Sufficient Follow-up Data Research Articles

Improved cephalic index following early cranial vault remodeling in patients with isolated nonsyndromic sagittal synostosis

Isolated nonsyndromic sagittal synostosis (SS) is the most common form of craniosynostosis in children, accounting for approximately 60% of all craniosynostoses. The typical cranial measurement used to define and follow SS is the cephalic index (CI). Several surgical techniques have been suggested, but agreement on type and timing of surgery is lacking. This study aimed to evaluate the authors' institutional experience of surgically treating SS using a modified subtotal cranial vault remodeling technique in a population-based cohort. Special attention was directed toward the effect of patient age at time of surgery on long-term CI outcome. A retrospective analysis was conducted on all patients with isolated nonsyndromic SS who were surgically treated from 2003 to 2011. Data from electronic medical records were gathered. Eighty-two patients with SS were identified, 77 fulfilled inclusion criteria, and 72 had sufficient follow-up data and were included. CI during follow-up after surgery was investigated with ANOVA and a linear mixed model. In total, 72 patients were analyzed, consisting of 16 females (22%) and 56 males (78%). The mean ± SD age at surgery was 4.1 ± 3.1 months. Blood transfusions were received by 81% of patients (26% intraoperatively, 64% postoperatively, 9% both). The mean ± SD time in the pediatric ICU was 1.1 ± 0.25 days, and the mean ± SD total hospital length of stay was 4.6 ± 2.0 days. No patient required reoperation. The mean ± SD CI increased from 69 ± 3 to 87 ± 5 for patients who underwent surgery before 45 days of age. Surgery resulted in a larger increase in CI for patients who underwent surgery at a younger age compared with older patients (p < 0.05, Tukey's HSD test). In the comparison of patients who underwent surgery before 45 days of age with patients who underwent surgery at 45-90, 90-180, and more than 180 days of age, the linear mixed model estimated a long-term loss of CI of 3.0, 5.5, and 7.4 points, respectively. The modified subtotal cranial vault remodeling technique used in this study significantly improved CI in patients with SS. The best results were achieved when surgery was performed early in life.

Relief of Sitting Pain by Resecting Posterior Femoral Cutaneous Nerve, and Elucidation of Its Anatomical Branching Pattern.

Injury to the posterior femoral cutaneous nerve (PFCN) produces sitting pain in the buttock, posterior thigh, and/or the ischial tuberosity. The anatomy of the PFCN has not been well described, and just one small cohort of patients has been reported to have resection of the PFCN. Retrospective review of all patients undergoing resection of the PFCN for sitting pain by the senior author between 2012 and 2019 was performed. Evaluation was done by chart review, intraoperative description of the anatomy of the PFCN, and the outcome of resection of the PFCN with implantation of the proximal nerve into the gluteus muscle. Outcome was determined by direct patient examination, email reports, and telephonic interview. Fifty-two patients were included in this study, of which nine were bilateral operative procedures. Thirty-four patients had sufficient follow-up data at a mean of 23 months (3-85 months, range). MRI evidence of hamstring injury was present in 50% of the patients. The classic PFCN anatomy was present in 44% of limbs with the other 56% having a high division permitting branches to the lateral buttock and posterior thigh to be preserved. In patients with bilateral anatomy observations, symmetry was present in 67%. An excellent result (absence of sitting pain, normal activities of daily living [ADL]) was obtained in 53%, a good result (some residual sitting pain with some reduction in ADL), was obtained in 26% and no improvement was observed in 21% of patients. Sitting pain due to injury to the PFCN can be relieved by the resection of the PFCN with implantation of the proximal end into muscle. Presence of an anatomical variation, a high division of the PFCN, can permit preservation of sensation in the lateral buttock and posterior thigh in the patient whose symptoms involve just the perineum and ischial tuberosity.

