Clinical research: heart failure
Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias

https://doi.org/10.1016/S0735-1097(03)01042-8Get rights and content
Under an Elsevier user license
open archive

Abstract

Objectives

This study was conducted to assess the safety and effectiveness of cardiac resynchronization therapy (CRT) when combined with an implantable cardioverter defibrillator (ICD).

Background

Long-term outcome of CRT was measured in patients with symptomatic heart failure (HF), intraventricular conduction delay, and malignant ventricular tachyarrhythmias (ventricular tachycardia/ventricular fibrillation [VT/VF]) requiring therapy from an ICD.

Methods

Patients (n = 490) were implanted with a device capable of providing both CRT and ICD therapy and randomized to CRT (n = 245) or control (no CRT, n = 245) for up to six months. The primary end point was progression of HF, defined as all-cause mortality, hospitalization for HF, and VT/VF requiring device intervention. Secondary end points included peak oxygen consumption (VO2), 6-min walk (6 MW), New York Heart Association (NYHA) class, quality of life (QOL), and echocardiographic analysis.

Results

A 15% reduction in HF progression was observed, but this was statistically insignificant (p = 0.35). The CRT, however, significantly improved peak VO2(0.8 ml/kg/min vs. 0.0 ml/kg/min, p = 0.030) and 6 MW (35 m vs. 15 m, p = 0.043). Changes in NYHA class (p = 0.10) and QOL (p = 0.40) were not statistically significant. The CRT demonstrated significant reductions in ventricular dimensions (left ventricular internal diameter in diastole = −3.4 mm vs. −0.3 mm, p < 0.001 and left ventricular internal diameter in systole = −4.0 mm vs. −0.7 mm, p < 0.001) and improvement in left ventricular ejection fraction (5.1% vs. 2.8%, p = 0.020). A subgroup of patients with advanced HF (NYHA class III/IV) consistently demonstrated improvement across all functional status end points.

Conclusions

The CRT improved functional status in patients indicated for an ICD who also have symptomatic HF and intraventricular conduction delay.

Abbreviations

CRT
cardiac resynchronization therapy
HF
heart failure
HFEC
Heart Failure Events Committee
ICD
implantable cardioverter defibrillator
LV
left ventricle/left ventricular
LVEF
left ventricular ejection fraction
LVIDd
left ventricular internal diameter in diastole
LVIDs
left ventricular internal diameter in systole
NYHA
New York Heart Association classification
QOL
quality of life
VO2
oxygen consumption
VT/VF
ventricular tachycardia/ventricular fibrillation
6 MW
6-min walk

Cited by (0)

The study received financial support from Guidant Corporation, St. Paul, Minnesota.