Effect of Venous Cannulation on the Incidence of Atrial Fibrillation in Patients Undergoing Coronary Artery Bypass

NCT04641611 | Completed

• 1 other identifier: 000
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Context Atrial fibrillation is the most frequent arrhythmia following coronary artery bypass grafting. POAF is associated with worse outcomes following CABG. In addition, recurrence of AF is associated with longer hospital stay and higher rate of neurological and renal complications compared to a single episode of AF Objective To estimate the proportion of eligible people who are willing to participate, number of participants who drop out of the trial and use the results of this study to inform a larger study. Study Design: Pilot randomized controlled trial. Patients will be blinded to the intervention. Participants: The study population will include 40 patients. Patients admitted to the Jewish General Hospital for elective coronary artery bypass grafting from May 2021 will be included in the study. Patients will be included if they were in sinus rhythm with a HR ≥50 bpm, undergoing on-pump coronary artery bypass grafting and hemodynamically stable. Patients will be excluded from the study if they meet any of the following criteria: Second or third degree heart block, LVEF \<35%, left atrial volume index ≥42 ml/m2, right atrial volume index \> 47 ml/m2, any degree of tricuspid regurgitation, any degree of right ventricular dysfunction, emergency or minimally invasive operation, concurrent valve operation, history of atrial fibrillation or previous cardiac surgery Study Interventions and Measures Patients will be randomly assigned to one of two treatment groups according to the venous cannulation technique used during surgery. Group A will undergo cavoatrial cannulation with a 2-stage venous cannula. Group B will undergo bicaval cannulation with snares. Similar surgical methods will be used in all treatment groups . The primary endpoint will be defined as any episode of atrial fibrillation in any participant lasting \>5 minutes in duration or any episode leading to hemodynamic compromise (SBP\<90 mmHg) or causing symptoms (angina or dyspnea). Atrial fibrillation will be diagnosed using telemetry and a 12-lead ECG. Patients will be followed up in 1 month with a 12-lead ECG to determine their rhythm. The secondary endpoints are the development of RV dysfunction, tricuspid regurgitation and any increase in left atrial volume index as detected by post-operative transthoracic echocardiography.

Conditions

Atrial Fibrillation

Keywords

Atrial fibrillation; Coronary Artery Bypass; Cardiac surgery; Risk Factors

Outcome Measures

Primary Outcomes (1)

• Atrial fibrillation

  Number of participants who develop atrial fibrillation that requires treatment. Atrial fibrillation will be defined as any episode in any participant lasting \>5 minutes in duration or any episode leading to hemodynamic compromise (SBP\<90 mmHg) or causing symptoms (angina or dyspnea).

  During hospital admission and clinic visit at 30 days from hospital discharge date.

Secondary Outcomes (3)

• Tricuspid regurgitation

  on transthoracic echocardiogram performed on day 2-5 post-operatively

• Right ventricular dysfunction

  on transthoracic echocardiogram performed on day 2-5 post-operatively

• Increase in Left atrial index

  on transthoracic echocardiogram performed on day 2-5 post-operatively

Study Arms (2)

Cavoatrial cannulation

ACTIVE COMPARATOR

Cannulation of the atrium with 2-stage venous cannula.

Other: Cavoatrial cannulation

Bicaval cannulation

EXPERIMENTAL

Cannulating the superior and inferior vena cavae with separate cannulas, inserted through 2 separate incisions in the right artium going into the superior and inferior vena cavae. No slush added. This technique is used in Right heart procedure (Pulmonic and tricuspid valve) and mitral valve procedures. This technique is not routinely used in CABG operations.

Other: Bicaval cannulation

Interventions

Bicaval cannulation OTHER

Cannulation of SVC and IVC through right atrium in patients undergoing CABG. with snares applied

Bicaval cannulation

Cavoatrial cannulation OTHER

Cannulating the right atrium and Inferior vena cava with a 2-stage cannula

Cavoatrial cannulation

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients admitted for coronary artery bypass grafting under the care of the principal investigator at the Jewish General Hospital during the study period will be included if they meet all the following criteria:
• Age \>18 years
• Sinus rhythm with HR \>50bpm
• Scheduled to undergo isolated elective on-pump CABG
• Hemodynamically stable.

You may not qualify if:

• Patients will be excluded from the study if they meet any of the following criteria:
• Second or third degree heart block
• LVEF \<35%
• left atrial volume index ≥42 ml/m2
• right atrial volume index \> 47 ml/m2
• any degree of tricuspid regurgitation
• any degree of right ventricular dysfunction
• emergency or minimally invasive operation
• concurrent valve operation
• history of atrial fibrillation
• previous cardiac surgery
• previous catheter ablation for atrial fibrillation
• pre-operative use of class I or III anti-arrhythmics.

Sponsors & Collaborators

• Dr. Jean-Francois Morin: lead

Study Sites (1)

Jewish General Hospital.

Montreal, Quebec, H3T 1E2, Canada

Location

Related Publications (27)

• Maesen B, Nijs J, Maessen J, Allessie M, Schotten U. Post-operative atrial fibrillation: a maze of mechanisms. Europace. 2012 Feb;14(2):159-74. doi: 10.1093/europace/eur208. Epub 2011 Aug 6.

  PMID: 21821851 BACKGROUND

• Attaran S, Shaw M, Bond L, Pullan MD, Fabri BM. Atrial fibrillation postcardiac surgery: a common but a morbid complication. Interact Cardiovasc Thorac Surg. 2011 May;12(5):772-7. doi: 10.1510/icvts.2010.243782. Epub 2011 Feb 28.

  PMID: 21357310 BACKGROUND

• Mariscalco G, Klersy C, Zanobini M, Banach M, Ferrarese S, Borsani P, Cantore C, Biglioli P, Sala A. Atrial fibrillation after isolated coronary surgery affects late survival. Circulation. 2008 Oct 14;118(16):1612-8. doi: 10.1161/CIRCULATIONAHA.108.777789. Epub 2008 Sep 29.

  PMID: 18824644 BACKGROUND

• Filardo G, Hamilton C, Hebeler RF Jr, Hamman B, Grayburn P. New-onset postoperative atrial fibrillation after isolated coronary artery bypass graft surgery and long-term survival. Circ Cardiovasc Qual Outcomes. 2009 May;2(3):164-9. doi: 10.1161/CIRCOUTCOMES.108.816843. Epub 2009 Apr 24.

  PMID: 20031833 BACKGROUND

• Mathew JP, Fontes ML, Tudor IC, Ramsay J, Duke P, Mazer CD, Barash PG, Hsu PH, Mangano DT; Investigators of the Ischemia Research and Education Foundation; Multicenter Study of Perioperative Ischemia Research Group. A multicenter risk index for atrial fibrillation after cardiac surgery. JAMA. 2004 Apr 14;291(14):1720-9. doi: 10.1001/jama.291.14.1720.

  PMID: 15082699 BACKGROUND

• Perrier S, Meyer N, Hoang Minh T, Announe T, Bentz J, Billaud P, Mommerot A, Mazzucotelli JP, Kindo M. Predictors of Atrial Fibrillation After Coronary Artery Bypass Grafting: A Bayesian Analysis. Ann Thorac Surg. 2017 Jan;103(1):92-97. doi: 10.1016/j.athoracsur.2016.05.115. Epub 2016 Aug 28.

  PMID: 27577036 BACKGROUND

• Rousou JA, Meeran MK, Engelman RM, Breyer RH, Lemeshow S. Does the type of venous drainage or cardioplegia affect postoperative conduction and atrial arrhythmias? Circulation. 1985 Sep;72(3 Pt 2):II259-63.

  PMID: 3875436 BACKGROUND

• Maisel WH, Rawn JD, Stevenson WG. Atrial fibrillation after cardiac surgery. Ann Intern Med. 2001 Dec 18;135(12):1061-73. doi: 10.7326/0003-4819-135-12-200112180-00010.

