Observational, Retrospective, Single-center Study Aimed at Evaluating Long-term Outcomes Following Transvenous Lead Extraction of Infected Cardiac Implantable Electronic Devices.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cardiac Implantable Electronic Device (CIED). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Long Term Outcomes of Cardiac Implantable Electronic Device Infections and Transvenous Lead Extraction: a Single Center Retrospective
Overview
The study aims to review the centre experience in previous 20 years to understand clinical course of patients underwent TLE for lead and pocket infection, to better understand prognosis, re-implant indication, timing and strategy, and long term outcomes.
Primary outcome measures
- Major clinical adverse outcomes [Time frame: 1 year and 5 years follow up]
- Major clinical adverse outcomes [Time frame: 1 year and 5 years follow up]
- Major clinical adverse outcomes [Time frame: 1 year and 5 years follow up]
Secondary outcome measures (1)
- need of re-implantation of CIED for patients who underwent TLE [Time frame: discharge, 1 and 5 years]
Eligibility criteria
Inclusion criteria
- Patients ≥ 18 years.
- Patients who underwent explantation of a single-chamber, dual-chamber, or biventricular pacemaker, or an intracardiac defibrillator, due to pocket infection, lead-related infection, or endocarditis at San Raffaele Hospital between January 2004 and November 2020.
Exclusion criteria
- Lack of active status of follow-up
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
- Case-only
Study locations
Center list to be confirmed — check the primary protocol.
Publications
- Sohail MR, Henrikson CA, Braid-Forbes MJ, Forbes KF, Lerner DJ. Mortality and cost associated with cardiovascular implantable electronic device infections. Arch Intern Med. 2011 Nov 14;171(20):1821-8. doi: 10.1001/archinternmed.2011.441. Epub 2011 Sep 12. PMID 21911623
- Vaidya VR, Alraies MC, Kelli HM, Patel N, Nairooz R, Maher J, et al. Transvenous lead extraction: predictors of mortality and outcomes in over 10,000 procedures. Heart Rhythm. 2021;18(7):1099-1105. doi:10.1016/j.hrthm.2021.03.013
- Maytin M, Jones SO, Epstein LM. Long-term mortality after transvenous lead extraction. Circ Arrhythm Electrophysiol. 2012 Apr;5(2):252-7. doi: 10.1161/CIRCEP.111.965277. Epub 2012 Feb 23. PMID 22362891
- Bongiorni MG, Kennergren C, Butter C, Deharo JC, Kutarski A, Rinaldi CA, Romano SL, Maggioni AP, Andarala M, Auricchio A, Kuck KH, Blomstrom-Lundqvist C; ELECTRa Investigators. The European Lead Extraction ConTRolled (ELECTRa) study: a European Heart Rhythm Association (EHRA) Registry of Transvenous Lead Extraction Outcomes. Eur Heart J. 2017 Oct 21;38(40):2995-3005. doi: 10.1093/eurheartj/ehx080. PMID 28369414
Identifiers
NCT: NCT07530107 · CIED EXTRACTION