Impact of Aortic Geometry on Vascular Remodeling After Stent Implantation in Coarctation of the Aorta

Overview

This study aims to assess: 1. Aortic geometrical changes and their relationship to hypertension and cardiovascular events. 2. Aortic geometrical differences between healthy individuals and patients with repaired coarctation of the aorta.

Detailed description

Coarctation of the aorta (CoA) is a congenital narrowing of the aortic lumen, accounting for 5-8% of congenital heart diseases, with an incidence of 1 in 3000-4000 live births . This narrowing leads to altered hemodynamics, including increased left ventricular afterload, systemic hypertension, and long-term vascular remodeling, which can persist even after anatomical correction .

Despite advances in interventions like stent implantation for native or recurrent CoA, many patients remain hypertensive post-procedure . This residual hypertension may not be purely mechanical but linked to persistent vascular dysfunction, abnormal aortic compliance, or inadequate aortic wall remodeling .

Aortic stiffness is now recognized as a key cardiovascular risk factor in CoA patients . Reduced elasticity contributes to high systolic blood pressure, increased cardiac workload, and late cardiovascular complications \[7\]. Moreover, abnormal aortic arch geometry-particularly the "gothic arch"-has been linked to impaired vascular function and unfavorable hemodynamics \[13\].

While cardiac magnetic resonance (CMR) is the standard for evaluating aortic stiffness and ventricular function , CT Aortography offers high-resolution images to assess aortic distensibility, luminal changes, and residual stenosis, especially post-stenting . When combined with blood pressure and ECG data, these insights can provide a fuller picture of outcomes .

This study investigates the relationship between post-stenting blood pressure and aortic geometry-including arch shape and residual stenosis-using CT Aortography in CoA patients. It also explores ECG changes as potential non-invasive markers of ventricular strain and hemodynamic stress ..

Interventions

• Radiation CT aortography
  Performed before and after stenting using a multidetector CT scanner (device model and parameters to be specified). Analysis will include: * Evaluation of aortic arch geometry (normal / gothic / crenel). * Measurement of residual stenosis at the site of coarctation. * Aortic diameter measurements at predefined anatomical levels: Ascending aorta (AA), Proximal descending thoracic aorta (PDA), At the level of the diaphragm (DA), Abdominal aorta (AbAo). \- Aortic tortuosity. All CT data will be
• Radiation CMR
  CMR examinations will be performed using a commercially available 1.5 Tesla whole-body scanner (Ingenia, Philips Healthcare, release 4.1.3.0). In pediatric or uncooperative patients, free-breathing sequences were used when breath-holding was not feasible. Brachial blood pressure was measured in the right arm in the supine position immediately before image acquisition using automated oscillometric devices. Cine steady-state free precession (SSFP) sequences were obtained in multiple views includ

Primary outcome measures

• Change in Systolic Blood Pressure [Time frame: Baseline and 6 months post-stenting]
• Change in Diastolic Blood Pressure [Time frame: Baseline and 6 months post-stenting]

Secondary outcome measures (12)

• Aortic Arch Morphology Classification [Time frame: Baseline (within hospital stay, up to 2 days)]
• Aortic Elasticity [Time frame: Baseline and 6 months post-stenting]
• Aortic Distensibility [Time frame: Baseline and 6 months post-stenting]
• Aortic Arch Angle [Time frame: Baseline and 6 months post-stenting]
• Aortic Arch Curvature [Time frame: Baseline and 6 months post-stenting]
• Residual Stenosis [Time frame: 6 months post-stenting]
• Left Ventricular Ejection Fraction (LVEF) [Time frame: Baseline and 6 months post-stenting]
• LV Global Longitudinal Strain [Time frame: Baseline and 6 months post-stenting]
• LV Mass Index (LVMI) [Time frame: Baseline and 6 months post-stenting]
• Left Atrial Volume Index (LAVI) [Time frame: Baseline and 6 months post-stenting]
• QTc Dispersion [Time frame: Baseline and 6 months post-stenting]
• Presence of Left Ventricular Hypertrophy on ECG [Time frame: Baseline and 6 months post-stenting]

Eligibility criteria

Inclusion criteria

Age ≥ 12 years.

