Clinical trial NCT02875405: The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery
Official title: The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: postoperative
pericardiotomy
prevention
cardiac surgery
left
posterior
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
Collaborators: name: Catholic University of the Sacred Heart
First posted: 2016-08-23
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine if preforming a posterior left pericardiotomy prevents atrial fibrillation after cardiac surgery.

Detailed description: Post-operative atrial fibrillation (POAF) is a common complication of cardiac surgery which is observed in 30-40% of patients. POAF may cause stroke, systemic embolism or cardiac failure and Its detection mandates for additional treatment with variable combinations of drugs to control cardiac rate or rhythm, anticoagulation, and electrical cardioversion, with their side effects and complications. As a result, POAF prolongs hospital stay and increases the costs of hospitalization. Several strategies aimed at reducing the incidence of POAF have been investigated, including beta-blockers, amiodarone, and statins, with unsatisfactory results. Posterior left pericardiotomy has been associated with a reduction in the incidence of POAF in a few studies. However, these studies are flawed by methodological limitations in terms of sample size, inclusion/exclusion criteria, randomization procedure, and suboptimal electrocardiographic monitoring strategies. Moreover, posterior left pericardiotomy requires additional operative time and is associated with procedure-specific complications. As a result, current evidence on posterior pericardiectomy failed to translate into changes in clinical practice and the incidence of POAF remains high.

Eligibility criteria: Inclusion Criteria:

* all consecutive patients admitted to the department of cardiothoracic surgery of the NYPH-WCMC will be screened for enrollment.

Exclusion Criteria:

* preoperative non-sinus rhythm
* history of previous atrial arrhythmia of any type
* reoperations
* mitral or tricuspid valve disease
* surgery of the descending thoracic or thoracoabdominal aorta
* need for hypothermic circulatory arrest
* off pump operation
* urgent/emergent presentation
* disease of the left pleura or previous left thoracotomy
* chest deformity

Primary outcomes:
measure: Number of participants that experience Postoperative Atrial Fibrillation (POAF)
timeFrame: During hospitalization, approximately 5 days
Secondary outcomes:
measure: Duration of Postoperative Atrial Fibrillation (POAF)
timeFrame: During hospitalization, approximately 5 days
measure: Duration of Hospitalization
timeFrame: During hospitalization, up to 100 days after surgery
Other outcomes:
Locations:
city: New York
country: United States
facility: Weil Cornell Medical College Department of Cardiothoracic Surgery
state: New York
Study officials:
affiliation: Weill Cornell Medical College New York Presbyterian Hospital
name: Leonard N Girardi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Cornell Medical College New York Presbyterian Hospital
name: Mario F Gaudino, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Abouarab AA, Leonard JR, Ohmes LB, Lau C, Rong LQ, Ivascu NS, Pryor KO, Munjal M, Crea F, Massetti M, Sanna T, Girardi LN, Gaudino M. Posterior Left pericardiotomy for the prevention of postoperative Atrial fibrillation after Cardiac Surgery (PALACS): study protocol for a randomized controlled trial. Trials. 2017 Dec 13;18(1):593. doi: 10.1186/s13063-017-2334-4.