PMID- 23487543
OWN - NLM
STAT- MEDLINE
DCOM- 20140122
LR  - 20220408
IS  - 1532-2092 (Electronic)
IS  - 1099-5129 (Linking)
VI  - 15
IP  - 6
DP  - 2013 Jun
TI  - Many response criteria are poor predictors of outcomes after cardiac 
      resynchronization therapy: validation using data from the randomized trial.
PG  - 835-44
LID - 10.1093/europace/eus390 [doi]
AB  - AIMS: The aim of the study was to assess the predictive value for outcomes of 
      various response criteria currently used in patients undergoing cardiac 
      resynchronization therapy (CRT). METHODS AND RESULTS: Data from TRUST CRT 
      randomized trial in patients with New York Heart Association (NYHA) III-IV class, 
      QRS >/= 120 ms, ejection fraction </= 35%, and mechanical dyssynchrony was analysed. 
      Ninety-seven subjects who survived 6 months after implantation of 
      CRT-defibrillator were classified as responders or non-responders depending on 15 
      criteria used in most of the previous trials. Blindly adjudicated data on major 
      adverse cardiac events (MACEs) within 1 year after classification were used to 
      calculate the predictive value of response criteria. After adjustment for 
      baseline confounding variables only eight criteria were significantly predictive 
      for future MACEs. Sensitivity and specificity ranged substantially for clinical 
      (32-94% and 26-63%) and echocardiographic criteria (40-93% and 22-70%, 
      respectively). The most powerful clinical predictor was >a NYHA class reduction >/= 
      1 [adjusted relative risk (RR) 4.41 for non-responders; 95% confidence interval 
      (CI) 1.75-11.04, P = 0.002], while the strongest echocardiographic predictor was 
      a reduction in the left ventricular end-systolic index by > 15% (RR 3.49; 95% CI 
      1.59-7.64, P = 0.002). A combination of these two criteria did not improve the 
      predictive value of a single parameter. Both criteria showed multiple significant 
      interactions with baseline patients' characteristics. CONCLUSION: Only some of 
      the commonly used response criteria predict outcome in patients undergoing CRT. 
      The predictive value varies substantially across different criteria, with a 
      higher sensitivity observed for the clinical parameters and a higher specificity 
      observed for echocardiographic parameters. Combining various criteria adds little 
      to their prognostic value. The predictive accuracy of various criteria can be 
      different in various subgroups due to multiple interactions with baseline 
      characteristics. CLINICALTRIALS. GOV IDENTIFIER: NCT00814840.
FAU - Boidol, Joanna
AU  - Boidol J
AD  - Department of Cardiology, Congenital Heart Disease and Electrotherapy, Silesian 
      Medical University, Silesian Centre for Heart Diseases, Sklodowskiej-Curie Street 
      9, 41-800 Zabrze, Poland.
FAU - Sredniawa, Beata
AU  - Sredniawa B
FAU - Kowalski, Oskar
AU  - Kowalski O
FAU - Szulik, Mariola
AU  - Szulik M
FAU - Mazurek, Michal
AU  - Mazurek M
FAU - Sokal, Adam
AU  - Sokal A
FAU - Pruszkowska-Skrzep, Patrycja
AU  - Pruszkowska-Skrzep P
FAU - Kukulski, Tomasz
AU  - Kukulski T
FAU - Kalarus, Zbigniew
AU  - Kalarus Z
FAU - Lenarczyk, Radoslaw
AU  - Lenarczyk R
CN  - Triple-Site Versus Standard Cardiac Resynchronisation Trial (TRUST CRT) 
      Investigators
LA  - eng
SI  - ClinicalTrials.gov/NCT00814840
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Validation Study
DEP - 20130313
PL  - England
TA  - Europace
JT  - Europace : European pacing, arrhythmias, and cardiac electrophysiology : journal 
      of the working groups on cardiac pacing, arrhythmias, and cardiac cellular 
      electrophysiology of the European Society of Cardiology
JID - 100883649
SB  - IM
MH  - Aged
MH  - Cardiac Resynchronization Therapy/*mortality
MH  - Echocardiography/*statistics & numerical data
MH  - Female
MH  - Heart Failure/diagnosis/*mortality/*prevention & control
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Outcome Assessment, Health Care/*methods/*statistics & numerical data
MH  - Poland/epidemiology
MH  - Prognosis
MH  - Reproducibility of Results
MH  - Risk Assessment/methods
MH  - Risk Factors
MH  - Sensitivity and Specificity
MH  - Survival Analysis
MH  - Survival Rate
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Cardiac resynchronization
OT  - Pacing
OT  - Predictors
OT  - Randomized trial
OT  - Response
OT  - Response criteria
EDAT- 2013/03/15 06:00
MHDA- 2014/01/23 06:00
CRDT- 2013/03/15 06:00
PHST- 2013/03/15 06:00 [entrez]
PHST- 2013/03/15 06:00 [pubmed]
PHST- 2014/01/23 06:00 [medline]
AID - eus390 [pii]
AID - 10.1093/europace/eus390 [doi]
PST - ppublish
SO  - Europace. 2013 Jun;15(6):835-44. doi: 10.1093/europace/eus390. Epub 2013 Mar 13.