Diagnosed with native or recurrent coarctation of the aorta.

Transcatheter systolic pressure gradient ≥ 20 mmHg.

Body weight ≥ 20 kg.

Availability of pre- and post-stenting CT aortography data.

Exclusion criteria

Patients with obstructive lesion of LVOT or aortic valve dysfunction greater than moderate (requiring surgical intervention)..

Patients with other causes of secondary hypertension.

Associated complex congenital heart defects (aside from simple septal defects and patent ductus arteriosus)

Genetic syndromes

Connective tissue disorder

History of surgery involving the aortic root or ascending aorta.

Incomplete imaging or missing data relevant to the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model

Cohort

Study locations

Egypt · 1 center

• Institutional Review Board (IRB) of Faculty of Medicine — Asyut

Publications

• Shepherd B, Abbas A, McParland P, Fitzsimmons S, Shambrook J, Peebles C, Brown I, Harden S. MRI in adult patients with aortic coarctation: diagnosis and follow-up. Clin Radiol. 2015 Apr;70(4):433-45. doi: 10.1016/j.crad.2014.12.005. Epub 2015 Jan 3. PMID 25559379
• Toro-Salazar OH, Steinberger J, Thomas W, Rocchini AP, Carpenter B, Moller JH. Long-term follow-up of patients after coarctation of the aorta repair. Am J Cardiol. 2002 Mar 1;89(5):541-7. doi: 10.1016/s0002-9149(01)02293-7. PMID 11867038
• Parati G, Stergiou GS, Asmar R, Bilo G, de Leeuw P, Imai Y, Kario K, Lurbe E, Manolis A, Mengden T, O'Brien E, Ohkubo T, Padfield P, Palatini P, Pickering T, Redon J, Revera M, Ruilope LM, Shennan A, Staessen JA, Tisler A, Waeber B, Zanchetti A, Mancia G; ESH Working Group on Blood Pressure Monitoring. European Society of Hypertension guidelines for blood pressure monitoring at home: a summary rep PMID 18622223
• Iriart X, Laik J, Cremer A, Martin C, Pillois X, Jalal Z, Roubertie F, Thambo JB. Predictive factors for residual hypertension following aortic coarctation stenting. J Clin Hypertens (Greenwich). 2019 Feb;21(2):291-298. doi: 10.1111/jch.13452. Epub 2018 Dec 25. PMID 30585428
• Pushparajah K, Duong P, Mathur S, Babu-Narayan S. EDUCATIONAL SERIES IN CONGENITAL HEART DISEASE: Cardiovascular MRI and CT in congenital heart disease. Echo Res Pract. 2019 Oct 1;6(4):R121-38. doi: 10.1530/ERP-19-0048. Online ahead of print. PMID 31730044
• Faganello G, Cioffi G, Rossini M, Ognibeni F, Giollo A, Fisicaro M, Russo G, Di Nora C, Doimo S, Tarantini L, Mazzone C, Cherubini A, D'Agata Mottolesi B, Pandullo C, Di Lenarda A, Sinagra G, Viapiana O. Are aortic coarctation and rheumatoid arthritis different models of aortic stiffness? Data from an echocardiographic study. Cardiovasc Ultrasound. 2018 Jun 26;16(1):9. doi: 10.1186/s12947-018-0126 PMID 29940971
• Agasthi P, Pujari SH, Tseng A, Graziano JN, Marcotte F, Majdalany D, Mookadam F, Hagler DJ, Arsanjani R. Management of adults with coarctation of aorta. World J Cardiol. 2020 May 26;12(5):167-191. doi: 10.4330/wjc.v12.i5.167. PMID 32547712
• Ou P, Mousseaux E, Celermajer DS, Pedroni E, Vouhe P, Sidi D, Bonnet D. Aortic arch shape deformation after coarctation surgery: effect on blood pressure response. J Thorac Cardiovasc Surg. 2006 Nov;132(5):1105-11. doi: 10.1016/j.jtcvs.2006.05.061. PMID 17059930

Identifiers

NCT: NCT07131111 · Vascular remodeling in COA

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