Safety and Performance of a New Burr Hole Covering Device: Results of the Multicenter COVER Registry.

BACKGROUND: Burr hole covering in brain surgical procedures can avoid complications and unaesthetic results. The aim of this registry was to assess the safety and performance of a new polymeric burr hole covering device (Cranial COVER, NEOS Surgery). METHODS: A multicenter, prospective, clinical registry design was used for the study. All the patients who fulfilled the inclusion criteria were included in the study and followed up for 6 months. Baseline clinical parameters, surgical variables (technical success of the implantation, surgeon satisfaction), postoperative variables (aesthetic and functional results, neuroimaging artifacts), and adverse events were evaluated. RESULTS: Forty-three Cranial COVER devices were implanted in 30 patients. Most of them were implanted in frontal locations (53.5%). After implantation, 97.7% of the devices completely covered the burr hole, and 100% perfectly adapted to the skull surface. All surgeons ranked their satisfaction with the implantation procedure as very high or high. No artifacts were detected in any of the neuroimaging studies performed and no adverse events related with the device or its implantation were reported during the follow-up. There were significantly more scalp depressions associated with uncovered than with Cranial COVER-covered burr holes (p = 0.040). Patient satisfaction with covered burr holes located in the frontal and parietal areas was 9.0 ± 1.4 over 10. CONCLUSION: Cranial COVER is a safe and reliable burr hole covering system that offers excellent cosmetic results and high satisfaction rates for both surgeons and patients. Cranial COVER is highly adaptable to the skull surface, and it was predominantly used in frontal locations due to their cosmetic importance.

Budget impact analysis of demineralized bone matrix in combination with autograft in lumbar spinal fusion procedures for the treatment of lumbar degenerative disc disease in Spain.

OBJECTIVE: To estimate the budget impact (BI) of introducing local autograft (LA) combined with demineralized bone matrix (LA + DBM) in lumbar spinal fusion (LSF) procedures to treat lumbar degenerative disc disease (LDDD) in Spain. METHODS: A decision tree model was developed to evaluate the 4-year BI associated with introducing LA + DBM putty to replace currently available grafting methods, including iliac crest bone graft (ICBG), LA alone, and LA combined with beta-tricalcium phosphate (LA + ceramics), with 30%, 40%, and 30% market shares, respectively. The analysis was conducted for a hypothetical cohort of 100 patients with LDDD receiving LSF, assuming LA + DBM would replace 100% of the standard of care mix. The fusion rates extracted from the literature were validated by an expert panel. Costs (€2017) were obtained from different Spanish sources. Budget impact and incremental cost per successful fusion were calculated from the perspective of the Spanish National Health System (NHS). RESULTS: Over 4 years, replacing currently available options with LA + DBM for 100 patients resulted in an additional cost of €12,330 (€123/patient), and an additional 14 successful fusions, implying a cost of €881 per additional successful fusion. When costs of productivity loss were included, the introduction of LA + DBM resulted in cost savings of €70,294 (€703/patient). LIMITATIONS: The lack of high-quality, homogeneous, head-to-head research studying the efficacy of grafting procedures available to patients undergoing LSF, in addition to a lack of long-term follow-up in existing studies. Therefore, the number of fusions occurring within the model's time horizon may be underestimated. CONCLUSIONS: Acquisition costs of DBM were partially offset by costs of failed fusions, adverse events and reoperation when switching 100 hypothetical LDDD patients undergoing LSF procedures from standard of care grafting methods to LA + DBM from the perspective of the Spanish NHS. DBM cost was entirely offset when costs of lost productivity were considered.

Health-related quality of life in patients undergoing lumbar total disc replacement: A comparison with the general population.

