IMPORTANCE Splenic arterial embolization (SAE) improves the rate of spleen rescue, yet the advantage of prophylactic SAE (pSAE) compared with surveillance and then embolization only if necessary (SURV) for patients at high risk of spleen rupture remains controversial. OBJECTIVE To determine whether the 1-month spleen salvage rate is better after pSAE or SURV. DESIGN, SETTING, AND PARTICIPANTSIn this randomized clinical trial conducted between February 6, 2014, and September 1, 2017, at 16 institutions in France, 133 patients with splenic trauma at high risk of rupture were randomized to undergo pSAE or SURV. All analyses were performed on a per-protocol basis, as well as an intention-to-treat analysis for specific events.INTERVENTIONS Prophylactic SAE, preferably using an arterial approach via the femoral artery, or SURV. MAIN OUTCOMES AND MEASURESThe primary end point was an intact spleen or a spleen with at least 50% vascularized parenchyma detected on an arterial computed tomography scan at 1 month after trauma, assessed by senior radiologists masked to the treatment group. Secondary end points included splenectomy and pseudoaneurysm, secondary SAE after inclusion, complications, length of hospital stay, quality-of-life score, and length of time off work or studies during the 6-month follow-up.RESULTS A total of 140 patients were randomized, and 133 (105 men [78.9%]; median age, 30 years [interquartile range, 23-47 years]) were retained in the study. For the primary end point, data from 117 patients (57 who underwent pSAE and 60 who underwent SURV) could be analyzed. The number of patients with at least a 50% viable spleen detected on a computed tomography scan at month 1 was not significantly different between the pSAE and SURV groups (56 of 57 [98.2%] vs 56 of 60 [93.3%]; difference, 4.9%; 95% CI, −2.4% to 12.1%; P = .37). By the day 5 visit, there were significantly fewer splenic pseudoaneurysms among patients in the pSAE group than in the SURV group (1 of 65 [1.5%] vs 8 of 65 [12.3%]; difference, −10.8%; 95% CI, −19.3% to −2.1%; P = .03), significantly fewer secondary embolizations among patients in the pSAE group than in the SURV group (1 of 65 [1.5%] vs 19 of 65 [29.2%]; difference, −27.7%; 95% CI, −41.0% to −15.9%; P < .001), and no difference in the overall complication rate between the pSAE and SURV groups (19 of 65 [29.2%] vs 27 of 65 [41.5%]; difference, −12.3%; 95% CI, −28.3% to 4.4%; P = .14). Between the day 5 and month 1 visits, the overall complication rate was not significantly different between the pSAE and SURV groups (11 of 59 [18.6%] vs 12 of 63 [19.0%]; difference, −0.4%; 95% CI, −14.4% to 13.6%; P = .96). The median length of hospitalization was significantly shorter for patients in the pSAE group than for those in the SURV group (9 days [interquartile range, 6-14 days] vs 13 days [interquartile range, 9-17 days]; P = .002).CONCLUSIONS AND RELEVANCE Among patients with splenic trauma at high risk of rupture, the 1-month spleen salvage rate was not statistically different between patients...
Background and Purpose: Acute ischemic stroke and large vessel occlusion can be concurrent with the coronavirus disease 2019 (COVID-19) infection. Outcomes after mechanical thrombectomy (MT) for large vessel occlusion in patients with COVID-19 are substantially unknown. Our aim was to study early outcomes after MT in patients with COVID-19. Methods: Multicenter, European, cohort study involving 34 stroke centers in France, Italy, Spain, and Belgium. Data were collected between March 1, 2020 and May 5, 2020. Consecutive laboratory-confirmed COVID-19 cases with large vessel occlusion, who were treated with MT, were included. Primary investigated outcome: 30-day mortality. Secondary outcomes: early neurological improvement (National Institutes of Health Stroke Scale improvement ≥8 points or 24 hours National Institutes of Health Stroke Scale 0–1), successful reperfusion (modified Thrombolysis in Cerebral Infarction grade ≥2b), and symptomatic intracranial hemorrhage. Results: We evaluated 93 patients with COVID-19 with large vessel occlusion who underwent MT (median age, 71 years [interquartile range, 59–79]; 63 men [67.7%]). Median pretreatment National Institutes of Health Stroke Scale and Alberta Stroke Program Early Computed Tomography score were 17 (interquartile range, 11–21) and 8 (interquartile range, 7–9), respectively. Anterior circulation acute ischemic stroke represented 93.5% of cases. The rate modified Thrombolysis in Cerebral Infarction 2b to 3 was 79.6% (74 patients [95% CI, 71.3–87.8]). Thirty-day mortality was 29% (27 patients [95% CI, 20–39.4]). Early neurological improvement was 19.5% (17 patients [95% CI, 11.8–29.5]), and symptomatic intracranial hemorrhage was 5.4% (5 patients [95% CI, 1.7–12.1]). Patients who died at 30 days exhibited significantly lower lymphocyte count, higher levels of aspartate, and LDH (lactate dehydrogenase). After adjustment for age, initial National Institutes of Health Stroke Scale, Alberta Stroke Program Early Computed Tomography score, and successful reperfusion, these biological markers remained associated with increased odds of 30-day mortality (adjusted odds ratio of 2.70 [95% CI, 1.21–5.98] per SD-log decrease in lymphocyte count, 2.66 [95% CI, 1.22–5.77] per SD-log increase in aspartate, and 4.30 [95% CI, 1.43–12.91] per SD-log increase in LDH). Conclusions: The 29% rate of 30-day mortality after MT among patients with COVID-19 is not negligible. Abnormalities of lymphocyte count, LDH and aspartate may depict a patient’s profiles with poorer outcomes after MT. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT04406090.
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