Prolonged Posterior Pericardial Chest Tube Treatment to Reduce Rates of Postoperative Atrial Fibrillation Following Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Region Skane
- 入组人数
- 624
- 试验地点
- 1
- 主要终点
- Proportion of patients with POAF the first 7 postoperative days
研究概览
简要总结
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.
详细描述
Postoperative atrial fibrillation (POAF) occurs in 20-50% of cardiac surgery patients and is associated with poorer surgical outcomes. Buildup of fluid in the pericardium due to intraoperative or postoperative bleeding may induce inflammation in the atrial myocardium, leading to POAF. Evacuation of pericardial blood by creating an opening in the pericardium (posterior pericardiotomy) significantly lowers POAF rates after cardiac surgery. However, its clinical use is limited due to several risks, including injury to the pulmonary veins, esophagus, and phrenic nerve. A posterior pericardial chest tube, used routinely by some cardiothoracic surgeons, may be a superior alternative given its low risk of procedural complications.
The PROPER trial is a new Nordic collaboration aiming to evaluate the effect of prolonged posterior pericardial chest tube treatment rates of POAF after cardiac surgery in a randomized, controlled, interventional multicenter trial. The evidence provided by this study will enable direct clinical implementation of the intervention following completion of the trial.
Cardiac surgery results in a local and general inflammatory state, and activation of the autonomic nervous system. These conditions may lead to new-onset POAF. POAF occurs in 20-50% of patients following cardiac surgery and is associated with poorer surgical outcomes, including increased risk of stroke, acute kidney injury, prolonged length of hospital stay, and higher mortality rates. In addition, oral anticoagulation (OAC) treatment is frequently initiated after POAF and is rarely discontinued despite most patients regaining sinus rhythm before hospital discharge and over 90% within 60 days of surgery. OAC treatment exposes the patients to a significant risk of major bleeding complications.
Reports suggest that intraoperative and postoperative bleeding is a significant trigger of POAF through its induction of oxidative stress and inflammation of the atrial myocardium. To this end, several studies have shown that drainage of pericardial blood significantly reduces POAF rates after cardiac surgery. Two meta-analyses suggest that a procedure known as posterior pericardiotomy, which involves making a longitudinal incision in the posterior pericardium, may reduce POAF rates by 55-58%. Most recently, a clinical trial including 420 patients who were randomized to posterior pericardiotomy versus conventional treatment found a 45% lower rate of POAF in the intervention group. Despite the compelling evidence that posterior pericardiotomy reduces the rate of POAF, it is rarely used clinically, likely due to the risk of injuring the pulmonary veins, esophagus, or the phrenic nerve during the procedure. Alternatively, aortic surgery patients who received a posterior pericardial chest tube - which may be a superior alternative due to its low rate of complications - were found to have a 68% lower rate of POAF than patients in the control group. This study, however, was limited by its single-center design, small study sample, and lack of generalizability to other types of cardiac surgery. Whether posterior pericardial chest tubes are a feasible treatment to prevent POAF in surgical patients is still unknown.
The preliminary results demonstrate the feasibility of the planned study to administer posterior pericardial chest tube treatment to cardiac surgery patients and monitor them for arrhythmias using the SmartCardia heart rate monitor. The SmartCardia heart monitor is portable and allows for monitoring of the heart rhythm up to 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Control: Standard care
Patients in the control arm will receive 1-2 mediastinal and 0-2 pleural chest tubes (per clinical routine and surgeon's preference). No posterior pericardial chest tube will be inserted in control patients. All other aspects of postoperative care will follow standard clinical routines and will be identical in the intervention and control arms.
Prolonged treatment with posterior pericardial chest tube plus standard of 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.
干预措施: Prolonged treatment with posterior pericardial chest tube plus standard care (Procedure)
结局指标
主要结局
Proportion of patients with POAF the first 7 postoperative days
时间窗: 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)
次要结局
- Proportion of patients with POAF until day 14 postoperative(From enrollment to postoperative day 14)
- Percentage of POAF burden(From application of SmartCardia monitor until end of recording ((defined as the first 14 postoperative days or battery life of the monitor, whichever is first))
- Proportion of patients with and frequency of DC conversions during hospital admission(From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is first)
- Cumulative dose of amiodarone administered during hospital admission(From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is first)
- Length of ICU and hospital stay(From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is first)
- Proportion of patients with pericardial tamponade(From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is first)
- Proportion of patients requiring re-exploration for bleeding(From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is first)
- Proportion of patients with circulatory arrest(From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is first)
- Proportion of patients with surgical site infection(From end of surgery to until 1 year follow up)
- Proportion of patients with mediastinitis(From end of surgery to until 1 year follow up)
- Cardiac- or vein graft injury(From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is first)
- Proportion of patients receiving OAC treatment(From end of surgery to until 1 year follow up)
- Proportion of patients requiring pleural drainage(From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is first)
- Number of days with a posterior pericardial chest tube(From day of surgery to end of treatment or until follow up at postoperative day 30 whichever is first)
- Volume of posterior pericardial chest tube output at extraction(From enrollment to end of hospital stay or until follow up at postoperative day 30 whichever is first)
- Proportion of patients with AF at any time since last assessment(After hospital discharge until 1 year follow up)
- Proportion of patients with ischemic stroke(From hospital discharge until 5 year follow up)
- Mortality(After hospital discharge until 5 year follow up)
- Proportion of patients hospitalized due to bleeding.(From hospital discharge until 5 year follow up)
- Quality of life survey(From hospital discharge until 1 year follow up)
- Postoperative recovery(From hospital discharge until 1 year follow up)
- Healthcare cost-benefit analysis(From hospital discharge until 5 year follow up)