OBJECTIVES: In up to half of the cases, low back pain (LBP) is thought to be related to a degeneration of the lumbar disc. Lumbar total disc replacement (LTDR) emerged as an alternative to fusion, but its use and indications are still subject to debate. The purpose of this paper was to compare Health-related Quality of life (HRQOL) in patients undergoing LTDR for one or two-level degenerative disc disease (DDD) with the paired age and gender general population values and to assess functional disability and residual pain at one year after the surgical procedure. MATERIAL AND METHODS: A series of 51 patients operated on for a one or two level DDD, were evaluated at one year after the surgical procedure. HRQOL was compared to that of paired age and gender general population using the EQ-5D-5L questionnaire. Disability, back (BP) and leg pain (LP) were compared to the preoperative values. RESULTS: ODI showed a mean improvement of 31.78 (p<0.001, 95% CI 27.39-36.17), BP-VAS of 5.29/10 (95% CI 4.56-6.02), LP-VAS of 4.03/10 (95% CI 3.15-4.92) at one year compared to the preoperative assessment. HRQOL had similar values to the general population in 32 patients and inferior in 19 patients. "Pain" was the HRQOL dimension in which most of the patients had inferior results compared to data from the general population. Patients with previous spinal surgery had lower improvements in HRQOL index, disability, and pain than those without previous surgery. CONCLUSIONS: We found that the majority of patients improved their HQOL to values similar to those of the general population. Disability and pain are significantly reduced compared to preoperative evaluations. Larger scale studies are needed to identify the best candidates for LTDR.

Tratamiento de la neuralgia del trigémino: actualización y perspectivas futuras de las técnicas percutáneas / Treatment of trigeminal neuralgia: an update and future prospects of percutaneous techniques

Introducción. La neuralgia del trigémino es uno de los síndromes de dolor facial más graves. La incidencia anual varía entre el 4-13% y altera de forma significativa la calidad de vida de los afectados. Cuando el dolor no puede controlarse con tratamiento farmacológico, existen diferentes opciones quirúrgicas. La selección de la técnica está basada en estudios observacionales y su aplicación depende de la experiencia de cada centro. Objetivos. Evaluar la efectividad y el nivel de evidencia del tratamiento farmacológico y quirúrgico en la neuralgia del trigémino, y analizar el papel actual de las técnicas percutáneas en el tratamiento de esta patología. Desarrollo. El tratamiento inicial de la neuralgia del trigémino es el farmacológico y la carbamacepina es el único fármaco con suficiente nivel de evidencia. Las técnicas quirúrgicas percutáneas son efectivas y de fácil aplicación, pero la tendencia a la recidiva conduce a la preferencia por la microdescompresión vascular. Sin embargo, no hay estudios comparativos que determinen la superioridad de alguna técnica con buen nivel de evidencia. Se han revisado las tres técnicas percutá- neas más utilizadas, la compresión con balón, la rizotomía con glicerol y la termocoagulación por radiofrecuencia. Esta última es la que ha presentado mayor desarrollo en los últimos años, con la aparición de técnicas neurofisiológicas que pueden optimizar los resultados. Conclusiones. La selección de una técnica quirúrgica en la neuralgia del trigémino no está bien apoyada por ensayos clínicos aleatorizados. Los nuevos procedimientos en la aplicación de la radiofrecuencia pueden mejorar las perspectivas del tratamiento de esta patología (AU)

Introduction. Trigeminal neuralgia is one of the most severe facial pain syndromes. The annual incidence varies between 4-13% and has a significant effect on patients’ quality of life. When the pain cannot be controlled by pharmacological treatment, several different surgical options can be considered. The choice of technique will be based on observational studies and its application depends on the experience of each centre. Aims. To assess the effectiveness and level of evidence of pharmacological and surgical treatment in trigeminal neuralgia, and to analyse the current role of percutaneous techniques in the treatment of this pathology. Development. The initial treatment of trigeminal neuralgia is pharmacological and carbamazepine is the only drug with a sufficiently high level of evidence. The percutaneous surgical techniques are effective and easy to apply, but the tendency for relapses to appear means there is a preference for vascular microdecompression. Yet, there are no reports of comparative studies that determine the superiority of a technique with a good level of evidence. The three most commonly used percutaneous techniques, balloon compression, glycerol rhizotomy and thermocoagulation by radiofrequency, were reviewed. This last technique is the one that has undergone the greatest development in recent years, with the emergence of neurophysiological techniques that make it possible to optimise results. Conclusions. The selection of a surgical technique for use in trigeminal neuralgia does not have much backing from randomised clinical trials. The new procedures in the application of radiofrequency can improve the treatment prospects of this pathology (AU)

