Can Lumbosacral Magnetic Resonance Imaging be Performed Safely in Patients with a Sacral Neuromodulation Device? An In-Vivo Prospective Study

Guzman-Negron J M1, Pizarro-Berdichevsky J2, Gill B C1, Goldman H B1

Research Type

Clinical

Abstract Category

Overactive Bladder

Abstract 438
Neuromodulation
Scientific Podium Short Oral Session 22
Thursday 30th August 2018
14:52 - 15:00
Hall A
Neuromodulation Urgency Urinary Incontinence Imaging Overactive Bladder
1. Glickman Urological and Kidney Institute, Cleveland Clinic, 2. Urogynecology Unit, Sotero del Rio Hospital and Division Obstetricia y Ginecologia Pontificia Universidad Catolica de Chile
Presenter
H

Howard B Goldman

Links

Abstract

Hypothesis / aims of study
To determine the safety of sacral neuromodulation (SNM) in patients during lumbosacral 1.5 Tesla (T) magnetic resonance imaging (MRI).
Study design, materials and methods
We prospectively recruited InterstimTM II model implanted patients requiring lumbar/spine or pelvis 1.5 T MRI. Patients completed validated questionnaires and a survey regarding their usual SNM sensation pre MRI scan. The implantable pulse generator (IPG) was interrogated and impedances and battery life were assessed pre and post MRI. Patients were monitored during MRI study. An MRI-related adverse events questionnaire was completed post MRI. Validated questionnaires were completed 1 month after the MRI to assess for any changes in SNM therapeutic efficacy. Descriptive statistics were calculated.
Results
Eleven patients were enrolled in the study. All patients underwent lumbar/spine MRI. The most common indication for MRI was lower back pain 55% (6/11). Immediately after the MRI only 1 patient reported discomfort at the site of the IPG during the MRI, however, discomfort was only present during the scan and not afterwards. Two of the patients reported warmth at the site of the IPG during the MRI, again, this sensation was only present during scanning. None of the patients experienced stimulation or movement at the IPG site and no paresthesia was reported. There were no significant changes in impedances and battery life during IPG interrogation post MRI. Threshold amplitudes for sensation and localization of stimulation were unchanged post MRI. Urogenital Distress Inventory (UDI-6) and Incontinence Impact Questionnaires (IIQ-7) 1 month after MRI did not show worsening scores compared to pre MRI scores. None of the patients reported a negative Patient Global Impression of Improvement (PGI-I) score 1 month after MRI.
Interpretation of results
In this study, we found that no subjects with implanted SNM devices had any significant adverse events from undergoing 1.5 T lumbar MRI. Additionally, SNM therapeutic efficacy did not change 1 month post-MRI. A main safety concern of SNM with MRI is device heating during scanning due to transmitted radiofrequency power. Utilizing a phantom model, Quirouet et. al. demonstrated the risk of device heating is very low for lumbosacral 1.5 T MRI with an intact SNM system or with a fractured lead [1]. We utilized multiple instruments to measure safety and therapeutic efficacy before and after. SNM devices were switched off before undergoing MRI, patients were periodically interviewed throughout the scan and none terminated the scan due to intolerance. No patients verbalized any sensation of heating during the MRI scan. However, when prompted about symptoms after the scan, 2 patients recalled a warm sensation and 1 patient reported mild discomfort near the IPG during the MRI. Otherwise, following the scan, no patients reported pain or discomfort.

As a number of patients undergo SNM explantation to facilitate MRI, it is important to recognize that many patients explanted do not pursue SNM re-implantation. As shown recently by Lloyd et al., only 10% of explanted patients pursued subsequent re-implantation [2]. Therefore, the results of our study have the potential to improve device management surrounding MRI by establishing evidence of the ability to perform MRI near implanted SNM devices. Furthermore, our findings can translate into improved healthcare efficiency and reduced costs, by, providing a basis for reducing device explants to accommodate MRI, as well as enabling the implantation of devices in appropriate patients who know they may require future MRI studies.
Concluding message
No significant adverse events occurred in patients implanted with an InterStimTM II device who underwent 1.5 T non-head MRI scan. Rare complaints reported were discomfort and warmth at the IPG site during scanning. Therapeutic efficacy of SNM was not affected 1 month after undergoing a non-head MRI scan.
References
  1. Quirouet A, Bhattacharyya PK, Dielubanza EJ, et al. Sacral neuromodulation device heating during lumbar and pelvic magnetic resonance imaging – A phantom study. Urology 2017; 107: 61-66.
  2. Lloyd J.C., Gill B.C., Pizarro-Berdichevsky J., et al. 2017. Removal of Sacral Nerve Stimulation Devices for Magnetic Resonance Imaging: What Happens Next? Neuromodulation 2017; 20: 836–840.
Disclosures
<span class="text-strong">Funding</span> Society of Urodynamics, Female Pelvic Medicine, and Urogenital Reconstruction (SUFU) Grant <span class="text-strong">Clinical Trial</span> No <span class="text-strong">Subjects</span> Human <span class="text-strong">Ethics Committee</span> Institutional Review Board of the Cleveland Clinic <span class="text-strong">Helsinki</span> Yes <span class="text-strong">Informed Consent</span> Yes