Baseline Patient Demographics Research Articles

Isolated para-aortic nodal recurrence after treatment of early stage cervical carcinoma

ObjectiveSurgical evaluation of lymph node metastasis is paramount in the treatment of cervical cancer. We sought to explore the outcomes of patients with and without para-aortic lymphadenectomy undergoing curative-intent radical hysterectomy for stage IA-IIA cervical cancer. MethodsInstitutional data were retrospectively reviewed to identify women undergoing curative-intent radical hysterectomy with concurrent lymphadenectomy for stage IA-IIA cervical carcinoma from 2004 to 2021. Any carcinoma histology was allowed. Clinical risk stratification was performed according to GOG 92 and GOG 109 protocols. Disease outcomes, patterns of recurrence, and survival were analyzed with Chi square, t-test, Kaplan-Meier, and Cox proportional hazards multivariable statistics. Results300 patients were identified, 265 met inclusion criteria. Median follow up was 56 months. Pelvic lymphadenectomy (PLND) was performed in 71%, with the remainder undergoing combined para-aortic dissection (PPaLND). Baseline patient demographics and presence of clinical risk factors were well balanced between groups. PPaLND was more common in patients undergoing open surgery (OR 10.58, p <.0001), and tumors were larger in this group (2.96 vs 2.12 cm, p = .0002) and more likely non-squamous histology (OR 2.02, p = .017). Recurrence of disease was present in 13% of cases, with no difference between PLND and PPaLND regardless of histology. There were zero cases of isolated PaLN recurrence in either group. Neither progression free nor overall survival was different between groups. Prophylactic extended field radiation (EFRT) was not prescribed. ConclusionOmission of PaLN dissection, in the absence of suspicious nodes, did not decrease survival. There were no isolated PaLN recurrences after PLND alone.

P494 Impact of early optimization of ustekinumab on mid-term targets in severe Crohn’s disease: THE MUST study

Abstract Background As a substantial proportion of patients with Crohn’s disease (CD) experiences a refractory disease course, immediate drug intensification may be an option to optimize the effectiveness of current biotherapies. Aim : to compare the one-year efficacy of immediate dose escalation of ustekinumab 90 mg to 4-weekly with that of 8-weekly dosing after intravenous (iv) induction in severe active CD patients. Methods The MUST (meta-optimization of Ustekinumab) study is a real-life multicenter observational French retrospective cohort study including patients with severe active CD. All patients from three academic IBD centers who received induction therapy with IV ustekinumab followed with subcutaneous (sc) UST 90 mg, either 4-weekly (MUST group) or 8-weekly (STD group) were included from Jan 2019 to Dec 2020. The choice of treatment regimen was left at the physician’s discretion. Severe active CD was defined by HBI &amp;gt; 16 and stool frequency (SF) ≥ 4 and abdominal pain (AP) ≥ 2 over one week and at least one objective evidence of inflammation (CRP ≥ 5 mg/L and/or FCal ≥ 250 μg/g and/or radiologic and/or endoscopic signs of disease activity). The primary endpoint was PRO-2 based clinical remission defined by SF≤2-8 and AP ≤1, and either FCal &amp;lt;250 μg/g and/or CRP &amp;lt;5 mg/L at week 52. Key secondary endpoints were PRO-2 remission, endoscopic improvement and steroid-free clinical remission at week 52. Results 203 adult patients were included, either in the MUST group (n = 59) or in the STD group (n = 144). Baseline patient demographics and disease characteristics were similar between groups. Median disease duration was 9 years (IQR: 5 – 14 yrs), 66% were females. Disease location according to the Montreal classification was L1 and L3 in 36% and 44 % of patients. All had previously been exposed to more than one biotherapy, 27% experienced perianal CD, and 35% had undergone previous CD-related surgery. At week 52, the adjusted difference between the two groups for the primary endpoint was 15.8% (95% confidence interval (CI) 0.21 – 0.94; p = 0.029) with significantly higher clinical remission in the MUST group. The adjusted difference for PRO-2 remission was 3.7% (CI 0.45 - 1.66; p = 0.64). All patients, except one in the STD group, were weaned off steroids at week 52. Endoscopic improvement was similar in both groups (61.9% vs. 61.5%, p=0.98). Adverse events were not significantly different in both arms (42.4% vs 34.7%, p=0.338). Conclusion In the treat-to-target era, our real-life study shows that immediate escalation of ustekinumab therapy to 4-weekly dosing could achieve higher clinical remission at one year than 8-weekly dosing in severe CD. These findings should be confirmed in a dedicated prospective randomized trial.

An Update on Tissue Contraction in Immediate Breast Reconstruction Using an Adjustable Implant Partially Filled With Air.

