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1.
World Neurosurg ; 183: 227-238.e5, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38181878

RESUMEN

OBJECTIVE: Spasticity is a form of muscle hypertonia secondary to various diseases, including traumatic brain injury, spinal cord injury, cerebral palsy, and multiple sclerosis. Medical treatments are available; however, these often result in insufficient clinical response. This review evaluates the role of epidural spinal cord stimulation (SCS) in the treatment of spasticity and associated functional outcomes. METHODS: A systematic review of the literature was performed using the Embase, CENTRAL, and MEDLINE databases. We included studies that used epidural SCS to treat spasticity. Studies investigating functional electric stimulation, transcutaneous SCS, and animal models of spasticity were excluded. We also excluded studies that used SCS to treat other symptoms such as pain. RESULTS: Thirty-four studies were included in the final analysis. The pooled rate of subjective improvement in spasticity was 78% (95% confidence interval, 64%-91%; I2 = 77%), 40% (95% confidence interval, 7%-73%; I2 = 88%) for increased H-reflex threshold or decreased Hoffman reflex/muscle response wave ratio, and 73% (65%-80%; I2 = 50%) for improved ambulation. Patients with spinal causes had better outcomes compared with patients with cerebral causes. Up to 10% of patients experienced complications including infections and hardware malfunction. CONCLUSIONS: Our review of the literature suggests that SCS may be a safe and useful tool for the management of spasticity; however, there is significant heterogeneity among studies. The quality of studies is also low. Further studies are needed to fully evaluate the usefulness of this technology, including various stimulation paradigms across different causes of spasticity.


Asunto(s)
Espasticidad Muscular , Estimulación de la Médula Espinal , Humanos , Espasticidad Muscular/terapia , Espasticidad Muscular/etiología , Estimulación de la Médula Espinal/métodos , Espacio Epidural , Resultado del Tratamiento
2.
Ann Indian Acad Neurol ; 26(4): 507-512, 2023.
Artículo en Inglés | MEDLINE | ID: mdl-37970246

RESUMEN

Background: Deep brain stimulation (DBS) is an efficient modality for the treatment of movement disorders. Differing from the constant voltage (CV)-DBS devices, constant current (CC)-DBS devices may allow more precise stimulation of the target brain regions since they are less influenced by impedance. If internal pulse generators (IPGs) of DBS devices are required to be connected with electrodes of different brands, employing proper adapters is necessary. Such connected DBS devices are called mixed or hybrid devices. Objectives: As there is sparse information about the clinical mixed devices, we studied their safety and efficacy. Materials and Methods: Clinical scores of 13 patients implanted with mixed DBS devices were determined with the Unified Parkinson's Disease Rating Scale (UPDRS) in Parkinson's disease (PD) (n = 10) and with the Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) in dystonia (n = 3). Patient satisfaction was assessed with the Timmerman questionnaire. The Clinical Global Impression Improvement (CGI-I) Scale was also evaluated. Results: Patients' overall satisfaction was considerably higher with mixed devices. The UPDRS and BFMDRS clinical scores did not significantly differ after switching to a mixed DBS device. Three patients before the DBS switch suffered from side effects under the CV mode. These patients got rid of the side effects in their follow-up with a reduction in pulse width values. Discussion: Mixed devices working in CC mode are well tolerated with high patient satisfaction. Conclusion: Besides patient satisfaction, mixed IPGs are also considered safe.

3.
Radiol Case Rep ; 17(10): 3806-3809, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-35965939

RESUMEN

A 72-year-old male with severe dilated cardiomyopathy, benefited of implantable cardiac defibrillator implementation. Device control shows high impedance. On X-ray, electrodes were completely twisted in the generator pocket, they were replaced and the generator was fixed to pectoralis-major fascia. Nurses report patient abnormal movements, scratching implantation area. This was identified as probably the trigger of the complication.

