Ventricular Fibrillation Clinical Trial
Official title:
Failure of Chronically Implanted Defibrillator Leads -Incidence and Management A Retrospective Multicenter Study
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.
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.
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Observational Model: Case Control, Time Perspective: Retrospective
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