Clinical review: Serious adverse events associated with the use of rituximab - a critical care perspective

IntroductionAlthough acute transverse myelitis (ATM) is a rare neurological condition (1.34-4.6 cases per million/year) COVID-19-associated ATM cases have occurred during the pandemic.Case-finding methodsWe report a patient from Panama with SARS-CoV-2 infection complicated by ATM and present a comprehensive clinical review of 43 patients with COVID-19-associated ATM from 21 countries published from March 2020 to January 2021. In addition, 3 cases of ATM were reported as serious adverse events during the clinical trials of the COVID-19 vaccine ChAdOx1 nCoV-19 (AZD1222).ResultsAll patients had typical features of ATM with acute onset of paralysis, sensory level and sphincter deficits due to spinal cord lesions demonstrated by imaging. There were 23 males (53%) and 20 females (47%) ranging from ages 21- to 73- years-old (mean age, 49 years), with two peaks at 29 and 58 years, excluding 3 pediatric cases. The main clinical manifestations were quadriplegia (58%) and paraplegia (42%). MRI reports were available in 40 patients; localized ATM lesions affected ≤3 cord segments (12 cases, 30%) at cervical (5 cases) and thoracic cord levels (7 cases); 28 cases (70%) had longitudinally-extensive ATM (LEATM) involving ≥4 spinal cord segments (cervicothoracic in 18 cases and thoracolumbar-sacral in 10 patients). Acute disseminated encephalomyelitis (ADEM) occurred in 8 patients, mainly women (67%) ranging from 27- to 64-years-old. Three ATM patients also had blindness from myeloneuritis optica (MNO) and two more also had acute motor axonal neuropathy (AMAN).ConclusionsWe found ATM to be an unexpectedly frequent neurological complication of COVID-19. Most cases (68%) had a latency of 10 days to 6 weeks that may indicate post-infectious neurological complications mediated by the host’s response to the virus. In 32% a brief latency (15 hours to 5 days) suggested a direct neurotropic effect of SARS-CoV-2. The occurrence of 3 reported ATM adverse effects among 11,636 participants in the AZD1222 vaccine trials is extremely high considering a worldwide incidence of 0.5/million COVID-19-associated ATM cases found in this report. The pathogenesis of ATM remains unknown, but it is conceivable that SARS-CoV-2 antigens –perhaps also present in the AZD1222 COVID-19 vaccine or its chimpanzee adenovirus adjuvant– may induce immune mechanisms leading to the myelitis.

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A response to ?The effect of critical care outreach on postoperative serious adverse events?, Story DA, Shelton AC, Poustie SJ, Colin-Thome NJ and McNicol PL, Anaesthesia 2004; 59: 762?6

Anaesthesia ◽

10.1111/j.1365-2044.2004.04009.x ◽

2004 ◽

Vol 59 (11) ◽

pp. 1152-1152

Author(s):

J. B. Sartain

Keyword(s):

Critical Care ◽

Adverse Events ◽

Serious Adverse Events ◽

Critical Care Outreach

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Serious adverse events in academic critical care research

Canadian Medical Association Journal ◽

10.1503/cmaj.071366 ◽

2008 ◽

Vol 178 (9) ◽

pp. 1181-1184 ◽

Cited By ~ 22

Author(s):

D. Cook ◽

F. Lauzier ◽

M. G. Rocha ◽

M. J. Sayles ◽

S. Finfer

Keyword(s):

Critical Care ◽

Adverse Events ◽

Serious Adverse Events ◽

Care Research

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The effect of critical care outreach on postoperative serious adverse events

Anaesthesia ◽

10.1111/j.1365-2044.2004.03835.x ◽

2004 ◽

Vol 59 (8) ◽

pp. 762-766 ◽

Cited By ~ 35

Author(s):

D. A. Story ◽

A. C. Shelton ◽

S. J. Poustie ◽

N. J. Colin-Thome ◽

P. L. McNicol

Keyword(s):

Critical Care ◽

Adverse Events ◽

Serious Adverse Events ◽

Critical Care Outreach

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Statin-induced adverse effects – facts and genes

Orvosi Hetilap ◽

10.1556/oh.2013.29530 ◽

2013 ◽

Vol 154 (3) ◽

pp. 83-92

Author(s):

Mariann Harangi ◽

Noémi Zsíros ◽

Lilla Juhász ◽

György Paragh

Keyword(s):

Risk Factors ◽

Single Nucleotide Polymorphisms ◽

Adverse Effects ◽

Adverse Events ◽

Statin Therapy ◽

Significant Proportion ◽

Gene Mutations ◽

Nucleotide Polymorphisms ◽

Serious Adverse Events ◽

Single Nucleotide

Statin therapy is considered to be safe and rarely associated with serious adverse events. However, a significant proportion of patients on statin therapy show some degree of intolerance which can lead to decreased adherence to statin therapy. The authors summarize the symptoms, signs and frequencies of the most common statin-induced adverse effects and their most important risk factors including some single nucleotide polymorphisms and gene mutations. Also, they review the available approaches to detect and manage the statin-intolerant patients. Orv. Hetil., 2013, 154, 83–92.

