Aortic Valve Leaflets Reconstruction (Ozaki Procedure) in Aortic Valve Diseases

Autologous Pericardial Tricuspid Reconstruction of Aortic Valve Leaflets (Ozaki Procedure) in Aortic Valve Diseases

Prospective Cohort Study aims at elaborating the outcomes of the Tricuspid Reconstruction of Aortic valve leaflets using autologous pericardium (Ozaki procedure) in the adult and paediatric patients. A very promising technique with the potential benefits of dodging oral anticoagulation, foreign material, and suitable for patients with small aortic annuli and in infectious endocarditis.

Performing hemodynamic evaluation, assess the clinical implementation and report preliminary results at follow up .

Study Overview

• Status: Completed
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Procedure: OZAKI technique

Detailed Description

Heart valve disease signifies a severe growing public health problem in developing countries, with aortic valve stenosis being the most common issue. Heart valve disease is commonly initiated by atherosclerotic degenerative processes, congenital anomalies, or rheumatic process. Aortic valve replacement is the gold standard in the treatment of patients with severe aortic stenosis and aortic regurgitation. Mechanical valves are favoured in younger patients (<60 years) owing to longer life-time, whereas biological valves are used for elderly patients in order to evade oral anticoagulation.

Options for aortic valve disease have improved in the last era including replacement, repair, and reconstructive options. A variety of creative techniques including leaflet extensions, neo-leaflet creation, resuspension or plication of prolapsing leaflets, and commissuroplasty to repair valves have been officially become skilled at, specially in pediatric population . In adults, the introduction of trans-catheter aortic valve inserting now permits treatment of degenerative aortic stenosis in the oldest and the highest risk patients. However, surgical treatment choices for pediatric patients with complex congenital aortic valve disease stay restricted.

In recent years, much attention has been given to the Ozaki procedure, an alternative way of repairing aortic valve, involving the use of autologous pericardium for the aortic leaflet reconstruction. Diseased leaflets are removed carefully. The distance between each commissure is measured with invented sizing apparatus. The new leaflet of the size corresponding to the measured value is trimmed with an original template from glutaraldehyde-treated autologous pericardium. Finally, the annular margin of the pericardial leaflet was running sutured with each annulus. Commissural coaptation was secured with additional sutures. The coaptation of three new leaflets were always insured with direct vision.

• Study Type: Observational
• Enrollment (Actual): 1

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt
    • Assiut University

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing aortic valve reconstruction using autologous pericardium (OZAKI technique) at Assiut University Hospitals in conjunction with Al-Nas hospital in cairo.

Description

Inclusion Criteria:

• Subject with AV disease.
• Documented symptomatic moderate or greater aortic stenosis
• small aortic annulus patients
• A symptomatic aortic insufficiency patient with left ventricular dysfunction or significant left ventricular dilatation.
• Patients with aortic regurgitation caused by: a dilated aortic annulus, conjoined cusp prolapse in bicuspid aortic valves (BAV), single cusp prolapse in tricuspid aortic valve (especially in paediatric population), and aortic valve cusp perforation from endocarditis.
• Concomitant intervention of the aortic root, Concomitant intervention of the aortic arch, Concomitant valve surgery and Concomitant intervention at congenital anomaly.

Exclusion Criteria:

• Patients with previous aortic valve surgery.
• missing informed consent
• Participation in another clinical research.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Ozaki group; Patients undergoing aortic valve reconstruction using autologous pericardium (OZAKI technique) at Assiut University Hospitals in conjunction with Al-Nas hospital in cairo.

Procedure: OZAKI technique; an alternative way of repairing aortic valve, involving the use of autologous pericardium for the aortic leaflet reconstruction. Diseased leaflets are removed carefully. The distance between each commissure is measured with invented sizing apparatus. The new leaflet of the size corresponding to the measured value is trimmed with an original template from glutaraldehyde-treated autologous pericardium. Finally, the annular margin of the pericardial leaflet was running sutured with each annulus. Commissural coaptation was secured with additional sutures. The coaptation of three new leaflets were always insured with direct vision.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
aortic transvalvular gradient	analyse aortic valve stenosis or insufficiency measured by transthoracic echocardiography	at follow up frame through one year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of hospitalization	number of days spent	average 5-7 days
number of patients developed complications	the study will be monitored for Endocarditis, thromboembolic manifestation, intracranial hemorrhage	through one year
conduction disturbances	the patients will be monitored for arrhythmia	6 months post operative

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
aortic valve re intervention or aortic regurge	analyse aortic valve stenosis or insufficiency measured by transthoracic echocardiography	through one year
LV dimensions and EF%.	Follow up Echocardiography data such as LV dimensions and EF%.	through one year

Collaborators and Investigators

• Sponsor: Assiut University
• Collaborators: AL-Nas Hospital
• Investigators: Principal Investigator: Ali Abd Elwahab, PHD, Assiut University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2021
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): July 30, 2023

Study Registration Dates

• First Submitted: March 19, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 25, 2021

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Aortic Valve Disease; Heart Defects, Congenital; Heart Valve Diseases
• Other Study ID Numbers: 17200559

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No