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Investigating Complications Associated With Occipital Nerve Stimulation: A MAUDE Study
Doran, Joseph; Ward, Max; Ward, Brittany; Paskhover, Boris; Umanoff, Michael; Mammis, Antonios
OBJECTIVES/OBJECTIVE:The objectives of this study are to utilize the MAUDE data base to enhance our understanding of the complication profile for Occipital Nerve Stimulation, a therapy for which the current level of evidence is limited. Additionally, it is our objective to describe a systematic approach to processing the MAUDE data, which addresses its flaws and enhances its utility. METHODS:From the FDA website, we accessed adverse events reports from the MAUDE data base for devices used in Occipital Nerve Stimulation between June 30, 2007 and June 30, 2017. All reports were sorted into an overall classification for types of adverse events, types of patient complaints, and types of specific device-related complications. We then evaluated for the total number of adverse event reports that contained each of the patient complains and device-related complications. RESULTS:A total of 1233 adverse event records were obtained. Eight hundred twenty-two records were classified as surgically manageable post-operative complications, 121 as device malfunction, 29 as patient compliance issues, and 27 as intra-operative complications. Two hundred thirty-seven records were not classified. A total of 683 records contained patient complaints including 467 complaints of ineffective stimulation, 122 complaints of inappropriate or over-stimulation, 50 complaints of device-shock, and 44 complaints of IPG site pain. We found 581 post-operative device-related complications, which included 206 instances of lead migration, 157 reports of lead erosion, 155 infections, 46 lead-fractures, and 17 lead disconnections. CONCLUSION/CONCLUSIONS:The MAUDE data base is a useful tool to investigate device related complications and helps fill the current gap in ONS data. Reviewing the types and frequencies of complications reported over the years allows clinicians with less personal experience to have a more realistic expectation of complications and make informed decisions based on the patient's unique needs. Additionally, patient complaint data are useful in establishing more realistic expectations for patient outcomes.
PMID: 29345415
ISSN: 1525-1403
CID: 4611382
Endoscopic Pericranial Flap Repair of Occipital-Frontal Electrode Erosion [Case Report]
Ward, Max; Kandinov, Aron; Mammis, Antonios; Umanoff, Michael; Paskhover, Boris
INTRODUCTION/BACKGROUND:Occipital-frontal nerve stimulation is an off-label therapy for treating chronic refractory migraine and orofacial pain. Though effective, patients experience a high rate of complications including lead migration and erosion through the overlying skin. CASE DESCRIPTION/METHODS:We present a case of frontal electrode erosion that was revised via pericranial flap repair. The patient presented with multiple lead migrations, necessitating multiple revision surgeries with eventual frontal wound dehiscence. The choice was made to wrap the electrode in a pericranial flap to prevent recurrent lead migration. Two weeks postoperatively, the wound was well healed and the patient reported that the midline electrode was functioning properly. DISCUSSION/CONCLUSIONS:Pericranial flap revision confers little additional risk when compared with simple wound closure, and the surgeon can proceed without total electrode removal, additional incisions, or lead tunneling. The flap provides a highly vascular additional layer of stability to the electrode, reducing the likelihood of further lead exposure without compromising the efficacy of the device. These results suggest that endoscopic pericranial flap revision is a viable technique for the repair of occipital nerve stimulation lead erosions.
