PMID- 17540662
OWN - NLM
STAT- MEDLINE
DCOM- 20071120
LR  - 20070719
IS  - 1099-5129 (Print)
IS  - 1099-5129 (Linking)
VI  - 9
IP  - 7
DP  - 2007 Jul
TI  - Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: 
      procedural success rate and safety.
PG  - 516-22
AB  - AIMS: To assess procedural characteristics and adjudicated procedure-related 
      (<or=30 days) major adverse events among patients who underwent cardiac 
      resynchronization therapy (CRT) implantation in the CARE-HF study. The CARE-HF 
      study shows that CRT improves symptoms and reduces morbidity and mortality in New 
      York Heart Association (NYHA) class III/IV chronic heart failure (CHF) patients. 
      However, safe and proper implantation of pacing systems remains key to effective 
      CRT delivery. METHODS AND RESULTS: Generalized linear modeling was used to 
      examine the relationships between first implant success/failure and: NYHA class; 
      beta-adrenergic blocker use; underlying ischemic vs. non-ischemic heart disease; 
      history of coronary artery bypass graft or valve surgery; left ventricular (LV) 
      end-diastolic volume<or=vs. >300 cm(3); and, influence of the participating 
      study-centres. Implantation was attempted in 404/409 patients assigned to CRT, 
      and in 65/404 patients assigned to medical therapy. Among these 469 patients, 450 
      (95.9%) received a successfully implanted and activated device. Complications 
      occurred within 24 h in 47 patients (10.0%), mainly lead dislodgments (n = 10, 
      2.1%) and coronary sinus dissection/perforation (n = 10, 2.1%), and between 24 h 
      and 30 days in 26 patients (5.5%), mainly lead dislodgment (n = 13, 2.8%). Mean 
      LV lead stimulation threshold was significantly higher than at the right atrium 
      or right ventricle, though remained stable, delivering effective, and reliable 
      CRT. Implanting experience was the only predictor of procedural outcome. 
      CONCLUSION: Transvenous CRT system implantation, using a CS lead designed for 
      long-term LV pacing, was safe and reliable. As implanting centres become more 
      experienced, this success rate is expected to increase further.
FAU - Gras, D
AU  - Gras D
AD  - Nouvelles Cliniques Nantaises, Nantes, France.
FAU - Bocker, D
AU  - Bocker D
FAU - Lunati, M
AU  - Lunati M
FAU - Wellens, H J J
AU  - Wellens HJ
FAU - Calvert, M
AU  - Calvert M
FAU - Freemantle, N
AU  - Freemantle N
FAU - Gervais, R
AU  - Gervais R
FAU - Kappenberger, L
AU  - Kappenberger L
FAU - Tavazzi, L
AU  - Tavazzi L
FAU - Erdmann, E
AU  - Erdmann E
FAU - Cleland, J G F
AU  - Cleland JG
FAU - Daubert, J-C
AU  - Daubert JC
CN  - CARE-HF Study Steering Committee and Investigators
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
DEP - 20070531
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 Pacing, Artificial/adverse effects/mortality
MH  - *Defibrillators, Implantable
MH  - Female
MH  - Heart Failure/mortality/therapy
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Pacemaker, Artificial
MH  - Postoperative Complications
MH  - Survival Analysis
MH  - Treatment Outcome
EDAT- 2007/06/02 09:00
MHDA- 2007/12/06 09:00
CRDT- 2007/06/02 09:00
PHST- 2007/06/02 09:00 [pubmed]
PHST- 2007/12/06 09:00 [medline]
PHST- 2007/06/02 09:00 [entrez]
AID - eum080 [pii]
AID - 10.1093/europace/eum080 [doi]
PST - ppublish
SO  - Europace. 2007 Jul;9(7):516-22. doi: 10.1093/europace/eum080. Epub 2007 May 31.