Reduction of inappropriate ICD therapies in patients with primary prevention of sudden cardiac death: DECREASE study.

BACKGROUND: A significant number of patients with an implantable cardioverter/defibrillator (ICD) for primary prevention receive inappropriate shocks. Previous studies have reported a reduction of inappropriate therapies with simple modifications of ICD detection settings, however, inclusion criteria and settings varied markedly between studies. Our aim was to investigate the effect of raising the ICD detection zone in the entire primary prevention ICD population.

METHODS AND RESULTS: 543 patients receiving an ICD for primary prevention were randomized to either conventional or progressive ICD programming. The detection rate was programmed at 171 bpm for ventricular tachycardia (VT) and 214 bpm for ventricular fibrillation (VF) in the Conventional group and 187 bpm for VT and 240 bpm for VF in the Progressive group. 43 % of patients received single-chamber and 57 % dual-chamber detection devices (DDD-ICD 19 %; CRT-D 38 %). The primary endpoint consisted of inappropriate therapies and untreated VT/VF. The primary endpoint was reached in 35 patients (13 %) in the Conventional group and 17 patients (6 %) in the Progressive group (p = 0.004). Progressive ICD programming led to significantly fewer amount of patients with ICD therapies (26 vs. 14 %; p < 0.001) and shocks (11 vs. 5 %; p = 0.023) compared to conventional ICD programming. Sub-analyses showed the greatest reduction of inappropriate therapies and shocks in dual-chamber detection devices with progressive compared to single-chamber detection devices with conventional ICD programming (p < 0.001).

CONCLUSIONS: Progressive ICD programming reduces the number of inappropriate therapies and shocks in a broad primary prevention ICD population particularly in combination with dual-chamber detection algorithms.

CLINICAL TRIAL REGISTRATION: https://clinicaltrials.gov ; ClinicalTrials.gov identifier NCT01217528.