Real-world clinical burden among patients with and without heart failure worsening after cardiac resynchronization therapy

Abstract

Objective

Cardiac resynchronization therapy (CRT) can improve cardiac function in patients with heart failure (HF); however, in some patients, HF worsens despite CRT. This study characterized the long-term clinical burden of patients with and without HF worsening (HFW) within 6 months post CRT implantation.

Methods

A claims database (2007–2018) was used to identify two cohorts of adults: those with HFW within 180 days post-CRT and those with no HFW (NHFW). The evaluated clinical outcomes were cardiovascular events/complications, HF-related interventions, hospice enrollment, and all-cause mortality. Inverse probability of treatment weighting (IPTW) was used to adjust for confounders; adjusted comparisons were assessed using weighted Cox proportional hazard ratios (HRs).

Results

Among the 12,753 adults analyzed (HFW: N = 4,785; NHFW: N = 7,968), the mean age was 72 years and the mean duration of follow-up was approximately 2 years. The clinical burden was greater for HFW than for NHFW in terms of all-cause mortality (19.7% vs. 12.1%) and occurrence of atrial fibrillation (57.4% vs. 51.2%). In the IPTW-adjusted Cox proportional hazard analyses, patients with HFW had a 54% higher average hazard of experiencing all-cause mortality compared to NHFW (adjusted average HR = 1.54, 95% confidence interval [CI]: 1.41–1.70; p < .001). Of the clinical events experienced by ≥5% of patients, the greatest differences in average hazard were for HF decompensation (adjusted average HR = 1.83, 95% CI: 1.60–2.09) and HF decompensation or death (HR = 1.63, 95%CI: 1.50–1.77).

Conclusion

Patients with early HFW post-CRT experienced a significantly higher clinical burden than those without HFW. Vigilance for signs of worsening HF in the first 6 months post-CRT is warranted.

Keywords:

• Cardiac resynchronization therapy
• cardiovascular complication
• heart failure
• heart failure worsening

Transparency

Declaration of funding

This work was supported by Medtronic.

Declaration of financial/other relationships

Eugene S. Chung receives consulting honoraria from Medtronic, Abbot, and ERB Systems. John Rickard has received consulting fees from Medtronic as well as speaking fees and research funding from Abbott. Xiaoxiao Lu was an employee of Medtronic at the time this work was conducted. Maral DerSarkissian, Miriam L. Zichlin, Natalia Swartz, Alexandra Greatsinger, and Mei S. Duh are employees of Analysis Group., a consulting firm that received funding for the analyses that were conducted. Hoi Ching Cheung was an employee of Analysis Group at the time this work was conducted. Peer reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions

Study design, clinical input, data interpretation, and manuscript writing and editing: Eugene S. Chung, John Rickard, and Xiaoxiao Lu. Formal analysis, data interpretation, and manuscript writing and editing: Maral DerSarkissian, Miriam L. Zichlin, Hoi Ching Cheung, Natalia Swartz, Alexandra Greatsinger, and Mei S. Duh. All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this article and take responsibility for the integrity of the work as a whole.

Acknowledgements

Medical writing support was provided by Gloria DeWalt, an employee of Analysis Group; financial support for this assistance was provided by Medtronic.

Data availability statement

The data analyzed in this study are not publicly available due to licensing agreements with Optum Clinformatics© Data Mart Database.

Ethics statement

Not applicable to the de-identified claims data used in this study.