Restoring Hand Functions in People with Tetraplegia through Multi-Contact, Fascicular, and Auto-Pilot Stimulation: A Proof-of-Concept Demonstration.

Two multi-contact epineural electrodes were placed around radial and median nerves of two subjects with high tetraplegia C4, American Spinal Injury Association Impairment Scale (AIS) A, group 0 of the International Classification for Surgery of the Hand in Tetraplegia. The purpose was to study the safety and capability of these electrodes to generate synergistic motor activation and functional movements and to test control interfaces that allow subjects to trigger pre-programmed stimulation sequences. The device consists of a pair of neural cuff electrodes and percutaneous cables with two extracorporeal connection cables inserted during a surgical procedure and maintained for 28 days. Continuity tests of the electrodes, selectivity of movements induced, motor capacities for grasping and gripping, conformity of the control order, tolerance, and acceptability were assessed. Neither of the two participants showed general and local comorbidity. Acceptability was optimal. None of the stimulation configurations generated contradictory movements. The success rate in task execution by the electro-stimulated hand exceeded the target of 50% (54% and 51% for patients 1 and 2, respectively). The compliance rate of the control orders in both patients was >90% using motion inertial measurement unit (IMU)-based detection and 100% using electromyography (EMG)-based detection in patient 1. These results support the relevance of neural stimulation of the tetraplegic upper limb with a more selective approach, using multi-contact epineural electrodes with nine and six contact points for the median and radial nerve respectively.

Remoção Percutânea de Eletrodos de Estimulação Cardíaca Artificial em um Único Centro Sul-Americano / Percutaneous Removal of Cardiac Leads in a Single Center in South America

Resumo Fundamento: Nas últimas décadas, o número de dispositivos eletrônicos cardíacos implantáveis (DCEI) aumentou consideravelmente, assim como a necessidade de remoção destes. Neste contexto, a remoção percutânea apresenta-se como uma técnica segura e capaz de evitar uma cirurgia cardíaca convencional. Objetivos: Primário: descrever a taxa de sucesso e complicações da remoção percutânea de DCEI em um hospital público brasileiro. Secundário: estabelecer preditores de sucesso e complicações. Métodos: Serie de casos retrospectiva de todos os pacientes submetidos à remoção de DCEI em um hospital público brasileiro no período de janeiro de 2013 a junho de 2018. Remoção, explante e extração de eletrodos, complicações e desfechos foram definidos conforme a diretriz norte-americana de 2017. Variáveis categóricas foram comparadas pelos testes Qui-quadrado ou Fisher, enquanto variáveis contínuas, por testes não pareados. O nível de significância adotado nas análises estatísticas foi de 5%. Resultados: 61 pacientes foram submetidos à remoção de DCEI, sendo 51 extrações e 10 explantes. No total, 128 eletrodos foram removidos. Taxa de sucesso clínico foi 100% no grupo do explante e 90,2% no da extração (p=0,58). Complicações maiores foram encontradas em 6,6% dos pacientes. Falha do procedimento foi associada a eletrodos de ventrículo (p=0,05) e átrio (p=0,04) direito implantados há mais tempo. Duração do procedimento (p=0,003) e necessidade de transfusão sanguínea (p<0,001) foram associadas a maior índice de complicação. Conclusão: As taxas de complicação e sucesso clínico observadas foram de 11,5% e 91,8%, respectivamente. Remoções de eletrodos atriais e ventriculares mais antigos estiveram associados a menores taxa de sucesso. Procedimentos mais longos e necessidade de transfusão sanguínea foram associados a complicações.

Abstract Background: In the last decade, the number of cardiac electronic devices has risen considerably and consequently the occasional need for their removal. Concurrently, the transvenous lead removal became a safe procedure that could prevent open-heart surgery. Objective: The primary objective of this study was to describe the successful performance and the complication rates of pacemaker removals in a Brazilian public hospital. Our secondary aim was to describe the variables associated to successes and complications. Methods: A retrospective case series was conducted in patients submitted to pacemaker removal in a Brazilian public hospital from January 2013 to June 2018. Removal, explant, extraction, success and complication rates were defined by the 2017 Heart Rhythm Society Guideline. Categorical variables were compared using x2 or Fisher's tests, while continuous variables were compared by unpaired tests. A p-value of 0.05 was considered statistically significant. Results: Cardiac device removals were performed in 61 patients, of which 51 were submitted to lead extractions and 10 to lead explants. In total, 128 leads were removed. Our clinical success rate was 100% in the explant group and 90.2% in the extraction one (p=0.58). Major complications were observed in 6.6% patients. Procedure failure was associated to older right ventricle (p=0.05) and atrial leads (p=0,04). Procedure duration (p=0.003) and need for blood transfusion (p<0,001) were associated to more complications. Conclusion: Complications and clinical success were observed in 11.5% and 91.8% of the population, respectively. Removal of older atrial and ventricular leads were associated with lower success rates. Longer procedures and blood transfusions were associated with complications.