4.
J Neurosurg ; : 1-13, 2019 Oct 11.
Artículo en Inglés | MEDLINE | ID: mdl-31604331

RESUMEN

OBJECTIVE: Lead placement for deep brain stimulation (DBS) using intraoperative MRI (iMRI) relies solely on real-time intraoperative neuroimaging to guide electrode placement, without microelectrode recording (MER) or electrical stimulation. There is limited information, however, on outcomes after iMRI-guided DBS for dystonia. The authors evaluated clinical outcomes and targeting accuracy in patients with dystonia who underwent lead placement using an iMRI targeting platform. METHODS: Patients with dystonia undergoing iMRI-guided lead placement in the globus pallidus pars internus (GPi) were identified. Patients with a prior ablative or MER-guided procedure were excluded from clinical outcomes analysis. Burke-Fahn-Marsden Dystonia Rating Scale (BFMDRS) scores and Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores were assessed preoperatively and at 6 and 12 months postoperatively. Other measures analyzed include lead accuracy, complications/adverse events, and stimulation parameters. RESULTS: A total of 60 leads were implanted in 30 patients. Stereotactic lead accuracy in the axial plane was 0.93 ± 0.12 mm from the intended target. Nineteen patients (idiopathic focal, n = 7; idiopathic segmental, n = 5; DYT1, n = 1; tardive, n = 2; other secondary, n = 4) were included in clinical outcomes analysis. The mean improvement in BFMDRS score was 51.9% ± 9.7% at 6 months and 63.4% ± 8.0% at 1 year. TWSTRS scores in patients with predominant cervical dystonia (n = 13) improved by 53.3% ± 10.5% at 6 months and 67.6% ± 9.0% at 1 year. Serious complications occurred in 6 patients (20%), involving 8 of 60 implanted leads (13.3%). The rate of serious complications across all patients undergoing iMRI-guided DBS at the authors' institution was further reviewed, including an additional 53 patients undergoing GPi-DBS for Parkinson disease. In this expanded cohort, serious complications occurred in 11 patients (13.3%) involving 15 leads (10.1%). CONCLUSIONS: Intraoperative MRI-guided lead placement in patients with dystonia showed improvement in clinical outcomes comparable to previously reported results using awake MER-guided lead placement. The accuracy of lead placement was high, and the procedure was well tolerated in the majority of patients. However, a number of patients experienced serious adverse events that were attributable to the introduction of a novel technique into a busy neurosurgical practice, and which led to the revision of protocols, product inserts, and on-site training.

5.
J Neurosurg ; : 1-10, 2019 Sep 24.
Artículo en Inglés | MEDLINE | ID: mdl-31553940

RESUMEN

OBJECTIVE: The objective of this open-label, nonrandomized trial was to evaluate the efficacy and safety of bilateral caudate nucleus deep brain stimulation (DBS) for treatment-resistant tinnitus. METHODS: Six participants underwent DBS electrode implantation. One participant was removed from the study for suicidality unrelated to brain stimulation. Participants underwent a stimulation optimization period that ranged from 5 to 13 months, during which the most promising stimulation parameters for tinnitus reduction for each individual were determined. These individual optimal stimulation parameters were then used during 24 weeks of continuous caudate stimulation to reach the endpoint. The primary outcome for efficacy was the Tinnitus Functional Index (TFI), and executive function (EF) safety was a composite z-score from multiple neuropsychological tests (EF score). The secondary outcome for efficacy was the Tinnitus Handicap Inventory (THI); for neuropsychiatric safety it was the Frontal Systems Behavior Scale (FrSBe), and for hearing safety it was pure tone audiometry at 0.5, 1, 2, 3, 4, and 6 kHz and word recognition score (WRS). Other monitored outcomes included surgery- and device-related adverse events (AEs). Five participants provided full analyzable data sets. Primary and secondary outcomes were based on differences in measurements between baseline and endpoint. RESULTS: The treatment effect size of caudate DBS for tinnitus was assessed by TFI [mean (SE), 23.3 (12.4)] and THI [30.8 (10.4)] scores, both of which were statistically significant (Wilcoxon signed-rank test, 1-tailed; alpha = 0.05). Based on clinically significant treatment response categorical analysis, there were 3 responders determined by TFI (≥ 13-point decrease) and 4 by THI (≥ 20-point decrease) scores. Safety outcomes according to EF score, FrSBe, audiometric thresholds, and WRS showed no significant change with continuous caudate stimulation. Surgery-related and device-related AEs were expected, transient, and reversible. There was only one serious AE, a suicide attempt unrelated to caudate neuromodulation in a participant in whom stimulation was in the off mode for 2 months prior to the event. CONCLUSIONS: Bilateral caudate nucleus neuromodulation by DBS for severe, refractory tinnitus in this phase I trial showed very encouraging results. Primary and secondary outcomes revealed a highly variable treatment effect size and 60%-80% treatment response rate for clinically significant benefit, and no safety concerns. The design of a phase II trial may benefit from targeting refinement for final DBS lead placement to decrease the duration of the stimulation optimization period and to increase treatment effect size uniformity.Clinical trial registration no.: NCT01988688 (clinicaltrials.gov).