[Treatment of trigeminal neuralgia: an update and future prospects of percutaneous techniques]. / Tratamiento de la neuralgia del trigemino: actualizacion y perspectivas futuras de las tecnicas percutaneas.

INTRODUCTION: Trigeminal neuralgia is one of the most severe facial pain syndromes. The annual incidence varies between 4-13% and has a significant effect on patients' quality of life. When the pain cannot be controlled by pharmacological treatment, several different surgical options can be considered. The choice of technique will be based on observational studies and its application depends on the experience of each centre. AIMS: To assess the effectiveness and level of evidence of pharmacological and surgical treatment in trigeminal neuralgia, and to analyse the current role of percutaneous techniques in the treatment of this pathology. DEVELOPMENT: The initial treatment of trigeminal neuralgia is pharmacological and carbamazepine is the only drug with a sufficiently high level of evidence. The percutaneous surgical techniques are effective and easy to apply, but the tendency for relapses to appear means there is a preference for vascular microdecompression. Yet, there are no reports of comparative studies that determine the superiority of a technique with a good level of evidence. The three most commonly used percutaneous techniques, balloon compression, glycerol rhizotomy and thermocoagulation by radiofrequency, were reviewed. This last technique is the one that has undergone the greatest development in recent years, with the emergence of neurophysiological techniques that make it possible to optimise results. CONCLUSIONS: The selection of a surgical technique for use in trigeminal neuralgia does not have much backing from randomised clinical trials. The new procedures in the application of radiofrequency can improve the treatment prospects of this pathology.

TITLE: Tratamiento de la neuralgia del trigemino: actualizacion y perspectivas futuras de las tecnicas percutaneas.Introduccion. La neuralgia del trigemino es uno de los sindromes de dolor facial mas graves. La incidencia anual varia entre el 4-13% y altera de forma significativa la calidad de vida de los afectados. Cuando el dolor no puede controlarse con tratamiento farmacologico, existen diferentes opciones quirurgicas. La seleccion de la tecnica esta basada en estudios observacionales y su aplicacion depende de la experiencia de cada centro. Objetivos. Evaluar la efectividad y el nivel de evidencia del tratamiento farmacologico y quirurgico en la neuralgia del trigemino, y analizar el papel actual de las tecnicas percutaneas en el tratamiento de esta patologia. Desarrollo. El tratamiento inicial de la neuralgia del trigemino es el farmacologico y la carbamacepina es el unico farmaco con suficiente nivel de evidencia. Las tecnicas quirurgicas percutaneas son efectivas y de facil aplicacion, pero la tendencia a la recidiva conduce a la preferencia por la microdescompresion vascular. Sin embargo, no hay estudios comparativos que determinen la superioridad de alguna tecnica con buen nivel de evidencia. Se han revisado las tres tecnicas percutaneas mas utilizadas, la compresion con balon, la rizotomia con glicerol y la termocoagulacion por radiofrecuencia. Esta ultima es la que ha presentado mayor desarrollo en los ultimos años, con la aparicion de tecnicas neurofisiologicas que pueden optimizar los resultados. Conclusiones. La seleccion de una tecnica quirurgica en la neuralgia del trigemino no esta bien apoyada por ensayos clinicos aleatorizados. Los nuevos procedimientos en la aplicacion de la radiofrecuencia pueden mejorar las perspectivas del tratamiento de esta patologia.