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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, VOâ‚‚ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with TOF | The study cohort consists of adult patients (≥18 years) with previously repaired Tetralogy of Fallot (TOF) who underwent routine clinical follow-up, including cardiac imaging, functional testing, and laboratory investigations. Patients included underwent surgical repair using either valve-sparing techniques or valved conduits and had follow-up assessments performed at least 3 months post-surgery. Data will be retrospectively collected from medical records, imaging databases, and clinical documentation. The cohort includes patients in sinus rhythm or with a documented history of ventricular arrhythmia, all of whom were referred for routine cardiovascular magnetic resonance (CMR) imaging and other functional assessments as part of standard care. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CMR, stress ECG, Holter, BnP | Diagnostic Test | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| NYHA Class | New York Heart Association (NYHA) classification 1 to 4 | 1 year |
| cardiac magnetic resonance (CMR) | myocardial strain parameters | 1 years |
| Exercise capacity (METs) | Functional capacity 1-15 | 1 years |
| NT-proBNP levels | Mg/dl | 1 yeqrs |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Arrhythmia in Adults with Repaired Tetralogy of Fallot (TOF) | 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. |
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Inclusion criteria:
Exclusion criteria:
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The study population includes adult patients (age ≥18 years) with previously repaired Tetralogy of Fallot (TOF), who were referred for routine clinical follow-up at least 3 months post-surgical correction. These patients underwent standard evaluations including cardiovascular magnetic resonance (CMR), transthoracic echocardiography, ECG, Holter monitoring, NT-proBNP measurement, and exercise stress testing. Patients were either in sinus rhythm or had a documented history of ventricular arrhythmia. Individuals with other major congenital heart defects, significant valvular disease, or contraindications to CMR were excluded.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alaa AA Abdelhafez | Contact | 01140522334 | alaaabdelrahman300@aun.edu.eg |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24076489 | Background | Villafane J, Feinstein JA, Jenkins KJ, Vincent RN, Walsh EP, Dubin AM, Geva T, Towbin JA, Cohen MS, Fraser C, Dearani J, Rosenthal D, Kaufman B, Graham TP Jr; Adult Congenital and Pediatric Cardiology Section, American College of Cardiology. Hot topics in tetralogy of Fallot. J Am Coll Cardiol. 2013 Dec 10;62(23):2155-66. doi: 10.1016/j.jacc.2013.07.100. Epub 2013 Sep 27. | |
| 1622697 |
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|
| At time of most recent follow-up (minimum 3 months post-surgical repair) |
| Background |
| Carvalho JS, Shinebourne EA, Busst C, Rigby ML, Redington AN. Exercise capacity after complete repair of tetralogy of Fallot: deleterious effects of residual pulmonary regurgitation. Br Heart J. 1992 Jun;67(6):470-3. doi: 10.1136/hrt.67.6.470. |
| 34384226 | Background | Steinmetz M, Stumpfig T, Seehase M, Schuster A, Kowallick J, Muller M, Unterberg-Buchwald C, Kutty S, Lotz J, Uecker M, Paul T. Impaired Exercise Tolerance in Repaired Tetralogy of Fallot Is Associated With Impaired Biventricular Contractile Reserve: An Exercise-Stress Real-Time Cardiovascular Magnetic Resonance Study. Circ Cardiovasc Imaging. 2021 Aug;14(8):e011823. doi: 10.1161/CIRCIMAGING.120.011823. Epub 2021 Aug 13. |
| 20620859 | Background | Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available. |
| 19130998 | Background | Baumgartner H, Hung J, Bermejo J, Chambers JB, Evangelista A, Griffin BP, Iung B, Otto CM, Pellikka PA, Quinones M; American Society of Echocardiography; European Association of Echocardiography. Echocardiographic assessment of valve stenosis: EAE/ASE recommendations for clinical practice. J Am Soc Echocardiogr. 2009 Jan;22(1):1-23; quiz 101-2. doi: 10.1016/j.echo.2008.11.029. No abstract available. |
| 20591618 | Background | Renella P, Aboulhosn J, Lohan DG, Jonnala P, Finn JP, Satou GM, Williams RJ, Child JS. Two-dimensional and Doppler echocardiography reliably predict severe pulmonary regurgitation as quantified by cardiac magnetic resonance. J Am Soc Echocardiogr. 2010 Aug;23(8):880-6. doi: 10.1016/j.echo.2010.05.019. Epub 2010 Jul 1. |