Bioprothetic Valve Versus Mechanical Valve of Bioprothetic Valve Versus Mechanical Valve

Long-term Outcomes of Bioprothetic Valve Versus Mechanical Valve

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.

Study Overview

• Status: Recruiting
• Conditions: Valve Heart Disease
• Intervention / Treatment: Other: valve

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.

• Study Type: Observational
• Enrollment (Estimated): 30000

Contacts and Locations

• Study Contact: Name: Nai-Hsin Chi; Phone Number: 265081 886-2-23123456; Email: chinaihsin@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • Recruiting
    • National Taiwan University Hospital
    • Contact: Nai-Hsin Chi, M.D./Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A total of 30,000 individuals (including this institution and other domestic units).

Description

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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Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Bioprothetic valve; Groups undergoing cardiac valve surgery with bioprothetic valve.	Other: valve; bioprothetic valve versus mechanical valve
Mechanical valve; Groups undergoing cardiac valve surgery with mechanical valves.	Other: valve; bioprothetic valve versus mechanical valve

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
all-cause mortality	included estimated survival using a Cox regression model. Survival data were obtained for all NHIRD databases. Operative mortality was defined as death during the index hospitalization or within 30 days of the operation. Long-term survival data included death from all causes. survival outcome was measured months after the index operation.	1998-2019

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
composite outcome and individual component of major adverse prosthesis-related events, including death, major bleeding, ischemic stroke, endocarditis, and aortic valve reoperation	each of which were defined as an emergency room visit or hospital admission with related diagnosis codes as the primary diagnosis	1998-2019

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Chair: Nai-Hsin Chi, Attending Physician

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 18, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Heart Valve Diseases
• Other Study ID Numbers: 202012072RIND

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No