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

Weill Medical College of Cornell University420 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

420

Conditions

Atrial Fibrillation

Interventions

Posterior left pericardiotomyPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Weil Cornell Medical College Department of Cardiothoracic Surgery

New York, New York, United States

Outcomes

Primary Outcomes

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.

Time frame: During hospitalization, approximately 5 days

Secondary Outcomes

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)

Time frame: During hospitalization, approximately 5 days

Duration of Hospitalization

Time (hours) spent in hospital after surgery completion

Time frame: During hospitalization, up to 100 days after surgery

Data from ClinicalTrials.gov

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