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

Completed

• Conditions: Aortic Valve Replacement

• Registration Number: NCT06782620
• Lead Sponsor: Medical University of Vienna

Brief Summary

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.

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 Timeline

• Study Start: 2020-01-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31
• Status Verified: 2025-01
• Study First Submitted: 2025-01-13
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 3761

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival	up to 12 years	overall Survival

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria