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To compare rates of severe maternal morbidity (SMM) for pregnant patients with a cardiac diagnosis classified by the modified World Health Organization (mWHO) classification to those without a cardiac diagnosis.This retrospective study using the 2015-2019 Nationwide Readmissions Database identified hospitalizations, comorbidities, and outcomes using diagnosis and procedure codes. The primary exposure was cardiac diagnosis, classified into low-risk (mWHO class I and II) and moderate-to-high-risk (mWHO class II/III, III, or IV). The primary outcome was SMM or death during the delivery hospitalization; secondary outcomes included cardiac-specific SMM during delivery hospitalizations and readmissions after the delivery hospitalization.A weighted national estimate of 14,995,122 delivery admissions was identified, including 46,541 (0.31%) with mWHO I-II diagnoses and 37,330 (0.25%) with mWHO II/III-IV diagnoses. Patients with mWHO II/III-IV diagnoses experienced SMM at the highest rates (22.8% vs 1.6% for no diagnosis; with adjusted relative risk (aRR) of 5.67 [95% CI: 5.36-6.00]). The risk of death was also highest for patients with mWHO II/III-IV diagnoses (0.3% vs0.1% for no diagnosis; aRR 18.07 [95% CI: 12.25-26.66]). Elevated risk of SMM and death persisted to 11 months postpartum for those patients with mWHO II/III-IV diagnoses.In this nationwide database, SMM is highest among individuals with moderate-to-severe cardiac disease based on mWHO classification. This risk persists in the year postpartum. These results can be used to enhance pregnancy counseling.

Objective The use of extracorporeal membrane oxygenation (ECMO) therapy has increased in the adult population. Studies from the H1N1 influenza pandemic suggest that ECMO deployment in pregnancy is associated with favorable outcomes. With increasing numbers of pregnant women affected by COVID-19 (coronavirus disease 2019) and potentially requiring this life-saving therapy, we sought to compare comorbidities, costs, and outcomes between pregnancy- and nonpregnancy-associated ECMO therapy among reproductive-aged female patients. Study Design We used the 2013 to 2019 National Readmissions Database. Diagnosis and procedural coding were used to identify ECMO deployment, potential indications, comorbid conditions, and pregnancy outcomes. The primary outcome was in-hospital mortality during the patient's initial ECMO stay. Secondary outcomes included length of stay and hospital charges/costs, occurrence of thromboembolic or bleeding complications during ECMO hospitalization, and mortality and readmissions up to 330 days following ECMO stay. Univariate and multivariate regression models were used to model the associations between pregnancy status and outcomes. Results The sample included 324 pregnancy-associated hospitalizations and 3,805 nonpregnancy-associated hospitalizations, corresponding to national estimates of 665 and 7,653 over the study period, respectively. Pregnancy-associated ECMO had lower incidence of in-hospital death (adjusted odds ratio [aOR]: 0.56, 95% confidence interval [CI]: 0.41–0.75) and bleeding complications (aOR: 0.67, 95% CI: 0.49–0.93). Length of stay was significantly shorter (adjusted rate ratio (aRR): 0.86, 95% CI: 0.77–0.96) and total hospital costs were less (aRR: 0.83, 95% CI: 0.75–0.93). Differences in the incidence of thromboembolic events (aOR: 1.04, 95% CI: 0.78–1.38) were not statistically significant. Conclusion Pregnancy-associated ECMO therapy had lower incidence of in-hospital death, bleeding complications, total inpatient cost, and length of stay when compared with nonpregnancy-associated ECMO therapy without increased thromboembolic complications. Pregnancy-associated ECMO therapy should be offered to eligible patients. Key Points

Background Multiple guidelines regarding risk stratification for venous thromboembolism (VTE) incidence following cesarean delivery have been promulgated. Objective To estimate the percentage of cesarean delivery patients for which pharmacologic VTE would be recommended and subsequent incidence of VTE, based on several guidelines. Patients/methods This retrospective cohort study used data from the Nationwide Readmissions Database from October 2015 through December 2017. Diagnosis and procedure codes were used to identify patients undergoing cesarean delivery, incidence of VTE, and risk factors used to stratify risk in the existing guidelines. Time-to-event analysis was used to analyze data, stratified by risk categorization in 2011 American College of Gynecology and Obstetrics (ACOG), 2012 American College of Chest Physician (ACCP), 2015 Royal College of Obstetricians and Gynecologists (RCOG) and 2018 American Society for Hematology (ASH) guidelines. Results/conclusions In a cohort of 1,235,149 cesarean deliveries, VTE incidence was 2.1 per 1,000 deliveries at 330 days following delivery (95% confidence interval: 2.0 - 2.2). Proportions of patients that would be recommended for pharmacologic prophylaxis ranged from 0.2% in 2018 ASH guidelines to 73.4% in 2015 RCOG criteria. Among groups considered at elevated risk for VTE for which pharmacologic prophylaxis would be recommended, VTE incidence varied from 35.2 per 1,000 deliveries based on 2018 ASH criteria to 2.5 per 1,000 in 2015 RCOG criteria. In a large cohort of cesarean deliveries in the United States, application of different risk stratification guidelines identified widely different proportions at risk of VTE following delivery, with implications for being categorized as having elevated risk.

