Freestyle-Perimount Calcification Comparison

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

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.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Disease; Valve Heart Disease
• Intervention / Treatment: Diagnostic test: Multislice CT scanning for aortic wall calcification; Diagnostic test: Transthoracic stress echocardiography

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 90

Contacts and Locations

Study Locations

• Belgium
  • Limburg
    • Genk, Limburg, Belgium, 3600
      • Ziekenhuis Oost Limburg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 60 years (Child, Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients operated for aortic valve stenosis at least three years earlier undergoing a valve replacement with Freestyle (FS) or Perimount (PM) bioprosthesis under the age of 60 years.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Freestyle group; Patients treated with a Freestyle aortic valve bioprosthesis	Diagnostic test: Multislice CT scanning for aortic wall calcification; Multislice CT scanning for aortic wall calcification; Diagnostic test: Transthoracic stress echocardiography; Transthoracic stress echocardiography
Perimount group; Patients treated with a Perimount aortic valve bioprosthesis	Diagnostic test: Multislice CT scanning for aortic wall calcification; Multislice CT scanning for aortic wall calcification; Diagnostic test: Transthoracic stress echocardiography; Transthoracic stress echocardiography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Echocardiographic function of the aortic valve at rest and during exercise: Valve regurgitation	Aortic valve regurgitation: vena contracta (mm)	3 years
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
Exercise capacity: maximum oxygen consumption	max oxygen consumption measured in ml/kg*min	3 years

Collaborators and Investigators

• Sponsor: Ziekenhuis Oost-Limburg
• Collaborators: Universitaire Ziekenhuizen KU Leuven
• Investigators: Principal Investigator: Matteo Pettinari, Ziekenhuis Oost-Limburg

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2021
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: March 17, 2020
• First Submitted That Met QC Criteria: April 22, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): July 24, 2024
• Last Update Submitted That Met QC Criteria: July 23, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases; Aortic Valve Disease
• Other Study ID Numbers: ctu2020003

Drug and device information, study documents

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