6.
J Neurosurg ; : 1-9, 2019 Aug 16.
Artículo en Inglés | MEDLINE | ID: mdl-31419794

RESUMEN

OBJECTIVE: Rechargeable neurostimulators for deep brain stimulation have been available since 2008, promising longer battery life and fewer replacement surgeries compared to non-rechargeable systems. Long-term data on how recharging affects movement disorder patients are sparse. This is the first multicenter, patient-focused, industry-independent study on rechargeable neurostimulators. METHODS: Four neurosurgical centers sent a questionnaire to all adult movement disorder patients with a rechargeable neurostimulator implanted at the time of the trial. The primary endpoint was the convenience of the recharging process rated on an ordinal scale from "very hard" (1) to "very easy" (5). Secondary endpoints were charge burden (time spent per week on recharging), user confidence, and complication rates. Endpoints were compared for several subgroups. RESULTS: Datasets of 195 movement disorder patients (66.1% of sent questionnaires) with Parkinson's disease (PD), tremor, or dystonia were returned and included in the analysis. Patients had a mean age of 61.3 years and the device was implanted for a mean of 40.3 months. The overall convenience of recharging was rated as "easy" (4). The mean charge burden was 122 min/wk and showed a positive correlation with duration of therapy; 93.8% of users felt confident recharging the device. The rate of surgical revisions was 4.1%, and the infection rate was 2.1%. Failed recharges occurred in 8.7% of patients, and 3.6% of patients experienced an interruption of therapy because of a failed recharge. Convenience ratings by PD patients were significantly worse than ratings by dystonia patients. Caregivers recharged the device for the patient in 12.3% of cases. Patients who switched from a non-rechargeable to a rechargeable neurostimulator found recharging to be significantly less convenient at a higher charge burden than did patients whose primary implant was rechargeable. Age did not have a significant impact on any endpoint. CONCLUSIONS: Overall, patients with movement disorders rated recharging as easy, with low complication rates and acceptable charge burden.

8.
Neuroimage Clin ; 20: 580-593, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-30186762

RESUMEN

Background: Deep brain stimulation (DBS) of the superolateral branch of the medial forebrain bundle (slMFB) emerges as a - yet experimental - treatment for major depressive disorder (MDD) and other treatment refractory psychiatric diseases. First experiences have been reported from two open label pilot trials in major depression (MDD) and long-term effectiveness for MDD (50 months) has been reported. Objective: To give a detailed description of the surgical technique for DBS of the superolateral branch of the medial forebrain bundle (slMFB) in MDD. Methods: Surgical experience from bilateral implantation procedures in n = 24 patients with MDD is reported. The detailed procedure of tractography-assisted targeting together with detailed electrophysiology in 144 trajectories in the target region (recording and stimulation) is described. Achieved electrode positions were evaluated based on postoperative helical CT and fused to preoperative high resolution anatomical magnetic resonance imaging (MRI; Philips Medical Systems, Best, Netherlands), including the pre-operative diffusion tensor imaging (DTI) tractographic information (StealthViz DTI, Medtronic, USA; Framelink 5.0, Medtronic, USA). Midcommissural point (MCP) coordinates of effective contact (EC) location, together with angles of entry into the target region were evaluated. To investigate incidental stimulation of surrounding nuclei (subthalamic nucleus, STN; substantia nigra, SNr; and red nucleus, RN) as a possible mechanism, a therapeutic triangle (TT) was defined, located between these structures (based on MRI criteria in T2) and evaluated with respect to EC locations. Results: Bilateral slMFB DBS was performed in all patients. We identified an electrophysiological environment (defined by autonomic reaction, passive microelectrode recording, acute effects and oculomotor effects) that helps to identify the proper target site on the operation table. Postoperative MCP-evaluation of effective contacts (EC) shows a significant variability with respect to localization. Evaluation of the TT shows that responders will typically have their active contacts inside the triangle and that surrounding nuclei (STN, SNr, RN) are not directly hit by EC, indicating a predominant white matter stimulation. The individual EC position within the triangle cannot be predicted and is based on individual slMFB (tractography) geometry. There was one intracranial bleeding (FORESEE I study) during a first implantation attempt in a patient who later received full bilateral implantation. Typical oculomotor side effects are idiosyncratic for the target region and at inferior contacts. Conclusion: The detailed surgical procedure of slMFB DBS implantation has not been described before. The slMFB emerges as an interesting region for the treatment of major depression (and other psychiatric diseases) with DBS. So far it has only been successfully researched in open label clinical case series and in 15 patients published. Stimulation probably achieves its effect through direct white-matter modulation of slMFB fibers. The surgical implantation comprises a standardized protocol combining tractographic imaging based on DTI, targeting and electrophysiological evaluation of the target region. To this end, slMFB DBS surgery is in technical aspects comparable to typical movement disorder surgery. In our view, slMFB DBS should only be performed under tractographic assistance.


