CIED Implantation Technique at Assiut University Heart Hospital in Relation to ESC Guidelines
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
- The protocol lists: CIEDimplantation.
- Who it may be relevant to
- Registry conditions: CIED-related Infections, CIED Implantation. 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
Magnitude of Alignment With ESC Guidelines in Implantation Techniques of Cardiac Implantable Electronic Devices and Its Impact on Clinical Outcomes
Overview
This prospective observational cohort study will evaluate the extent to which cardiac implantable electronic device (CIED) implantation techniques at Assiut University Heart Hospital (AUHH) align with the evidence-based recommendations of the European Society of Cardiology (ESC).
Detailed description
There is a huge and growing body of evidence demonstrating the importance of cardiac implantable electronic devices (CIEDs) in improving quality of life and survival among specific groups of patients with heart disease. This has led to an increasing number of implanted CIEDs, with approximately 1.2-1.4 million procedures performed annually worldwide. Over the years, advancements in device technology and implantation techniques have significantly improved patient outcomes and device longevity.
However, variations in implantation practices persist across different centers due to differences in training, available resources, and institutional protocols. The European Society of Cardiology (ESC) has established evidence-based guidelines outlining the optimal technique for CIED implantation, aiming to standardize practices and minimize procedure-related complications. These guidelines cover various aspects of the implantation process, including pre-procedural assessment, choice of venous access, lead positioning, infection prevention strategies, and post-implantation follow-up.
At Assiut University Heart Hospital, CIED implantation is routinely performed; however, the extent to which current practice aligns with the ESC-recommended optimal technique remains unclear. Understanding this alignment is crucial, as deviations from best practices may contribute to avoidable early complications, suboptimal device function, or reduced patient satisfaction.
This study aims to compare the current pacemaker implantation technique utilized at Assiut University Heart Hospital with the optimal implantation approach outlined in the latest ESC guidelines. Furthermore, it seeks to assess whether discrepancies or variations in CIED implantation techniques translate into differences in outcomes and complication rates. Assessing the degree of adherence to international guidelines by identifying gaps and areas for improvement may contribute to enhancing procedural quality, efficiency, patient safety, and clinical outcomes.
Interventions
- Device CIEDimplantation
Compare current procedural CIED practice at AUHH to recent ESC guidelines.
Primary outcome measures
- Incidence of procedure-related early complications (composite) [Time frame: 30 day]
Secondary outcome measures (1)
- Incidence of late complications after pacemaker implantation [Time frame: 12 month]
Eligibility criteria
Inclusion criteria
- All addult patients (≥18 years) referred foran indicatedCIED implantation at Assiut University Heart Hospital
Exclusion criteria
- Previous implantation of CIED implantation
- General contraindications of CIED
- Patient refusal
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
Center list to be confirmed — check the primary protocol.
Publications
- Hayes DL, Furman S. Cardiac pacing: how it started, where we are, where we are going. J Cardiovasc Electrophysiol. 2004 May;15(5):619-27. doi: 10.1046/j.1540-8167.2004.04088.x. No abstract available. PMID 15149441
- Da Costa A, Kirkorian G, Isaaz K, Touboul P. [Secondary infections after pacemaker implantation]. Rev Med Interne. 2000 Mar;21(3):256-65. doi: 10.1016/s0248-8663(00)80045-4. French. PMID 10763187
- Kranick S, Mishra N, Theertham A, Vo H, Hiltner E, Coromilas J, Kassotis J. A Survey of Antibiotic Use During Insertion of Cardiovascular Implantable Devices Among United States Implanters. Angiology. 2023 Apr;74(4):351-356. doi: 10.1177/00033197221114689. Epub 2022 Jul 11. PMID 35816293
Identifiers
NCT: NCT07210801 · CIED Implantation Technique