ES19.05 Incorporating Patient Reported Outcomes into the Lung Cancer Registry

Coupled with advances in early detection, the rapid pace of innovation in lung cancer research is beginning to improve survival rates and extend lives for those diagnosed with lung cancer. Many more people are surviving with the disease long-term and facing new challenges (Vavala et al., Respirology, 2020). As survivorship increases, there is a growing imperative to more completely understand health-related quality of life issues that people with lung cancer are facing. This is compounded by the plethora of new treatment options – many of which do not yet have sufficient follow-up data to understand long-term side-effects and impacts on health and well-being. Patient reported outcomes are an essential part of understanding the true patient experience. Physician and patient reporting of symptomatic toxicities are often not concordant (DiMaio et al., Journal of Clinical Oncology, 2015). Incorporating patient reported symptom reporting into clinical workflow has even been demonstrated to not only reduce emergency department visits but to improve overall survival (Basch et al, Journal of Clinical Oncology, 2016). Real-world data sources like the Lung Cancer Registry (www.lungcancerregistry.org) provide access to thousands of patients globally that are living with lung cancer. Multiple studies have now been incorporated into the Lung Cancer Registry to demonstrate the feasibility and accessibility of collecting patient reported outcomes in a real-world setting as well as to better understand quality of life issues. An initial study examining the feasibility of collecting patient-reported outcomes from people diagnosed with lung cancer taking PD-1/PD-L1 immune checkpoint inhibitors in a real-world setting was performed in the Registry in 2018-2019 (Jim et al., manuscript submitted). This examination of 226 people revealed that 25% of patients experienced a treatment delay, 12% had an emergency room visit, and 9% were hospitalized due to toxicity. There was no significant difference in health-related quality of life events between the four immune checkpoint inhibitors examined. Notably, patients reported a lower overall health related quality of life, functional well-being, and emotional well-being compared to general population and cancer norms (Brucker et al., Eval Health Prof, 2005). Fatigue, aching joints, aching muscles, insomnia, shortness of breath, itching, and skin dryness were reported by more than half of study participants. These data indicate key areas of concern for those who are may be living long-term on or after treatment with immune checkpoint inhibitor therapy and underscore the importance of appropriate palliative and survivorship care. After confirming the feasibility of the immunotherapy study, the Lung Cancer Registry incorporated longitudinal tracking of patient-reported outcomes on a quarterly basis, starting in late November, 2019. Multiple stakeholders, including patients, caregivers, academic, and industry collaborators were consulted in the design of the questionnaires. After providing informed consent for an IRB-approved, observational research study, participants are asked about symptoms and side-effects every three months and complete the EORTC QLQ-C30 quality of life survey instrument (Aaronsen et al, J Natl Cancer Inst, 1993) as well as the EORTC LC-29 survey (Koller et al., Lancet Oncol, 2020). This data is coupled with patient-provided information about changes in cancer status (such as stage, recurrence, and biomarker testing) and information on treatment changes. Early analyses of these data show that the questionnaires are feasible and demonstrate expected trends, such as reduced physical functioning in stage IV patients currently taking first or second line chemotherapy compared to similar patients currently taking a targeted therapy or immunotherapy. Finally, the Lung Cancer Registry has partnered with a multidisciplinary team of investigators (including patients and patient advocates) to launch a landmark study on Women’s sexual health (https://www.iaslc.org/iaslc-news/ilcn/shawl-largest-study-its-kind-evaluates-sexual-dysfunction-women-lung-cancer). Initially prompted by patient experiences that were expressed to the principal investigator, this study utilizes PROMIS measures assessing sexual health (Flynn et al., J Sex Med, 2013) to understand sexual side effects after lung cancer treatment. To date, there is very little known on this topic. Clinical trials for new lung cancer therapeutics generally do not collect this information. The study will be actively accruing until the end of Q1 2021. The investigators aim to learn more about the problems being faced with the goal of providing effective management strategies in the future. Taken together, all of these studies underscore the need to learn directly from people living with lung cancer to ensure that we are effectively designing and implementing appropriate supportive care and side-effect management within clinical care pathways. Utilizing real-world sources such as registries to complement quality of life data being collected in lung cancer clinical trials will improve knowledge around toxicities and side-effects and can lead to new management strategics and overall improved well-being for those diagnosed with lung cancer. patient reported outcomes, quality of life, Survivorship

Real-world effectiveness and safety of glecaprevir/pibrentasvir therapy in patients with chronic hepatitis C virus infection in Switzerland.

In the era of pangenotypic treatment regimens against hepatitis C virus (HCV) infection, data from postmarketing observational studies are crucial to better understand the treatment patterns used in specific countries and treatment outcomes under real-life conditions. We report data from Switzerland from an ongoing, multinational postmarketing observational study on the pangenotypic treatment regimen of glecaprevir (GLE; NS3/4A protease inhibitor) and pibrentasvir (PIB; NS5A inhibitor), coformulated as GLE/PIB. Adults infected with chronic HCV genotypes 1&ndash;6 were eligible to participate in the postmarketing observational study if they started GLE/PIB at the treating physician&rsquo;s discretion. The primary objective was to evaluate the effectiveness of GLE/PIB based on sustained virological response 12 weeks after completion of treatment (SVR12); secondary outcomes included patient-reported outcomes (Fatigue Severity Scale, Work Productivity and Activity Impairment Questionnaire, Pictorial Representation of Illness and Self Measure tool) and safety data. In Switzerland, 109 patients were enrolled, and 107 patients received &ge;1 dose GLE/PIB (94.4% non-cirrhotic; 43.9%/14.0%/29.0%/13.1% GT1/GT2/GT3/GT4; 89.7% treatment-na&iuml;ve; 91.6% assigned to an 8-week GLE/PIB regimen). Overall, 95 of 98 patients with sufficient follow-up data (96.9%) achieved SVR12 (95% confidence interval [CI] 91.4% to 99.0%), and 91.6% in the safety population (including six non-virological failures). The three treatment failures were due to relapse. All three failures were GT3, without cirrhosis and treatment na&iuml;ve. Patient-reported outcomes improved as well. GLE/PIB was well tolerated with no serious adverse events and no adverse events leading to discontinuation or interruption of GLE/PIB treatment. These real-world effectiveness and safety data of GLE/PIB in patients from Switzerland were consistent with those seen in the multinational registration trials. (Trial registration number: Clinicaltrials.gov: NCT03303599.).

