Clinical trial NCT06041308: Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve
Official title: Long-term Outcomes of Bioprothetic Valve Versus Mechanical Valve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Valve Heart Disease
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 30000
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 30,000 individuals (including this institution and other domestic units).

Brief summary: In this study, the investigators aim to use data identified through the hospital's integrated medical database and National Health Insurance database to explore the long-term performance and benefits of biological and mechanical valves. This research aims to provide more recommendations and references for valve replacement in different patient populations.

Detailed description: Long-term follow-up of valve surgery is essential in all cardiac surgeries and is the most commonly discussed indicator. The choice of valves has evolved over the past 30 years, offering two options: biological valves and mechanical valves. Biological valves have seen advancements in the last 15 years, including new processes and improved valve preservation methods. The question of whether these new process valves offer better long-term effectiveness has become a hot research topic in recent years.

Mechanical valves have a longer lifespan, but the need for long-term anticoagulant use to prevent mechanical valve thrombosis has raised concerns about anticoagulant side effects, abnormal clotting function, and bleeding. Biological valves, on the other hand, do not require long-term anticoagulation and only necessitate 2-3 months of anticoagulant treatment. However, the risk of biological valve degeneration results in an average lifespan of 10 to 20 years, which cannot match the durability of mechanical valves. This is the drawback of using biological valves.

Therefore, the investigators hope to utilize the hospital's integrated medical database and the long-term National Health Insurance database for tracking. The investigators aim to observe valve performance in different patient groups, such as young people, the elderly, patients on dialysis, those with rheumatic autoimmune diseases, and those taking specific medications, among others.

Eligibility criteria: Inclusion Criteria:This is a retrospective study, and we plan to utilize data from the hospital's integrated medical database and the National Health Insurance database from January 2007 to December 2019. We will identify all patients within the data who were diagnosed with valve diseases and underwent valve replacement surgery.

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Exclusion Criteria:Individuals under 20 years of age.

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Primary outcomes:
measure: all-cause mortality
timeFrame: 1998-2019
Secondary outcomes:
measure: composite outcome and individual component of major adverse prosthesis-related events, including death, major bleeding, ischemic stroke, endocarditis, and aortic valve reoperation
timeFrame: 1998-2019
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: attending physician
name: Nai-Hsin Chi
role: STUDY_CHAIR
References: