Prolonged Chest Tube Treatment to Reduce Rates of Atrial Fibrillation Following Cardiac Surgery
NCT ID: NCT06800781
Last Updated: 2025-03-17
Study Results
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Basic Information
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RECRUITING
NA
624 participants
INTERVENTIONAL
2025-02-10
2033-12-31
Brief Summary
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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.
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Detailed Description
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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.
In 2023, investigators in Lund conducted an internal pilot study where 14 patients received either a 20Ch or 18Ch posterior pericardial chest tube with a bellow drain (n=7 in each group). Both chest tubes extracted 150-200 mL blood with no reported physical discomfort; 1 and 3 patients in these arms developed POAF, respectively. As a follow-up to this study, from June to August 2024, investigators treated an additional 8 patients with 20Ch chest tubes and 11 patients with the 18Ch chest tubes to determine which chest tube was best suited for the trial. The 20Ch chest tubes were typically extracted on postoperative day (POD) 3 (IQR 3-3) with a median chest tube output between POD 1 and extraction of 100 (50-125) ml. The 18Ch chest tubes were extracted on POD 3 (IQR 3-3) and evacuated 185 (140-250) ml of fluid between POD 1 and extraction. Patients receiving the 20Ch chest tubes reported a discomfort level of 0.5 (0-1.5) on a visual analog scale (VAS), while those receiving the 18Ch chest tubes reported a level of 0 (0-1). Three patients in the 20Ch group (38%) and 4 patients in the 18Ch group (36%) developed POAF.
Pilot studies have shown that both the 18Ch and the 20Ch chest tubes effectively evacuate blood from the pericardium. Although the 18Ch chest tube evacuated a higher fluid volume on POD 1, upon inspection, no tubes were obstructed by clots after removal. This suggests that the 20Ch chest tube evacuated posterior pericardial blood more efficiently on POD 0 (while connected to the remaining standard tubes), leaving less fluid to be drained on POD 1 and onward. Since nurses at the ward and ICU were more positive towards handling the familiar 20Ch chest tube, and since the manufacturer of the 18Ch chest tubes ran out of stock during the pilot study period, investigators believe that the 20Ch chest tube is the superior alternative for this study.
While no conclusions regarding changes in POAF rates could be drawn from the pilot studies due to the small sample sizes, internal team has in parallel conducted a retrospective, observational study in Iceland on the effect of posterior pericardial chest tube on POAF rates after routine cardiac surgery. Investigators have found that a posterior pericardial chest tube significantly reduced POAF rates in a propensity score-matched population of 1,106 patients undergoing coronary artery bypass grafting and aortic valve replacement (OR 0.66 \[95%CI 0.51-0.86\], p=0.002). A manuscript detailing the results of this study is currently under revision at The Journal of Cardiothoracic and Vascular Surgery Open.
The current evidence is insufficient to support placing an additional chest tube or to justify its adoption into clinical practice.
Therefore, a large, high-quality, multicenter clinical trial on the effect of posterior pericardial chest tube treatment after cardiac surgery is warranted. The aim of this study is to evaluate whether prolonged treatment with a posterior pericardial chest tube reduces the frequency of POAF after routine cardiac surgery. The SmartCardia monitor will aid in determine whether a patient has experienced POAF during the first 14 postoperative days. If successful, the trial could benefit cardiac surgery patients by reducing the incidence of a disabling postsurgical complication, thereby minimizing patient harm and potentially lowering healthcare costs.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
No interventions assigned to this group
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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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The Swedish Research Council
OTHER_GOV
Region Skane
OTHER
Responsible Party
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Principal Investigators
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Igor Zindovic Zindovic, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Region Skåne
Locations
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Lund University hospital
Lund, , Sweden
Countries
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Central Contacts
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References
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Sezai, A. et al. Ann Thorac Cardiovasc Surg 27, 191-199, (2021).
Rabelo, L. G. et al. Abstract presented at 104th Annual Meeting of AATS, (2024).
Fragão-Marques, M. et al. Ann Thorac Cardiovasc Surg 26, 342-351, (2020).
Eryilmaz S, Emiroglu O, Eyileten Z, Akar R, Yazicioglu L, Tasoz R, Kaya B, Uysalel A, Ucanok K, Corapcioglu T, Ozyurda U. Effect of posterior pericardial drainage on the incidence of pericardial effusion after ascending aortic surgery. J Thorac Cardiovasc Surg. 2006 Jul;132(1):27-31. doi: 10.1016/j.jtcvs.2006.01.049.
