Evidence map›Paper›PMID 34487571›Full record

ArticleNeurourology and urodynamics2021

Magnetic resonance imaging interactions with a sacral neuromodulation system.

Xuechen Huang, Guangqiang Jay Jiang

Abstract read
In one paragraph

Article in Neurourology and urodynamics, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 7 papers.

0numbers the graph read from it
0cells of the map it votes in
7citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

7 citing papers in PubMed.

  1. Review
  2. Review
  3. Article
  4. Article
  5. Review
  6. Pathways and parameters of sacral neuromodulation in rats.American journal of physiology. Renal physiology · 2023
    Article
  7. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Xuechen HuangAxonics Inc., Irvine, CA, USA.ORCID 0000-0003-2835-4161
Guangqiang Jay JiangAxonics Inc., Irvine, CA, USA.ORCID 0000-0001-6982-6191

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsSacral neuromodulation (SNM) has successfully treated patients with functional urinary and/or bowel disorders for more than two decades. Historically, patients with the InterStim system (Medtronic) were contraindicated for Magnetic Resonance Imaging (MRI) scans. In 2012, Medtronic obtained Food and Drug Administration (FDA) approval for allowing 1.5 Tesla (T) MRI head scans. In September 2019, the Axonics System (Axonics) received FDA approval for 1.5 T full-body MR Conditional labeling and then 3 T full-body MR Conditional labeling in July 2020. In August 2020, Medtronic received 1.5 and 3 T full-body MR Conditional labeling from the FDA for their new SNM systems (InterStim II and Micro devices with SureScan

methodsThis paper explains the fundamentals of MRI physics, its interactions with active implantable medical devices (AIMDs), the subsequent potential safety hazards with emphasis on radio frequency (RF)-related safety, and the risks associated with "Off-label" scans, including abandoned and broken leads.

resultsMRI guidelines provided by the AIMD device manufacturer should be followed to ensure MRI scan safety and avoid any unnecessary risk to patients.

conclusionsMRI guidelines provided by the device manufacturer are the best resource for guidance for performing safe MRI scanning. Specific conditions should be fully understood and generalizations on MRI safety claims based on partial analysis or case studies should be avoided.

Indexed as

Electric Stimulation TherapyMagnetic Resonance ImagingHumansRadio WavesSacrococcygeal RegionSacrumimplantable neurostimulatorMRI physics

Identifiers

PMID34487571
PMCPMC9290516

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.