Asunto(s)
Estimulación Encefálica Profunda/métodos , Trastorno Depresivo Mayor/diagnóstico por imagen , Trastorno Depresivo Mayor/cirugía , Imagen de Difusión Tensora/métodos , Haz Prosencefálico Medial/diagnóstico por imagen , Haz Prosencefálico Medial/cirugía , Adulto , Anciano , Estudios de Cohortes , Femenino , Humanos , Monitorización Neurofisiológica Intraoperatoria/métodos , Masculino , Microelectrodos , Persona de Mediana Edad
9.
Stereotact Funct Neurosurg ; 96(3): 151-156, 2018.
Artículo en Inglés | MEDLINE | ID: mdl-29920479

RESUMEN

OBJECTIVES: Deep brain stimulation for Parkinson's disease (PD) utilises an implantable pulse generator (IPG) whose finite lifespan in non-rechargeable systems necessitates their periodic replacement. We wish to determine if there is any significant difference in longevity of 2 commonly used IPG systems; the Medtronic Kinetra, and the Medtronic Activa Primary Cell (PC), which has come to replace it. METHODS: All patients with bilateral Subthalamic Nucleus stimulators for PD performed in our centre were included. Battery life was then assessed using a Kaplan-Meier approach and comparisons between the Kinetra and Activa PC batteries were performed using log-rank tests. RESULTS: Complete data was available for 183 patients. There was a significant difference in the average battery duration with an estimated median battery life in the Kinetra cohort of 6.6 years (95% CI 6.4-6.7), compared to 4.5 years (95% CI 4.4-4.5) in the Activa PC cohort (p < 0.001). CONCLUSION: The Activa PC IPG demonstrates a significantly reduced battery life of 2.1 years, with a median battery life of 4.5 years in comparison to 6.6 years in the Kinetra IPG. Future technology developments should therefore be focused on improving the battery life of the newer IPG systems.


Asunto(s)
Estimulación Encefálica Profunda/instrumentación , Suministros de Energía Eléctrica , Electrodos Implantados , Enfermedad de Parkinson/terapia , Núcleo Subtalámico/fisiología , Anciano , Femenino , Humanos , Longevidad , Masculino , Persona de Mediana Edad
10.
Acta Neurochir (Wien) ; 160(4): 831-833, 2018 04.
Artículo en Inglés | MEDLINE | ID: mdl-29468441

RESUMEN

To report on a less-invasive technique for replacing a broken lead in a spinal cord stimulation (SCS) device that makes use of St. Jude Medical's "Epiducer" device. A 53-year-old woman suffered a loss of stimulation on her internal pulse generator (IPG), which was found to have a broken lead. The broken lead was withdrawn using the Epiducer device with minimal invasiveness and without pain. A new lead was put in place, and successful stimulation using the IPG resumed. Follow-up 3 weeks later showed a well-functioning SCS system. An Epiducer can be used to revise the SCS system in a minimal invasive way without a new puncture. Follow-up study of this technique as well as others for revising an SCS system should be encouraged and used in comparison study.


