Prognosis and Risks for Probable Chronic Lung Allograft Dysfunction: A Prospective Multicenter Study.

RATIONALE: Chronic lung allograft dysfunction (CLAD) hinders lung transplant success. A 2019 consensus refined CLAD diagnosis, introducing probable or definite CLAD based on persistence of lung function decline. Outcomes and risks for probable CLAD remain uncertain. OBJECTIVES: Determine the prognosis and clinical risks for probable CLAD in a prospective multicenter cohort. METHODS: Clinical Trials in Organ Transplantation-20 included 745 CLAD-eligible adult lung recipients at 5 centers and applied rigorous methods to prospectively adjudicate probable CLAD. The impact of probable CLAD on graft loss was determined using a Cox model that considered CLAD as a time-dependent covariate. Regularized Cox modeling with LASSO penalty was used to evaluate donor or recipient characteristics and the occurrence and timing of posttransplant events as probable CLAD risks. Similar analyses were performed for definite CLAD. MEASUREMENTS AND MAIN RESULTS: Probable CLAD occurred in 29.7% of patients at 3 years posttransplant and conferred a marked increase in risk for graft loss (unadjusted HR 4.38, p<0.001). Most patients (80%) with probable CLAD progressed to definite CLAD. Cytomegalovirus infection and specifically late presence (>90 days posttransplant) of donor-specific alloantibodies, acute rejection, acute lung injury, or organizing pneumonia contributed the greatest independent information about probable CLAD risk. Definite CLAD risks were similar. CONCLUSIONS: Probable CLAD identifies patients at high risk for graft loss, supporting prospective identification of this condition for early initiation of CLAD-directed interventions. More effective strategies to prevent posttransplant cytomegalovirus, inhibit allospecific immunity, and reduce tissue injury are needed to reduce probable CLAD and improve lung recipient survival.

Treatment With Tissue Plasminogen Activator in the Golden Hour and the Shape of the 4.5-Hour Time-Benefit Curve in the National United States Get With The Guidelines-Stroke Population.

BACKGROUND: Earlier tissue plasminogen activator treatment improves ischemic stroke outcome, but aspects of the time-benefit relationship still not well delineated are: (1) the degree of additional benefit accrued with treatment in the first 60 minutes after onset, and (2) the shape of the time-benefit curve through 4.5 hours. METHODS: We analyzed patients who had acute ischemic stroke treated with intravenous tissue plasminogen activator within 4.5 hours of onset from the Get With The Guidelines-Stroke US national program. Onset-to-treatment time was analyzed as a continuous, potentially nonlinear variable and as a categorical variable comparing patients treated within 60 minutes of onset with later epochs. RESULTS: Among 65 384 tissue plasminogen activator-treated patients, the median onset-to-treatment time was 141 minutes (interquartile range, 110-173) and 878 patients (1.3%) were treated within the first 60 minutes. Treatment within 60 minutes, compared with treatment within 61 to 270 minutes, was associated with increased odds of discharge to home (adjusted odds ratio, 1.25; 95% confidence interval, 1.07-1.45), independent ambulation at discharge (adjusted odds ratio, 1.22; 95% confidence interval, 1.03-1.45), and freedom from disability (modified Rankin Scale 0-1) at discharge (adjusted odds ratio, 1.72; 95% confidence interval, 1.21-2.46), without increased hemorrhagic complications or in-hospital mortality. The pace of decline in benefit of tissue plasminogen activator from onset-to-treatment times of 20 through 270 minutes was mildly nonlinear for discharge to home, with more rapid benefit loss in the first 170 minutes than later, and linear for independent ambulation and in-hospital mortality. CONCLUSIONS: Thrombolysis started within the first 60 minutes after onset is associated with best outcomes for patients with acute ischemic stroke, and benefit declined more rapidly early after onset for the ability to be discharged home. These findings support intensive efforts to organize stroke systems of care to improve the timeliness of thrombolytic therapy in acute ischemic stroke.

Contemporary management and outcomes of acute type A aortic dissection: An analysis of the STS adult cardiac surgery database.

PURPOSE: Management of acute type A aortic dissection (AAAD) is challenging and operative strategies are varied. We used the STS Adult Cardiac Surgery Database (STS ACSD) to describe contemporary surgical strategies and outcomes for AAAD. METHODS: Between July 2011 and September 2012, 2982 patients with AAAD underwent operations at 640 centers in North America. RESULTS: In this cohort, median age was 60 years old, 66% were male, and 80% had hypertension. The most common arterial cannulation strategies included femoral (36%), axillary (27%), and direct aortic (19%). The median perfusion and cross-clamp times were 181 and 102 min, respectively. The lowest temperature on bypass showed significant variation. Hypothermic circulatory arrest (HCA) was used in 78% of cases. Among those undergoing HCA, brain protection strategies included antegrade cerebral perfusion (31%), retrograde cerebral perfusion (25%), both (4%), and none (40%). Median HCA plus cerebral perfusion time was 40 min. Major complications included prolonged ventilation (53%), reoperation (19%), renal failure (18%), permanent stroke (11%), and paralysis (3%). Operative mortality was 17%. The median intensive care unit and hospital length of stays were 4.7 and 9.0 days, respectively. Among 640 centers, the median number of cases performed during the study period was three. Resuscitation, unresponsive state, cardiogenic shock, inotrope use, age >70, diabetes, and female sex were found to be independent predictors of mortality. CONCLUSIONS: These data describe contemporary patient characteristics, operative strategies, and outcomes for AAAD in North America. Mortality and morbidity for AAAD remain high.

Drip and ship thrombolytic therapy for acute ischemic stroke: use, temporal trends, and outcomes.

BACKGROUND AND PURPOSE: Interhospital transfer after use of intravenous tissue-type plasminogen activator (tPA) in acute stroke (drip and ship) is increasingly frequent. Small studies have suggested that drip and ship tPA is safe and increases rates of tPA use; however, little is known about real-world practice patterns. We sought to evaluate temporal trends in drip and ship tPA use and to compare the patient and hospital characteristics with that of conventional (front door) thrombolysis. METHODS: We analyzed data from 44 667 patients with ischemic stroke treated with intravenous tPA ≤3 hours of symptom onset in the Get With The Guidelines-Stroke program from April 2003 to October 2010 in 1440 hospitals. The main outcomes were the frequency of drip and ship tPA use over time, the characteristics of patients treated, and in-hospital outcomes, treatments, and complications. RESULTS: Among 44 667 patients treated with tPA, the drip and ship method was a common method (n=10 475; 23.5%), the use of which increased in parallel with the traditional tPA method over time. Patients treated by the drip and ship method differed significantly from front-door patients, with lower National Institutes of Health Stroke Scale scores when recorded (n=35 467). Crude in-hospital mortality (10.9%) and symptomatic intracranial hemorrhage (5.7%) in patients treated by the drip and ship method were slightly higher compared with those in front-door patients, and these differences persisted after risk adjustment. CONCLUSIONS: Drip and ship tPA is common, used in 1 in 4 patients treated with tPA in the United States. Modest differences in mortality and symptomatic intracranial hemorrhage may be because of patient selection bias, post-tPA care differences, or unmeasured confounding. The drip and ship paradigm may facilitate widespread tPA use in patients with acute stroke.

Comparative effectiveness of revascularization strategies.

BACKGROUND: Questions persist concerning the comparative effectiveness of percutaneous coronary intervention (PCI) and coronary-artery bypass grafting (CABG). The American College of Cardiology Foundation (ACCF) and the Society of Thoracic Surgeons (STS) collaborated to compare the rates of long-term survival after PCI and CABG. METHODS: We linked the ACCF National Cardiovascular Data Registry and the STS Adult Cardiac Surgery Database to claims data from the Centers for Medicare and Medicaid Services for the years 2004 through 2008. Outcomes were compared with the use of propensity scores and inverse-probability-weighting adjustment to reduce treatment-selection bias. RESULTS: Among patients 65 years of age or older who had two-vessel or three-vessel coronary artery disease without acute myocardial infarction, 86,244 underwent CABG and 103,549 underwent PCI. The median follow-up period was 2.67 years. At 1 year, there was no significant difference in adjusted mortality between the groups (6.24% in the CABG group as compared with 6.55% in the PCI group; risk ratio, 0.95; 95% confidence interval [CI], 0.90 to 1.00). At 4 years, there was lower mortality with CABG than with PCI (16.4% vs. 20.8%; risk ratio, 0.79; 95% CI, 0.76 to 0.82). Similar results were noted in multiple subgroups and with the use of several different analytic methods. Residual confounding was assessed by means of a sensitivity analysis. CONCLUSIONS: In this observational study, we found that, among older patients with multivessel coronary disease that did not require emergency treatment, there was a long-term survival advantage among patients who underwent CABG as compared with patients who underwent PCI. (Funded by the National Heart, Lung, and Blood Institute.).

