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The Clinical and Economic Impact of Extended Battery Longevity of a Substernal Extravascular Implantable Cardioverter Defibrillator
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  • Bradley Knight,
  • Nicolas Clementy,
  • Anish Amin,
  • Ulrika Birgersdotter-Green,
  • Henri Roukoz,
  • Reece Holbrook,
  • Jaimie Manlucu
Bradley Knight
Northwestern University

Corresponding Author:[email protected]

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Nicolas Clementy
Clinique du Millenaire
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Anish Amin
Riverside Methodist Hospital
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Ulrika Birgersdotter-Green
University of California San Diego
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Henri Roukoz
University of Minnesota Physicians
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Reece Holbrook
Medtronic Cardiac Rhythm and Heart Failure Management
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Jaimie Manlucu
London Health Sciences Centre University Hospital
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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 . 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. 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). 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.
11 Jul 2023Submitted to Journal of Cardiovascular Electrophysiology
11 Jul 2023Submission Checks Completed
11 Jul 2023Assigned to Editor
11 Jul 2023Review(s) Completed, Editorial Evaluation Pending
18 Aug 2023Reviewer(s) Assigned
16 Sep 2023Editorial Decision: Revise Minor
29 Sep 20231st Revision Received
19 Oct 2023Assigned to Editor
19 Oct 2023Submission Checks Completed
19 Oct 2023Review(s) Completed, Editorial Evaluation Pending
19 Oct 2023Reviewer(s) Assigned
02 Nov 2023Editorial Decision: Revise Minor
07 Nov 20232nd Revision Received
07 Nov 2023Assigned to Editor
07 Nov 2023Submission Checks Completed
07 Nov 2023Review(s) Completed, Editorial Evaluation Pending
07 Nov 2023Reviewer(s) Assigned