spinal cord stimulator

脊髓刺激器
  • 文章类型: Journal Article
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  • 文章类型: Journal Article
    回顾性队列研究。
    医疗事故索赔分析由几个专业进行,以提高患者护理质量,并确定医生可以改善其实践以减轻医疗事故发生率的领域。美国食品和药物管理局已经标记了超过80,000的脊髓刺激器(SCS)造成的伤害,使它们成为第三大标志的医疗设备。本研究通过查询两个广泛用于法医学研究的法律数据库,分析了由于SCS引起的渎职索赔。
    WestlawEdge和VerdictSearch被查询为2000年至2022年之间使用关键字“脊髓刺激器”提起的渎职案件。“案件纳入标准被定义为原告基于SCS引起的医疗事故索赔的诉讼基础。收集的其他数据包括案件审理日期,原告的性别和年龄,被告专业,判决裁决,提交的索赔的位置,付款或结算金额,和持续的伤害。
    在经过审查的1773例病例中,包括45例,并归类为电池或植入式脉冲发生器故障(35.56%),铅并发症(28.89%),手术并发症(20.00%),和杂项(15.56%)。四宗(8.89%)案件达成和解,11(24.44%)在原告判决中,30人(68.00%)导致被告判决。由于与SCS相关的感染而提出的索赔更有可能导致被告判决(p=0.047),而由于神经缺陷而提出的索赔更有可能导致原告判决(p=0.020)。4起案件的平均结算额为1975309.61美元。
    我们的研究结果表明,术前使用MRI获得足够的神经影像学检查,披露神经系统风险,特别是知情同意后瘫痪,术中和术后用前后(AP)和侧位X线片进行X线检查,以确保正确的SCS放置是可以减轻由于SCS引起的不当行为的做法。电池缺陷和铅并发症是与SCS相关的渎职索赔的最常见理由。
    UNASSIGNED: Retrospective cohort study.
    UNASSIGNED: Malpractice claims analysis is performed by several specialties to improve quality of patient care and to identify areas where physicians can improve their practice to mitigate the incidence of committing malpractice. The Food and Drug Administration has flagged over 80,000 injuries caused by spinal cord stimulator (SCS), making them the 3rd most flagged medical device. This study analyzed malpractice claims due to SCS by querying two legal databases widely used in medicolegal research.
    UNASSIGNED: Westlaw Edge and VerdictSearch were queried for malpractice cases filed between the years 2000 and 2022 using the keywords \"spinal cord stimulator.\" Case inclusion criteria was defined as a plaintiff\'s basis of litigation resting on a claim of medical malpractice due to SCS. Additional data collected included date of case hearing, plaintiff sex and age, defendant specialty, verdict ruling, location of the filed claim, payment or settlement amount, and sustained injuries.
    UNASSIGNED: Of the 1773 reviewed cases, 45 cases were included and categorized as battery or implantable pulse generator malfunction (35.56 %), lead complications (28.89 %), surgical complications (20.00 %), and miscellaneous (15.56 %). Four (8.89 %) cases resulted in settlement, 11 (24.44 %) in a plaintiff verdict, and 30 (68.00 %) resulted in a defendant verdict. Claims filed due to infection related to SCS were more likely to result in a defendant verdict (p = .047), whereas claims filed due to neurological deficit were more likely to result in a plaintiff verdict (p = .020). The average settlement amount for the 4 cases is $1,975,309.61.
    UNASSIGNED: Our findings suggest obtaining adequate neuroimaging preoperatively with MRIs, disclosing neurological risks specifically paralysis on informed consent, and evaluating radiography intraoperative and postoperatively with anterior-posterior (AP) and lateral x-ray films to ensure proper SCS placement are practices that may mitigate malpractice due to SCS. Battery defects and lead complications were the most common grounds for SCS-related malpractice claims.
