Postoperative Atrial Fibrillation
Conditions
Keywords
magnetic resonance imaging, implantable holter monitor, atrial heart disease
Brief summary
Postoperative atrial fibrillation (POAF) occurs in 20-40% of patients undergoing coronary artery bypass grafting (CABG) and is a marker of atrial vulnerability. It is strongly associated with AF recurrence, stroke, and cardiovascular mortality. It presents risk factors with atrial heart disease. The latter refers to all structural, electrical, and mechanical alterations of the atrium that create a substrate conducive to AF. Multiparametric cardiac MRI is currently the most comprehensive test for assessing atrial heart disease, thanks to its structural and functional analysis (atrial fibrosis, atrial strain, intracavitary 4D flow). However, to date, no prospective study has evaluated these parameters as predictors of AF recurrence after CAP. At the same time, an implantable Holter monitor will be used to enable detailed and continuous detection of recurrence episodes, overcoming the limitations of conventional monitoring strategies. By combining multiparametric imaging, histological analysis, and continuous monitoring for the first time, this study proposes a paradigm shift in the assessment of postoperative AF: moving from a descriptive and ad hoc approach to a mechanistic, integrative, and predictive approach.
Interventions
DEVICE4D cardiac MRI with gadoteric acid
4D cardiac MRI with gadoteric acid injection will be performed prior the surgery, according to a standardized technical protocol.
BIOLOGICALBlood sample
Peripheral venous blood sample (1 x 6 ml EDTA tube): taken during preoperative assessment to measure inflammatory biomarkers (CRP, IL-1, TNF-α).
Implantation of a Holter monitor (Implantable Loop Recorder) prior to surgery, performed preoperatively under local anesthesia. The ILR will enable continuous recording of the heart rhythm for 12 months with automatic data transmission via remote monitoring. The minimally invasive procedure will be performed by an experienced cardiologist under the usual safety conditions.
PROCEDURERight atrial biopsy
During the surgical procedure (coronary artery bypass grafting), a right atrial biopsy will be performed using a brief, low-risk procedure on a small tissue sample. The sample will be analyzed using Masson's trichrome staining to assess atrial fibrosis.
Sponsors
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Prospective single-center pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years * Indication for surgical myocardial revascularization by isolated coronary artery bypass grafting, to be performed in the cardiac surgery department of Saint-Étienne University Hospital. * Patient affiliated with or entitled to social security coverage * Patient who has received informed information about the study and has co-signed, with the investigator, a consent form to participate in the study
Exclusion criteria
* Contraindication related to cardiac MRI * Contraindication related to ILR implantation * Documented history of atrial fibrillation * Concomitant indication for valve surgery or other associated cardiac intervention * Inability to understand French * Patient refusal to participate in the study and/or inability to express consent or sign the informed consent form * Patient subject to legal protection measures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the predictive value of atrial heart disease characterized by multiparametric MRI (late enhancement fibrosis, atrial strain, and exploratory 4D flow parameters) for the recurrence of atrial fibrillation documented by Implantable Loop Recorder. | through study completion, an average of 12 months | Recurrence of atrial fibrillation, defined as an episode lasting ≥ 30 seconds documented by the Implantable Loop Recorder (ILR) implanted preoperatively and recorded during the 12-month follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluate the link between atrial heart disease characterized by MRI (fibrosis, strain, 4D flow) and the occurrence of postoperative atrial fibrillation (POAF) during the first week following coronary artery bypass grafting. | through the first postoperative week | POAF will be defined as an episode of AF ≥ 30 seconds, detected by the preoperatively implanted ILR and recorded during the first postoperative week. |
| Correlate MRI parameters of atrial remodeling with histological assessment of fibrosis on intraoperative atrial biopsy | through the first postoperative week | Percentage of histological fibrosis. Analysis of atrial fibrosis using Masson's trichrome staining on intraoperative atrial biopsy (normal threshold ≤ 10%). The objective is to establish a correlation between histological data and MRI parameters. |
| Exploring the value of atrial hemodynamic parameters obtained by 4D flow MRI (vorticity, intra-atrial velocities) as predictive markers of atrial fibrillation | Before the surgery | measurement of intra-auricular blood flow using 4D-flow MRI, including velocities (cm/s), flow volumes (mL/s or mL), and vorticity indices (s-¹) |
| To study the association between serum inflammatory biomarkers (CRP, IL-1, TNF-α) and Atrial Fibrillation recurrence. | before the surgery | Preoperative measurement of pro-inflammatory cytokines (IL-1, TNF-α, CRP). |
| Determine the impact of atrial fibrillation recurrence documented by ILR on the occurrence of major cardiovascular events | through study completion, an average of 12 months | Number of ischemic strokes, hospitalizations for heart failure, cardiovascular deaths occurring within one year of surgery, and all-cause deaths. |
Countries
France
Contacts
CONTACTKarim Benali, MD
STUDY_DIRECTORJean-Baptiste GUICHARD, MD
Hospital Clinic of Barcelona
Outcome results
None listed