Asunto(s)
Electrodos Implantados/efectos adversos , Falla de Equipo , Procedimientos Quirúrgicos Mínimamente Invasivos/métodos , Reoperación , Estimulación de la Médula Espinal/efectos adversos , Femenino , Humanos , Persona de Mediana Edad , Estimulación de la Médula Espinal/instrumentación , Estimulación de la Médula Espinal/métodos
11.
Oper Neurosurg (Hagerstown) ; 13(4): 529-534, 2017 08 01.
Artículo en Inglés | MEDLINE | ID: mdl-28838110

RESUMEN

BACKGROUND: Deep brain stimulation is increasingly used to treat a variety of disorders. As the prevalence of this technology increases, greater demands are placed on neurosurgical practitioners to improve cosmetic results, maximize patient comfort, and minimize complication rates. We have increasingly employed subpectoral implantation of internal pulse generators (IPGs) to improve patient satisfaction. OBJECTIVE: To determine the complication rates of subpectorally placed IPGs as compared to those placed in a subcutaneous location. METHODS: We reviewed a series of 301 patients from a single institution. Complication rates including infection, hematoma, and lead fracture were recorded. Rates were compared for subcutaneously and subpectorally located devices. RESULTS: Of the records reviewed, we found 301 patients who underwent 308 procedures for initial IPG implantation. Of these, 275 were subpectoral IPG implantation, 19 were infraclavicular subcutaneous implantation, and 14 were subcutaneous implantation in the abdomen. A total of 6 IPG pocket infections occurred, 2 subpectoral and 4 infraclavicular subcutaneous. Of the IPG infections, 2 of the infraclavicular subcutaneous devices had associated erosions. Two patients had their devices relocated from a subpectoral pocket to a subcutaneous pocket in the abdomen due to discomfort. Two patients in the subpectoral group suffered from hematoma requiring evacuation. Two patients in the infraclavicular subcutaneous group had lead fracture occur. CONCLUSIONS: Subpectoral implantation of deep brain stimulation IPGs is a viable alternative with a low complication rate. This technique may offer a lower rate of infection and wound erosion.


Asunto(s)
Estimulación Encefálica Profunda/métodos , Suministros de Energía Eléctrica , Temblor Esencial/terapia , Enfermedad de Parkinson/terapia , Músculos Pectorales/cirugía , Anciano , Cosméticos , Electrodos Implantados , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Estudios Retrospectivos , Resultado del Tratamiento
12.
Neuromodulation ; 20(5): 444-449, 2017 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-28466562

RESUMEN

INTRODUCTION: Deep brain stimulation (DBS) is a well-recognized treatment for patients with movement disorders and other neurological diseases. The implantable pulse generator (IPG) is a fundamental component of the DBS system. Although IPG implantation and replacement surgeries are comparatively minor procedures relative to the brain lead insertion, patients often require multiple IPG replacements during their lifetime with each operation carrying a small but possibly cumulative risk of complications. To better educate our patients and improve surgical outcomes, we reviewed our series of patients at our institution. METHODS: Using electronic health record data, we retrospectively reviewed all initial and subsequent IPG surgeries from patients who underwent at least one IPG surgery between the years of 2010 and 2015 at the Cleveland Clinic main campus. We calculated infection rates for initial IPG implantation surgeries and the infection rate for subsequent replacements. Fisher's exact tests were used to evaluate the chance of an infection between the initial implantation and replacement. Fisher's exact tests and simple logistic regression analyses were used to determine the predictive ability of selected demographic and clinical variables RESULTS: Our final sample included 697 patients and 1537 surgeries. For all patients, the infection rate at the first surgery was 2.01%; at the second surgery, it was 0.44%; and at the third surgery, it was 1.83%. When considering only patients that underwent at least three replacement surgeries (n = 114) the infection rate did not change in a significant manner with subsequent interventions compared to the first replacement. No other variable of interest was a significant predictor of infection. CONCLUSION: We did not find increasing rates of infection with subsequent IPG replacement procedures.