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  • 文章类型: Case Reports
    背柱脊髓刺激器植入的最常见并发症是硬件迁移。很少报道桨或经皮导线植入后脊髓损伤,总体发病率为0.42%。本报告描述了在植入一个胸板电极以解决椎板切除术后疼痛综合征后立即出现的术后不完全性截瘫的情况。尽管突然取出了电极,术后皮质类固醇,和一个疗程的住院康复,患者因持续性不完全性截瘫出院。尽管脊髓神经调节很少发生脊髓损伤,认识到可能导致类似破坏性并发症的危险因素非常重要.
    The most common complication of dorsal column spinal cord stimulator implantation is hardware migration. Spinal cord injury following paddle or percutaneous lead implant is rarely reported, with an overall incidence of 0.42%. This report describes a case of immediate post-operative incomplete paraplegia following implantation of one thoracic paddle electrode to address post-laminectomy pain syndrome. Despite emergent removal of the electrode, post-operative corticosteroids, and a course of inpatient rehabilitation, the patient discharged with persistent incomplete paraplegia. Although there is rare occurrence of spinal cord injury with spinal cord neuromodulation, it is important to recognize risk factors which may lead to similar devastating complications.
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  • 文章类型: Journal Article
    鞘内泵(ITP)适用于难治性癌症疼痛和减少全身阿片类药物的需求。虽然尚未表明癌症疼痛,脊髓刺激器(SCS)用于癌症疼痛的标签外,越来越多的证据表明它们的功效。
    对同时接受ITP和至少SCS癌症疼痛试验的患者进行回顾性图表回顾。主要结果是疼痛数字评定量表(NRS)和每日吗啡当量(MEQs)。
    确定了17名患者。在3个月的随访中,ITP和SCS均与疼痛评分显着下降相关。但这种减少随后变得不显著。ITP,但不是SCS,与MEQ显着下降有关。
    ITP和SCS都可能对癌痛有效,但SCS的阿片类药物保护作用可能有限。ITP和SCS在缓解癌症相关疼痛的能力方面可能是互补的。
    UNASSIGNED: Intrathecal pumps (ITPs) are indicated for refractory cancer pain and decrease systemic opioid requirements. While not yet indicated for cancer pain, spinal cord stimulators (SCSs) are used off-label for cancer pain, with increasing evidence of their efficacy.
    UNASSIGNED: A retrospective chart review was conducted of patients who underwent both ITP and at least SCS trial for cancer pain. Primary outcomes were pain numeric rating scale (NRS) and daily morphine equivalents (MEQs).
    UNASSIGNED: Seventeen patients were identified. Both ITP and SCS were associated with significant decreases in pain ratings at the 3-month follow-up, but this decrease became nonsignificant subsequently. ITP, but not SCS, was associated with a significant decrease in MEQ.
    UNASSIGNED: ITP and SCS may both provide efficacy for cancer pain, but the opioid-sparing effects of SCS may be limited. ITP and SCS may potentially be complementary in their ability to provide relief from cancer-related pain.
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  • 文章类型: Journal Article
    脊髓刺激(SCS)是一种用于治疗各种慢性疼痛状况的治疗方式,在过去的50年中迅速发展。不幸的是,随着时间的推移,植入SCS的患者经历了导致疼痛缓解减少的习惯现象。因此,新的刺激波形和SCS应用的发现已被证明可以延长疗效并降低外植率。本文探讨了各种SCS波形,他们的应用,并提出了一种分级的习惯缓解方法。我们怀疑神经习惯现象与药理学相似。因此,我们敦促进一步探索早期引入这些刺激策略以减轻脊髓刺激习惯。
    Spinal cord stimulation (SCS) is a therapeutic modality for the treatment of various chronic pain conditions that has rapidly evolved over the past 50 years. Unfortunately, over time, patients implanted with SCS undergo a habituation phenomenon leading to decreased pain relief. Consequently, the discovery of new stimulation waveforms and SCS applications has been shown to prolong efficacy and reduce explantation rates. This article explores various SCS waveforms, their applications, and proposes a graded approach to habituation mitigation. We suspect the neural habituation phenomenon parallels that seen in pharmacology. Consequently, we urge further exploration of the early introduction of these stimulation strategies to abate spinal cord stimulation habituation.
