Impact of Targeted Preoperative Dental Screening on Post-procedural Risk of Infective Endocarditis in Patients Undergoing Transcatheter Aortic Valve Implantation: a Prospective Observational Study
| Registry | NCT06330766, acronym DENTAVI |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Enrollment | 1000 (Estimated) |
| Sponsor | Odense University Hospital (Other) |
| Conditions | Transcatheter Aortic Valve Implantation, Dental, Endocarditis |
| Interventions | No preoperative dental screening (Procedure) |
| Dates | start 2020-01-01, primary completion 2027-01-01 (estimated), completion 2027-01-01 (estimated), first posted 2024-03-26, last updated 2026-10-21 |
| Locations | 1 site in Denmark |
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All trials for Transcatheter Aortic Valve Implantation All trials for Dental All trials of No preoperative dental screening
In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with Transcatheter Aortic Valve Implantation (TAVI) was changed from mandatory to targeted PDS to between June 2023 to october 2023. The investigators will therefore compare the risk of IE before june 2023 and after october 2023.
Infective endocarditis (IE), a condition linked with significant mortality and morbidity rates, is particularly concerning for patients with prosthetic left-sided valves.
These patients face an elevated IE risk, estimated at about 1% annually in tertiary care settings, cumulatively impacting around one in every 20 patients over a decade.
In line with this, both the American Heart Association (AHA) and the European Society of Cardiology (ESC) strongly advocate for the elimination of potential dental sepsis sources at least two weeks before prosthetic valve implantation, except in urgent cases.
These guidelines, while not grounded in randomized trials, largely draw upon registry data detailing IE incidence among surgical aortic valve replacement (SAVR) patients.
In a recent study the investigators found no difference in risk of IE when comparing mandatory preoperative dental screening (MPDS) with no preoperative dental screening (NPDS).
Thus, this prospective registry-based observational before-and-after study aims to investigate the impact of different preoperative dental screening practices on the risk of IE in patients undergoing.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| No preoperative dental screening | Procedure: No preoperative dental screening | No preoperative dental screening in patients undergoing TAVI | |
| Mandatory preoperative dental screening | Mandatory preoperative dental screening in patients undergoing TAVI |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Patients undergoing TAVI Exclusion Criteria: * None
| Facility | City | Country | Status |
|---|---|---|---|
| Odense University Hospital, Cardiology Department | Odense, Odense | Denmark | Recruiting |