Abstract
BackgroundImplantable cardioverter-defibrillators (ICDs) are widely used for the prevention of sudden cardiac death. At present, both clinical benefit and cost-effectiveness of ICD therapy in primary prevention patients are topics of discussion, as only a minority of these patients will eventually receive appropriate ICD therapy.Methods/designThe DO-IT Registry is a nationwide prospective cohort with a target enrolment of 1,500 primary prevention ICD patients with reduced left ventricular function in a setting of structural heart disease. The primary outcome measures are death and appropriate ICD therapy for ventricular tachyarrhythmias. Secondary outcome measures are inappropriate ICD therapy, death of any cause, hospitalisation for ICD related complications and for cardiovascular reasons. As of December 2016, data on demographic, clinical, and ICD characteristics of 1,468 patients have been collected. Follow-up will continue up to 24 months after inclusion of the last patient. During follow-up, clinical and ICD data are collected based on the normal follow-up of these patients, assuming ICD interrogations take place every six months and clinical follow-up is once a year. At baseline, the mean age was 66 (standard deviation [SD] 10) years and 27% were women.ConclusionThe DO-IT Registry represents a real-world nationwide cohort of patients receiving ICDs for primary prevention of sudden cardiac death with reduced left ventricular function in a setting of structural heart disease. The registry investigates the efficacy of the current practice and aims to develop prediction rules to identify subgroups who will not (sufficiently) benefit from ICD implantation and to provide results regarding costs and budget impact of targeted supply of primary preventions ICDs.Electronic supplementary materialThe online version of this article (doi: 10.1007/s12471-017-1016-x) contains supplementary material, which is available to authorized users.
Highlights
Implantable cardioverter-defibrillators (ICDs) are widely used for the prevention of sudden cardiac death
The question arises whether primary prevention patients will be subject to the same number of ICD implantation for primary prevention of sudden cardiac death
There are some differences between the baseline characteristics of the DO-IT patients and the patients included in the largest randomised control trials (RCTs), MADIT II [8] and sudden cardiac death (SCD)-HEFT [3] (Tab. 2)
Summary
Implantable cardioverter-defibrillators (ICDs) are widely used for the prevention of sudden cardiac death. Conclusion The DO-IT Registry represents a real-world nationwide cohort of patients receiving ICDs for primary prevention of sudden cardiac death with reduced left ventricular function in a setting of structural heart disease. A class I indication is recommended for patients with an LVEF Ä 30% and NYHA I functional capacity [9, 10] At present, both clinical benefit and cost-effectiveness of ICD therapy in patients with a primary prevention indication of SCD are being discussed. During mid-term followup, approximately two thirds of primary prevention ICD patients will never receive appropriate therapy for ventricular arrhythmias [3, 11,12,13] They remain at risk of inappropriate shocks and device complications [14,15,16], which may impair recipients’ quality of life [17].
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