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  • 文章类型: Journal Article
    背景:COVID-19后的从头慢性神经性疼痛已被广泛认可。然而,目前尚无发表的研究调查SARS-CoV-2感染对需要脊髓刺激器(SCS)植入的已有神经性疼痛患者的影响.这里,作者旨在分析他们所在机构接受脊髓刺激器(SCS)植入或系统翻修手术5年的患者的结局.具体来说,将随访期间感染COVID-19的患者与未感染COVID-19的对照组的短期和长期结局进行比较.
    方法:本研究纳入的患者在2017年1月1日至2022年1月31日期间进行了脊髓刺激器植入(从头和翻修手术),用于治疗任何病因的神经性疼痛。被认为符合研究条件的患者被邀请参加电话调查,通过电话调查收集临床结果数据。用改良形式的简明疼痛量表(BPI)评估疼痛评分。
    结果:在91例患者中,截至调查时,已有48人(52.7%)感染了COVID-19。感染COVID-19的患者在感染后和调查时,在“最小疼痛”领域的BPI评分明显更差,与手术后6个月的得分相比。22.9%(n=11)感染COVID-19的患者在感染后症状发生变化。在这个小组中,10/11领域和2/11领域的BPI评分在感染后有统计学意义的下降。COVID-19症状严重程度恶化与BPI评分恶化无关。
    结论:SARS-CoV-2感染,占SCS原位患者的很大比例,至少会导致疼痛控制的短暂恶化。进一步的前瞻性多中心研究表明这种现象的患病率。
    BACKGROUND: De-novo chronic neuropathic pain following COVID-19 is widely recognised. However, there are currently no published studies investigating the effect of SARS-CoV-2 infection on patients with pre-existing neuropathic pain who have required spinal cord stimulator (SCS) implantation. Here, the authors aimed to analyse outcomes in their institution\'s patients who had spinal cord stimulator (SCS) implantation or revision procedures to the system over a 5-year period. Specifically, the short-term and long-term outcomes of patients who contracted COVID-19 during the follow-up period were compared to the control group of patients who did not.
    METHODS: Patients included in this study had spinal cord stimulator implantation (de-novo and revision procedures) between 1 January 2017 and 31 January 2022, for neuropathic pain of any aetiology. Patients deemed eligible for the study were invited to participate in a telephone survey through which clinical outcome data were collected. Pain scores were assessed with a modified form of the Brief Pain Inventory (BPI).
    RESULTS: Of 91 patients, 48 (52.7%) had contracted COVID-19 by the time of the survey. Patients who contracted COVID-19 had significantly worse BPI scores in the \'Least pain\' domain following their infection and at time of the survey, when compared to their score 6 months after the operation. 22.9% (n = 11) of the patients who contracted COVID-19 experienced a change in their symptoms following their infection. Within this sub-group, there was a statistically significant deterioration in BPI scores in 10/11 domains following their infection and in 2/11 domains at time of the survey. Worsening severity of COVID-19 symptoms was not associated with worse BPI scores.
    CONCLUSIONS: Infection with SARS-CoV-2, in a significant proportion of patients with an SCS in situ, causes at least a transient deterioration in pain control. Further prospective multicentre studies are indicated to establish the prevalence of this phenomenon.