Gillinov, A. M. et al. N Engl J Med 374, 1911-1921, (2016).
Kiviniemi T, Bustamante-Munguira J, Olsson C, Jeppsson A, Halfwerk FR, Hartikainen J, Suwalski P, Zindovic I, Copa GR, van Schaagen FRN, Hanke T, Cebotari S, Malmberg M, Fernandez-Gutierrez M, Bjurbom M, Schersten H, Speekenbrink R, Riekkinen T, Ek D, Vasankari T, Lip GYH, Airaksinen KEJ, van Putte B; LAA-CLOSURE Investigators. A randomized prospective multicenter trial for stroke prevention by prophylactic surgical closure of the left atrial appendage in patients undergoing bioprosthetic aortic valve surgery--LAA-CLOSURE trial protocol. Am Heart J. 2021 Jul;237:127-134. doi: 10.1016/j.ahj.2021.03.014. Epub 2021 Mar 30.
Hogue CW Jr, Domitrovich PP, Stein PK, Despotis GD, Re L, Schuessler RB, Kleiger RE, Rottman JN. RR interval dynamics before atrial fibrillation in patients after coronary artery bypass graft surgery. Circulation. 1998 Aug 4;98(5):429-34. doi: 10.1161/01.cir.98.5.429.
Paparella, D. et al. Eur J Cardiothorac Surg 21, 232-244, (2002).
Xiong T, Pu L, Ma YF, Zhu YL, Li H, Cui X, Li YX. Posterior pericardiotomy to prevent new-onset atrial fibrillation after coronary artery bypass grafting: a systematic review and meta-analysis of 10 randomized controlled trials. J Cardiothorac Surg. 2021 Aug 14;16(1):233. doi: 10.1186/s13019-021-01611-x.
Gozdek M, Pawliszak W, Hagner W, Zalewski P, Kowalewski J, Paparella D, Carrel T, Anisimowicz L, Kowalewski M. Systematic review and meta-analysis of randomized controlled trials assessing safety and efficacy of posterior pericardial drainage in patients undergoing heart surgery. J Thorac Cardiovasc Surg. 2017 Apr;153(4):865-875.e12. doi: 10.1016/j.jtcvs.2016.11.057. Epub 2016 Dec 19.
Gaudino M, Sanna T, Ballman KV, Robinson NB, Hameed I, Audisio K, Rahouma M, Di Franco A, Soletti GJ, Lau C, Rong LQ, Massetti M, Gillinov M, Ad N, Voisine P, DiMaio JM, Chikwe J, Fremes SE, Crea F, Puskas JD, Girardi L; PALACS Investigators. Posterior left pericardiotomy for the prevention of atrial fibrillation after cardiac surgery: an adaptive, single-centre, single-blind, randomised, controlled trial. Lancet. 2021 Dec 4;398(10316):2075-2083. doi: 10.1016/S0140-6736(21)02490-9. Epub 2021 Nov 14.
St-Onge S, Perrault LP, Demers P, Boyle EM, Gillinov AM, Cox J, Melby S. Pericardial Blood as a Trigger for Postoperative Atrial Fibrillation After Cardiac Surgery. Ann Thorac Surg. 2018 Jan;105(1):321-328. doi: 10.1016/j.athoracsur.2017.07.045. Epub 2017 Nov 24.
Taha A, Nielsen SJ, Bergfeldt L, Ahlsson A, Friberg L, Bjorck S, Franzen S, Jeppsson A. New-Onset Atrial Fibrillation After Coronary Artery Bypass Grafting and Long-Term Outcome: A Population-Based Nationwide Study From the SWEDEHEART Registry. J Am Heart Assoc. 2021 Jan 5;10(1):e017966. doi: 10.1161/JAHA.120.017966. Epub 2020 Nov 30.
Hindricks, G. et al. Eur Heart J 42, 373-498, (2021).
El-Chami MF, Kilgo P, Thourani V, Lattouf OM, Delurgio DB, Guyton RA, Leon AR, Puskas JD. New-onset atrial fibrillation predicts long-term mortality after coronary artery bypass graft. J Am Coll Cardiol. 2010 Mar 30;55(13):1370-6. doi: 10.1016/j.jacc.2009.10.058.
Related Links
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SWEDEHEART, annal report 2023
Other Identifiers
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2023-07117-01
Identifier Type: -
Identifier Source: org_study_id
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