Association of Prosthesis Types for Aortic or Mitral Valve Replacement With Long-term Risk of Mental Disorders

Patients were enrolled if the patients aged 60 to 70 years who underwent surgical aortic or mitral valve replacement. The age range was restricted to 60 to 70 years to ensure comparability in surgical indications between prosthesis types. Patients who underwent concomitant coronary artery bypass grafting or aortic surgery were excluded. To construct a cohort at risk for incident mental disorders, we excluded patients with a diagnosis of depression, anxiety disorder , or sleep disorder within one year prior to the index date. These conditions were identified using International Classification of Diseases, Tenth Revision codes recorded in claims data.

The exposure of interest was the type of prosthetic valve implanted at the index surgery. Patients were classified into mutually exclusive groups based on the prosthesis type recorded at the index procedure. The primary outcome was incident mental disorder after valve replacement, defined as a composite of depression, and anxiety disorder.

Study Overview

• Status: Completed
• Conditions: Valvular Heart Disease Patients; Aortic or Mitral Valve Replacement

Detailed Description

Patients were enrolled if the patients aged 60 to 70 years who underwent surgical aortic or mitral valve replacement between January 1, 2013 and December 31, 2023 using procedure codes recorded in inpatient claims (N=5,428). The age range was restricted to 60 to 70 years to ensure comparability in surgical indications between prosthesis types. Patients who underwent concomitant coronary artery bypass grafting or aortic surgery were excluded (n=2,404). To construct a cohort at risk for incident mental disorders, we excluded patients with a diagnosis of depression (n=304), anxiety disorder (n=365), or sleep disorder (n=324) within one year prior to the index date. These conditions were identified using International Classification of Diseases, Tenth Revision codes recorded in claims data.

The exposure of interest was the type of prosthetic valve implanted at the index surgery. Mechanical prostheses were identified using procedure codes G200, G202, and G204, whereas biologic prostheses were identified using codes G201 and G203. Patients were classified into mutually exclusive groups based on the prosthesis type recorded at the index procedure. The primary outcome was incident mental disorder after valve replacement, defined as a composite of depression, and anxiety disorder. Depression was defined using ICD-10 codes F32 and F33. Anxiety disorder was defined using codes F40 and F41.

• Study Type: Observational
• Enrollment (Actual): 1811

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 60 to 70 years who underwent surgical aortic or mitral valve replacement between January 1, 2013 and December 31, 2023 using procedure codes recorded in inpatient claims

Description

Inclusion Criteria:

• Patients aged 60 to 70 years who underwent surgical aortic or mitral valve replacement between January 1, 2013 and December 31, 2023 using procedure codes recorded in inpatient claims

Exclusion Criteria:

• Patients with a diagnosis of depression (n=307), anxiety disorder (n=263), or sleep disorder (n=197) within one year prior to the index date.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Mechanical prostheses; Patients who received mechanical prostheses
Biologic prostheses; Patients who received biologic prostheses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incident mental disorder after valve replacement	Defined as a composite of depression, anxiety disorder, and sleep disorder.	5 years after surgery

Collaborators and Investigators

• Sponsor: Samsung Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2013
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: March 19, 2026
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): May 15, 2026
• Last Update Submitted That Met QC Criteria: May 12, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Prosthesis types

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO