EFFECTIVENESS OF CRT--D THERAPY IN HEART FAILURE PATIENTS AT EMORY BY Louise Pelletier Savoye, MD Degree to be awarded: M.P.H. Career MPH Kimberly Rask, MD, PhD __________________________________________________ Javed Butler, MD, MPH _________________________________________________ Melissa Alperin, MPH, CHES Date Director, Career MPH Program Público
Savoye, Louise P (2010)
Published
Abstract
Abstract
EFFECTIVENESS OF CRT-D THERAPY
IN HEART FAILURE PATIENTS AT EMORY
BY
Louise Pelletier Savoye
Purpose: The efficacy of cardiac resynchronization
therapy combined with defibrillator devices
(CRT-D) for the reduction of mortality in heart failure patients
has been demonstrated through
randomized clinical trials but accounts of the "real-world"
effectiveness of CRT-D devices are
more limited. The purpose of this study is to explore the
effectiveness of CRT-D therapy in a
general hospital cohort and to examine the factors that are
associated with survival
outcomes in these patients.
Hypothesis: Patient survival outcomes in a general hospital
population would differ from those in a
clinical trial setting.
Methods: A retrospective, cohort study was conducted of 228
patients who received an initial CRT-D
device between January 2004 and December 2005 according to
guideline-based indications. Primary
endpoint was the composite outcome of death, cardiac
transplantation, or LVAD implantation.
Data was collected on baseline characteristics, clinical
outcomes and
participation status in an observational trial or registry. A
multivariate model was constructed to
determine factors associated with time to event for the primary
endpoint.
Results: Mean age of patients was 62.5 +/-13.7 years; 70.2%
were men, 69.9% were Caucasian 29.1%
were black. Median follow-up was 3.8 years. During this period, 93
patients (40.8%) experienced
the composite endpoint ; 86 patients died, 6 underwent
transplantation and 1 received LVAD. Survival
at 6, 12, 18, and 24 months was 95%, 89%, 86%, and 81%
respectively. These outcomes are comparable
with the CRT--â€D arm of the COMPANION trial (6 month
survival: 95%; 12 month survival 88%) and the
CRT-D arm of CARE-HF (12 month survival 90%). Increased creatinine
level and digitalis use were
associated with a higher HR for the death outcome (HR= 1.238 and
1.605
respectively). Increasing EF was associated with a lower HR (.833)
as was participation in an
observational registry (HR= .477).
Conclusion: Despite the broader clinical characteristics of
this hospital cohort compared to clinical trial
cohorts enrol ed according to inclusion/exclusion criteria, the
clinical outcomes for survival are very
similar to those observed in major RCTs such as COMPANION and
CARE-HF.
Table of Contents
Table of Contents
Chapter I:
Introduction--------------------------------------------------------------------1
Introduction and Rationale
---------------------------------------------------------1
Problem
Statement-------------------------------------------------------------------1
Purpose Statement
-------------------------------------------------------------------3
Research
Questions------------------------------------------------------------------4
Significance
Statement--------------------------------------------------------------4
Definition of Terms
-----------------------------------------------------------------5
Chapter II: Review of the
Literature----------------------------------------------------6
CRT-D Efficacy in Clinical Trials
------------------------------------------------6
CRT-D Outcomes in Observational Studies
-------------------------------------8
Patient
Characteristics---------------------------------------------------------------9
CRT-D Outcome
Predictors--------------------------------------------------------9
Chapter III: Methodology
-----------------------------------------------------------------14
Introduction---------------------------------------------------------------------------14
Population and
Sample--------------------------------------------------------------14
Research Design
---------------------------------------------------------------------14
Procedures and Instruments
--------------------------------------------------------15
Plans for Data Analysis
-------------------------------------------------------------15
Limitations and Delimitations
-----------------------------------------------------16
Chapter IV:
Results-------------------------------------------------------------------------18
Introduction---------------------------------------------------------------------------18
Patient
Characteristics---------------------------------------------------------------18
Survival
-------------------------------------------------------------------------------19
Multivariate Analysis of Survival
-------------------------------------------------21
Clinical Trial and Observational Study Participation
---------------------------22
Other Findings
-----------------------------------------------------------------------23
Chapter V: Conclusions, Implications, and Recommendations
-------------------25
Introduction---------------------------------------------------------------------------25
Summary and Conclusions of the
Study------------------------------------------25
Implications
--------------------------------------------------------------------------32
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