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  • 文章类型: Journal Article
    目的:在成功的经皮圆柱形电极5至7天的脊髓刺激试验后,随后的永久性手术桨状导线(SPL)放置可能会受到试验导线(TLs)诱导的硬膜外瘢痕的阻碍.我们的目标是确定TL和随后的SPL放置之间的延迟是否会引起硬膜外瘢痕形成的增强,并增加了清除瘢痕以实现最佳SPL放置所需的椎板切开术扩展的需求。
    方法:使用前瞻性维护的数据库,2013年6月至2023年11月,一项单机构/外科医生回顾性研究确定了261例新放置胸腰椎SPL的患者.数据来自患者图表,包括,但不限于,TL和SPL之间的时序,手术时间,并且需要扩展椎板切开术。
    结果:我们发现,如果在放置TL(0/26)的十天内放置SPL,我们的患者不需要由于TL硬膜外瘢痕形成和更长的手术时间而需要椎板切开术。导致10天后放置SPL的患者的手术时间更短(122.42±10.72分钟vs140.75±4.72分钟;p=0.005)。我们发现与可能是导致硬膜外瘢痕形成/椎板切开术延伸的混杂因素的其他医学合并症或与SPL放置水平无关联。椎管的大小,或SPL放置指示。
    结论:TL放置导致硬膜外腔瘢痕形成,在放置10天后出现成熟。在大约34%的患者中,由于需要延长椎板切开术和随后清除硬膜外瘢痕以实现最佳SPL放置,这导致手术时间延长.
    OBJECTIVE: After a successful percutaneous cylindrical electrode five-to-seven-day trial of spinal cord stimulation, subsequent permanent surgical paddle lead (SPL) placement can be impeded by epidural scar induced by the trial leads (TLs). Our goal was to determine whether a delay between TL and subsequent SPL placement provokes enhanced epidural scarring with an increased need for laminotomy extension required for scar removal for optimal SPL placement.
    METHODS: Using a prospectively maintained data base, a single-facility/surgeon retrospective study identified 261 patients with newly placed thoracolumbar SPLs from June 2013 to November 2023. Data were obtained from the patients\' charts, including, but not limited to, timing between TL and SPL, operative time, and need for extension of laminotomy.
    RESULTS: We found that the need for laminotomy extension due to TL epidural scarring and longer operative times was not required in our patients if the SPL was placed within ten days of placement of the TL (0/26), leading to shorter operative times in those with SPL placed after ten days (122.42 ± 10.72 minutes vs 140.75 ± 4.72 minutes; p = 0.005). We found no association with other medical comorbidities that may be confounding factors leading to epidural scarring/extension of laminotomy or association with level of SPL placement, size of the spinal canal, or indication for SPL placement.
    CONCLUSIONS: TL placement leads to scarring in the epidural space that appears to mature after ten days of its placement. In approximately 34% of patients, this leads to prolonged operative time owing to the need for extension of laminotomy and subsequent clearing of epidural scar for optimal SPL placement.
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  • 文章类型: Journal Article
    这项前瞻性研究的目的是开发一种用于脊髓刺激(SCS)试验的虚拟现实模拟器(VRS),并确定其有效性。
    我们通过整合患者成像数据分析开发了用于SCS训练的VRS,制作人造X射线图像,并使用空间对齐技术和虚拟现实技术。模拟器是由在执行SCS方面具有丰富经验的医生创建的,并且可以在虚拟环境中模拟过程的感觉。使用20名新手学员的队列评估了SCS试验模拟器的有效性。主要结果是手术持续时间,检查表得分,捕获的C臂图像数量,和整体学员满意度。
    使用VRS的队列具有更好的Zwisch量表评分(P<0.001),在较短的时间内完成手术(P<0.001),拍摄的C臂图像较少(P<0.001),报告的总体满意度(P=0.011)高于未报告的队列。
    我们开发了一种现实而有效的VRS,用于教育新手学员进行SCS试验,从而消除了与尸体训练相关的辐射暴露风险。这项研究的结果表明,我们的VRS具有作为工具资源的潜力,可以整合到SCS试验的教育框架中。
    UNASSIGNED: The aim of this prospective study was to develop a virtual reality simulator (VRS) for spinal cord stimulation (SCS) trials and establish its effectiveness.
    UNASSIGNED: We developed a VRS for SCS training by integrating patient imaging data analytics, creating artificial X-ray images, and using spatial alignment techniques and virtual reality technologies. The simulator was created by a physician with considerable experience in performing SCS, and can simulate the feeling of the procedure in a virtual environment. The efficacy of the simulator for SCS trials was assessed using a cohort of 20 novice trainees. The primary outcomes were duration of the procedure, checklist score, number of C-arm images captured, and overall trainee satisfaction.