Postpartum hemorrhage remains a leading cause of maternal morbidity and mortality in the United States. Several state maternal morbidity and mortality committees have reviewed areas of opportunity concerning postpartum hemorrhage management and found that common patterns include delays in recognition and response to hemorrhage. Hospital systems and state perinatal quality collaboratives have found that comprehensive, interdisciplinary response to postpartum hemorrhage care improves patient outcomes and, in some instances, reduces racial disparities. A key component of this focus involves the implementation of stage-based hemorrhage protocols for postpartum hemorrhage management. Stage-based hemorrhage protocols are designed to reduce delays in the diagnosis and management and avoid the pitfalls of cognitive biases. These protocols are complex, and their effectiveness is tied to the quality of their implementation. Systematic benchmarking and development of quality metrics for adherence to postpartum hemorrhage bundles would be expected to improve clinical outcomes, but evidence regarding the effectiveness of this practice in the literature is limited. Here, key features of stage-based interventions and evidence regarding the use of quality metrics for postpartum hemorrhage protocol adherence have been outlined.

Postpartum hemorrhage is the leading cause of maternal morbidity and mortality worldwide, with uterine atony estimated to account for 70% to 80% of cases, thereby remaining the single most common cause. Pharmacotherapy remains the first-line preventative therapy for postpartum hemorrhage. These therapies may be single (oxytocin, carbetocin, methylergonovine, ergometrine, misoprostol, prostaglandin analogs, or tranexamic acid) or combination therapies, acting in an additive, infra-additive, or synergistic fashion to prevent postpartum hemorrhage. Evidence is strong for the use of oxytocin, the first-line uterotonic agent in the United States for prevention of postpartum hemorrhage. Although carbetocin, a long-acting analog of oxytocin, is not yet available for use in the United States, it is likely the most effective single pharmacologic therapy for prevention of postpartum hemorrhage and need for additional uterotonics. Use of second-line uterotonics such as methylergonovine, misoprostol, and carboprost in combination with oxytocin has an additive or synergistic effect and a greater risk reduction for postpartum hemorrhage prevention compared with oxytocin alone. Therefore, combined therapy rather than oxytocin alone should be advised for preventing postpartum hemorrhage. Tranexamic acid has been found to be both effective and safe for decreasing maternal mortality in women with postpartum hemorrhage, and prophylactic use of tranexamic acid may decrease the need for packed red blood cell transfusions and/or uterotonics. The WOMAN-2 Trial, designed to assess if tranexamic acid prevents postpartum hemorrhage in women with moderate to severe anemia undergoing vaginal delivery, is currently recruiting participants. The additive, infra-additive, or synergistic action of oxytocin in combination with other second-line therapies deserves further study.

Unacceptably high rates of severe maternal morbidity and mortality in the United States and stark racial disparities in outcomes are generating efforts to improve both research capacity and quality improvement in obstetrical care. Comprehensive, high-quality datasets on which to build these efforts are crucial to the success of obstetrical quality improvement efforts. However, existing data sources in obstetrics have notable limitations. Other medical and surgical specialties have addressed similar challenges through the creation of national registries, and we argue that obstetrics must take the same approach to improve outcomes. In this article, we summarized the current availability and limitations of large-scale data in obstetrics research and compared the data with registries developed in other specialties. Moreover, we have outlined the guiding principles for the development of a national obstetrics registry and have proposed future directions.

Objective Pyelonephritis is the most common nonobstetric cause for hospitalization during pregnancy. The maternal and obstetric complications associated with antepartum pyelonephritis are well described. However, it is not clear whether these risks extend into the postpartum period. The primary objective of this study was to describe the morbidity associated with postpartum pyelonephritis, by comparing the morbidity associated with pyelonephritis in the postpartum period to morbidity seen during pregnancy or delivery. Methods A retrospective cohort study was performed using the Nationwide Readmissions Database (NRD), an all-payor sample of discharges from approximately 60% of U.S. hospitalizations. Discharges between October 2015 and December 2018 were included. Maternity-associated hospitalizations, diagnosis of pyelonephritis, comorbid conditions, and incidence of severe maternal morbidity were identified using International Classification of Disease-10th Revision (ICD-10) diagnosis and procedure codes. Bivariate statistics, weighted to account for the complex survey methods in the NRD, were used to evaluate the association between antepartum, delivery, and postpartum hospital stays associated with pyelonephritis and maternal morbidity. Weighted regression models were used to evaluate the association between admission timing and maternal outcomes. Results A total of 32,850 pyelonephritis admissions were identified, corresponding to a national estimate of 61,837 admissions. Of these, 1,465 (2.4%) were postpartum, 55,056 (89.0%) were antepartum, and 5,317 (8.6%) involved a delivery stay. Rates of severe maternal morbidity were higher in the postpartum group than the antepartum or delivery hospitalization groups (59.5 vs. 12.9 and 15.8%, respectively, p Conclusion Though relatively uncommon, postpartum hospitalizations for pyelonephritis are associated with higher rates of severe maternal morbidity, driven by differential rates of sepsis, than are antepartum or delivery-associated hospitalizations.

Background Infective endocarditis (IE) is a rare but serious infection that complicates pregnancy. Little is known about IE management and outcomes in this population. Methods The National Readmissions Database was used to obtain data between October 2015 and October 2018. Billing codes identified admissions for IE in female patients of reproductive age. Demographic characteristics, comorbidities, and outcomes were compared between patients with maternity-associated and nonmaternity-associated IE and obstetric patients who delivered with and without IE. Weighted regressions were used to examine outcomes in adjusted models. Results We identified 12 602 reproductive-aged female patients with a diagnosis of IE, of which 382 (weighted national estimate, 748) were maternity-associated. Of these cases, 117 (weighted national estimate, 217) occurred during a delivery admission. Compared with patients with nonmaternity-associated IE, maternity-associated infection was associated with younger age (mean, 29.0 vs 36.6 years; P < .001), Medicaid coverage (72.5% vs 47.2%; P < .001), and drug use (76.2% vs 59.8%; P < .001). Mortality was comparable (8.1% vs 10.6%; adjusted rate ratio [aRR], 1.03; 95% confidence interval [CI]: .71–1.48). Compared with patients who delivered without IE, IE complicating delivery was associated with worse maternal and fetal outcomes, including maternal mortality (17.2% vs Conclusions Maternity-associated IE does not appear to confer additional risk for adverse outcome over nonmaternity-associated infection. Patients who deliver with IE have worse maternal and fetal outcomes than those whose deliveries are not complicated by IE.