RARE-09. PRESERVATION OF ENDOCRINE FUNCTION AFTER OMMAYA RESERVOIR INSERTION IN CHILDREN WITH CYSTIC CRANIOPHARYNGIOMA

INTRODUCTIONChildren with craniopharyngiomas (CP) can be subjected to significant morbidities caused by radical surgery and/or radiation with severe long-term consequences. Ommaya reservoir Insertion (ORI) into cystic CP represents a minimally invasive procedure that aims to preserve endocrine, hypothalamic and neurocognitive function. The purpose of this study was to determine the relevance of upfront ORI (+/- intracystic treatment) for preservation of endocrine function.METHODSA retrospective chart review of children with CP treated at the Hospital for Sick Children between 01/01/2000 and 15/01/2020 was undertaken. Endocrine function was reviewed at the time of initial ORI or surgical resection and throughout the course of follow-up. Event free survival (EFS) was defined as the time to additional surgical resection or irradiation.RESULTSFifty-five patients with sufficient endocrine follow-up data were included. The median age of diagnosis was 8.3 years (range 2.1–18.0 years), 31 were males. ORI was performed as upfront treatment in 30 patients, gross total or partial resection in 24 patients and radiation in 1 patient, respectively. Endocrine function remained stable after ORI with a median EFS of 19.2 (0 – 105.3) months while the majority of patients who underwent surgical resection had documented worsened endocrine function postoperatively (median of 0; range 0 – 29.4 months) (p< 0.001). The event most commonly related to secondary endocrine deterioration was initial or delayed surgical resection.CONCLUSIONSEndocrine function was preserved in patients with upfront ORI (+/- intracystic treatment). Further studies will elucidate the implications of ORI with respect to ophthalmological, vascular and neurocognitive long-term outcome.

Impact of repeated operations for progressive low-grade gliomas

BackgroundMaximal, aggressive resection of diffuse low-grade gliomas (DLGG) is well established as the standard of care in neuro-oncology. The role of repeat resection for tumor progression is unclear. ObjectiveTo assess the role of repeated operation for DLGG, and the effect on malignant transformation and survival. MethodsWe conducted a historical cohort study in which all patients undergoing multiple resections of DLGG between the years 1995–2019 were evaluated for overall survival (OS) and time to transformation (TTT). We then compared the outcome of this group with that of a matched control group comprised of patients who underwent only one operation despite being eligible for repeat surgery at tumor progression, but had received non-surgical oncological therapy or declined additional treatment. ResultsOf 607 patients in our departmental DLGG database, 93 patients underwent 2 or more surgeries and had sufficient follow-up and imaging data to be included in the study group. Thirty-eight patients were included in the matched control group. Early (less than 1 year) progression was associated with decreased survival and shorter TTT in the study group. Patients undergoing multiple resections had significantly longer TTT and OS compared to patients who underwent a single surgery. This effect was especially noted in patients who had radiological evidence of tumor transformation. ConclusionsRepeated resections of LGG are safe and offer survival benefit in select patients. Early progression following resection is associated with worse prognosis. Patients with evidence of radiological transformation may benefit the most from re-resection.

Para-aortic lymphadenectomy did not improve overall survival among women with type I endometrial cancer.