Insurance status and outcome after intracerebral hemorrhage: findings from Get With The Guidelines-stroke.

BACKGROUND: [corrected] Few studies have examined associations among insurance status, treatment, and outcomes in patients hospitalized for intracerebral hemorrhage (ICH). METHODS: Through retrospective analyses of the Get With The Guidelines (GWTG)-Stroke database, a national prospective stroke registry, from April 2003 to April 2011, we identified 95,986 nontransferred subjects hospitalized with ICH. Insurance status was categorized as Private/Other, Medicaid, Medicare, or None/Not Documented (ND). Associations between insurance status and in-hospital outcomes and quality of care measures were analyzed using patient- and hospital-specific variables as covariates. RESULTS: There were significant differences in age and frequency of comorbid conditions by insurance group. Compliance with evidence-based quality of care indicators varied across all insurance status groups (P < .0001) but was generally high. In adjusted analysis with the Private insurance group as reference, the None/ND group most consistently demonstrated higher odds ratios (ORs) for quality of care measures (Dysphagia Screen: OR 1.10, 95% confidence interval [CI] 1.02-1.17, P = .0096; Stroke Education: OR 1.16, 95% CI 1.05-1.29, P = .0042; and Rehabilitation: OR 1.25, 95% CI 1.08-1.44, P = .0027). In-hospital mortality rates were higher for None/ND, Medicaid, and Medicare patients; after risk adjustment, the None/ND group had the highest mortality risk (OR 1.29, 95% CI 1.21-1.38, P < .0001). Medicare and Medicaid patients had lower adjusted odds for both independent ambulation at discharge and discharge to home when compared with the Private/Other group. CONCLUSIONS: GWTG-Stroke ICH patients demonstrated differences in mortality, functional status, discharge destination, and quality of care measures associated with insurance status.

Hospitalized hemorrhagic stroke patients with renal insufficiency: clinical characteristics, care patterns, and outcomes.

BACKGROUND: There is a paucity of information on clinical characteristics, care patterns, and clinical outcomes for hospitalized intracerebral hemorrhage (ICH) patients with chronic kidney disease (CKD). We assessed characteristics, care processes, and in-hospital outcome among ICH patients with CKD in the Get With the Guidelines-Stroke (GWTG-Stroke) program. METHODS: We analyzed 113,059 ICH patients hospitalized at 1472 US centers participating in the GWTG-Stroke program between January 2009 and December 2012. In-hospital mortality and use of 2 predefined ICH performance measures were examined based on glomerular filtration rate. Renal dysfunction was categorized as a dichotomous (+CKD = estimated glomerular filtration rate <60) or rank ordered variable as CKD (<60), and by clinical stage: (normal [≥90], mild [≥60-<90], moderate [≥30-<60], severe [≥15-<30], and/or kidney failure [<15 or dialysis]). RESULTS: There were 33,219 (29%) ICH patients with CKD. Patients with CKD were more likely to be older, female, and with comorbid conditions such as diabetes. Compared with patients with normal kidney function, those with CKD were slightly less likely to receive deep venous thrombosis (DVT) prophylaxis but similarly received discharge smoking cessation intervention. Inpatient mortality was also higher for those with CKD (adjusted odds ratio [OR], 1.47; 95% confidence interval [CI], 1.42-1.52), mild dysfunction (adjusted OR, 1.12; 95% CI, 1.08-1.16), moderate dysfunction (adjusted OR, 1.46; 95% CI, 1.39-1.53), severe dysfunction (adjusted OR, 1.96; 95% CI, 1.81-2.12), and kidney failure (adjusted OR, 2.22; 95% CI, 2.04-2.43) relative to those with normal renal function. CONCLUSIONS: Chronic kidney disease is present in nearly a third of patients hospitalized with ICH and is associated with slightly worse care and substantially higher mortality than those with normal renal function.

The Society of Thoracic Surgeons Database Analysis: Comparing Sublobar Techniques in Stage IA Lung Cancer.

