Page 10 - tmp

Surgical Aspects of the Possover LION Procedure
A minimally invasive and fully reversible laparoscopic Substudy 1 did not need further approval. Substudy 2 was approved
technique, the laparoscopic implantation of neuroprosthesis by the regional ethical committee (1-16-02-129-16) and the Danish
(the LION procedure), was developed by Possover for the Medical Agency (Journal no. 2017080415).
precise placement of an implantable pulse generator (IPG) and
placement of one to four leads for stimulating nerves of the Hardware
lumbosacral plexus. A substantial number of published cases Substudy 1. In the feasibility part of the study, the St. Jude system
support the effect of the technique regarding the treatment with an EON mini IPG and four quattrode leads were implanted and
of overactive and atonic bladder disturbances, neurogenic the IPG programming was done using the St. Jude/Abbott Rapid
bowel dysfunction, and abdominopelvic neuropathic pain. 6–10 Programmer System.
Unexpectedly, the clinical observation was made that four Substudy 2. In the controlled study, we used the Boston Scientific
patients with either complete or incomplete chronic traumatic Precision Spectra IPG with four linear ST leads of 50 or 70 cm
SCI significantly regained motor and sensory function afterward (model no. M365SC2218500 and M365SC2218700), the FreeLink
having the LION procedure performed for bladder and bowel remote control system (model no. M365SC52500), and the
9
dysfunction. An updated case series of 18 SCI patients having standard wireless charging system (model no.M365SC641230); all
the LION procedure performed report that 16 are now capable programming was done using the Clinician Programmer (model
of weight bearing standing and 12 are furthermore capable of no. M365SC7150400) and associated programming software, the
11
voluntary stepping. Recently, the LION procedure has been BionicNavigator 01.2.
carried out in collaboration between The Spinal Cord Injury
Center of Western Denmark, Aarhus University Hospital, and Paraclinical Investigations
Department of Surgery at Viborg Regional Hospital with the
guidance and support from Professor Possover. Diagnostic Imaging
The Possover LION procedure has never before been described Eight patients had bedside ultrasound of the pacemaker site
through a controlled, randomized trial, and potential side effects performed by a physician including a clinical examination after
and safety aspects have not been prospectively evaluated. 3, 7, 14, 21, and 42 days.
The present study reports the surgical aspects and safety results Eight patients had a postoperative CT scan performed
and observed complications from (a) a feasibility study and (b) a approximately 10 days and 8 weeks after surgery to check for lead
randomized controlled study evaluating the effect of the Possover migration/displacement.
LION procedure. All CT scans were performed without intravenous contrast
as diagnostic scans (not low dose), from the umbilical region
and downward to the proximal femur region. The average
MAterIAls And Methods cumulative radiation dose per patient was 8 mSv (range: 6–10.9).
The present study reports are obtained from a series of 21 eligible Coronal and sagittal, 2 mm slice thickness, reconstructions
SCI patients having surgery at Viborg Regional Hospital, Denmark, were made.
with the Possover LION procedure. The presented study material is Optimal lead placement was defined as the location of the
derived from two substudies: first, a feasibility study (substudy 1) sciatic nerve electrode leads near the greater sciatic foramen.
with four eligible SCI patients and second, a randomized controlled Distance from the acetabular roof to the SNEL, chiefly measured
study with two treatment arms (substudy 2) with the active group in sagittal reconstructions, was used to evaluate the precise
allocated to direct surgical intervention with performed Possover migration/displacement.
LION procedure and subsequent neurorehabilitation, and the Femoral nerve electrode lead (FNEL) near to the musculus
control group allocated to delayed surgical intervention with iliopsoas and inguinal canal was decided as an optimal placement.
12 month of preconditioning using guided self-training with Distance from the superior iliac spine anterior to the FNEL top on
external neuromuscular electrical stimulation. Inclusion criteria: coronal reconstructions was used to evaluate the precise migration/
Traumatic SCI below level Th5 with spastic paraplegia, AIS grades displacement. See Figure 1 for an example of well-placed leads.
A, B or C. Age between 18 and 50 years. Exclusion criteria: other Arrows indicate the lead and IPG placement.
implanted devices (e.g., cardiac pacemakers, baclofen pumps),
severe episodes of dysautonomia, drug or alcohol abuse, unstable Blood Samples
medical or psychiatric disorder, previous pelvic disorder or surgery Blood samples measuring C-reactive peptide (CRP) were drawn on
that may interfere with the Possover LION procedure, planned the day of operation and daily until discharge from the hospital.
pregnancy, known compliance issues, logistic obstacles (e.g., Patients had a clinical follow-up between postoperative days 7 to
planned journeys, other planned surgery). 10, where CRP measures were obtained as well.
Patients Clinical Assessment
Twenty patients undergoing the Possover LION procedure at Viborg Eligible patients were examined by specialist neurologists
Regional Hospital were included in this study. One additional and evaluated by trained neurorehabilitation physiotherapists
patient underwent operation, but the operation was aborted, regarding compliance before participation.
and the patient failed to have the electrodes implanted due to a
frozen pelvis. Study Procedure
The Possover LION procedure involved laparoscopic exposure of
Ethics both the femoral and sciatic nerves bilaterally. For a comprehensive
The study was conducted in accordance with the Helsinki II description, we refer to the International School of Neuropelveology
declaration. Patients gave verbal and written informed consent. textbook 2015.

76 World Journal of Laparoscopic Surgery, Volume 14 Issue 2 (May–August 2021)