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: 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. Methods: 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. Results: 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: 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.