How Will You Know if an Interstim Lead Has Migrated

Turk J Urol. 2020 Nov; 46(6): 492–495.

A rare case of tined lead migration of InterStim device into the rectum with subsequent novel combined surgical-endoscopic removal technique

Leonidas Karapanos

1Department of Urology, Uro-Oncology, Robot Assisted and Reconstructive Surgery, University of Cologne, Faculty of medicine, University Hospital Cologne, Cologne, Germany

Seung-Hun Chon

2Department of Full general, Visceral, Cancer and Transplant Surgery, Academy of Cologne, Faculty of medicine, University Hospital Cologne, Cologne, Germany

Ruud Kokx

1Department of Urology, Uro-Oncology, Robot Assisted and Reconstructive Surgery, Academy of Cologne, Faculty of medicine, University Hospital Cologne, Cologne, Germany

Maximilian Schmautz

1Department of Urology, Uro-Oncology, Robot Assisted and Reconstructive Surgery, University of Cologne, Faculty of medicine, University Hospital Cologne, Cologne, Germany

Axel Heidenreich

iDepartment of Urology, Uro-Oncology, Robot Assisted and Reconstructive Surgery, University of Cologne, Kinesthesia of medicine, University Hospital Cologne, Cologne, Germany

Received 2020 Jul 23; Accustomed 2020 Aug 17.

Abstract

After the introduction of cocky-anchoring tined leads in 2002, lead migration later on sacral neuromodulation (SNM) in the form of InterStimTM (Medtronic, Minneapolis, MN) has been reduced; however, information technology remains a considerable complexity of this otherwise low-gamble process. As intestinal perforation through pb migration or primary incorrect positioning portrays a rarity and has been scarcely reported in the literature, no algorithm for explantation in such cases has been adamant. We present a case of a young man with an SNM device implant (InterStim II®) because of neurogenic urinary retention, who was admitted with inflammation, localized at the sacral atomic number 82 insertion site. Our diagnostic algorithm revealed a tined lead electrode protruding into the rectum without concomitant abscess. We performed an interdisciplinary surgical approach combining regular incisions over the sacrum and buttocks for dissection of the lead and the implanted pulse generator, respectively, with an endoscopic transanal atomic number 82 extraction. This method prevented farther bacterial seeding in the surrounding tissues of the colon and, therefore, presacral abscess formation or sacral osteomyelitis. Combined surgical-endoscopic removal of the InterStim device is an effective and condom procedure that should be included in the armamentarium of urologists performing neuromodulation surgery in cases of intestinal perforation.

Keywords: Implantable neurostimulators, implanted stimulation electrodes, abdominal perforation, postoperative complications

Introduction

Sacral neuromodulation (SNM) in the form of InterStimTM (Medtronic, Minneapolis, MN) is an established treatment for fecal incontinence and urinary disorders such as refractory overactive float) and non-obstructive urinary retentiveness as well as an "off-label" treatment for neurogenic lower urinary tract dysfunction and bladder hurting syndrome. Although SNM is a relatively safety surgical procedure, a loftier revision charge per unit of 24.iv%, as well as a removal charge per unit of 19%, is reported because of adverse events during a v-year follow upwards.[1] The virtually common complications are implant site pain in up to 32.5%, paresthesia in up to 19%, and implant site infection in upward to ten% of the cases, followed by decrease or loss of device efficacy.[2] In a multicenter trial with a total infectious complexity charge per unit of iii.3%, a difference between early (<1 month after implantation) vs. late (>1 month) infections was noticed. The time of infection implicated different treatment strategies, as lxx% of early device infections were successfully treated with antibiotics, while all late infections required device removal later on failed conservative treatment.[iii] The complication of pb migration could be successfully decreased after Nutrient and Drug Administration approval of self-anchoring tined leads with four sets of silicone tines proximal to the electrodes with a reported dislodgment charge per unit of upward to ii.1%.[4] Last just not least, a lead fracture could also portray a possible source of complications. Although electric current evidence suggests that it is generally safe for residual atomic number 82 fragments to remain in situ long-term, including in patients undergoing MRI, a secondary rectal injury through a fragmented lead has been described in the literature.[5]

Case presentation

A 25-year-old human being presented with significant right-sided sacral hurting, inflammation, and ulceration, localized at the sacral lead insertion site. At the fourth dimension of presentation, no gastrointestinal-related symptoms were reported (Figure i). He had undergone a bilateral full-system SNM implant (InterStim II®) in the S3 sacral foramina 1-year earlier because of neurogenic urinary retentiveness because of a lower motor neuron lesion (LMNL) acquired past a machine accident.

