A Contemporary Guide to Management of Lead Removal, Fragments and Ghost Leads: Solutions to Accommodate Changing Technology

Choi K1, Davis L1, Nakamura F2, Valadon C2, Cope Z3, Park A1, Siegel S4

Research Type

Clinical

Abstract Category

Female Lower Urinary Tract Symptoms (LUTS) / Voiding Dysfunction

Abstract 430
Open Discussion ePosters
Scientific Open Discussion Session 10
Wednesday 27th September 2023
17:25 - 17:30 (ePoster Station 3)
Exhibit Hall
Incontinence Neuromodulation New Devices
1. University of Louisville, Dept of Urology, 2. University of Louisville, School of Medicine, 3. University of Louisville, Dept of Obstetrics and Gynecology, 4. Minnesota Urology Centers for Female Urology and Continence Care
Presenter
Links

Poster

Abstract

Hypothesis / aims of study
With the advent of MRI-compatible Sacral Neuromodulation (SNM) devices, concerns pertaining to patients with previously implanted, non-compliant devices are slowly being resolved. However, a large number of patients still have older SNM devices presently implanted, either in-part or whole. There is no standardized method of removing intact or fragmented retained SNM leads or “ghost leads”- a term used to describe retained plastic housing and contacts with all filament remnants removed. In this paper, we aim to provide a summary of published methods for the removal of retained leads, fragments, and ghost leads. We also discuss the method we are currently using to remove retained SNM elements and examine the safety of MRI in patients whose retained leads and fragments may not be removable despite these methods.
Study design, materials and methods
A contemporary summary of published SNM lead removal methods is provided, as well as the method used in our practice, and the potential use of MRI in those patients whose leads are unable to be extracted. In addition, a three-patient case series is included to illustrate our method in practice and provide contextual factors leading to decisions for explantation.
Results
There are very few published articles describing procedures to safely and efficiently remove various types of retained leads. We believe our technique provides certain advantages over the antecedent methods which we detail here. Furthermore, in spite of historical concerns, we believe there are safe and effective means to perform MRI on appropriately selected patients in the event that whole leads, fragments, or ghost leads are unable to be removed. We propose that further, potentially more invasive means of removal are therefore unnecessary in these patients.
Interpretation of results
Though MRI incompatibility is a key reason for removing older SNM devices, various reasons for explantation exist that affect newer models as well, including but not limited to – insufficient clinical result or device failure due to lead fracture or migration, pain and paresthesias due to suboptimal placement, or infection of the IPG or lead. To further relate our findings in the context of newer devices, our future directions will include projects involving mouse-model experiments, removing retained Neuspera devices utilizing the methods described in this paper.
Concluding message
Removal of intact or fragmented leads, or ghost leads, may be necessary secondary to an adverse event, the need for routine device replacement, or for patients that require study with MRI. Our technique has been successful in removing challenging leads and fragments in their entirety without adverse sequela, and we propose it as a viable option when patients require removal of various retained components. Additionally, if it becomes impossible to retrieve a retained lead, invasive measures such as the involvement of neurosurgery to assist with removal may be unnecessary as many studies have shown encouraging safety results regarding the use of MRI in patients with all types of retained lead components.
Figure 1 Upper: lead fragment with filaments and pseudocapsule. Lower: ghost lead with no filament.
Figure 2 Weitlaner retractor and hemostat used to delineate the spatial orientation and laterality of the ghost leads respectively
References
  1. Gormley EA, Lightner DJ, Burgio KL, et al. Diagnosis and treatment of overactive bladder (non-neurogenic) in adults: AUA/SUFU guideline. J Urol. 2012;188: 2455-2463.
  2. Siegel S, Noblett K, Mangel J, et al. Five-Year Followup Results of a Prospective, Multicenter Study of Patients with Overactive Bladder Treated with Sacral Neuromodulation. The Journal of Urology. 2018;199: 229-236.
  3. Sukhu T, Kennelly MJ, Kurpad R. Sacral neuromodulation in overactive bladder: a review and current perspectives. Res Rep Urol. 2016;8: 193-199.
Disclosures
Funding Dr. Steven Siegel is Chief Medical Officer of Neuspera Medical Clinical Trial No Subjects Human Ethics Committee University of Louisville Institutional Review Board Helsinki Yes Informed Consent No
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