Association Between Surgical Aortic Valve Replacement and Long-term Outcomes in 50 to 65-year-olds

Association Between Surgical Aortic Valve Replacement and Long-term Outcomes in 50 to 65-year-olds: Results of the AUTHEARTVISIT Study

The goal of this observational study o is to compare outcomes after either biological or mechanical aortic valve replacement. The main question it aims to answer:

Is survival better after mechanical aortic valve replacement compared to biological aortic valve replacement? Are there less complications and reoperations after mechanical aortic valve replacement compared to biological aortic valve replacement? We perform a retrospective Data Collection of anonymized Austrian health insurance data.

Study Overview

• Status: Completed
• Conditions: Aortic Valve Replacement

Detailed Description

Objectives: In recent years, age recommendations for the utilization of biological prostheses rather than mechanical prostheses for surgical aortic valve replacement (sAVR) have been significantly reduced. This study evaluated survival rates, major adverse cardiac events (MACEs), and reoperation risks following surgical (sM-AVR) and biological (sB-AVR) AVR, with the aim of providing data to inform optimal prosthesis selection for middle-aged patients between 50 and 65 years.

Methods: A population-based cohort study was conducted using data from the Austrian Health System from 2010 to 2020. Patients undergoing isolated sAVR (n=3761) were categorized into sM-AVR (n=1018) and sB-AVR (n=2743) groups. Propensity score matching (PSM) was applied to balance covariates. The primary endpoint was all-cause mortality. The secondary endpoints included MACEs, reoperation, stroke, bleeding, and post-reoperation survival. Outcomes were assessed using Cox regression and Kaplan-Meier analyses.

• Study Type: Observational
• Enrollment (Actual): 3761

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

• age between 50 and 65 years
• st. p. isolated biological or mechanical aortic valve replacement

Description

Inclusion Criteria:

• age between 50 and 65 years
• st. p. isolated biological or mechanical aortic valve replacement

Exclusion Criteria:

• transcatheter aortic valve implantation (TAVI; MEL codes DB025, DB026, DB021, or XN010) as index procedure
• age <50 or >65 years
• concomitant heart surgery or additional procedures during the index operation
• patients receiving a coronary artery stent (MEL codes DD050 or DD060) within four months before AVR

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
sB-AVR; Patients with biological Aortic valve replacement
sM-AVR; Patients with mechanical Aortic valve replacement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Survival	overall Survival	up to 12 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
reoperation-free survival	reoperation-free survival after either biological or mechanical AVR	up to 12 years
reoperation	reoperation after either biological or mechanical AVR	up to 12 years
MACEs	MACEs after either biological or mechanical AVR	up to 12 years
heart failure	heart failure after either biological or mechanical AVR	up to 12 years
embolic stroke or ICH	embolic stroke or ICH after either biological or mechanical AVR	up to 12 years
myocardial infarction	myocardial infarction after either biological or mechanical AVR	up to 12 years
non-embolic bleeding	non-embolic bleeding after either biological or mechanical AVR	up to 12 years

Collaborators and Investigators

• Sponsor: Medical University of Vienna
• Investigators: Principal Investigator: Hendrik J Ankersmit, Univ. Prof. Dr., Medical University of Vienna

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): December 31, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: January 13, 2025
• First Submitted That Met QC Criteria: January 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 17, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: aortic valve replacement; mechanical AVR; biological AVR
• Other Study ID Numbers: GS1-EK-4/722-2021

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• product manufactured in and exported from the U.S.: No