  PMID: 11747385 BACKGROUND

• Haissaguerre M, Jais P, Shah DC, Takahashi A, Hocini M, Quiniou G, Garrigue S, Le Mouroux A, Le Metayer P, Clementy J. Spontaneous initiation of atrial fibrillation by ectopic beats originating in the pulmonary veins. N Engl J Med. 1998 Sep 3;339(10):659-66. doi: 10.1056/NEJM199809033391003.

  PMID: 9725923 BACKGROUND

• Schotten U, Verheule S, Kirchhof P, Goette A. Pathophysiological mechanisms of atrial fibrillation: a translational appraisal. Physiol Rev. 2011 Jan;91(1):265-325. doi: 10.1152/physrev.00031.2009.

  PMID: 21248168 BACKGROUND

• Crystal E, Garfinkle MS, Connolly SS, Ginger TT, Sleik K, Yusuf SS. Interventions for preventing post-operative atrial fibrillation in patients undergoing heart surgery. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003611. doi: 10.1002/14651858.CD003611.pub2.

  PMID: 15495059 BACKGROUND

• Boos CJ, Anderson RA, Lip GY. Is atrial fibrillation an inflammatory disorder? Eur Heart J. 2006 Jan;27(2):136-49. doi: 10.1093/eurheartj/ehi645. Epub 2005 Nov 8.

  PMID: 16278230 BACKGROUND

• Mathew JP, Parks R, Savino JS, Friedman AS, Koch C, Mangano DT, Browner WS. Atrial fibrillation following coronary artery bypass graft surgery: predictors, outcomes, and resource utilization. MultiCenter Study of Perioperative Ischemia Research Group. JAMA. 1996 Jul 24-31;276(4):300-6.

  PMID: 8656542 BACKGROUND

• Amar D, Shi W, Hogue CW Jr, Zhang H, Passman RS, Thomas B, Bach PB, Damiano R, Thaler HT. Clinical prediction rule for atrial fibrillation after coronary artery bypass grafting. J Am Coll Cardiol. 2004 Sep 15;44(6):1248-53. doi: 10.1016/j.jacc.2004.05.078.

  PMID: 15364327 BACKGROUND

• Chua SK, Shyu KG, Lu MJ, Lien LM, Lin CH, Chao HH, Lo HM. Clinical utility of CHADS2 and CHA2DS2-VASc scoring systems for predicting postoperative atrial fibrillation after cardiac surgery. J Thorac Cardiovasc Surg. 2013 Oct;146(4):919-926.e1. doi: 10.1016/j.jtcvs.2013.03.040. Epub 2013 Apr 26.

  PMID: 23628495 BACKGROUND

• Khan AM, Lubitz SA, Sullivan LM, Sun JX, Levy D, Vasan RS, Magnani JW, Ellinor PT, Benjamin EJ, Wang TJ. Low serum magnesium and the development of atrial fibrillation in the community: the Framingham Heart Study. Circulation. 2013 Jan 1;127(1):33-8. doi: 10.1161/CIRCULATIONAHA.111.082511. Epub 2012 Nov 21.

  PMID: 23172839 BACKGROUND

• Zaman AG, Archbold RA, Helft G, Paul EA, Curzen NP, Mills PG. Atrial fibrillation after coronary artery bypass surgery: a model for preoperative risk stratification. Circulation. 2000 Mar 28;101(12):1403-8. doi: 10.1161/01.cir.101.12.1403.

  PMID: 10736284 BACKGROUND

• Booth JV, Phillips-Bute B, McCants CB, Podgoreanu MV, Smith PK, Mathew JP, Newman MF. Low serum magnesium level predicts major adverse cardiac events after coronary artery bypass graft surgery. Am Heart J. 2003 Jun;145(6):1108-13. doi: 10.1016/S0002-8703(03)00077-2.

