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BackgroundTo counter the COVID-19 pandemic, mRNA vaccines, namely tozinameran and elasomeran, have been authorized in several countries. These next generation vaccines have shown high efficacy against COVID-19 and demonstrated a favorable safety profile. As widespread vaccinations efforts are taking place, incidents of myocarditis and pericarditis cases following vaccination have been reported. This safety signal has been recently confirmed by the European Medicine Agency and the U.S. Food and Drug Administration. This study aimed to investigate and analyze this safety signal using a dual pharmacovigilance database analysis. MethodsThis is as an observational study of reports of inflammatory heart reactions associated with mRNA COVID-19 vaccines reported in the World Health Organizations global individual case safety report database (up to June 30th 2021), and in the U.S. Vaccine Adverse Event Reporting System (VAERS, up to May 21st 2021). Cases were described, and disproportionality analyses using reporting odds-ratios (ROR) and their 95% confidence interval (95%CI) were performed to assess relative risk of reporting according to patient sex and age. ResultsAt a global scale, the inflammatory heart reactions most frequently reported were myocarditis (1241, 55%) and pericarditis (851, 37%), the majority requiring hospitalization (n=796 (64%)). Overall, patients were young (median age 33 [21-54] years). The main age group was 18-29 years old (704, 31%), and mostly males (1555, 68%). Pericarditis onset was delayed compared to myocarditis with a median time to onset of 8 [3-21] vs. 3 [2-6] days, respectively (p=0.001). Regarding myocarditis, an important disproportionate reporting in males (ROR, 9.4 [8.3-10.6]) as well as in adolescents (ROR, 22.3 [19.2-25.9]) and 18-29 years old (ROR, 6.6 [5.9-7.5]) compared to older patients were observed. ConclusionsThe inflammatory heart reactions, namely myocarditis and pericarditis, have been reported world-wide shortly following COVID-19 mRNA vaccination. An important disproportionate reporting among adolescents and young adults, particularly in males, was observed especially for myocarditis. Guidelines must take this specific risk into account and to optimize vaccination protocols according to sex and age. While the substantial benefits of COVID-19 vaccination still prevail over risks, clinicians and the public should be aware of these reactions and seek appropriate medical attention.
RESUMO
STUDY DESIGN: Retrospective review of an initial cohort of consecutive patients undergoing robot-assisted pedicle screw placement.PURPOSE: We aimed to evaluate the learning curve, if any, of this new technology over the course of our experience.OVERVIEW OF LITERATURE: Percutaneous pedicle screws have specific advantages over open freehand screws. However, they require intraoperative imaging for their placement (e.g., fluoroscopy and navigation) and require increased surgeon training and skill with the learning curve estimated at approximately 20–30 cases. To our knowledge, this is the first study that measures the learning curve of robot-guided purely percutaneous pedicle screw placement with comprehensive objective postoperative computed tomography (CT) scoring, time per screw placement, and fluoroscopy time.METHODS: We included the first 80 consecutive patients undergoing robot-assisted spinal surgery at Melbourne Private Hospital. Data were collected for pedicle screw placement accuracy, placement time, fluoroscopy time, and revision rate. Patient demographic and relevant perioperative and procedural data were also collected. The patients were divided equally into four sub-groups as per their chronological date of surgery to evaluate how the learning curve affected screw placement outcomes.RESULTS: Total 80 patients were included; 73 (91%) had complete data and postoperative CT imaging that could help assess that placement of 352 thoracolumbar pedicle screws. The rate of clinically acceptable screw placement was high (96.6%, 95.4%, 95.6%, and 90.7%, in groups 1 to 4, respectively, p=0.314) over time. The median time per screw was 7.0 minutes (6.5, 7.0, 6.0, and 6.0 minutes in groups 1 to 4, respectively, p=0.605). Intraoperative revision occurred in only 1 of the 352 screws (0.3%).CONCLUSIONS: We found that robot-assisted screw placement had high accuracy, low placement time, low fluoroscopy time, and a low complication rate. However, there were no significant differences in these parameters at the initial experience and the practiced, experience placement (after approximately 1 year), indicating that robot-assisted pedicle screw placement has a very short (almost no) learning curve.
