Cardiac resynchronization therapy for the treatment of heart failure in patients with intraventricular conduction delay and malignant ventricular tachyarrhythmias.
OBJECTIVE
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.
Higgins
Steven L
SL
Scripps Memorial Hospital, La Jolla, California 92038-0028, USA. EPDocHiggins@msn.com
Hummel
John D
JD
Niazi
Imran K
IK
Giudici
Michael C
MC
Worley
Seth J
SJ
Saxon
Leslie A
LA
Boehmer
John P
JP
Higginbotham
Michael B
MB
De Marco
Teresa
T
Foster
Elyse
E
Yong
Patrick G
PG
D000368:Aged; D002304:Cardiac Pacing, Artificial / Q000379:methods*; D018592:Cross-Over Studies; D017147:Defibrillators, Implantable; D004311:Double-Blind Method; D005260:Female; D006329:Heart Conduction System / Q000503:physiopathology*; D006333:Heart Failure / Q000628:therapy*; D006801:Humans; D008297:Male; D010138:Pacemaker, Artificial; D017180:Tachycardia, Ventricular / Q000150:complications / Q000628:therapy*; D014693:Ventricular Fibrillation / Q000150:complications / Q000628:therapy*