BACKGROUND In the Northern Hemisphere, influenza season typically starts in December and lasts through March. Pregnant people are at increased risk for influenza-related morbidity and mortality. Potentially, new viral strains or reduced provider suspicion leading to delayed diagnosis of late-season influenza could result in an increased risk of severe infection. OBJECTIVE This study aimed to assess the incidence and morbidity associated with late-season influenza in pregnancy, compared with influenza in other seasons. STUDY DESIGN This was a retrospective cohort study using the 2007–2018 National Inpatient Sample. Pregnant patients with discharge diagnosis codes consistent with influenza infection were compared on the basis of hospital admission quarter (quarter 1: October to December; quarter 2: January to March; quarter 3: April to June; quarter 4: July to September), with quarter 3 defined as “late-season.” The primary outcome was the severe maternal morbidity composite defined by the Centers for Disease Control and Prevention. The secondary outcomes included sepsis, shock, acute renal failure, acute heart failure, temporary tracheostomy, and invasive mechanical ventilation. Associations between outcomes and quarter of infection were adjusted for age, hospitalization type (antepartum, delivery, or postpartum), and comorbid conditions using relative risk regression, weighted to reflect the National Inpatient Sample design. RESULTS Of 7355 hospitalizations, corresponding to a weighted national estimate of 36,042, 2266 (30.8%) occurred in quarter 1, 4051 (55.0%) in quarter 2, 633 (8.6%) in quarter 3, and 405 (5.5%) in quarter 4. A nonsignificant trend toward higher rates of severe maternal morbidity was seen in the “late-season” compared with other quarters (13.9% [quarter 3] vs 10.5% [quarter 1] vs 12.1% [quarter 2] vs 13.6% [quarter 4]; P=.07). Moreover, sepsis was more common in patients with late-season influenza (8.0% [quarter 3] vs 4.8% [quarter 1] vs 5.8% [quarter 2] vs 5.9% [quarter 4]; P=.03). In the adjusted analyses, patients with late-season influenza had a 1.34 (95% confidence interval, 1.01–1.78) higher risk of severe maternal morbidity and 1.57 (95% confidence interval, 1.06–2.32) higher risk of sepsis than patients with influenza in quarter 1. CONCLUSION Influenza infection between April and June, that is, late-season influenza, is associated with a higher risk of severe maternal morbidity and sepsis in pregnant patients. Obstetrical providers must continue to have awareness and suspicion for influenza infection during these months.

Background The epidemiology, and outcome of infective endocarditis (IE) among solid organ transplant (SOT) recipients is unknown. Methods We used data from the 2013-2018 Nationwide Readmissions Database (NRD). IE- and SOT-associated hospitalizations were identified using diagnosis and procedure codes. Outcomes included inpatient mortality, length of stay, and inpatient costs. Adjusted analyses were performed using weighted regression models. Results A total of 99,052 IE-associated hospitalizations, corresponding to a weighted national estimate of 193,164, were included for analysis. Of these, 794 (weighted n = 1,574) were associated with transplant history (SOT-IE). Mortality was not significantly different between SOT-IE and non-SOT-IE (17.2% vs. 15.8%, adjusted relative risk [aRR]: 0.86, 95% confidence interval [CI] [0.71, 1.03]), and fewer SOT-IE patients underwent valve repair or replacement than non-SOT-IE (12.5% vs. 16.2%, aRR 0.82, 95% CI [0.71, 0.95]). We then compared outcomes of patients diagnosed with IE during their index transplant hospitalization (index-SOT-IE) to patients without IE during their transplant hospitalization (index-SOT). Index-SOT-IE occurred most frequently among heart transplant recipients (45.1%), and was associated with greater mortality (27.1% vs. 2.3%, aRR 6.07, 95% CI [3.32, 11.11]). Conclusion Dual diagnosis of SOT and IE was associated with worse outcomes among SOT recipients during index hospitalization, but not overall among patients with IE.

Objective The aim of the study is to compare maternal and neonatal outcomes among patients who are normotensive, hypertensive by Stage I American College of Cardiology-American Heart Association (ACC-AHA) criteria, and hypertensive by American College of Obstetricians and Gynecologists (ACOG) criteria. Study Design Secondary analysis of a prospective first trimester cohort study between 2007 and 2010 at three institutions in Baltimore, MD, was conducted. Blood pressure at 11 to 14 weeks' gestation was classified as (1) normotensive (systolic blood pressure [SBP] Results Among 3,422 women enrolled, 2,976 with delivery data from singleton pregnancies of nonanomalous fetuses were included. In total, 20.2% met hypertension criteria (Stage I ACC-AHA n = 254, 8.5%; ACOG n = 347, 11.7%). The Stage I ACC-AHA group's risk for developing preeclampsia was threefold higher than the normotensive group (adjusted relative risk [aRR] 3.70, 95% confidence interval [CI] 2.40–5.70). The Stage I ACC-AHA group had lower preeclampsia risk than the ACOG group but the difference was not significant (aRR 0.87, 95% CI 0.55–1.37). The Stage I ACC-AHA group was more likely than the normotensive group to deliver preterm (aRR 1.44, 95% CI 1.02–2.01) and deliver an SGA neonate (aRR 1.51, 95% CI 1.07–2.12). The Stage I ACC-AHA group was less likely to deliver preterm compared with the ACOG group (aRR 0.65, 95% CI 0.45–0.93), but differences in SGA were not significant (aRR 1.31, 95% CI 0.84–2.03). Conclusion Pregnant patients with Stage I ACC-AHA hypertension in the first trimester had higher rates of preeclampsia, preterm birth, and SGA neonates compared with normotensive women. Adverse maternal and neonatal outcomes were numerically lower in the Stage I ACC-AHA group compared with the ACOG group, but these comparisons only reached statistical significance for preterm birth. Optimal pregnancy management for first trimester Stage I ACC-AHA hypertension requires active study. Key Points

