Preclinical and benchtop evaluation of a dedicated tool for insertable cardiac monitor explantation.
- 1Children's National Medical Center, Washington, District of Columbia.
- 2Johns Hopkins University, Department of Mechanical Engineering, Baltimore, Maryland.
Abstract
Background
Insertable cardiac monitors (ICMs) are widely used for long-term rhythm surveillance, yet explantation can be challenging because of fibrotic encapsulation, tissue variability, and device migration. Current removal typically relies on general surgical instruments, and no dedicated tool exists for difficult ICM explants.Objective
This study aimed to evaluate the performance of a purpose-built cardiac monitor extraction tool (CM-eX) compared with standard removal technique using benchtop and chronic animal models.Methods
The CM-eX was designed and fabricated. Benchtop testing used a 2-layer synthetic gel model simulating fibrotic encapsulation and subcutaneous tissue. 80 ICM removals were performed using CM-eX, standard instruments, or direct wire pullout. Metrics included removal time and peak insertion and removal forces. Electromyography was recorded as a measure of operator demand. Chronic animal testing was performed in 9 rats implanted bilaterally with ICMs and explanted after a 3-month survival period, with each animal serving as its own control.Results
In benchtop models, removal time was similar between the CM-eX and standard instruments (P = .40), whereas the CM-eX required significantly lower removal force than direct pullout (P < .0001). Overall EMG activity was similar between methods. In the chronic animal model, the CM-eX was associated with faster explant in 8 of 9 paired comparisons, with a mean reduction of 28% vs standard instruments. No device slippage or procedural complications were observed.Conclusion
In preclinical testing, the CM-eX demonstrated feasible ICM removal with reduced extraction force in benchtop models and directional improvements in explant time in an animal model. These findings support its potential to facilitate more controlled and consistent ICM explantation.
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BibTeX
@article{gonzalez2026preclinical,
title = {{Preclinical and benchtop evaluation of a dedicated tool for insertable cardiac monitor explantation.}},
author = {Bryan Gonzalez and Vanessa Ogueri and Devon Guerrelli and Justin D Opfermann and Mischa Cho and Charles I Berul and Ryan P O'Hara},
journal = {Heart rhythm O2},
year = {2026},
month = jul,
doi = {10.1016/j.hroo.2026.07.003},
url = {https://europepmc.org/article/MED/42936125},
note = {CC BY-NC-ND},
}
RIS
TY - JOUR
TI - Preclinical and benchtop evaluation of a dedicated tool for insertable cardiac monitor explantation.
AU - Bryan Gonzalez
AU - Vanessa Ogueri
AU - Devon Guerrelli
AU - Justin D Opfermann
AU - Mischa Cho
AU - Charles I Berul
AU - Ryan P O'Hara
PY - 2026
DA - 2026/07/09
JO - Heart rhythm O2
DO - 10.1016/j.hroo.2026.07.003
UR - https://europepmc.org/article/MED/42936125
AB - Background Insertable cardiac monitors (ICMs) are widely used for long-term rhythm surveillance, yet explantation can be challenging because of fibrotic encapsulation, tissue variability, and device migration. Current removal typically relies on general surgical instruments, and no dedicated tool exists for difficult ICM explants.Objective This study aimed to evaluate the performance of a purpose-built cardiac monitor extraction tool (CM-eX) compared with standard removal technique using benchtop and chronic animal models.Methods The CM-eX was designed and fabricated. Benchtop testing used a 2-layer synthetic gel model simulating fibrotic encapsulation and subcutaneous tissue. 80 ICM removals were performed using CM-eX, standard instruments, or direct wire pullout. Metrics included removal time and peak insertion and removal forces. Electromyography was recorded as a measure of operator demand. Chronic animal testing was performed in 9 rats implanted bilaterally with ICMs and explanted after a 3-month survival period, with each animal serving as its own control.Results In benchtop models, removal time was similar between the CM-eX and standard instruments (P = .40), whereas the CM-eX required significantly lower removal force than direct pullout (P < .0001). Overall EMG activity was similar between methods. In the chronic animal model, the CM-eX was associated with faster explant in 8 of 9 paired comparisons, with a mean reduction of 28% vs standard instruments. No device slippage or procedural complications were observed.Conclusion In preclinical testing, the CM-eX demonstrated feasible ICM removal with reduced extraction force in benchtop models and directional improvements in explant time in an animal model. These findings support its potential to facilitate more controlled and consistent ICM explantation.
SN - 2666-5018
ER -