Background With the use of nipple-sparing mastectomy (NSM) and skin-sparing mastectomy (SSM) techniques, utilizing a prepectoral underfilled adjustable saline implant allows for tissue contraction and thickening of the flap. This procedure allows for immediate reconstruction using an adjustable implant as a spacer with less risk of skin flap compromise and improves cosmetic outcomes. Methods A retrospective chart review of patients presenting to a single surgeon from September 2013 to September 2021 for breast reconstruction utilizing an underfilled prepectoral adjustable implant following SSM or NSM was performed. Baseline patient demographics, clinical information, postoperative complications, conversion to silicone implant, and contraction distance were recorded and analyzed. Results Fifty-four patients underwent prepectoral breast reconstruction using a Spectrum™ adjustable implant following an NSM or SSM. Tissue contraction and skin flap elevation were observed in all patients. The amount of tissue contraction averaged 4.4 cm (mean). Seven patients (12.96%) developed seromas. Four patients (7.41%) developed hematomas in the early postoperative period. Two patients (3.67%) developed capsular contracture. Two patients (3.67%) had a displaced port. After converting the air to saline, 25 patients (46.29%) opted for a secondary reconstructive procedure to exchange the saline implants for silicone gel implants. Conclusion Tissue contraction reduces the need for skin excision in ptotic breasts undergoing reconstruction procedures following NSM or SSM. The partially filled implant initially functions as a spacer to prevent flap adherence to the pectoral muscleand minimizes tension on the flap to promote flap thickening, elevation around the underfilled implant, and maximizes breast projection and overall aesthetic outcome.

Epidemiologic Changes of Facial Bone Fracture before and after Coronavirus Disease 2019: A Level 1 Trauma Center in Korea

Background The coronavirus disease 2019 (COVID-19) outbreak has had a major impact worldwide. Several countries have implemented restrictions on social interaction ("social distancing"). Several studies have reported that the epidemiology of trauma patients, such as those with facial bone fractures, has changed after COVID-19 pandemic. This study aimed to further explore these specific changes. Methods This was a retrospective study of patients who presented to a single institution with facial bone fractures between January 1, 2016, and December 31, 2020. Baseline patient demographics, clinical information, type of fracture, etiology, and operative management were compared before and after COVID-19. Results Of all cases, 3,409 occurred before COVID-19, and 602 occurred after COVID-19. Since the outbreak of COVID-19, the number of patients with facial fractures has not decreased significantly. A significant increase was noted in fractures that occurred outdoors ( p < 0.001). However, a decrease was observed in operative management between the groups ( p < 0.001). There was no significant difference in the proportion of assault, fall-down, industrial accident, or roll-down. In contrast, the proportion of traffic accidents and slip-down categories increased significantly ( p < 0.05). Moreover, a significant decrease was found in the proportion of the sports category ( p = 0.001) Conclusions It was confirmed through this study that COVID-19 pandemic also affected epidemiology of facial fractures. Focusing on these changes, it is necessary to develop safety measures to reduce facial fractures.

Usefulness of resuscitative endovascular balloon occlusion of the aorta compared to aortic cross-clamping in severely injured trauma patients: Analysis from the Japan Trauma Data Bank.

To compare in-hospital mortality of severely injured trauma patients who underwent resuscitative endovascular balloon occlusion of the aorta (REBOA) or aortic cross-clamping (ACC). In this multicenter, retrospective cohort study using data from a nationwide trauma registry of tertiary emergency medical centers in Japan (n= 280), trauma patients who underwent aortic occlusion at the emergency department from 2004 to 2019 were divided into two groups according to the treatment they received: patients treated with ACC and patients who underwent placement of a REBOA catheter. Multiple imputations were used to handle the missing data. In-hospital mortality of the patients who underwent REBOA or ACC was compared using a mixed-effect logistic regression analysis and a propensity score-matching analysis, in which the confounders, including baseline patient demographics and severity, were adjusted. Of 1,670 patients (1,137 with REBOA and 533 with ACC), 66% were male. The median age was 56 years, and the mortality rate was 55.2% in the REBOA group and 81.6% in the ACC group. The mixed-effect model regression analysis showed a significantly lower odds ratio for in-hospital mortality rate in the REBOA group (odds ratio 0.17; 95% confidence interval, 0.12-0.26). A similar odds ratio was observed in the propensity score matching analysis (odds ratio 0.27; 95% confidence interval, 0.18-0.40). Compared with ACC, REBOA use was associated with decreased mortality in severely injured trauma patients.

Dose Delays, Dose Reductions, and Relative Total Dose Intensity in Patients With Advanced Cancer Who Exercised During Neoadjuvant Chemotherapy Treatment.

When it comes to chemotherapy, maintaining the dose and schedule of treatment are of vital importance, as clinical evidence suggests that dose intensity is associated with optimal treatment outcomes for various tumors. Yet, reduced dose intensity is a common method of mitigating the chemotherapy-induced side effects. Exercise has been shown to attenuate chemotherapy-related symptoms that frequently cluster together. Understanding this, we conducted a retrospective analysis in patients with advanced disease treated with adjuvant or neoadjuvant chemotherapy regimens and who completed exercise training during treatment. Data were collected retrospectively in a chart review of 184 patients, aged 18 years or older and treated for Stage IIIA-IV cancer. Data collection included baseline patient demographics and clinical characteristics, including age at diagnosis, cancer stage at initial diagnosis, chemotherapy regimen, and planned dose and schedule. Cancer types included brain (6.5%), breast (35.9%), colorectal (8.7%), non-Hodgkin's lymphoma (7.6%), Hodgkin's lymphoma (11.4%), non-small cell lung (16.8%), ovarian (10.9%), and pancreatic (2.2%). All patients completed at least 12 weeks of prescribed, individualized exercise. Each program included cardiovascular, resistance training, and flexibility components, under the supervision of a certified exercise oncology trainer once a week. RDI was measured for each myelosuppressive agent in a regimen over the entire chemotherapy course and then averaged across the myelosuppressive agents in a regimen. An RDI of less than 85% was designated as the clinically meaningful threshold for reduction in RDI based on previously published studies. A considerable proportion of patients across regimens had dose delays (18.3%-74.3%) and dose reductions (18.1%-84.6%). Between 12% and 83.9% of patients missed at least 1 dose of a myelosuppressive agent that was part of their standard regimen. Overall, 50.8% of patients received less than 85% of the RDI. In short, patients with advanced cancer and an exercise adherence above 84.3% saw fewer chemotherapy dose delays and dose reductions. These delays and reductions occurred significantly less frequently compared to the published norms in the sedentary population (P < .05).

