P822CRT-D non-responders “downgrading": single center experience

Abstract

Background: In CRT-D non-responders at the device battery end of life (EOL) the lack of official guidelines could provoke the individual expert decision to "downgrade" CRT-D therapy to ICD only therapy, especially due to general health system austerity policy in some geographies. Aim(s): To investigate Echo-findings, NYHA Class, 6-min hall walk test (6-min HWT) heart failure (HF) hospitalization rate and mortality in CRT-D non-responders after "downgrading" to ICD. Method(s): This single-center prospective study included 19 CRT-D patients with no clinical and Echo-response at the device battery EOL. Patients were randomized in 1:1 fashion: ICD group (system "downgraded" to ICD device), and CRT-D group (CRT-D device re-implanted). Patients were followed up from 0.3 to 4.1 years (median 1.9 years). All patients gave informed consent. Result(s): ICD group constituted 11 patients and CRT-D group 8 patients. At the primo-implantation and at the enrollment of the study ICD group and CRT-D group have had no significant differences in terms of left ventricular ejection fraction (LVEF), LV end-systolic volume (ESV), NYHA class, 6 min HWT, age, gender and HF etiology. Two patients in ICD group had severe HF worsening few days after loss of LV stimulation and CRT-D was re-implanted. They were excluded from further analysis. After median 1.3 years of follow-up in ICD group there were 5 deaths (1 due to cerebrovascular insult, 4 due to terminal HF) and 6 hospitalization, and in CRT-D group after median 2.1 years of follow-up there were 2 deaths (due to terminal HF) and 2 hospitalization (p<0.01). LVEF in ICD group increased for 1% versus 5% in CRT-D group (p=0.03), and LV ESV increased for 10 ml in ICD group versus 32ml in CRT-D group (p<0.01). NYHA class at 1 year follow-up increased in ICD group for 0.2 versus 1.0 in CRT-D group (p<0.01). Conclusion(s): Our results showed significantly higher mortality and worse clinical and Echo-outcome in patients in whom CRT-D at device battery EOL was replaced with ICD due to conventional definition of non-response.