Background: Selective fusion of double curves in patients with scoliosis is considered to spare fusion levels. In 2011, we studied the lumbosacral takeoff angle, defined as the angle between the center-sacral vertical line and a line through the centra of S1, L5, and L4. The lumbosacral takeoff angle was shown to moderately correlate with the lumbar Cobb angle, and a predictive equation was developed to predict the lumbar Cobb angle after selective fusions. The purposes of the present study were to validate that equation in a separate cohort and to assess differences in outcomes following selective and nonselective fusion. Methods: Patients with Lenke 1B, 1C, 3B, or 3C curve patterns undergoing fusion (both selective and nonselective) with pedicle screw constructs and a minimum of 2 years of follow-up were included. Selective fusion was defined as a lowest level of fixation cephalad to or at the apex of the lumbar curve. To validate the previously derived equation, we used this data set and analysis of variance to check for differences between the actual and calculated postoperative lumbar Cobb angles. Pearson correlation, multiple linear regression, and t tests were used to explore relationships and differences between the selective and nonselective fusion groups. Results: The mean calculated postoperative lumbar Cobb angle (and standard deviation) (22.35° ± 3.82°) was not significantly different from the actual postoperative lumbar Cobb angle (21.08° ± 7.75°), with an average model error of −1.268° (95% confidence interval, −2.649° to 0.112°). The preoperative lumbar Cobb angle was larger in patients with deformities that were chosen for nonselective fusion (50.2° versus 38.9°; p < 0.001). Performing selective fusion resulted in a 3.5° correction of the lumbosacral takeoff angle (p < 0.001), whereas nonselective fusion resulted in a 9.3° correction (p < 0.001). Conclusions: The lumbosacral takeoff angle can be used to predict the residual lumbar Cobb angle and may be used by surgeons to aid in the decision between selective and nonselective fusion. The change in the lumbosacral takeoff angle following selective fusion is small. Improvement in the lumbosacral takeoff angle and coronal balance is greater in association with nonselective fusion. Level of Evidence: Therapeutic Level III. See Instructions for Authors for a complete description of levels of evidence.

Background Normal or near normal coronary arteries (NNCA) or nonobstructive coronary artery disease (CAD) are commonly found on invasive coronary angiography (ICA). Hypothesis We aimed to determine long‐term outcomes by severity of CAD in a contemporary cohort of patients undergoing ICA for evaluation for ischemic heart disease. Methods We assessed a consecutive cohort of 925 patients who underwent non‐emergent ICA over 24 months. Cardiac death (CD), nonfatal myocardial infarction (NFMI), late revascularization, and medication use were assessed. Results Follow‐up data was available in 850 patients. Of patients without heart failure, at a median of 6.0 years, there was a significant decrease in survival free from CD or NFMI, and from all cardiac events, for those with obstructive CAD compared with patients with NNCAs or nonobstructive CAD (p < .001 for both). No differences between NNCA and nonobstructive CAD patients in rates of CD or NFMI (2.0% vs. 2.1%/year, p = .58) or all cardiac events (2.4% vs. 2.9%/year, p = .84) were observed. Conclusion Long‐term follow‐up in a contemporary cohort of consecutive patients undergoing non‐emergent ICA for detection of CAD showed no difference in annual rates of CD or NFMI, or total cardiac events, in patients with NNCAs versus those with nonobstructive CAD, whereas patients with obstructive CAD had significantly more events. Event rates were low and similar by gender. Use of aspirin, lipid lowering therapy, and beta‐blockers increased in all subgroups after ICA. We speculate this may explain the low incidence of subsequent cardiac events, and similar event rates in patients with NNCA and nonobstructive CAD, even in patients presenting with non‐ST‐elevation MI.

e13603 Background: Oncology clinical trials that use imaging based surrogate endpoints such as Progression Free Survival (PFS) and Overall Response Rate (ORR) generally have eligibility criteria based on imaging. Examples include but are not limited to the presence of a RECIST measurable lesion at baseline for studies where ORR is the primary endpoint, the absence of disease at baseline in recurrence studies, the absence of exclusionary brain metastases, and the presence or absence of a particular stage of disease at baseline, such as the absence of T4b, M1, and >N2 disease in studies of muscle invasive bladder cancer. Our experience suggested the percentage of subjects who did not meet those criteria during Blinded Independent Central Review (BICR) may be higher than expected and could have a significant effect on the statistical power of studies. We reviewed a large cohort of subjects (n = 8746) to determine the fraction of subjects who were considered for enrollment or enrolled in oncology clinical trials by investigators and were deemed ineligible during BICR. Methods: We analyzed 66 trials with a total of 8,746 total subjects. Trials were selected based on initiation between June 2020 and June 2021 and involvement of one (1) or more imaging eligibility criteria. Trials in this cohort fit into 2 categories: those that had prospective real time eligibility review where subjects could not be enrolled until the eligibility review was completed in real time (“eligibility review trials”) and those trials that did not have a prospective eligibility review however the data was available for retrospective analysis (“efficacy only trials”). Our analysis determined the fraction of subjects that were prospectively and retrospectively ineligible under each respective category. Results: In these categories, 56% of the subjects (n = 4934) were involved in efficacy only trials. Following BICR review, 12% (n = 614) of the subjects were found to be ineligible retrospectively. Conversely, 44% of the subjects (n = 3812) were enrolled in trials where Clario performed a prospective eligibility review. We found that only 89 of those subjects were deemed ineligible at the time of the prospective eligibility review (2%). This translates to 2% of the subjects were deemed eligible by the investigators, but ineligible by the Clario review. The 10% difference suggests that the eligibility review prevents inclusion of a significant number of subjects that are subsequently determined to have not met the initial imaging eligibility requirements. Conclusions: Eligibility review appears to improve standardization of subject eligibility. These data suggest that the omission of an eligibility review can cascade into censoring more than 10% of subjects. This could have significant impacts on the statistical power of a study and should be considered during study designs.

Complement-mediated thrombotic microangiopathy is a rare form of thrombotic microangiopathy but has high rates of mortality and morbidity. Effective treatment exists with eculizumab for this condition, but administration of treatment is often delayed because of overlapping symptoms with other causes of thrombotic microangiopathy. We present a case of a 78-year-old male who was eventually diagnosed with complement-mediated thrombotic microangiopathy. We also discuss the use of the PLASMIC scoring model to assist in more rapid diagnosis and discernment between various thrombotic microangiopathies.

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