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Ulceration over the atomic number 82 insertion signal (asterisk) and unremarkable scar over implanted pulse generator at the right buttocks (arrow)

Within the context of our diagnostic algorithm, SNM generator interrogation revealed a normal impedance test but lost sensory response of the right-sided implant even to high stimulation amplitudes. A reprogramming failed to re-establish the initial postoperative responses. An anterior/posterior sacral ten-ray was performed, in which a suspicious profound and medial projection of the right pb was noticed (Figure 2a). Comparing the current localization with the archived fluoroscopic images from the original implantation, a distinct migration of the right-sided lead was perceived (Figure 2b). Blood analysis showed no leukocytosis, with a slight rise of C-reactive protein (CRP) (35 mg/L).

An external file that holds a picture, illustration, etc.  Object name is TJU-46-6-492-g02.jpg

Inductive/posterior x-ray showing a also deep and medial projection of the correct lead (a), lateral intraoperative fluoroscopic imaging proving a correct localization of both leads (b), CT-Scan imaging with sagittal (c), and axial view (d) of bilateral sacral neuromodulation device with a displacement of the right-sided lead in the rectum (arrows)

To assess the presence of a profound abscess and to exclude a visceral perforation, a computer tomography (CT) of the pelvis was performed, suspecting a penetration of the rectum with a 2 cm protrusion of the correct-sided quadripolar atomic number 82 into the colonic lumen. The left-sided pb, besides equally both implanted pulse generator (IPGs), were located in proper position (Figure 2c, d). A diagnostic sigmoidoscopy revealed a rectal wall perforation by the electrode xi cm proximal to the anus (Figure 3a, b).

An external file that holds a picture, illustration, etc.  Object name is TJU-46-6-492-g03.jpg

Sigmoidoscopy findings with visible 2 cm of the tip of the lead in the rectal lumen (a and b), Intraoperative images of grasping the lead with a snare, and the rectal wall defect after lead removal (c and d)

An imminent interdisciplinary surgical treatment was performed under general anesthesia. The patient was placed in a prone position with abducted hips and prepped, draping the anus in a separate surgical field. The right-sided pocket at the lateral buttocks was incised and the IPG extracted. The right-sided inflammatory scar over the sacrum was resected and sent for microbiological examination. The pb wire was dissected down to the fascia and cut sharply with scissors without extracting it through the sacral foramen to avoid fecal seeding at the surgical site. Simultaneously, a flexible endoscopy (GIF-H190; Olympus Tokyo Olympus Corporation, Tokyo, Japan) was performed. The endoscope was moved toward to the perforation site. Once the desired position had been reached, the lead was grasped with a snare (MTW; Endoscopy Industry, Germany), and a transanal extraction was performed (Figure 3c, d). After thorough consideration, the extraperitoneal rectal wall defect was left open to secondary healing, since the lead diameter of i.27 mm was considered small-scale and a chief closure not beneficial. The surgical site in a higher place the sacrum was washed-out with an antibiotic solution of vancomycin and gentamycin and closed primarily, leaving a ten-F closed suction drainage over the sacrum for 24 hours. The total surgical fourth dimension was 43 minutes. Bacterial culture revealed colonization of the surgical site by Escherichia coli and Morganella morganii; blood cultures remained negative.

The patient got discharged on the third postoperative day with oral antibiotics. Outpatient follow-up examinations 3 and 12 weeks after revealed no surgical site infection and no symptoms. Micturition was unchanged with an IPSS-Score of two points, without any significant postvoid residual because of the yet functioning left-sided neurostimulator; thus, no reimplantation of the correct-sided device was required.

Give-and-take

To the all-time of our knowledge, nosotros present the first instance of an interdisciplinary, complete SNM device removal after migration of an intact tined lead through the rectum wall with consistent lead-implant site infection. A primary rectal injury at the moment of implantation through a misplaced lead could exist excluded through a retrospective investigation of the archived intraoperative fluoroscopic imaging. The initial surgery was performed past a senior consultant with many years of experience. The choice of bilateral implantation was based on a previous percutaneous nerve evaluation showing superior effectiveness of bilateral, compared to unilateral, leads. Although a deep insertion of the guidewire intraoperatively cannot exist excluded, the correct localization of the implanted tined leads is an operational standard in our clinic.

