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

NCT06330766 | Recruiting

• 1 other identifier: PET24
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Transcatheter Aortic Valve Implantation; Dental; Endocarditis

Keywords

Transcatheter aortic valve implantation; TAVI; Preoperative dental screening; Infectious endocarditis

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Infectious Endocarditis

  Infectious endocarditis diagnosed by healthcare professionals

  Through study completion, an average of 1 year

Secondary Outcomes (6)

• Number of Participants undergoing Oral surgical procedure at dental screening

  Through study completion, an average of 1 year

• Number of Participants undergoing Tooth extraction at dental screening

  Through study completion, an average of 1 year

• The different Bacteria types causing the infectious endocarditis assessed by blood culture

  Through study completion, an average of 1 year

• Number patients with Bacteremia assessed by positive blood culture

  Through study completion, an average of 1 year

• Number of Participants with IE caused by bacteria from oral foci

  Through study completion, an average of 1 year

Study Arms (2)

No preoperative dental screening

No preoperative dental screening in patients undergoing TAVI

Procedure: No preoperative dental screening

Mandatory preoperative dental screening

Mandatory preoperative dental screening in patients undergoing TAVI

Interventions

No preoperative dental screening PROCEDURE

Discontinuance of mandatory preoperative dental screening prior TAVI which also can include oral surgery.

No preoperative dental screening

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients undergoing TAVI

You may not qualify if:

• None

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital, Cardiology Department

Odense, 5000, Denmark

RECRUITING

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Baddour LM, Wilson WR, Bayer AS, Fowler VG Jr, Tleyjeh IM, Rybak MJ, Barsic B, Lockhart PB, Gewitz MH, Levison ME, Bolger AF, Steckelberg JM, Baltimore RS, Fink AM, O'Gara P, Taubert KA; American Heart Association Committee on Rheumatic Fever, Endocarditis, and Kawasaki Disease of the Council on Cardiovascular Disease in the Young, Council on Clinical Cardiology, Council on Cardiovascular Surgery and Anesthesia, and Stroke Council. Infective Endocarditis in Adults: Diagnosis, Antimicrobial Therapy, and Management of Complications: A Scientific Statement for Healthcare Professionals From the American Heart Association. Circulation. 2015 Oct 13;132(15):1435-86. doi: 10.1161/CIR.0000000000000296. Epub 2015 Sep 15.

  PMID: 26373316 BACKGROUND

• 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.

  PMID: 37622656 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 33332150 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 34453165 BACKGROUND

• 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.

  PMID: 38188272 BACKGROUND

MeSH Terms

Conditions

Endocarditis; Endocarditis, Subacute Bacterial

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Endocarditis, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Streptococcal Infections; Gram-Positive Bacterial Infections; Cardiovascular Infections

Study Officials

• Jordi S Dahl, MD,PhD,DMSc

  Odense University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordi S Dahl, MD,PhD,DMSc

CONTACT

004524638899; Jordi.Sanchez.Dahl@rsyd.dk

Lytfi Krasniqi, MD

CONTACT

004524638899; Lytfi.Krasniqi@rsyd.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Chief physician in charge of cardiology imaging

Study Record Dates

• First Submitted: February 19, 2024
• First Posted: March 26, 2024
• Study Start: January 1, 2020
• Primary Completion: January 1, 2026
• Study Completion: January 1, 2026
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR, ANALYTIC CODE
• Time Frame: To be announced
• Access Criteria: A signed data access agreement, compliant with regional legislation and data authority requirements, must be obtained prior to data release.

Locations

DK (1)