CLINICAL RESEARCH: SAFETY ISSUE
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
Angel R. León, MD*,*,
William T. Abraham, MD , ,
Anne B. Curtis, MD ,
James P. Daubert, MD||,
Westby G. Fisher, MD,¶,
John Gurley, MD,
David L. Hayes, MD#,
Randy Lieberman, MD**,
Susan Petersen-Stejskal, BS,
Kevin Wheelan, MD for the MIRACLE Study Program
* Carlyle Fraser Heart Center/Division of Cardiology, Emory University, Atlanta, Georgia
University of Kentucky, Lexington, Kentucky
The Ohio State University Heart Center, Columbus, Ohio
University of Florida, Gainesville, Florida
|| University of Rochester Medical Center, Rochester, New York
¶ Northwestern University, Evanston, Illinois
# The Mayo Clinic, Rochester, Minnesota
** Harper Hospital, Detroit, Michigan
Medtronic, Inc., Minneapolis, Minnesota
Baylor University Medical Center, Dallas, Texas
Manuscript received November 24, 2004;
revised manuscript received March 1, 2005,
accepted March 10, 2005.
* Reprint requests and correspondence: Dr. Angel R. León, Cardiology, MOT 6th Floor, Emory Crawford Long Hospital, 550 Peachtree Street, Atlanta, Georgia 30308 (Email: angel_leon{at}emoryhealthcare.org).
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.
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Abbreviations and Acronyms
| | AERC = Adverse Events Review Committee | | CRT = cardiac resynchronization therapy | | CS = coronary sinus | | ICD = implantable cardioverter-defibrillator | | LV = left ventricle/ventricular | | MIRACLE = Multicenter InSync Randomized Clinical Evaluation | | NYHA = New York Heart Association | | RA = right atrial/atrium | | RV = right ventricle/ventricular | | SCD = sudden cardiac death |
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