title: Safety of transvenous cardiac resynchronization system implantation in patients with chronic heart failure: combined results of over 2,000 patients from a multicenter study program.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the safety of implanting a cardiac resynchronization therapy (CRT) system.
  
  
  BACKGROUND
  Clinicians and patients require data on the safety of the CRT implant procedure to estimate procedural risk.
  
  
  METHODS
  We evaluated outcomes of transvenous CRT system implantation in 2,078 patients from the Multicenter InSync Randomized Clinical Evaluation (MIRACLE) study, the MIRACLE Implantable Cardioverter-Defibrillator (ICD) study, and the InSync III study. We compared the MIRACLE study to the InSync III study and the MIRACLE ICD study randomized phase to its general phase to evaluate the effect of new technologies.
  
  
  RESULTS
  The implant attempt succeeded in 1,903 of 2,078 (91.6%) patients. Implant time decreased from 2.7 h in the MIRACLE study to 2.3 h in the InSync III study (p < 0.001), and from 2.8 h in the MIRACLE ICD study randomized phase to 2.4 h in the general phase (p < 0.001). The implant procedure produced 62 perioperative complications in 53 (9.3%) MIRACLE trial patients; 159 in 135 (21.1%) MIRACLE ICD study randomized phase patients and 71 in 62 (13.9%) general phase patients (p < 0.05 vs. randomized); and 41 in 37 (8.8%) InSync III study patients (p = NS vs. the MIRACLE study). We observed 73 postoperative complications in 62 (11.7%) MIRACLE trial patients, 77 in 68 (11.9%) MIRACLE ICD study randomized phase patients and 56 in 45 (11.0%) general phase patients (p = NS), and 37 in 34 (8.6%) InSync III study patients (p = NS). A total of 8% of patients required reoperation to treat lead dislodgement, extracardiac stimulation, or infection during follow-up.
  
  
  CONCLUSIONS
  Transvenous CRT system implantation appears safe, well-tolerated, has a high success rate, and improves with operator experience and the addition of new technologies.
authors.affiliation: Carlyle Fraser Heart Center/Division of Cardiology, Emory University, Atlanta, Georgia, USA. angel_leon@emoryhealthcare.org
authors.forename: Angel R
authors.initials: AR
authors.lastname: León
authors.forename: William T
authors.initials: WT
authors.lastname: Abraham
authors.forename: Anne B
authors.initials: AB
authors.lastname: Curtis
authors.forename: James P
authors.initials: JP
authors.lastname: Daubert
authors.forename: Westby G
authors.initials: WG
authors.lastname: Fisher
authors.forename: John
authors.initials: J
authors.lastname: Gurley
authors.forename: David L
authors.initials: DL
authors.lastname: Hayes
authors.forename: Randy
authors.initials: R
authors.lastname: Lieberman
authors.forename: Susan
authors.initials: S
authors.lastname: Petersen-Stejskal
authors.forename: Kevin
authors.initials: K
authors.lastname: Wheelan
mesh_terms: D000368:Aged; D002303:Cardiac Output, Low / Q000628:therapy*; D002304:Cardiac Pacing, Artificial / Q000009:adverse effects* / Q000379:methods*; D002908:Chronic Disease; D002986:Clinical Trials as Topic; D005260:Female; D005548:Foreign-Body Migration / Q000601:surgery; D006352:Heart Ventricles; D006801:Humans; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D016032:Randomized Controlled Trials as Topic; D012086:Reoperation; D013530:Surgical Wound Infection / Q000601:surgery; D016896:Treatment Outcome