Why the study?
Is the totally subcutaneous implantable defibrillator (S-ICD) safe and effective for the management of VT/VF?
Is the totally subcutaneous implantable defibrillator (S-ICD) safe and effective for the management of VT/VF?
The S-ICD provides safe and effective therapy for VT/VF, with safety profiles improving through strategic programming and greater operator experience.
S-ICD efficacy for VT/VF may support selective use with experience; leaves open randomized confirmation amid mixed evidence.
The S-ICD demonstrated high efficacy for VT/VF. Complications and inappropriate shock rates were reduced consistently with strategic programming and as operator experience increased. These data provide further evidence for the safety and efficacy of the S-ICD. (Boston Scientific Post Market S-ICD Registry [EFFORTLESS]; NCT01085435; S-ICD® System IDE Clinical Study; NCT01064076).
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Burke et al. (2015) studied this question.
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