Differences In Baseline Comorbidities Research Articles

The Predictors of Incidental Durotomy in Patients Undergoing Pedicle Subtraction Osteotomy for the Correction of Adult Spinal Deformity.

Background: Pedicle subtraction osteotomy (PSO) is a powerful tool for sagittal plane correction in patients with rigid adult spinal deformity (ASD); however, it is associated with high intraoperative blood loss and the increased risk of durotomy. The objective of the present study was to identify intraoperative techniques and baseline patient factors capable of predicting intraoperative durotomy. Methods: A tri-institutional database was retrospectively queried for all patients who underwent PSO for ASD. Data on baseline comorbidities, surgical history, surgeon characteristics and intraoperative maneuvers were gathered. PSO aggressiveness was defined as conventional (Schwab 3 PSO) or an extended PSO (Schwab type 4). The primary outcome of the study was the occurrence of durotomy intraoperatively. Univariable analyses were performed with Mann-Whitney U tests, Chi-squared analyses, and Fisher's exact tests. Statistical significance was defined by p < 0.05. Results: One hundred and sixteen patients were identified (mean age 61.9 ± 12.6 yr; 44.8% male), of whom 51 (44.0%) experienced intraoperative durotomy. There were no significant differences in baseline comorbidities between those who did and did not experience durotomy, with the exception that baseline weight and body mass index were higher in patients who did not suffer durotomy. Prior surgery (OR 2.73; 95% CI [1.13, 6.58]; p = 0.03) and, more specifically, prior decompression at the PSO level (OR 4.23; 95% CI [1.92, 9.34]; p < 0.001) was predictive of durotomy. A comparison of surgeon training showed no statistically significant difference in durotomy rate between fellowship and non-fellowship trained surgeons, or between orthopedic surgeons and neurosurgeons. The PSO level, PSO aggressiveness, the presence of stenosis at the PSO level, nor the surgical instrument used predicted the odds of durotomy occurrence. Those experiencing durotomy had similar hospitalization durations, rates of reoperation and rates of nonroutine discharge. Conclusions: In this large multisite series, a history of prior decompression at the PSO level was associated with a four-fold increase in intraoperative durotomy risk. Notably the use of extended (versus) standard PSO, surgical technique, nor baseline patient characteristics predicted durotomy. Durotomies occurred in 44% of patients and may prolong operative times. Additional prospective investigations are merited.

Race-ethnicity and sex differences in 1-year survival following percutaneous coronary intervention among Medicare fee-for-service beneficiaries.

Existing literature describing differences in survival following percutaneous coronary intervention (PCI)by patient sex, race-ethnicity and the role of socioeconomic characteristics (SEC)is limited. Evaluate differences in 1-year survival after PCI by sex and race-ethnicity, and explore the contribution of SEC to observed differences. Using a 20% sample of Medicare claims data for beneficiaries aged 65+, we identified fee-for-service patients who received PCI from 2007 to 2015. We performed logistic regression to assess how sex and race-ethnicity relate to procedural indication, inpatient versus outpatient setting, and 1-year mortality. We evaluated whether these relationships are moderated by sequentially controlling for factors including age, comorbidities, presence of acute myocardial infarction (AMI),county SEC, medical resource availabilityand inpatient versus outpatient procedural status. We identified 300,491 PCI procedures, of which 94,863 (31.6%) were outpatient. There was a significant transition to outpatient PCI during the study period, especially for men compared with women and White patients compared with Black patients. Black patients were 3.50 percentage points (p < 0.001) and women were 3.41 percentage points (p < 0.001) more likely than White and male patients to undergo PCI at the time of AMI, which typically occurs in the inpatient setting. Controlling for age and calendar year, Black patients were 2.87 percentage points more likely than non-Hispanic White patients to die within 1 year after PCI. After controlling for Black-White differences in comorbidities, the differences in 1-year mortality decreased to 0.95 percentage points, which then became nonsignificant when further controlling for county resources and state of residence. Women were more likely to experience PCI in the setting of AMI and had less transition to outpatient care during the period. Black patients experienced higher 1-year mortality following PCI, which is explained by differences in baseline comorbidities, county medical resources, and state of residence.

Machine learning facilitates the prediction of long-term mortality in patients with tricuspid regurgitation

ObjectiveTricuspid regurgitation (TR) is a prevalent valve disease associated with significant morbidity and mortality. We aimed to apply machine learning (ML) to assess risk stratification in patients with ≥moderate TR.MethodsPatients...

Breakthrough invasive fungal infections on isavuconazole prophylaxis in hematologic malignancy & hematopoietic stem cell transplant patients.

