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

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

Detailed Description
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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.

Official Title
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The Effect of Posterior Pericardiotomy on the Incidence of Atrial Fibrillation After Cardiac Surgery

Conditions
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Atrial Fibrillation

Intervention / Treatment
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* Procedure: Posterior left pericardiotomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Received pericardiotomy<br>Patient will receive a posterior left pericardiotomy at the time of surgery | Procedure: Posterior left pericardiotomy<br>* Patient will receive a posterior left sided pericardiotomy. The incision will be made posterior to the phrenic nerve and run from the inferior left pulmonary vein to the diaphragm.<br>|
| No Intervention: No Pericardiotomy<br>Patient will not receive posterior left pericardiotomy. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that experience Postoperative Atrial Fibrillation (POAF) | POAF occurrences are defined as any irregular heart rhythm, without detectable P-wave, that lasts more than 30 seconds. | During hospitalization, approximately 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Postoperative Atrial Fibrillation (POAF) | Time spent in atrial fibrillation (seconds), defined as the time from the first evidence of atrial fibrillation to the first evidence of sinus rhythm restoration on cardiac monitoring strips or standard electrocardiograms (EKG) | During hospitalization, approximately 5 days | 
| Duration of Hospitalization | Time (hours) spent in hospital after surgery completion | During hospitalization, up to 100 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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posterior, postoperative, pericardiotomy, prevention, cardiac surgery, left