  PMID: 12796771 BACKGROUND

• Fairley JL, Zhang L, Glassford NJ, Bellomo R. Magnesium status and magnesium therapy in cardiac surgery: A systematic review and meta-analysis focusing on arrhythmia prevention. J Crit Care. 2017 Dec;42:69-77. doi: 10.1016/j.jcrc.2017.05.038. Epub 2017 Jun 21.

  PMID: 28688240 BACKGROUND

• Lancaster TS, Schill MR, Greenberg JW, Moon MR, Schuessler RB, Damiano RJ Jr, Melby SJ. Potassium and Magnesium Supplementation Do Not Protect Against Atrial Fibrillation After Cardiac Operation: A Time-Matched Analysis. Ann Thorac Surg. 2016 Oct;102(4):1181-8. doi: 10.1016/j.athoracsur.2016.06.066. Epub 2016 Sep 2.

  PMID: 27596917 BACKGROUND

• Cook RC, Yamashita MH, Kearns M, Ramanathan K, Gin K, Humphries KH. Prophylactic magnesium does not prevent atrial fibrillation after cardiac surgery: a meta-analysis. Ann Thorac Surg. 2013 Feb;95(2):533-41. doi: 10.1016/j.athoracsur.2012.09.008. Epub 2012 Nov 7.

  PMID: 23141526 BACKGROUND

• Kalus JS, Caron MF, White CM, Mather JF, Gallagher R, Boden WE, Kluger J. Impact of fluid balance on incidence of atrial fibrillation after cardiothoracic surgery. Am J Cardiol. 2004 Dec 1;94(11):1423-5. doi: 10.1016/j.amjcard.2004.08.017.

  PMID: 15566917 BACKGROUND

• Matsuura K, Ogino H, Matsuda H, Minatoya K, Sasaki H, Yagihara T, Kitamura S. Impact of volume status on the incidence of atrial fibrillation following aortic arch repair. Heart Vessels. 2007 Jan;22(1):21-4. doi: 10.1007/s00380-006-0928-y. Epub 2007 Jan 26.

  PMID: 17285441 BACKGROUND

• Panesar SS, Athanasiou T, Nair S, Rao C, Jones C, Nicolaou M, Darzi A. Early outcomes in the elderly: a meta-analysis of 4921 patients undergoing coronary artery bypass grafting--comparison between off-pump and on-pump techniques. Heart. 2006 Dec;92(12):1808-16. doi: 10.1136/hrt.2006.088450. Epub 2006 Jun 14.

  PMID: 16775087 BACKGROUND

• Tchervenkov CI, Wynands JE, Symes JF, Malcolm ID, Dobell AR, Morin JE. Persistent atrial activity during cardioplegic arrest: a possible factor in the etiology of postoperative supraventricular tachyarrhythmias. Ann Thorac Surg. 1983 Oct;36(4):437-43. doi: 10.1016/s0003-4975(10)60484-5.

  PMID: 6605126 BACKGROUND

• Rosenfeldt FL, Watson DA. II. Interference with local myocardial cooling by heat gain during aortic cross-clamping. Ann Thorac Surg. 1979 Jan;27(1):13-6. doi: 10.1016/s0003-4975(10)62964-5.

  PMID: 453953 BACKGROUND

• Bennett EV Jr, Fewel JG, Grover FL, Trinkle JK. Myocardial preservation: effect of venous drainage. Ann Thorac Surg. 1983 Aug;36(2):132-42. doi: 10.1016/s0003-4975(10)60446-8.

  PMID: 6882072 BACKGROUND

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean-François Morin, MD,FRCSC

  Jewish General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patient will be blinded with regards to type of venous cannulation performed intra-operatively. Measurement of outcome will be performed by an independent cardiologist, who is blinded to treatment allocation.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Surgical director, Division of Cardiac and Vascular surgery and Cardiology

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: November 24, 2020
• Study Start: July 1, 2022
• Primary Completion: February 1, 2024
• Study Completion: March 1, 2024
• Last Updated: April 9, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)