Background Little is known about infective endocarditis (IE) occurring during pregnancy. In this analysis, we sought to define the patient characteristics, risk factors, and outcome of maternity-associated IE (maIE). Methods The National Readmissions Database was used to identify admissions for IE in female patients aged 12 – 55 years discharged between Oct. 2015 and Dec. 2017. Demographics, comorbidities, and outcomes were obtained. Differences between groups were analyzed using weighted Chi-squared test for categorical variables and weighted linear regression for continuous variables. Weighted multivariate regressions adjusted for demographics, hospital, etiologic organism, and comorbid conditions to assess the association between maternity status and outcomes. Results Out of 10,271 identified IE admissions (corresponding to a national estimate of 19,626 admissions), maIE accounted for 320 (national estimate 617) (3.1%). Of these maIE admissions, 41.2% were antepartum admissions, 26.3% resulted in delivery, 18.3% were postpartum, and 11.3% were an early or abnormal pregnancy. Patients with maIE were younger (28.4 ± 3.9 vs. 36.6 ± 8.0, P < 0.001) and more likely insured by Medicaid (73.3% vs. 46.6%, P < 0.001). Although generally healthier, patients with maIE had higher rates of drug abuse (75.7% vs. 58.5%, P < 0.001). In unadjusted comparisons maIE was associated with lower rates of 60-day mortality and thromboembolic events. In adjusted analysis only differences between rates of thromboembolic events were significant (adjusted incremental difference: -17.1%, 95% confidence interval: -22.7% to -11.6%). Differences in rates of valve procedures, mechanical ventilation, length of stay, and inpatient costs were not statistically significant (Figure). Regression-adjusted Outcomes Conclusion Compared with other reproductive aged female IE patients, patients with maIE are younger, healthier, more likely insured by Medicaid, and report higher rates of drug abuse. After adjustment, they receive similar management and do not appear to be at higher risk for adverse outcomes including mortality. Disclosures Vance G. Fowler, Jr., MD, MHS, Achaogen (Consultant)Actavis (Grant/Research Support)Advanced Liquid Logics (Grant/Research Support)Affinergy (Consultant, Research Grant or Support)Affinium (Consultant)Allergan (Grant/Research Support)Ampliphi Biosciences (Consultant)Basilea (Consultant, Research Grant or Support)Bayer (Consultant)C3J (Consultant)Cerexa (Consultant, Research Grant or Support)Contrafect (Consultant, Research Grant or Support)Cubist (Grant/Research Support)Debiopharm (Consultant)Destiny (Consultant)Durata (Consultant)Forest (Grant/Research Support)Genentech (Consultant, Research Grant or Support)Integrated Biotherapeutics (Consultant)Janssen (Consultant, Research Grant or Support)Karius (Grant/Research Support)Locus (Grant/Research Support)Medical Biosurfaces (Grant/Research Support)Medicines Co. (Consultant)Medimmune (Consultant, Research Grant or Support)Merck (Consultant, Research Grant or Support)NIH (Grant/Research Support)Novadigm (Consultant)Novartis (Consultant, Research Grant or Support)Pfizer (Grant/Research Support)Regeneron (Consultant, Research Grant or Support)Tetraphase (Consultant)Theravance (Consultant, Research Grant or Support)Trius (Consultant)xBiotech (Consultant)

Background: The necessity for rapid evaluation and treatment of acute ischemic stroke with intravenous tPA (tissue-type plasminogen activator) may increase the risk of administrating tPA to patients presenting with noncerebrovascular conditions that closely resemble stroke (stroke mimics). However, there are limited data on thrombolysis safety in stroke mimics. Methods and Results: Using data from the Get With The Guidelines–Stroke Registry, we identified 72 582 patients with suspected ischemic stroke treated with tPA from 485 US hospitals between January 2010 and December 2017. We documented the use of tPA in stroke mimics, defined as patients who present with stroke-like symptoms, but after workup are determined not to have suffered from a stroke or transient ischemic attack, and compared characteristics and outcomes in stroke mimics versus those with ischemic stroke. Overall, 3.5% of tPA treatments were given to stroke mimics. Among them, 38.2% had a final nonstroke diagnoses of migraine, functional disorder, seizure, and electrolyte or metabolic imbalance. Compared with tPA-treated true ischemic strokes, tPA-treated mimics were younger (median 54 versus 71 years), had a less severe National Institute of Health Stroke Scale (median 6 versus 8), and a lower prevalence of cardiovascular risk factors, except for a higher prevalence of prior stroke/transient ischemic attack (31.3% versus 26.1%, all P Conclusions: In this large cohort of patients treated with tPA, relatively few patients who received tPA for presumed stroke were ultimately not diagnosed with a stroke or transient ischemic attack. The complication rates associated with tPA in stroke mimics were low. Despite the potential risk of administering tPA to stroke mimics, opportunity remains for continued improvement in the rapid and accurate diagnosis and treatment of ischemic stroke.

