Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest Trial (GOT ICE): A Randomized Clinical Trial Comparing Outcomes After Aortic Arch Surgery.

BACKGROUND: Deep hypothermia has been the standard for hypothermic circulatory arrest (HCA) during aortic arch surgery. However, centers worldwide have shifted toward lesser hypothermia with antegrade cerebral perfusion. This has been supported by retrospective data, but there has yet to be a multicenter, prospective randomized study comparing deep versus moderate hypothermia during HCA. METHODS: This was a randomized single-blind trial (GOT ICE [Cognitive Effects of Body Temperature During Hypothermic Circulatory Arrest]) of patients undergoing arch surgery with HCA plus antegrade cerebral perfusion at 4 US referral aortic centers (August 2016-December 2021). Patients were randomized to 1 of 3 hypothermia groups: DP, deep (≤20.0 °C); LM, low-moderate (20.1-24.0 °C); and HM, high-moderate (24.1-28.0 °C). The primary outcome was composite global cognitive change score between baseline and 4 weeks postoperatively. Analysis followed the intention-to-treat principle to evaluate if: (1) LM noninferior to DP on global cognitive change score; (2) DP superior to HM. The secondary outcomes were domain-specific cognitive change scores, neuroimaging findings, quality of life, and adverse events. RESULTS: A total of 308 patients consented; 282 met inclusion and were randomized. A total of 273 completed surgery, and 251 completed the 4-week follow-up (DP, 85 [34%]; LM, 80 [34%]; HM, 86 [34%]). Mean global cognitive change score from baseline to 4 weeks in the LM group was noninferior to the DP group; likewise, no significant difference was observed between DP and HM. Noninferiority of LM versus DP, and lack of difference between DP and HM, remained for domain-specific cognitive change scores, except structured verbal memory, with noninferiority of LM versus DP not established and structured verbal memory better preserved in DP versus HM (P = 0.036). There were no significant differences in structural or functional magnetic resonance imaging brain imaging between groups postoperatively. Regardless of temperature, patients who underwent HCA demonstrated significant reductions in cerebral gray matter volume, cortical thickness, and regional brain functional connectivity. Thirty-day in-hospital mortality, major morbidity, and quality of life were not different between groups. CONCLUSIONS: This randomized multicenter study evaluating arch surgery HCA temperature strategies found low-moderate hypothermia noninferior to traditional deep hypothermia on global cognitive change 4 weeks after surgery, although in secondary analysis, structured verbal memory was better preserved in the deep group. The verbal memory differences in the low- and high-moderate groups and structural and functional connectivity reductions from baseline merit further investigation and suggest opportunities to further optimize brain perfusion during HCA. REGISTRATION: URL: https://www.clinicaltrials.gov; Unique identifier: NCT02834065.

Comparative Effectiveness of Anti-TNF in Combination With Low-Dose Methotrexate vs Anti-TNF Monotherapy in Pediatric Crohn's Disease: A Pragmatic Randomized Trial.

BACKGROUND & AIMS: Tumor necrosis factor inhibitors, including infliximab and adalimumab, are a mainstay of pediatric Crohn's disease therapy; however, nonresponse and loss of response are common. As combination therapy with methotrexate may improve response, we performed a multicenter, randomized, double-blind, placebo-controlled pragmatic trial to compare tumor necrosis factor inhibitors with oral methotrexate to tumor necrosis factor inhibitor monotherapy. METHODS: Patients with pediatric Crohn's disease initiating infliximab or adalimumab were randomized in 1:1 allocation to methotrexate or placebo and followed for 12-36 months. The primary outcome was a composite indicator of treatment failure. Secondary outcomes included anti-drug antibodies and patient-reported outcomes of pain interference and fatigue. Adverse events (AEs) and serious AEs (SAEs) were collected. RESULTS: Of 297 participants (mean age, 13.9 years, 35% were female), 156 were assigned to methotrexate (110 infliximab initiators and 46 adalimumab initiators) and 141 to placebo (102 infliximab initiators and 39 adalimumab initiators). In the overall population, time to treatment failure did not differ by study arm (hazard ratio, 0.69; 95% CI, 0.45-1.05). Among infliximab initiators, there were no differences between combination and monotherapy (hazard ratio, 0.93; 95% CI, 0.55-1.56). Among adalimumab initiators, combination therapy was associated with longer time to treatment failure (hazard ratio, 0.40; 95% CI, 0.19-0.81). A trend toward lower anti-drug antibody development in the combination therapy arm was not significant (infliximab: odds ratio, 0.72; 95% CI, 0.49-1.07; adalimumab: odds ratio, 0.71; 95% CI, 0.24-2.07). No differences in patient-reported outcomes were observed. Combination therapy resulted in more AEs but fewer SAEs. CONCLUSIONS: Among adalimumab but not infliximab initiators, patients with pediatric Crohn's disease treated with methotrexate combination therapy experienced a 2-fold reduction in treatment failure with a tolerable safety profile. CLINICALTRIALS: gov, Number: NCT02772965.