    UNASSIGNED: The cohort that utilized the VRS had better Zwisch scale scores (P <0.001), completed the procedure in a shorter time (P <0.001), took fewer C-arm images (P <0.001), and reported better overall satisfaction (P = 0.011) than the cohort that did not.
    UNASSIGNED: We developed a realistic and efficient VRS for educating novice trainees on SCS trials, thereby eliminating the risk of radiation exposure associated with cadaver training. The results of this study indicate that our VRS has potential as an instrumental resource that can be integrated into the educational framework for SCS trials.
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    文章类型: Journal Article
    背景:脊髓刺激器(SCS)手术,无论是使用开放还是经皮入路,在一系列神经性疼痛中变得越来越普遍,包括椎板切除术后综合征和复杂的区域疼痛综合征。然而,关于SCS后当天出院模式相关因素的知识有限。
    目的:本研究的目的是确定与SCS放置后当天出院相关的因素。主要结果是当天出院。
    方法:回顾性,使用全国数据库进行队列研究。
    方法:纳入标准包括2014年1月1日至2021年12月31日接受经皮或开放性SCS的患者。排除标准包括数据缺失的患者(n=178)和未列出适应症的SCS植入物患者(n=1,817)。对结果数据和与SCS后当天出院相关的协变量进行了多变量分析。
    结果:应用纳入和排除标准后,共有18058名患者保留在最终数据集中,包括7,339例接受经皮SCS的患者和10,719例接受开放式SCS手术的患者。经过分析,与SCS后当天出院率增加相关的因素包括男性(比值比[OR]1.16;95%CI,1.09-1.24;P<0.001),接受医疗补助的患者(OR1.64;95%CI,0.1.34-2.01;P<0.001),和美国中西部的医院(OR1.66;95%CI,1.45-1.90;P<0.001)和美国西部的医院(OR1.32;95%CI,1.20-1.46;P<0.001)。与SCS后当天出院率降低相关的因素包括开放方法(OR0.21;95%CI,0.19-0.23;P<0.001),西班牙裔种族(OR0.61;95%CI,0.54-0.69;P<0.001)和年龄增加(OR0.99;95%CI,0.98-0.99;P<0.001)。
    结论:由于我们的研究是回顾性的,数据受到各种偏见的影响,包括变量混杂,数据输入中的人为错误,和结果的概括性。
    结论:这些结果可用于帮助确定SCS手术后医院病床的需求。未来的研究应侧重于确定某些人口和地理因素可能影响当天出院率的具体原因。我们的研究提供了与开放和经皮SCS植入后当天出院率相关的因素的重要见解,并强调了以患者为中心的需求,基于证据的医疗保健服务方法。
    BACKGROUND: Spinal cord stimulator (SCS) surgeries, whether performed using the open or percutaneous approach, are becoming increasingly common for a range of neuropathic pain conditions, including post-laminectomy syndrome and complex regional pain syndrome. However, there is limited knowledge regarding the factors linked to same-day discharge patterns following SCS.
    OBJECTIVE: The purpose of this study was to identify factors associated with same-day discharge after SCS placement. The primary outcome was same-day discharge.
    METHODS: Retrospective, cohort study using a nationwide database.
    METHODS: Inclusion criteria included patients who underwent percutaneous or open SCS from January 1, 2014 through December 31, 2021. Exclusion criteria included patients with missing data (n = 178) and those with SCS implants for unlisted indications (n = 1,817). A multivariable analysis was conducted on the outcome data and co-variates associated with same-day discharge after SCS.
