Skip to main content
construction release_alert
Scholars@Duke will be undergoing maintenance April 11-15. Some features may be unavailable during this time.
cancel
Journal cover image

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.

Publication ,  Journal Article
León, AR; Abraham, WT; Curtis, AB; Daubert, JP; Fisher, WG; Gurley, J; Hayes, DL; Lieberman, R; Petersen-Stejskal, S; Wheelan, K ...
Published in: J Am Coll Cardiol
December 20, 2005

OBJECTIVES: 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.

Duke Scholars

Altmetric Attention Stats
Dimensions Citation Stats

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

December 20, 2005

Volume

46

Issue

12

Start / End Page

2348 / 2356

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Surgical Wound Infection
  • Reoperation
  • Randomized Controlled Trials as Topic
  • Multicenter Studies as Topic
  • Middle Aged
  • Male
  • Humans
  • Heart Ventricles
  • Foreign-Body Migration
 

Citation

APA
Chicago
ICMJE
MLA
NLM
León, A. R., Abraham, W. T., Curtis, A. B., Daubert, J. P., Fisher, W. G., Gurley, J., … MIRACLE Study Program, . (2005). 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. J Am Coll Cardiol, 46(12), 2348–2356. https://doi.org/10.1016/j.jacc.2005.08.031
León, Angel R., William T. Abraham, Anne B. Curtis, James P. Daubert, Westby G. Fisher, John Gurley, David L. Hayes, et al. “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.J Am Coll Cardiol 46, no. 12 (December 20, 2005): 2348–56. https://doi.org/10.1016/j.jacc.2005.08.031.
León AR, Abraham WT, Curtis AB, Daubert JP, Fisher WG, Gurley J, et al. 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. J Am Coll Cardiol. 2005 Dec 20;46(12):2348–56.
León, Angel R., et al. “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.J Am Coll Cardiol, vol. 46, no. 12, Dec. 2005, pp. 2348–56. Pubmed, doi:10.1016/j.jacc.2005.08.031.
León AR, Abraham WT, Curtis AB, Daubert JP, Fisher WG, Gurley J, Hayes DL, Lieberman R, Petersen-Stejskal S, Wheelan K, MIRACLE Study Program. 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. J Am Coll Cardiol. 2005 Dec 20;46(12):2348–2356.
Journal cover image

Published In

J Am Coll Cardiol

DOI

EISSN

1558-3597

Publication Date

December 20, 2005

Volume

46

Issue

12

Start / End Page

2348 / 2356

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Surgical Wound Infection
  • Reoperation
  • Randomized Controlled Trials as Topic
  • Multicenter Studies as Topic
  • Middle Aged
  • Male
  • Humans
  • Heart Ventricles
  • Foreign-Body Migration