Author + information
- Received July 30, 2018
- Revision received November 5, 2018
- Accepted November 5, 2018
- Published online March 25, 2019.
- Fadi Shamoun, MDa,∗ (, )
- Teresa De Marco, MDb,
- David DeMets, PhDc,
- Chaoqun Mei, MSc,
- JoAnn Lindenfeld, MDd,
- Leslie A. Saxon, MDe,
- John P. Boehmer, MDf,
- Jill Leigh, BSg,
- Patrick Yong, MSEEh,
- Arthur M. Feldman, MD, PhDi and
- Michael R. Bristow, MD, PhDi
- aDepartment of Cardiovascular Diseases, Mayo Clinic Arizona, Scottsdale, Arizona
- bDepartment of Medicine, Division of Cardiology, University of California Medical Center, San Francisco, California
- cStatistical Data Analysis Center, University of Wisconsin Madison, Wisconsin
- dDepartment of Medicine, Division of Cardiology, Vanderbilt University, Nashville, Tennessee
- eDepartment of Medicine, Division of Cardiology, University of Southern California, Los Angeles, California
- fDepartment of Medicine, Division of Cardiology, Pennsylvania State University Medical Center, Hershey, Pennsylvania
- gBoston Scientific, St. Paul, Minnesota
- hDepartment of Medicine, Division of Cardiology, Temple University, Philadelphia, Pennsylvania
- iDepartment of Medicine, Division of Cardiology and Cardiovascular Institute, University of Colorado, Boulder and Aurora, Colorado
- ↵∗Address for correspondence:
Dr. Fadi Shamoun, Department of Cardiovascular Diseases, Mayo Clinic Arizona, 13400 East Shea Boulevard, Scottsdale, Arizona 85259.
Objectives This study tested the hypothesis that the extent of left ventricular (LV) eccentric structural remodeling in heart failure with reduced ejection fraction (HFrEF) is directly associated with clinical event responses to cardiac resynchronization therapy (CRT).
Background Whether the severity of LV structural remodeling influences CRT treatment effects is unknown.
Methods COMPANION (Comparison of Medical Therapy, Pacing and Defibrillation in Heart Failure) trial data were analyzed retrospectively. Left ventricular internal dimensions at end diastole indexed by body surface area (LVEDDI) were measured pre-randomization by 2-dimensional echocardiography. LVEDDI values were stratified around the median value of 35 mm/m2, and CRT (including CRT-P [CRT with only pacing capability] and/or CRT-D [CRT with an implantable defibrillator]) treatment effects were assessed and compared by LVEDDI group. Patients assigned to these treatments were compared to those undergoing optimal pharmacologic therapy (OPT) for the outcomes of all-cause mortality (ACM) or ACM and heart-failure hospitalization (ACM/HFH).
Results In the LVEDDI ≥35 mm/m2 group (n = 614), CRT vs. OPT was associated with a lower ACM/HFH hazard ratio (HR) (HR: 0.53; 95% confidence interval [CI]: 0.40 to 0.70; p <0.001), whereas in the LVEDDI <35 mm/m2 group, the CRT vs. OPT ACM/HFH hazard ratio was not statistically significant (HR: 0.80; 95% CI: 0.59 to 1.08; p = 0.15). For ACM alone, in the LVEDDI ≥35 mm/m2 group, the hazard ratio for CRT-P was 0.59 (95% CI: 0.39 to 0.90; p = 0.012) and for CRT-D 0.50 (95% CI: 0.32 to 0.77; p = 0.002). Neither of the CRT groups showed a statistically significant reduction in ACM in the LVEDDI <35 mm/m2 group.
Conclusions Larger versus smaller LVEDDIs are associated with a reduction in ACM with CRT-P or CRT-D treatment, and with a more effective reduction in ACM/HFH for the combined CRT treatment groups.
Supported by Boston Scientific and by the Statistical Data Analysis Center, University of Wisconsin, Madison, Wisconsin. Analysis of data was supported by Statistical Data Analysis Center, University of Wisconsin. Dr. De Marco has received consulting fees from Boston Scientific; and is a speaker for Novartis. Dr. Lindenfield has consultant relationships with Abbott Lab, Edwards Life Science, Novartis, Boston Scientific, VWave, Relypsa, ResMed, CVRX, and Cardiotronix. Dr. Saxon is Executive Director, University of Southern California Center for Body Computing; and has received fees for consulting for Abbott Lab. Dr. Boehmer has received fees for consulting from Boston Scientific and Medtronic; and has received research support from Boston Scientific and Abbott Lab. Ms. Leigh is an employee of Boston Scientific. Mr. Yong is an employee of Boston Scientific. Dr. Bristow is a compensated Director of ARCA biopharma; and holds equity in ARCA biopharma. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose. Barry Greenberg, MD, served as Guest Editor for this article.
- Received July 30, 2018.
- Revision received November 5, 2018.
- Accepted November 5, 2018.
- 2019 American College of Cardiology Foundation
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