Effect of Outreach Messages on Adolescent Well-Child Visits and Coronavirus Disease 2019 Vaccine Rates: A Randomized, Controlled Trial.

OBJECTIVE: To determine effectiveness of text/telephone outreach messages, with and without coronavirus disease 2019 (COVID-19) vaccine information. STUDY DESIGN: We conducted an intent-to-treat, multiarm, randomized clinical trial with adolescents aged 12-17 years. Eligible patients did not have an adolescent well-care visit in the past year or scheduled in the next 45 days or an active electronic health record portal account. We randomized participants to the standard message, COVID-19 vaccine message, or no message (control) group and delivered 2 text messages or telephone calls (per family preference) to the message groups. The primary outcome was adolescent well-care visit completion within 8 weeks, and secondary outcomes were adolescent well-care visit scheduled within 2 weeks and receiving COVID-19 vaccine within 8 weeks. RESULTS: We randomized 1235 adolescents (mean age, 14 ± 1.5 years; 51.6% male; 76.7% Black; 4.1% Hispanic/Latinx; 88.3% publicly insured). The standard message group had higher odds of scheduling an adolescent well-care visit compared with the control group (OR, 2.07; 95% CI, 1.21-3.52) and COVID-19 vaccine message group (OR, 1.66; 95% CI, 1.00-2.74). The odds of completing an adolescent well-care visit did not differ significantly (standard message group vs control group; OR, 1.35; 95% CI, 0.88-2.06; COVID-19 vaccine message group vs control group, OR, 1.33; 95% CI, 0.87-2.03). In per-protocol analyses, adolescents in the standard message group were twice as likely as the control group to receive the COVID-19 vaccine (OR, 2.48; 95% CI, 1.05-5.86). CONCLUSIONS: Outreach messages were minimally effective. Efforts are needed to address widening disparities. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT04904744.

Adolescent Decision-Making Involvement in the Receipt of Genomic Testing Results.

OBJECTIVE: To examine hypothesized predictors of adolescent and parent involvement in the decision about which genomic results to receive. STUDY DESIGN: We conducted a longitudinal cohort study during phase 3 of the electronic Medical Records and Genomics (eMERGE) Network. Dyads reported on how they preferred to make choices (adolescent only, parent only, or jointly). Dyads used a decision tool to choose independently the categories of genetic testing results they wanted. We summarized independent choices, identifying initially discordant dyads. After a facilitated discussion, dyads made a joint decision. Dyads then completed the Decision-Making Involvement Scale (DMIS). We conducted bivariate correlations between DMIS subscale scores and the following hypothesized predictors: adolescent age, preference for adolescent to make their own decision, and discordance on initial independent choices. RESULTS: The sample included 163 adolescents, aged 13-17 years and parents (86.5% mothers). Dyads lacked agreement on how they wanted to make the final decision (weighted kappa statistic 0.04; 95% CI -0.08 to 0.16). These preferences, as well as the adolescent's age and adolescent-parent discordance on initial choices for specific categories of genetic testing results to receive, were associated with subsequent decision-making involvement behaviors as measured by DMIS subscales. Dyads with discordant initial preferences had significantly greater scores on the DMIS Joint/Options subscale than those with concordant initial preferences (adolescent report M [SD] 2.46 [0.60] vs 2.10 [0.68], P < .001). CONCLUSIONS: Through facilitated discussion, adolescents and parents can work together and reach agreement about receipt of genomic screening results.

Emergency and Compassionate Use of a Novel Ascending Endograft for Ascending and Arch Aortic Pathology.

PURPOSE: Patients with complicated ascending aortic pathology, including patients with acute type A aortic dissection may be at extreme risk for open repair. Thoracic endovascular aortic repair (TEVAR), infrequently used for the ascending aorta, may be considered an alternative in this setting. We describe early results for emergency and compassionate (E&C) use of a novel endograft, specifically designed for use to treat pathology of the ascending aorta. MATERIALS AND METHODS: This case series evaluated 19 patients (mean age, 68.84±13.12 years; 57.9% female) treated with ascending TEVAR for acute and chronic acute (4), subacute (1), or chronic (1) aortic dissection or pseudoaneurysm (13). Six of the 19 patients (31.5%) were treated under compassionate use and 13 patients (68.4%) were treated under the emergency use exemption. Ten patients (52.6%) received additional devices to extend treatment into the arch and descending aorta. RESULTS: Device delivery was achieved in all patients (100%). Thirty-day mortality and stroke occurred in 3 patients (15.8%) and in 1 patient (5.3%), respectively. In 1 patient (5.3%), with an Unanticipated Adverse Device Event, the aorta ruptured when the endograft eroded into the adventitial portion of dissection site at the posterior aspect of the ascending wall. Devices were explanted in 2 patients (10.5%), 353 and 610 days after the index procedure, respectively. Six patients had endoleaks (31.6%), including type I (n=2, 10.5%), type II endoleaks (n=3, 15.8%), and indeterminate endoleak (n=1, 5.3%). CONCLUSIONS: Delivery and deployment of a novel ascending thoracic stent graft with or without an additional branched arch extension is feasible in patients with complex anatomy and pathology, including acute aortic dissection and pseudoaneurysm. Additional experience with this novel device will further refine the patient population most suitable for endovascular ascending aortic repair for these pathologies. CLINICAL IMPACT: This study describes a novel stent graft specifically designed for treatment of ascending aortic pathology, including acute type A dissection. The patients described in this series constituted a group outside the formal US FDA sponsored clinical trial, and were those accepted as part of an emergency and compassionate use basis.

ARISE: First-In-Human Evaluation of a Novel Stent Graft to Treat Ascending Aortic Dissection.

BACKGROUND: Operative mortality for type A aortic dissection is still 10-20% at centers of excellence. Additionally, 10-20% are not considered as viable candidates for open surgical repair and not offered life-saving emergency surgery. ARISE is a multicenter investigation evaluating the novel GORE® Ascending Stent Graft (ASG; Flagstaff, AZ). OBJECTIVE: The purpose of this study is to assess early feasibility of using these investigational devices to treat ascending aortic dissection. METHODS: This a prospective, multicenter, non-randomized, single-arm study that enrolls patients at high surgical risk with appropriate anatomical requirements based on computed tomography imaging at 7 of 9 US sites. Devices are delivered transfemorally under fluoroscopic guidance. Primary endpoint is all-cause mortality at 30 days. Secondary endpoints include major adverse cardiovascular and cerebrovascular events (MACCE) at 30 days, 6 months, and 12 months. RESULTS: Nineteen patients were enrolled with a mean age of 75.7 years (range 47-91) and 11 (57.9%) were female. Ten (52.6%) had DeBakey type I disease, and the rest were type II. Sixteen (84.2%) of the patients were acute. Patients were treated with safe access, (7/19 (36.8%) percutaneous, 10/19 (52.6%) transfemoral, 2/19 (10.5%) iliac conduit), delivery, and deployment completed in all cases. Median procedure time was 154 mins (range 52-392) and median contrast used was 111 mL (range 75-200). MACCE at 30 days occurred in 5 patients including mortality 3/19 (15.8%), disabling stroke in 1/19 (5.3%), and myocardial infarction in 1/19 (5.3%). CONCLUSION: Results from the ARISE early feasibility study of a specific ascending stent graft device to treat ascending aortic dissection are promising.

Outcomes of endovascular repair of aortic aneurysms with the GORE thoracic branch endoprosthesis for left subclavian artery preservation.