We hypothesize that the rectum penetration occurred through spontaneous migration over time, equally the patient reported no inciting events or trauma as a trigger for this complication. Obvious causes of migration could non be identified, as the patient, with a normal torso-mass-alphabetize (24 kg/mii), was not obese. Even so, the germination of a presacral hematoma with temporary amore of the lumbosacral plexus, contributing to atomic number 82 migration, could be hypothesized. On checking the tape files retrospectively, we found the patient had reported painful paresthesia at the correct thigh immediately subsequently the implantation, just after spontaneous resolution in a few days, no further investigations were done at that time. However, in follow-up investigations at 6 and 24 weeks postoperatively, bilateral impedance tests were normal (<4000 ohms) and the patient indicated no loss of effectiveness or altered perineal/scrotal sensory response to stimulation. No further clinical signs could be identified, which could have led to a suspicion of migration at that time.

This case led to a change in our clinical practice, as whatsoever neurological symptoms present postimplant are currently investigated through imaging (x-ray and/or CT-scan) irrespective of the duration of symptoms. Suspected hematoma equally well as pb migration should be ruled out, or, if confirmed, treated every bit shortly as possible. In cases of modest presacral hematomas, a "surveillance" strategy can also exist chosen, equally spontaneous resolution without long-term complications is expected.

It has been debated whether a lead should be left in situ or removed past all means in case of a lead fracture, because of the possible take chances of migration into the surrounding tissues or organs, highlighting the major complication of peritonitis post-obit intestinal perforation. Shannon et al.[v] reported a successful endoscopic retrieval of a migrated tined lead fragment from the sigmoid colon following a previous accidental lead wire fracture during a removal attempt four months earlier. In our case, the SNM device was unfractured, so a combined surgical-endoscopic approach was required to explant both the lead wire and the IPG simultaneously. Okhunov et al.[six] described a standardized surgical technique for the removal of tined lead wires for InterStim devices through the sacral foramina using surgical autopsy deep to the level of the fascia and gentle traction using a right-angle clamp. However, this is contraindicated in cases of intestinal injury because of the adventure of bacterial seeding along the lead passage through soft tissues, possibly causing postoperative presacral abscess formation. Sufficient drainage of such abscesses is proven catchy and, in the worst case, may require open surgery.

The above-presented technique of combined surgical-endoscopic retrieval of the penetrating pb wire prevents bacterial seeding in the surrounding tissues of the colon and, therefore, abscess formation or sacral osteomyelitis. In this particular example, the rectal wall defect was tiny, and was left open to secondary heeling. Although primary closure of small extraperitoneal defects has not been proven benign in a multicenter oncological series, an endoscopic sealing of the intestinal wall through clipping could be considered in case of larger defects or intraperitoneal localization.[vii]

Physicians should maintain a loftier index of suspicion in cases of delayed implant site infections, which do not respond to antibiotics, equally the underlying cause may exist retrograde fecal bacteria colonization after colonic injury. Tined lead migration is yet an existent complication, only since colonic injury through migration is a rarity, so far no existent protocol for removal has been determined. Nosotros propose that a multidisciplinary arroyo combining a minimal surgical measure with an endoscopic removal technique should be implemented in the salve strategy regarding neuromodulation surgery.

Main Points

  • Tined atomic number 82 migration afterward sacral neuromodulation is a rare but considerable complexity.

  • Colonic injury through migration of the lead is a rarity merely should exist kept in mind in instance of wound inflammation or bowel symptoms including peritonitis.

  • Diagnostic algorithms using sacral 10-ray and computer tomography should be performed in case a atomic number 82 fracture or dislocation is suspected.

  • In instance of bowel injury, a multidisciplinary approach combining a minimal surgical measure with an endoscopic removal technique should be used for the removal of intact InterStim® devices.

Footnotes

Informed Consent: Written informed consent was obtained from patients who participated in this case.

Peer-review: Externally peer-reviewed.

Author Contributions: Concept - L.Yard.; Design - L.K., R.K.; Supervision - A.H.; Resources - 50.K., Due south.H.C., M.S.; Materials - Fifty.K., S.H.C.; Data Collection and/or Processing - L.K., R.One thousand., M.S.; Analysis and/or Estimation - Fifty.K., A.H.; Literature Search - L.K.; Writing Manuscript - 50.Yard.; Critical Review - R.K., M.South., South.H.C., A.H.

Disharmonize of Interest: The authors accept no conflicts of interest to declare.

Financial Disclosure: The authors declared that this study has received no financial support.

References

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Source: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7608536/

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