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

Condition(s) studied

Investigational drug(s) / intervention(s)

Prolonged treatment with posterior pericardial chest tube plus standard care: Prolonged treatment with posterior pericardial chest tube plus standard care All patients will receive chest tubes based on each surgeon's preference. Usually, 1 or 2 tubes are inserted in the mediastinum, and 1 is inserted into each open pleural cavity. Patients in the intervention arm will receive an additional posterior 20Ch chest tube. In cases where the surgeon routinely inserts 2 mediastinal chest tubes, they will use 1-2 anterior mediastinal tubes in the intervention group, based on their preference. The posterior chest tube will be positioned between the inferior aspect of the heart and the pericardium and connected to an active suction system per routine. Once the remaining chest tubes are extracted, the posterior chest tube will remain positioned in the pericardium and be reconnected from active suction to a collection bag for passive drainage. The chest tube will be removed on postoperative Day 3 or when chest tube output is \<50 mL/24 h.

Study 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

Primary outcome measure(s)

• Proportion of patients with POAF the first 7 postoperative days — From enrollment (randomization) to postoperative day 7
  The primary endpoint will be defined as the proportion of patients with POAF (an episode of atrial fibrillation (AF) or atrial flutter sustained for \>30 seconds) registred by any available source in the first 7 postoperative days (i.e 12-lead EKG, telemetric monitoring, SmartCardia monitor)

Trial sites (1)

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