IMPORTANCE Peripheral facial nerve (Bell) palsy has been reported and widely suggested as a possible adverse effect of the BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine. Israel is currently the leading country in vaccination rates per capita, exclusively using the BNT162b2 vaccine, and all residents of Israel are obligatory members of a national digital health registry system. These factors enable early analysis of adverse events.OBJECTIVE To examine whether the BNT162b2 vaccine is associated with an increased risk of acute-onset peripheral facial nerve palsy. DESIGN, SETTING, AND PARTICIPANTSThis case-control study was performed from January 1 to February 28, 2021, at the emergency department of a tertiary referral center in central Israel. Patients admitted for facial nerve palsy were matched by age, sex, and date of admission with control patients admitted for other reasons. EXPOSURES Recent vaccination with the BNT162b2 vaccine.MAIN OUTCOMES AND MEASURES Adjusted odds ratio for recent exposure to the BNT162b2 vaccine among patients with acute-onset peripheral facial nerve palsy. The proportion of patients with Bell palsy exposed to the BNT162b2 vaccine was compared between groups, and raw and adjusted odds ratios for exposure to the vaccine were calculated. A secondary comparison with the overall number of patients with facial nerve palsy in preceding years was performed.RESULTS Thirty-seven patients were admitted for facial nerve palsy during the study period, 22 (59.5%) of whom were male, and their mean (SD) age was 50.9 (20.2) years. Among recently vaccinated patients (21 [56.7%]), the mean (SD) time from vaccination to occurrence of palsy was 9.3 (4.2 [range, 3-14]) days from the first dose and 14.0 (12.6 [range, 1-23]) days from the second dose. Among 74 matched controls (2:1 ratio) with identical age, sex, and admittance date, a similar proportion were vaccinated recently (44 [59.5%]). The adjusted odds ratio for exposure was 0.84 (95% CI, 0.37-1.90; P = .67). Furthermore, analysis of the number of admissions for facial nerve palsy during the same period in preceding years (2015-2020) revealed a relatively stable trend (mean [SD], 26.8 [5.8]; median, 27.5 [range,[17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32][33][34][35]). CONCLUSIONS AND RELEVANCEIn this case-control analysis, no association was found between recent vaccination with the BNT162b2 vaccine and risk of facial nerve palsy.
ESBL-PE carriers who receive cephalosporin-based prophylaxis are at increased risk of SSI following colorectal surgery.
Purpose Coronavirus disease 2019 (COVID-19) caused a global pandemic with millions infected worldwide. Little is known on the ocular involvement associated with the disease. The aim of this study was to assess the clinical and molecular ocular involvement among patients with confirmed COVID-19 admitted to a tertiary care facility. Methods Consecutive patients admitted to the COVID-19 Ward of the Shamir Medical Center in Israel during March and April, 2020 were included. The control group included patients negative for COVID-19 admitted during a similar period to a different ward. Patients were examined by trained Ophthalmologists. SARS-CoV-2 conjunctival swab samples were obtained. Results Included were 48 patients, 16 with confirmed COVID-19 and 32 controls. Median patient age was 68.5 (interquartile range: 31.5, mean: 63 ± 21) years and 48% were male. Active conjunctival injection was present in three patients (19%) with COVID-19, compared to none in the controls (p = 0.034). Patients with COVID-19 were more likely to complain of foreign body sensation (31.3% vs 3.1%, p = 0.005) and redness of the eye (25% vs 0%, p = 0.003). Conjunctival injection was associated with loss of smell and taste (75% vs 7.7%, p = 0.018). Viral conjunctival swab tests all showed negative results for all three viral genes tested (E, N, and RdRp). Conclusions Among patients admitted to a tertiary referral center with confirmed COVID-19, active conjunctival injection was noted in one out of five cases, and was associated with loss of smell and taste. Conjunctival swabs for viral RNA were negative in patients with and without ocular involvement.