Real-World Effectiveness of 9-12Months of Guselkumab Therapy among Patients with Moderate-to-Severe Plaque Psoriasis in the CorEvitas Psoriasis Registry.

Guselkumab, an anti-interleukin-23 biologic therapy, has been shown to significantly reduce disease activity and improve patient-reported outcome measures (PROMs) among patients with moderate-to-severe plaque psoriasis in clinical trials. However, characterization of the real-world effectiveness of guselkumab among patients living in the USA and Canada is warranted. Patients who participated in the CorEvitas Psoriasis Registry between 18 July 2017 and 10 March 2020 were included if they met the following criteria: Investigator's Global Assessment (IGA) score ≥ 3 and body surface area (BSA) ≥ 10% (moderate-to-severe psoriasis), initiated guselkumab at a registry (index) visit, and had a registry follow-up visit after 9-12months of persistent guselkumab therapy. Data were retrieved for baseline patient demographics and disease characteristics, treatment history, disease activity, and PROMs. Outcomes were assessed at index and follow-up visits; response rates and mean changes were calculated. Among 113 patients, mean age was 49.7years, mean psoriasis duration was 17.5years, and 65.5% of patients were biologic experienced. At baseline, mean IGA score was 3.3, Psoriasis Area Severity Index (PASI) score was 13.6, and Dermatology Life Quality Index (DLQI) score was 9.6. At follow-up, IGA0/1, PASI 90, and DLQI 0/1 were achieved by 62.2%, 56.8%, and 54.7% of patients, respectively. Statistically significant improvements were observed in all disease activity scores and PROMs, including the EuroQoL Visual Analogue Scale, Work Productivity and Activity Impairment, Patient Global Assessment, fatigue, skin pain, and itch (p < 0.05). This real-world study showed that patients with moderate-to-severe psoriasis who received 9-12months of persistent guselkumab therapy experienced improvements in disease severity and PROMs.

Analysis of the association between location and patient prognosis in spontaneous intracerebral hemorrhage in the basal ganglia and thalamus: A retrospective single-center study

Spontaneous intracerebral hemorrhage (ICH) causes profound neurological sequelae in survivors. The patient's prognosis is closely linked to the location and amount of hemorrhage. Therefore, we explored the relationship between the hemorrhage location within the basal ganglia, including the thalamus, and its clinical outcomes in patients with spontaneous intracerebral hemorrhage. A retrospective analysis of consecutively enrolled patients with basal ganglia and thalamic intracerebral hemorrhage treated conservatively at a single tertiary neurosurgical center was conducted between January 2014 and December 2020. Patients were divided into 2 groups according to the lateralization of the right or left hemisphere hemorrhage. Furthermore, baseline patient demographics, hematoma volume, location of the hemorrhage (i.e., caudate nucleus, globus palidus, putamen, internal capsule anterior limb, internal capsule posterior limb, thalamus), and clinical outcomes were evaluated. Clinical outcomes were assessed using the modified Rankin scale at the 1-year follow-up. An modified Rankin scale score between 3 and 6 was considered a poor outcome. In the analysis according to location, the prognosis was poor when the ICH was localized to the posterior limb of the internal capsule (P < .000) and globus palidus (P = .001) in the right hemisphere. Similarly, the prognosis was also poor when the ICH was localized to the posterior limb of the internal capsule (P < .000), globus palidus (P < .000), putamen (P = .018), and thalamus (P < .000) of the left hemisphere. In the spontaneous intracerebral hemorrhages of the basal ganglia and thalamus, hemorrhaging within the internal capsule and the left thalamus's bilateral posterior limbs is associated with a poor prognosis. Multivariable logistic analysis showed that hematoma volume (odds ratio [OR] = 70.85, 95% confidence interval [CI]: 1.95-60.53, P = .007) and the posterior limb of the internal capsule (OR = 10.98, 95% CI:1.02-118.49, P = .048) were independent predictors of poor outcomes in the right hemisphere, while hematoma volume (OR = 70.85, 95% CI: 1.95-60.53, P = .007), the posterior limb of the internal capsule (OR = 10.98, 95% CI:1.02-118.49, P = .048) and thalamus (OR = 10.98, 95% CI:1.02-118.49, P = .048) were independent predictors of poor outcomes in the left hemisphere.

