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NCT06403839 Clinical Trial

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

Endocarditis Clinical Trial

— DENSVAR  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06403839
Other study ID # PET24SVAR
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2020
Est. completion date March 1, 2028

Study information
Verified date June 2024
Source Odense University Hospital
Contact Lytfi Krasniqi, MD
Phone 004524638899
Email Lytfi.Krasniqi@rsyd.dk
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 1000
Est. completion date March 1, 2028
Est. primary completion date March 1, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patients undergoing surgical valve replacement Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Denmark Odense University Hospital, Cardiac Surgery Department Odense

Sponsors (1)
Lead Sponsor Collaborator
Odense University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (10)

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. — View Citation

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. — View Citation

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):3948-4042. doi: 10.1093/eurheartj/ehad193. No abstract available. Erratum In: Eur Heart J. 2023 Sep 20;: Eur Heart J. 2024 Jan 1;45(1):56. — View Citation

Krasniqi L, Schodt Riber LP, Nissen H, Terkelsen CJ, Andersen NH, Freeman P, Povlsen JA, Gerke O, Clavel MA, Dahl JS. Impact of mandatory preoperative dental screening on post-procedural risk of infective endocarditis in patients undergoing transcatheter aortic valve implantation: a nationwide retrospective observational study. Lancet Reg Health Eur. 2023 Nov 22;36:100789. doi: 10.1016/j.lanepe.2023.100789. eCollection 2024 Jan. — View Citation

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. — View Citation

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. Erratum In: Eur Heart J. 2019 Jul 14;40(27):2230. doi: 10.1093/eurheartj/ehz020. — View Citation

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;143(5):e72-e227. doi: 10.1161/CIR.0000000000000923. Epub 2020 Dec 17. No abstract available. Erratum In: Circulation. 2021 Feb 2;143(5):e229. doi: 10.1161/CIR.0000000000000955. Circulation. 2023 Aug 22;148(8):e8. doi: 10.1161/CIR.0000000000001177. Circulation. 2023 Nov 14;148(20):e185. doi: 10.1161/CIR.0000000000001190. — View Citation

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. — View Citation

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. — View Citation

Vahanian A, Beyersdorf F, Praz F, Milojevic M, Baldus S, Bauersachs J, Capodanno D, Conradi L, De Bonis M, De Paulis R, Delgado V, Freemantle N, Gilard M, Haugaa KH, Jeppsson A, Juni P, Pierard L, Prendergast BD, Sadaba JR, Tribouilloy C, Wojakowski W; ESC/EACTS Scientific Document Group. 2021 ESC/EACTS Guidelines for the management of valvular heart disease. Eur Heart J. 2022 Feb 12;43(7):561-632. doi: 10.1093/eurheartj/ehab395. No abstract available. Erratum In: Eur Heart J. 2022 Feb 18;: — View Citation

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