OBJECTIVE: Thoracic endovascular aortic repair has emerged as the dominant paradigm for treatment of patients with descending thoracic aortic aneurysms. For aneurysms involving the aortic arch in the region of the left subclavian artery (LSA), branch vessel preservation to maintain blood flow to the LSA is recommended. Branched aortic endografts are an alternative to surgical revascularization of the LSA. METHODS: Across 34 investigative sites, 84 patients with zone 2 aneurysms were enrolled in a nonrandomized, prospective study of a single branched aortic endograft. The thoracic branch endoprosthesis device allows for graft placement proximal to the LSA and incorporates a single side branch for left subclavian perfusion. RESULTS: More than one-half of the patients were male (63%). Their average age was 70 ± 11 years. The aneurysm morphology was fusiform in 43 and saccular in 41 patients. The mean aneurysm diameter at screening was 56.2 mm. The mean follow-up was 30 months (range, 2.6-50.7 months). Reported here are the patient outcomes at 1 and 12 months. Predefined technical success with implantation of the device in landing zone 2 was achieved in 92% of patients (n = 77). There were no cases of aortic rupture, lesion-related mortality, or new-onset renal failure. There was no perioperative (30-day) mortality. A single case each of permanent paraplegia and paraparesis occurred. Three patients experienced a procedure-related stroke. Through 12 months, four patients died; none of the deaths were adjudicated as related to the device or procedure. One aortic reintervention was required. A single case of aortic enlargement (core laboratory) was reported at 6 months. Type I (n = 3) and III (n = 5) endoleaks occurred in 9.8% of patients, of which one (type III) required reintervention. CONCLUSIONS: Results from this device study in patients with zone 2 aneurysms demonstrate that early safety and efficacy outcomes are maintained up to 12 months after the endovascular procedure with low mortality and reintervention rates and an acceptable frequency of procedural complications, including neurologic complications.

Surgical debranching versus branched endografting in zone 2 thoracic endovascular aortic repair.

BACKGROUND: Left subclavian artery (LSA) revascularization has been recommended for patients undergoing elective thoracic endovascular aortic repair (TEVAR) with a proximal zone 2 landing requiring coverage of the LSA. The clinical standard of care remains surgical LSA revascularization. However, recently, the feasibility of using branched endografts has been demonstrated. We compared the perioperative and mid-term outcomes of these approaches. METHODS: We performed a retrospective review of consecutive patients who underwent TEVAR with a proximal zone 2 landing at a single center from 2014 to 2020. The patients were divided into cohorts for comparison: those who underwent surgical revascularization (SR-TEVAR group) and those who underwent thoracic branched endografting with an investigational device (TBE group). Those patients who did not undergo LSA revascularization were excluded. Perioperative outcomes, including procedural success, death, stroke, limb ischemia, and length of stay, were compared. Kaplan-Meier survival curves were compared using the log-rank test. The cumulative incidence of device-related endoleak (types I and III) and device-related reintervention, accounting for death as a competing hazard, were compared using the Fine-Gray test. RESULTS: A total of 55 patients were included: 31 (56%) in the SR-TEVAR group and 24 (44%) in the TBE group. The preoperative demographics and comorbidities were similar between the two groups. Procedural success was 100% in both cohorts, with no periprocedural strokes or left upper extremity ischemic events. One operative or 30-day death (TBE, 4.2%; vs SR-TEVAR, 3.2%; P = .99) occurred in each cohort. The total operative time (TBE, 203 ± 79 minutes; vs SR-TEVAR, 250 ± 79 minutes; P = .03) and total length of stay (TBE, 5.2 ± 3.6 days; vs SR-TEVAR, 9.9 ± 7.2 minutes; P = .004) were both significantly shorter in the TBE group. No difference was found in mid-term survival (log-rank test, P = .50) nor the cumulative incidence of device-related endoleak (Fine-Gray test, P = .51) or reintervention (Fine-Gray test, P = .72). No occlusions of the TBE graft or surgical bypass or transpositions had occurred after a mean follow-up of 28 ± 16 and 34 ± 24 months, respectively. CONCLUSIONS: TBE can be performed with procedural success rate and safety profile comparable to those of TEVAR with surgical revascularization, with a decreased total length of stay, for patients requiring proximal zone 2 coverage. The mid-term outcomes for each approach were also similar. Prospective, randomized comparisons of these techniques are warranted.

An Immersive Virtual Reality Curriculum for Pediatric Hematology Clinicians on Shared Decision-making for Hydroxyurea in Sickle Cell Anemia.