BACKGROUND: This study compares sublobar resections-wedge resection and segmentectomy-in clinical stage IA lung cancers. It tests the hypothesis that overall survival after wedge resection is similar to segmentectomy. METHODS: Adults undergoing wedge resection or segmentectomy for clinical stage IA lung cancer were identified from The Society of Thoracic Surgeons General Thoracic Surgery Database. Eligible patients were linked to the Centers for Medicare and Medicaid Services database using a matching algorithm. The primary outcome was long-term overall survival. Propensity scores overlap weighting (PSOW) adjustment of wedge resection using validated covariates was used for group difference mitigation. Kaplan-Meier and Cox regression models analyzed survival. All-cause first readmission, and morbidity and mortality were examined using PSOW regression models. RESULTS: Of 9756 patients, 6141 met inclusion criteria, comprising 2154 segmentectomies and 3987 wedge resections. PSOW reduced differences between the groups. Unadjusted perioperative mortality was comparable, but wedge resection showed lower major morbidity rates. Weighted regression analysis indicated reduced mortality and major morbidity risks in wedge resection. Kaplan-Meier analysis revealed no mortality difference between groups, which was confirmed by PSOW Cox regression models. The cumulative risk of readmission was also comparable for both groups, with Cox Fine-Gray models showing no difference in rehospitalization risks. CONCLUSIONS: In clinical stage IA lung cancer, relative to segmentectomy, wedge resection has comparable overall survival and lower perioperative morbidity, suggesting it is an equally effective option for the broader population of patients with clinical stage IA lung cancer, not only those at highest risk of complications.

Equity in Heart Failure Care: A Get With the Guidelines Analysis of Between- and Within-Hospital Differences in Care by Sex, Race, Ethnicity, and Insurance.

BACKGROUND: Disparities in guideline-based quality measures likely contribute to differences in heart failure (HF) outcomes. We evaluated between- and within-hospital differences in the quality of care across sex, race, ethnicity, and insurance for patients hospitalized for HF. METHODS: This retrospective analysis included patients hospitalized for HF across 596 hospitals in the Get With the Guidelines-HF registry between 2016 and 2021. We evaluated performance across 7 measures stratified by patient sex, race, ethnicity, and insurance. We evaluated differences in performance with and without adjustment for the treating hospital. We also measured variation in hospital-specific disparities. RESULTS: Among 685 227 patients, the median patient age was 72 (interquartile range, 61-82) and 47.2% were women. Measure performance was significantly lower (worse) for women compared with men for all 7 measures before adjustment. For 4 of 7 measures, there were no significant sex-related differences after patient-level adjustment. For 20 of 25 other comparisons, racial and ethnic minorities and Medicaid/uninsured patients had similar or higher (better) adjusted measure performance compared with White and Medicare/privately insured patients, respectively. Angiotensin receptor neprilysin inhibitor measure performance was significantly lower for Asian, Hispanic, and Medicaid/uninsured patients, and cardiac resynchronization therapy implant/prescription was lower among women and Black patients after hospital adjustment, indicating within-hospital differences. There was hospital-level variation in these differences. For cardiac resynchronization therapy implantation/prescription, 278 hospitals (46.6%) had ≥2% lower implant/prescription for Black versus White patients compared with 109 hospitals (18.3%) with the same or higher cardiac resynchronization therapy implantation/prescription for Black patients. CONCLUSIONS: HF quality measure performance was equitable for most measures. There were within-hospital differences in angiotensin receptor neprilysin inhibitor and cardiac resynchronization therapy implant/prescription for historically marginalized groups. The magnitude of hospital-specific disparities varied across hospitals.

Prediction of long-term mortality after percutaneous coronary intervention in older adults: results from the National Cardiovascular Data Registry.