The Impact of Cognitive Impairment on Postoperative Complications After Spinal Surgery: A Matched Analysis

The coprevalence of age-related comorbidities such as cognitive impairment and spinal disorders is increasing. No studies to date have assessed the postoperative spine surgery outcomes of patients with mild cognitive impairment (MCI) or severe cognitive impairment (dementia) compared with those without preexisting cognitive impairment. Using all-payer claims database, 235,123 persons undergoing either cervical or lumbar spine procedures between January 2010 and October 2020 were identified. Exact 1:1:1 matching based on baseline patient demographics and comorbidities was used to create a dementia group, MCI group, and control group without MCI/dementia (n= 3636). The primary outcome was the rate of any 30-day major postoperative complications. Secondary outcomes included the rates of revision surgery, readmission rates within 30 days, and health care costs within 1 year postoperatively. Compared with the control group, patients with dementia had an 8-fold and 5.4-fold increase in all-cause 30-day complications after undergoing cervical and lumbar spine procedures, respectively. Similarly, patients with MCI had a 3.1-fold and 2.2-fold increase in all-cause 30-day complications, respectively. Patients with either MCI or dementia had increased rates of pneumonia and urinary tract infection after either spine procedure compared with control (P < 0.01). Odds of revision surgery were increased in the lumbar surgery cohort for dementia (3.43; 95% confidence interval, 1.69-6.95) and for MCI (2.41; 95% confidence interval, 1.14-5.05). This is the first study to characterize the postoperative complications profile of patients with preexisting dementia or MCI undergoing cervical and lumbar spine surgery. Both dementia and MCI are associated with increased postoperative complications within 30 days.

Paediatric high-grade osteosarcoma and its prognostic factors: a 10-year retrospective study.

This retrospective study was conducted to identify the characteristics of paediatric high-grade osteosarcoma and define its prognostic factors. We identified paediatric patients (aged <19 years at diagnosis) diagnosed with high-grade osteosarcoma from 1 January 2009 to 31 December 2018 in two hospitals in Hong Kong, then retrospectively evaluated their medical records to identify prognostic factors. In total, 52 patients were included in this study (22 girls, 42.3%). Femoral tumour was the most common form of osteosarcoma. Most patients (78.8%) had localised disease at diagnosis. The lung was the most common site of metastasis. Almost half (n=23, 46.9%) of the patients showed a good response to chemotherapy (ie, chemonecrosis >90%). Most patients (n=40, 80%) underwent limb-salvage surgery. The event-free survival and overall survival rates were 55.8% and 71.2%, respectively. Prognostic factors independently associated with poor event-free survival and poor overall survival were the presence of metastasis at diagnosis, poor tumour chemonecrosis, and the need for amputation. This multicentre review of paediatric high-grade osteosarcoma showed that the baseline patient demographics, event-free survival, and overall survival in Hong Kong were similar to previous findings in other countries. Patients with metastatic disease at diagnosis and poor chemonecrosis had worse survival outcomes. Molecular analyses of genetic abnormalities may help to identify targeted therapies in future studies.

Clinical Experience with Azacitidine and Venetoclax +/- Gemtuzumab in Pediatric Patients with Relapsed or Refractory Acute Leukemias: A Report from the Children's Hospital of Philadelphia

