CT-evaluation of Coronary Ostia Height After Surgical Aortic Valve Replacement.

Not Applicable

• Conditions: Aortic Valve Stenosis; Regurgitation, Aortic; Stenoses, Aortic; Valve Disease, Aortic; Aortic Regurgitation; Coronary; Obstruction; Heart Valve Diseases; Aortic Valve Insufficiency; Aortic Stenosis, Severe
• Interventions: Radiation: CT scan with contrast medium

• Registration Number: NCT05714293
• Lead Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Brief Summary

The goal of this interventional, single-center study is to demonstrate if there is a change in the coronary ostia height after surgical aortic valve replacement and if it depends on the type of prosthesis or surgical technique used. The study involves patients undergoing elective surgical aortic valve replacement with a bioprosthesis. Participants enrolled will undergo a CT scan before and after surgery (at least 90 days after surgery) to analyze coronary ostia height.

Detailed Description

Aortic valve stenosis is the most frequent heart valve disease in the adult population. The development of biological prostheses with slower valve degeneration and easier antithrombotic management and changes in the indications for the treatment of this valve disease, have allowed a reduction in the age in which such prostheses are implanted thus leading to a greater use of biological prostheses rather than mechanical ones. In the next few years this will cause a higher rate of structural valve degeneration resulting in stenosis and/or insufficiency. In patients considered to be at high surgical risk, the transcatheter implantation of a valve-in-valve (VIV) represents a valid alternative to standard surgery, except for coronary obstruction which appears more frequent in VIV procedures, especially in patients receiving VIV after surgical aortic valve replacement. The risk factors mainly associated with this complication are represented by the type of implanted prostheses and the anatomical relationship between the coronary ostia and the expected final position of the cusps of the bioprostheses transcatheter-implanted.Recent studies have demonstrated how coronary height seems to be significantly reduced in case of surgical aortic valve replacement with a supra-annular technique, as occurs in our center.

Aim of this interventional, single-center study is to demonstrate whether there is a change in the coronary ostia height after surgical aortic valve replacement and whether it possibly depends on the type of prosthesis.

All patients undergoing elective aortic valve replacement surgery at our institution who meet the inclusion criteria for the study will be contacted to perform a postoperative CT scan at least 90 days after surgery.

Study Timeline

• Study Start: 2023-01-11
• Study First Submitted: 2023-01-27
• Study First Submitted QC: 2023-01-27
• Study First Posted: 2023-02-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-23
• Last Update Posted: 2024-02-26
• Primary Completion: 2024-11-10
• Study Completion: 2025-01-10

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Age ≥ 18 years;
• Aortic valve stenosis or insufficiency with indication for elective aortic valve replacement with a bioprosthesis;
• Possible concomitant coronary artery disease with indication for surgical or percutaneous revascularization;
• CT imaging of the thorax with iodinated contrast agent carried out before surgery;
• Signed informed consent, inclusive of release of medical information.

Exclusion Criteria

• Aortic valve replacement in bicuspid valve or endocarditis;
• Aortic valve replacement associated with surgery of ascending aorta/aortic root;
• Aortic valve replacement associated with other cardiac valve surgery;
• Previous cardiac surgery of any kind;
• Patient unable to give informed consent or potentially noncompliant with the study protocol, in the judgment of the investigator;
• Participation in another clinical trial that could interfere with the endpoints of this study;
• Pregnant at time of screening;
• Allergy or hypersensitivity to iodinated contrast agent;
• End-stage renal disease on dialysis.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgical Aortic Valve Replacement	CT scan with contrast medium	Patients undergoing surgical aortic valve replacement with a bioprosthesis will be asked to perform a thorax CT scan before surgery and one more at least 90 days after surgery.

Primary Outcome Measures

Name	Time	Method
Coronary ostia height differences.	At least 90 days after surgery	Differences in coronary ostia height before and after surgical aortic valve replacement.

Secondary Outcome Measures

Name	Time	Method
Coronary ostia height differences between different bioprostheses.	At least 90 days after surgery	Differences in coronary ostia height before and after surgical aortic valve replacement according to different bioprostheses used.

Trial Locations

Locations (1)

Policlinico Agostino Gemelli; 🇮🇹 Roma, Italy