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Clinical Trial
. 2003 Oct 15;42(8):1454-9.
doi: 10.1016/s0735-1097(03)01042-8.

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

Steven L Higgins  1 , John D Hummel, Imran K Niazi, Michael C Giudici, Seth J Worley, Leslie A Saxon, John P Boehmer, Michael B Higginbotham, Teresa De Marco, Elyse Foster, Patrick G Yong
Affiliations
Free article
Clinical Trial

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

Steven L Higgins et al. J Am Coll Cardiol. .
Free article

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 (VO(2)), 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 VO(2) (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.

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Comment in

  • The points for pacing.
    Warner Stevenson L. Warner Stevenson L. J Am Coll Cardiol. 2003 Oct 15;42(8):1460-2. doi: 10.1016/s0735-1097(03)01045-3. J Am Coll Cardiol. 2003. PMID: 14563592 Clinical Trial. No abstract available.