Aortic Root Enlargement Versus Aortic Root Replacement in the Management of Cases With Small Aortic Root

Each type of Aortic valve surgery has its advantages and disadvantages; we aim to differentiate between two types of aortic valve surgery: aortic root replacement (using either Ross procedure or stentless bioprosthesis procedure) and mechanical aortic valve replacement.

Study Overview

• Status: Not yet recruiting
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Procedure: Aortic valve surgery

Detailed Description

Aortic valve replacement has been performed since the 1950s. Since then, the surgical procedure has been optimized to reduce the risk of procedure-related complications. In addition, technical advances in the design of valves have significantly improved long-term prognosis. After the initial use of mechanical ball-caged valves, numerous monoleaflet and bileaflet valves have been introduced and evaluated. Moreover, bioprosthetic valves came on the market in the 1960s as an alternative to mechanical valve.

The pulmonary autograft was introduced in clinical practice as a substitute for the diseased aortic valve by Donald Ross in 1967. The original implant technique, namely subcoronary freehand grafting, was associated with substantial prevalence of early and late valve dysfunction, thereby limiting widespread adoption of the operation. More recent experience with pulmonary autografts used for complete or partial aortic root replacement allowed for satisfactory functional behavior of the valve .

Homografts for aortic valve replacement were the first biologic stentless prostheses used in clinical practice in the 1960s. Binet introduced a stentless porcine bioprosthesis, but the valve was abandoned because of poor tissue fixation. Due to limited availability and a relatively difficult implantation technique, mechanical AVR became the popular therapeutic option. The disadvantage of life-long anticoagulation therapy in mechanical AVR prompted the development of xenogeneic bioprostheses. Although porcine aortic valves or pericardial tissue mounted on a stent made the implantation technique easier, these valves sacrificed orifice area and increased stress at the attachment of the stent, which caused earlier primary tissue failure. Optimizing hemodynamics to prevent patient-prosthetic mismatch and improve durability revived the use of stentless bioprostheses in the early 1990s.

Patients with an expected survival of less than 10 years (more than 65 years old, renal disease, lung disease, patients who are more than 60 years old), ejection fraction of less than 40%, or coronary disease would be reasonable candidates for aortic bioprostheses to avoid anticoagulation with an extremely low likelihood of aortic valve reoperation. Results tend to favor mechanical aortic valves in patients under age 65 years with a life expectancy of at least 10 years.

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

• Study Contact: Name: Ali Abdelraouf, Assistant lecturer; Phone Number: 01004396639; Email: Aliabdelraouf92@yahoo.com

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

All patients who presented to Cardiothoracic Surgery Department, Assiut University Heart Hospital and Aswan heart center who meet the listed inclusion will be eligible for the study. The charts will be reviewed and eligible patients will be filtered

Description

Inclusion Criteria:

• Patients undergoing Aortic valve surgery.

Exclusion Criteria:

• Patients who have other procedure with aortic valve surgery.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Mechanical aortic valve replacement; simple procedure but need long term of anticoagulant	Procedure: Aortic valve surgery; mechanical aortic valve replacement versus ross procedure and stentless bioprothesis
Aortic root replacement; complicated procedure but without anticoagulant	Procedure: Aortic valve surgery; mechanical aortic valve replacement versus ross procedure and stentless bioprothesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with failure of surgery	Number of participants with failure of initial intervention , Requiring a second intervention i.e redo aortic valve surgery	baseline

Collaborators and Investigators

• Sponsor: Assiut University

Study record dates

Study Major Dates

• Study Start (Anticipated): February 10, 2022
• Primary Completion (Anticipated): February 1, 2024
• Study Completion (Anticipated): February 1, 2024

Study Registration Dates

• First Submitted: December 20, 2021
• First Submitted That Met QC Criteria: December 20, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): February 7, 2022
• Last Update Submitted That Met QC Criteria: January 23, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: Aortic valve surgery

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