Isavuconazole (ISA) is a newer antifungal used in patients with history of hematologic malignancies and hematopoietic transplant and cellular therapies (HM/TCT). Although it has a more favorable side-effect profile, breakthrough invasive fungal infections (bIFIs) while on ISA have been reported. In this single-center retrospective study evaluating HM/TCT patients who received prophylactic ISA for ≥7 days, we evaluated the incidence and potential risk factors for bIFIs. We evaluated 106 patients who received prophylactic ISA. The patients were predominantly male (60.4%) with median age of 65 (range: 21-91) years. Acute myeloid leukemia (48/106, 45.3%) was the most common HM, with majority having relapsed and/or refractory disease (43/106, 40.6%) or receiving ongoing therapy (38/106, 35.8%). Nineteen patients (17.9%) developed bIFIs-nine proven [Fusarium (3), Candida (2), Mucorales plus Aspergillus (2), Mucorales (1), Colletotrichum (1)], four probable invasive pulmonary Aspergillus, and six possible infections. Twelve patients were neutropenic for a median of 28 (8-253) days prior to bIFI diagnosis. ISA levels checked within 7 days of bIFI diagnosis (median: 3.65μg/mL) were comparable to industry-sponsored clinical trials. All-cause mortality among the bIFI cases was 47.4% (9/19).We also noted clinically significant cytomegalovirus co-infection in 5.3% (1/19). On univariate analysis, there were no significant differences in baseline comorbidities and potential risk factors between the two groups. ISA prophylaxis was associated with a significant cumulative incidence of bIFIs. Despite the appealing side-effect and drug-interaction profile of ISA, clinicians must be vigilant about the potential risk for bIFIs.

Sex differences in clinical characteristics and outcomes associated with alcoholic hepatitis.

Alcohol-associated liver disease is increasing among females with an earlier onset and more severe disease at lower levels of exposure. However, there is paucity of literature regarding sex differences related to alcoholic hepatitis. Hospitalized patients with alcoholic hepatitis were selected from the US Nationwide readmissions database 2019. In this cohort, we evaluated sex differences in baseline comorbidities, alcoholic hepatitis related complications and mortality. A subset of patients with alcoholic hepatitis who were hospitalized between January and June 2019 were identified to study sex differences in 6 month readmission rate, mortality during readmission, and composite of mortality during index hospitalization or readmission. Among 112 790 patients with alcoholic hepatitis, 33.3% were female. Female patients were younger [48 (38-57) vs. 49 (39-58) years; both P < 0.001] but had higher rates of important medical and mental-health related comorbidities. Compared with males, females had higher rates of hepatic encephalopathy (11.5% vs. 10.1; P < 0.001), ascites (27.9% vs. 22.5%; P < 0.001), portal hypertension (18.5% vs. 16.4%; P < 0.001), cirrhosis (37.3% vs. 31.9%; P < 0.001), weight loss (19.0% vs. 14.5%; P < 0.001), hepatorenal syndrome (4.4% vs. 3.8%; P < 0.001), spontaneous bacterial peritonitis (1.9% vs. 1.7%; P = 0.026), sepsis (11.1% vs. 9.5%; P < 0.001), and blood transfusion (12.9% vs. 8.7%; P < 0.001). Females had a similar in-hospital mortality rate (4.3%) compared to males (4.1%; P = 0.202; adjusted odds ratio (OR) 1.02, 95% CI (cardiac index) 0.89-1.15; P = 0.994). In the subset of patients ( N = 58 688), females had a higher 6-month readmission rate (48.9% vs. 44.9%; adjusted OR 1.12 (1.06-1.18); P < 0.001), mortality during readmission (4.4% vs. 3.2%; OR 1.23 (1.08-1.40); P < 0.01), and composite of mortality during index hospitalization or readmission (8.7% vs. 7.2%; OR 1.15 (1.04-1.27); P < 0.01). Compared to their male counterparts, females with alcoholic hepatitis were generally younger but had higher rates of comorbidities, alcoholic hepatitis related complications, rehospitalizations and associated mortality. The greater risks of alcohol-associated liver dysfunction in females indicate the need for more aggressive management.

#5890 THE IMPACT OF CKD STATUS BEFORE KIDNEY TRANSPLANTION ON ALPHATORQUEVIRUS DNA LEVELS

Abstract Background and Aims Torque teno virus (TTV) is a non-pathogenic anellovirus whose replication kinetics reflects the overall state of immunosuppression. Although chronic kidney disease (CKD) induces a well-stabilised dysfunction of the immune system, long-term use of renal replacement therapies (RRT) itself could also modify the immune response. Method We analyzed TTV DNA loads at baseline (in the pre-transplant assessment), day 7 and months 1, 3,6 and 12 after kidney transplantation (KT). Recipients were categorized according to their RRT status: pre-emptive KT (pre-KT), hemodialysis (HD) and peritoneal dialysis (PD). TTV DNA load was measured by real-time polymerase chain reaction. Results A total of 221 CKD patients were analyzed. The mean age was 53.9 ± 15.7 years, 72.4% were males, and hypertension (85.1%) and diabetes (30.1%) were the most common comorbidities. According to the pre-transplant TTR status, 159 (72.0%) were on HD, 35 (15.8%) on PD and 27 (12.2%) received pre-KT. There were no differences in baseline comorbidities or age between patients according to their RRT status, except for residual diuresis (P &amp;lt;0.01). HD patients had higher serum albumin levels than patients receiving pre-KT or PD (4.4 ± 0.5 vs. 4.1 ± 0.6 vs. 3.9 ± 0.4 g/dL, respectively, P &amp;lt;0.01). PD patients exhibited higher TTV DNA load (3.4 ±1.2 log10 copies/mL) than HD (2.8 ± 1.6 log10 copies/mL) or pre-KT patients (2.4 ± 2.1 log10 copies/mL), although the differences were not statistically significant. PD patients had lower time on dialysis than HD patients (18.4± 16.2 vs. 37.5± 53.6 months, respectively; P = 0.038). Although PD patients had higher TTV DNA load during the post-transplant follow-up than HD and pre-KT patients, viral kinetics were comparable across these three groups by month 12 after transplantation. Time on dialysis was not associated with TTV DNA load (P = 0.18). RRT status was not associated with the incidence of post-transplant infection or a composite of opportunistic infection and/or de novo malignancy. Conclusion TTV DNA load could be useful identifying KT recipients at high risk of immunosuppression-related complications. Although PD patients presented a non-significant higher TTV DNA load, we did not find differences according to the modality of prior RRT or the time on dialysis.