Although hydroxyurea (HU) is an effective treatment for sickle cell anemia, uptake remains low. Shared decision-making (SDM) is a recommended strategy for HU initiation to elicit family preferences; however, clinicians lack SDM training. We implemented an immersive virtual reality (VR) curriculum at 8 pediatric institutions to train clinicians on SDM that included counseling virtual patients. Clinicians' self-reported confidence significantly improved following the VR simulations on all communication skills assessed, including asking open-ended questions, eliciting specific concerns, and confirming understanding (Ps≤0.01 for all). VR may be an effective method for educating clinicians to engage in SDM for HU.

Outcomes of aortic root enlargement during isolated aortic valve replacement.

OBJECTIVES: Aortic root enlargement (ARE) lowers the risk of patient prosthesis mismatch after surgical aortic valve replacement (SAVR) in patients with small annular size. Whether ARE is associated with increased operative mortality is controversial. This study compares the early and intermediate outcomes in patients undergoing SAVR with and without ARE. METHODS: All patients undergoing isolated SAVR with and without ARE from 2015 to 2020 were analyzed. Propensity-matching was used to adjust for possible confounding variables. Kaplan-Meier analysis and log-rank test were used to estimate and compare overall outcomes and survival in the study cohorts. RESULTS: Among 868 isolated SAVRs, ARE was performed in 54 (6.2%) patients. Before matching, mean age was similar but female sex (67.4% vs. 29.6%; SD: -0.82) and previous AVR (18.9% vs. 3.9%; SD: -0.48) were more common in patients undergoing SAVR + ARE versus SAVR alone. A bovine pericardial patch was used for 81.5% (44 of 54) of ARE, with a Dacron patch in the rest. After propensity matching, the average cardiopulmonary bypass (138.2 ± 34.9 vs. 102.9 ± 33.0 min; p < 0.01) and cross-clamp times (113.8 ± 26.7 vs. 83.0 ± 28.4 min; p < 0.01) were longer in the SAVR + ARE group. There were no significant differences in postoperative stroke, new-onset dialysis, pacemaker placement, reoperation for bleeding, length of hospital stay, or 30-day readmission. Thirty-day mortality (0% vs. 0.6%, p = 1.0) and 5-year survival (96.3% vs. 95.7%, p = 0.86) were also similar. CONCLUSIONS: ARE during surgical AVR can be safely performed without an increase in complications with excellent early and intermediate-term survival.

Factors Associated with Attention Deficit Hyperactivity Disorder Medication Use in Community Care Settings.

OBJECTIVES: To examine patient- and provider-level factors associated with receiving attention-deficit/hyperactivity disorder (ADHD) medication treatment in a community care setting. We hypothesized that the likelihood of ADHD medication receipt would be lower in groups with specific patient sociodemographic (eg, female sex, race other than white) and clinical (eg, comorbid conditions) characteristics as well as physician characteristics (eg, older age, more years since completing training). STUDY DESIGN: A retrospective cohort study was conducted with 577 children (mean age, 7.8 years; 70% male) presenting for ADHD to 50 community-based practices. The bivariate relationship between each patient- and physician-level predictor and whether the child was prescribed ADHD medication was assessed. A multivariable model predicting ADHD medication prescription was conducted using predictors with significant (P < .05) bivariate associations. RESULTS: Sixty-nine percent of children were prescribed ADHD medication in the year after initial presentation for ADHD-related concerns. Eleven of 31 predictors demonstrated a significant (P < .05) bivariate relationship with medication prescription. In the multivariable model, being male (OR, 1.34; 95% CI, 1.01-1.78; P = .02), living in a neighborhood with higher medical expenditures (OR, 1.11 for every $100 increase; 95% CI, 1.03-1.21; P = .005), and higher scores on parent inattention ratings (OR, 1.06; 95% CI, 1.03-1.10; P < .0001) increased the likelihood of ADHD medication prescription. CONCLUSIONS: We found that some children, based on sociodemographic and clinical characteristics, are less likely to receive an ADHD medication prescription. An important next step will be to examine the source and reasons for these disparities in an effort to develop strategies for minimizing treatment barriers.

Thoracic endovascular stent graft repair for ascending aortic diseases.

