Atrial Dyssynchrony to Predict Arrhythmias in the Postoperative Setting of Cardiovascular Surgery. (SAD-POAF)

Atrial Electromechanical Alteration as a Predictor of Arrhythmias in the Postoperative Period After Cardiovascular Surgery

This study aims to improve the prediction for developing arrhythmias in the postoperative period of cardiovascular surgery by using non-invasive echocardiographic techniques that are sensitive to detect inter and intra-atrial dyssynchrony. The main question it aims to answer is:

Do patients with atrial dyssynchrony are at increased risk of developing arrhythmias in the postoperative period of cardiovascular surgery?

Patients admitted to the protocol will undergo an echocardiogram with atrial strain before surgery to determine the presence or absence of intra- and inter-atrial dyssynchrony and will be followed during hospitalization to assess the occurrence of atrial fibrillation in the postoperative period.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Complications; Atrial Fibrillation
• Intervention / Treatment: Diagnostic test: Atrial dyssynchrony

Detailed Description

The overall objective is to improve the prediction of the risk of developing arrhythmias in the postoperative period with non-invasive techniques that are sensitive to detect inter- and intra-atrial dysrhythmias.

Specific objectives

1. To describe the alterations in left and right atrial deformation by strain method to identify intra- and inter-atrial activation dyssynchrony.
2. To determine that dyssynchrony predicts a higher incidence of atrial fibrillation in the postoperative period after cardiovascular surgery.
3. To evaluate whether novel atrial function analysis techniques, such as left atrial ejection fraction assessed via 3D echocardiography, are associated with a higher incidence of postoperative atrial fibrillation.

All patients will undergo a full Doppler echocardiogram with two-dimensional atrial Strain determination with speckle tracking, using an Philips EPIC CVx series echocardiogram machine with S5-1 and X5-1 probes. The images will be obtained in left lateral decubitus. In forced expiration, 3 consecutive beats will be recorded and digitally saved for later analysis in the 4 and 2 chamber views. Both atria must be visualized so that neither atrial wall are lost in the evaluation. Echocardiographic measurements will focus primarily on the indexed left atrial volume obtained by averaging the values obtained in 2 and 4 chambers by the multiple disc method. In these views, the left ventricular ejection fraction will be obtained by the Simpson biplane method. The left atrium will be further subdivided into basal, medial and atrial roof segments, resulting in a total of 12 segments, 6 of which can be observed in the four-chamber view and 6 in the two-chamber view. The right atrium will be divided similarly but will contribute a mere three additional segments to the total (for a total of 15 segments), as the right septal segments were previously regarded as part of the left atrium. The time to maximum deflection, defined as the interval between the onset of the P wave on the electrocardiogram and the maximum deflection of the atrial contraction determined by strain rate, will be measured for each of the 15 atrial segments previously described. To determine interatrial synchrony, an adaptation of the atrial strain will be made so that both atria can be evaluated simultaneously. This new evaluation, which we have designated "OMEGA" (ω) due to its resemblance to the shape of the strain image, will yield the time to maximum deformation of the lateral segments of the right atrium and the lateral segments of the left atrium. Consequently, the difference in activation timing between the lateral segments of the right and left atria will determine the presence of an activation delta between the walls.

A comprehensive analysis of atrial deformation using left and right atrial strain will also be performed. Subsequently, the time-to-peak deformation will be measured from the onset of the P-wave to the peak negative atrial strain deflection, which correlates with atrial contractile strain. Activation time differences derived from this methodology will also be measured to provide an additional assessment of the interatrial activation delay (delta).

Patients will be followed during hospitalization with continuous electrocardiographic monitoring for the first 5 days after surgery to detect the incidence of atrial fibrillation. Patients will undergo telephonic follow-up at 28 and 365 days post-intervention, utilizing a targeted interview to evaluate for the onset of supraventricular arrhythmias.

Study data will be collected and managed using REDCap electronic data capture tools hosted at Faculty of Medicine, National University of Cuyo to a protocol designed specifically for this study.

The sample size calculation is performed according to Schoenfeld's method for Cox models. To detect a hazard ratio of 2.5 for atrial fibrillation events based on the presence or absence of interatrial dyssynchrony-estimating a cumulative event rate of 0.38 in the dyssynchronous group and 0.18 in the synchronous group, with a 0.44 proportion of dyssynchronous patients-and assuming a two-sided alpha level of 0.05 and 80% power, a total sample of 138 patients is determined.

Statistical analysis results are reported as mean (SD), median (p25-p75) or frequency (%). Comparisons between groups were performed with the Student t test or chi-squared analysis. The association between clinical variables and the study end-points was evaluated using survival analysis methodology (Cox regression models). The Kaplan-Meier method was used to estimate the cumulative probability of PAF detection and stroke recurrence in both groups, and comparisons were made by the log-rank test. Significance was set at P < 0.05.

