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1.
N Engl J Med ; 383(6): 526-536, 2020 08 06.
Artigo em Inglês | MEDLINE | ID: mdl-32757521

RESUMO

BACKGROUND: The subcutaneous implantable cardioverter-defibrillator (ICD) was designed to avoid complications related to the transvenous ICD lead by using an entirely extrathoracic placement. Evidence comparing these systems has been based primarily on observational studies. METHODS: We conducted a noninferiority trial in which patients with an indication for an ICD but no indication for pacing were assigned to receive a subcutaneous ICD or transvenous ICD. The primary end point was the composite of device-related complications and inappropriate shocks; the noninferiority margin for the upper boundary of the 95% confidence interval for the hazard ratio (subcutaneous ICD vs. transvenous ICD) was 1.45. A superiority analysis was prespecified if noninferiority was established. Secondary end points included death and appropriate shocks. RESULTS: A total of 849 patients (426 in the subcutaneous ICD group and 423 in the transvenous ICD group) were included in the analyses. At a median follow-up of 49.1 months, a primary end-point event occurred in 68 patients in the subcutaneous ICD group and in 68 patients in the transvenous ICD group (48-month Kaplan-Meier estimated cumulative incidence, 15.1% and 15.7%, respectively; hazard ratio, 0.99; 95% confidence interval [CI], 0.71 to 1.39; P = 0.01 for noninferiority; P = 0.95 for superiority). Device-related complications occurred in 31 patients in the subcutaneous ICD group and in 44 in the transvenous ICD group (hazard ratio, 0.69; 95% CI, 0.44 to 1.09); inappropriate shocks occurred in 41 and 29 patients, respectively (hazard ratio, 1.43; 95% CI, 0.89 to 2.30). Death occurred in 83 patients in the subcutaneous ICD group and in 68 in the transvenous ICD group (hazard ratio, 1.23; 95% CI, 0.89 to 1.70); appropriate shocks occurred in 83 and 57 patients, respectively (hazard ratio, 1.52; 95% CI, 1.08 to 2.12). CONCLUSIONS: In patients with an indication for an ICD but no indication for pacing, the subcutaneous ICD was noninferior to the transvenous ICD with respect to device-related complications and inappropriate shocks. (Funded by Boston Scientific; PRAETORIAN ClinicalTrials.gov number, NCT01296022.).


Assuntos
Arritmias Cardíacas/terapia , Desfibriladores Implantáveis/efeitos adversos , Idoso , Cardiomiopatias/terapia , Morte Súbita Cardíaca/epidemiologia , Morte Súbita Cardíaca/prevenção & controle , Eletrodos Implantados/efeitos adversos , Falha de Equipamento , Feminino , Seguimentos , Cardiopatias/terapia , Humanos , Incidência , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Desenho de Prótese
2.
J Laryngol Otol ; 134(6): 493-496, 2020 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-32618542

RESUMO

OBJECTIVE: Safe cochlear implantation is challenging in patients with canal wall down mastoid cavities, and the presence of large meatoplasties increases the risk of external canal overclosure. This paper describes our results of obliteration of the mastoid cavity with conchal cartilage as an alternative procedure in cases of canal wall down mastoidectomy with very large meatoplasty. METHODS: The cases of seven patients with a canal wall down mastoidectomy cavity who underwent cochlear implantation were retrospectively reviewed. Post-operative complications were analysed. The mean follow-up duration was 4.5 years. RESULTS: There was no hint of cholesteatoma recurrence and all patients have been free of symptoms during follow up. Only one patient showed cable extrusion six months after surgery, and implantation of the contralateral ear was needed. CONCLUSION: Pseudo-obliteration of the mastoid cavity with a cartilage multi-layered palisade reconstruction covering the electrode may be a safe alternative in selected patients with a large meatoplasty.


Assuntos
Cartilagem/transplante , Meato Acústico Externo/cirurgia , Processo Mastoide/cirurgia , Mastoidectomia/efeitos adversos , Adulto , Idoso , Colesteatoma da Orelha Média/epidemiologia , Doença Crônica , Implante Coclear/métodos , Eletrodos Implantados/efeitos adversos , Feminino , Seguimentos , Humanos , Masculino , Processo Mastoide/patologia , Pessoa de Meia-Idade , Otite Média/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Procedimentos Cirúrgicos Reconstrutivos/métodos , Recidiva , Estudos Retrospectivos
3.
J Neuroeng Rehabil ; 17(1): 95, 2020 07 14.
Artigo em Inglês | MEDLINE | ID: mdl-32664972