Asunto(s)
Estimulación Encefálica Profunda/instrumentación , Estimulación Encefálica Profunda/tendencias , Electrodos Implantados/tendencias , Reoperación/instrumentación , Reoperación/tendencias , Infección de la Herida Quirúrgica/cirugía , Anciano , Anciano de 80 o más Años , Estimulación Encefálica Profunda/efectos adversos , Electrodos Implantados/efectos adversos , Electrodos Implantados/microbiología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Reoperación/efectos adversos , Estudios Retrospectivos , Infección de la Herida Quirúrgica/diagnóstico , Infección de la Herida Quirúrgica/etiología
13.
J Neurosurg ; 127(4): 892-898, 2017 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-28009238

RESUMEN

OBJECTIVE The aim of this study was to evaluate the safety of 3-T MRI in patients with implanted deep brain stimulation (DBS) systems. METHODS This study was performed in 2 phases. In an initial phantom study, a Lucite phantom filled with tissue-mimicking gel was assembled. The system was equipped with a single DBS electrode connected to an internal pulse generator. The tip of the electrode was coupled to a fiber optic thermometer with a temperature resolution of 0.1°C. Both anatomical (T1- and T2-weighted) and functional MRI sequences were tested. A temperature change within 2°C from baseline was considered safe. After findings from the phantom study suggested safety, 10 patients with implanted DBS systems targeting various brain areas provided informed consent and underwent 3-T MRI using the same imaging sequences. Detailed neurological evaluations and internal pulse generator interrogations were performed before and after imaging. RESULTS During phantom testing, the maximum temperature increase was registered using the T2-weighted sequence. The maximal temperature changes at the tip of the DBS electrode were < 1°C for all sequences tested. In all patients, adequate images were obtained with structural imaging, although a significant artifact from lead connectors interfered with functional imaging quality. No heating, warmth, or adverse neurological effects were observed. CONCLUSIONS To the authors' knowledge, this was the first study to assess the clinical safety of 3-T MRI in patients with a fully implanted DBS system (electrodes, extensions, and pulse generator). It provided preliminary data that will allow further examination and assessment of the safety of 3-T imaging studies in patients with implanted DBS systems. The authors cannot advocate widespread use of this type of imaging in patients with DBS implants until more safety data are obtained.


Asunto(s)
Estimulación Encefálica Profunda/instrumentación , Neuroestimuladores Implantables , Imagen por Resonancia Magnética , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Imagen por Resonancia Magnética/efectos adversos , Masculino , Persona de Mediana Edad , Fantasmas de Imagen , Estudios Prospectivos
14.
J Neurosurg ; 124(5): 1517-23, 2016 May.
Artículo en Inglés | MEDLINE | ID: mdl-26587660

RESUMEN

OBJECT The objective of this study was to compare the cost of deep brain stimulation (DBS) performed awake versus asleep at a single US academic health center and to compare costs across the University HealthSystem Consortium (UHC) Clinical Database. METHODS Inpatient and outpatient demographic and hospital financial data for patients receiving a neurostimulator lead implant (from the first quarter of 2009 to the second quarter of 2014) were collected and analyzed. Inpatient charges included those associated with International Classification of Diseases, Ninth Revision (ICD-9) procedure code 0293 (implantation or replacement of intracranial neurostimulator lead). Outpatient charges included all preoperative charges ≤ 30 days prior to implant and all postoperative charges ≤ 30 days after implant. The cost of care based on reported charges and a cost-to-charge ratio was estimated. The UHC database was queried (January 2011 to March 2014) with the same ICD-9 code. Procedure cost data across like hospitals (27 UHC hospitals) conducting similar DBS procedures were compared. RESULTS Two hundred eleven DBS procedures (53 awake and 158 asleep) were performed at a single US academic health center during the study period. The average patient age ( ± SD) was 65 ± 9 years old and 39% of patients were female. The most common primary diagnosis was Parkinson's disease (61.1%) followed by essential and other forms of tremor (36%). Overall average DBS procedure cost was $39,152 ± $5340. Asleep DBS cost $38,850 ± $4830, which was not significantly different than the awake DBS cost of $40,052 ± $6604. The standard deviation for asleep DBS was significantly lower (p ≤ 0.05). In 2013, the median cost for a neurostimulator implant lead was $34,052 at UHC-affiliated hospitals that performed at least 5 procedures a year. At Oregon Health & Science University, the median cost was $17,150 and the observed single academic health center cost for a neurostimulator lead implant was less than the expected cost (ratio 0.97). CONCLUSIONS In this single academic medical center cost analysis, DBS performed asleep was associated with a lower cost variation relative to the awake procedure. Furthermore, costs compared favorably to UHC-affiliated hospitals. While asleep DBS is not yet standard practice, this center exclusively performs asleep DBS at a lower cost than comparable institutions.


