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

Summary

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

Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Aortic surgery with hypothermic circulatory arrest
* Previous cardiac surgery
* Previous radiation of the chest due to malignancy
* Ongoing infection at time of surgery
* Ongoing treatment with immunosuppressants, including oral corticosteroids
* Patient already included in another interventional clinical trial
* Patient listed abroad, which would render them to be lost to follow-up after discharge
* Patient does not understand study information given in the local language or, for other reasons, is deemed unfit to participate according to the investigators.

Conditions4

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