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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3761 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-01

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Aortic Valve Replacement

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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sB-AVR

Patients with biological Aortic valve replacement

No interventions assigned to this group

sM-AVR

Patients with mechanical Aortic valve replacement

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No