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\begin{document}

\title{The Clinical and Economic Impact of Extended Battery Longevity of a
Substernal Extravascular Implantable Cardioverter Defibrillator}



\author[1]{Bradley Knight}%
\author[2]{Nicolas Clementy}%
\author[3]{Anish Amin}%
\author[4]{Ulrika Birgersdotter-Green}%
\author[5]{Henri Roukoz}%
\author[6]{Reece Holbrook}%
\author[7]{Jaimie Manlucu}%
\affil[1]{Northwestern University}%
\affil[2]{Clinique du Millenaire}%
\affil[3]{Riverside Methodist Hospital}%
\affil[4]{University of California San Diego}%
\affil[5]{University of Minnesota Physicians}%
\affil[6]{Medtronic Cardiac Rhythm and Heart Failure Management}%
\affil[7]{London Health Sciences Centre University Hospital}%


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  \date{May 17, 2024}


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\begin{abstract}
\emph{Background and Aims:} The extravascular implantable cardioverter
defibrillator (EV ICD) has an extended projected battery longevity
compared to the subcutaneous implantable cardioverter defibrillator
(S-ICD). This study used modeling to characterize the need for generator
changes, long-term complications, and overall costs for both the EV ICD
and S-ICD in healthcare systems of various countries \emph{.}
\emph{Methods:} Battery longevity data were modelled using a Markov
model from averages reported in device labelling for the S-ICD and with
engineering estimates based on real life usage from EV ICD Pivotal Study
patient data to introduce variability. Clinical demographic data of
recipients were derived from published literature. The primary outcomes
were defined as the number of generator replacement surgeries,
complications, and total healthcare system costs due to battery
depletion over the expected lifetime of patients receiving EV ICD or
S-ICD therapy. A one-way sensitivity analysis of the model was performed
for the US healthcare system. \emph{Results:} Average modelled battery
longevity was determined to be 7.3 years for the S-ICD compared to 11.8
years for the EV ICD. The probability of a complication after a
replacement procedure was 1.4\%, with an operative mortality rate of
0.02\%. The use of an EV ICD was associated with 1.4-1.6 fewer
replacements on average over an expected patient lifetime as compared to
an S-ICD and a 24.3-26.0\% reduction in cost. The US sensitivity
analysis found use of an EV ICD resulted in a reduction in replacement
surgeries of greater than 1 (1.1-1.6) along with 5-figure cost savings
in all scenarios (\$18,602-\$40,948). \emph{Conclusion:} The longer
projected battery life of the EV ICD compared to the S-ICD has the
potential to meaningfully reduce long-term morbidity and healthcare
resources related to generator changes from the perspective of multiple
diverse healthcare systems.%
\end{abstract}%



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\verb`2023 02 20 EV ICD Longevity Manuscript_clean.docx`  available at \url{https://authorea.com/users/409287/articles/654033-the-clinical-and-economic-impact-of-extended-battery-longevity-of-a-substernal-extravascular-implantable-cardioverter-defibrillator}\selectlanguage{english}
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\includegraphics[width=0.70\columnwidth]{figures/EV-ICD-Battery-Longevity-Graphical-Abstract-update-Feb20-2023-2/EV-ICD-Battery-Longevity-Graphical-Abstract-update-Feb20-2023-2}

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