Transforaminal intrathecal delivery of nusinersen using cone-beam computed tomography for children with spinal muscular atrophy and extensive surgical instrumentation: early results of technical success and safety

Weaver, John J; Natarajan, Niranjana; Shaw, Dennis; Apkon, Susan; Koo, Kevin S. H.; Shivaram, Giridhar M.; Monroe, Eric J.

doi:10.1007/s00247-017-4031-6

Cited by 51 publications

(59 citation statements)

References 21 publications

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“…Previous studies have specifically examined radiation exposure during nusinersen injection using fluoroscopy and CT guidance and have found similar results to our estimation. Repeated radiation exposure for the delivery of nusinersen is a risk that needs to be balanced with the benefit of the treatment, and further research into this topic is needed 2–4 …”

Section: Discussionmentioning

confidence: 99%

Intrathecal delivery of nusinersen in individuals with complicated spines

et al. 2020

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Background The treatment of spinal muscular atrophy (SMA) with nusinersen requires intrathecal medication administration, which can be challenging in individuals with complicated spines. This retrospective case series reviews the nusinersen treatment experience at one academic medical center with children and adults with SMA and complicated spines. Methods Twenty medical records of individuals receiving nusinersen were reviewed and administration methods summarized and assessed. Results Ten children and 10 adults were treated, and 55% had complicated spines. In total, 163 treatments were given, 91 in those with complicated spines. In the complicated spines, 74% of treatments were done by means of fluoroscopic lumbar puncture, 22% by means of intrathecal Ommaya reservoir, 3% by means of palpation, and < 1% by means of computed tomography‐guided transforaminal approach. Conclusions A large majority of individuals with complicated spines can receive intrathecal nusinersen using fluoroscopic guidance in the lumbar region. Other delivery methods are available but less frequently used.

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Section: Discussionmentioning

confidence: 99%

Intrathecal delivery of nusinersen in individuals with complicated spines

et al. 2020

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“…In some children, use of spinal ultrasonography, fluoroscopy, conical CT guidance, and a transforaminal approach increases rates of successful intrathecal access. 24,25 In rare cases, laminectomies and intraspinal catheter and subcutaneous reservoir placements are performed by orthopedic surgeons to facilitate treatment. In patients in whom lumbar access is impossible, nusinersen delivery has been accomplished via fluoroscopic-guided lateral cervical puncture at the C1-2 interspace.…”

Section: Clinical Contextmentioning

confidence: 99%

Evidence in focus: Nusinersen use in spinal muscular atrophy [RETIRED]

et al. 2018

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ObjectiveTo identify the level of evidence for use of nusinersen to treat spinal muscular atrophy (SMA) and review clinical considerations regarding use.MethodsThe author panel systematically reviewed nusinersen clinical trials for patients with SMA and assigned level of evidence statements based on the American Academy of Neurology's 2017 therapeutic classification of evidence scheme. Safety information, regulatory decisions, and clinical context were also reviewed.ResultsFour published clinical trials were identified, 3 of which were rated above Class IV. There is Class III evidence that in infants with homozygous deletions or mutations of SMN1, nusinersen improves the probability of permanent ventilation-free survival at 24 months vs a well-defined historical cohort. There is Class I evidence that in term infants with SMA and 2 copies of SMN2, treatment with nusinersen started in individuals younger than 7 months results in a better motor milestone response and higher rates of event-free survival than sham control. There is Class I evidence that in children aged 2–12 years with SMA symptom onset after 6 months of age, nusinersen results in greater improvement in motor function at 15 months than sham control. Nusinersen was safe and well-tolerated.Clinical contextEvidence of efficacy is currently highest for treatment of infantile- and childhood-onset SMA in the early and middle symptomatic phases. While approved indications for nusinersen use in North America and Europe are broad, payer coverage for populations outside those in clinical trials remain variable. Evidence, availability, cost, and patient preferences all influence decision-making regarding nusinersen use.

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“…Researchers described use of this method for periradicular injections in 2 series of 143 and 231 patients and reported no major complications, although we view these reports cautiously because the thecal sac was not punctured in these studies . A transforaminal approach has been recently reported in a pediatric SMA cohort, and it is unclear whether smaller foramina in pediatric patients puts them at higher risk of complications.…”

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confidence: 96%