Background: Intravenous rt-PA (recombinant tissue-type plasminogen activator) is effective in improving outcomes in ischemic stroke; however, there are few data on the use of rt-PA in patients who are receiving a non–vitamin K antagonist oral anticoagulant (NOAC). Methods: Using data from the American Heart Association Get With The Guidelines-Stroke Registry, we examined the outcomes of use of thrombolytic therapy in patients with ischemic stroke who received anticoagulation with NOACs versus those on warfarin (international normalized ratio Results: Of 42 887 patients with ischemic stroke treated with intravenous rt-PA within 4.5 hours, 251 were taking NOACs (dabigatran 87, rivaroxaban 129, and apixaban 35) before their stroke, 1500 were taking warfarin, and 41 136 were on neither. Patients on NOACs or warfarin were older, had more comorbid conditions, and experienced more severe strokes than did those who were not on anticoagulation (median National Institutes of Health Stroke Scale 12, 13, and 9, respectively). Unadjusted rates of symptomatic intracranial hemorrhage in the NOAC, warfarin, and none groups were 4.8%, 4.9%, and 3.9%, respectively ( P =0.11). In comparison with those not on anticoagulation, the adjusted odds ratio for symptomatic intracranial hemorrhage for those on NOACs was 0.92 (95% confidence interval, 0.51–1.65) and for those on warfarin the adjusted odds ratio was 0.85 (95% confidence interval, 0.66–1.10). There were also no significant differences in the risk for life-threatening/serious systemic hemorrhage, any rt-PA complication, in-hospital mortality, and modified Rankin Scale at discharge across 3 groups. Similar results were also found after propensity score matching. Conclusions: Although experience of using rt-PA in patients with ischemic stroke on a NOAC is limited, these preliminary observations suggest that rt-PA appears to be reasonably well tolerated without prohibitive risks for adverse events among selected NOAC-treated patients. Future studies should evaluate the safety and efficacy of intravenous rt-PA in patients with ischemic stroke who are taking NOACs.

Highlights • Solitary fibrous tumors are typically indolent tumors of the pleura. • Primary origin in the female reproductive organs is rare, as are aggressive forms. • We report a case of a vulvar solitary fibrous tumor, notable for extensive spinal metastasis.

Background With over 30,000 solid organ transplants (SOT) performed annually the United States alone, there is an urgent need to understand the risks and outcomes of infective endocarditis (IE) in SOT recipients. Methods We used data from the 2013–2017 Nationwide Readmissions Database (NRD). Hospitalizations associated with IE were identified using diagnosis and procedure codes. The cohort included all patients with IE, stratified by history of solid organ transplant (heart, liver, kidney, lung, intestines, pancreas). Outcomes included 60-day rates of mortality, (extracorporeal membrane oxygenation) ECMO deployment, thromboembolic events, length of stay, and inpatient costs. Regression models, weighted to account for the NRD sample design, were used to model associations between outcomes and transplant history, adjusting for patient age, sex, facility characteristics, comorbid conditions, and potential IE organism. Results A total of 175,682 hospitalizations associated with IE, corresponding to a national estimate of 345,236, were included. Of these, 1,299 (weighted estimate = 2,511) were associated with history of transplant. Transplant recipients were younger (54.2 vs. 59.4 years, p < 0.001), less likely to be female (33.2% vs. 40.1%), had higher rates of renal and liver disease (93.1% vs. 39.2% and 16.2% vs. 8.6%, respectively, p < 0.001 for both). The most common SOT organ (allowing for multiple organs) was kidney (75%) followed by liver (11.5%) and heart (10.5%). Compared to non-SOT patients with IE, SOT recipients with IE were associated with lower risk of mortality [adjusted relative risk (aRR): 0.74, 95% confidence interval (CI) (0.61, 0.89)], lower risk of prolonged mechanical ventilation [aRR 0.80 (0.68, 0.93)], 2.2 fewer inpatient days (-3.5 to -0.8) and $7,000 lower charges (-$9,700, -$4,300), after adjustment. Conclusion IE complicated by SOT history was associated with paradoxically better outcomes than IE in patients without SOT history. The selection process underlying receipt of transplant may partially explain these differences in outcomes. Disclosures Vance G. Fowler, Jr., MD, MHS, Achaogen (Consultant)Actavis (Grant/Research Support)Advanced Liquid Logics (Grant/Research Support)Affinergy (Consultant, Research Grant or Support)Affinium (Consultant)Allergan (Grant/Research Support)Ampliphi Biosciences (Consultant)Basilea (Consultant, Research Grant or Support)Bayer (Consultant)C3J (Consultant)Cerexa (Consultant, Research Grant or Support)Contrafect (Consultant, Research Grant or Support)Cubist (Grant/Research Support)Debiopharm (Consultant)Destiny (Consultant)Durata (Consultant)Forest (Grant/Research Support)Genentech (Consultant, Research Grant or Support)Integrated Biotherapeutics (Consultant)Janssen (Consultant, Research Grant or Support)Karius (Grant/Research Support)Locus (Grant/Research Support)Medical Biosurfaces (Grant/Research Support)Medicines Co. (Consultant)Medimmune (Consultant, Research Grant or Support)Merck (Consultant, Research Grant or Support)NIH (Grant/Research Support)Novadigm (Consultant)Novartis (Consultant, Research Grant or Support)Pfizer (Grant/Research Support)Regeneron (Consultant, Research Grant or Support)Tetraphase (Consultant)Theravance (Consultant, Research Grant or Support)Trius (Consultant)xBiotech (Consultant)

