ImportanceIn patients with severe aortic valve stenosis at intermediate surgical risk, transcatheter aortic valve replacement (TAVR) with a self-expanding supra-annular valve was noninferior to surgery for all-cause mortality or disabling stroke at 2 years. Comparisons of longer-term clinical and hemodynamic outcomes in these patients are limited.ObjectiveTo report prespecified secondary 5-year outcomes from the Symptomatic Aortic Stenosis in Intermediate Risk Subjects Who Need Aortic Valve Replacement (SURTAVI) randomized clinical trial.Design, Setting, and ParticipantsSURTAVI is a prospective randomized, unblinded clinical trial. Randomization was stratified by investigational site and need for revascularization determined by the local heart teams. Patients with severe aortic valve stenosis deemed to be at intermediate risk of 30-day surgical mortality were enrolled at 87 centers from June 19, 2012, to June 30, 2016, in Europe and North America. Analysis took place between August and October 2021.InterventionPatients were randomized to TAVR with a self-expanding, supra-annular transcatheter or a surgical bioprosthesis.Main Outcomes and MeasuresThe prespecified secondary end points of death or disabling stroke and other adverse events and hemodynamic findings at 5 years. An independent clinical event committee adjudicated all serious adverse events and an independent echocardiographic core laboratory evaluated all echocardiograms at 5 years.ResultsA total of 1660 individuals underwent an attempted TAVR (n = 864) or surgical (n = 796) procedure. The mean (SD) age was 79.8 (6.2) years, 724 (43.6%) were female, and the mean (SD) Society of Thoracic Surgery Predicted Risk of Mortality score was 4.5% (1.6%). At 5 years, the rates of death or disabling stroke were similar (TAVR, 31.3% vs surgery, 30.8%; hazard ratio, 1.02 [95% CI, 0.85-1.22]; P = .85). Transprosthetic gradients remained lower (mean [SD], 8.6 [5.5] mm Hg vs 11.2 [6.0] mm Hg; P < .001) and aortic valve areas were higher (mean [SD], 2.2 [0.7] cm2 vs 1.8 [0.6] cm2; P < .001) with TAVR vs surgery. More patients had moderate/severe paravalvular leak with TAVR than surgery (11 [3.0%] vs 2 [0.7%]; risk difference, 2.37% [95% CI, 0.17%- 4.85%]; P = .05). New pacemaker implantation rates were higher for TAVR than surgery at 5 years (289 [39.1%] vs 94 [15.1%]; hazard ratio, 3.30 [95% CI, 2.61-4.17]; log-rank P < .001), as were valve reintervention rates (27 [3.5%] vs 11 [1.9%]; hazard ratio, 2.21 [95% CI, 1.10-4.45]; log-rank P = .02), although between 2 and 5 years only 6 patients who underwent TAVR and 7 who underwent surgery required a reintervention.Conclusions and RelevanceAmong intermediate-risk patients with symptomatic severe aortic stenosis, major clinical outcomes at 5 years were similar for TAVR and surgery. TAVR was associated with superior hemodynamic valve performance but also with more paravalvular leak and valve reinterventions.
C57BL/6 mice exhibit spontaneous cerebellar malformations consisting of heterotopic neurons and glia in the molecular layer of the posterior vermis, indicative of neuronal migration defect during cerebellar development. Recognizing that many genetically engineered (GE) mouse lines are produced from C57BL/6 ES cells or backcrossed to this strain, we performed histological analyses and found that cerebellar heterotopia were a common feature present in the majority of GE lines on this background. Furthermore, we identify GE mouse lines that will be valuable in the study of cerebellar malformations including diverse driver, reporter, and optogenetic lines. Finally, we discuss the implications that these data have on the use of C57BL/6 mice and GE mice on this background in studies of cerebellar development or as models of disease.
Background While the American Society of Anesthesiologists (ASA) Physical Status (PS) is used to adjust for greater mortality risk with higher ASA PS classification, inaccurate classification can lead to inaccurate comparison of institutions. The purpose of this study was to assess the effect of audit and feedback with a rule-based artificial intelligence algorithm on the accuracy of ASA PS classification. Methods We reviewed 78,121 anesthetic records from January 1, 2017 to February 19, 2020. The first intervention entailed audit and feedback emphasizing accurately documenting ASA PS classification using BMI, while the second intervention consisted of implementing a rule-based artificial intelligence algorithm. If a patient with a BMI ≥40 kg/m2 had a documented ASA PS classification of 1 or 2, the provider was alerted to change the ASA PS classification to 3 or above. The primary outcome was the overall proportion of patients with inaccurate ASA PS classification based on BMI per month. Secondary outcomes included: the proportion of patients with a BMI ≥40 or a BMI 30-39.9 who had inaccurate ASA PS classification, and the proportion of patients documented as having ASA 3-5. Data were analyzed using interrupted time series analysis. Results For the primary outcome, the slope for ASA PS classification inaccurately incorporating BMI was unchanging before the first intervention (parameter coefficient 0.002, 95% CI -0.034 to 0.038; P=0.911). Following the first intervention, there was an immediate level change (parameter coefficient -0.821, 95% CI -1.236 to -0.0406; P<0.001) without significant change in slope (parameter coefficient -0.048, 95% CI -0.100 to 0.004; P=0.067). The post-intervention slope was negative (parameter coefficient -0.046, 95% CI -0.083 to -0.009; P=0.017). Following the second intervention, there was no level change (parameter coefficient 0.203, 95% CI -0.380 to 0.463; P=0.839) and no significant change in slope (parameter coefficient 0.013, 95% CI -0.043 to 0.043; P=0.641). The post-intervention slope was not significant (parameter coefficient -0.034, 95% CI -0.078 to 0.010; P=0.121). The proportion of patients whose ASA PS classification inaccurately incorporated BMI at the first and final timepoint of the study was 2.6% and 0.8%, respectively. Conclusions Our quality improvement efforts successfully modified clinician behavior to accurately incorporate BMI into the ASA PS classification. By combining audit and feedback methodology with a rule-based artificial intelligence algorithm, we created a process that resulted in immediate and sustained effects. Improving ASA PS classification accuracy is important because it affects quality metrics, research design, resource allocation, and workflow processes.
Aim: We investigated whether sex is associated with pain scores and opioid administration after laparoscopic sleeve gastrectomy. Materials & methods: We performed a single-center, retrospective analysis of laparoscopic sleeve gastrectomy patients from December 2016–July 2018. Multivariable linear regressions were performed to investigate the association of sex with pain scores and opioid administration. Results: Baseline pain scores were similar between women and men (n = 266; 78% women). Men reported lower pain scores in all phases of care and received more opioids during their hospitalization (ß = 25.48; 95% CI: 5.77–45.20; p = 0.01), compared with women. Conclusion: Our data suggest that women self-report greater postoperative pain scores, while men received more opioids during their hospitalization. Further studies are needed to understand the reasons for such differences in postoperative pain management.
A spinal cord stimulator (SCS) is an intervention that has become increasingly popular due to its efficacy in treating pain. With the increasing number of SCSs implanted annually, there has been an equal increase in complications, which include infections. We present a patient who underwent an uncomplicated permanent placement of SCS and later developed worsening back pain, weakness, and fever after a mechanical fall and was subsequently found to have vertebral osteomyelitis without an identifiable infection source. While no source or definitive pathogen was discovered, if there is a concern for osteomyelitis radiographically, even in an uncommon situation when medical workup returns inconclusive, explant of the SCS is warranted.
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