Heart Valve Disease, Infective Endocarditis (IE)
Conditions
Keywords
Dental screening, valve intervention, endocarditis, TAVI, valve surgery
Brief summary
This randomized, multicenter, open-label trial evaluates whether preoperative dental screening improves outcomes in patients undergoing surgical or transcatheter cardiac valve intervention. Participants are randomized 1:1 to preoperative dental screening or no screening. The primary outcome is time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis within 2 years. The study uses registry-based follow-up to ensure complete outcome ascertainment.
Detailed description
Infective endocarditis is associated with high morbidity and mortality in patients with prosthetic heart valves. Current recommendations for preoperative dental screening are based on observational data, and randomized evidence is lacking. This is a pragmatic, multicenter, randomized controlled trial conducted in Sweden. Patients accepted for surgical or transcatheter valve intervention are randomized 1:1 to: * Preoperative dental screening * No preoperative dental screening Dental treatment in the intervention group is performed according to clinical practice. No routine dental screening is performed in the control group. The primary endpoint is a composite of all-cause death, redo-intervention of the index valve, and definite infective endocarditis within 2 years. All analyses will follow the intention-to-treat principle using time-to-event methods.
Interventions
No routine dental screening prior to valve intervention.
OTHERPreoperative dental screening
Dental examination prior to valve intervention; treatment performed if indicated.
Sponsors
Region Skane
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * Accepted for cardiac valve intervention * Able to provide informed consent
Exclusion criteria
* Previous or ongoing infective endocarditis * Urgent surgery * Pain from loose tooth/teeth * Immunosuppressive therapy (excluding corticosteroids) * Inability to provide informed consent * Expected loss to follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite outcome of death, redo-intervention, or infective endocarditis | 2 years | Time to first occurrence of all-cause death, redo-intervention of the index valve, or definite infective endocarditis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| All-cause mortality | 2 years | — |
| Redo-intervention of index valve | 2 years | — |
| Definite infective endocarditis | 2 years | — |
| CIED extraction | 2 years | Extraction of Cardiovascular Implantable Electronic Device (CIED) |
| Oral health (GOHAI score) | 3 months | The GOHAI consists of 12 items with a total score ranging from 12 to 60, where higher scores indicate better oral health-related quality of life. |
| Quality of life (EQ-5D-5L index and VAS score) | 3 months | The EQ-5D-5L descriptive system generates an index value typically ranging from less than 0 (worse than death) to 1 (full health), where higher values indicate better health-related quality of life. The EQ Visual Analogue Scale (EQ VAS) ranges from 0 to 100, where higher scores indicate better perceived health. |
Countries
Sweden
Contacts
CONTACTPatrik Gilje, MD-PhD
Outcome results
None listed