Background The prevalence and impact of infective endocarditis (IE) on organ transplant recipients is unknown. We used a large cohort of transplant recipients to assess the impact of IE on outcomes during index transplant hospitalization. Methods We used data from the 2013-2017 Nationwide Readmissions Database (NRD). Hospitalizations associated with solid organ transplantation procedures (heart, liver, kidney, lung, intestines, pancreas) were included. Outcomes included 60-day rates of mortality, ECMO deployment, thromboembolic events, length of stay, and inpatient costs. For data obtained October 2015 and later, rates of graft rejection and graft failure were also measured. Regression models, weighted to account for the NRD sample design, were used to model associations between outcomes and transplant procedure, adjusting for patient age, sex, facility characteristics, comorbid conditions, and organs transplanted. Results A total of 75,069 hospitalizations for organ transplantation, corresponding to a national estimate of 160,368, were included. A diagnosis of IE was associated with 416 (weighted estimate = 898). IE cases were less likely to be female (22.2% vs. 37.9%, p< 0.001), and had higher rates of underlying pulmonary disease. The most common organ transplanted in the hospitalization during which IE was diagnosed (allowing for multiple organs) was heart (84.5%) followed by kidney (8.9%) and liver (7.9%), (p< 0.001). IE was associated with higher mortality [adjusted relative risk (aRR): 1.70, 95% confidence interval (CI) (1.09, 2.66)], prolonged ventilation (aRR 1.32 [1.06, 1.65], 4.6 additional inpatient days (CI: 1.5, 7.6) and $28,300 more inpatient cost (CI: $12,000, $44,700) (Table). 60-Day Outcomes, Stratified by IE During Index Transplant Hospitalization Conclusion IE complicating hospitalization for organ transplantation is associated with higher rates of morbidity and mortality. IE during index transplant hospitalization occurs most frequently in heart transplant recipients. Understanding the high rate of IE in heart recipients in the early post-transplant period requires further study. Disclosures Vance G. Fowler, Jr., MD, MHS, Achaogen (Consultant)Actavis (Grant/Research Support)Advanced Liquid Logics (Grant/Research Support)Affinergy (Consultant, Research Grant or Support)Affinium (Consultant)Allergan (Grant/Research Support)Ampliphi Biosciences (Consultant)Basilea (Consultant, Research Grant or Support)Bayer (Consultant)C3J (Consultant)Cerexa (Consultant, Research Grant or Support)Contrafect (Consultant, Research Grant or Support)Cubist (Grant/Research Support)Debiopharm (Consultant)Destiny (Consultant)Durata (Consultant)Forest (Grant/Research Support)Genentech (Consultant, Research Grant or Support)Integrated Biotherapeutics (Consultant)Janssen (Consultant, Research Grant or Support)Karius (Grant/Research Support)Locus (Grant/Research Support)Medical Biosurfaces (Grant/Research Support)Medicines Co. (Consultant)Medimmune (Consultant, Research Grant or Support)Merck (Consultant, Research Grant or Support)NIH (Grant/Research Support)Novadigm (Consultant)Novartis (Consultant, Research Grant or Support)Pfizer (Grant/Research Support)Regeneron (Consultant, Research Grant or Support)Tetraphase (Consultant)Theravance (Consultant, Research Grant or Support)Trius (Consultant)xBiotech (Consultant)

Background Infective endocarditis (IE) is a rare but serious complication of pregnancy. Its impact on delivery outcomes is unknown. In this study, we use a national administrative database to compare outcomes of deliveries complicated by IE to non-IE deliveries. Methods The National Readmissions Database was used to identify discharges between Oct. 2015 and Dec. 2017 for deliveries in patients aged 12 – 55 years with concomitant IE, which were compared to those deliveries without IE. Demographics, comorbidities, and outcomes were obtained. Differences between groups were analyzed using weighted Chi-squared test for categorical variables and weighted linear regression for continuous variables. Weighted multivariate regression models adjusted for demographic, facility, and comorbidity conditions were used to evaluate the association between IE and delivery outcomes. Results We identified 88 individuals with IE complicating their delivery hospitalization, corresponding to a national estimate of 162 admissions during the study period, who were compared to 4,401,879 delivery hospitalizations not complicated by IE (weighted national estimate 8,375,536). Patients with IE were more likely to reside in ZIP codes with median incomes in the lowest national quartile (46.3% vs. 28.1%, P = 0.003) and were more likely to be insured by Medicaid (76.5% vs. 42.1%, P < 0.001). Rates of pre-existing cardiac valve disease (39.9% vs. 0.2%, P < 0.001) and congenital heart disease (6.6% vs 0.1%, P < 0.001) were higher in those with IE, as well as drug abuse (69.3% vs. 2.6%, P < 0.001). Unadjusted analyses demonstrated higher rates of in-hospital mortality for IE-associated admissions (12.1% versus 0.005%), along with high rates of severe maternal morbidity, stillbirth, preterm birth, and cesarean birth, and longer lengths of stay and total hospital costs. These differences persisted despite adjustment using multivariate methods (Table). Clinical and Resource Utilization Outcomes Conclusion The presence of IE during an admission for delivery is associated with poorer outcomes for both pregnant patients and their fetuses. The occurrence of IE during pregnancy was associated with lower income, a history of cardiac disease, and drug abuse. Disclosures Vance G. Fowler, Jr., MD, MHS, Achaogen (Consultant)Actavis (Grant/Research Support)Advanced Liquid Logics (Grant/Research Support)Affinergy (Consultant, Research Grant or Support)Affinium (Consultant)Allergan (Grant/Research Support)Ampliphi Biosciences (Consultant)Basilea (Consultant, Research Grant or Support)Bayer (Consultant)C3J (Consultant)Cerexa (Consultant, Research Grant or Support)Contrafect (Consultant, Research Grant or Support)Cubist (Grant/Research Support)Debiopharm (Consultant)Destiny (Consultant)Durata (Consultant)Forest (Grant/Research Support)Genentech (Consultant, Research Grant or Support)Integrated Biotherapeutics (Consultant)Janssen (Consultant, Research Grant or Support)Karius (Grant/Research Support)Locus (Grant/Research Support)Medical Biosurfaces (Grant/Research Support)Medicines Co. (Consultant)Medimmune (Consultant, Research Grant or Support)Merck (Consultant, Research Grant or Support)NIH (Grant/Research Support)Novadigm (Consultant)Novartis (Consultant, Research Grant or Support)Pfizer (Grant/Research Support)Regeneron (Consultant, Research Grant or Support)Tetraphase (Consultant)Theravance (Consultant, Research Grant or Support)Trius (Consultant)xBiotech (Consultant)

