Elsevier

American Heart Journal

Volume 201, July 2018, Pages 17-24
American Heart Journal

Clinical Investigation
The relationship between baseline and follow-up left ventricular ejection fraction with adverse events among primary prevention ICD patients

https://doi.org/10.1016/j.ahj.2018.03.017Get rights and content

Abstract

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.

Section snippets

Patient population

We performed a retrospective landmark analysis of HF patients in the Duke Echocardiography Laboratory Database (DELD) who underwent primary prevention ICD implantation (EF ≤35%) without cardiac resynchronization therapy (CRT) at Duke University from 2006–2013 and had a baseline LVEF within ≤6 months of the ICD procedure and a follow-up LVEF 1–3 years after ICD implantation. The DELD is a comprehensive prospectively recorded echocardiography database that includes all clinical echocardiograms

Cohort derivation

A total of 1745 dual or single chamber primary prevention ICD procedures were performed between 2006 and 2015 at Duke University Hospital. After excluding patients with: prior ICD procedures (n = 343); no baseline LVEF assessment at Duke within 6 months of index procedure (n = 243); a pre-implantation LVEF >35% (n = 192); death or loss to follow-up within 3 years of ICD implantation (n = 454); and LVAD or cardiac transplant within 3 years of ICD implantation (n = 32), a total of 481 patients

Discussion

Our study sought to define the comparative prognostic utility of baseline versus long-term follow-up LVEF among primary prevention ICD patients. It provides several clinically relevant findings. First, neither baseline nor follow-up LVEF were found to have significant relationships with risk of LVAD, transplant or death. Second, baseline and follow-up LVEF were associated with appropriate ICD therapies. Third, although LVEF improvement is associated with a significantly lower probability of

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 increased risk of LVAD, transplant, or death. Although follow-up LVEF assessment can be an important tool for risk stratification of ventricular arrhythmias in ICD patients, it should be used in conjunction with the pre-implantation LVEF, as both measures have independent predictive value.

The following are the

References (19)

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Funding: Dr. Friedman received salary support through the NIH T32 training grant HL069749.

Conflicts of Interest: DJ Friedman reports educational grants from Boston Scientific and St Jude Medical, research grants from the National Cardiovascular Data Registry, and salary support through NIH T32 training grant HL069749–13. M Fudim reports research funding from AHA; and consulting services for Coridea and Cibiem. SD Pokorney reports research grants from Gilead, Boston Scientific, Pfizer, Bristol-Myers Squibb, Janssen Pharmaceuticals, and the Food and Drug Administration; consulting support from Boston Scientific, Medtronic, Pfizer, and Bristol Myers-Squibb. EJ Velazquez reports research grants from NHLBI, Alnylam Pharmaceuticals, Amgen, Novartis Pharmaceutical Corp., Pfizer; consulting services for Amgen, Merck & Co., Novartis Pharmaceutical Corp.; and speakers bureau honoraria from Expert Exchange. The rest of the authors have nothing to disclose.

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