Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane

About this trial

Evacuation of pericardial blood by posterior pericardiotomy or use of a posterior pericardial chest tube lowers postoperative atrial fibrillation (POAF) rates after cardiac surgery by 45-68%. Although it cannot be generalized due to trial undersizing, posterior pericardial chest tube treatment may be a superior alternative to pericardiotomy, given its low risk of procedural complications.

This interventional multicenter trial will assess whether prolonged treatment with a posterior pericardial chest tube lowers POAF rates after cardiac surgery. Investigators will randomize 624 patients undergoing routine cardiac surgery at Nordic sites 1:1 to receive a posterior pericardial chest tube as adjunct to standard care for up to 3 postoperative days or standard care alone. The primary outcome is the proportion of patients with POAF up to 7 days post-surgery; the study will be powered to detect a relative risk reduction of 30% in the intervention arm. Secondary outcomes are AF burden; days with chest tubes and their output; proportion of patients with POAF up to 14 days post-surgery; direct current conversions during hospital admission; length of ICU/hospital stay; postoperative complications, mortality, ischemic stroke, and major bleeding at 30/90 days and 1/3/5 years; and quality of life/postoperative recovery at 90 days and 1 year. This trial may provide quality clinical evidence supporting the adoption of a simple method to prevent POAF, thus reducing healthcare costs.

Eligibility criteria

Qualifiers

Age ≥ 18 years

Undergoing non-emergent surgery (>24 hours between decision to operate and surgical procedure) with coronary artery bypass grafting, aortic valve replacement, aortic surgery without the use of circulatory arrest, or any combination of these procedures

Able to give written informed consent

Disqualifiers

History of atrial fibrillation (AF) or atrial flutter

History of electrophysiological interventions or treatment with antiarrhythmic drugs due to arrhythmias other than AF

Pre- or postoperative prophylactic treatment with amiodarone

Existing pacemaker, ICD, or CRT device without a functional atrial lead

Trial design

Treatments tested in this trial

  • Prolonged treatment with posterior pericardial chest tube plus standard care

Treatment groups

624 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Region Skane

Lead sponsor

The Swedish Research Council

Collaborator