Background: Children with refractory or relapsed (R/R) leukemia, particularly acute myeloid leukemia (AML), have limited curative options. Allogeneic hematopoietic stem cell transplantation (HSCT) for patients who achieve subsequent complete remission (CR) after relapse is generally required for long-term cure, but many children with multiply-R/R AML are unable to achieve CR with conventional salvage regimens. Dual therapy with the hypomethylating agent azacitidine and BCL-2 inhibitor venetoclax (aza/ven) is well-tolerated in adults with AML and has become the standard of care for elderly patients or those with co-morbid conditions precluding intensive chemotherapy. The safety of venetoclax in combination with cytarabine +/- idarubicin was established in children with R/R AML (Karol Lancet Oncology 2020), but pediatric experience with the aza/ven combination remains limited. We sought to describe our institutional experience with aza/ven-based therapy in children and adolescents/young adults with R/R acute leukemias. Methods: We conducted a retrospective chart review of patients aged 0-21 years at initial leukemia diagnosis who were treated with commercially-available aza/ven at the Children's Hospital of Philadelphia (CHOP) from January 1, 2019 to June 30, 2022. Data were collected for baseline patient demographics, leukemia immunophenoptyping and genetics, therapy administration, clinical response, and post-aza/ven outcomes. Azacitidine 100 mg/m2 daily intravenously (IV) was given on days 1-5 of each 28-day cycle. Venetoclax was given daily as oral tablets with 3-day ramp-up dosing to minimize tumor lysis syndrome (TLS) risk as 200 mg (day 1), 400 mg (day 2), and 800 mg (days 3-28) adult equivalent dosing (Place Future Oncology 2018) with 50% dose reduction for patients receiving concomitant azoles. Results: Thirty-seven pediatric patients with R/R acute leukemia received aza/ven-based therapy at CHOP during the study period; 27 (72.9%) had AML, 7 (18.9%) had B-cell acute lymphoblastic leukemia (B-ALL), 1 had T-cell ALL (2.7%), and 2 (5.4%) had mixed phenotype acute leukemia (MPAL). Six children did not complete a full 28-day cycle of aza/ven due to progressive disease (n=4) or severe TLS (n=2). Within the cohort of patients who completed 1 cycle, 22/31 (71%) had multiply-relapsed leukemia, and 9/31 (29%) had primary chemorefractory disease. The median age at initial leukemia diagnosis was 8 years (range 0.5-21). Patients in this cohort received a median of 2 aza/ven cycles (range 1-6). Eight patients with AML also received one dose of gemtuzumab ozogamicin (GO) 3 mg/m2 IV (given on day 4, 5, or 8) with cycle 1 aza/ven; 3 patients received additional GO in subsequent cycles. Twelve of 31 patients who completed 1 cycle aza/ven had cycle 2 or later chemotherapy held or delayed, most commonly to facilitate resolution of drug-, infection- or leukemia-induced cytopenias. Amongst the 29 patients who underwent bone marrow response assessment after aza/ven cycle 1 (n=25) or cycle 2 (n=4), 14 were in CR with negative measurable residual disease (MRD) by flow cytometry (<0.1% for AML, <0.01% for ALL/MPAL), including young children with high-risk AML genetics such as CBFA2T3-GLIS2 and ETV6-EP300 fusions. One additional patient with residual leukemia after cycle 1 aza/ven achieved MRD-negative CR after cycle 2. The remaining patients had either persistent leukemia detectable in peripheral blood or were MRD+ in bone marrow at first response assessment.After receipt of aza/ven, 11 patients with AML and 1 with MPAL proceeded to HSCT, 2 patients with B-ALL were treated with autologous CD19 chimeric antigen receptor T cells (CD19CART), and 1 patient with AML received allogeneic CD123CART. The study cohort was followed for a median of 7.8 months (range 1-32 months). At last follow up, 39% (12/31) of patients were alive (Figure 1). Conclusions: We report the experience of a single institution with 37 pediatric patients with multiply-R/R AML, ALL, and MPAL treated with aza/ven-based therapy, often in the outpatient clinic with good tolerability. Importantly, MRD-negative CR was achieved in 14/37 children (37.8%), nearly always after one cycle of aza/ven, which enabled consolidative HSCT in most responders and long-term survival of some patients. Formal clinical trial evaluation of aza/ven in children with R/R acute leukemias, ideally at an earlier stage of relapse, is warranted. Figure 1View largeDownload PPTFigure 1View largeDownload PPT Close modal

The role of extracranial carotid duplex in predicting functional outcome in first time lacunae strokes

ABSTRACT Background Stroke is the third largest cause of death both worldwide and in Taiwan. Among the various stroke subtypes, lacunae strokes account for 20 to 30% of the total stroke population. Through vigorous risk control factors, the effective prevention and the long-term functional outcome remains are yet to be investigated. Carotid duplex is a non-invasive neuroimaging modality that is routinely applied to stroke patients. In the current research, we correlate baseline carotid duplex examination parameters with functional outcome assessment in an attempt to ascertain important variables for early outcome prediction. Method We retrospectively recruited lacunae ischemic stroke patients from the Department of Neurology, Changhua Christian Hospital. Patient baseline demographics, biochemistry, neuroimaging, and outcome assessments were thoroughly evaluated via a modified Rankin Scale (mRS), NIHSS, and Barthel index scores, both prior and subsequent to patient discharge for a period of up to one year. Patients were divided into two groups based on their functional recovery status. This current study utilizes the Kaplan–Meier method to draw the survival curve and adopts the Cox proportional hazards model to estimate the hazard ratio between the two groups. The risk modeling method is also applied to formulate the best fit in seeking and identifying the variables, which has the most impact on determining theoutcome predictor. All statistical analyses were performed using R for Windows (version 3.6.3), with p < 0.05 meaning statistical significance and 0.05 < p < 0.1 denoting marginal statistical significance. Results One hundred forty-one ischemic lacunae stroke patients are included in the study, of which the follow-ups of 69 patients showed no physical functionality improvement, whereas 72 patients demonstrated favorable functional outcomes. In terms of underlying diseases, more than 80% of the patients suffered from hyperlipidemia upon hospitalization and more than 40% of the patients suffered from diabetes mellitus and heart disease. There was a significant difference in pulmonary disease between improvement and non-improvement in disability (1.4% vs 10.1%, p = 0.034). The average age of the improved group was lower than that of the non-improved group (65.5 vs. 72, p = 0.014), and the WBC was higher (8 vs 6.95, p = 0.005); furthermore, higher NIHSS scores (6.5 vs 3, p = 0.001) and lower Barthel index scores (47.5 vs 80, p < 0.001) were also noted. The group with improved mRS required a longer hospital stay (with a median of 10 days), while their un-improved counterpart required 8 days (p < 0.05). The majority of patients were discharged within 30 days, and there was a slight difference between the two survival curves (marginal statistical significance, 0.05 < p < 0.1). The hazard ratio of the improved group was 0.7188. There was a difference in the end diastolic velocity (EDV) of common carotid artery (CCA) between the lesion and non-lesion sides of the patients (p < 0.05). Risk-stratifying models indicate that diabetes mellitus, peak systolic velocity (PSV) of the internal carotid artery (ICA) on the lesion side, the diameter of the ICA on the non-lesion side, and the pulsatility index (PI) of the ICA and external carotid artery (ECA) were selected as the most important factors affecting the end diastolic velocity (EDV) of the common carotid artery (CCA) in all four models. Conclusion In the current study, the most suitable length of stay in hospital for lacunae stroke patients to fully recuperate is ten days. Additionally, CCA EDV might be the key determinant, with baseline diabetes mellitus acting in a medium role, capable of altering long-term outcome functionality and recovery.

