Freestyle-Perimount Calcification Comparison

Aortic Valve Disease Clinical Trial

Official title:

In Vivo Calcium Score Measurement After Freestyle Full Root Replacement in Young Adults

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04359030
• Other study ID #: ctu2020003
• Status: Recruiting
• Start date: November 15, 2021
• Est. completion date: October 1, 2022

Study information

• Verified date: March 2022
• Source: Ziekenhuis Oost-Limburg
• Contact: matteo pettinari
• Phone: +3289327077
• Email: matteo.pettinari[@]zol.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stented bioprostheses (Perimount Magna Ease, PM). A 3D CT scan will be used to assess the calcification score and to determine the relationship between calcification and aortic valve leaflet.

Description:

A recent update of the American Hear Association and American College of Cardiology Guidelines for the Management of Patients With Valvular Heart Disease1 recommended that for patients between 50 and 70 years of age, it is reasonable to the choice of either a mechanical or bioprosthetic valve; the threshold for biological valves continues to decrease and more younger adults will receive this kind of prosthesis. However the best biological option for these patients is still a matter of debate. Stented bio-prosthesis is the most common choice. However, the predicted 15-year risk of needing reoperation because of structural deterioration is 22% for patients 50 years of age2.

In the late 80's stentless valve as the Medtronic Freestyle (FS) has been introduced with the hope that it may provide physiological flow in the aortic root, sinuses, and coronary orifices and a low risk of thromboembolism. Several randomized study and meta-analysis demonstrated improved hemodynamic, a larger orifice area and a midterm survival advantage of stentless aortic valve compared to stented aortic valve replacement3, 4. The FS valve is believed to provide greater durability and superior hemodynamic performance due to the low mechanical stress on the leaflet tissues. The failure mode of the FS is thought to be mostly calcification of the aorta wall and cusp tears because collagen degradation5. This phenomenon is inflammation mediated process.

Aim of this study is to evaluate the rate and anatomy of the aortic wall and leaflet calcification of the FS prosthesis implanted as full root in patients younger than 60 years compared to a stented bioprostheses (Perimount Magna Ease, PM). A 3D CT scan will be used to assess the calcification score and to determine the relationship between calcification and aortic valve leaflet.

Between 2007 and 2017, among patients younger than 60 years of age, 51 patients underwent a full root replacement with a FS and 49 received a Perimount Magna Ease prosthesis. Those patients will undergo a 3D CT scan. The group of the patient with PM will be matched in function of age and interval of follow-up with the FS group.

A transthoracic echocardiogram will be performed to check residual valve insufficiency and trans-valvular gradients. A cardiopulmonary exercise test ( with extraction of maximal oxygen consumption ) combined with a trans thoracic echocardiography (stress echocardiography) will be performed to evaluate the patients exercise capacity and its influence on the cardiac and valve function.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: October 1, 2022
• Est. primary completion date: June 1, 2022
• Gender: All
• Age group: N/A to 60 Years

Eligibility

Inclusion Criteria:

• Provision of signed and dated informed consent form

• Patients treated with FS or PM

• Age less than 60 at the moment of the implant

Exclusion Criteria:

• Kidney failure or contrast allergy

• Previous endocarditis and aortic dissection

• Pregnancy or lactation

Related Conditions & MeSH terms

• Aortic Valve Disease
• Heart Diseases
• Heart Valve Diseases
• Valve Heart Disease

Intervention

Diagnostic Test:
• Multislice CT scanning for aortic wall calcification
Multislice CT scanning for aortic wall calcification
• Transthoracic stress echocardiography
Transthoracic stress echocardiography

Locations

Country	Name	City	State
Belgium	Ziekenhuis Oost Limburg	Genk	Limburg

Sponsors (2)

Lead Sponsor	Collaborator
Ziekenhuis Oost-Limburg	Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of aortic leaflet Calcium-score in FS and PM valve	The Agatston score. The score is calculated using a weighted value assigned to the highest density of calcification in a given coronary artery. The density is measured in Hounsfield units (HU), and score of 1 for 130-199 HU, 2 for 200-299 HU, 3 for 300-399 HU, and 4 for 400 HU and greater. The higher the score the more the calcification.	3 years
Secondary	Echocardiographic function of the aortic valve at rest and during exercise: transvalvular mean and peak gradient	Aortic valve mean and peak gradient: mmHg	3 years
Secondary	Echocardiographic function of the aortic valve at rest and during exercise: Valve regurgitation	Aortic valve regurgitation: vena contracta (mm)	3 years
Secondary	Exercise capacity: New York Heart Association class	New York Heart Association class from 1 to 4 with 1=no dyspnea during exercise till 4= dyspnea in rest;	3 years
Secondary	Exercise capacity: maximum oxygen consumption	max oxygen consumption measured in ml/kg*min	3 years