Five-Year Outcomes of Coarctoplasty with Stents in the Pediatric Population: Results from a Retrospective Single-Center Cohort with Centrally Adjudicated Outcomes.

Transcatheter stent implantation is a widely performed procedure for treating native coarctation of the aorta (CoA) in pediatric patients. However, data on mid- to long-term outcomes are limited. The aim of this study was to evaluate the mid-term safety and efficacy of transcatheter CoA stenting based on centrally adjudicated outcomes. This retrospective cohort study included patients aged 15 years or younger undergoing de novo stenting for CoA or recoarctation (reCoA) between 2006 and 2017. Immediate and 5-year outcomes were assessed. Immediate outcomes (procedural and in-hospital) were retrieved from electronic records. Rates of 5-year reCoA, stent fractures, aneurysmal/pseudoaneurysmal formation, and all-cause mortality were mid-term outcomes. The study included 274 patients (64% male and 36% female) with a median (interquartile range) age of 9 (6-12) years. Procedural success was achieved in 251 patients (91.6%). Procedural complications occurred in 4 patients (1.4%), consisting of stent migration in 1 (0.3%) and small non-expanding non-flow-limiting aortic wall injuries in 3 (1.1%). Major vascular access complications were observed in 18 patients (6.6%), acute limb ischemia in 8 (2.9%). In-hospital mortality occurred in 4 patients (1.4%). Five-year cumulative incidence rates of stent fractures, reCoA, and aortic aneurysmal/pseudoaneurysmal formation were 17/100 (17%), 73/154 (48%), and 8/101 (7.92%), respectively. Of 73 reCoAs, 47 were treated with balloon angioplasty, and 15 underwent a second stent implantation. Five-year all-cause mortality occurred in 4/251 (1.6%) patients. Coarctoplasty with stents was safe and effective in our pediatric population during a 5-year follow-up despite a high rate of reCoA.

Association of New-Onset Seizures With SARS-CoV-2 Vaccines: A Systematic Review and Meta-Analysis of Randomized Clinical Trials.

Importance: Seizures have been reported as an adverse effect of the SARS-CoV-2 vaccine. However, no study has answered the question of whether there is any association between seizures in the general population and COVID-19 vaccination. Objective: To evaluate the seizure incidence among SARS-CoV-2 vaccine recipients compared with those who received a placebo. Data Sources: A systematic search of MEDLINE (via PubMed), Web of Science, Scopus, Cochrane Library, Google Scholar, review publications, editorials, letters to editors, and conference papers, along with the references of the included studies from December 2019 to July 7, 2023. Study Selection: Randomized clinical trials (RCTs) reporting seizure incidence with SARS-CoV-2 vaccination were included. Data Extraction and Synthesis: This study is reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses framework and used the Mantel-Haenszel method with random- and common-effect models. The risk of bias of the studies was assessed using the Cochrane assessment tool for RCTs. Main Outcomes and Measures: The outcome of interest was new-onset seizure incidence proportion compared among (1) SARS-CoV-2 vaccine recipients and (2) placebo recipients. Results: Six RCTs were included in the study. Results of the pooled analysis comparing the incidence of new-onset seizure between the 63 521 vaccine and 54 919 placebo recipients in the 28-day follow-up after vaccine/placebo injection showed no statistically significant difference between the 2 groups (9 events [0.014%] in vaccine and 1 event [0.002%] in placebo recipients; odds ratio [OR], 2.70; 95% CI, 0.76-9.57; P = .12; I2 = 0%, τ2 = 0, Cochran Q P = .74). Likewise, in the entire blinded-phase period after injection, with a median of more than 43 days, no significant difference was identified between the vaccine and placebo groups regarding incident new-onset seizure (13/43 724 events [0.03%] in vaccine and 5/40 612 [0.012%] in placebo recipients; OR, 2.31; 95% CI, 0.86-6.23, P = .10, I2 = 0%, τ2 = 0, Cochran Q P = .95). Conclusions and Relevance: According to this systematic review and meta-analysis, there was no statistically significant difference in the risk of new-onset seizure incidence between vaccinated individuals and placebo recipients.

Sex-based association between high-density lipoprotein cholesterol and adverse outcomes after coronary artery bypass grafting.

BACKGROUND: High-density lipoprotein cholesterol (HDL-C) is shown to be an independent protective factor against coronary artery diseases (CAD). Yet there are limited studies focusing on the association between HDL-C and coronary artery bypass graft (CABG) surgery outcomes. HYPOTHESIS: Low levels of HDL-C are associated with higher incidence of adverse outcomes in patients undergoing CABG. METHODS: This registry-based study included 17,772 patients who underwent elective isolated CABG between 2007 and 2017. Patients were classified into low and desirable HDL-C groups based on their serum HDL-C levels at admission and were followed for one-year post-surgery. The study population included 13,321 patients with low HDL-C and 4,451 with desirable HDL-C. proportional hazard Cox models were performed to evaluate the association between HDL-C levels and incidence of mortality as well as major adverse cardiovascular and cerebrovascular events (MACCE), while adjusting for potential confounders. Moreover, participants were stratified based on sex and the association was also investigated in each subgroup separately. RESULTS: No significant difference was found between the groups regarding incidence of both mortality and MACCE, after adjusting with Inverse Probability Weighting (IPW) [HR (95%CI): 0.84 (0.46-1.53), p-value:0.575 and HR (95% CI): 0.91 (0.56-1.50), p-value:0.733, respectively]. According to the sex-based subgroup analysis, no significant association was observed after adjustment with IPW analysis. However, as we examined the association between the interaction of HDL-C levels, sex and cardiovascular outcomes, we found a significant association (HR;1.19 (95%CI: 1.04-1.45); p = 0.030). CONCLUSION: HDL-C level was not associated with either mortality or MACCE during one year after CABG procedure. Sex-based analysis showed that in males, HDL-C is significantly more protective against these outcomes, compared to females. Further studies are necessary to elucidate the exact mechanisms mediating such association.