Abstract 14359: Impact of Marital Stress on 12-month Health Outcomes Among Young Adults With Acute Myocardial Infarction

Background: Psychosocial stress is associated with worse cardiac outcomes, but little is known about the prognostic impact of marital stress in young adults (≤55 years) with acute myocardial infarction (AMI). We investigated the association between marital stress and 1-year health outcomes in young AMI survivors. Methods: We used data from the VIRGO study (Variation in Recovery: Role of Gender on Outcomes of Young AMI Patients), which enrolled people aged 18-55 years with AMI (2008-2012). Marital stress was assessed among married/partnered participants at 1 month post-AMI using the Stockholm Marital Stress Scale, categorized as absent/mild, moderate, and severe. Main outcomes were physical/mental health status, generic/disease-specific quality of life, angina, depressive symptoms, and all-cause readmission at 1 year post-AMI. Linear and logistic regression models were sequentially adjusted for baseline health status, demographics, and socioeconomic factors (including education level, income level, employment status, and insurance status). Results: Among the 1593 married/partnered participants in our study, more women reported severe marital stress than men (39.4% vs 30.4%, p=0.001). Having severe marital stress was associated with worse physical and mental health, lower generic and cardiovascular-specific quality of life, more angina and depressive symptoms, and 1.48 times higher all-cause readmission at 1 year post-AMI. These associations remained significant after adjusting for baseline health score and patient demographics ( Table Model 1 ), but they attenuated and became non-significant when further adjusting for socioeconomic factors ( Model 2 ). Conclusion: Marital stress was associated with worse health outcomes in young AMI patients, which can be partially mediated by socioeconomic factors. Further research is needed to understand this complex relationship and potential causal pathway associated with these findings.

How to Create an Orthopaedic Arthroplasty Database Project: A Step-by-Step Guide Part II: Study Execution

In recent years, the use of national databases in orthopaedic surgery research has grown substantially with database studies comprising an estimated ∼10% of all published lower extremity arthroplasty research. The aim of this review is to serve as a guide on how to: (1) design; (2) execute; and (3) publish an orthopaedic database arthroplasty project. In part II, we discuss how to collect data, propose a novel checklist/standards for presenting orthopaedic database information (SOPOD), discuss methods for appropriate data interpretation/analysis, and summarize how to convert findings to a manuscript (providing a previously published example study). Data collection can be divided into two stages: baseline patient demographics and primary/secondary outcomes of interest. Our proposed SOPOD is more orthopaedic-centered and builds upon previous standards for observational studies from the EQUATOR network. There are a host of statistical methods available to analyze data to compare baseline demographics, primary/secondary outcomes, and reduce type 1 errors seen in large datasets. When drafting a manuscript, it is important to consider and discuss the limitations of database studies, including their retrospective nature, issues with coding/billing, differences in statistical versus clinical significance (or relevance), lack of surgery details (approach, laterality, and implants), and limited sampling or follow-up. We hope this paper will serve as a starting point for those interested in conducting lower extremity arthroplasty database studies.

P-151 ROLE OF INDOCYANINE GREEN TO MITIGATE WOUND COMPLICATIONS IN ANTERIOR COMPONENT SEPARATION TECHNIQUE FOR VENTRAL HERNIA REPAIR- OUR EARLY EXPERIENCE

Abstract Aim The subjective ease of anterior component separation technique (ACST) has made it a widely used surgical option amongst budding surgeons for ventral hernia repairs (VHR). However, surgical site occurrences (SSO) like flap necrosis due to compromised perfusion have frequently been reported. This study aims to evaluate the impact of adoption of indocyanine green-fluorescence angiography (ICG-FA) to map soft tissue perfusion on wound-related complications following open ACST in VHR. Material &amp; Methods We performed a retrospective review of patients who underwent VHR with open ACST at a single centre between March 2018 and July 2020. The study comprised of consecutive cases of ACST with onlay meshplasty done before (March 2018–April 2019, n=24) and after (May 2019 to July 2020, n=19) implementation of ICG-FA for intra-operative perfusion mapping of subcutaneous tissue and skin. Results The pre-ICG group and post-ICG group were similar in terms of baseline patient demographics and peri-operative details. The rate of SSO was higher in the pre-ICG group, but this result was not statistically significant (46% vs. 26%; p value 0.189). Skin necrosis, however, was observed in significantly less number of patients in the post-ICG cohort (29% vs. 5%; p value 0.045). No mesh infection was observed in either group. Conclusion This study demonstrates the effectiveness of perfusion mapping by the use of ICG-FA to determine potential areas of decreased perfusion and thereby minimize wound complications.