(203) Phosphodiesterase-5 Inhibitor Use and Progression to Heart Failure in Men with Coronary Artery Disease and Erectile Dysfunction

Abstract Introduction Erectile dysfunction (ED) is defined as an inability to reach or sustain an erection for satisfactory intercourse, and this condition affects more than 10 million men in the United States alone. Coronary artery disease (CAD) and ED often co-occur due to shared vascular risk factors for this condition. Phosphodiesterase-5-inhibitors (PDE5i) such as sildenafil and tadalafil are approved as first line treatments for ED, when early trials have demonstrated marked improvements in erectile function. PDE5i such as tadalafil have also been associated with decreased risk of death and cardiovascular disease, as it may alter endothelial function to improve myocardial perfusion and cardiac contractility. To date, information specific to the type of PDE5i used in relation to their perceived cardiac benefits has been limited. Objective We investigated whether the choice of PDE5i may impact progression to heart failure and other major adverse cardiac events (MACE) among men with both CAD and ED. We hypothesized that tadalafil, with its high affinity to PDE5 receptors compared with sildenafil, may provide greater clinical benefits in reducing MACE. Methods A retrospective, propensity-matched, cohort study was performed using the TriNetX Research Network. Patients with an ICD-10 diagnosis of CAD and ED but without pulmonary hypertension were captured from January 2011 to December 2016, with follow up restricted to 5 years. Patients were subdivided and analyzed via pairwise fashion according to known prescriptions for tadalafil, sildenafil, or no treatment (NT). Propensity matching was performed using baseline comorbidities of hypertension, ischemic heart disease, cerebral infarction, diabetes, and hyperlipidemia. Outcomes of interest included 5-year rates of heart failure (HF), acute myocardial infarction (MI), and mortality. Results Prior to propensity score matching, significant differences in baseline comorbidities were noted, with the highest rates of hypertension (9,653 [79.0%]), ischemic heart disease (9,109 [74.6%]), hyperlipidemia (8,541 [69.9%]), and cerebral infarction (690 [5.6%]) in the sildenafil group, and diabetes in the NT group (8,521 [38.2%]). Following propensity score matching, no significant differences were noted (Table 1). When compared with NT, both tadalafil and sildenafil were associated with reduced progression to HF, MI, and overall mortality. Most importantly, compared with sildenafil, tadalafil demonstrated lower progression to HF (HR: 0.85 [0.77-0.94]), MI (HR: 0.86 [0.76-0.97]) and mortality (HR: 0.85 [0.76-0.95]) (Table 2, Figure 1). Conclusions Tadalafil use was associated with a significant reduction in progression to HF, MI, and mortality, compared with sildenafil or no treatment. These preliminary results may signal meaningful clinical differences in drug choice for men suffering from CAD and ED, and therefore require further inquiry. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Endo.

PO-01-018 PRE-OPERATIVE DISCONTINUATION OF NOVEL ORAL ANTICOAGULANTS IN CARDIOVASCULAR SURGERY: IS TWO DAYS ENOUGH?

Discontinuation of novel oral anticoagulants (NOACs) to minimize peri-operative bleeding risk is integral before invasive cardiovascular surgery (CVS). There is little data on the optimal number of days NOACs should be held pre-operatively in these patients. A retrospective evaluation of major bleeding, and its association with the number of days NOACs were held pre-operatively, and whether or not heparin bridging was used. Major bleeding was defined according to the International Society on Thrombosis and Haemostasis (ISTH). Major bleeding is defined as: either a hemoglobin drop of >20 g/L, 2U blood transfusion, symptomatic/ critical organ bleeding, or fatal bleeding. Baseline and follow-up clinical information were collected for consecutive CVS patients treated with NOACs between 2013-2016 at a single tertiary care centre. Multivariate logistic regression models were employed to evaluate major bleeding and post-operative bleeding risks associated with different NOACs hold periods. In 107 (72.9% male) patients (age= 73.6±7.7 years), 89 (83.2%) of whom had a history of Atrial Fibrillation (AF), NOACs were stopped on average 4.5±2.4 days pre-operation, including: 17 (Group 1) within ≤2 days, 63 (Group 2) ≥3 days without heparin, and 27 (Group 3) ≥3 days with heparin bridging. There were no statistically significant differences in baseline comorbidities between the three Groups. Major bleeding rates ranged from 58.8, 30.6, 55.6% (p= 0.03), and bleeding episode rates ranged between 52.9, 16.1, 44.4% (p= 0.002) in Groups 1, 2, and 3 respectively. Multivariate logistic regression adjusted for age, sex, NOAC type, and procedure type (elective vs. emergent), showed that stopping NOAC ≥3 days (vs. ≤2 days) before surgery without heparin bridging (i.e. Group 2) was independently associated with a significantly lower risks of major bleeding (OR: 0.29 [0.08, 1.00], p= 0.05) and bleeding episode (OR: 0.16 [0.04, 0.61], p= 0.007). Compared to ≤2 days hold, NOAC hold of ≥3 days with heparin was not associated with lower risks of major bleeding (OR: 0.96 [0.25, 3.65], p= 0.95) and bleeding episode (OR: 0.77 [0.21, 2.91], p= 0.70). NOAC discontinuation ≥3 days without heparin bridging before CVS was associated with significantly lower risk of major bleeding and post-operative bleeding episode compared to the ≤2 days stop period.

