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Completed

NCT Number: NCT07168889

The Choice of Mitral Valve Surgery Type and Mid-term Outcomes in Patients up to 70-years: Results of the AUTHEARTVISIT Study

The goal of this observational study is to learn about the long-term effects of mechanical versus biological mitral valve replacement in patients aged 70 years or younger. The main question it aims to answer is:

Do patients who receive a mechanical mitral valve live longer and need fewer repeat operations compared with those who receive a biological valve? Participants are patients in Austria who already had mitral valve surgery between 2010 and 2020 as part of their regular medical care. Information about their surgeries, health conditions, and outcomes was collected from national health insurance records. Researchers will follow these patients for up to 10 years to compare survival, reoperation rates, and other heart-related events between mechanical and biological valve recipients.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

About this study

This nationwide, registry-based, retrospective cohort study is part of the AUTHEART VISIT project, which investigates long-term outcomes of cardiac surgery in Austria. The present analysis focuses on patients aged 70 years or younger undergoing surgical mitral valve replacement (MVR) between January 1, 2010 and December 31, 2020. The aim is to evaluate differences in survival, reoperation rates, and cardiovascular outcomes between patients receiving mechanical mitral valve replacement (SMMVR) and those receiving biological mitral valve replacement (SBMVR).

Data source and registry procedures:

Data were obtained from the Austrian Health Insurance Funds, which cover approximately 98% of the Austrian population. The registry includes detailed patient-level information on diagnoses, procedures, and outcomes based on mandatory coding for reimbursement (ICD-10 for diagnoses and MEL codes for surgical procedures). The data are anonymized prior to analysis.

Quality assurance:

Data integrity is ensured by several mechanisms:

Data validation: Automatic data checks are performed to confirm plausibility, completeness, and consistency with predefined coding rules.

Source verification: Information is cross-checked against external records where available (e.g., insurance billing and hospital discharge data).

Data dictionary: A standardized coding framework is maintained, including MEL codes for procedures and ICD-10 for diagnoses. Definitions of outcomes are harmonized with prior AUTHEART VISIT studies.

Standard operating procedures: Established registry protocols govern data management, statistical analysis, and reporting.

Sample size and follow-up:

The study population includes all eligible patients undergoing mitral valve surgery in Austria during the study period (N=3520), with 413 undergoing sM-MVR, 487 undergoing sB-MVR, and 2620 undergoing mitral valve repair (MVRe). Median follow-up times were 6.6 years for SMMVR, 7.4 years for SBMVR, and 5.8 years for MVRe.

Handling of missing data:

Cases with implausible entries (e.g., death date before index surgery) are excluded. Missing values in baseline covariates are addressed through exclusion or handled in the propensity score weighting model. Outcome variables are based on administrative coding, minimizing missingness.

Statistical analysis plan:

The primary outcome is all-cause mortality. Secondary outcomes include reoperation, reoperation-free survival, major adverse cardiac events (MACE), myocardial infarction, heart failure, stroke, and bleeding. Time-to-event analyses are conducted using Cox proportional hazards models adjusted for age, sex, comorbidities, and concomitant procedures. To account for potential imbalances between groups, inverse probability of treatment weighting (IPTW) is applied based on a multinomial logistic regression model. Weighted and unweighted Kaplan-Meier curves are generated, with subgroup analyses by age. Cause-specific hazard models are used for secondary outcomes. Proportional hazards assumptions are evaluated using Schoenfeld residuals. A p-value <0.05 is considered statistically significant.

This registry-based approach provides comprehensive, real-world evidence on prosthesis choice in surgical MVR, with rigorous quality assurance procedures to ensure reliability and generalizability of results.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mitral valve surgery between 01.01.2010 and 31.12.2020

Exclusion criteria

  • concomitant procedures on other valves

Treatment and study plan

Primary outcomes

  1. all-cause death

    Time frame: 10 years

    rate of all-cause death

Secondary outcomes

  1. major adverse cardiac events

    Time frame: 10 years

    rate of major adverse cardiac events

  2. reoperation-free survival

    Time frame: 10 years

    rate of reoperation-free survival

  3. reoperation

    Time frame: 10 years

    rate of reoperation

  4. myocardial infarction

    Time frame: 10 years

    rate of myocardial infarction

  5. heart failure

    Time frame: 10 years

    rate of heart failure

  6. stroke

    Time frame: 10 years

    rate of stroke

  7. intracerebral hemorrhage

    Time frame: 10 years

    rate of intracerebral hemorrhage

  8. bleeding other than ICH

    Time frame: 10 years

    rate of bleeding other than ICH

Sponsors and collaborators

Lead sponsor

Alissa Florian

Other

Registry information

Important dates

Study start
2010
Primary completion
2020
Study completion
2020
First posted
Sep 11, 2025
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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