Anatomic and functional discordance among patients with non-obstructive coronary disease

Abstract Background Non-obstructive coronary artery disease (CAD) is associated with increased adverse cardiovascular (CV) events. However, it is unclear if functional stenosis, as assessed by FFRCT &amp;lt;0.80, further stratifies risk among patients with non-obstructive CAD and which factors contribute to this anatomic-functional discordance (stenosis &amp;lt;50% and FFRCT &amp;lt;0.80). Purpose We hypothesized that patients with anatomically non-obstructive CAD by CTA and an abnormal FFRCT value of ≤0.80 have a phenomenon termed anatomic-functional discordance, and this discordance would be associated with increased adverse outcomes. Methods Patients in the ADVANCE (Assessing Diagnostic Value of Non-invasive FFRCT in Coronary Care) Registry who had exclusively non-obstructive CAD (anatomic stenosis &amp;lt;50%) were stratified by FFRCT &amp;gt;0.80 in all coronary vessels (concordant) vs. FFRCT &amp;lt;0.80 in at least one vessel (discordant). Baseline patient demographics, coronary computed tomography angiography findings, downstream testing and clinical outcomes were compared between groups. The primary composite endpoint included revascularization, CV hospitalization, heart failure, arrhythmia, non-fatal myocardial infarction, unplanned hospitalization for an acute coronary syndrome leading to urgent revascularization, and all-cause death. Results Among 1,261 patients with non-obstructive CAD, 543 (43.1%) had functional stenosis with FFRCT &amp;lt;0.80. Patients in the discordant group were older, more likely to have hypertension, hyperlipidemia, and had significantly higher indexed left ventricular (LV) mass and significantly lower coronary volume-to-mass ratios when compared with patients in the concordant group. Downstream non-invasive testing was more common among patients with discordance (35.9% vs 20.2%, p&amp;lt;0.0001) and more frequently resulted in a positive downstream test (10.3% vs. 3.3%, p&amp;lt;0.0001). Invasive angiography was also more common among patients with discordance (25.2% vs. 11.6%, p&amp;lt;0.0001). Anatomic-functional discordance was associated with higher rates of CV hospitalization and percutaneous coronary intervention (both p&amp;lt;0.0001), but no significant difference in all-cause death. After adjustment, anatomic-functional discordance was associated with a significantly higher risk of the composite endpoint (adjusted HR 2.79, 95% CI 1.67–4.65), Figure 1. As shown in Figure 2, the more vessels with anatomic-functional discordance, the higher the rate of adverse cardiac events. Conclusion Anatomic-functional discordance was present in nearly half of patients with exclusively non-obstructive CAD. The lower coronary volume: LV mass ratio may reflect abnormal coronary physiology at lower thresholds of anatomical stenosis among those with discordance. Compared to patients with concordance, patients with discordance had worse clinical outcomes suggesting that anatomic-functional discordance may stratify risk for adverse CV events among patients with non-obstructive CAD. Funding Acknowledgement Type of funding sources: Other. Main funding source(s): The analysis was an investigator-initiated analysis sponsored by Heart Flow.

Effect of proton radiation therapy on cardiovascular implantable electronic devices [CIED

Abstract Background The number of cancer patients with CIED receiving radiotherapy has increased dramatically with improving life expectancy in both patients with cardiovascular disease and cancer. The advent of proton therapy adds new concern for potential malfunction in CIED devices, both due to significant neutron scatter and its use of strong magnets to focus radiation beams. Therefore, we aimed to assess the incidence of CIED malfunction secondary to proton therapy in this patient cohort. Methods We retrospectively analyzed patients with CIED undergoing proton therapy at our institute between 2011–2021. Each device was programmed pre-treatment and monitored post-treatment according to a special protocol developed in our centre. Treatments were prescribed to doses up to 70 Gy (RBE) and delivered using either passive-scattering or pencil beam techniques. Distances between the CIED and treated volumes ranged from 10–50 cm. We analyzed baseline patient demographics, CIED demographics, CIED outcomes pre-proton therapy as well as post-proton therapy including device reset and requirement for replacement, analyzing up to most recent check. Results Fifty-one patients with CIED underwent proton therapy during the study period. Estimated neutron dose ranged from 0.05–2.0 mSv/GyRBE for this patient cohort. Baseline demographics outlines in table 1. Of note 26/51 patients underwent proton therapy for ophthalmic malignancies, 6/51 for brain/skull malignancies. CIED comprised of 39 pacemakers and 12 implantable cardioverter defibrillators. Fourteen patients were pacemaker-dependent. Using 95% Confidence Interval, ventricular threshold, impedance, and amplitude, as well as atrial threshold and amplitude were unchanged, whereas atrial impedance measurements had a change pre- and post-proton therapy (Table 2). No patients had a device reset. One patient had a premature battery depletion three months post-radiotherapy for pancreatic cancer. Conclusions Our findings suggest that proton therapy does not significantly impact CIED function. Whilst caution remains as further data is accrued, close monitoring, particularly with the advent of remote monitoring, of these patients should be recommended. Funding Acknowledgement Type of funding sources: None.

Health care utilization in a nurse practitioner-led atrial fibrillation clinic.