Outcomes of catheter ablation for ventricular tachycardia in patients with sarcoidosis: Insights from theNational Inpatient Sample database (2002-2018).

Data on utilization, major complications, and in-hospital mortality of catheter ablation (CA) for sarcoidosis-related ventricular tachycardia (VT) are limited. We sought to determine the outcomes of sarcoidosis-related VT, and incidence and predictors of complications associated with the CA procedure. We queried the 2002-2018 National Inpatient Sample database to identify patients aged ≥18 years with sarcoidosis admitted with VT. A 1:3 propensity score-matched (PSM) analysis was used to compare patient outcomes between CA and medically managed groups. Multivariable regression was performed to determine independent predictors of in-hospital mortality and procedural complications associated with the CA procedure. Of 3220 sarcoidosis patients with VT, 132 (4.1%) underwent CA. Patients who underwent CA were younger, male predominant, more likely Caucasian, had differences in baseline comorbidities including more likely to have heart failure, less likely to have prior myocardial infarction, COPD, or severe renal disease, had a higher mean household income, and more likely admitted to a larger/urban teaching hospital. After PSM, we examined 106 CA cases and 318 medically managed cases. There was a trend toward a lower in-hospital mortality rate in the CA group when compared to the medically managed group (1.9% vs. 6.6%, p = 0.08). The most common complications were pericardial drainage (5.3%), postoperative hemorrhage (3.8%), accidental puncture periprocedure (3.0%), and cardiac tamponade (2.3%). Independent predictors of in-hospital mortality and procedural complications among the CA group included congestive heart failure (odds ratio[OR], 13.2; 95% confidence interval[CI], 1.7-104.2) and mild to moderate renal disease (OR, 3.9; 95% CI, 1.1-13.3). Compared to patients with sarcoidosis-related VT who received medical therapy alone, those who underwent CA have a trend for a lower mortality rate despite procedure-related complications occurring as high as 9.1%. Additional studies are recommended to better evaluate the benefits and risks of VT ablation in this group.

Palliative Inotropes in Advanced Heart Failure: Comparing Outcomes Between Milrinone and Dobutamine

BackgroundWe sought to describe and compare outcomes among advanced patients with heart failure (not candidates for orthotopic heart transplant/left ventricular assist device) on long-term milrinone or dobutamine, which are not well-studied in the contemporary era. Methods and ResultsWe included adults with refractory stage D heart failure who were not candidates for orthotopic heart transplant or left ventricular assist device and discharged on palliative dobutamine or milrinone. The primary outcome was 1-year survival. A 6-month predictor of survival analysis was conducted. A total of 248 patients (133 on milrinone, 115 on dobutamine) were included. There were no differences in baseline comorbidities between milrinone and dobutamine cohorts, except for the prevalence of chronic kidney disease, which was higher in the dobutamine group. On discharge, the proportion of patients on beta-blockers and mineralocorticoid antagonists was higher in milrinone group. Overall, the 1-year mortality rate was 70%. The dobutamine cohort had a significantly higher 1-year mortality rate (84% vs 58%, P <0.001). The type of inotrope did not predict survival at 6 months when adjusted for discharge medications and comorbidities. Beta-blockers and angiotensin-converting enzyme/angiotensin receptor blocker/angiotensin receptor neprilysin inhibitor continued at discharge predicted survival at 6 months. ConclusionsThe 1-year mortality from palliative inotropes remains high. Compared with dobutamine, use of milrinone was associated with improved survival owing to better optimization of guideline-directed medical therapy, primarily beta-blocker therapy.

Conventional Versus Hypofractionated Radiation for High-Risk Prostate Cancer Patients (CHIRP): 24-Month Patient-Reported Outcomes of the Randomized Phase 2 CHIRP Trial

In this study, we report the 24-month patient-reported outcomes of the randomized phase 2 CHIRP trial that compared conventional and hypofractionated radiation therapy (RT) in the treatment of high-risk prostate cancer. Men with high-risk localized prostate cancer were randomized to either conventional (78 Gy/39 fractions) or hypofractionated RT (68 Gy/25 fractions). All patients received pelvic nodal RT and adjuvant androgen deprivation therapy. Quality of life (QoL) data were collected through the expanded prostate cancer index composite and the short-form 12 (SF-12) health-related QoL questionnaire at baseline and at 3, 6, 12, 18, and 24 months posttreatment. We assessed change from baseline to account for differences in baseline comorbidities. Independent t test was used to identify differences between the 2 groups. Ninety-six participants were included in the QoL analysis, 49 in the hypofractionation arm and 47 in the standard fractionation arm. Urinary and sexual scores were similar between the 2 arms at all time points. Bowel bother scores exhibited a consistent trend favoring the standard arm from 3- to 18-months posttreatment and were statistically significant at 12 months (P = .016). SF-12 physical component scores showed a consistent trend favoring the hypofractionation arm from 6- to 18-months posttreatment and were statistically significant at 18 months (P = .017). At 24 months, there were no significant differences in QoL scores between the 2 groups. At 24 months post-RT, there were no major differences in patient-reported QoL between standard and hypofractionated RT. Early statistically significant differences in bowel bother and SF-12 physical component scores were no longer present at 24 months.

