Pericardiotomy in Cardiac Surgery Trial
Population Health Research Institute
Summary
PRINCE is an international, multicentre, randomized controlled trial of posterior pericardiotomy in patients without a history of atrial fibrillation (AF) or flutter undergoing cardiac surgery.
Description
Approximately 30% of cardiac surgical patients develop post-operative atrial fibrillation (POAF). Its incidence varies depending on the type of cardiac operation. POAF is associated with short- and long-term adverse events, including mortality, stroke, and heart failure. POAF has also been significantly associated with unplanned hospitalization for heart failure. During cardiac surgery, pericardial fluid tends to collect posterior to the left atrium. Even small amounts of fluid may trigger atrial arrhythmias. A posterior left pericardiotomy is a surgical procedure that involves cauterizing an…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Patients greater than or equal to 18 years of age * Requiring surgical intervention on the proximal aorta, cardiac valves, and/or coronary arteries * Able to provide informed consent Exclusion Criteria: * History of atrial fibrillation or flutter * Cardiac surgery procedures not included in the inclusion criteria (planned ventricular assistance device, aortic arch, transplantation surgery) * Prior cardiac surgery requiring opening of the pericardium * Previous surgical instrumentation of the left pleural cavity * Patient undergoing minimally invasive cardiac surgery
Interventions
- ProcedureLeft Posterior Pericardiotomy
The surgeon will perform a left posterior pericardiotomy while the patient is on cardiopulmonary bypass. A soft channel drain will be put into place at an angle directed toward the posterior pericardium. The surgeon will grasp the pericardium and use cautery to make a 4- to 5-cm opening between the left inferior pulmonary vein and the diaphragm. The previously prepared channel drain is cut to the desired length and placed through the pericardiotomy along the diaphragm and into the pleural space.
Locations (4)
- Weill Cornell MedicineNew York, New York
- Medical University ViennaVienna, State of Vienna
- Hamilton Health SciencesHamilton, Ontario
- University of Foggia, Policlinico FoggiaFoggia, Foggia