Clinical and economic impact of ventricular assist device infections: a real-world claims analysis

Abstract

Background

VAD therapy has revolutionized the treatment of end-stage heart failure, but infections remain an important complication. The objective of this study was to characterize the clinical and economic impacts of VAD-specific infections.

Methods

A retrospective analysis of a United States claims database identified members ≥ 18 years with a claim for a VAD implant procedure, at least 6 months of pre-implant baseline data, and 12 months of follow-up between 1 June 2016 and 31 December 2019. Cumulative incidence of infection was calculated. Infection and non-infection cohorts were compared regarding mortality, healthcare utilization, and total cost. Regression models were used to identify risk factors associated with infections and mortality.

Results

A total of 2,259 patients with a VAD implant were included, with 369 experiencing infection (12-month cumulative incidence 16.1%). Patients with infection were 2.1 times more likely to die (p < 0.001, 95% CI [1.5–2.9]). The mean 12-month total cost per US patient was $354,339 for the non-infection cohort and $397,546 for the infection cohort, a difference of $43,207 (p < 0.0001).

Conclusions

VAD infections were associated with higher mortality, more healthcare utilization, and higher total cost. Strategies to minimize VAD-specific infections could lead to improved clinical and economic outcomes.

Keywords:

• VAD
• infections
• mortality
• cost

JEL CLASSIFICATION CODES:

• B21
• B2
• B
• C13
• C1
• C

Transparency

Declaration of financial/other relationships

AYP: investigator-initiated research grant from MSD outside the submitted work; EF: advisor/consultant/advisory boards/honoraria Medtronic outside the submitted work; MM: advisor for Medtronic outside the submitted work; SSE: consultant Medtronic, Abiomed, Inspired Therapeutics, BioVentrix outside the submitted work; DM: consultant for Abbott outside the submitted work; DZ: consultant/research/grants/speaker fees Abbott, Medtronic, Berlin Heart, Abiomed, Edwards outside the submitted work; RH, JM, SS: employment Medtronic; NM: consultant Abbott, Medtronic, SynCardia, Carmat, Xylocor outside the submitted work.

Author contributions

AP, NM, EF, MM, SES, DM, DZ, RH, JM, and SS were members of the writing committee that drafted the manuscript. JM conducted the analysis. All authors had access to the full data through Medtronic. All authors reviewed and approved the manuscript, and all authors agree to be accountable for all aspects of the work. No other individuals met the International Committee of Medical Journal Editors authorship guideline criteria for this work. AP and NM had final responsibility for submitting the manuscript.

Acknowledgements

The authors would like to acknowledge the contributions of Luke Jacobsen, Pat Zimmerman, Evan Stanelle, and Colleen Longacre for consulting advice on statistical modeling, Lucas Higuera for data validation, Denise Griesmann for coding definitions, and Leslie Sweet for clinical perspective during the design of the study (Medtronic contributors).

Additional information

Funding

This work was supported by Medtronic plc.