Conventional vs. Hypofractionation Radiation for High-Risk Prostate Cancer Patients (CHIRP): 24 Months Patient-Reported Quality of Life Outcomes of the Randomized Phase II CHIRP Trial

<h3>Purpose/Objective(s)</h3> The CHIRP study is a randomized phase II clinical trial that compared clinical outcomes between standard fractionation (78Gy in 39 fractions) and hypofractionation (68Gy in 25 fractions) in the treatment of high-risk prostate cancer. We performed a quality of life (QoL) sub-study to assess patient-reported outcomes up to 24 months post therapy. <h3>Materials/Methods</h3> Men with high-risk prostate cancer (stage T3/T4 and/or PSA ≥20 ng/ml and/or Gleason score 8 to 10) without clinical or radiological evidence of nodal or distant metastases were included in the CHIRP trial. QoL data was collected through the Expanded Prostate Cancer Index Composite (EPIC) and the Short Form 12 (SF12) health-related QoL questionnaire at baseline, 3 months, 6 months, 12 months, 18 months and 24 months post treatment. We assessed change from baseline (follow-up score minus bassline score) to account for differences in baseline comorbidities. Analysis of Variance (ANOVA), using a significance level of 0.05, was used to identify differences between the two groups. <h3>Results</h3> A total of 96 participants were included in the QoL sub-study, with 49 patients in the hypofractionation arm and 47 patients in the standard fractionation arm. Baseline urinary function favored patients in the standard arm (<i>P</i> = 0.04). All other baseline QoL parameters were balanced. At 3 months (<i>P</i> = 0.155), 6 months (<i>P</i> = 0.197), 12 months (<i>P</i> = 0.016) and 18 months (<i>P</i> = 0.120) post treatment, the bowel bother scores trended to favor the standard fractionation arm, and was statistically significant at 12 months (<i>P</i> = 0.016). At 6 months (<i>P</i> = 0.187), 12 months (<i>P</i> = 0.063) and 18 months (<i>P</i> = 0.017) post treatment, the SF12 physical component score (PCS) trended to favor the hypofractionation arm, and was statistically significant at 18 months (<i>P</i> = 0.017). At 24 months, there were no differences in QoL scores between the 2 groups. <h3>Conclusion</h3> The patient-reported QoL scores were similar between the standard fractionation arm (78Gy in 39 fractions) and the hypofractionation arm (68Gy in 25 fractions) up to 24 months after radiotherapy. Early statistically significant differences in bowel bother and physical component score were no longer present at 24 months.

Abstract 16375: The Association Between Pregestational Hypertension and Cardiovascular Events in Pregnant Females, a Population-based Study

Introduction: Pregestational hypertension is associated with poor fetal and maternal outcomes, however, the impact on maternal cardiovascular outcomes is not well defined. In this study, we aim to study the impact of pregestational hypertension on maternal cardiovascular outcomes. Methods: Pregnant women hospitalized from January 2016 to December 2017 were identified in the Nationwide Inpatient Sample. Pregnant females with pregestational hypertension were identified using AHRQ comorbidity measures. Outcomes of interest were mortality, myocardial infarction (MI), and stroke. Multivariate regression analysis adjusting for differences in baseline comorbidities was used for odds ratio (OR) and 95% confidence interval (CI). Results: Among 8,141,277 pregnant women, 224,295 (2.76%) had pregestational hypertension. Pregnant females with pregestational hypertension were significantly older (mean age of 31.52 +/- 6.03 vs. 28.65 +/- 5.84, p-value&lt;0.001), and had a higher burden of comorbidities includingpregestational diabetes mellitus (10.4% vs. 1.1%, p-value&lt;0.001), gestational diabetes (26.3% vs. 8.1%, p-value&lt;0.001), obesity (27.6% vs. 7.7%, p-value&lt;0.001), smoking (16.4% vs. 9.8%,p-value&lt;0.001), hyperlipidemia (2.1% vs. 0.2%, p-value&lt;0.001), and depression; 6.6% vs. 3.0%, p-value&lt;0.001. Females with pregestational hypertension had more cesarean section; 46.6% vs. 29.2%, p-value&lt;0.001, intra-uterine death; 1.3% vs. 0.4%, p-value&lt;0.001, and spontaneous abortion; 0.6% vs. 0.3%, p-value&lt;0.001. Pregetational hypertension had higher mortality rate (55.7 vs. 10.1 per 100,000 hospitalizations, p-value&lt;0.001), MI rate (207.3 vs. 9.3 per 100,000 hospitalizations, p-value&lt;0.001), and stroke rate (288.4 vs. 22.6 per 100,000 hospitalizations, p-value&lt;0.001). Pregestational hypertension was associated with significantly worse outcomes including in-hospital mortality (aOR 3.01, 95% CI 2.48-3.67), MI (aOR 8.27, 95% CI 7.30-9.35), and stroke (aOR 9.31, 95% CI 8.47-10.24). Conclusions: Pregestational hypertension is associated with poor maternal cardiovascular outcomes in pregnancy. Further efforts should be directed to identifying high-risk females and better approaches to management are warranted.