To compare outcomes and prognosis among women with type I endometrial cancer undergoing hysterectomy and bilateral salpingo-oophorectomy (H-BSO) with or without systematic pelvic lymphadenectomy (PLD) or para-aortic lymphadenectomy (PALD). Retrospective review of women postoperatively diagnosed with type I endometrial cancer who underwent H-BSO at a university hospital in Chengdu, China (January 2010 to June 2012). Women were divided into no lymphadenectomy (PLD-/PALD-), systematic pelvic lymphadenectomy (PLD+/PALD-), or combined pelvic and para-aortic lymphadenectomy (PLD+/PALD+) groups. Follow-up was by telephone. Postoperative outcomes and prognosis were compared and risk factors were analyzed. In total, 333 women met the inclusion criteria: 121 underwent PLD+/PALD-, 166 underwent PLD+/PALD+, and 46 underwent PLD-/PALD-. There were no differences in pre-operative characteristics among the groups (all P>0.05). The PLD+/PALD+ group had a higher laparotomy rate (P=0.001), the PLD-/PALD- group had shorter operation time (P=0.001) and lower blood loss (P<0.001). There were no differences between the PLD+/PALD- and PLD+/PALD+ groups. Overall, 291 women had sufficient follow-up data; there was no difference in overall survival, and PALD was not a predictor of survival. Postoperative outcomes were similar among all surgical groups; a survival benefit of PALD was not demonstrated.

Absent well-characterized onconeural antibodies in 283 patients with various polyneuropathies: A retrospective monocenter study

BackgroundParaneoplastic neurological syndromes (PNS) might present as polyneuropathies (PNP). Because PNS are rare and PNP are frequent, it may be difficult to decide in patients with PNP of unclear or presumably idiopathic etiology whether to test for onconeural antibodies, which are highly predictive for PNS. In this regard, this is the largest study investigating the prevalence of onconeural antibodies in patients with PNP, in order to clarify whether such testing should be standard. MethodsOf 1842 consecutive patients, 283 were suitable and had stored serum samples for screening for onconeural antibodies (anti-Hu, Yo, Ri, CV2/CRMP5, Ma2, and amphiphysin) by ELISA: 159 patients with PNP of – despite laborious work-up – unknown etiology without cancer, 67 with Guillain-Barré syndrome (GBS), 31 with chronic inflammatory demyelinating PNP (CIDP), and 26 with cancer and PNP. ResultsNone of the 283 screening samples revealed high concentrations for any of the tested antibodies. Thirteen sera (4.6%) showing positive reactivity in the screening ELISA (11 with PNP of unknown etiology without cancer, one with GBS, and one with CIDP) most likely represented increased background activity, as confirmatory assays (immunoblotting and immunohistochemistry) were negative. Furthermore, none of these 13 patients had diagnosed cancer and 10 with sufficient follow-up data did not develop cancer during follow-up. Interestingly, none of the patients with known cancer and PNP was screened positive for any antibody reactivity. ConclusionsOur data suggest that routine screening for onconeural antibodies in etiologically unclear and in presumably idiopathic (GBS and CIDP) PNP is not mandatory.

Postacute Care Utilization in Postsurgical Orthogeriatric Hip Fracture Care.

Among surgical patients, utilization of institutional-based postacute care (PAC) presents a notable financial burden and is associated with increased risk of complications and mortality rates when compared with discharge home. The purpose of this study was to identify predictors of postdischarge disposition to PAC in geriatric patients after surgical fixation of native hip fractures. We have done a query of the American College of Surgeons National Surgical Quality Improvement Program to identify geriatric (≥65 years) patients who sustained surgical femoral neck, intertrochanteric, and subtrochanteric hip fractures in 2016. Multivariate regression was used to compute risk factors for discharge to and prolonged stay (>30 days) in PAC. Eight thousand one hundred thirty-three geriatric hip fracture patients with sufficient follow-up data were identified. Of these, 6,670 patients (82.0%) were initially discharged to PAC after their hip fracture episode of care, and 2,986 patients (36.7%) remained in PAC for >30 days. Age (odds ratio [OR] 1.06 [1.05 to 1.08], P < 0.001), partial (OR 2.41 [1.57 to 3.71], P < 0.001) or total dependence (OR 3.03 [1.92 to 4.46], P < 0.001) for activities of daily living, dementia (OR 1.62 [1.33 to 1.96], P < 0.001), diabetes (OR 1.46 [1.14 to 1.85], P = 0.002), hypertension (OR 1.32 [1.10 to 1.58], P = 0.002), and total hospital length of stay (OR 1.04 [1.01 to 1.08], P = 0.006) were independent risk factors for discharge to PAC. Age (OR 1.05 [1.04 to 1.06], P < 0.001), partial (OR 2.86 [1.93 to 3.79], P < 0.001) or total dependence (OR 3.12 [1.45 to 4.79], P < 0.001) for activities of daily living, American Society of Anesthesiologist's classification (OR 1.27 [1.13 to 1.43], P < 0.001), dementia (OR 1.49 [1.28 to 1.74], P < 0.001), and total hospital length of stay (OR 1.10 [1.08 to 1.13], P < 0.001) were independent risk factors for prolonged PAC stay >30 days. Discharge to PAC is the norm among patients undergoing hip fracture surgery. Provider foreknowledge of risk factors may help improve hip fracture outcomes and decrease healthcare costs.