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Adverse Events Reporting System as Experienced by Critical-Care Nurses in KwaZulu-Natal, South Africa

Africa Journal of Nursing and Midwifery ◽

10.25159/2520-5293/2456 ◽

2018 ◽

Vol 20 (1) ◽

Author(s):

Thusile Mabel Gqaleni ◽

Busisiwe Rosemary Bhengu

Keyword(s):

South Africa ◽

Critical Care ◽

Adverse Events ◽

Patient Care ◽

Family Involvement ◽

Reporting System ◽

Legal Framework ◽

Critical Care Nurses ◽

Kwazulu Natal ◽

Life Threatening

Critically ill patients admitted to critical-care units (CCUs) might have life-threatening or potentially life-threatening problems. Adverse events (AEs) occur frequently in CCUs, resulting in compromised quality of patient care. This study explores the experiences of critical-care nurses (CCNs) in relation to how the reported AEs were analysed and handled in CCUs. The study was conducted in the CCUs of five purposively selected hospitals in KwaZulu-Natal, South Africa. A descriptive qualitative design was used to obtain data through in-depth interviews from a purposive sample of five unit managers working in the CCUs to provide a deeper meaning of their experiences. This study was a part of a bigger study using a mixed-methods approach. The recorded qualitative data were analysed using Tesch’s content analysis. The main categories of information that emerged during the data analysis were (i) the existence of an AE reporting system, (ii) the occurrence of AEs, (iii) the promotion of and barriers to AE reporting, and (iv) the handling of AEs. The findings demonstrated that there were major gaps that affected the maximum utilisation of the reporting system. In addition, even though the system existed in other institutions, it was not utilised at all, hence affecting quality patient care. The following are recommended: (1) a non-punitive and non-confrontational system should be promoted, and (2) an organisational culture should be encouraged where support structures are formed within institutions, which consist of a legal framework, patient and family involvement, effective AE feedback, and education and training of staff.

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Phosphene perceptions and safety of chronic visual cortex stimulation in a blind subject

Journal of Neurosurgery ◽

10.3171/2019.3.jns182774 ◽

2020 ◽

Vol 132 (6) ◽

pp. 2000-2007 ◽

Cited By ~ 3

Author(s):

Soroush Niketeghad ◽

Abirami Muralidharan ◽

Uday Patel ◽

Jessy D. Dorn ◽

Laura Bonelli ◽

...

Keyword(s):

Visual Cortex ◽

Adverse Events ◽

Clinical Intervention ◽

Occipital Cortex ◽

Neuronal Population ◽

Serious Adverse Events ◽

Stimulation Parameters ◽

The Right ◽

Visual Cortical ◽

Stimulation Of

Stimulation of primary visual cortices has the potential to restore some degree of vision to blind individuals. Developing safe and reliable visual cortical prostheses requires assessment of the long-term stability, feasibility, and safety of generating stimulation-evoked perceptions.A NeuroPace responsive neurostimulation system was implanted in a blind individual with an 8-year history of bare light perception, and stimulation-evoked phosphenes were evaluated over 19 months (41 test sessions). Electrical stimulation was delivered via two four-contact subdural electrode strips implanted over the right medial occipital cortex. Current and charge thresholds for eliciting visual perception (phosphenes) were measured, as were the shape, size, location, and intensity of the phosphenes. Adverse events were also assessed.Stimulation of all contacts resulted in phosphene perception. Phosphenes appeared completely or partially in the left hemifield. Stimulation of the electrodes below the calcarine sulcus elicited phosphenes in the superior hemifield and vice versa. Changing the stimulation parameters of frequency, pulse width, and burst duration affected current thresholds for eliciting phosphenes, and increasing the amplitude or frequency of stimulation resulted in brighter perceptions. While stimulation thresholds decreased between an average of 5% and 12% after 19 months, spatial mapping of phosphenes remained consistent over time. Although no serious adverse events were observed, the subject experienced mild headaches and dizziness in three instances, symptoms that did not persist for more than a few hours and for which no clinical intervention was required.Using an off-the-shelf neurostimulator, the authors were able to reliably generate phosphenes in different areas of the visual field over 19 months with no serious adverse events, providing preliminary proof of feasibility and safety to proceed with visual epicortical prosthetic clinical trials. Moreover, they systematically explored the relationship between stimulation parameters and phosphene thresholds and discovered the direct relation of perception thresholds based on primary visual cortex (V1) neuronal population excitation thresholds.

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