IMPLANTABLE SUBCUTANEOUS STRING DEFIBRILLATOR - SINGLE CENTER STUDY

Background
Implantable Subcutaneous String Defibrillator (ISSD) is a new class of implantable cardioverter defibrillator (ICD), designed to overcome current ICDs limitations. It incorporates all the components of a standard ICD within a flexible, string-like device without any metal can, and uses a novel dual pathway subcutaneous shock vector configuration.
Methods
We conducted an acute clinical trial in order to assess the energy requirements of the ISSD shock vector, and to examine the ISSD implantation procedure. We implanted the ISSD and performed defibrillation attempts using different energy levels (DFT testing) prior to ISSD explant in 22 patients who were candidates for ICD implantation.
Results
Statistical analysis of the defibrillation data in the study showed that when using the ISSD, the required shock energy to guarantee 99% successful tachyarrhythmia termination was 60.55J. The implant procedure proved to be simple, straightforward and short but requires fluoroscopy imaging, though only prior to implant.
Conclusions
The ISSD novel dual pathway subcutaneous shock vector may require less energy than the existing subcutaneous defibrillator, yet more than an intravenous ICD. The simple implant procedure can be less invasive comparing standard S-ICD.