The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery (PALACS)

Weill Cornell Medicine (WCM)

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Procedure: Posterior left pericardiotomy

Study type: Interventional

Funder types: Other

Identifiers

NCT02875405

1502015867

Details and patient eligibility

About

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

Full 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.

Enrollment: 420 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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420 participants in 2 patient groups

Received pericardiotomy

Experimental group

Description:

Patient will receive a posterior left pericardiotomy at the time of surgery

Treatment:

Procedure: Posterior left pericardiotomy

No Pericardiotomy

No Intervention group

Description:

Patient will not receive posterior left pericardiotomy.