Lancet
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Multicenter Study
Mortality and pulmonary complications in patients undergoing surgery with perioperative SARS-CoV-2 infection: an international cohort study.
This massively-multicenter (235 hospitals, 24 countries; mainly Europe & N. America) cohort study investigated post-operative morbidity and mortality in those with confirmed SARS-CoV-2 infection.
Why is this significant?
Early data suggested that COVID-19 patients who underwent even minor elective surgery suffered worse post-operative outcomes, particularly higher mortality.
This large cohort study confirms these concerns and will assist decision making around the timing of surgery for COVID-19 patients and the process for re-commencing elective surgery in communities hardest hit by the pandemic.
What did they do?
Over a 3 month period in early 2020 the researchers analysed 1,128 patients who underwent emergency (74%) or elective (25%) surgery across 24 countries. Patients diagnosed with COVID seven days pre-op or 30 days post-op were included, although the majority of patients (74%) had SARS-CoV-2 infection diagnosed post-operatively.
And they found?
30-day mortality was extremely high (24%).
Pulmonary complications (pneumonia, ARDS or unexpected post-op ventilation) were very common (51%) and were associated with an even higher mortality (38%; and 83% of all deaths).
Mortality was unsurprisingly associated with older age ≥ 70 years, male sex, ASA ≥ 3, emergency surgery, major surgery, and malignancy.
Other interesting observations...
- Nonetheless 'lower-risk' groups still suffered significant 30-day mortality rates, eg. 30-49 year olds (6%), women (18%), ASA 1-2 (12%), no-comorbidities (7%).
- Being asymptomatic at admission did not have a significant protective effect (22% vs 27% mortality).
- Dyspnoea and/or sputum on admission were the only symptoms associated with worse outcomes.
- 20% of patients suffered ARDS, with a 63% mortality rate.
- Although emergency surgery was higher risk, elective surgery still carried a 19% mortality rate. Even minor surgery resulted in a 16% mortality rate!
- Even obstetrics (2% mortality) and gynaecology (5%) demonstrated orders of magnitude-higher mortality than expected.
- There was no statistically significant difference between local, regional or general anaesthesia.
- Pulmonary embolus was only seen in 2% at 30 days and when present did not appear to impact mortality.
Why such high post-operative COVID mortality?
The authors suggest this could be due to the combination of pro-inflammatory cytokine and immunosuppressive responses to surgery, and/or mechanical ventilation associated with general anaesthesia (although the later was not significantly associated with higher mortality).
Implications
Surgery for those with known or suspected COVID-19 should be avoided or delayed until after recovery from infection, as allowed by the underlying surgical pathology. When surgery cannot be delayed less-invasive surgery is preferable, and post-operative recovery should be closely monitored.
Keep in mind
Although RT-PCR testing was the main diagnostic test, in some settings clinical criteria (6%) and/or chest CT (7%) were instead used for diagnosis. Additionally, hospital data collection during a pandemic emergency carries higher risk of error, although this should not effect the broad validity of the research conclusions.
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Randomized Controlled Trial Multicenter Study
Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA.
Ubrogepant is a calcitonin gene-related peptide (CGRP) receptor antagonist that is approved for acute treatment of migraine. The prodrome is the earliest phase of a migraine attack and is characterised by non-aura symptoms that precede headache onset. The aim of this trial was to evaluate the efficacy, safety, and tolerability of ubrogepant 100 mg compared with placebo for the acute treatment of migraine when administered during the prodrome. ⋯ AbbVie.
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Simple protective behavioural changes, namely physical distancing, face-mask use & eye protection, are associated with a significant risk reduction in coronavirus transmission.
pearl -
Randomized Controlled Trial Multicenter Study
Methotrexate to treat hand osteoarthritis with synovitis (METHODS): an Australian, multisite, parallel-group, double-blind, randomised, placebo-controlled trial.
Hand osteoarthritis is a disabling condition with few effective therapies. Hand osteoarthritis with synovitis is a common inflammatory phenotype associated with pain. We aimed to examine the efficacy and safety of methotrexate at 6 months in participants with hand osteoarthritis and synovitis. ⋯ National Health and Medical Research Council of Australia.
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Randomized Controlled Trial Multicenter Study
Sunitinib for metastatic progressive phaeochromocytomas and paragangliomas: results from FIRSTMAPPP, an academic, multicentre, international, randomised, placebo-controlled, double-blind, phase 2 trial.
No randomised controlled trial has ever been done in patients with metastatic phaeochromocytomas and paragangliomas. Preclinical and first clinical evidence suggested beneficial effects of sunitinib. We aimed to evaluate the safety and efficacy of sunitinib in patients with metastatic phaeochromocytomas and paragangliomas. ⋯ French Ministry of Health, through the National Institute for Cancer, German Ministry of Education and Research, and the German Research Foundation within the CRC/Transregio 205/2, EU Seventh Framework Programme, and a private donator grant.