Long-term safety of spinal cord stimulation systems in a prospective, global registry of patients with chronic pain.

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

Real-World Outcomes Using a Spinal Cord Stimulation Device Capable of Combination Therapy for Chronic Pain: A European, Multicenter Experience.

Given the differing mechanisms thought to underlie therapeutic sub- and supra-perception-based neurostimulative modalities, Spinal Cord Stimulation (SCS) systems designed for combined delivery of these approaches may help improve analgesic outcomes and quality of life, and reduce treatment failures. This multicenter, observational case-series evaluated 188 patients with chronic back and/or leg pain implanted with an SCS device capable of sequential or simultaneous delivery of sub-perception and supra-perception stimulation programming (i.e., combination therapy) at 16 in Europe. Following implantation, patients were provided with an array of advanced supra-perception programs (e.g., paresthesia-based SCS using multiple independent current sources), and a custom set of sub-perception programs optimized with specific waveforms and/or field shapes. A mean overall pain score of 7.9 ± 1.7 (Standard Deviation (SD)) was reported pre-trial (Baseline). Overall pain was reduced by 4.4 ± 2.8 points (NRS) at 3-months (n = 117) and at 12 months post-implant (n = 90), respectively (p < 0.0001). Substantial quality-of-life (EQ-5D-5L) improvement as assessed at last follow-up was also observed (n = 60). These results suggest that an implanted SCS device capable of combination therapy, while also enabled with patient-specific waveform optimization and stimulation field targeting capabilities, can enable highly effective pain relief and improve quality of life in patients suffering with chronic pain.

Real-world evidence on spinal cord neuromodulation and pain: Long-term effectiveness analysis in a single-center cohort.

Introduction: Chronic pain inflicts damage in multiple spheres of patient's life and remains a challenge for health care providers. Real-world evidence derived from outcome registries represents a key aspect of the ongoing systematic assessment and future development of neurostimulation devices. Research question: The objective of the present study was to assess the long-term effectiveness of neurostimulation as a treatment for spinal chronic pain. Material and methods: The patients analyzed in the present study represent a singlecenter cohort of 52 individuals. Primary outcome measures included numeric pain rating scale, Beck depression index II and Oswestry disability index variation from baseline to 36-month visits. Secondary outcomes included its evaluation at 6-month, 12-month and 24-month visits. Results: A significant improvement in targeted pain, depression and disability values were observed at 36-month follow-up (P â€‹< â€‹0.001, P â€‹= â€‹0.009 and P â€‹< â€‹0.001 respectively). Those results were consistent in the leg and back pain subgroup but not in the neck, chest and arm pain subgroup. The decrease in pain, depression and disability values happened progressively through time, with the exception of the 12-month visit, where a mild stagnation was observed. Discussion and conclusion: Our results suggest that spinal cord stimulation is an effective long-term treatment for spinal chronic pain in real-world conditions when applied to a variety of patients and conditions usually seen in routine practice. Nevertheless, some fluctuations may occur during treatment so prolonged follow-up periods should be considered before rendering an unsuccessful therapy diagnosis.

Tumor fibroso solitario extra-intramedular de localización dorsal / Solitary fibrous tumor: A clinical case

Introducción: El tumor fibroso solitario (TFS) es un tumor poco frecuente de origen mesenquimal, que se localiza principalmente en pleura. De extraordinaria infrecuencia es su localización a nivel intraespinal, siendo la región torácica la más frecuente. Presentación del caso: Presentamos el caso de una paciente de 48 años con hipoestesia ascendente progresiva en miembros inferiores y mielopatía de un mes de evolución, que se diagnosticó de un tumor intraespinal en segmento D3-D4. Fue intervenida quirúrgicamente mediante abordaje dorsal posterior y laminoplastia D3-D4, hallándose un tumor intradural con componente intramedular, de 18×12mm, aproximadamente. La resección fue completa y la anatomía patológica resultó el diagnóstico de tumor fibroso solitario. La paciente, tras 7 meses de seguimiento se encuentra asintomática. Discusión: La resección completa tumoral junto con las características histopatológicas son los principales factores pronósticos, teniendo la cirugía un papel protagonista en este tipo de neoplasia. Conclusión: Son muy pocos los casos publicados en la literatura de tumor fibroso solitario con localización intraespinal. Con este artículo aportamos un nuevo caso a la misma

Introduction: Solitary fibrous tumor (TFS) is a rare tumor of mesenchymal origin, located mainly in the pleura. It is extraordinarily infrequent find it at the intraespinal level, being the thoracic region the most frequent. Case presentation: We present the case of a 48-year-old patient with progressive ascending lower limb and myelopathy of one month of evolution, with intraspinal location at the D3-D4 level. It was surgically operated by posterior dorsal approach and D3-D4 laminoplasty, with an intradural tumor with an intramedullary component of approximately 18×12mm. The resection was complete and the pathological anatomy gave the diagnosis of solitary fibrous tumor. The patient is currently asymptomatic. Discussion: Complete tumor resection and histopathological features are the main prognostic factors. Surgery have a main role in this type of neoplasia. Conclusion: There are few case published of solitary fibrous tumor with intraspinal localization. We apport another case to the literature

Solitary fibrous tumor: A clinical case. / Tumor fibroso solitario extra-intramedular de localización dorsal.

INTRODUCTION: Solitary fibrous tumor (TFS) is a rare tumor of mesenchymal origin, located mainly in the pleura. It is extraordinarily infrequent find it at the intraespinal level, being the thoracic region the most frequent. CASE PRESENTATION: We present the case of a 48-year-old patient with progressive ascending lower limb and myelopathy of one month of evolution, with intraspinal location at the D3-D4 level. It was surgically operated by posterior dorsal approach and D3-D4 laminoplasty, with an intradural tumor with an intramedullary component of approximately 18×12mm. The resection was complete and the pathological anatomy gave the diagnosis of solitary fibrous tumor. The patient is currently asymptomatic. DISCUSSION: Complete tumor resection and histopathological features are the main prognostic factors. Surgery have a main role in this type of neoplasia. CONCLUSION: There are few case published of solitary fibrous tumor with intraspinal localization. We apport another case to the literature.