Discrimination of Right Versus Left Septal Accessory Pathway Before and During the Electrophysiological Study

Study of ECG and electrophysiological criteria which discriminate right versus left septal AP (both posteroseptal and anteroseptal AP). Both manifest and concealed APs will be considered .

Study Overview

• Status: Recruiting
• Conditions: Accessory Pathway; WPW Syndrome
• Intervention / Treatment: Procedure: Radiofrequency ablation

Detailed Description

Radiofrequency catheter ablation is now the preferred treatment for patients with symptomatic Wolff-Parkinson-White (WPW) syndrome or recurrent symptomatic orthodromic reciprocating tachycardia . Successful ablation depends on the accurate localization of the accessory pathway (AP). Posteroseptal (inferior paraseptal) APs represent the second most common atrioventricular (AV) connection site after left free wall AP and often pose a diagnostic challenge. This is due to complex anatomy at the crux of the four cardiac chambers, where a small area may encompass APs that may be approached from the right or left endocardium, or require an epicardial ablation inside the coronary sinus (CS).

APs located in the posteroseptal area can take a variety of courses. Four different course types may be distinguished.

1. Endocardially between the inferior paraseptal right atrium and the right ventricle. This area includes the inferior part of the Koch's triangle and the area surrounding the CS ostium.
2. Endocardially between the inferior paraseptal left atrium and the left ventricle.
3. Coursing between the inferior paraseptal right atrium and the left ventricle in the pyramidal space, given that the right atrium lies directly on the posterior superior process of the left ventricle. This anatomical conformation results from the fact that the interatrial septum lies leftward to the interventricular septum and the tricuspid annulus is displaced 5-10 mm apically with respect to the mitral annulus. The right atrial endocardial aspect overlying the posterior superior process of the left ventricle lies between the most posterior aspect of the right fibrous trigone and the CS ostium, medial to the tricuspid valve. Because of its close proximity, ablation of these APs may be possible from the proximal CS.
4. Epicardially, connecting the musculature overlying the CS to the ventricle. These connections are related to sleeve-like extensions of the CS musculature that cover the proximal portion of the middle cardiac vein or posterior coronary veins. Most of these APs are ablated with a coronary venous These APs are referred to as 'epicardial CS' APs.

The procedural risks of inferior paraseptal AP ablation differ depending on whether a left-sided approach or a CS ablation is required .

Anteroseptal Aps are rare but associated with lower success rates and higher incidence of atrioventricular(AV) block. Anteroseptal AP can be ablated from right side , however Some including true para-Hisian APs can be safely and effectively ablated from the aortic cusps. Compared with the ablation at the right anteroseptal area, RF delivered at the aortic cusps has a higher immediate success, lower complication rate, and good long-term outcome. The aortic cusps should always be considered as the initial target for ablation of para-Hisian Aps . Data regarding the electro- cardiographic and electrophysiological characteristics as well as the safety and efficacy of catheter ablation of anteroseptal APs through the aortic cusps are limited Considering these differences, an accurate anticipation of location of septal AP is critical to inform the discussion and consent process with the patient and to guide the mapping strategy.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Antony Youssef, Bachelor; Phone Number: +201281106216; Email: tony.sameh9771@gmail.com
• Study Contact Backup: Name: Marwan Sayed, PhD; Phone Number: +201090686492; Email: marwancordio@aun.edu.eg

Study Locations

• Egypt
  • Assiut, Egypt, 71511
    • Recruiting
    • Faculty of Medicine Assiut University
    • Contact: Salah El-Dein Sayed Atta, Professor; Phone Number: +201091318801; Email: salah_s_atta@hotmail.com
    • Contact: Marwan Sayed Mahmoud, Lecturer; Phone Number: +201090686492; Email: marwancordio@aun.edu.eg

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All patients with suggested septal AP (both manifest and concealed AP)

Description

Inclusion Criteria:

• All patients with suggested septal AP (both manifest and concealed AP) undergoing electrophysiological study and ablation in EP cath lab in cardiology department, Assiut University Heart hospital.

Exclusion Criteria:

• Patients with redo AP or failed ablation.
• Patients with more than one AP.
• Congenital or structural heart diseases.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Right group; Septal accessory pathway more to right	Procedure: Radiofrequency ablation; Radiofrequency ablation of the septal accessory pathway
Left group; Septal accessory pathway more to left	Procedure: Radiofrequency ablation; Radiofrequency ablation of the septal accessory pathway

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Differentiate right from left septal manifest accessory pathway using ECG	Onset of delta wave in each lead will be measured from the onset of the earliest delta wave in any of the ECG leads.The polarity of the delta wave will be measured within the initial 20 msec of the preexcitation and will be classified as positive (+), negative (-), or isoelectric (+-). Localization of the site of the accessory pathway will be done using Arruda's algorithm and Fitzpatrick's algorithm	Baseline