Identification and use of treatment (tx) options in patients (pts) with advanced non-small cell lung cancer (aNSCLC) after comprehensive genomic profiling (CGP): A real-world study.

9076 Background: The number of targeted txs for NSCLC is increasing. By analyzing numerous molecular alterations, CGP may open more targeted tx options than single biomarker testing. Methods: We analyzed a database linking Flatiron Health electronic health record-based clinical and Foundation Medicine, Inc. (FMI) CGP genomic alteration (GA) data in US pts diagnosed from 1/2011 with aNSCLC, primarily from community practices, and with follow-up through 6/2018. We examined the prevalence and distribution of genomic findings, and agreement between tx received and CGP-directed tx options (approved for aNSCLC/other tumors) on the FMI report as a measure of clinical utility. The latter was evaluated in a subset of pts with sufficient tx and follow-up data after FMI testing. Results: Among 5112 FMI-tested pts (first test observed 8/2012), 49% had their FMI test before starting any line of tx, 97% had ≥ 1 GA with known/likely function (median = 5), and 85% had ≥ 1 potential tx option (52% had ≥ 1 option for aNSCLC and 33% had ≥ 1 for another tumor type only). In 1366 pts evaluable for tx agreement after FMI testing, 572 (42%) received a tx listed on the FMI report and 111 (8%) were enrolled in clinical trials. Pts with a tx option approved for aNSCLC were more likely to have a tx agreeing with an option on the FMI report (67% of 754) v pts with a tx option approved in another tumor type only (8% of 612). Among the 1366 pts, 14% had EGFR/ALK/ROS1/BRAF (EARB) tx options only. The remaining 1170 had a non-EARB tx option, either as their only option (1014; 87%), or in addition to an EARB tx option (156; 13%). The non-EARB tx options included 377 pts (32%) with a tumor mutational burden-associated tx option. In these 1170 pts, 341 (29%) had an agreeing tx besides EARB, and 100 (9%) were enrolled on trials. Conclusions: FMI CGP identified potential NSCLC-specific tx options/a clinical trial opportunity for 52% of pts with aNSCLC. Of the pts evaluated for tx agreement, almost ½ received a tx agreeing with an option on the FMI report and/or were enrolled in a clinical trial. FMI CGP adds value beyond single biomarker testing by identifying txs and trial options in a meaningful proportion of pts.

The Nature and Cost of Readmissions after Work-Related Traumatic Spinal Injuries in New South Wales, Australia.

This study aimed to measure the subsequent health and health service cost burden of a cohort of workers hospitalised after sustaining work-related traumatic spinal injuries (TSI) across New South Wales, Australia. A record-linkage study (June 2013–June 2016) of hospitalised cases of work-related spinal injury (ICD10-AM code U73.0 or workers compensation) was conducted. Of the 824 individuals injured during this time, 740 had sufficient follow-up data to analyse readmissions ≤90 days post-acute hospital discharge. Individuals with TSI were predominantly male (86.2%), mean age 46.6 years. Around 8% (n = 61) experienced 119 unplanned readmission episodes within 28 days from discharge, over half with the primary diagnosis being for care involving rehabilitation. Other readmissions involved device complications/infections (7.5%), genitourinary or respiratory infections (10%) or mental health needs (4.3%). The mean ± SD readmission cost was $6946 ± $14,532 per patient. Unplanned readmissions shortly post-discharge for TSI indicate unresolved issues within acute-care, or poor support services organisation in discharge planning. This study offers evidence of unmet needs after acute TSI and can assist trauma care-coordinators’ comprehensive assessments of these patients prior to discharge. Improved quantification of the ongoing personal and health service after work-related injury is a vital part of the information needed to improve recovery after major work-related trauma.

What Is the Effect of Treating Mandibular Fractures on Weight and Prealbumin?

Fracture healing relies on the body to coordinate an inflammatory and anabolic reaction to re-establish osseous union. Although many factors affect this process or even disrupt it, the role of the body's nutritional reserves is not well understood. The purposes of this study were to describe the weight changes and to identify trends in laboratory values commonly used in nutritional assessment during mandibular fracture treatment. A prospective cohort study was designed. The study cohort included patients who sustained a mandibular fracture from September 1, 2017, to March 31, 2018. The primary outcome variable was the percentage weight change from baseline. Secondary outcome variables included serum albumin and serum prealbumin levels. Weight change was analyzed using a linear mixed model. Paired Wilcoxon tests were used to compare laboratory values with baseline levels. Thirty-nine patients met the inclusion criteria with sufficient follow-up data for analysis. The linear mixed model predicted a peak weight loss of 4.1% of the initial body weight by day 34. The serum prealbumin level increased over the study period (P<.001), and the albumin level was increased from baseline at week 3 (P<.05) but not significantly different from baseline after that time. During the course of treatment for mandibular fractures, patients lost an average of more than 4% of their body weight. However, the study did not show any meaningful change in nutritional laboratory values. Although it is important for patients and surgeons to be able to anticipate a weight loss of about 4 to 5% during mandibular fracture treatment, it is unlikely that this represents a large challenge to the nutritional status of patients.

