir M, Gelsomino S, Ghilli L, Rossi A, et al. Atrial fibrillation after cardiac surgery: incidence, risk factors, and economic burden. J Cardiothorac Vasc Anesth. 2010;24(6):952–958. doi: 10.1053/j.jvca.2010.03.009.
    1. LaPar DJ, Speir AM, Crosby IK, Fonner E, Brown M, et al. Postoperative atrial fibrillation significantly increases mortality, hospital readmission, and hospital costs. Ann Thorac Surg. 2014;98(2):527–533. doi: 10.1016/j.athoracsur.2014.03.039.

Source: PubMed

Patrocinadores y Colaboradores

Condiciones médicas

Intervenciones de drogas

3
Suscribir