RESUMO

BACKGROUND: Peripheral nerve stimulation with implanted nerve cuff electrodes can restore standing, stepping and other functions to individuals with spinal cord injury (SCI). We performed the first study to evaluate the clinical electrodiagnostic changes due to electrode implantation acutely, chronic presence on the nerve peri- and post-operatively, and long-term delivery of electrical stimulation. METHODS: A man with bilateral lower extremity paralysis secondary to cervical SCI sustained 5 years prior to enrollment received an implanted standing neuroprosthesis including composite flat interface nerve electrodes (C-FINEs) electrodes implanted around the proximal femoral nerves near the inguinal ligaments. Electromyography quantified neurophysiology preoperatively, intraoperatively, and through 1 year postoperatively. Stimulation charge thresholds, evoked knee extension moments, and weight distribution during standing quantified neuroprosthesis function over the same interval. RESULTS: Femoral compound motor unit action potentials increased 31% in amplitude and 34% in area while evoked knee extension moments increased significantly (p < 0.01) by 79% over 1 year of rehabilitation with standing and quadriceps exercises. Charge thresholds were low and stable, averaging 19.7 nC ± 6.2 (SEM). Changes in saphenous nerve action potentials and needle electromyography suggested minor nerve irritation perioperatively. CONCLUSIONS: This is the first human trial reporting acute and chronic neurophysiologic changes due to application of and stimulation through nerve cuff electrodes. Electrodiagnostics indicated preserved nerve health with strengthened responses following stimulated exercise. Temporary electrodiagnostic changes suggest minor nerve irritation only intra- and peri-operatively, not continuing chronically nor impacting function. These outcomes follow implantation of a neuroprosthesis enabling standing and demonstrate the ability to safely implant electrodes on the proximal femoral nerve close to the inguinal ligament. We demonstrate the electrodiagnostic findings that can be expected from implanting nerve cuff electrodes and their time-course for resolution, potentially applicable to prostheses modulating other peripheral nerves and functions. TRIAL REGISTRATION: ClinicalTrials.gov NCT01923662 , retrospectively registered August 15, 2013.


Assuntos
Terapia por Estimulação Elétrica/métodos , Eletrodos Implantados/efeitos adversos , Nervo Femoral/fisiologia , Próteses Neurais/efeitos adversos , Potenciais de Ação , Adulto , Fenômenos Biomecânicos , Terapia por Estimulação Elétrica/efeitos adversos , Eletrodiagnóstico , Eletromiografia , Humanos , Joelho , Masculino , Força Muscular , Paralisia/reabilitação , Paraplegia/reabilitação , Complicações Pós-Operatórias/epidemiologia , Traumatismos da Medula Espinal/reabilitação
4.
Neurosurgery ; 87(1): E23-E30, 2020 07 01.
Artigo em Inglês | MEDLINE | ID: mdl-32357217

RESUMO

BACKGROUND: Both stereoelectroencephalography (SEEG) and subdural strip electrodes (SSE) are used for intracranial electroencephalographic recordings in the invasive investigation of patients with drug-resistant epilepsy. OBJECTIVE: To compare SEEG and SSE with respect to feasibility, complications, and outcome in this single-center study. METHODS: Patient characteristics, periprocedural parameters, complications, and outcome were acquired from a pro- and retrospectively managed databank to compare SEEG and SSE cases. RESULTS: A total of 500 intracranial electroencephalographic monitoring cases in 450 patients were analyzed (145 SEEG and 355 SSE). Both groups were of similar age, gender distribution, and duration of epilepsy. Implantation of each SEEG electrode took 13.9 ± 7.6 min (20 ± 12 min for each SSE; P < .01). Radiation exposure to the patient was 4.3 ± 7.7 s to a dose area product of 14.6 ± 27.9 rad*cm2 for SEEG and 9.4 ± 8.9 s with 21 ± 22.4 rad*cm2 for SSE (P < .01). There was no difference in the length of stay (12.2 ± 7.2 and 12 ± 6.3 d). The complication rate was low in both groups. No infections were seen in SEEG cases (2.3% after SSE). The rate of hemorrhage was 2.8% for SEEG and 1.4% for SSE. Surgical outcome was similar. CONCLUSION: SEEG allows targeting deeply situated foci with a non-inferior safety profile to SSE and seizure outcome comparable to SSE.


