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3.
Pain Manag ; 13(2): 115-127, 2023 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-36691862

RESUMO

Aim: The availability of long-term (>2 years) safety outcomes of spinal cord stimulation (SCS) remains limited. We evaluated safety in a global SCS registry for chronic pain. Methods: Participants were prospectively enrolled globally at 79 implanting centers and followed out to 3 years after device implantation. Results: Of 1881 participants enrolled, 1289 received a permanent SCS implant (1776 completed trial). The annualized rate of device explant was 3.5% (all causes), and 1.1% due to inadequate pain relief. Total incidence of device explantation >3 years was 7.6% (n = 98). Of these, 32 subjects (2.5%) indicated inadequate pain relief as cause for removal. Implant site infection (11 events) was the most common device-related serious adverse event (<1%). Conclusion: This prospective, global, real-world study demonstrates a high-level of safety for SCS with low rate of explant/serious adverse events. Clinical Trial Registration: NCT01719055 (ClinicalTrials.gov).


Assuntos
Dor Crônica , Estimulação da Medula Espinal , Humanos , Estimulação da Medula Espinal/efeitos adversos , Estudos Prospectivos , Dor Crônica/terapia , Complicações Pós-Operatórias , Sistema de Registros , Medula Espinal , Resultado do Tratamento
4.
Front Pain Res (Lausanne) ; 3: 900566, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35782225

RESUMO

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.

6.
Reg Anesth Pain Med ; 41(2): 135-9, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-26866298

RESUMO

BACKGROUND AND OBJECTIVES: Intrathecal (IT) drug delivery systems (IDDSs) have been valuable in managing refractory chronic cancer and noncancer pain for more than 3 decades. These devices, time tested and overall reliable, have lately been noted at this institution to cease infusing unexpectedly. If not immediately recognized and rectified, this abrupt malfunction may lead to significant patient harm. METHODS: A series of 13 patients from 1 academic center whose Medtronic SynchroMed II pumps malfunctioned from 2013 to 2015 is described. Data from the patient population with regard to variables that may increase the rate of IDDS malfunction are analyzed. The risk factors for IDDS malfunction, Medtronic-issued recalls, and current literature on IT device failure are reviewed. RESULTS: The total prevalence of device motor stall among the population of this institution is 9.03%. The incidence rate of IDDS failure is calculated at 0.04 device failures per patient per year. Increased length of time from implant was the only statistically significant (P = 0.00009) risk factor for device failure identified in this population. Dysfunction in the motor gear train was found after destructive analysis of several devices in this series. CONCLUSIONS: Higher rates of device failure are associated with the use of off-label IT drugs. However, device failure may still occur while infusing only approved medications. Implanted patients should be properly informed and educated to differentiate and recognize the critical error alarm of their device as well as the signs and symptoms of IT medication overdose and withdrawal.


Assuntos
Sistemas de Liberação de Medicamentos/instrumentação , Falha de Equipamento , Bombas de Infusão Implantáveis , Sistemas de Liberação de Medicamentos/efeitos adversos , Feminino , Seguimentos , Humanos , Bombas de Infusão Implantáveis/efeitos adversos , Injeções Espinhais , Masculino
7.
Curr Opin Anaesthesiol ; 26(5): 573-9, 2013 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-23963231

RESUMO

PURPOSE OF REVIEW: Percutaneous lumbar decompression is a minimally invasive procedure for the treatment of symptomatic lumbar spinal stenosis (LSS). The purpose of this article is to review the current literature on percutaneous lumbar decompression as well as review the safety and outcomes associated with the procedure. RECENT FINDINGS: LSS is a significant cause of chronic pain and a common indication for invasive spine surgery. The recent literature shows that percutaneous lumbar decompression is a minimally invasive treatment option that affords a high level of safety, improved function, decreased pain scores, and is cost-effective. SUMMARY: This minimally invasive procedure is an option for patients with central canal LSS who have continued pain-following conservative treatment such as physical therapy, oral medications, and lumbar spine injections. Percutaneous lumbar decompression is a procedure that bridges the gap between invasive surgery and more conservative treatment for LSS. This percutaneous technique provides increasing options to those patients with central canal lumbar stenosis who may not be candidates for an invasive decompression procedure. Overall, this procedure has been found to be well tolerated and effective in reducing pain while generally improving function.


Assuntos
Descompressão Cirúrgica/métodos , Vértebras Lombares/cirurgia , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Estenose Espinal/cirurgia , Descompressão Cirúrgica/efeitos adversos , Descompressão Cirúrgica/economia , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos/efeitos adversos , Procedimentos Cirúrgicos Minimamente Invasivos/economia , Escala Visual Analógica
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