A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery

Atrial Fibrillation New Onset Clinical Trial

Official title:

A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05780320
• Other study ID #: 2004P001528
• Status: Active, not recruiting
• Start date: September 19, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2023
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Postoperative atrial fibrillation (POAF) is a common complication following cardiac surgery with an estimated incidence around 35%. It has been found to be an independent predictor of 30-day and 6-month mortality, stroke, renal failure, respiratory failure, and need for permanent pacemaker among others. Previous studies including meta-analyses demonstrate a protective benefit of prophylactic amiodarone to decrease the risk of POAF. However, this has not been widely adopted, and recent society guidelines only give prophylactic amiodarone a Class IIA recommendation, citing risk of amiodarone-related toxicity and hypotension as reasons for the Class IIA recommendation. A meta-analysis comparing cumulative doses of amiodarone found that moderate to higher doses of amiodarone have a marginally increased benefit in reducing the incidence of postoperative atrial fibrillation over lower doses; however, the study did not assess risk of complications stratified by cumulative doses, which has been previously described. Finally, a recent meta-analysis showed that a posterior pericardiotomy was highly effective at reducing postoperative atrial fibrillation. Consequently, the investigators' institution has adopted a pharmaco-surgical approach (prophylactic amiodarone and posterior pericardiotomy) in an effort to reduce postoperative atrial fibrillation after coronary artery bypass cardiac surgery for all patients who meet inclusion/exclusion criteria.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 242
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Preoperative normal sinus rhythm

• Procedures:

• CABG

• CABG + concomitant valve or aortic replacement/repair

Exclusion Criteria:

• Emergent operation

Procedures:

• MAZE or PVI performed

• Isolated valve replacement or repair

• Isolated aortic procedures

• Heart transplant

• Lung transplant Pre-existing atrial arrhythmias Pre-operative amiodarone use Contraindications to amiodarone use

• PR interval > 240 ms

• 2nd or 3rd degree heart block

• QTc > 550ms

• 2nd or 3rd degree heart block

• Liver impairment (INR > 1.7, AST/ALT > 2x normal)

• Uncontrolled hypothyroidism/hyperthyroidism

• Interstitial lung disease

• Allergy to amiodarone

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Fibrillation New Onset

Intervention

Other:
• Prophylactic amiodarone and posterior pericardiotomy
Patients after the implementation of the protocol receive postoperative prophylactic amiodarone and a posterior pericardiotomy. The amiodarone regimen consists of amiodarone 1mg/min x 10 hours (600 mg total) via central line upon arrival to the intensive care unit followed by 400 mg PO BID on postoperative days 1 and 2 followed by 200 mg PO BID on postoperative days 3 and 4 or until discharge, whichever occurs first. The posterior pericardiotomy occurs during the cardiac procedure.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (8)

Arsenault KA, Yusuf AM, Crystal E, Healey JS, Morillo CA, Nair GM, Whitlock RP. Interventions for preventing post-operative atrial fibrillation in patients undergoing heart surgery. Cochrane Database Syst Rev. 2013 Jan 31;2013(1):CD003611. doi: 10.1002/14651858.CD003611.pub3. — View Citation

Buckley MS, Nolan PE Jr, Slack MK, Tisdale JE, Hilleman DE, Copeland JG. Amiodarone prophylaxis for atrial fibrillation after cardiac surgery: meta-analysis of dose response and timing of initiation. Pharmacotherapy. 2007 Mar;27(3):360-8. doi: 10.1592/phco.27.3.360. — View Citation

Chatterjee S, Sardar P, Mukherjee D, Lichstein E, Aikat S. Timing and route of amiodarone for prevention of postoperative atrial fibrillation after cardiac surgery: a network regression meta-analysis. Pacing Clin Electrophysiol. 2013 Aug;36(8):1017-23. doi: 10.1111/pace.12140. Epub 2013 Apr 29. — View Citation

Colunga Biancatelli RM, Congedo V, Calvosa L, Ciacciarelli M, Polidoro A, Iuliano L. Adverse reactions of Amiodarone. J Geriatr Cardiol. 2019 Jul;16(7):552-566. doi: 10.11909/j.issn.1671-5411.2019.07.004. — View Citation

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. — View Citation

Greenberg JW, Lancaster TS, Schuessler RB, Melby SJ. Postoperative atrial fibrillation following cardiac surgery: a persistent complication. Eur J Cardiothorac Surg. 2017 Oct 1;52(4):665-672. doi: 10.1093/ejcts/ezx039. — View Citation

Orr CF, Ahlskog JE. Frequency, characteristics, and risk factors for amiodarone neurotoxicity. Arch Neurol. 2009 Jul;66(7):865-9. doi: 10.1001/archneurol.2009.96. — View Citation

Wolkove N, Baltzan M. Amiodarone pulmonary toxicity. Can Respir J. 2009 Mar-Apr;16(2):43-8. doi: 10.1155/2009/282540. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative atrial fibrillation	At least 1 minute duration detected by continuous telemetry or 12-lead electrocardiogram.	Prior to patient discharge or within 30 days after surgery.
Secondary	Operative mortality	Operative mortality as defined by either in-hospital death or death within 30 days of discharge.	Either in-hospital death or death within 30 days of discharge
Secondary	Stroke	Characterized by deficits lasting > 24 hours and/or imaging findings of infarction	Either in-hospital or within 30 days of procedure
Secondary	Transient ischemic attack	Characterized by examination findings lasting < 24 hours without associated imaging findings	Either in-hospital or within 30 days of procedure
Secondary	Initiation of systemic anticoagulation	New indication of systemic anticoagulation for stroke prophylaxis due to atrial fibrillation	Either in-hospital or within 30 days of procedure
Secondary	Persistence of atrial fibrillation at discharge	Atrial fibrillation as diagnosed by final ECG	At postoperative surgical visit (around 4-6 weeks)
Secondary	Postoperative hospital length of stay	The postoperative length of stay will be calculated starting from the end of the procedure to time of discharge	Up to 90 days
Secondary	Readmission	Rates of hospital readmission will be estimated for patients in each of the study intervention groups. Readmissions will be counted in this calculation if patients are admitted to the hospital. Emergency room visits without admission and outpatient visits will not count toward this calculation of readmission rates.	Within 30 days of procedure
Secondary	Symptomatic bradycardia	Symptomatic bradycardia (HR < 55 bpm) requiring intervention	Either in-hospital or within 30 days of procedure
Secondary	Number of patients with Amiodarone-related pulmonary toxicity	Clinical diagnosis of amiodarone-related pulmonary toxicity that uses a combination of x-ray findings consistent with known amiodarone-related pulmonary toxicity and clinical findings including shortness of breath, non-productive cough, and other diagnoses have been excluded.	Either in-hospital or within 30 days of procedure
Secondary	Postoperative pleural effusions requiring intervention	Postoperative pleural effusions requiring interventions including thoracostomy drainage or surgical drainage	Either in-hospital or within 30 days of procedure