Assuntos
Epilepsia Resistente a Medicamentos , Eletrocorticografia/instrumentação , Monitorização Neurofisiológica/instrumentação , Técnicas Estereotáxicas , Adulto , Epilepsia Resistente a Medicamentos/cirurgia , Eletrocorticografia/efeitos adversos , Eletrocorticografia/métodos , Eletrodos Implantados/efeitos adversos , Estudos de Viabilidade , Feminino , Humanos , Pessoa de Meia-Idade , Monitorização Neurofisiológica/efeitos adversos , Monitorização Neurofisiológica/métodos , Estudos Retrospectivos
5.
Neurourol Urodyn ; 39(5): 1482-1488, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-32339339

RESUMO

AIMS: Sacral neuromodulation (SNM) is a guideline-recommended treatment for voiding dysfunction including urgency, urge incontinence, and nonobstructive retention as well as fecal incontinence. The Axonics® System is a miniaturized, rechargeable SNM system designed to provide therapy for at least 15 years, which is expected to significantly reduce revision surgeries as it will not require replacement as frequently as the non-rechargeable SNM system. The ARTISAN-SNM study is a pivotal study designed to treat patients with urinary urgency incontinence (UUI). Clinical results at 1-year are presented. METHODS: A total of 129 eligible UUI patients were treated. All participants were implanted with a quadripolar tined lead and neurostimulator in a single procedure. Efficacy data were collected using a 3-day bladder diary, a validated quality of life questionnaire (ICIQ-OABqol), and a participant satisfaction questionnaire. Therapy responders were defined as participants with ≥50% reduction in UUI episodes compared to baseline. Data were analyzed on all 129 participants. RESULTS: At 1 year, 89% of the participants were therapy responders. The average UUI episodes per day reduced from 5.6 ± 0.3 at baseline to 1.4 ± 0.2. Participants experienced an overall clinically meaningful improvement of 34 points on the ICIQ-OABqol questionnaire. All study participants (100%) were able to recharge their device at 1 year, and 96% of participants reported that the frequency and duration of recharging was acceptable. There were no serious device-related adverse events. CONCLUSIONS: The Axonics System is safe and effective at 1 year, with 89% of participants experiencing clinically and statistically significant improvements in UUI symptoms.


Assuntos
Terapia por Estimulação Elétrica/instrumentação , Eletrodos Implantados , Plexo Lombossacral/cirurgia , Incontinência Urinária de Urgência/terapia , Procedimentos Cirúrgicos Urológicos/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Terapia por Estimulação Elétrica/efeitos adversos , Terapia por Estimulação Elétrica/métodos , Eletrodos Implantados/efeitos adversos , Incontinência Fecal/complicações , Incontinência Fecal/epidemiologia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Próteses e Implantes , Qualidade de Vida , Inquéritos e Questionários , Resultado do Tratamento , Incontinência Urinária de Urgência/psicologia , Retenção Urinária/complicações , Retenção Urinária/terapia , Adulto Jovem
6.
J Neurosci ; 40(11): 2371-2380, 2020 03 11.
Artigo em Inglês | MEDLINE | ID: mdl-32047056

RESUMO

Chronic electroencephalography (EEG) is a widely used tool for monitoring cortical electrical activity in experimental animals. Although chronic implants allow for high-quality, long-term recordings in preclinical studies, the electrodes are foreign objects and might therefore be expected to induce a local inflammatory response. We here analyzed the effects of chronic cranial electrode implantation on glymphatic fluid transport and in provoking structural changes in the meninges and cerebral cortex of male and female mice. Immunohistochemical analysis of brain tissue and dura revealed reactive gliosis in the cortex underlying the electrodes and extensive meningeal lymphangiogenesis in the surrounding dura. Meningeal lymphangiogenesis was also evident in mice prepared with the commonly used chronic cranial window. Glymphatic influx of a CSF tracer was significantly enhanced at 30 d postsurgery in both awake and ketamine-xylazine anesthetized mice with electrodes, supporting the concept that glymphatic influx and intracranial lymphatic drainage are interconnected. Altogether, the experimental results provide clear evidence that chronic implantation of EEG electrodes is associated with significant changes in the brain's fluid transport system. Future studies involving EEG recordings and chronic cranial windows must consider the physiological consequences of cranial implants, which include glial scarring, meningeal lymphangiogenesis, and increased glymphatic activity.SIGNIFICANCE STATEMENT This study shows that implantation of extradural electrodes provokes meningeal lymphangiogenesis, enhanced glymphatic influx of CSF, and reactive gliosis. The analysis based on CSF tracer injection in combination with immunohistochemistry showed that chronically implanted electroencephalography electrodes were surrounded by lymphatic sprouts originating from lymphatic vasculature along the dural sinuses and the middle meningeal artery. Likewise, chronic cranial windows provoked lymphatic sprouting. Tracer influx assessed in coronal slices was increased in agreement with previous reports identifying a close association between glymphatic activity and the meningeal lymphatic vasculature. Lymphangiogenesis in the meninges and altered glymphatic fluid transport after electrode implantation have not previously been described and adds new insights to the foreign body response of the CNS.