Atrial fibrillation (AF) is the most common cardiac arrhythmia and is emerging in prevalence with an increasingly aging population. The complex nature of the disease and its association with significant morbidity and mortality has resulted in a call for a new integrative, multidisciplinary approach to AF management. Determine if the use of a nurse practitioner (NP)-led AF clinic (NPAFC) can improve care for patients. An NPAFC was designed to serve as an independent clinic for standardizing patient care and improving access to care. Baseline patient demographics, care pathway, and interventions were characterized in clinic. Primary outcomes were hospitalizations and emergency department (ER) visits, before and after clinic implementation. Overall, 1,442 patients were enrolled in the AF clinic between January 2016 and June 2018. The mean age at the first AF clinic visit was 68.7 ± 12.6 years, 54% were male, and the mean body mass index was 31 ± 7 kg/m2. Among the patients, 45.2% had paroxysmal AF, 43.6% persistent AF, and 5.5% permanent AF. With an average of 3 ± 3 clinic visits per patient, the number of patients with ≥1 hospitalization decreased by 78% after clinic implementation. Similarly, the number of patients with ≥1 ER visit decreased by 79%, and 22.7% of patients avoided at least one ER visit. The number of patients with ≥1 hospitalization or ≥1ER visit decreased within two years after the implementation of an NPAFC. Implementation of an NP-led AF clinic in the United States may reduce hospitalizations and ER visits if implemented in an integrative model.

S702 Effects of Gastrointestinal Comorbidities on Mortality in Patients Admitted for Systemic Lupus Erythematosus

Introduction: Systemic Lupus Erythematosus (SLE) is a chronic autoimmune inflammatory disease with multi-organ involvement. Gastrointestinal manifestations typically arise as a result of adverse reactions, therapeutic agents or infections. However, SLE gastrointestinal involvement is important to identify because undertreatment can lead to life threatening complications such as lupus mesenteric vasculitis, protein losing enteropathy, and acute pancreatitis. Our project aims to look at the effects of gastrointestinal comorbidities on the mortality of patients admitted for SLE. Methods: A retrospective analysis of the largest inpatient database, the National Inpatient Sample, was performed from 2001-2013. Primary diagnosis of SLE and comorbidities including gastrointestinal bleeding (GIB), dysphagia, gastroesophageal reflux disease (GERD), Celiac disease, Crohn’s disease, Ulcerative colitis, serositis, pancreatitis, malabsorption was extracted using International Classification of Diseases, Ninth Revision (ICD-9) codes. A propensity-matched multivariable logistic regression analysis was performed to analyze the correlation of patients against their healthy counterparts and the effect on mortality. Propensity matching was performed to adjust for baseline patient and hospital demographics. All significance levels of p< 0.01. Results: After adjusting for age, race, median income, insurance status, hospital region, and Charlson Comorbidity Severity, it was found that GIB was significantly associated with mortality. Patients with GIB admitted for SLE were 3.85 times more likely to die compared to those without GIB. GERD, dysphagia, Celiac disease, Crohn’s disease, Ulcerative colitis, serositis, pancreatitis, and malabsorption were not significantly associated with mortality in SLE patients. (Figure) Conclusion: SLE patients who present with GIB are more likely to die compared to those without SLE. This may be due to SLE patients having prolonged bleeding times. Additionally, many SLE patients have renal involvement and chronic kidney disease which may further exacerbate coagulation and hemostasis problems. SLE patients are also at risk for lupus mesenteric vasculitis, a potential life threatening cause for bleeding. Accurate diagnosis and early treatment of GIB in SLE patients is necessary to reduce mortality risk. Future studies should investigate factors that increase GIB risk in SLE patients.Figure 1.: Predictors of mortality in patient with SLE and concurrent GI diseases.

519. CLINICAL OUTCOMES OF ESOPHAGECTOMY IN ADVANCED AGE PATIENTS – A PROPENSITY SCORE MATCHING STUDY IN A LOCAL INSTITUTE

Abstract Esophagectomy for esophageal cancer is associated with high operative morbidity and mortality. While more patients diagnosed with esophageal cancer in advanced age, current study was to address the feasibility and safety of esophagectomy for advanced age patients. Total 62 patients who underwent esophagectomy from 2017-2021 were recruited from local institute database. These patients were divided into 2 groups: group I (age &amp;lt;70), group II (age ≥70). Propensity score matching (PSM) analysis was performed with patient baseline demographics, tumour characteristics, and operation details. After PSM, 19 patients on each arm were identified. Primary outcome was major surgical morbidity rate (Clavien-Dindo Grade ≥3). Secondary outcomes included perioperative parameters, length of hospital stay, short-term mortality and overall survival. The perioperative outcomes included day to resume oral feeding and mobilization were similar between two groups. There was a trend toward higher rate of chest infection (5.3% vs 26.3%, p=0.180) in group II. The length of hospital stay was significantly longer in older age group as well (9 days vs. 13 days, p=0.032). Nevertheless, there was no statistically significant difference in major surgical morbidity rate (10.5% vs. 5.3%, p=1.000) and 30-day mortality rate (0% vs. 5.3%, p=1.000) between two groups. Esophagectomy was safe and feasible in selected advanced age patients with good performance status. There was no increase in major surgical complication rate and short-term mortality. oldage.xlsx (could not be inserted)