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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07489313
Enrollment
1811
Registered
2026-03-24
Start date
2013-01-01
Completion date
2023-12-31
Last updated
2026-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic or Mitral Valve Replacement, Valvular Heart Disease Patients

Brief summary

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.

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.

Interventions

None listed

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
60 Years to 70 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Incident mental disorder after valve replacement5 years after surgeryDefined as a composite of depression, anxiety disorder, and sleep disorder.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 16, 2026