Assuntos
Dura-Máter/metabolismo , Eletrodos Implantados/efeitos adversos , Reação a Corpo Estranho/etiologia , Gliose/etiologia , Sistema Glinfático/fisiologia , Linfangiogênese , Animais , Astrócitos/fisiologia , Córtex Cerebral/patologia , Líquido Cefalorraquidiano/fisiologia , Dura-Máter/patologia , Eletroencefalografia/instrumentação , Feminino , Reação a Corpo Estranho/metabolismo , Gliose/metabolismo , Gliose/patologia , Masculino , Camundongos , Camundongos Endogâmicos C57BL , Microglia/fisiologia , Técnica de Janela Cutânea , Fases do Sono/fisiologia
7.
Acta Neurochir (Wien) ; 162(5): 1077-1079, 2020 05.
Artigo em Inglês | MEDLINE | ID: mdl-32034494

RESUMO

We report on a patient with thalamic deep brain stimulation (DBS) for essential tremor who was admitted to a stroke unit with transient vertigo, dysarthria, and gait disturbance. Transient ischemic attacks were assumed but fluctuating neurological symptoms persisted until presentation to a DBS center. Here, unstable high monopolar impedances of the right-hemispheric electrode contacts were detected. Surgical revision revealed a fracture of the pocket adaptor connecting this electrode to the impulse generator. Replacement resulted in stable impedances and remitted the transient neurological symptoms. Emergency and stroke doctors should be aware of neurological symptoms induced by technical dysfunctions in DBS.


Assuntos
Estimulação Encefálica Profunda/efeitos adversos , Erros de Diagnóstico , Eletrodos Implantados/efeitos adversos , Falha de Equipamento , Tremor Essencial/terapia , Ataque Isquêmico Transitório/diagnóstico , Idoso , Estimulação Encefálica Profunda/instrumentação , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Tálamo/fisiopatologia
8.
Pain Pract ; 20(5): 544-549, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-31925885

RESUMO

INTRODUCTION: Lead migration has been regarded as a frequent complication after percutaneous spinal cord stimulation (SCS). Thus far, repeated reinsertion of leads or replacement of paddle electrodes after removing percutaneous leads has been performed, but a salvage surgical technique using the remaining electrode has not been reported. Here, we describe a case in which unilateral lead migration was successfully treated with the insertion of a paddle electrode. CASE SUMMARY: A 44-year-old male paraplegic patient with chronic neuropathic pain in the right leg and low back for 7 years underwent a percutaneous spinal cord stimulation procedure 5 times over 2 years because of repeated unilateral lead migration. The left lead underwent repeated migration and was difficult to reinsert due to epidural adhesion. After confirming the position and stimulation area of the remaining lead, we decided to insert another paddle electrode beside the remaining lead. We performed a T10 laminotomy and inserted a paddle electrode on the right side, using it in combination with the previous left lead. After surgery, the patient was satisfied with a wide coverage area. DISCUSSION: We recommend salvage additional paddle electrode insertion rather than removing both leads during revision SCS. This surgical method increases the possibility of covering the dorsal column (DC) of the spinal cord, is cost effective, and decreases the possibility of failing to cover dorsal column using the paddle electrode during open surgery because the remaining lead's position and stimulation area guide the insertion of the additional paddle lead.


Assuntos
Eletrodos Implantados/efeitos adversos , Migração de Corpo Estranho/cirurgia , Reoperação/métodos , Estimulação da Medula Espinal/instrumentação , Adulto , Humanos , Masculino
9.
Int J Cardiol ; 300: 154-160, 2020 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-31402163

RESUMO

BACKGROUND: While major complications associated with CIED lead extractions are uncommon, they carry a significant risk of morbidity and mortality in the absence of surgical intervention. However, there is limited data on the differences in outcomes of these procedures between centers with and without on-site CS support. The present study examined outcomes of transvenous cardiac implantable electronic device (CIED) lead extractions according to admitting hospitals' cardiac surgery (CS) facilities. METHODS: We analyzed the National Inpatient Sample for CIED lead extraction procedures, stratified by hospitals' CS facilities into two groups; on-site and off-site CS. Logistic regression analyses were performed to estimate the adjusted odds (aOR) of procedure-related complications in off-site CS centers. RESULTS: In 221,606 procedures over an 11-year-period, CIED lead extractions were increasingly undertaken in on-site as opposed to off-site CS centers (Onsite CS 2004 vs. 2014: 78.2% vs. 90.4%, p < 0.001) during the study period. In comparison to on-site CS group, patients admitted to off-site CS group were older, less comorbid, and experienced lower adjusted odds of major adverse cardiovascular events (0.72 [0.67, 0.77]), mortality (0.60 [0.52, 0.69]), procedure-related bleeding (0.48 [0.44, 0.54]) and complications (thoracic: 0.81 [0.75, 0.88]; cardiac: 0.45 [0.38, 0.54]) (p < 0.001 for all). CONCLUSIONS: Our national analysis demonstrates that transvenous CIED lead extractions are being increasingly undertaken in centers with on-site CS surgery, in compliance with international guideline recommendations. Patients managed with lead extractions in on-site CS centers are more comorbid and critically ill compared to those admitted to off-site CS centers, and remain at a higher risk of procedure-related complications.


Assuntos
Procedimentos Cirúrgicos Cardíacos/tendências , Serviço Hospitalar de Cardiologia/tendências , Desfibriladores Implantáveis/tendências , Remoção de Dispositivo/tendências , Eletrodos Implantados/tendências , Marca-Passo Artificial/tendências , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Bases de Dados Factuais/tendências , Desfibriladores Implantáveis/efeitos adversos , Eletrodos Implantados/efeitos adversos , Feminino , Hospitalização/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Marca-Passo Artificial/efeitos adversos , Fatores de Risco , Resultado do Tratamento , Estados Unidos/epidemiologia
10.
Acta Neuropsychiatr ; 32(2): 57-64, 2020 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-31452489

RESUMO

OBJECTIVE: Deep brain stimulation (DBS) was approved by Food and Drug Administration for Parkinson's disease, essential tremor, primary generalised or segmental dystonia and obsessive-compulsive disorder (OCD) treatment. The exact mechanism of DBS remains unclear which causes side effects. The aim of this review was to assess variables causing stimulation-induced chronic psychiatric/personality-changing side effects. METHODS: The analysis of scientific database (PubMed, Cochrane Library, EMBASE) was conducted. The included articles had to be research study or case report and DBS to be conducted in therapeutic purposes. The researches with mental disorders in patients' medical histories were excluded. RESULTS: Seventeen articles were used in the review. In the group of movement disorders the characteristic of side effects was strongly related to the placement of the electrode implantation. Tiredness/fatigue was correlated with DBS in thalamus. Implantations in subthalamic nucleus were mostly followed by affective side effects such as depression or suicide. The higher voltage of electrode was connected with more severe depression after implantation. The analysis of affective disorder contained only three articles - two about OCD and one about depression. Forgetfulness and word-finding problems as activities connected with cognition may be an inevitable side effect if obsessive thoughts are to be inhibited. CONCLUSION: DBS of subthalamic nucleus should be seen as the most hazardous place of implantation. As a result there is a strong need of 'gold standards' based on the connectivity research and closer cooperation of scientists and clinicians.


Assuntos
Estimulação Encefálica Profunda/efeitos adversos , Depressão/etiologia , Eletrodos Implantados/efeitos adversos , Fadiga/etiologia , Transtornos dos Movimentos/terapia , Núcleo Subtalâmico , Suicídio , Humanos
11.
Pain Pract ; 20(5): 534-538, 2020 06.
Artigo em Inglês | MEDLINE | ID: mdl-31793221

RESUMO

BACKGROUND: Spinal cord stimulation (SCS) is a relatively safe therapy for the treatment of pain but has the potential for several complications, including lead migration and breakage. While instances of lead breakage and electrode shearing have been described, there are no reported cases of stimulator lead transection and migration to the foramen magnum. AIMS: We describe the case of a 53-year-old woman who reported that her cervical spinal cord stimulator was no longer functioning after a traumatic fall. CASE: Fluoroscopy of the neck revealed that one of the MRI conditional leads had migrated cephalad, and the distal aspect appeared to be transected. This was confirmed by computerized tomography, which showed a transected portion of the lead in the epidural space, just inferior to the posterior aspect of the foramen magnum. An SCS device revision was performed to replace the lead, but the distal transected tip was left in place in the epidural space adjacent to the foramen magnum to avoid complications of retrieval. DISCUSSION/CONCLUSION: Given the location of the transected portion of the lead, we recommended avoiding MRI imaging. In addition, we advised the patient that a repeat x-ray may be necessary if she has increased neck pain or any other concerning symptoms. In this report, we discuss the known complications with SCS, as well as management of a retained lead fragment.


Assuntos
Eletrodos Implantados/efeitos adversos , Migração de Corpo Estranho , Estimulação da Medula Espinal/instrumentação , Medula Cervical , Feminino , Forame Magno , Migração de Corpo Estranho/cirurgia , Humanos , Pessoa de Meia-Idade , Reoperação
12.
Folia Med Cracov ; 59(2): 61-66, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31659349

RESUMO

Increasing numbers of implanted cardiovascular electronic devices, results in a need for lead extractions, which has increased to an annual volume of over 10,000 worldwide. We present a cadaveric dissection body with a single chamber pacemaker implanted 5y before death.