Asunto(s)
Anestesia General/economía , Sedación Consciente/economía , Costos y Análisis de Costo , Estimulación Encefálica Profunda/economía , Enfermedad de Parkinson/economía , Enfermedad de Parkinson/terapia , Centros Médicos Académicos , Anciano , Procedimientos Quirúrgicos Ambulatorios/economía , Femenino , Precios de Hospital , Hospitalización/economía , Humanos , Masculino , Persona de Mediana Edad , Oregon , Evaluación de Procesos y Resultados en Atención de Salud
15.
J Neurosurg ; 125(1): 75-84, 2016 07.
Artículo en Inglés | MEDLINE | ID: mdl-26684775

RESUMEN

OBJECT This report describes the stereotactic technique, hospitalization, and 90-day perioperative safety of bilateral deep brain stimulation (DBS) of the fornix in patients who underwent DBS for the treatment of mild, probable Alzheimer's disease (AD). METHODS The ADvance Trial is a multicenter, 12-month, double-blind, randomized, controlled feasibility study being conducted to evaluate the safety, efficacy, and tolerability of DBS of the fornix in patients with mild, probable AD. Intraoperative and perioperative data were collected prospectively. All patients underwent postoperative MRI. Stereotactic analyses were performed in a blinded fashion by a single surgeon. Adverse events (AEs) were reported to an independent clinical events committee and adjudicated to determine the relationship between the AE and the study procedure. RESULTS Between June 6, 2012, and April 28, 2014, a total of 42 patients with mild, probable AD were treated with bilateral fornix DBS (mean age 68.2 ± 7.8 years; range 48.0-79.7 years; 23 men and 19 women). The mean planned target coordinates were x = 5.2 ± 1.0 mm (range 3.0-7.9 mm), y = 9.6 ± 0.9 mm (range 8.0-11.6 mm), z = -7.5 ± 1.2 mm (range -5.4 to -10.0 mm), and the mean postoperative stereotactic radial error on MRI was 1.5 ± 1.0 mm (range 0.2-4.0 mm). The mean length of hospitalization was 1.4 ± 0.8 days. Twenty-six (61.9%) patients experienced 64 AEs related to the study procedure, of which 7 were serious AEs experienced by 5 patients (11.9%). Four (9.5%) patients required return to surgery: 2 patients for explantation due to infection, 1 patient for lead repositioning, and 1 patient for chronic subdural hematoma. No patients experienced neurological deficits as a result of the study, and no deaths were reported. CONCLUSIONS Accurate targeting of DBS to the fornix without direct injury to it is feasible across surgeons and treatment centers. At 90 days after surgery, bilateral fornix DBS was well tolerated by patients with mild, probable AD. Clinical trial registration no.: NCT01608061 ( clinicaltrials.gov ).


Asunto(s)
Enfermedad de Alzheimer/terapia , Estimulación Encefálica Profunda/métodos , Fórnix , Técnicas Estereotáxicas , Anciano , Estimulación Encefálica Profunda/efectos adversos , Método Doble Ciego , Estudios de Factibilidad , Femenino , Hospitalización , Humanos , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
16.
Expert Rev Med Devices ; 13(3): 233-42, 2016.
Artículo en Inglés | MEDLINE | ID: mdl-26708299

RESUMEN

Recently burst stimulation and 10 kHz stimulation have been developed as novel stimulation designs. Both appear to be superior to classical tonic stimulation in the amount of responders and the amount of pain suppression and have as an extra advantage that they are paresthesia-free. This evolution is very important as it shifts the focus of research from better targeting by developing new lead configurations to better communication with the nervous system. It can be envisioned that this is only the start of a new trend in spinal cord, brain, and peripheral nerve stimulation and that more new stimulation designs will be developed in the near future such as pseudorandom burst stimulation, pleasure stimulation, noise stimulation and reconditioning stimulation. This evolution mandates a new approach in the development of internal pulse generators, and the most obvious approach is to develop an upgradable stimulator, on which new stimulation designs can be downloaded, analogous to the apps people download on their smartphones. This will create a shift from hardware driven products to software driven stimulators.


