Dutch outcome in implantable cardioverter-defibrillator therapy (DO-IT): registry design and baseline characteristics of a prospective observational cohort study to predict appropriate indication for implantable cardioverter-defibrillator

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.

Differential multivariable risk prediction of appropriate shock versus competing mortality - A prospective cohort study to estimate benefits from ICD therapy

“…For identification, risk markers such as those from our current study could be utilized. The data of large observational ICD studies such as the prospective EU-CERT-ICD-study (NCT 02064192) and the Dutch DO-IT study [41] will become available in the second half of 2018 and can also influence the design of future randomized trials. Open field = not selected as model variable; AF = atrial fibrillation; eGFR = estimated glomerular filtration rate; EP = electrophysiological; LVEF = left ventricular ejection fraction; NT-proBNP = n-terminal pro brain natriuretic peptide, NYHA = New York Heart Association.…”

Rationale and design of the EU‐CERT‐ICD prospective study: comparative effectiveness of prophylactic ICD implantation

“…68 The randomized REevaluation of optimal treatment Strategies for prEvenTion of Sudden Cardiac Death in patients with ischemic cardiomyopathy trial was proposed to reassess the effects of primary prophylactic ICD therapy in ischaemic cardiomyopathy. 68 The randomized REevaluation of optimal treatment Strategies for prEvenTion of Sudden Cardiac Death in patients with ischemic cardiomyopathy trial was proposed to reassess the effects of primary prophylactic ICD therapy in ischaemic cardiomyopathy.…”

“…In parallel to EU-CERT-ICD, the Dutch Outcome in Implantable cardioverter-defibrillator Therapy registry study funded by Dutch health insurers will report similar outcomes including cost-effectiveness in 1500 primary prophylactic ICD patients from multiple implant centres in the Netherlands in late 2018. 68 The randomized REevaluation of optimal treatment Strategies for prEvenTion of Sudden Cardiac Death in patients with ischemic cardiomyopathy trial was proposed to reassess the effects of primary prophylactic ICD therapy in ischaemic cardiomyopathy. 69 Another trial probing the prophylactic indication of defibrillators-the randomized Re-evaluation of Optimal Re-synchronisation Therapy in Patients with Chronic Heart Failure trial in 2000 patients with an LVEF ≤ 35% and 188 CRT treatment-is funded by the German health system 70 and starting up.…”

Handling missing predictor values when validating and applying a prediction model to new patients

“…This registry included 1433 patients between September 2014 and June 2016 from all Dutch ICD implanting hospitals. 23 Only patients with a primary indication according to the Dutch national guidelines for ICD therapy were included. Patients were followed for occurrence of appropriate ICD therapy (defibrillator shock or antitachycardia pacing for ventricular tachyarrhythmias) or all cause death.…”

“…The various methods will be illustrated with simulated data and data from an ongoing project on the prediction of mortality after primary therapy with an implantation cardioverter defibrillator (ICD) in heart failure patients at risk for cardiac arrhythmia and death (the DO-IT Registry). 23…”