The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery-Extended Follow-Up (PALACS-EF)

The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery - Extended Follow-Up (PALACS-EF) Study

The purpose of the Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery (PALACS, NCT02875405) trial was to determine if performing posterior left pericardiotomy at the time of cardiac surgery prevents atrial fibrillation after cardiac surgery. The purpose of the Posterior left pericardiotomy for the prevention of AtriaL fibrillation After Cardiac Surgery-Extended Follow-Up (PALACS-EF) study is to evaluate the effect of posterior left pericardiotomy on 5-year clinical outcomes.

Study Overview

• Status: Completed
• Conditions: Atrial Fibrillation
• Intervention / Treatment: Other: Non-Interventional

Detailed Description

Post-operative atrial fibrillation (POAF) is a common complication of cardiac surgery which is observed in 30-40% of patients. POAF has also been associated with stroke, systemic embolism or cardiac failure during the years after surgery. Several strategies aimed at reducing the incidence of POAF have been investigated, including beta-blockers, amiodarone, and statins, with unsatisfactory results. In the randomized prospective clinical trial, the PALACS trial, 420 patients were randomized either to the intervention group, which received left posterior pericardiotomy at time of cardiac surgery, or to the control group, which did not receive posterior left pericardiotomy at time of cardiac surgery. Posterior left pericardiotomy was associated with a reduction in the incidence of POAF after surgery, but not with improvement in 30-day patient outcomes.

This non-interventional, prospective study is an extension follow-up study (PALACS-EF) of all patients who were enrolled in the original PALACS trial. It is designed to evaluate differences in clinical outcomes between patients who received posterior left pericardiotomy (intervention) versus those who did not (control) at median follow-up of 5 years.

• Study Type: Observational
• Enrollment (Actual): 420

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medical College Department of Cardiothoracic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled in the PALACS trial

Description

Inclusion Criteria:

• This study will include all the subjects enrolled in the PALACS trial

Exclusion Criteria:

• Not enrolled in the PALACS trial

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Posterior Pericardiotomy; All patients who were randomized to receive posterior pericardiotomy (intervention) in the original PALACS trial.	Other: Non-Interventional; This study is a non-interventional study of all patients previously enrolled in the PALACS trial
No Posterior Pericardiotomy (control); All patients who were randomized to receive no intervention/no posterior pericardiotomy in the original PALACS trial

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first occurrence of the composite of all-cause mortality and hospital readmission for cardiovascular causes	Median five-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first occurrence of the composite of all-cause mortality and all-cause hospital readmission		Median five-year follow-up
Number of Adverse Events	The following adverse events will be included in the count: Myocardial infarction, stroke, transient ischemic attack, new arrhythmia (atrial fibrillation versus non-atrial fibrillation), heart failure, systemic embolism	Median five-year follow-up

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Leonard N Girardi, MD, Weill Cornell Medical College New York Presbyterian Hospital; Study Chair: Mario Gaudino, MD, Weill Cornell Medical College New York Presbyterian Hospital

Publications and helpful links

General Publications

• Gaudino M, Sanna T, Ballman KV, Robinson NB, Hameed I, Audisio K, Rahouma M, Di Franco A, Soletti GJ, Lau C, Rong LQ, Massetti M, Gillinov M, Ad N, Voisine P, DiMaio JM, Chikwe J, Fremes SE, Crea F, Puskas JD, Girardi L; PALACS Investigators. Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial. Lancet. 2021 Dec 4;398(10316):2075-2083. doi: 10.1016/S0140-6736(21)02490-9. Epub 2021 Nov 14.
• Biancari F, Mahar MA. 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 May;139(5):1158-61. doi: 10.1016/j.jtcvs.2009.07.012. Epub 2009 Aug 18.
• 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 Apr;14(4):384-9. doi: 10.1093/icvts/ivr099. Epub 2012 Jan 9.

Helpful Links

• Weill Cornell Department of Cardiothoracic Surgery

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2022
• Primary Completion (Actual): September 26, 2024
• Study Completion (Actual): October 13, 2024

Study Registration Dates

• First Submitted: June 5, 2023
• First Submitted That Met QC Criteria: June 5, 2023
• First Posted (Actual): June 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 28, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: cardiac surgery; prevention; postoperative; left posterior pericardiotomy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: 1502015867-Extension

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No