An Open-Label, Single-Arm, Efficacy Study of Tranexamic Acid in Adolescents with Heavy Menstrual Bleeding.

Heavy menstrual bleeding (HMB) occurs in up to 40% of adolescent girls, significantly affecting their daily activities. Identifying alternative treatment strategies for HMB is particularly important for adolescents who prefer not to take hormonal contraception. Our objective was to determine whether use of tranexamic acid (TA) would increase health-related quality of life and decrease menstrual blood loss (MBL) in adolescents with HMB. DESIGN, SETTING, PARTICIPANTS, INTERVENTIONS, AND MAIN OUTCOME MEASURES: In an open-label, multi-institutional, single-arm, efficacy study, patients 18years of age or younger with HMB were treated with oral TA 1300mg 3 times daily during the first 5days of menses and monitored over the course of 4 menstrual cycles (1 baseline; 3 treatment cycles). Assessment of MBL was performed using the Menorrhagia Impact Questionnaire (MIQ) and the Pictorial Blood Assessment Chart. The MIQ includes Likert scale items, validated to assess the influence of HMB on quality of life. In previous studies, a 1-point decrease or more in score correlated with clinically significant improvement. Thirty-two patients enrolled in the study, and 25 had sufficient follow-up data to be deemed evaluable. The mean age of the participants was 14.7years (range, 11-18years). There was an overall improvement in all items of the MIQ, with a greater than 1-point improvement in the MIQ perceived blood loss scale. When using TA, mean Pictorial Blood Assessment Chart score improved by 100 points. There were no medication-related serious adverse events. Use of TA in female adolescents with HMB is well tolerated and leads to clinically meaningful reduction in MBL.

Lipid profile, familial hypercholesterolemia prevalence, and 2-year cardiovascular outcome assessment in acute coronary syndrome: Real-life data of a retrospective cohort

The aim of this retrospective study based on real-life data was to evaluate the lipid profile and demographic, clinical, and laboratory features of patients with acute coronary syndrome (ACS) at a tertiary center and to examine the mortality rate. Information including endpoint data for at least 2 years following the index ACS event was retrieved from hospital records. Patients without sufficient follow-up data were called by phone. Modified Dutch Lipid Clinic Network criteria were used to identify the presence of familial hypercholesterolemia (FH). Factors affecting mortality in the 2-year follow-up period were evaluated using Cox regression analysis. A total of 985 ACS patients (215 females) between 21 and 93 years of age were included. The females were older and had a lower smoking rate than the males. In females, the history of obesity and hypertension, the diabetes rate, and the thyroid-stimulating hormone level were higher than those of the males. In 95.6% of the patients, lipid parameters were measured upon hospital admission. No significant difference in dyslipidemia frequency was observed between genders. The frequency of FH was 7.6%. The rate of lipid-lowering drug use was <20% at admission, >90% at discharge, and decreased to 50% in the follow-up period. The mortality rate was 3.8% in the in-hospital period and 8.1% during the 2 years of follow-up. The mortality rate in ACS patients was 3.8% in the in-hospital period and 8.1% in the 2-year follow-up period. The frequency of hypercholesterolemia was 89.5% and the rate of lipid-lowering drug use was insufficient. Secondary prevention after ACS was not adequately employed even at a tertiary center. The FH frequency was 7.6% and those with FH were observed to have ACS at a younger age than those without.

The burden of chronic elbow dislocations in Cambodia and early results of a cost-effective surgical approach.

Chronic elbow dislocation presents a surgical challenge and there is difficulty in balancing stability with early mobilisation. We present a series of 103 patients treated with open reduction via a posterior approach and provide early results of an alternative combined medial and lateral approach (Soddo technique, Anderson etal.). Of the 103 patients, 81% initially consulted a traditional healer and the mean dislocation period was 11 weeks. There was significant loss to follow-up. Only 12 patients having undergone the posterior approach had complete datasets. The mean preoperative arc of movement was 10° and the postoperative arc was 65° at a mean follow-up of 16 weeks. Five patients treated with the Soddo technique had sufficient follow-up data. The mean preoperative arc was 20° and the mean postoperative arc was 95° (mean follow-up of 20 days). Those having undergone the Soddo technique achieved a 20° greater increase in range of movement and no re-dislocations.

