Assessment of Diagnostic and Therapeutic Practices for Cardiac Implantable Electronic Devices Suspected Infections in Nancy University Hospital

NCT04501835 | Completed

• 1 other identifier: 2020PI077
• Study Type: observational
• Target: 184
• Locations: 1 country
• Sites: 1

Brief Summary

The frequency of cardiac implantable electronic devices (CIED) is constantly increasing. Devices infections are one of the most serious complications in terms of morbidity and mortality. Although the frequency of cardiac implantable devices infections is difficult to derminate due to divergent definitions, cohort studies report a trend of increasing. The infection can be localized at the pocket of the implantation, at intravascular or intra-cardiac portion of leads. Infectious endocarditis defined by involvement of the intra-cardiac portion of leads is the most serious form. The diagnosis is based on clinical, biological and multimodal imagery data. Early diagnosis and specific management are necessary to reduce mortality and morbidity. Since the last European recommendations on infectious endocarditis in 2015, the HeartRythm Society of patient described an algorithm to treat CIED infections and extraction indications. However, in practice, management of CEID infections remains center-dependent and data from robust international studies are missing. The main objective of our study is to evaluate the management of CEID suspected infections and the prognosis at 1 year in terms of survival according to the methods of treatment at the Nancy University Hospital and to compare the treatment with the latest recommendations in force

Conditions

Cardiac Implantable Electronic Device Infections

Outcome Measures

Primary Outcomes (1)

• Description of the practice

  Describe the diagnostic and therapeutic practices of patients hospitalized for CIED suspected infection

  From January 2014 to July 2020

Secondary Outcomes (1)

• Evaluation of local practices against current recommendations

  From January 2014 to July 2020

Study Arms (1)

Cardiac implantable electronic device infections

Patients hospitalised in Nancy University Hospital for suspected cardiac implantable electronic device infections

Other: Diagnostic and treatment evaluation

Interventions

Diagnostic and treatment evaluation OTHER

No intervention, description of the diagnostic evaluation and the treatment

Cardiac implantable electronic device infections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients hospitalized in Nancy University Hospital between January 2014 et July 2019 for CIED suspected infection

You may qualify if:

• All patients who have been hospitalized in Nancy University Hospital between January 2014 et July 2019 for suspected infection of cardiac implantable electronic device

You may not qualify if:

• Minor patients
• Epicardial CIED

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

De Ciancio

Vandœuvre-lès-Nancy, 54500, France

Location

Related Publications (4)

• Greenspon AJ, Patel JD, Lau E, Ochoa JA, Frisch DR, Ho RT, Pavri BB, Kurtz SM. 16-year trends in the infection burden for pacemakers and implantable cardioverter-defibrillators in the United States 1993 to 2008. J Am Coll Cardiol. 2011 Aug 30;58(10):1001-6. doi: 10.1016/j.jacc.2011.04.033.

  PMID: 21867833 BACKGROUND

• Joy PS, Kumar G, Poole JE, London B, Olshansky B. Cardiac implantable electronic device infections: Who is at greatest risk? Heart Rhythm. 2017 Jun;14(6):839-845. doi: 10.1016/j.hrthm.2017.03.019. Epub 2017 Mar 16.

  PMID: 28315744 BACKGROUND

• Habib G, Lancellotti P, Antunes MJ, Bongiorni MG, Casalta JP, Del Zotti F, Dulgheru R, El Khoury G, Erba PA, Iung B, Miro JM, Mulder BJ, Plonska-Gosciniak E, Price S, Roos-Hesselink J, Snygg-Martin U, Thuny F, Tornos Mas P, Vilacosta I, Zamorano JL; ESC Scientific Document Group. 2015 ESC Guidelines for the management of infective endocarditis: The Task Force for the Management of Infective Endocarditis of the European Society of Cardiology (ESC). Endorsed by: European Association for Cardio-Thoracic Surgery (EACTS), the European Association of Nuclear Medicine (EANM). Eur Heart J. 2015 Nov 21;36(44):3075-3128. doi: 10.1093/eurheartj/ehv319. Epub 2015 Aug 29. No abstract available.

  PMID: 26320109 BACKGROUND

• Kusumoto FM, Schoenfeld MH, Wilkoff BL, Berul CI, Birgersdotter-Green UM, Carrillo R, Cha YM, Clancy J, Deharo JC, Ellenbogen KA, Exner D, Hussein AA, Kennergren C, Krahn A, Lee R, Love CJ, Madden RA, Mazzetti HA, Moore JC, Parsonnet J, Patton KK, Rozner MA, Selzman KA, Shoda M, Srivathsan K, Strathmore NF, Swerdlow CD, Tompkins C, Wazni O. 2017 HRS expert consensus statement on cardiovascular implantable electronic device lead management and extraction. Heart Rhythm. 2017 Dec;14(12):e503-e551. doi: 10.1016/j.hrthm.2017.09.001. Epub 2017 Sep 15. No abstract available.

  PMID: 28919379 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 20, 2020
• First Posted: August 6, 2020
• Study Start: July 31, 2019
• Primary Completion: July 30, 2020
• Study Completion: September 30, 2020
• Last Updated: January 27, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 1 year
• Access Criteria: Data access request will be reviewed by investigator team. Requestors will be required to signe a data access agreement

Locations

FR (1)