BACKGROUND: The purpose of this study was to develop a long-term model to predict mortality after percutaneous coronary intervention in both patients with ST-segment elevation myocardial infarction and those with more stable coronary disease. METHODS AND RESULTS: The American College of Cardiology Foundation CathPCI Registry data were linked to the Centers for Medicare and Medicaid Services 100% denominator file by probabilistic matching. Preprocedure demographic and clinical variables from the CathPCI Registry were used to predict the probability of death over 3 years as recorded in the Centers for Medicare and Medicaid Services database. Between 2004 and 2007, 343 466 patients (66%) of 518 195 patients aged ≥65 years undergoing first percutaneous coronary intervention in the CathPCI Registry were successfully linked to Centers for Medicare and Medicaid Services data. This study population was randomly divided into 60% derivation and 40% validation cohorts. Median follow-up was 15 months, with mortality of 3.0% at 30 days and 8.7%, 13.4%, and 18.7% at 1, 2, and 3 years, respectively. Twenty-four characteristics related to demographics, clinical comorbidity, prior history of disease, and indices of disease severity and acuity were identified as being associated with mortality. The C indices in the validation cohorts for patients with and without ST-segment elevation myocardial infarction were 0.79 and 0.78. The model calibrated well across a wide range of predicted probabilities. CONCLUSIONS: On the basis of the large and nationally representative CathPCI Registry, we have developed a model that has excellent discrimination, calibration, and validation to predict survival up to 3 years after percutaneous coronary intervention.

Predictors of long-term survival after coronary artery bypass grafting surgery: results from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (the ASCERT study).

BACKGROUND: Most survival prediction models for coronary artery bypass grafting surgery are limited to in-hospital or 30-day end points. We estimate a long-term survival model using data from the Society of Thoracic Surgeons Adult Cardiac Surgery Database and Centers for Medicare and Medicaid Services. METHODS AND RESULTS: The final study cohort included 348 341 isolated coronary artery bypass grafting patients aged ≥65 years, discharged between January 1, 2002, and December 31, 2007, from 917 Society of Thoracic Surgeons-participating hospitals, randomly divided into training (n=174 506) and validation (n=173 835) samples. Through linkage with Centers for Medicare and Medicaid Services claims data, we ascertained vital status from date of surgery through December 31, 2008 (1- to 6-year follow-up). Because the proportional hazards assumption was violated, we fit 4 Cox regression models conditional on being alive at the beginning of the following intervals: 0 to 30 days, 31 to 180 days, 181 days to 2 years, and >2 years. Kaplan-Meier-estimated mortality was 3.2% at 30 days, 6.4% at 180 days, 8.1% at 1 year, and 23.3% at 3 years of follow-up. Harrell's C statistic for predicting overall survival time was 0.732. Some risk factors (eg, emergency status, shock, reoperation) were strong predictors of short-term outcome but, for early survivors, became nonsignificant within 2 years. The adverse impact of some other risk factors (eg, dialysis-dependent renal failure, insulin-dependent diabetes mellitus) continued to increase. CONCLUSIONS: Using clinical registry data and longitudinal claims data, we developed a long-term survival prediction model for isolated coronary artery bypass grafting. This provides valuable information for shared decision making, comparative effectiveness research, quality improvement, and provider profiling.

Relationship between sex, ejection fraction, and B-type natriuretic peptide levels in patients hospitalized with heart failure and associations with inhospital outcomes: findings from the Get With The Guideline-Heart Failure Registry.

BACKGROUND: In heart failure (HF), there are known differences in plasma B-type natriuretic peptide (BNP) levels between reduced and preserved ejection fraction (EF), but few HF studies have explored sex differences. We sought to evaluate the relationship between sex, EF, and BNP in HF patients and determine prognostic significance of BNP as it relates to sex and EF. METHODS: We included hospitals in Get With The Guidelines-Heart Failure that admitted 99,930 HF patients with reduced (EF <40%), borderline (EF 40%-49%), or preserved (EF ≥50%) EF. The primary end point was inhospital mortality. Multivariate models were used to compute odds ratios while accounting for hospital clustering. RESULTS: There were 47,025 patients with reduced (37% female), 13,950 with borderline (48% female), and 38,955 with preserved (65% female) EF. Women compared with men had higher admission median BNP levels with the greatest difference among reduced EF and smallest difference among preserved EF (median BNP in women vs men: EF reduced 1,259 vs 1,113 pg/mL, borderline 821 vs 732 pg/mL, and preserved 559 vs 540 pg/mL; P < .001 all comparisons). Ejection fraction and sex were independently associated with BNP. Inhospital mortality was 2.7%, and patients above the median BNP level had higher mortality than those below. After adjusting for over 20 clinical variables, the ability of BNP to predict inhospital mortality was similar among all subgroups (P for heterogeneity = .47). CONCLUSIONS: In a large registry, we found that despite sex/EF differences in BNP values, there was no significant difference in the ability of BNP to predict inhospital mortality among these subgroups.

