Reducing Events in Patients with Chronic Heart Failure (REDUCEhf ) Study Design: Continuous Hemodynamic Monitoring with an Implantable Defibrillator

Abstract

Background The use of implantable cardioverter defibrillators (ICDs) has been proven effective in the prevention of sudden cardiac death (SCD) and constitutes standard of care in appropriate populations. Combining a pressure sensing system with ICD therapy represents the first attempt to provide continuous hemodynamic monitoring using a device previously designed exclusively for SCD protection. Methods REDUCE is a prospective, multicenter, randomized, single‐blind, parallel‐controlled trial designed to assess the safety of the Chronicle ICD system (single chamber ICD with a hemodynamic monitoring system) and the effectiveness of a management strategy guided by intracardiac pressure information among ICD‐indicated New York Heart Association (NYHA) Class II or III heart failure (HF) patients. Those successfully implanted with a Chronicle ICD will be randomized to the Chronicle group or Control group. All patients will receive optimal medical therapy, but the hemodynamic information from the device will be used to guide patient management only in the Chronicle group. Primary endpoints include freedom from system‐related complications and relative risk reduction of one or more HF‐related events (hospitalizations, and emergency department and urgent care visits requiring intravenous therapy for HF). Approximately 850 patients will be enrolled in at least 75 centers in the United States to accrue the 419 events needed to test the primary effectiveness endpoint. Enrollment began in April 2006, and is expected to end during 2009. Conclusion REDUCE will assess the safety of the Chronicle ICD system and the effectiveness of a patient management strategy based on remote access to continuous intracardiac pressures in reducing HF‐related events. Copyright © 2007 Wiley Periodicals, Inc.

Why, when, and how to assess pulmonary congestion in heart failure: pathophysiological, clinical, and methodological implications

“…Anyway, the real clinical benefit of regularly monitoring congestion in HF outpatients has to be clearly established: a recent study showed a nonsignificant 21% decrease of all HF-related events after 6 month of follow-up in the group receiving fluid status monitoring (by an implanted intrathoracic impedance monitoring device) compared to controls [17]; yet, a retrospective analysis of the time to first HF hospitalization showed a significant risk reduction by 36%. These technologies are now being evaluated in a larger clinical trial [18]. Nonetheless, both American and European guidelines recommend a careful surveillance of the fluid status in the day-to-day management of patients with HF, in order to maintain fluid balance and to avoid volume expansion.…”

Influence of Intracardiac Pressure on Spontaneous Ventricular Arrhythmias in Patients With Systolic Heart Failure

“…Patients were implanted with an IHM-ICD device 6 attached to both a single-standard transvenous ICD lead and a second transvenous hemodynamic pressure sensing lead positioned in the right ventricular outflow tract. The IHM continuously measured and stored right ventricular dP/dt, systolic and diastolic pressures, and an estimate of pulmonary artery diastolic pressure (ePAD).…”

Devices for Following Heart Failure Patients

“…A variety of implantable hemodynamic monitoring devices are also in clinical trials and include stand-alone devices or those coupled with other indicated devices such as implantable cardioverter defibrillators (Table 11.3) [39].…”

“…Implantable hemodynamic monitors (IHM) vary in design, and include devices that continuously measure cardiovascular signals at the right ventricular outflow tract (Chronicle IHM and Chronicle ICD, Medtronic, Inc) with Internet based information systems [8,9,[39][40][41][42], left atrial pressure monitors that allow patient interaction using a handheld device [43,44], and devices that intermittently measure intrapulmonary artery pressures from an implanted device without wires or batteries, powered during interrogation (CardioMEMS, Inc) [45,46]. These devices offer a new paradigm of device-based monitoring and diagnostics that promise to provide a new basis for heart failure medical management.…”

“…The Reducing Events in patients with Chronic Heart Failure (REDUCEhf) trial is prospectively evaluating the combination of the Chronicle IHM with a single-chamber ICD in NYHA Class II and III patients indicated for ICD implantation [39]. This trial's efficacy endpoint is a composite of heart failure hospitalizations, emergency department visits, and urgent clinic visits requiring intravenous medical therapy.…”