title: Implantation of cardiac resynchronization therapy systems in the CARE-HF trial: procedural success rate and safety.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Nouvelles Cliniques Nantaises, Nantes, France.
authors.forename: D
authors.initials: D
authors.lastname: Gras
authors.forename: D
authors.initials: D
authors.lastname: Böcker
authors.forename: M
authors.initials: M
authors.lastname: Lunati
authors.forename: H J J
authors.initials: HJ
authors.lastname: Wellens
authors.forename: M
authors.initials: M
authors.lastname: Calvert
authors.forename: N
authors.initials: N
authors.lastname: Freemantle
authors.forename: R
authors.initials: R
authors.lastname: Gervais
authors.forename: L
authors.initials: L
authors.lastname: Kappenberger
authors.forename: L
authors.initials: L
authors.lastname: Tavazzi
authors.forename: E
authors.initials: E
authors.lastname: Erdmann
authors.forename: J G F
authors.initials: JG
authors.lastname: Cleland
authors.forename: J-C
authors.initials: JC
authors.lastname: Daubert
mesh_terms: D000368:Aged; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects / Q000401:mortality; D017147:Defibrillators, Implantable; D005260:Female; D006333:Heart Failure / Q000401:mortality / Q000628:therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D010138:Pacemaker, Artificial; D011183:Postoperative Complications; D016019:Survival Analysis; D016896:Treatment Outcome