• Study Type: Observational
• Enrollment (Estimated): 138

Contacts and Locations

• Study Contact: Name: Francisco Sánchez, PhD; Phone Number: 2659 +5492614135000; Email: fsanchez@fcm.uncu.edu.ar

Study Locations

• Argentina
  • Mendozz
    • Mendoza, Mendozz, Argentina, 5500
      • Recruiting
      • Clínica de Cuyo
      • Contact: Francisco Sanchez, PhD; Phone Number: 1250 542614059000; Email: fsanchez@fcm.uncu.edu.ar
      • Principal Investigator: Francisco Sanchez, PhD
      • Contact: Ariel Baigorria, Medical degree; Phone Number: 1142 +5492614059000; Email: ariel.baigorria@clinicadecuyo.com.ar

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a history of coronary artery disease, aortic stenosis or a combination of both pathologies, with indication for cardiovascular surgery according to the Guidelines for Cardiovascular Surgery of the European Society of Cardiology.

Description

Inclusion Criteria:

• Patients with criteria for non-mitral cardiovascular surgery, in sinus rhythm, and who gave informed consent to participate in the study.
• Absence of atrial fibrillation upon hospital admission for surgery.

Exclusion Criteria:

• Surgery of the mitral or tricuspid valve.
• History of previous atrial fibrillation.
• History of congenital heart disease or cardiac tumors.
• Emergency surgery of the heart
• Pour echocardiographic window

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of postoperatory atrial fibrillation	Arrhythmic episodes of at least 30 seconds duration will be considered postoperative atrial fibrillation when detected on continuous monitoring or when detected on a ward ECG, if the patient reported symptoms or required medical intervention.	From the end of surgery through hospital discharge, an average of 6 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial Fibrillation at 28 and 365 Days	Telephone follow-ups will be conducted with all patients at 28 and 365 days post-surgery. A brief interview will be administered to screen for the occurrence of arrhythmias during this period. Patients reporting a positive history will be scheduled for an on-site visit to request diagnostic tests documenting the arrhythmia.	From surgery through Day 28 and Day 365

Collaborators and Investigators

• Sponsor: School of Medicine. National University of Cuyo
• Investigators: Study Director: Emiliano Diez, PhD, National University of Cuyo