Assuntos
Cadáver , Eletrodos Implantados/efeitos adversos , Ventrículos do Coração/cirurgia , Marca-Passo Artificial/efeitos adversos , Idoso de 80 Anos ou mais , Humanos , Masculino , Fatores de Tempo
13.
Circ Arrhythm Electrophysiol ; 12(8): e007266, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31401856

RESUMO

BACKGROUND: Superior vena cava (SVC) tears are one of the most lethal complications in transvenous lead extraction. An endovascular balloon can occlude the SVC in the event of a laceration, preventing blood loss and offering a more controlled surgical field for repair. An early study demonstrated that proper use of this device is associated with reduced mortality. Thereafter, high-volume extractors at the Eleventh Annual Lead Management Symposium developed a best practice protocol for the endovascular balloon. METHODS: We collected data on adverse events in lead extraction from July 1, 2016, to July 31, 2018. Data were prospectively collected from both a US Food and Drug Administration-maintained database and physician reports of adverse events as they occurred. We gathered case details directly from extracting physicians. Confirmed SVC tears were analyzed for patient demographics, case details, and index hospitalization mortality. RESULTS: From July 1, 2016, to July 31, 2018, 116 confirmed SVC events were identified, of which 44.0% involved proper balloon use and 56.0% involved no use or improper use. When an endovascular balloon was properly used, 45 of 51 patients (88.2%) survived in comparison to 37 of 65 patients (56.9%) when a balloon was not used or improperly used (P=0.0002). Furthermore, multivariate regression modeling found that proper balloon deployment was an independent, negative predictor of in-hospital mortality for patients who experienced an SVC laceration (odds ratio, 0.13; 95% CI, 0.04-0.40; P<0.001). CONCLUSIONS: From July 1, 2016, through July 31, 2018, patients undergoing lead extraction were more likely to survive SVC tears when treatment included an endovascular balloon.


Assuntos
Oclusão com Balão/métodos , Remoção de Dispositivo/efeitos adversos , Eletrodos Implantados/efeitos adversos , Procedimentos Endovasculares/métodos , Complicações Intraoperatórias , Lesões do Sistema Vascular/cirurgia , Veia Cava Superior/cirurgia , Feminino , Seguimentos , Humanos , Masculino , Pessoa de Meia-Idade , Flebografia , Estudos Retrospectivos , Resultado do Tratamento , Lesões do Sistema Vascular/diagnóstico , Lesões do Sistema Vascular/etiologia , Veia Cava Superior/diagnóstico por imagem , Veia Cava Superior/lesões
15.
World Neurosurg ; 130: e839-e845, 2019 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31295613

RESUMO

BACKGROUND: Risk factors for infection after vagus nerve stimulation (VNS) device implantation represent an important issue but remain unclear. We hypothesized that specific risk factors for infection would be associated with VNS device implantation. This study reviewed patients with epilepsy who underwent VNS device implantation and undertook a statistical analysis of risk factors for surgical site infection (SSI). METHODS: We reviewed all medical records for patients who underwent VNS therapy in our facility between August 2011 and May 2018. Age, sex, height, body weight, body mass index (BMI), intelligence quotient (IQ), surgical incision opening time, blood loss, epilepsy classification, activities of daily living, and generator replacement were statistically compared between cases with and without SSI. RESULTS: We performed 208 VNS device implantation surgeries at our facility during the study period. Among these, 150 patients underwent initial implantation, 56 patients underwent first generator replacement, and 2 patients underwent second replacement. Six patients (2.7%) with initial implantation and 3 patients (5.4%) with first replacement showed SSI. Low BMI was a risk factor for infection at initial implantation (P < 0.0012) using a BMI within 1.78 kg/m2 of the cutoff for being underweight (100% sensitivity, 25% specificity). Low IQ (P = 0.0015) was also a risk factor for SSI. CONCLUSIONS: This study identified low BMI and low IQ at initial implantation as risk factors for infection.