Impact of Medicaid insurance on outcomes following endoscopic transsphenoidal pituitary surgery.

Despite the rise of studies in the neurosurgical literature suggesting that patients with Medicaid insurance have inferior outcomes, there remains a paucity of data on the impact of insurance on outcomes after endonasal endoscopic transsphenoidal surgery (EETS). Given the increasing importance of complications in quality-based healthcare metrics, the objective of this study was to assess whether Medicaid insurance type influences outcomes in EETS for pituitary adenoma. The authors analyzed a prospectively acquired database of EETS for pituitary adenoma from 2005 to 2018 at NewYork-Presbyterian Hospital, Weill Cornell Medicine. All patients with Medicaid insurance were identified. As a control group, the clinical, socioeconomic, and radiographic data of all other patients in the series with non-Medicaid insurance were reviewed. Statistical significance was determined with an alpha < 0.05 using Pearson chi-square and Fisher's exact tests for categorical variables and the independent-samples t-test for continuous variables. Of 584 patients undergoing EETS for pituitary adenoma, 57 (10%) had Medicaid insurance. The maximum tumor diameter was significantly larger for Medicaid patients (26.1 ± 12 vs 23.1 ± 11 mm for controls, p < 0.05). Baseline comorbidities including diabetes mellitus, hypertension, smoking history, and BMI were not significantly different between Medicaid patients and controls. Patients with Medicaid insurance had a significantly higher rate of any complication (14% vs 7% for controls, p < 0.05) and long-term cranial neuropathy (5% vs 1% for controls, p < 0.05). There were no statistically significant differences in endocrine outcome or vision outcome. The mean postoperative length of stay was significantly longer for Medicaid patients compared to the controls (9.4 ± 31 vs 3.6 ± 3 days, p < 0.05). This difference remained significant even when accounting for outliers (5.6 ± 2.5 vs 3.0 ± 2.7 days for controls, p < 0.05). The most common causes of extended length of stay greater than 1 standard deviation for Medicaid patients were management of perioperative complications and disposition challenges. The rate of 30-day readmission was 7% for Medicaid patients and 4.4% for controls, which was not a statistically significant difference. The authors found that larger tumor diameter, longer postoperative length of stay, higher rate of complications, and long-term cranial neuropathy were significantly associated with Medicaid insurance. There were no statistically significant differences in baseline comorbidities, apoplexy, endocrine outcome, vision outcome, or 30-day readmission.

Real-world evidence of the impact of prior antibiotic exposure on immune checkpoint inhibitor outcomes in patients with metastatic urothelial cancer.

452 Background: Prior research suggests that systemic antibiotic (ABX) exposure may impact gut microbiome and potentially result in suboptimal immune checkpoint inhibitor (ICI) treatment outcomes. A recent real-world analysis demonstrated that cumulative ABX exposure was associated with poorer outcomes across multiple tumor types independent of known prognostic clinical factors. Given the paucity of real-world data, we set out to evaluate the association of prior ABX exposure with ICI treatment outcomes among patients with metastatic urothelial cancer (mUC). Methods: This was a retrospective analysis using Truven Health MarketScan Commercial, Medicare Supplemental, and Coordination of Benefits (Medicare) databases. Patients with mUC, ≥18 years old, who received first line (1L) ICI therapy between 1/1/2016 and 12/31/2018 were analyzed. Prior ABX exposure was defined as any use in the 90 days prior to 1L ICI therapy initiation. Time to treatment discontinuation was used as a proxy to quantify ICI treatment outcomes. Results: Among the 304 ICI treated patients, 128 (42%) had ABX exposure within 90 days prior to ICI initiation. Statistically significant differences in baseline co-morbidities and urinary tract infections (36% vs. 17%; p&lt;0.001) were observed between patients with vs. without ABX exposure. The median time to treatment discontinuation was shorter for patients with ABX exposure (7.9 months) vs. without (9.3 months). In adjusted regression analysis, there was no statistically significant difference in time to treatment discontinuation between patients with vs. without ABX exposure (p=0.95). These findings were consistent in a sensitivity analysis looking at ABX exposure 30 and 60 days prior to 1L ICI initiation. Conclusions: In this real-world analysis of patients with mUC, those with ABX exposure within 90 days prior to 1L ICI initiation demonstrated similar outcomes to those without ABX exposure. While there was a shorter time to treatment discontinuation in the patients with vs. without ABX exposure, findings were not statistically significant. Further research is warranted to investigate the impact of concomitant ABX use on ICI outcomes.

