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

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

Trials, December 2017

29237510

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

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