Health Status of Patients After Surgically Implanted Biological and Mechanical Aortic Valves: a Population-based Retrospective Analysis (2010-2018)

The overall project aim is to study outcomes following aortic valve replacement with either mechanical valves or bioprostheses by retrieving data from the main social security carriers in Austria for the years 2010-2018.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Disease
• Intervention / Treatment: Device: Aortic Valve Replacement

Detailed Description

The purpose of this research project is to evaluate mortality (primary outcome) and incidence of heart attack, stroke, reoperation and first diagnosis of heart insufficiency (secondary outcomes) after aortic valve replacement. We aim to compare those outcomes between mechanical valves and bioprostheses.

Data will be retrieved from the main social security carriers in Austria (covering 98% of its population) from 2010-2018.

• Study Type: Observational
• Enrollment (Actual): 13993

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All patients who underwent isolated surgical aortic valve replacement in Austria above 18 years of age with no other concomitant heart surgery were included.

Description

Inclusion Criteria:

• isolated surgical aortic valve replacement in Austria

Exclusion Criteria:

• below 18 years of age
• concomitant heart surgery

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Aortic valve replacement with mechanical valves	Device: Aortic Valve Replacement; Surgical replacement of aortic valves
Aortic valve replacement with bioprostheses	Device: Aortic Valve Replacement; Surgical replacement of aortic valves

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall mortality	all cause mortality after aortic valve replacement	8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reoperation	incidence of reoperation after aortic valve replacement	8 years
stroke	incidence of stroke after aortic valve replacement	8 years
heart attack	incidence of heart attack after aortic valve replacement	8 years
heart insufficiency	incidence of heart insufficiency after aortic valve replacement	8 years

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Collaborators: Landesklinikum Sankt Polten; Sicknessfund Burgenland (BGKK); A.ö. Krankenhaus St. Josef Braunau GmbH

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2010
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2018

Study Registration Dates

• First Submitted: May 20, 2021
• First Submitted That Met QC Criteria: May 20, 2021
• First Posted (Actual): May 25, 2021

Study Record Updates

• Last Update Posted (Actual): November 18, 2022
• Last Update Submitted That Met QC Criteria: November 16, 2022
• Last Verified: November 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: AUTHEARTVISIT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes