Clinical trial NCT05780320: A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery
Official title: A Pharmaco-surgical Approach to Reduce Postoperative Atrial Fibrillation After Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation New Onset
Keywords: Postoperative atrial fibrillation
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2023-03-22
Enrollment: 242
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes all patients undergoing coronary artery bypass cardiac surgery at the Massachusetts General Hospital who meets the above criteria.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Postoperative atrial fibrillation
timeFrame: Prior to patient discharge or within 30 days after surgery.
Secondary outcomes:
measure: Operative mortality
timeFrame: Either in-hospital death or death within 30 days of discharge
measure: Stroke
timeFrame: Either in-hospital or within 30 days of procedure
measure: Transient ischemic attack
timeFrame: Either in-hospital or within 30 days of procedure
measure: Initiation of systemic anticoagulation
timeFrame: Either in-hospital or within 30 days of procedure
measure: Persistence of atrial fibrillation at discharge
timeFrame: At postoperative surgical visit (around 4-6 weeks)
measure: Postoperative hospital length of stay
timeFrame: Up to 90 days
measure: Readmission
timeFrame: Within 30 days of procedure
measure: Symptomatic bradycardia
timeFrame: Either in-hospital or within 30 days of procedure
measure: Number of patients with Amiodarone-related pulmonary toxicity
timeFrame: Either in-hospital or within 30 days of procedure
measure: Postoperative pleural effusions requiring intervention
timeFrame: Either in-hospital or within 30 days of procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Asishana A Osho, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.
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.
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.
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.
citation: Wolkove N, Baltzan M. Amiodarone pulmonary toxicity. Can Respir J. 2009 Mar-Apr;16(2):43-8. doi: 10.1155/2009/282540.
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.