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Lumped-Parameter and Finite Element Modeling of Heart Failure with Preserved Ejection Fraction
Published on: February 13, 2021
The relationship between baseline and follow-up left ventricular ejection fraction with adverse events among primary
Daniel J Friedman1, Marat Fudim1, Robert Overton2
1Division of Cardiology, Duke University Hospital, Durham, NC; Duke Clinical Research Institute, Durham, NC; Department of Medicine, Duke University Hospital, Durham, NC.
Insights
Left ventricular ejection fraction (LVEF) impacts appropriate ICD therapy risk in primary prevention patients. However, LVEF changes did not significantly affect the composite endpoint of death, LVAD, or transplant.
Area of Science:
- Cardiology
- Medical Devices
- Clinical Outcomes
Background:
- Left ventricular ejection fraction (LVEF) is crucial for selecting patients for primary prevention implantable cardioverter defibrillators (ICDs).
- The long-term impact of baseline and follow-up LVEF on clinical outcomes in these patients is not fully understood.
Purpose of the Study:
- To investigate the association between baseline and follow-up LVEF and clinical outcomes in primary prevention ICD recipients.
- To determine if LVEF improvement or absolute value predicts mortality, left ventricular assist device (LVAD) implantation, or transplant.
Main Methods:
- A study of 195 primary prevention ICD patients with baseline LVEF ≤35% and follow-up LVEF at 1-3 years post-implantation.
- Co-primary endpoints included time to death, LVAD, or transplant, and appropriate ICD therapy.
- Multivariable Cox proportional hazard models analyzed LVEF changes (≥10% improvement or ≥40% value).
Main Results:
- Neither baseline nor follow-up LVEF significantly predicted the composite endpoint of death, LVAD, or transplant.
- Both baseline and follow-up LVEF were independently associated with the risk of appropriate ICD therapy.
- A significant association was found between LVEF and appropriate ICD therapy, regardless of the definition used for follow-up LVEF.
Conclusions:
- In primary prevention ICD recipients, baseline and follow-up LVEF are independently linked to the long-term risk of appropriate ICD therapy.
- LVEF status was not associated with the composite endpoint of death, LVAD, or transplant in this patient cohort.
Background:
Left ventricular ejection fraction (LVEF) is used to select patients for primary prevention implantable cardioverter defibrillators (ICDs). The relationship between baseline and long-term follow-up LVEF and clinical outcomes among primary prevention ICD patients remains unclear.
Methods:
We studied 195 patients with a baseline LVEF ≤35% ≤6 months prior to ICD implantation and follow-up LVEF 1-3 years after ICD implantation without intervening left ventricular assist device (LVAD) or transplant. The co-primary study endpoints were: (1) a composite of time to death, LVAD, or transplant and (2) appropriate ICD therapy. We examined multivariable Cox proportional hazard models with a 3-year post-implant landmark view; the LVEF closest to the 3-year mark was considered the follow-up LVEF for analyses. Follow-up LVEF was examined using 2 definitions: (1) ≥10% improvement compared to baseline or (2) actual value of ≥40%.
Results:
Fifty patients (26%) had a LVEF improvement of ≥10% and 44 (23%) had a follow-up LVEF ≥40%. Neither baseline nor follow-up LVEF was significantly associated with the composite endpoint. In contrast, both baseline and follow-up LVEF were associated with risk for long-term ICD therapies, whether follow-up LVEF was modeled as a ≥10% absolute improvement (baseline LVEF HR 0.87, CI 0.91-0.93, P < .001; follow-up LVEF HR 0.18, CI 0.06-0.53, P = .002) or a ≥40% follow-up value (baseline LVEF HR 0.89, CI 0.83-0.96, P = .001, follow-up LVEF HR 0.26, CI 0.08-0.87, P = .03).
Conclusions:
Among primary prevention ICD recipients, both baseline and follow-up LVEF were independently associated with long-term risk for appropriate ICD therapy, but they were not associated with time to the composite of LVAD, transplant, or death.
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