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.

NCT Number	NCT07489313
Lead Sponsor	Samsung Medical Center
Conditions	Aortic or Mitral Valve Replacement, Valvular Heart Disease Patients
Enrollment	1,811 participants
Start Date	2013-01-01
Primary Completion	2023-12-31 (estimated)
Study Completion	2023-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-15