Assuntos
Índice de Massa Corporal , Eletrodos Implantados/efeitos adversos , Inteligência , Infecção da Ferida Cirúrgica/diagnóstico , Estimulação do Nervo Vago/efeitos adversos , Adolescente , Adulto , Criança , Pré-Escolar , Estudos Transversais , Seguimentos , Humanos , Lactente , Inteligência/fisiologia , Fatores de Risco , Infecção da Ferida Cirúrgica/etiologia , Resultado do Tratamento , Estimulação do Nervo Vago/instrumentação , Adulto Jovem
16.
Radiographics ; 39(4): 1056-1074, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31283461

RESUMO

Electronic stimulation devices are implanted in various locations in the body to decrease pain, modulate nerve function, or stimulate various end organs. The authors describe these devices using a craniocaudal approach, first describing deep brain stimulation (DBS) devices and ending with sacral nerve stimulation (SNS) devices. The radiology-relevant background information for each device and its imaging appearance are also described. These devices have a common design theme and include the following components: (a) a pulse generator that houses the battery and control electronics, (b) an insulated lead or wire that conveys signals to the last component, which is (c) an electrode that contacts the end organ and senses and/or acts on the end organ. DBS electrodes are inserted into various deep gray nuclei, most commonly to treat the symptoms of movement disorders. Occipital, trigeminal, and spinal nerve stimulation devices are used as second-line therapy to control craniofacial or back pain. For cardiac devices, the authors describe two newer devices, the subcutaneous implantable cardioverter defibrillator and the leadless pacemaker, both of which avoid complications related to having leads threaded through the venous system. Diaphragmatic stimulation devices stimulate the phrenic nerve to restore diaphragmatic movement. Gastric electrical stimulation devices act on various parts of the stomach for the treatment of gastroparesis or obesity. Finally, SNS devices are used to modulate urinary and defecatory functions. Common complications diagnosed at imaging include infection, hematoma, lead migration, and lead breakage. Understanding the components, normal function, and normal imaging appearance of each device allows the radiologist to identify complications. ©RSNA, 2019.


Assuntos
Diagnóstico por Imagem/métodos , Terapia por Estimulação Elétrica/métodos , Eletrodos Implantados , Hemorragia Cerebral/diagnóstico por imagem , Hemorragia Cerebral/etiologia , Estimulação Encefálica Profunda/efeitos adversos , Terapia por Estimulação Elétrica/efeitos adversos , Terapia por Estimulação Elétrica/instrumentação , Eletrodos Implantados/efeitos adversos , Desenho de Equipamento , Fluoroscopia , Gastroparesia/terapia , Humanos , Neuroimagem/métodos , Marca-Passo Artificial/efeitos adversos , Manejo da Dor , Infecções Relacionadas à Prótese/diagnóstico por imagem , Transtornos Urinários/terapia , Estimulação do Nervo Vago/efeitos adversos , Estimulação do Nervo Vago/instrumentação
17.
Stereotact Funct Neurosurg ; 97(2): 101-105, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31280257

RESUMO

BACKGROUND/AIMS: Internal pulse generator (IPG) replacement is considered a relatively minor surgery but exposes the deep brain stimulation system to the risk of infectious and mechanical adverse events. We retrospectively reviewed complications associated with IPG replacement surgery in our center and reviewed the most relevant publications on the issue. METHODS: A retrospective analysis of all the IPG replacements performed in our center from January 2003 until March 2018 was performed. A logistic regression model was used to analyze the risk factors associated with IPG infections at our center. RESULTS: A total of 171 IPG replacements in 93 patients were analyzed. The overall rate of replacement complications was 8.8%, whereas the rate of infection was 5.8%. IPG removal was required in 8 out of 10 infected cases. An increased risk of infection was found in patients with subcutaneous thoracic placement of the IPG (OR 5.3, p = 0.016). The most commonly isolated germ was Staphylococcus coagulase negative (60%). We found a non-significant trend towards increased risk of infection in patients with more than 3 replacements (p = 0.07). CONCLUSIONS: Infection is the most frequent complication related to IPG replacement. Staphylococcus coagulase negative is the most commonly isolated bacteria causing the infection. According to our results, the subcutaneous thoracic placement represents a greater risk of infection compared to subcutaneous abdominal placement.


Assuntos
Estimulação Encefálica Profunda/efeitos adversos , Estimulação Encefálica Profunda/instrumentação , Eletrodos Implantados/efeitos adversos , Neuroestimuladores Implantáveis/efeitos adversos , Complicações Pós-Operatórias/diagnóstico , Complicações Pós-Operatórias/etiologia , Adulto , Idoso , Estimulação Encefálica Profunda/métodos , Tremor Essencial/diagnóstico , Tremor Essencial/cirurgia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Doença de Parkinson/diagnóstico , Doença de Parkinson/cirurgia , Estudos Retrospectivos , Fatores de Risco
18.
Pain Res Manag ; 2019: 1236430, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31281554

