PMID- 14563591
OWN - NLM
STAT- MEDLINE
DCOM- 20031107
LR  - 20220331
IS  - 0735-1097 (Print)
IS  - 0735-1097 (Linking)
VI  - 42
IP  - 8
DP  - 2003 Oct 15
TI  - Cardiac resynchronization therapy for the treatment of heart failure in patients 
      with intraventricular conduction delay and malignant ventricular 
      tachyarrhythmias.
PG  - 1454-9
AB  - 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.
FAU - Higgins, Steven L
AU  - Higgins SL
AD  - Scripps Memorial Hospital, La Jolla, California 92038-0028, USA. 
      EPDocHiggins@msn.com
FAU - Hummel, John D
AU  - Hummel JD
FAU - Niazi, Imran K
AU  - Niazi IK
FAU - Giudici, Michael C
AU  - Giudici MC
FAU - Worley, Seth J
AU  - Worley SJ
FAU - Saxon, Leslie A
AU  - Saxon LA
FAU - Boehmer, John P
AU  - Boehmer JP
FAU - Higginbotham, Michael B
AU  - Higginbotham MB
FAU - De Marco, Teresa
AU  - De Marco T
FAU - Foster, Elyse
AU  - Foster E
FAU - Yong, Patrick G
AU  - Yong PG
LA  - eng
PT  - Clinical Trial
PT  - Clinical Trial, Phase I
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - J Am Coll Cardiol
JT  - Journal of the American College of Cardiology
JID - 8301365
SB  - IM
CIN - J Am Coll Cardiol. 2003 Oct 15;42(8):1460-2. PMID: 14563592
MH  - Aged
MH  - Cardiac Pacing, Artificial/*methods
MH  - Cross-Over Studies
MH  - *Defibrillators, Implantable
MH  - Double-Blind Method
MH  - Female
MH  - Heart Conduction System/*physiopathology
MH  - Heart Failure/*therapy
MH  - Humans
MH  - Male
MH  - *Pacemaker, Artificial
MH  - Tachycardia, Ventricular/complications/*therapy
MH  - Ventricular Fibrillation/complications/*therapy
EDAT- 2003/10/18 05:00
MHDA- 2003/11/08 05:00
CRDT- 2003/10/18 05:00
PHST- 2003/10/18 05:00 [pubmed]
PHST- 2003/11/08 05:00 [medline]
PHST- 2003/10/18 05:00 [entrez]
AID - S0735109703010428 [pii]
AID - 10.1016/s0735-1097(03)01042-8 [doi]
PST - ppublish
SO  - J Am Coll Cardiol. 2003 Oct 15;42(8):1454-9. doi: 10.1016/s0735-1097(03)01042-8.