882 Sex Differences in Outcomes of Patients Suffering From ST-Elevation Myocardial Infarction While Already in Hospital

Two cohorts face high mortality after ST-elevation myocardial infarction (STEMI): women and patients with STEMI that occur whilst already admitted to hospital, termed “in-hospital STEMI”. However, sex differences in outcomes of in-hospital STEMIs are unknown. From 2013-2018, consecutive patients presenting with STEMI treated with percutaneous coronary intervention (PCI) were prospectively recruited into the Victorian Cardiac Outcomes Registry. Female patients with in-hospital STEMI were compared to male in-hospital STEMI with a primary endpoint of 30-day major adverse cardiovascular events (MACE). Secondary endpoints included total mortality, symptom-to-device (STD) time, major adverse cardiovascular and cerebrovascular events (MACCE) and major bleeding. Adjustment was made for age, comorbidities, left ventricular function, cardiac arrest and cardiogenic shock. 7,493 patients underwent PCI for STEMI with 494 (6.6%) in-hospital STEMI of which 158/494 (31.9%) were women. Female patients with in-hospital STEMI were significantly older (69.5 versus 65.9 years, p=0.003) than men, with no differences in baseline comorbidities. Female in-hospital STEMI had significantly longer adjusted geometric mean STD time than men (104.6 versus 94.3 minutes, p<0.001). There were no sex differences in 30-day MACE, mortality, MACCE or major bleeding, with overall rates of 22.8%, 12.7%, 24.1% and 5.7% respectively. Female sex did not independently predict 30-day MACE. Patients with in-hospital STEMI suffer high MACE and mortality at 30 days. Women experience a mean 10-minute delay from symptom onset to reperfusion compared to men. However, even after adjustment for confounders, there were no sex differences observed in clinical outcomes.

Aortic Graft Infections – A Nationwide Study

Introduction: Aortic graft and endograft infections (AGI) are rare, but a dreaded complication after aortic surgery. The frequency is difficult to assess due to varying definitions but has been reported to range from 0.3-4%. Only recently a proposal for a unanimous definition of AGI (the MAGIC-criteria) was published. As of now, three major surgical techniques are used to treat AGI; 1) a semiconservative (SC) approach with infection drainage and preservation of the vascular prosthesis, 2) resection of the infected vascular prosthesis with extra-anatomic bypass (EAB), or 3) in-situ repair (ISR) with a vein-, aortic allo-, or antibiotic soaked graft. The literature lacks comparative studies and mainly consists of small single center retrospective studies with a high degree of selection and publication bias. The aim of this study was to assess the outcome and risk factors of surgical treatment of AGI in a large nationwide cohort. Methods: Patients with an AGI-related surgery in a specific European country1 between 1995 and 2016 were identified using the nationwide registry for vascular surgeries1. The MAGIC-criteria were used as definition of an AGI. All vascular centers in the country were invited to participate in the study. A predetermined protocol for data extraction was designed and used for a retrospective case record review. Survival was compared between the three surgical groups at 30-days, 1-year and 5-years (Kaplan-Meier analysis). Predictors for long-term mortality were assessed with Cox-regression. Results: A total of 122 patients with a surgically managed AGI were identified with an additional estimate of 40-50 cases still under review2. The case mix consisted of 25 (20.5%) SC, 58 (37.5%) EAB and 39 (32.0%) ISR. A graft enteric fistula (GEF) was present in 61(50.0%). Within the ISR-group there were 21 vein-grafts, eight Silver-Dacron grafts, seven antibiotic-soaked grafts and three standard PTFE or Dacron grafts. Patients undergoing SC had a higher frequency of coronary heart disease and congestive heart failure (p< 0.05), there were no other differences in base-line comorbidities, age, frequency of emergency surgery or GEF between the groups. The median follow-up among survivors was 5.3 years. The estimated survival was; 30 day: SC 80.8% vs EAB 82.5% vs ISR 83.8% (p = ns), 1 year: SC 46.2% vs EAB 69.1% vs ISR 70.3% (p = ns), 5 years: SC 26.9% vs EAB 41.9% vs ISR 49.2% (p = ns). Survival after SC was significantly worse than EAB and ISR (pooled survival curve analysis EAB + ISR vs SC, p = 0.043). In a Cox-regression analysis including age, surgical technique, presence of GEF and clinical shock at presentation as covariables, only age had a significant correlation with overall survival (HR 1.08, p< 0.001). Conclusion: In a large non-selected nationwide AGI-cohort, mortality after surgical repair remains high. In contrast with some previous studies we could not identify any clear survival benefit using ISR vs EAB. Advanced age correlated with worse outcome. A semi-conservative approach was associated with a worse long-term outcome, at least partially explained by a more advanced comorbidity burden within this cohort. [Kaplain-Meier estimated overall survival comparing the three surgical groups.] Disclosure: Nothing to disclose