Background and Purpose— Although there are no trials or large cohorts to inform clinical care, current guidelines caution against giving intravenous tPA (tissue-type plasminogen activator) to patients with acute ischemic stroke who are taking non–vitamin K antagonist oral anticoagulants (NOACs). We performed a literature review of intravenous tPA in patients treated with NOACs preceding stroke. Methods— A literature search of PubMed was performed encompassing January 2010 to March 2018. Patient characteristics, timing of last medication intake, laboratory testing, use of reversal, and outcomes ≤3 months after discharge were summarized. Results— We identified 55 studies with 492 NOAC patients receiving tPA (dabigatran, 181; rivaroxaban, 215; apixaban, 40; and unspecified NOAC, 56). Among patients with complete data, the median time from the last NOAC intake to symptom onset was 8 hours (interquartile range, 2.5–14.5), with 55.2% (80/145) within 12 hours. Few patients underwent sensitive laboratory tests, such as thrombin time, diluted thrombin time, or anti-Xa assays before tPA administration. The overall observed rates of symptomatic intracranial hemorrhage, mortality, and favorable outcomes (National Institutes of Health Stroke Scale score, ≤1; modified Rankin Scale score, 0–2; or neurological improvement in the National Institutes of Health Stroke Scale score, ≥8 points) were 4.3% (20/462), 11.3% (48/423), and 43.7% (164/375), respectively. Among dabigatran-treated patients, reversal with idarucizumab was associated with fewer symptomatic intracranial hemorrhage (4.5% [2/44] versus 7.4% [8/108]; unadjusted odds ratio, 0.60; 95% CI, 0.12–2.92), death (4.5% [2/44] versus 12.0% [13/108]; unadjusted odds ratio, 0.35; 95% CI, 0.08–1.61), and more favorable outcomes (79.1% [34/43] versus 39.2% [29/74]; unadjusted odds ratio, 5.86; 95% CI, 2.45–14.00), although the differences were not statistically significant for symptomatic intracranial hemorrhage and death. Conclusions— These preliminary observations suggest that tPA may be reasonably well tolerated without prohibitive risks of bleeding complications in selected patients on NOACs. Reversal of anticoagulant effects by idarucizumab for dabigatran-treated patients before tPA is an emerging strategy that was associated with more favorable outcomes.

Objectives The aim of this study was to determine diagnostic testing patterns after percutaneous coronary intervention (PCI). Background Little is known about patterns of diagnostic testing after PCI in the United States or the relationship of these patterns to clinical outcomes. Methods Centers for Medicare and Medicaid Services inpatient and outpatient claims were linked to National Cardiovascular Data Registry CathPCI Registry data from 2005 to 2007. Hospital quartiles of the cumulative incidence of diagnostic testing use within 12 and 24 months after PCI were compared for patient characteristics, repeat revascularization, acute myocardial infarction, and death. Results A total of 247,052 patients underwent PCI at 656 institutions. Patient and site characteristics were similar across quartiles of testing use. There was a 9% and 20% higher adjusted risk for repeat revascularization in quartiles 3 and 4 (highest testing rate), respectively, compared with quartile 1 (lowest testing rate) (p = 0.020 and p Conclusions Although patient characteristics were largely independent of rates of post-PCI testing, higher testing rates were not associated with lower risk for myocardial infarction or death, but repeat revascularization was significantly higher at these sites. Additional studies should examine whether increased testing is a marker for improved quality of post-PCI care or simply increased health care utilization.

Background and Purpose— Rehabilitation is recommended after a stroke to enhance recovery and improve outcomes, but hospital’s use of inpatient rehabilitation facilities (IRFs) or skilled nursing facility (SNF) and the factors associated with referral are unknown. Methods— We analyzed clinical registry and claims data for 31 775 Medicare beneficiaries presenting with acute ischemic stroke from 918 Get With The Guidelines-Stroke hospitals who were discharged to either IRF or SNF between 2006 and 2008. Using a multilevel logistic regression model, we evaluated patient and hospital characteristics, as well as geographic availability, in relation to discharge to either IRF or SNF. After accounting for observed factors, the median odds ratio was reported to quantify hospital-level variation in the use of IRF versus SNF. Results— Of 31 775 patients, 17 662 (55.6%) were discharged to IRF and 14 113 (44.4%) were discharged to SNF. Compared with SNF patients, IRF patients were younger, more were men, had less health-service use 6 months prestroke, and had fewer comorbid conditions and in-hospital complications. Use of IRF or SNF varied significantly across hospitals (median IRF use, 55.8%; interquartile range, 34.8%–75.0%; unadjusted median odds ratio, 2.59; 95% confidence interval, 2.44–2.77). Hospital-level variation in discharge rates to IRF or SNF persisted after adjustment for patient, clinical, and geographic variables (adjusted median odds ratio, 2.87; 95% confidence interval, 2.68–3.11). Conclusions— There is marked unexplained variation among hospitals in their use of IRF versus SNF poststroke even after accounting for clinical characteristics and geographic availability. Clinical Trial Registration— URL: https://clinicaltrials.gov . Unique identifier: NCT02284165.