PMID: 30144591
ISSN: 1878-8769
CID: 4611432
Novel Association Between Intrathecal Drug Administration and Arachnoiditis Ossificans [Case Report]
Ward, Max; Mammis, Antonios; Barry, Maureen T; Heary, Robert F
BACKGROUND:We present a case of delayed progression of adhesive arachnoiditis to arachnoiditis ossificans (AO) in a patient being treated with a high-dose polypharmaceutical intrathecal regimen. CASE DESCRIPTION/METHODS:The patient is a 39-year-old Caucasian male who was implanted with an intrathecal pump in 2006 to control severe low back pain and administered intrathecal pain medication for a period of 10 years. In 2016, he developed new-onset radicular pain and worsened sensation in his lower extremities. Computed tomography scan of the lumbar spine at that time demonstrated profound calcification of the arachnoid consistent with a diagnosis of AO. It was presumed that prolonged high-dose intrathecal medication precipitated this condition, and his intrathecal medications were titrated down with removal of the pump. CONCLUSIONS:It is unlikely that his condition occurred as a result of prior surgery, with the more likely cause being hyperplasia of the spinal arachnoid, leading to scarring and calcification, due to the high-dose intrathecal regimen. This case highlights the delayed progression from stable arachnoiditis to AO concurring with a regimen of high-dose intrathecal medications. Clinicians should closely monitor patients undergoing intrathecal drug administration, particularly at elevated doses, for indications of damage to the spinal arachnoid mater.
PMID: 29747017
ISSN: 1878-8769
CID: 4611422
The 50 Most Cited Articles in Invasive Neuromodulation
Ward, Max; Doran, Joseph; Paskhover, Boris; Mammis, Antonios
OBJECTIVE:Bibliometric analysis is a commonly used analytic tool for objective determination of the most influential and peer-recognized articles within a given field. This study is the first bibliometric analysis of the literature in the field of invasive neuromodulation, excluding deep brain stimulation. The objectives of this study are to identify the 50 most cited articles in invasive neuromodulation, provide an overview of the literature to assist in clinical education, and evaluate the effect of impact factor on manuscript recognition. METHODS:Bibliometric analysis was performed using the Science Citation Index from the Institute for Scientific Information, accessed through the Web of Science. Search terms relevant to the field of invasive neuromodulation were used to identify the 50 most cited journal articles between 1900 and 2016. RESULTS:The median number of citations was 236 (range, 173-578). The most common topics among the articles were vagus nerve stimulation (n = 24), spinal cord stimulation (n = 9), and motor cortex stimulation (n = 6). Median journal impact factor was 5.57. Most of these articles (n = 19) contained level I, II, or III evidence. CONCLUSIONS:This analysis provides a brief look into the most cited articles within the field, many of which evaluated innovated procedures and therapies that helped to drive surgical neuromodulation forward. These landmark articles contain vital clinical and educational information that remains relevant to clinicians and students within the field and provide insight into areas of expanding research. Journal impact factor may play a significant role in determining the literary relevance and general awareness of invasive neuromodulation studies.
PMID: 29548962
ISSN: 1878-8769
CID: 4611412
Neuromodulation Therapies for Alcohol Addiction: A Literature Review
Azevedo, Celeste A; Mammis, Antonios
OBJECTIVES/OBJECTIVE:receptor agonist baclofen. METHODS:A comprehensive literature search was conducted through EBSCOhost regarding the neurological therapies in the treatment of alcoholism discussed in this paper. RESULTS:To date, few studies have been conducted on the subject, sample sizes are consistently small, and long-term abstinence appears a common problem. tDCS has shown to temporarily reduce alcohol cravings but with a high number of long-term relapses, 50-70%. DBS and TMS, similarly, fail to overcome high relapse rates. In one DBS study, for example, only two of five patients achieved prolonged abstinence. ECT seems to avoid such problems, but only a single case study exists to date. As such, no solid conclusions can be made regarding its success in alcohol addiction treatment. Baclofen, however, implicated in studies with comparatively larger patient samples and higher efficacy rates, presents with great promise, particularly in patients with more severe forms of AUD. In one of the largest observational studies to date (100 subjects) 92% of patients reported craving suppression and long-term relapse rates were low. The side-effects of oral baclofen (i.e., somnolence, insomnia, dizziness, paresthesia, etc.) though, pose a principle limitation to its administration in alcohol addiction. CONCLUSIONS:Based on current information in the literature, the authors advocate that, following more extensive research on oral baclofen and its indications in the treatment of alcohol addiction, intrathecal administration be the next logical therapeutic option to be explored. In particular, those patients with severe AUD, requiring high doses of the medication, may benefit, as it eliminates the systemic side effects associated with oral baclofen.
PMID: 28055126
ISSN: 1525-1403
CID: 4611322
Infection Incidence Associated with External Ventriculostomy Placement: AÂ Comparison of Outcomes in the Emergency Department, Intensive Care Unit, and Operating Room
Kohli, Gurkirat; Singh, Roshansa; Herschman, Yehuda; Mammis, Antonios
BACKGROUND:External ventricular drain (EVD) placement is a common neurosurgical procedure used to control acute hydrocephalus and other neurosurgical complications. The infection and complication rates reported in the literature are highly variable, and iatrogenic factors determine the outcome of drain placement. We examined the impact of the setting of EVD placement (emergency department [ED] vs. intensive care unit [ICU] vs. operating room [OR]) and the experience of the operating surgeon on the infection rate, complication rate, EVD replacement, eventual placement of a ventriculoperitoneal shunt, and the need for further surgical intervention. METHODS:This was a retrospective, single-center study conducted at University Hospital in Newark, New Jersey. RESULTS:A total of 190 EVDs were placed in 163 patients. The infection rate was 6.13%, and the complication rate was 12.3%. Six out of the 10 patients with infection had the EVD placed in the ICU, but this was not significant (PÂ = 0.1172). Patients with a Glasgow Outcome Scale score of 1 or 2 (dead or vegetative) after the procedure were significantly more likely to have an EVD placed in the ED or ICU (PÂ = 0.0173). Although junior residents placed a greater number of drains than senior residents, the infection and complication rates were not significantly different between the 2 groups (PÂ = 0.1142 and 0.8502, respectively). EVD infection also was not significantly correlated with patient sex, age, initial diagnosis, drain replacement, or duration of drain placement. The most common organisms cultured were coagulase-negative Staphylococcus spp. and Staphylococcus aureus. CONCLUSIONS:This study did not identify any significantly greater risk of infection or complications with EVDs placed in the OR or at the bedside, or with EVDs placed by less-experienced surgeons.
PMID: 29097331
ISSN: 1878-8769
CID: 4611372
Thoracic Radiculopathy following Spinal Cord Stimulator Implantation Treated with Corticosteroids [Case Report]
Ghosh, Ritam; Holland, Ryan; Mammis, Antonios
INTRODUCTION/BACKGROUND:Spinal cord stimulation has been used since 1967 to manage chronic neuropathic pain. Although effective, the literature describes the complication rate to be as high as 35%. One rare complication following spinal cord stimulator (SCS) implantation is the development of radicular pain. We present a case series of 2 patients implanted with SCSs who developed thoracic radiculopathy following implantation that resolved with corticosteroids. CASE DETAILS/METHODS:Although this complication was previously thought to require surgical intervention, this case series describes the use of corticosteroids to resolve postimplantation thoracic radiculopathy. Two patients were studied in this case series who received permanent thoracic implantation of a paddle lead SCS. Several days later, both developed back pain radiating toward the umbilicus in a dermatomal pattern consistent with thoracic radiculopathy. Corticosteroids were administered to relieve this pain. One received 6 mg dexamethasone intravenously every 6 hours followed by an oral dexamethasone taper for 1 week. The other was treated with an oral methylprednisolone taper for 2 weeks. RESULTS:Upon follow-up, both patients no longer complained of the thoracic radiculopathy and were satisfied with the pain relief the stimulators provided. CONCLUSION/CONCLUSIONS:In conclusion, postsurgical radicular pain is a rare but troubling complication of SCS implantation. In order to avoid further surgical complications or the need to explant a device that provides satisfactory paresthesia coverage, pharmacologic management is desirable. This case series has demonstrated that the use of corticosteroids can effectively resolve postimplantation thoracic radicular pain in a specific subgroup of patients.
PMID: 28153621
ISSN: 1878-8769
CID: 4611332
Potential for Intrathecal Baclofen in Treatment of Essential Tremor
Hamad, Mousa; Holland, Ryan; Kamal, Naveed; Luceri, Robert; Mammis, Antonios
INTRODUCTION/BACKGROUND:Essential tremor (ET) is the most common movement disorder of adults, affecting an estimated 7 million Americans. Symptoms of ET range from slightly noticeable to debilitating, with 1 cohort study finding 15% of patients were forced into early retirement. Additionally, depression has also been correlated with the severity of disability of ET. Treatment options include propranolol and primidone. Current treatment options are not very effective, with more than half (56.3%) of patients discontinuing medications because of no changes in symptoms. METHODS:Unfortunately, there is a relative void and controversy in the literature explaining ET pathophysiology; however, the gamma-aminobutyric acid (GABA) hypothesis is the strongest. We conducted a PubMed search on 30 September 2015 with no time constraints using the search terms "essential tremor" and "baclofen," which resulted in a total of 5 articles. RESULTS:Neurohistopathologic studies have demonstrated decreased GABA-A and GABA-B receptors in the cerebellar cortex of ET patients. GABA, the major inhibitory neurotransmitter in the central nervous system, is proposed to have an inhibitory effect on pacemaker output activity of the cerebello-thalamo-cortical pathway, with lower receptors resulting in decreased inhibition of baseline tremors. Tariq et al showed delayed onset and intensity of tremor with oral administration of R-baclofen in a mouse model of ET. CONCLUSION/CONCLUSIONS:With a better side-effect profile and success in a physiologically related condition, we propose more clinical trials and research be carried out on intrathecal baclofen as a potential treatment option, especially drug refractory ET, so as to increase the quality of life of this patient population.
PMID: 28559069
ISSN: 1878-8769
CID: 4611352
Deep Brain Stimulation for the Treatment of Dejerine-Roussy Syndrome
Ward, Max; Mammis, Antonios
BACKGROUND/AIMS:Patients who suffer from Dejerine-Roussy syndrome commonly experience severe poststroke hemibody pain which has historically been attributed to thalamic lesions. Despite pharmacological treatment, a significant proportion of the population is resistant to traditional therapy. Deep brain stimulation is often appropriate for the treatment of resistant populations. In this review we aim to summarize the targets that are used to treat Dejerine-Roussy syndrome and provide insight into their clinical efficacy. METHODS:In reviewing the literature, we defined stimulation success as achievement of a minimum of 50% pain relief. RESULTS:Contemporary targets for deep brain stimulation are the ventral posterior medial/ventral posterior lateral thalamic nuclei, periaqueductal/periventricular gray matter, the ventral striatum/anterior limb of the internal capsule, left centromedian thalamic nuclei, the nucleus ventrocaudalis parvocellularis internis, and the posterior limb of the internal capsule. CONCLUSIONS:Due to technological advancements in deep brain stimulation, its therapeutic effects must be reevaluated. Despite a lack of controlled evidence, deep brain stimulation has been effectively used as a therapeutic in clinical pain management. Further clinical investigation is needed to definitively evaluate the therapeutic efficacy of deep brain stimulation in treating the drug-resistant patient population.
PMID: 28848107
ISSN: 1423-0372
CID: 4611362
Biomarkers for Chronic Neuropathic Pain and their Potential Application in Spinal Cord Stimulation: A Review
Nwagwu, Chibueze D; Sarris, Christina; Tao, Yuan-Xiang; Mammis, Antonios
This review was focused on understanding which substances inside the human body increase and decrease with increasing neuropathic pain. We reviewed various studies, and saw correlations between neuropathic pain and components of the immune system (this system defends the body against diseases and infections). Our findings will especially be useful for understanding ways to reduce or eliminate the discomfort, chronic neuropathic pain brings with it. Spinal cord stimulation (SCS) procedure is one of the few fairly efficient remedial treatments for pain. A follow-up study will apply our findings from this review to SCS, in order to understand the mechanism, and further optimize efficaciousness.
PMCID:5415348
PMID: 28480314
ISSN: 2330-4871
CID: 4611342