Death, Sudden, Cardiac, Ventricular Fibrillation
Conditions
Keywords
Implantable cardioverter defibrillator, lead failure, pace/sense lead, ICD complication, inappropriate therapy, Defibrillators
Brief summary
Comparison of two different approaches to address the problem of malfunctioning ICD-leads. These leads consist of two parts. One that is used for detection of arrhythmias(and pacing if required) (Pace/Sense) and a second part that is used to deliver therapy is needed (Shock-coil). The two approaches compared are: Replacement of the entire lead in case of any lead malfunction versus placement of an additional pace/sense-lead if the shock-coil of the exiting lead was still functional.
Detailed description
Therapy with an implantable cardioverter defibrillator (ICD) has become a standard treatment for an increasing number of patients suffering from different types of heart diseases which can lead to fatal arrhythmias. This therapy was established about 20 Years ago and malfunctioning electrodes of these devices have been, and still are a serious problem leading to inappropriate therapy (shocks)or missed live saving therapy. In case of a malfunctioning electrode it is established clinical practice to either replace the entire ICD electrode (which is used for detecting the arrhythmias as well as delivering the shock) or just to implant an additional electrode for detection of the arrhythmia (and pacing if required) given that the shock-part of the existing electrode is still functional. There is no longterm outcome data comparing these two strategies. We included 1317 consecutive patients with an ICD implanted at three European centers between 1993 and 2004. Incidence of lead failure, type of lead used, approach and outcome were evaluated.
Interventions
None listed
Sponsors
Study design
Eligibility
Inclusion criteria
* Implantation of an ICD between 1993 and 2004
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to lead failure or lead failure recurrence | from inclution to death or end of follow up (Jan 2004) |
Countries
Germany, Switzerland