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• Lebloa M, Pascale P. Preprocedural Discrimination of Posteroseptal Accessory Pathways Ablated from the Right Endocardium from Those Requiring a Left-sided or Epicardial Coronary Venous Approach. Arrhythm Electrophysiol Rev. 2022 Apr;11:e07. doi: 10.15420/aer.2021.55.
• Jazayeri MR, Dhala A, Deshpande S, Blanck Z, Sra J, Akhtar M. Posteroseptal accessory pathways: an overview of anatomical characteristics, electrocardiographic patterns, electrophysiological features, and ablative therapy. J Interv Cardiol. 1995 Feb;8(1):89-101. doi: 10.1111/j.1540-8183.1995.tb00519.x.
• Sealy WC, Mikat EM. Anatomical problems with identification and interruption of posterior septal Kent bundles. Ann Thorac Surg. 1983 Nov;36(5):584-95. doi: 10.1016/s0003-4975(10)60690-x.
• Guiraudon GM, Klein GJ, Sharma AD, Jones DL, McLellan DG. Surgical ablation of posterior septal accessory pathways in the Wolff-Parkinson-White syndrome by a closed heart technique. J Thorac Cardiovasc Surg. 1986 Sep;92(3 Pt 1):406-13.
• Sun Y, Arruda M, Otomo K, Beckman K, Nakagawa H, Calame J, Po S, Spector P, Lustgarten D, Herring L, Lazzara R, Jackman W. Coronary sinus-ventricular accessory connections producing posteroseptal and left posterior accessory pathways: incidence and electrophysiological identification. Circulation. 2002 Sep 10;106(11):1362-7. doi: 10.1161/01.cir.0000028464.12047.a6.
• Calkins H, Yong P, Miller JM, Olshansky B, Carlson M, Saul JP, Huang SK, Liem LB, Klein LS, Moser SA, Bloch DA, Gillette P, Prystowsky E. Catheter ablation of accessory pathways, atrioventricular nodal reentrant tachycardia, and the atrioventricular junction: final results of a prospective, multicenter clinical trial. The Atakr Multicenter Investigators Group. Circulation. 1999 Jan 19;99(2):262-70. doi: 10.1161/01.cir.99.2.262.
• Tai CT, Chen SA, Chiang CE, Lee SH, Chang MS. Electrocardiographic and electrophysiologic characteristics of anteroseptal, midseptal, and para-Hisian accessory pathways. Implication for radiofrequency catheter ablation. Chest. 1996 Mar;109(3):730-40. doi: 10.1378/chest.109.3.730.
• Letsas KP, Efremidis M, Vlachos K, Georgopoulos S, Karamichalakis N, Saplaouras A, Xydonas S, Valkanas K, Sideris A. Catheter ablation of anteroseptal accessory pathways from the aortic cusps: A case series and a review of the literature. J Arrhythm. 2016 Dec;32(6):443-448. doi: 10.1016/j.joa.2016.02.010. Epub 2016 Apr 19.
• Xu G, Liu T, Liu E, Ye L, Shehata M, Wang X, Li G. Radiofrequency catheter ablation at the non-coronary cusp for the treatment of para-hisian accessory pathways. Europace. 2015 Jun;17(6):962-8. doi: 10.1093/europace/euu271. Epub 2014 Oct 29.
• Arruda MS, McClelland JH, Wang X, Beckman KJ, Widman LE, Gonzalez MD, Nakagawa H, Lazzara R, Jackman WM. Development and validation of an ECG algorithm for identifying accessory pathway ablation site in Wolff-Parkinson-White syndrome. J Cardiovasc Electrophysiol. 1998 Jan;9(1):2-12. doi: 10.1111/j.1540-8167.1998.tb00861.x.
• Pambrun T, El Bouazzaoui R, Combes N, Combes S, Sousa P, Le Bloa M, Massoullie G, Cheniti G, Martin R, Pillois X, Duchateau J, Sacher F, Hocini M, Jais P, Derval N, Bortone A, Boveda S, Denis A, Haissaguerre M, Albenque JP. Maximal Pre-Excitation Based Algorithm for Localization of Manifest Accessory Pathways in Adults. JACC Clin Electrophysiol. 2018 Aug;4(8):1052-1061. doi: 10.1016/j.jacep.2018.03.018. Epub 2018 May 30.
• Fitzpatrick AP, Gonzales RP, Lesh MD, Modin GW, Lee RJ, Scheinman MM. New algorithm for the localization of accessory atrioventricular connections using a baseline electrocardiogram. J Am Coll Cardiol. 1994 Jan;23(1):107-16. doi: 10.1016/0735-1097(94)90508-8. Erratum In: J Am Coll Cardiol 1994 Apr;23(5):1272.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: November 27, 2024
• First Submitted That Met QC Criteria: December 5, 2024
• First Posted (Estimated): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Cardiovascular Diseases; Pathological Conditions, Anatomical; Heart Diseases; Arrhythmias, Cardiac; Pre-Excitation Syndromes; Accessory Atrioventricular Bundle
• Other Study ID Numbers: EPS for accessory pathway

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No