Background Carriers of extended-spectrum β-lactamase–producing Enterobacteriaceae (ESBL-PE) who receive cephalosporin-based prophylaxis have twice the risk of surgical site infection (SSI) following colorectal surgery as noncarriers. We tested whether ESBL-PE screening and personalized prophylaxis with ertapenem reduces SSI risk among carriers. Methods We conducted a prospective nonrandomized, nonblinded, interventional study in 3 hospitals in Israel, Switzerland, and Serbia. Patients were screened for ESBL-PE carriage before elective colorectal surgery. During the baseline phase, departmental guidelines advised prophylaxis with a cephalosporin plus metronidazole. In the intervention phase, guidelines were changed for ESBL-PE carriers to receive ertapenem. The primary outcome was any type of SSI within 30 days. We calculated adjusted risk differences (ARDs) following logistic regression. Results The intention-to-treat analysis compared 209 ESBL-PE carriers in the baseline phase to 269 in the intervention phase. SSI rates were 21.5% and 17.5%, respectively (ARD, –4.7% [95% confidence interval {CI}, –11.8% to 2.4%]). Unplanned crossover was high (15%), so to assess efficacy we performed an as-treated analysis comparing 247 patients who received cephalosporin-based prophylaxis with 221 who received ertapenem. SSI rates were 22.7% and 15.8%, respectively (ARD, –7.7% [95% CI, –14.6% to –.8%]), and rates of SSI caused by ESBL-PE were 6.5% and 0.9%, respectively (ARD, –5.6% [95% CI, –8.9% to –2.3%]). There was no significant difference in the rate of deep SSI. The number needed to treat to prevent 1 SSI in ESBL-PE carriers was 13. Conclusions Screening for ESBL-PE carriage before colorectal surgery and personalizing prophylaxis for carriers is efficacious in reducing SSI.
Importance: Posterior capsular opacification (PCO) is the most common complication after cataract surgery. Background: We aimed to assess the relationship between intraocular lens (IOL) diopter and formation of PCO among a consecutive real-world registry. Design: Cohort study. Participants: Included were 14 264 consecutive cases of uncomplicated cataract surgery performed during 2014 to 2018 in Helsinki University Hospital in Finland. Methods: Nd:YAG capsulotomies were used as an estimate of clinically significant PCO. A single eye of each patient and a single type of IOL were included. Main Outcome Measure: Nd:YAG posterior capsulotomy free survival. Results: Mean age was 73.2 ± 9.9 years and 61.8% were female. Mean followup time was 25.4 ± 16.8 months. Overall PCO rates were 1.1% at 1-year, 3.0% at 2-year, 7.1% at 3-year and 10.2% at 4-year. Patients with IOL diopters (D) in the lower quartile (≤20.0 D) had significantly higher rates of PCO (1.3% at 1-year, 4.4% at 2-years, 9.4% at 3-years and 14.2% at 4-years, P < .001). A logistic regression model showed increased risk for PCO formation with lower diopter IOLs; for ≤20.0 D: OR 1.343 (95% CI: 1.132-1.593), for ≤10.0 D: OR 2.409 (95% CI 1.203-4.287), P < .001 for all comparisons. In a multivariant regression accounting for possible confounders, results remained consistent. Conclusions and Relevance: Among a cohort of patients undergoing cataract surgery, use of lower diopter IOLs was associated with increased incidence of clinically significant PCO. Research into IOL biomechanics to decrease PCO may be warranted especially in lower diopter IOLs.
Background Late-onset upper eyelid edema is an uncommonly recognized complication of hyaluronic acid (HA)-based filler injection to the supraorbital area. Objectives The authors sought to report their experience in diagnosing and managing late-onset upper eyelid edema. Methods This was a noncomparative, retrospective study of a series of 17 consecutive patients who presented with upper eyelid edema 6 to 24 months after uneventful HA filler injection in the supraorbital area. Results The study group included 17 female patients. The average time of presentation was 13.9 months. Thirteen patients (76.4%) were satisfied after hyaluronidase and requested no further treatment (observation only); 4 patients (23.5%) elected to receive HA filler re-treatment, with satisfactory results. All patients were followed-up for at least 6 months after the re-treatment. Conclusions The incidence of late-onset upper eyelid edema is likely to increase as the number of patients undergoing HA filler injection to the supraorbital area increases. Our study emphasizes the importance of recognizing this condition and suggests a suitable noninvasive treatment with satisfying results for both the patient and the physician. Level of Evidence: 4
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