Aortic Valve Replacement
Conditions
Keywords
aortic valve replacement, mechanical AVR, biological AVR
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.
Interventions
None listed
Sponsors
Medical University of Vienna
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Survival | up to 12 years | overall Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| non-embolic bleeding | up to 12 years | non-embolic bleeding after either biological or mechanical AVR |
| 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 |
| myocardial infarction | up to 12 years | myocardial infarction 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 |
| MACEs | up to 12 years | MACEs after either biological or mechanical AVR |
Countries
Austria
Outcome results
None listed