OBJECTIVES: We describe the preliminary results of thoracic endovascular aortic repair (TEVAR) in a group of patients with ascending aortic disease from the Global Registry for Endovascular Aortic Treatment (GREAT). METHODS: We identified TEVAR performed for diseases truly originating from the ascending aorta. Between July 2011 and May 2015, 5014 patients were enrolled; six (0.12%) were identified and included in the analysis. One further patient was withdrawn from the study due to lack of a signed consent form. Patients having a "zone 0" proximal landing zone reported for their TEVAR without the presence of an ascending aortic disease were not included. Reinterventions of previous open and endovascular repair were also excluded. RESULTS: Three males and three females were treated. Mean age was 69 years ± 10 years (range, 58-83 years). Indication for TEVAR was atherosclerotic aneurysm (n = 4; ruptured, n = 1), complicated type A dissection (n = 1, rupture), and pseudoaneurysm (n = 1). Mean maximum aortic lesion diameter was 60 mm 14 (range, 39-77 mm). Urgent intervention was performed in three (50%) cases. Primary clinical success was 100%. There was no TEVAR-related in-hospital mortality. Open conversion was never required. Complication such as cerebrovascular accidents, valve impairment, or myocardial infarction did not occur. All patients were discharged home alive. No patient was lost at a median follow-up of 26 months (range, 16-72 months). During the follow-up, no patient died and ongoing primary clinical success was maintained in all patients. Reintervention was never required; endoleaks, migrations, fractures, or ruptures were not observed. CONCLUSIONS: Preliminary "real-world" experience of ascending TEVAR shows satisfactory outcomes at short-term follow-up. Although concerns remain for "off-label" use of standard devices, TEVAR-related complications were not observed. Longer follow-up data are expected to confirm durability of these results.

Development of a Hydroxyurea Decision Aid for Parents of Children With Sickle Cell Anemia.

National evidence-based guidelines recommend offering hydroxyurea to patients with sickle cell anemia 9 months of age and older using shared decision making, but offer no strategies to aid implementation. We developed a hydroxyurea multicomponent decision aid via a needs assessment, clinic observations, and iterative feedback to address parent decision needs and promote a discussion between clinicians and parents. A total of 75 parents and 28 clinicians participated across all phases. The decision aid was rated as useful. Hydroxyurea knowledge improved and decisional conflict decreased supporting the potential for use to facilitate shared decision making in pediatric sickle cell anemia.

Shared decision making for hydroxyurea treatment initiation in children with sickle cell anemia.

Clinical trials have demonstrated hydroxyurea's efficacy in improving health outcomes for children with sickle cell anemia (SCA) who have medical complications. New NHLBI clinical guidelines will recommend offering hydroxyurea to young patients regardless of clinical severity. Shared decision making may be an effective approach for implementing this practice change. Decision aids that help patients/parents feel empowered to make this decision and help providers feel comfortable in discussing hydroxyurea as a preventive treatment may facilitate shared discussions between families and providers. We recommend six strategies providers can use to facilitate these discussions while decision aids and tools are being developed. Pediatr Blood Cancer 2015;62:184-185. © 2014 Wiley Periodicals, Inc.

Randomized trial of surgical cutdown versus percutaneous access in transfemoral TAVR.

OBJECTIVES: To compare iliofemoral arterial complications with transfemoral transcatheter aortic valve replacement (TF-TAVR) utilizing surgical cutdown versus percutaneous access with closure devices in a randomized trial. BACKGROUND: Major vascular complications following TAVR are a significant risk of the procedure. There are no randomized data comparing whether access method in TF-TAVR influences the risk of such complications. METHODS: From June to December 2011, 30 consecutive patients undergoing TF-TAVR were randomized to either surgical cutdown (C) or percutaneous (P) access. Subjects underwent preoperative CT scans, pre- and post-operative bilateral femoral arterial ultrasound and angiography. The primary endpoint was the composite of major and minor vascular complications at 30 days, as defined by the Valve Academic Research Consortium-2. Multivariate predictors of vascular complications were identified. RESULTS: Of the 30 subjects enrolled, 27 were treated with the randomized method of access as randomized. Iliofemoral complications were observed in eight patients (26.7%; C = 4, P = 4), all of which were dissections and/or stenoses that required percutaneous and/or surgical intervention. There were two (13.3%) major and two (13.3%) minor complications in each group. Two covariates that were significantly associated with vascular complications included female sex and baseline femoral arterial velocity on ultrasound. CONCLUSIONS: While surgical cutdown in TF-TAVR is the recommended access for new centers initiating a TAVR program, this small randomized pilot study suggests the lesser invasive percutaneous method in an experienced center is equivalent in safety to the surgical method. Doppler ultrasound may be useful in predicting complications prior to the procedure.