RESUMO

Background: Spinal cord stimulation is an established treatment option for certain chronic pain conditions which have been previously unresponsive to conservative therapies or potentially for a subset of patients who have not improved following spine surgery. Prior to permanent lead implantation, stimulator lead trials are performed to ensure adequate patient benefit. During these trials, one of the most common complications and reasons for failure is the displacement and migration of the trial leads, resulting in lost therapeutic coverage. Other complications include infection and dislodged bulky dressings. There is a paucity of literature describing an adequate procedural method to prevent these common complications. Objective: This study utilizes a series of 19 patients to evaluate a new technique for securing percutaneous spinal cord simulator trial leads, which may minimize dislodgement and migration complications and improve the rate of trial success. Study Design: Retrospective case series. Setting: New Jersey Medical School, Department of Anesthesiology, Pain Management Division. Methods: A retrospective chart review was conducted on 19 consecutive patients undergoing placement of the percutaneous thoracic spinal cord stimulator trial leads for pain associated with lumbar spine pathology over a two-year period (2010-2012). Results: Of the 19 patients in our cohort, there was one trial lead displacement, no lead migrations, and no site infections. Thirteen patients went on to permanent lead implantation. This improved trial lead placement technique had a high success rate with a low number of complications. Limitations: Small sample size, retrospective case series, and no control group for comparison. Conclusion: This case series was able to demonstrate that our described novel spinal cord stimulator trial lead placement and dressing technique can decrease the incidence of lead displacement and migration, thus improving trial success.


Assuntos
Eletrodos Implantados/efeitos adversos , Migração de Corpo Estranho/prevenção & controle , Procedimentos Neurocirúrgicos/métodos , Estimulação da Medula Espinal/métodos , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Manejo da Dor/métodos , Estudos Retrospectivos
19.
Handb Clin Neurol ; 160: 67-81, 2019.
Artigo em Inglês | MEDLINE | ID: mdl-31277877

RESUMO

Since the purpose of clinical neurophysiology testing is to record the electrical activity of the nervous system, and often to electrically stimulate the peripheral or central nervous system (for evoked potentials, nerve conduction studies, etc.), these tests by their very nature demand an excellent electrical connection to the patient. This direct electrical connection by definition puts the patient at increased risk of electrical shock. When patients suffer from other nonneurological disorders that also require equipment to be attached to or inserted into their body, the additional and more direct electrical pathways to the heart make them even more vulnerable, especially when undergoing monitoring in the operating room or intensive care unit. Although we depend on the hospital's construction and utilities to follow appropriate regulations (the National Electrical Code in the United States) and on the vendors to sell only safe equipment (approved by the Food and Drug Administration in the United States), there may exist combinations of equipment and connections that put the patient at risk of injurious or fatal electrical shock. Regular testing and safe practices, informed by a scientific understanding of the risks, are the responsibilities of the healthcare providers in order to protect the patient from harm from electricity.


Assuntos
Traumatismos por Eletricidade/prevenção & controle , Terapia por Estimulação Elétrica/efeitos adversos , Monitorização Fisiológica/efeitos adversos , Segurança do Paciente , Traumatismos por Eletricidade/etiologia , Terapia por Estimulação Elétrica/normas , Eletricidade/efeitos adversos , Eletrodos Implantados/efeitos adversos , Humanos , Monitorização Fisiológica/normas , Condução Nervosa/fisiologia , Segurança do Paciente/normas
20.
No Shinkei Geka ; 47(7): 785-791, 2019 Jul.
Artigo em Japonês | MEDLINE | ID: mdl-31358698

RESUMO

We report a rare complication in a patient with Parkinson's disease who underwent deep brain stimulation(DBS)surgery. The patient was a 60-year-old woman who presented with frontal lobe signs, including ataxic gait and memory disturbance, that were caused by the unexpected migration of a burr hole cap into the brain three to four months after surgery. The patient had no incidence of a head injury prior to development of symptoms. The patient underwent surgery to extract the migrated cap from the frontal lobe, and her symptoms improved several months after the operation. The cap serves to fix the DBS lead to the skull using an adjunctive burr hole ring. It was intraoperatively confirmed that only the cap detached from the ring, and no cap or ring defects were detected in a postoperative quality check by the manufacturer. We have previously utilized a burr hole ring and cap, which are packaged along with the DBS electrode, when employing the product made by Medtronic Inc. No previous report has described the cap packed in the official DBS kit to have migrated into the intracranial space. It seems unlikely that the cap migration into the intracranial space would occur without the cap and/or ring breaking through either traumatic injury or from manufacturing defects. It is important to consider the migration of a burr hole cap into the intracranial space in the absence of head injury as a possible device complication after DBS surgery.


Assuntos
Estimulação Encefálica Profunda , Eletrodos Implantados , Lobo Frontal , Doença de Parkinson/terapia , Encéfalo , Estimulação Encefálica Profunda/efeitos adversos , Eletrodos Implantados/efeitos adversos , Feminino , Lobo Frontal/patologia , Humanos , Pessoa de Meia-Idade , Trepanação
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