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

Atrial Fibrillation Clinical Trial

— PALACS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02875405
• Other study ID #: 1502015867
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: August 24, 2021

Study information

• Verified date: August 2021
• Source: Weill Medical College of Cornell University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: August 24, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Procedure:
• Posterior left pericardiotomy
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.

Locations

Country	Name	City	State
United States	Weil Cornell Medical College Department of Cardiothoracic Surgery	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University	Catholic University of the Sacred Heart

Country where clinical trial is conducted

United States, 

References & Publications (2)

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.2009.07.01 — View 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Duration of Hospitalization	Time (hours) spent in hospital after surgery completion	During hospitalization, up to 100 days after surgery

External Links

•   Weill Cornell Department of Cardiothoracic Surgery