TOF
Conditions
Brief summary
Title: Functional Assessment and Arrhythmia Prediction in Adult Patients with Repaired Tetralogy of Fallot Using a Multimodality Approach Background: Tetralogy of Fallot (TOF) is the most common cyanotic congenital heart defect. Surgical repair has improved survival into adulthood, but long-term complications like arrhythmias and heart failure remain common. Assessing health-related quality of life (HRQOL) and cardiac function is essential. Aim: Assess functional status of adult patients with repaired TOF using a multimodal approach, including myocardial strain analysis via CMR. Identify predictors of arrhythmia using strain and clinical parameters. Methods: Design: Prospective observational study over one year. Population: Adults (≥18 years) with repaired TOF undergoing follow-up CMR. Assessments: Clinical evaluation (NYHA class) Echocardiography (RV size, function, valve status) Laboratory tests (BNP, NT-proBNP) Exercise testing (METs, VO₂ max) ECG & 24-hour Holter monitoring (QRS duration, arrhythmias) CMR (volumes, flow, fibrosis, strain analysis of RA, RV, LV) Outcomes: Primary: Functional assessment of repaired TOF patients. Secondary: Detection of arrhythmia and need for further interventions (e.g., ICD or ablation). Statistical Analysis: Comparison between arrhythmic and non-arrhythmic groups. Logistic regression for predictors of arrhythmia. ROC analysis to determine optimal strain cut-off values. Ethical Considerations: Ethics committee approval and informed consent. Data confidentiality maintained.
Interventions
DIAGNOSTIC_TESTCMR, stress ECG, Holter, BnP
This study involves no experimental intervention. All data were collected retrospectively from patients with repaired Tetralogy of Fallot (TOF) who underwent standard clinical follow-up. As part of routine care, patients received comprehensive multimodal functional assessment, including: Cardiac Magnetic Resonance Imaging (CMR) with feature-tracking strain analysis Transthoracic Echocardiography Exercise stress testing (treadmill ECG using Bruce protocol) 12-lead ECG and 24-hour Holter monitoring Laboratory evaluation including NT-proBNP levels NYHA functional class assessment
Sponsors
Assiut University
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria: * Adult TOF patients who were referred for surgical repair of TOF either valve sparing repair (VSR) or valved conduit (stented valve conduits, freestyle valved conduits, bio-prosthesis, or homograft). * Adults (age ≥18 years) with repaired TOF. * Undergoing routine CMR for clinical follow-up. * Sinus rhythm or known history of ventricular arrhythmia. *
Exclusion criteria
* Confounding other congenital defects e.g. AV canal. * Significant aortic regurgitation or stenosis. * Significant mitral regurgitation. * Residual significant major aorto-pulmonary collaterals (MAPCAs). * Patients with contraindications to CMR (e.g., pacemakers, severe renal impairment, claustrophobic). * Poor-quality CMR images precluding strain analysis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NYHA Class | 1 year | New York Heart Association (NYHA) classification 1 to 4 |
| cardiac magnetic resonance (CMR) | 1 years | myocardial strain parameters |
| Exercise capacity (METs) | 1 years | Functional capacity 1-15 |
| NT-proBNP levels | 1 yeqrs | Mg/dl |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Arrhythmia in Adults with Repaired Tetralogy of Fallot (TOF) | At time of most recent follow-up (minimum 3 months post-surgical repair) | Identification and documentation of arrhythmias based on standard 12-lead ECG and 24-hour Holter monitoring. Includes detection of premature ventricular contractions (PVCs), sustained or non-sustained ventricular tachycardia (VT), atrial flutter, atrial fibrillation, or other clinically significant arrhythmias requiring intervention. |
Contacts
Primary ContactAlaa AA Abdelhafez
Outcome results
None listed