Risk of disease relapse, safety and tolerability of SARS-CoV-2 vaccination in patients with chronic inflammatory neuropathies.

BACKGROUND AND PURPOSE: The aim was to evaluate the risk of relapse after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination, and its safety and tolerability, in patients with chronic inflammatory neuropathies. METHODS: In this multicenter, cohort and case-crossover study, the risk of relapse associated with SARS-CoV-2 vaccination was assessed by comparing the frequency of relapse in chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) and multifocal motor neuropathy (MMN) patients who underwent or did not undergo vaccination. Frequency of relapse in the 3 months prior to and after vaccination, and safety and tolerability of SARS-CoV-2 vaccination, were also assessed. RESULTS: In all, 336 patients were included (278 CIDP, 58 MMN). Three hundred and seven (91%) patients underwent SARS-CoV-2 vaccination. Twenty-nine patients (9%) did not undergo vaccination. Mild and transient relapses were observed in 16 (5%) patients (13 CIDP, 3 MMN) after SARS-CoV-2 vaccination and in none of the patients who did not undergo vaccination (relative risk [RR] 3.21, 95% confidence interval [CI] 0.19-52.25). There was no increase in the specific risk of relapse associated with type of vaccine or diagnosis. Comparison with the 3-month control period preceding vaccination revealed an increased risk of relapse after vaccination (RR 4.00, 95% CI 1.35-11.82), which was restricted to CIDP patients (RR 3.25, 95% CI 1.07-9.84). The safety profile of SARS-CoV-2 vaccination was characterized by short-term, mild-to-moderate local and systemic adverse events. CONCLUSIONS: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination in CIDP and MMN patients does not seem to be associated with an increased risk of relapse at the primary end-point, although a slightly increased risk in CIDP patients was found compared to the 3 months before vaccination.

[SYSVENT: Proof of Concept Study of a Prototype to Ventilate Critical Care Patients]. / SYSVENT: Prova de Conceito de um Protótipo para Ventilar Doentes em Cuidados Intensivos.

INTRODUCTION: The new coronavirus pandemic has led to scarcity of invasive ventilation resources in hospitals in several countries. In this context, the Portuguese Medical Association invited intensive care physicians who, in collaboration with SYSADVANCE S.A., developed SYSVENT OM1, a ventilator capable of operating in controlled and assisted modes (volume and pressure) and able to treat patients admitted to intensive care units. In this study we do the proof of concept comparing programmed tidal volume, inspiratory pressure and positive end-expiratory pressure with those measured by the ventilator and an external measuring equipment. MATERIAL AND METHODS: We set up the ventilator in tandem with an artificial lung and a flow analyzer. We measured expiratory tidal volume, and inspiratory pressure against three levels of compliance, each with six steps of tidal volume. Positive end-expiratory pressure was measured at 2 cmH2O incremental along eight steps. For each measurement, we performed three readings. RESULTS: Considering each of the three single variables, the mean value of the highest difference between programmed values and measured values is, for all of them, within what we considered to be acceptable for a prototype model (tidal volume = -28.1 mL, inspiratory pressure = 0.8 cmH2O and positive end-expiratory pressure = -1.1 cmH2O). This difference is greater when evaluated with the external measuring equipment in comparison with the ventilator. DISCUSSION: The results showed a good monitoring and accuracy performance. Technical limitations related with the artificial lung and the flow analyzer have been documented, which do not compromise the results, but limit their amplitude. CONCLUSION: For tested parameters, the ventilator has a good operating performance, is in accordance with the initial premises and has potential for clinical use.

Introdução: A pandemia pelo novo coronavírus provocou rotura em hospitais de vários países por falta de recursos para ventilaçãoinvasiva. Assim, a Ordem dos Médicos convidou intensivistas que, em colaboração com a SYSADVANCE S.A., desenvolveram o SYSVENT OM1, um ventilador capaz de operar em modos controlados e assistidos (volume e pressão) e apto para tratar doentes em cuidados intensivos. Neste estudo fazemos a prova de conceito, comparando volume-corrente, pressão inspiratória e pressão positiva tele-expiratória programados, com os valores medidos pelo ventilador e por um equipamento de medição externo.Material e Métodos: Montámos o ventilador em série com um pulmão artificial e um analisador de fluxos. Medimos o volume-corrente expiratório e a pressão inspiratória, em três níveis de compliance e seis patamares de volume-corrente. A pressão positiva tele-expiratória foi medida com incrementos de 2 cmH2O ao longo de oito patamares. Para cada medição realizámos três leituras.Resultados: Considerando cada uma das três variáveis isoladamente, a média da diferença máxima entre os valores programados e os valores medidos situa-se, para todas elas, dentro do que considerámos ser aceitável para um modelo protótipo (volume-corrente = -28,1 mL, pressão inspiratória = 0,8 cmH2O e pressão positiva tele-expiratória = -1,1 cmH2O). Essa diferença é maior quando avaliada com o equipamento de medição externa comparativamente com o ventilador.Discussão: Os resultados mostraram uma boa capacidade de monitorização e de precisão. Documentaram-se limitações técnicas relacionadas com o pulmão artificial e com o analisador de fluxos que não desvirtuam os resultados, mas limitam a sua amplitude.Conclusão: Para os parâmetros testados, o ventilador apresenta boa performance de funcionamento, está de acordo com as premissasiniciais e tem potencial para uso clínico.