    RESULTS: After applying inclusion and exclusion criteria, a total of 18,058 patients remained in the final data set, including 7,339 patients who underwent percutaneous SCS and 10,719 patients who underwent open SCS procedures. After analysis, factors associated with increased rates of same-day discharge after SCS included men (odds ratio [OR] 1.16; 95% CI, 1.09 -1.24;  P < 0.001), patients on Medicaid (OR 1.64; 95% CI, 0.1.34 - 2.01; P < 0.001), and hospitals in the US Midwest (OR 1.66; 95% CI, 1.45 - 1.90; P < 0.001) and hospitals in the US West (OR 1.32; 95% CI, 1.20 - 1.46; P < 0.001). Factors associated with decreased rates of same-day discharge after SCS included the open approach (OR 0.21; 95% CI, 0.19 - 0.23; P < 0.001), Hispanic ethnicity (OR 0.61; 95% CI, 0.54 - 0.69; P < 0.001) and increased age (OR 0.99; 95% CI, 0.98 - 0.99; P < 0.001).
    CONCLUSIONS: Since our study is retrospective, the data are subject to various biases, including variable confounding, human error in data entry, and generalizability of the results.
    CONCLUSIONS: These results can be used to help determine hospital bed needs post-SCS surgery. Future research should focus on identifying the specific reasons certain demographic and geographic factors might influence same-day discharge rates. Our study provides important insights into the factors associated with same-day discharge rates post open and percutaneous SCS implant and highlights the need for patient-centered, evidence-based approaches to health care delivery.
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  • 文章类型: Journal Article
    目的:本研究旨在确定经皮脊髓刺激(SCS)植入物患者报告的疼痛减轻百分比(RPPR)和计算的疼痛减轻百分比(CPPR)之间的一致性,并将RPPR和CPPR与患者满意度相关联。我们还试图确定哪些患者报告的预后指标在SCS患者中改善最大。
    方法:对50例经皮脊髓刺激器植入患者进行访谈和调查,平均随访时间为51.1个月,以评估其疼痛程度。疼痛缓解程度的印象,对治疗的满意度,并希望再次拥有该设备。从其植入前记录获得基线疼痛水平。
    结果:总体而言,发现RPPR为53.3%,而CPPR为44.4%。在所有患者中,21报告疼痛减轻<50%;然而,其中大多数(12/21,57%)对治疗结果感到满意.就个人结果的改善而言,日常生活活动是改善最多的指标,为82%,其次是情绪,睡眠,药物使用,医疗保健利用率为74%,62%,50%,48%,分别。
    结论:RPPR似乎是一个复杂的结果指标,可能与CPPR不一致。总体RPPR大于CPPR。根据我们的数据,这些独立有效的措施不应互换使用。50%的疼痛减轻阈值不是患者满意度和再次使用该装置的愿望所必需的。日常生活活动是这个队列中改进最大的指标,其次是情绪,睡眠,药物使用,以及医疗保健利用率的下降。
    OBJECTIVE: This study aimed to determine agreement between reported percentage pain reduction (RPPR) and calculated percentage pain reduction (CPPR) in patients with percutaneous spinal cord stimulation (SCS) implants, and to correlate RPPR and CPPR with patient satisfaction. We also sought to determine which patient-reported outcome measures are most improved in patients with SCS.
    METHODS: Fifty patients with percutaneous spinal cord stimulator implants with a mean follow-up of 51.1 months were interviewed and surveyed to assess their pain level, impression of degree of pain relief, satisfaction with the therapy, and desire to have the device again. Baseline pain level was obtained from their preimplant records.
    RESULTS: Overall, RPPR was found to be 53.3%, whereas CPPR was 44.4%. Of all patients, 21 reported <50% pain reduction; however, most of these (12/21, 57%) were satisfied with the outcome of therapy. In terms of individual improvement in outcomes, activities of daily life was the most improved measure at 82%, followed by mood, sleep, medication use, and health care utilization at 74%, 62%, 50%, and 48%, respectively.
    CONCLUSIONS: RPPR appears to be a complex outcome measure that may not agree with CPPR. Overall RPPR is greater than the CPPR. On the basis of our data, these independently valid measures should not be used interchangeably. A 50% pain reduction threshold is not a requisite for patient satisfaction and desire to have the device again. Activities of daily living was the most improved measure in this cohort, followed by mood, sleep, medication usage, and decrease in health care utilization.
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