Clinical trial NCT06330766: Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients
Official title: Impact of Targeted Preoperative Dental Screening on Post-procedural Risk of Infective Endocarditis in Patients Undergoing Transcatheter Aortic Valve Implantation: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Transcatheter Aortic Valve Implantation
Dental
Endocarditis
Keywords: Transcatheter aortic valve implantation
TAVI
Preoperative dental screening
Infectious endocarditis
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2024-03-26
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients undergoing TAVI from Oktober 2023 to January 2026 from Odense University Hospital and Aalborg University Hospital compared with same type of patients from the same centers from the period January 2020 to June 2023.

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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing TAVI

Exclusion Criteria:

* None

Primary outcomes:
measure: Number of Participants with Infectious Endocarditis
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Number of Participants undergoing Oral surgical procedure at dental screening
timeFrame: Through study completion, an average of 1 year
measure: Number of Participants undergoing Tooth extraction at dental screening
timeFrame: Through study completion, an average of 1 year
measure: The different Bacteria types causing the infectious endocarditis assessed by blood culture
timeFrame: Through study completion, an average of 1 year
measure: Number patients with Bacteremia assessed by positive blood culture
timeFrame: Through study completion, an average of 1 year
measure: Number of Participants with IE caused by bacteria from oral foci
timeFrame: Through study completion, an average of 1 year
measure: Number of Participants with Cardiac implantable electronic device risk of IE
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital, Cardiology Department
Study officials:
affiliation: Odense University Hospital
name: Jordi S Dahl, MD,PhD,DMSc
role: PRINCIPAL_INVESTIGATOR
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