Publications and helpful links

General Publications

• Sánchez FJ, Gonzalez VA, Farrando M, Baigorria Jayat AO, Segovia-Roldan M, García-Mendívil L, Ordovás L, Prado NJ, Pueyo E, Diez ER. Atrial Dyssynchrony Measured by Strain Echocardiography as a Marker of Proarrhythmic Remodeling and Oxidative Stress in Cardiac Surgery Patients. Oxid Med Cell Longev. 2020:8895078.
• Badano, L.P.; Kolias, T.J.; Muraru, D.; Abraham, T.P.; Aurigemma, G.; Edvardsen, T.; D'Hooge, J.; Donal, E.; Fraser, A.G.; Marwick, T.; et al. Standardization of left atrial, right ventricular, and right atrial deformation imaging using two-dimensional speckle tracking echocardiography: A consensus document of the EACVI/ASE/Industry Task Force to standardize deformation imaging. Eur. Heart J. Cardiovasc. Imaging 2018, 19, 591-600, doi:10.1093/ehjci/jey042.
• Aksu, U.; Kalkan, K.; Gulcu, O.; Aksakal, E.; Öztürk, M.; Topcu, S. The role of the right atrium in development of postoperative atrial fibrillation: A speckle tracking echocardiography study. J. Clin. Ultrasound 2019, 47, 470-476, doi:10.1002/jcu.22736.
• Müller, P.M.; Hars, C.; Schiedat, F.; Osche, L.I.B.; Gotzmann, M.; Strauch, J.; Dietrich, J.W.; Vogt, M.; Tannapfel, A.; Deneke, T.; et al. Correlation Between Total Atrial Conduction Time Estimated via Tissue Doppler Imaging ( PA-TDI Interval ), Structural Atrial Remodeling and New-Onset of Atrial Fibrillation. J. Cardiovasc. Electrophysiol. 2013, 24, 626-631, doi:10.1111/jce.12084
• Merckx, K.L.; Vos, C.B. De; Palmans, A.; Habets, J.; Tieleman, R.G. Atrial Activation Time Determined by Transthoracic Doppler Tissue Imaging Can Be Used as an Estimate of the Total Duration of Atrial Electrical Activation. 940-944, doi:10.1016/j.echo.2005.03.022.
• Xu, C.; Chen, K.; Yu, F.; Wang, Q.; Su, H.; Yang, D.; Xu, J.; Yan, J. Atrial Dyssynchrony: A New Predictor for Atrial High-Rate Episodes in Patients with Cardiac Resynchronization Therapy. Cardiol. 2019, 144, 18-26, doi:10.1159/000502541.
• Ciuffo, L.; Tao, S.; Gucuk Ipek, E.; Zghaib, T.; Balouch, M.; Lima, J.A.C.; Nazarian, S.; Spragg, D.D.; Marine, J.E.; Berger, R.D.; et al. Intra-Atrial Dyssynchrony During Sinus Rhythm Predicts Recurrence After the First Catheter Ablation for Atrial Fibrillation. JACC Cardiovasc. Imaging 2019, 12, 310-319, doi:10.1016/j.jcmg.2017.11.028.
• . Pathan, F.; D'Elia, N.; Nolan, M.T.; Marwick, T.H.; Negishi, K. Normal Ranges of Left Atrial Strain by Speckle-Tracking Echocardiography: A Systematic Review and Meta-Analysis. J. Am. Soc. Echocardiogr. 2017, 30, 59-70.e8, doi:10.1016/j.echo.2016.09.007.
• Swartz, M.F.; Fink, G.W.; Sarwar, M.F.; Hicks, G.L.; Yu, Y.; Hu, R.; Lutz, C.J.; Taffet, S.M.; Jalife, J. Elevated pre-operative serum peptides for collagen i and III synthesis result in post-surgical atrial fibrillation. J. Am. Coll. Cardiol. 2012, 60, 1799-1806, doi:10.1016/j.jacc.2012.06.048.
• Lacalzada-Almeida, J.; Izquierdo-Gómez, M.M.; Belleyo-Belkasem, C.; Barrio-Martínez, P.; GarcíaNiebla, J.; Elosua, R.; Jiménez-Sosa, A.; Escobar-Robledo, L.A.; Bayés de Luna, A. Interatrial block and atrial remodeling assessed using speckle tracking echocardiography. BMC Cardiovasc. Disord. 2018, 18, 1-9, doi:10.1186/s12872-018-0776-6.
• Hatam, N.; Aljalloud, A.; Mischke, K.; Karfis, E.A.; Autschbach, R.; Hoffmann, R.; Goetzenich, A. Interatrial conduction disturbance in postoperative atrial fibrillation: A comparative study of P-wave dispersion and Doppler myocardial imaging in cardiac surgery. J. Cardiothorac. Surg. 2014, 9, 1-9, doi:10.1186/1749-8090-9-114
• Osranek, M.; Kaniz, F.; Fatema, Q.; Al-Saileek, A.; Barnes, M.E.; Bailey, K.R. Left Atrial Volume Predicts the Risk of Atrial Fibrillation After Cardiac Surgery A Prospective Study. J. Am. Coll. Cardiol. 2006, 48, doi:10.1016/j.jacc.2006.03.054.
• Liberale, L.; Montecucco, F.; Tardif, J.C.; Libby, P.; Camici, G.G. Inflamm-ageing: the role of inflammation in age- dependent cardiovascular disease. Eur. Heart J. 2020, 41, 2974-2982, doi:10.1093/eurheartj/ehz961.
• . Zakkar, M.; Ascione, R.; James, A.F.; Angelini, G.D.; Suleiman, M.S. Inflammation, oxidative stress and postoperative atrial fibrillation in cardiac surgery. Pharmacol. Ther. 2015, 154, 13-20, doi:10.1016/j.pharmthera.2015.06.009.
• Maesen, B.; Nijs, J.; Maessen, J.; Allessie, M.; Schotten, U. Post-operative atrial fibrillation: A maze of mechanisms. Europace 2012, 14, 159-174, doi:10.1093/europace/eur208.
• Akintoye, E.; Sellke, F.; Marchioli, R.; Tavazzi, L.; Mozaffarian, D. Factors associated with postoperative atrial fibrillation and other adverse events after cardiac surgery. J. Thorac. Cardiovasc. Surg. 2018, 155, 242-251.e10, doi:10.1016/j.jtcvs.2017.07.063.
• . Steinberg, B.A.; Zhao, Y.; He, X.; Hernandez, A.F.; Fullerton, D.A.; Thomas, K.L.; Mills, R.; Klaskala, W.; Peterson, E.D.; Piccini, J.P. Quality and Outcomes Management of Postoperative Atrial Fibrillation and Subsequent Outcomes in Contemporary Patients Undergoing Cardiac Surgery : Insights From the Society of Thoracic Surgeons CAPS-Care Atrial Fibrillation Registry. 2014, 13, 7-13, doi:10.1002/clc.22230.
• Júnior, F.P.; Filho, G.F.T.; Sant'anna, J.R.M.; Py, P.M.; Prates, P.R.; Nesralla, I.A.; Kalil, R.A. Idade avançada e incidência de fibrilação atrial em pós-operatório de troca valvar aórtica. Brazilian J. Cardiovasc. Surg. 2014, 29, 45-50, doi:10.5935/1678-9741.20140010.

Study record dates

Study Major Dates

• Study Start (Actual): February 6, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: January 19, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 4, 2026

Study Record Updates

• Last Update Posted (Actual): February 10, 2026
• Last Update Submitted That Met QC Criteria: February 6, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Atrial fibrillation; Echocardiography; Cardiovascular surgery; Atrial strain
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Pathological Conditions, Signs and Symptoms; Atrial Fibrillation; Postoperative Complications
• Other Study ID Numbers: 003. 03/10/2023.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data dictionary of analyzed variables and the corresponding statistical analysis will be available upon formal request by email.
• IPD Sharing Time Frame: The information will be available three months following the completion of patient enrollment and for a duration of five years thereafter.
• IPD Sharing Access Criteria: Upon reasonable request.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No