PCV6 BURDEN OF MORTALITY IN PATIENTS WITH HEART FAILURE WITH PRESERVED EJECTION FRACTION - A LITERATURE REVIEW

HF can be categorised by ejection fraction (EF) into HF with reduced EF (HFrEF) and HF with preserved EF (HFpEF). A review was undertaken to understand cause-specific burden of mortality in patients with HFpEF. Literature search of English publications of last seven years (2012-2018) was performed in Embase® and MEDLINE®. Search terms were variations on ‘HF’ and ‘mortality’. All type of primary observational (non-interventional) studies reporting mortality in HFpEF were included. Of 2,748 citations reviewed, 48 studies met inclusion criteria and reported mortality in HFpEF patients. Thirty-nine of 48 studies provided a comparison of mortality estimates between HFpEF and HFrEF. Estimates forall-cause, cardiovascular (CV), HF, and non-CV mortality at 1 year follow-up among HFpEF patients ranged from 5.8-35.6%, 2.9-14.1%, 0.7-8.5%, and 1.9-4.6%, respectively. The variability across studies may be attributed to differences in baseline comorbidities, age of patient population, sample size, and how cause-specific mortality was attributed. In studies comparing HFpEF and HFrEF, 7/12, 2/8, and 3/5 studies showed significantly higher CV, HF, and sudden death rates in HFrEF as compared to HFpEF patients, respectively. However, 3/8 studies observed significantly higher non-CV mortality in HFpEF patients as compared to HFrEF. Though not significant, majority of other studies followed the same trend. In all-cause mortality, there was less difference between HFpEF and HFrEF, as higher non-CV mortality in HFpEF and higher CV mortality in HFrEF tended to equalize, although some studies reported somewhat higher rates in HFrEF. There was considerable variability in mortality estimates across different studies. However, comparisons between HFrEF and HFpEF were broadly consistent with higher CV mortality, HF mortality and sudden death rates in HFrEF than in HFpEF. Non-CV mortality constituted a higher proportion of deaths in HFpEF than in HFrEF.

Conversion of Adjustable Gastric Banding to Stapling Bariatric Procedures: Single- or Two-stage Approach.

The aim of this study was to compare the safety of single- versus two-stage conversion of adjustable gastric band (AGB) to gastric bypass (RYGB) or sleeve gastrectomy (SG). AGB patients often present for conversion to RYGB or SG. The impact of single- or two-stage approach of such conversion remains unclear. A statewide database was used to identify all patients who underwent AGB removal and concurrent (single-stage) or interval (two-stage) RYGB or SG. Propensity score matching schemes were constructed to account for differences in baseline comorbidities and demographics, allowing for matched pairs available for comparisons. A total of 4330 patients underwent AGB conversion. Complications, readmissions, and ED visits were noted in 394 (9.1%), 278 (6.42%), and 589 (13.6%) patients, respectively. Three hundred sixty-seven matched pairs underwent RYGB; single-stage patients experienced shorter length of stay (LOS) (median difference -1 d, P < 0.0001), less complications [risk difference (RD): -8.4%, 95% confidence interval (CI), -13.4% to -3.5%], readmissions (RD: -5.2%, 95% CI, -9.6% to -0.8%), and ED visits (RD: -5.7%, 95% CI, -11.3% to -0.2%). Eight hundred seventy-five matched pairs underwent SG; single-stage patients experienced improved outcomes in all measures examined. For single-stage procedures (809 pairs), RYGB was associated with longer LOS, and more complications (RD: 3.3%, 95% CI, 0.9%-5.8%), with similar readmissions, and ED visits. AGB conversion procedures have low morbidity. Single-stage conversion is associated with lower morbidity compared with the two-stage approach. Conversion to SG seems to be safer than RYGB.

Editor's Choice – Renal complications after EVAR with suprarenal versus infrarenal fixation among all users and routine users

BackgroundPrevious studies comparing endografts with suprarenal and infrarenal fixation for endovascular abdominal aortic aneurysm repair (EVAR) have found conflicting results and did not account for differences in patient selection. This study aims to evaluate the differences in outcomes among surgeons who routinely use either suprarenal or infrarenal fixation, as well as all surgeons in the Vascular Study Group of New England (VSGNE). MethodsAll patients undergoing EVAR in the VSGNE from 2003 to 2014 were identified. All ruptured aneurysms, repairs with concomitant procedures, and infrequently used stent grafts (<50) were excluded. Suprarenal endografts included Talent, Zenith, and Endurant; infrarenal endografts included AneuRx and Excluder. Grafts were compared among surgeons who used only one type of endograft (suprarenal or infrarenal) for >80% of cases, as well as all surgeons. Multivariate regression and Cox hazard models were utilised to account for patient demographics, comorbidities, operative differences, and procedure year. ResultsThis study identified 2574 patients (suprarenal, 1264; infrarenal, 1310) with 888 endografts placed by routine users (suprarenal, 409; infrarenal, 479). There were no differences in baseline comorbidities, including the estimated glomerular filtration rate, between suprarenal and infrarenal fixation, or between patients with endografts placed by routine and non-routine users. Patients treated with suprarenal endografts received more contrast than all users (102 mL vs. 100 mL, p = .01) and routine users (110 mL vs. 88 mL, p < .01), but other vascular and operative details were similar. Among all users, patients treated with suprarenal grafts had higher rates of creatinine increase >.5 mg/dL (3.7% vs. 2.0%, p = .01), length of stay >2 days (27% vs. 19%, p < .01), and discharge to a skilled nursing facility (9.2% vs. 6.7%, p = .02). There were no differences in 30 day or 1 year mortality. Following adjustment, suprarenal stent grafts remained associated with an increased risk of renal deterioration (OR 2.0; 95% CI 1.2–3.4) and prolonged length of stay (OR 1.8; 95% CI 1.4–2.2). Among routine users, suprarenal fixation was also associated with higher rates of renal dysfunction (3.7% vs. 1.3%, p = .02; OR 2.9; 95% CI 1.1–7.8). ConclusionDespite potential differences in patient selection, endografts with suprarenal fixation among all users and routine users were associated with higher rates of renal deterioration and longer length of hospital stay. Longer-term data are needed to determine the duration and severity of renal function decline and to identify potential benefits of decreased migration or endoleak.