SMART coils for intracranial aneurysm embolization: Follow-up outcomes

The SMART coil (Penumbra Inc., Alameda, CA, USA) is a new microcoil designed to enhance deliverability. Although prior studies have described its perioperative safety and efficacy, the follow-up outcomes after embolization of intracranial aneurysms using SMART coils have not been reported. Therefore, the aim of this retrospective cohort study is to assess the angiographic outcomes at interim follow-up after aneurysm embolization with SMART coils. We reviewed data from consecutive patients with intracranial aneurysms who underwent endovascular treatment using SMART coils between June 2016 and August 2017. Baseline data and follow-up angiographic outcomes using the modified Raymond-Roy classification (MRRC) were recorded. The study cohort comprised 33 patients with 34 aneurysms who underwent SMART coil embolization and had sufficient follow-up data. The mean age was 57 years, and 82% were female. The mean aneurysm maximum diameter and neck width were 6.1 ± 2.2 mm and 3.2 ± 1.2 mm, respectively, and 14.7% of aneurysms were ruptured. The overall complication rate was 12%. Initial mean coil packing density was 26%, and the initial MRRC was I, II, IIIa, and IIIb in 24%, 26%, 35%, and 15%, respectively. At last follow-up (mean duration 7.7 ± 3.2 months), the MRRC was I, II, IIIa, and IIIb in 62%, 26%, 3%, and 9%, respectively. The retreatment rate was 14.7%. The SMART coil is efficacious for the treatment of appropriately selected aneurysms, with an acceptable risk profile. The majority of residual aneurysms after the initial embolization procedure will progress to complete or near-complete occlusion at interim follow-up.

Early versus late wake therapy improves mood more in antepartum versus postpartum depression by differentially altering melatonin-sleep timing disturbances

BackgroundPeripartum major depression (MD) disables mothers and impairs emotional and neurocognitive development of offspring. We tested the hypothesis that critically-timed wake therapy (WT) relieves peripartum MD by altering melatonin and sleep timing, differentially, in antepartum vs. postpartum depressed patients (DP). MethodsIn a university clinical research center, we initially randomized 50 women – 26 antepartum (17 healthy comparison-HC, 9 DP) and 24 postpartum (8 HC, 16 DP) – to a cross-over trial of one night of early-night wake therapy (EWT: sleep 3:00–7:00 am) vs. late-night wake therapy (LWT: sleep 9:00 pm–01:00 am). Ultimately, we obtained mood, overnight plasma melatonin and polysomnography for: 15 antepartum women receiving EWT, 18 receiving LWT; 15 postpartum women receiving EWT, 14 receiving LWT. ResultsEWT improved mood more in antepartum vs. postpartum DP in conjunction with reduced (normalized) melatonin-sleep phase-angle differences (PADs) due to delayed melatonin onsets and advanced sleep onsets, and increased (from baseline) total sleep times (TST). LWT improved mood more in postpartum vs. antepartum DP in conjunction with increased TST. LimitationsSmall samples potentially rendered the study underpowered to detect group differences, making confirmation with larger samples essential. Sufficient follow-up data were not available in most women to document the duration of the mood response to wake therapy. ConclusionsEWT benefitted antepartum DP more by realigning melatonin and sleep timing, whereas LWT benefitted postpartum DP more by increasing TST. Thus, consistent with precision medicine aims, maximum mood benefits accrue from timing sleep/wake interventions to specific peripartum circadian pathophysiologies.

PCN26 - ASSESSING THE POTENTIAL VALUE OF AN INNOVATIVE ONCOLOGY THERAPY FROM THE HEALTH TECHNOLOGY ASSESSMENT (HTA) PERSPECTIVE: MARRYING CLINICAL VALUE FRAMEWORKS WITH ECONOMIC ASSESSMENT METHODOLOGY