The Impact of Statewide Enumerated Antibullying Laws and Local School Interventions on School Spaces, Physical Harm, and Suicide Attempts for LGBTQ Youth.

Purpose: Our goal was to evaluate the impact of enumerated antibullying laws and local interventions on school affirmation, risk of physical threat or harm, and suicide attempts for lesbian, gay, bisexual, transgender, and questioning (LGBTQ) youth. Methods: This study used cross-sectional data from three national sources that provided outcomes and potential predictors: (1) The Trevor Project National Survey 2022: based on the LGBTQ youth report, (2) Movement Advancement Project: presence of LGBTQ enumerated antibullying state laws, and (3) School Health Profiles 2020: statewide prevalence of school-level strategies to improve student wellness reported by school personnel. Bivariate and multivariable logistic regression models calculated the relative risks (RRs) for each outcome. Results: LGBTQ youth (n = 27,697) were surveyed. Youth were less likely to identify their school as nonaffirming in states with enumerated laws (RR: 0.97, confidence interval [CI]: 0.94-0.99) and in states with higher percentages of gay/straight alliances (GSAs) (RR: 0.97, 95% CI: 0.96-0.97). Youth were less likely to report a history of physical threat or harm in states with more GSAs (RR: 0.96, 95% CI: 0.95-0.97). Enumerated state laws were associated with a lower risk of suicide attempts among LGBTQ youth (RR: 0.82, 95% CI: 0.77-0.87). Universal strategies/policies not specific to LGBTQ youth did not reduce risk of physical threat/harm or suicide attempts. Conclusions: Statewide enumerated antibullying protections and the presence of a GSA were associated with a decreased risk of poor outcomes among LGBTQ youth. Longitudinal studies are needed to assess the impact of recent legislative changes.

Measure of Caregiver Attention-Deficit/Hyperactivity Disorder Knowledge Is Responsive to Decision Aid on Treatment for Attention-Deficit/Hyperactivity Disorder.

OBJECTIVE: Adapt and test a measure of knowledge for caregivers of children with attention-deficit/hyperactivity disorder (ADHD) and evaluate the impact of the information component of a decision aid (DA) on participant knowledge. METHODS: A set of seven knowledge items were created based on prior knowledge measures and clinical guidelines. As part of a larger cross-sectional survey study of caregivers of children diagnosed with ADHD, caregivers were randomized to one of two arms: 1) a DA arm, where participants reviewed the information component of the Cincinnati Children's Hospital's DA, and 2) a control arm, where participants were not shown a DA. All participants completed the seven knowledge items. Knowledge items were assessed for difficulty, quality of distractors, acceptability, and redundancy. Total knowledge scores (0-100) for the DA and control arm were compared. RESULTS: Caregivers were assigned to the DA arm (n = 243) or the control arm (n = 260). All 7 knowledge items were retained as no items were too difficult or too easy, all response options were used, there were little missing data, and no items were redundant. The overall knowledge score was normally distributed, and almost covered the full range of scores (5-100). Those who received the DA component had higher knowledge scores (M=68, SD=23) than those who did not receive the DA component (M=60, SD=19, P < .01, d=0.4). CONCLUSIONS: The Caregiver ADHD Knowledge (CAKe) measure was acceptable and demonstrated construct validity as those who were assigned to review the DA component demonstrated greater knowledge than those who were not assigned to review the DA component.

Improving Screening for Social Determinants of Health in an Outpatient Complex Care Clinic.

BACKGROUND: Families of children with medical complexity (CMC) may face challenges related to Social Determinants of Health (SDoH). Although standardized SDoH screening has been implemented in numerous medical settings, there has been limited study of screening among CMC. Our global aim is to improve access to institutional and community resources for families of CMC with identified needs. Here, we aimed to establish SDoH screening for families in our outpatient Complex Care Center and attain a screening rate of 80%. METHODS: A multidisciplinary team in our clinic used quality improvement methods to implement and study an expanded SDoH screen, which included 3 questions specific to the needs of CMC (ie, emergency planning, social support, and medical equipment concerns). Interventions, informed and refined by 5 key drivers, were tested over a 12-month period. A statistical process control chart tracked key outcome and process measures over time. RESULTS: SDoH screening sustained a mean of 80% after implementation during the study period. Incorporating registration staff in screen distribution was our most impactful intervention. At least 1 SDoH concern was identified on 56% of screens; concerns specific to CMC and mental health were most frequently reported. A total of 309 responses to positive screens were reported in total. CONCLUSIONS: Successful implementation of an expanded, tailored SDoH screen revealed a multitude of social needs specific to families of CMC that otherwise may not have been recognized. Our team continues to develop and distribute resources to address identified needs.

