Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Surgical Valve Replacement Patients

Official title

Impact of Targeted Preoperative Dental Screening on Post-procedural Risk of Infective Endocarditis in Patients Undergoing Surgical Valve Replacement: a Prospective Observational Study

Overview

In Odense University Hospital preoperative dental screening (PDS) protocol for patients treated with surgical valve replacement was changed from mandatory to targeted PDS to from march 2024. The investigators will therefore compare the risk of IE before vs after march 2024.

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 valve replacement 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.

Interventions

• Procedure No preoperative dental screening
  Discontinuance of mandatory preoperative dental screening prior surgical valve replacement which also can include oral surgery.

Primary outcome measures

• Number of Participants with Infectious Endocarditis [Time frame: Through study completion, an average of 1 year]

Secondary outcome measures (6)

• Number of Participants undergoing Oral surgical procedure at dental screening [Time frame: Through study completion, an average of 1 year]
• Number of Participants undergoing Tooth extraction at dental screening [Time frame: Through study completion, an average of 1 year]
• The different Bacteria types causing the infectious endocarditis assessed by blood culture [Time frame: Through study completion, an average of 1 year]
• Number patients with Bacteremia assessed by positive blood culture [Time frame: Through study completion, an average of 1 year]
• Number of Participants with IE caused by bacteria from oral foci [Time frame: Through study completion, an average of 1 year]
• Number of Participants with Cardiac implantable electronic device risk of IE [Time frame: Through study completion, an average of 1 year]

Eligibility criteria

Inclusion criteria

• Patients undergoing surgical valve replacement

Exclusion criteria

• None

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Denmark · 1 center

• Odense University Hospital, Cardiac Surgery Department — Odense

Publications

• Que YA, Moreillon P. Infective endocarditis. Nat Rev Cardiol. 2011 Jun;8(6):322-36. doi: 10.1038/nrcardio.2011.43. Epub 2011 Apr 12. PMID 21487430
• Piper C, Korfer R, Horstkotte D. Prosthetic valve endocarditis. Heart. 2001 May;85(5):590-3. doi: 10.1136/heart.85.5.590. No abstract available. PMID 11303018
• Ostergaard L, Valeur N, Ihlemann N, Smerup MH, Bundgaard H, Gislason G, Torp-Pedersen C, Bruun NE, Kober L, Fosbol EL. Incidence and factors associated with infective endocarditis in patients undergoing left-sided heart valve replacement. Eur Heart J. 2018 Jul 21;39(28):2668-2675. doi: 10.1093/eurheartj/ehy153. PMID 29584858
• Delgado V, Ajmone Marsan N, de Waha S, Bonaros N, Brida M, Burri H, Caselli S, Doenst T, Ederhy S, Erba PA, Foldager D, Fosbol EL, Kovac J, Mestres CA, Miller OI, Miro JM, Pazdernik M, Pizzi MN, Quintana E, Rasmussen TB, Ristic AD, Rodes-Cabau J, Sionis A, Zuhlke LJ, Borger MA; ESC Scientific Document Group. 2023 ESC Guidelines for the management of endocarditis. Eur Heart J. 2023 Oct 14;44(39):39 PMID 37622656
• Mentias A, Girotra S, Desai MY, Horwitz PA, Rossen JD, Saad M, Panaich S, Kapadia S, Sarrazin MV. Incidence, Predictors, and Outcomes of Endocarditis After Transcatheter Aortic Valve Replacement in the United States. JACC Cardiovasc Interv. 2020 Sep 14;13(17):1973-1982. doi: 10.1016/j.jcin.2020.05.012. PMID 32912457
• Butt JH, Ihlemann N, De Backer O, Sondergaard L, Havers-Borgersen E, Gislason GH, Torp-Pedersen C, Kober L, Fosbol EL. Long-Term Risk of Infective Endocarditis After Transcatheter Aortic Valve Replacement. J Am Coll Cardiol. 2019 Apr 9;73(13):1646-1655. doi: 10.1016/j.jacc.2018.12.078. PMID 30947917
• Otto CM, Nishimura RA, Bonow RO, Carabello BA, Erwin JP 3rd, Gentile F, Jneid H, Krieger EV, Mack M, McLeod C, O'Gara PT, Rigolin VH, Sundt TM 3rd, Thompson A, Toly C. 2020 ACC/AHA Guideline for the Management of Patients With Valvular Heart Disease: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. Circulation. 2021 Feb 2;14 PMID 33332150
• Buckley AJ, Hensey M, O'Connor S, Maree A. Dental screening prior to transcatheter versus surgical aortic valve replacement: International Survey of Current Practices. Catheter Cardiovasc Interv. 2023 Jul;102(1):176-177. doi: 10.1002/ccd.30675. Epub 2023 May 7. No abstract available. PMID 37149755

Identifiers

NCT: NCT06403839 · PET24SVAR

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