This study assessed the clinical benefit of oncology regimens for an ultra-rare tumor using concepts from European Society of Medical Oncology (ESMO) and American Society of Clinical Oncology (ASCO) frameworks. It also enhanced clinical assessment of these frameworks by accounting for potential long-term benefits of a novel treatment. An enhanced value framework (EVF) was developed by combining ESMO and ASCO frameworks with well-validated approaches for projecting long-term survival. Published single-arm data for chemotherapies and patient-level data from recently approved immuno-oncology (IO) agent for treating aggressive ultra-rare tumor in metastatic setting was used. Under the ESMO Magnitude of Clinical Benefit Scale (MCBS), form 2a was selected due to lack of sufficient follow-up data on potential curative benefits in terms of overall survival (OS) at the time of approval. Along with OS benefit (1 to 4, indicating increasing OS benefit), MCBS also valued improvements in toxicity and/or quality of life (QoL) (1 for significant improvement in either). The ASCO value framework calculated incremental net health benefit (NHB) by combining scores attributable to clinical benefit, toxicity, and bonus benefits. The projected mean OS over life-time for IO was 42.5 months in the base case compared with 4.2 months for chemotherapies, driven mostly by improvements in progression-free survival (35.0 vs 2.5 months). Under ESMO MCBS version 1.1, IO scored 3 points higher than chemotherapies for efficacy (4 over 1) as well as 1 for improvement in both toxicity and QoL. Under the ASCO framework, the NHB of IO vs chemotherapies ranged from 212-218, with 193 attributable to clinical benefit, 0-5 to toxicity, and 20 bonus points. From HTA perspective, the IO agent for ultra-rare tumor in this case study was determined to provide considerable clinical benefit, irrespective of value framework used to assess benefits associated with the product.

Risk factors for radioactive iodine-avid metastatic lymph nodes on post I-131 ablation SPECT/CT in low- or intermediate-risk groups of papillary thyroid cancer

ObjectivePost I-131 ablation single-photon emission computed tomography (SPECT)/CT can show radioactive iodine (RAI)-avid cervical metastatic lymph nodes (mLN) in differentiated thyroid cancer. This study aimed to evaluate the incidence of RAI-avid mLN on post I-131 ablation SPECT/CT and the risk factors related to metastasis among patients with papillary thyroid cancer (PTC) in the low- or intermediate-risk groups.Study design and settingAmong 339 patients with PTC who underwent total thyroidectomy followed by I-131 ablation, 292 (228 women, 64 men) belonging to the low- or intermediate-risk groups before I-131 ablation, and with sufficient clinical follow-up data were enrolled. The risk groups were classified based on the American Thyroid Association 2015 guideline. Each patient was followed-up for at least 24 months after the ablation (median: 30 months). The clinical, pathologic, and biochemical factors of PTC were reviewed, and their relationships to RAI-avid mLN on SPECT/CT were analyzed.ResultsOf the 292 patients, 61 and 231 belonged to the low-and intermediate-risk groups, respectively. Four (6.5%) patients in the low-risk group and 31 (13.0%) patients in the intermediate-risk group had RAI-avid mLN. A high preablation TSH-stimulated serum thyroglobulin (Tg) level in the low- or intermediate-risk group predicted the presence of RAI-avid mLN (cut-off = 0.5; hazard ratio (HR): 2.96; p = 0.04). In the subgroup analysis by risk group, TSH-stimulated serum Tg only predicted RAI-avid mLN in the low-risk group (cut-off = 1.0; HR: 5.3; p = 0.03).ConclusionThe incidence of RAI-avid mLN on postablation SPECT/CT was relatively high in both low- and intermediate-risk patients with PTC, and high preablation TSH-stimulated serum Tg level was a predictor of metastasis, especially in the low-risk group. A selective treatment approach should be considered in patients with high preablation TSH-stimulated serum Tg level.

Idiopathic Sudden Sensorineural Hearing Loss Is Not a Sentinel Event for Acute Myocardial Infarction.

Given ongoing debate about the suggested association, the primary objective was to determine if idiopathic sudden sensorineural hearing loss (ISSNHL) was a sentinel event for acute myocardial infarction (AMI) in adults. Case-control study. United States MarketScan administrative health claims database. Aged 18 years or older, had a diagnosis of ISSNHL on or after January 1st, 2011 and had sufficient follow-up data available to assess for AMI occurrence. N/A. Incidence rates (per 1,000 patient years) of AMI for cases and controls were computed. Adjusted and unadjusted Cox proportional hazards models were created to explore possible associations between ISSNHL and initial AMI. A total of 10,749 ISSNHL cases and 10,749 matched controls were included. There were no significant differences in the incidence rate of AMI between ISSNHL cases (8.29 events/1,000 person-years) and controls (9.25 events/1,000 person-years), nor were there differences within age groups, sex, or comorbidity status (overall incidence rate ratio 0.90; 95% confidence interval [CI] 0.70-1.15 p = 0.39). The unadjusted and adjusted Cox proportional hazards models did not demonstrate an association between ISSNHL and initial AMI (hazard ratio [HR]: 0.90, 95% CI: 0.70-1.15; HR: 0.86, 95% CI: 0.67-1.10, respectively). ISSNHL is not a predictor of an initial AMI in adult patients from the United States. Considerable inconsistencies in associations between cardiovascular risk factors and ISSNHL exist in the literature. Further work is needed to confirm or refute direct associations between cardiovascular disease risk factors and ISSNHL before definitive mechanistic conclusions can be made.