Outcomes of a Novel Single Branched Aortic Stent Graft for Treatment of Type B Aortic Dissection.

BACKGROUND: Intervention on Type B dissection frequently requires landing the proximal edge of the stent graft between the left common carotid artery and left subclavian artery (LSA). The Gore® TAG® Thoracic Branch Endoprosthesis (TBE) is a technology which allows LSA preservation with a single internal branch. METHODS: This study was a prospective non-randomized single-arm clinical trial of patients with type B aortic dissection that were treated with the single branched device. Patients with operative indications for acute, chronic or residual Type B dissections that originated distal to the origin of a left subclavian artery suitable for branch graft placement were eligible for the study. Native aortic and surgical graft proximal landing zones were eligible. RESULTS: Among the 132 patients, there were 25 (18.9%) acute type B dissections, 79 (59.8%) of chronic type B dissections and 28 (21.1%) of residual dissections after previous open Type A repair. Percutaneous access was used in 105 (79.5%) patients. Overall, 30-day mortality occurred in 6 patients (4.5%). The overall 30 day stroke rate was 2/132(1.5%) and the one-year freedom from stroke was 96.8%. Device Technical Success and Procedural Success was achieved in 129/132(97.7%) and 110/132(83.3%) of subjects, respectively and there was one instance of loss of side branch patency. There was no persistent antegrade false lumen flow observed. CONCLUSIONS: In this study of a novel branched endograft device to preserve the LSA in patients with type B dissection undergoing TEVAR, we demonstrate acceptable safety and efficacy outcomes at one year.

Hospital and Surgeon Surgical Valvar Volume and Survival after Multi-Valve Cardiac Surgery in Medicare Beneficiaries.

OBJECTIVE: Long-term outcomes after multi-valve cardiac surgery remain under-evaluated. METHODS: Medicare administrative claims from 2008-2019 identified beneficiaries undergoing multi-valve surgery. Operative characteristics were doubly-adjudicated using International Classification of Diseases and Current Procedural Technology codes. A multivariable flexible parametric model evaluated predictors of survival; regression standardization was performed to predict standardized survival probabilities (SSP) at varying percentiles of annual valvar volume. RESULTS: Of 476,092 cardiac surgeries involving the aortic (AVS), mitral (MVS), or tricuspid (TVS) valve, 63,083 (13.3%) were identified as involving multi-valve surgery: 22,884 MVS+TVS, 30,697 AVS+MVS, 3,443 AVS+TVS and 6,059 AVS+MVS+TVS. Surgery occurred at 1,157 hospitals by 2,922 surgeons. Annual valvar volume (total AVS+MVS+TVS) was tallied for surgeons and hospitals. Median survival varied substantially by type of multi-valve surgery: 8.09 [7.90-8.24] years in MVS/TVS, 6.65 [6.49-6.81] years in AVS/MVS, 5.77 [5.37-6.13] in AVS/TVS, and 6.02 [5.64-6.38] in AVS/MVS/TVS. SSPs were calculated across combined hospital/surgeon volume percentiles; the median SSP increased with increasing percentile of combined hospital/surgeon volume: 5%tile: 5.77 [5.58,5.98], 25%tile: 6.18 [6.07,6.28], 50%tile: 6.56 [6.44,6.68], 75%tile: 6.86 [6.75,6.97], and 95%tile: 7.58 [7.34,7.83] years, respectively. CONCLUSIONS: Survival varied significantly by type of multi-valve surgery, worsened with addition of concomitant interventions and improved substantially with increasing annual hospital and surgeon volume. Hospital volume was associated with an improved early hazard for death that abated beyond 3 months post-surgery), while surgeon volume was associated with an improved hazard for death that persisted even beyond the first post-operative year. Consideration should be given to referring multi-valve cases to high-volume hospitals and surgeons.