PMID- 16569543
OWN - NLM
STAT- MEDLINE
DCOM- 20060421
LR  - 20071115
IS  - 1097-6744 (Electronic)
IS  - 0002-8703 (Linking)
VI  - 151
IP  - 4
DP  - 2006 Apr
TI  - Clinical predictors and timing of New York Heart Association class improvement 
      with cardiac resynchronization therapy in patients with advanced chronic heart 
      failure: results from the Multicenter InSync Randomized Clinical Evaluation 
      (MIRACLE) and Multicenter InSync ICD Randomized Clinical Evaluation (MIRACLE-ICD) 
      trials.
PG  - 837-43
AB  - BACKGROUND: Based on current patient selection criteria, a significant proportion 
      of recipients of cardiac resynchronization therapy (CRT) do not respond to 
      treatment. The purpose of this analysis is to identify predictors and 
      characterize the timing of response to CRT in patients with advanced heart 
      failure. METHODS: Patients randomized to receive CRT in the MIRACLE and 
      MIRACLE-ICD trials, designed to assess the benefit of CRT compared with standard 
      medical therapy in patients with advanced heart failure, left ventricular 
      ejection fraction <0.35, and QRS > or =130 milliseconds, were included for this 
      analysis. Patients with an improvement of > or =1 New York Heart Association 
      (NYHA) class from baseline to the 6-month follow-up were considered responders 
      and those who had no change or worse NYHA class or died were classified as 
      nonresponders. Responders were subdivided into early (within 1-3 months) and late 
      (6 months). RESULTS: One hundred forty-three (64%) of 224 and 190 (61%) of 313 
      patients in the MIRACLE and MIRACLE-ICD trials, respectively, responded to 
      therapy, with 81 (57%) of 143 and 100 (53%) of 190 responding early. Several but 
      differing factors predicted CRT response and timing in the two trials with a high 
      sensitivity (89%-90%) but, owing to a low specificity (31%-49%), a modest 
      predictive accuracy (66%-75%). CONCLUSIONS: Based on improvement of > or =1 NYHA 
      class, less than two thirds of patients enrolled in the MIRACLE or MIRACLE-ICD 
      trials responded to CRT, with just more than half responding within the first 
      month. Several factors predicted CRT response and timing, but given their modest 
      predictive accuracy, comparable for both studies, additional methods for 
      selecting candidates most likely to benefit from CRT are needed.
FAU - Pires, Luis A
AU  - Pires LA
AD  - The Heart Rhythm Center, Division of Cardiology, St John Hospital and Medical 
      Center, Detroit, MI 48236, USA. luis.pires@stjohn.org
FAU - Abraham, William T
AU  - Abraham WT
FAU - Young, James B
AU  - Young JB
FAU - Johnson, Katrina M
AU  - Johnson KM
CN  - MIRACLE and MIRACLE-ICD Investigators
LA  - eng
PT  - Journal Article
PL  - United States
TA  - Am Heart J
JT  - American heart journal
JID - 0370465
SB  - IM
MH  - Aged
MH  - *Cardiac Pacing, Artificial
MH  - Defibrillators, Implantable
MH  - *Electric Countershock
MH  - Female
MH  - Heart Failure/physiopathology/*therapy
MH  - Humans
MH  - Logistic Models
MH  - Male
MH  - Middle Aged
MH  - Pacemaker, Artificial
MH  - Randomized Controlled Trials as Topic
MH  - Retrospective Studies
MH  - Treatment Outcome
MH  - Ventricular Function, Left
EDAT- 2006/03/30 09:00
MHDA- 2006/04/25 09:00
CRDT- 2006/03/30 09:00
PHST- 2005/05/05 00:00 [received]
PHST- 2005/06/14 00:00 [accepted]
PHST- 2006/03/30 09:00 [pubmed]
PHST- 2006/04/25 09:00 [medline]
PHST- 2006/03/30 09:00 [entrez]
AID - S0002-8703(05)00637-X [pii]
AID - 10.1016/j.ahj.2005.06.024 [doi]
PST - ppublish
SO  - Am Heart J. 2006 Apr;151(4):837-43. doi: 10.1016/j.ahj.2005.06.024.