Measurement of the long-term impact of medical treatments on resource utilization is essential to health technology assessment. Whether such measurement is performed using a randomized trial or observational study, most cohorts include some patients who were alive at the end of their data availability but whose resource use was not measured for the entire period of interest; these patients are said to be censored at the point from which subsequent resource use is unknown. Even when censoring occurs at random, conventional survival analysis methods produce biased cost estimates due to heterogeneity in cost trajectories (Lin et al. 1997). Previous methods to address the issue of estimating resource use with censored data have notable limitations. Early approaches using survival-adjusted models were shown to produce biased estimates when death and censoring occurred continuously during the study period, rather than at predictable, discrete intervals such as every 30 days (Lin et al. 1997). Inverse probability weighting (IPW) approaches solve this limitation (Bang and Tsiatis 2000; Lin 2000), but they do not allow decomposition of a treatment's effect on resource use into an effect due to the treatment altering how long a patient lives (the survival effect) and an effect due to the treatment altering how many resources a surviving patient consumes (the intensity effect) (Basu and Manning 2010). Such decomposition, which is possible with survival-adjusted methodologies, is of interest in health technology assessment because it allows for more detailed examination of how treatments affect long-term costs of care. An extreme example of a treatment affecting both survival and resource use is highly active antiretroviral therapy (HAART) for human immunodeficiency virus infection. HAART dramatically improves survival, meaning a substantial survival effect due to prolonged life spans among patients receiving HAART is likely. In addition, there is also an important intensity effect associated with HAART usage, consisting of increased costs for antiretroviral medications, but lower costs due to prevention of opportunistic infections. However, most cost analyses of HAART have not considered potential survival effects (Schackman et al. 2006). Although most cost-effectiveness analyses do not consider survival effect-induced costs (Gold et al. 1996), failing to incorporate these effects may bias them in favor of therapies that extend life span versus therapies that improve quality of life (Meltzer 1997). Furthermore, if an analytic objective is to forecast long-term expenditures for a third-party payer, incorporation of survival effect-induced costs is essential. A recently developed approach extends the survival-adjusted methodology to produce consistent estimates for resource use, even when censoring and death occur continuously throughout the follow-up period. The approach also preserves the ability to decompose differences in resource use into survival and intensity effects (Basu and Manning 2010). In addition to these advantages, the authors identify an additional important and poorly appreciated limitation of IPW methods: the potential for considerable bias when IPW estimators are used to evaluate the costs of treatments that have both intensity and survival effects, as well as substantial precision loss. The authors show that this bias is eliminated with the use of their approach. We apply Basu and Manning's new methodology to compare the effects of percutaneous coronary intervention (PCI) versus coronary artery bypass grafting (CABG) on survival and resource use for elderly patients with symptomatic multivessel coronary artery disease. Clinical Context PCI and CABG are both treatments for coronary artery disease (CAD; blockages in the arteries that oxygenate the heart). PCI is performed by interventional cardiologists and involves reopening blocked arteries through the use of instruments threaded into the heart via catheters inserted in the patient's arm or leg. CABG is performed by cardiothoracic surgeons and involves sewing vessels from elsewhere in the patient's body onto the heart, allowing blood to bypass the blocked coronary arteries. PCI is less invasive than CABG and is increasingly the CAD procedure elderly patients receive (Sheridan et al. 2008). A systematic review of PCI versus CABG on survival from randomized trials published between 1996 and 2006 found similar overall survival after 1 and 5 years postrevascularization (Bravata et al. 2007). However, elderly patients were routinely excluded from many studies listed in the review, and results from recent randomized trials and observational studies suggest that among elderly patients with complex multivessel coronary disease, CABG provides a survival benefit over PCI (Sheridan et al. 2010; Kappetein et al. 2011; Weintraub et al. 2012). For this reason, a comparison of resource use between PCI and CABG must consider the possibility of differential survival between the two procedures. We use an innovative approach to determine how PCI differentially affects institutional days and resource use compared to CABG through decomposed survival and intensity effects. Specifically, we assess the effects of PCI versus CABG on survival, institutional (hospital or long-term care) days, and Medicare payments for up to 6 years of follow-up for a national sample of elderly Medicare beneficiaries treated with multivessel coronary revascularization.

Background— Patterns of noninvasive stress test (ST) and invasive coronary angiography (CA) utilization after percutaneous coronary intervention (PCI) are not well described in older populations. Methods and Results— We linked National Cardiovascular Data Registry CathPCI Registry data with longitudinal Medicare claims data for 250 350 patients undergoing PCI from 2005 to 2007 and described subsequent testing and outcomes. Between 60 days post-PCI and end of follow-up (median 24 months), 49% (n=122 894) received ST first, 10% (n=25 512) underwent invasive CA first, and 41% (n=101 944) had no testing. Several clinical risk factors at time of index PCI were associated with decreased likelihood of downstream testing (ST or CA, P P Conclusions— In this descriptive analysis, ST and invasive CA were common in older patients after PCI. Paradoxically, patients with higher risk features at baseline were less likely to undergo post-PCI testing. The revascularization yield was low on patients referred for ST after PCI, with only 9% undergoing revascularization within 90 days.