Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients

Recruiting

• Conditions: Dental; Endocarditis; Transcatheter Aortic Valve Implantation
• Interventions: Procedure: No preoperative dental screening

• Registration Number: NCT06330766
• Lead Sponsor: Odense University Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2024-02-19
• Status Verified: 2024-03
• Study First Submitted QC: 2024-03-19
• Last Update Submitted: 2024-03-19
• Study First Posted: 2024-03-26
• Last Update Posted: 2024-03-26
• Primary Completion: 2026-01-01
• Study Completion: 2026-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• Patients undergoing TAVI

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Exclusion Criteria

• None

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
No preoperative dental screening	No preoperative dental screening	No preoperative dental screening in patients undergoing TAVI

Primary Outcome Measures

Name	Time	Method
Number of Participants with Infectious Endocarditis	Through study completion, an average of 1 year	Infectious endocarditis diagnosed by healthcare professionals

Secondary Outcome Measures

Name	Time	Method
Number of Participants undergoing Oral surgical procedure at dental screening	Through study completion, an average of 1 year	Number of oral surgical procedure performed in patients as part of the dental screening
Number of Participants undergoing Tooth extraction at dental screening	Through study completion, an average of 1 year	Number of Tooth extraction procedure performed in patients as part of the dental screening
The different Bacteria types causing the infectious endocarditis assessed by blood culture	Through study completion, an average of 1 year	Reporting all the different bacteria type causing infectious endocarditis, including the rate of each bacteria.
Number of Participants with IE caused by bacteria from oral foci	Through study completion, an average of 1 year	Infectious Endocarditis caused by bacteria from oral foci
Number patients with Bacteremia assessed by positive blood culture	Through study completion, an average of 1 year	Cases of bacteremia in the population.
Number of Participants with Cardiac implantable electronic device risk of IE	Through study completion, an average of 1 year	Cardiac implantable electronic device risk of IE

Trial Locations

Locations (1)

Odense University Hospital, Cardiology Department; 🇩🇰 Odense, Denmark