Asunto(s)
Equipos y Suministros , Estimulación de la Médula Espinal/instrumentación , Ensayos Clínicos como Asunto , Equipos y Suministros/economía , Equipos y Suministros/ética , Humanos , Estimulación de la Médula Espinal/economía
18.
World Neurosurg ; 84(4): 1020-9, 2015 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-26038334

RESUMEN

OBJECTIVE: Deep brain stimulation (DBS) is a cost-effective strategy for the treatment of different neurologic disorders. However, DBS procedures are associated with high costs of implantation and replacement of the internal pulse generator (IPG). Different manufacturers propose the use of rechargeable IPGs. The objective of this study is to compare the implantation costs of nonrechargeable IPGs versus the estimated costs of rechargeable IPGs in different categories of patients to evaluate if an economic advantage for the health care system could be derived. METHODS: The study looked at 149 patients who underwent a surgical procedure for IPG replacement. In a hypothetical scenario, rechargeable IPGs were implanted instead of nonrechargeable IPGs at the time of DBS system implantation. Another scenario was outlined in a perspective period of time, corresponding to the patients' life expectancy. Costs were calculated, and inferential analysis was performed. RESULTS: A savings of €234,194, including the cost of management of complications, was calculated during a follow-up period of 7.9 years. In a comprehensive life expectancy period of 47 years, a savings of €5,918,188 would be obtained (P < 0.05). Long-term group data point out that a relevant savings would be expected from implantation of rechargeable IPGs in dystonic patients (P < 0.05) and patients with Parkinson disease (P < 0.05), and a savings is projected to occur in other categories of patients (P < 0.05). CONCLUSIONS: Implantation of rechargeable IPGs presents clinical advantages compared with nonrechargeable devices. A huge economic savings can be realized with the implantation of rechargeable IPGs in categories of patients implanted with IPGs for DBS.


Asunto(s)
Estimulación Encefálica Profunda/instrumentación , Suministros de Energía Eléctrica/economía , Electrodos Implantados , Adolescente , Adulto , Factores de Edad , Anciano , Anciano de 80 o más Años , Niño , Preescolar , Ahorro de Costo , Análisis Costo-Beneficio , Estimulación Encefálica Profunda/economía , Remoción de Dispositivos/economía , Distonía/economía , Distonía/terapia , Femenino , Estudios de Seguimiento , Costos de la Atención en Salud , Humanos , Masculino , Persona de Mediana Edad , Enfermedad de Parkinson/economía , Enfermedad de Parkinson/cirugía , Adulto Joven
20.
Neuromodulation ; 17(8): 729-30, 2014 Dec.
Artículo en Inglés | MEDLINE | ID: mdl-24528856

RESUMEN

OBJECTIVE: The study aims to describe a novel cosmetic implantation technique of internal pulse generators (IPGs) for deep brain stimulation (DBS) electrodes. MATERIALS AND METHODS: Thirty Parkinson patients during the interval 2001 to 2012 underwent posterior (cervical, dorsal, and lateral subcostal ) subcutaneous implantation of DBS connection cables and IPGs in the prone position. RESULTS: No surgical complications occurred in any of the patients who underwent this procedure; all of the patients reported a high level of satisfaction with the cosmetic results due to the excellent concealment of the implanted devices. CONCLUSIONS: Although this procedure is a little more time consuming compared with the conventional procedure, it is safe and leads to very good cosmetic results in DBS patients, which has significant benefits from the standpoint of social and work activities.


Asunto(s)
Estimulación Encefálica Profunda/métodos , Electrodos Implantados , Enfermedad de Parkinson/terapia , Adolescente , Adulto , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Adulto Joven
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