Sudden Intrathecal Drug Delivery Device Motor Stalls

Galica, Ryan; Hayek, Salim M.; Veizi, I. Elias; Lawrence, Melinda M.; Khalil, Al-Amin A.; McEwan, Matthew T.

doi:10.1097/aap.0000000000000368

Cited by 23 publications

(7 citation statements)

References 19 publications

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“…The 78‐month survival rate decreased from 97.2 to 90% in pumps infusing off‐label medications, which was mirrored in the 2015 PPR with survival of 96.4% on‐label and 88.9% off‐label, with an increased risk of failure to be 2.4. However, a higher pump failure rate (9% at a median follow‐up of four years) was recently reported in a large series from a tertiary medical center . Most off‐label use occurred in patients with pumps implanted for pain as opposed to spasticity, and as expected, the majority of chronic pain patients are receiving off‐label polypharmacy .…”

Section: Device‐related Complicationsmentioning

confidence: 86%

“…According to the same report, the SynchroMed II pump failure rate at five years with on‐label drugs is 2.8%; while it was 5.3% at five years with off‐label drugs and 3.6% at four years. A recent report from a tertiary care center identified 13 pump failures in 144 SynchroMed II implants, a rate of 9% . The median time from implant to pump failure in the 13 cases was 48 months.…”

Section: Medications Used In Intrathecal Drug Delivery For Painmentioning

confidence: 99%

See 1 more Smart Citation

The Polyanalgesic Consensus Conference (PACC): Recommendations for Intrathecal Drug Delivery: Guidance for Improving Safety and Mitigating Risks

Deer¹,

Pope²,

Hayek

et al. 2017

Neuromodulation: Technology at the Neural Interface

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133

144

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Section: Device‐related Complicationsmentioning

confidence: 86%

Section: Medications Used In Intrathecal Drug Delivery For Painmentioning

confidence: 99%

The Polyanalgesic Consensus Conference (PACC): Recommendations for Intrathecal Drug Delivery: Guidance for Improving Safety and Mitigating Risks

Deer¹,

Pope²,

Hayek

et al. 2017

Neuromodulation: Technology at the Neural Interface

Self Cite

133

144

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“…AEs within the PSR are collected prospectively with risk-based monitoring to ensure accuracy and completeness. The risks associated with ITB therapy and the SynchroMed infusion system have been well studied, with publications on individual patient cases or series reports (20)(21)(22)(23) and as many as 359 patients (24). The 1743 patients enrolled in the PSR and their average 44.6 months and cumulative 6481 patient-years of follow-up provide a currently unmatched source of safety data.…”

Section: Discussionmentioning

confidence: 99%

Intrathecal Baclofen for Severe Spasticity: Longitudinal Data From the Product Surveillance Registry

Schiess

Eldabe

Konrad

et al. 2020

Neuromodulation: Technology at the Neural Interface

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Objective: To assist in the assessment of intrathecal baclofen (ITB) therapy risks and benefits by providing surgical intervention rate, safety, and elective device replacement rate data. Materials and Methods: An ongoing prospective, long-term, multicenter Product Surveillance Registry (PSR) (NCT01524276) enrolled consented patients implanted with the SynchroMed II infusion system. Pump and catheter performance data were collected, with patients followed prospectively for events related to the device, procedure, and therapy. Investigators provided event descriptions, patient symptoms, and patient outcomes. Results: We analyzed registry data from 1743 patients (77% adult, 46.8% female) treated with ITB for severe spasticity at 53 registry sites between August 2003 and October 2017, for an accumulated 6481 patient-years. Discontinuation from the registry was largely (58.6% of discontinued patients) due to study site closure and patient relocation; exit due to an adverse event was limited to 0.3%. After 10 years, 87.2% of adult and 76.3% of pediatric patients continued with ITB. Overall, 99.1% of pumps reaching end of battery life were replaced at the time of explant. Conclusions: ITB therapy for the treatment of severe spasticity requires surgical implantation of a programmable infusion system for chronic drug delivery. If complications arise, many necessitate surgical intervention for correction. For spinal and cerebral spasticity in pediatric and adult patients, discontinuation rates due to an adverse event were low (0.3%), and there was high acceptance (99.1%) of surgical intervention for therapy continuation. Patient/caregiver willingness to accept surgical and other risks for therapy continuation was extremely high.

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“…The most common complications are catheter related, including catheter migration, occlusion, leak or fracture (207)(208)(209). Much less common are motor stalls in peristaltic pumps (207,210,211). Evaluation of suspected device malfunction begins with history, physical examination and device interrogation.…”

Section: Post-operative Complicationsmentioning

confidence: 99%

Intrathecal Drug Delivery: Advances and Applications in the Management of Chronic Pain Patient

et al. 2022

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Advances in our understanding of the biology of spinal systems in organizing and defining the content of exteroceptive information upon which higher centers define the state of the organism and its role in the regulation of somatic and automatic output, defining the motor response of the organism, along with the unique biology and spatial organization of this space, have resulted in an increased focus on therapeutics targeted at this extracranial neuraxial space. Intrathecal (IT) drug delivery systems (IDDS) are well-established as an effective therapeutic approach to patients with chronic non-malignant or malignant pain and as a tool for management of patients with severe spasticity and to deliver therapeutics that address a myriad of spinal pathologies. The risk to benefit ratio of IDD makes it a useful interventional approach. While not without risks, this approach has a significant therapeutic safety margin when employed using drugs with a validated safety profile and by skilled practioners. The present review addresses current advances in our understanding of the biology and dynamics of the intrathecal space, therapeutic platforms, novel therapeutics, delivery technology, issues of safety and rational implementation of its therapy, with a particular emphasis upon the management of pain.

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Sudden Intrathecal Drug Delivery Device Motor Stalls

Cited by 23 publications

References 19 publications

The Polyanalgesic Consensus Conference (PACC): Recommendations for Intrathecal Drug Delivery: Guidance for Improving Safety and Mitigating Risks

The Polyanalgesic Consensus Conference (PACC): Recommendations for Intrathecal Drug Delivery: Guidance for Improving Safety and Mitigating Risks

Intrathecal Baclofen for Severe Spasticity: Longitudinal Data From the Product Surveillance Registry

Intrathecal Drug Delivery: Advances and Applications in the Management of Chronic Pain Patient

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