Admission heart rate and in-hospital outcomes in patients hospitalized for heart failure in sinus rhythm and in atrial fibrillation.

BACKGROUND: Prior studies have suggested an association between higher heart rate and higher mortality, particularly in chronic heart failure (HF). Whether this relationship holds true in patients hospitalized with HF and differs between patients in sinus rhythm (SR) and atrial fibrillation (AF) has not been well studied. METHODS: We examined 145,221 admissions for HF from 295 hospitals enrolled in Get With The Guidelines-Heart Failure from January 2005 through September 2011. The associations of admission heart rate with in-hospital outcomes were evaluated overall and by heart rhythm. RESULTS: Patients presenting at higher heart rate tended to be younger and have less comorbidities. In-hospital mortality had a J-shaped relationship with heart rate, with the lowest mortality rate associated with heart rates between 70 and 75. However, the relationship differed between patients presenting in SR and AF: at heart rates above 100, the mortality curve for AF plateaued, whereas that for SR continued to rise. Higher heart rate was independently associated with higher mortality (SR adjusted OR 1.21, 95% CI 1.15-1.28 per 10 beat per minute increase in heart rate between 70-105; AF adjusted OR 1.20, 95% CI 1.14-1.27). Findings were similar when stratifying patients by ischemic etiology, diabetes, ejection fraction, blood pressure, and ß-blocker use. CONCLUSIONS: Higher admission heart rate is independently associated with worse outcomes in patients admitted for HF, including those in SR and AF. Whether early heart rate reduction improves outcomes in patients hospitalized with HF is worthy of investigation.

Age differences in the use of implantable cardioverter-defibrillators among older patients hospitalized with heart failure.

INTRODUCTION: Practice guidelines recommend the use of ICDs in patients with heart failure (HF) and a left ventricular ejection fraction (LVEF) of ≤ 35% in the absence of contraindications. METHODS AND RESULTS: We performed an analysis of ICD use among patients admitted with HF with LVEF of ≤ 35% and discharged alive from 251 hospitals participating in the American Heart Association's Get With The Guidelines-HF Program between January 2005 and September 2011. Among 35,772 guideline-eligible patients, 17,639 received an ICD prior to hospitalization (10,886), during hospitalization (4,876), or were discharged with plans to undergo ICD placement after hospitalization (1,877). After adjustment, increasing age was associated with lower ICD use (odds ratio [OR] 0.89, 95% confidence interval [CI] 0.87-0.91 per 5-year increase in age, P < 0.0001). Compared with patient age < 55 years, older age groups ≥ 65 years were less likely to receive an ICD (P < 0.003). Compared with men in the same age group, women were significantly less likely to receive an ICD; this difference was more marked with increasing age (P value for interaction = 0.006). There was a temporal increase in ICD use (adjusted OR 1.23, 95% CI 1.15-1.31 of ICD use per year) that was similar in each age group (P value for interaction = 0.665). CONCLUSIONS: Eligible older HF patients age ≥ 65 years were significantly less likely to receive an ICD. With increasing age, women were less likely to receive an ICD than men. ICD use significantly increased over time in all age groups; however, age-related differences in ICD use persisted.

Time to treatment with intravenous tissue plasminogen activator and outcome from acute ischemic stroke.

IMPORTANCE: Randomized clinical trials suggest the benefit of intravenous tissue-type plasminogen activator (tPA) in acute ischemic stroke is time dependent. However, modest sample sizes have limited characterization of the extent to which onset to treatment (OTT) time influences outcome; and the generalizability of findings to clinical practice is uncertain. OBJECTIVE: To evaluate the degree to which OTT time is associated with outcome among patients with acute ischemic stroke treated with intraveneous tPA. DESIGN, SETTING, AND PATIENTS: Data were analyzed from 58,353 patients with acute ischemic stroke treated with tPA within 4.5 hours of symptom onset in 1395 hospitals participating in the Get With The Guidelines-Stroke Program, April 2003 to March 2012. MAIN OUTCOMES AND MEASURES: Relationship between OTT time and in-hospital mortality, symptomatic intracranial hemorrhage, ambulatory status at discharge, and discharge destination. RESULTS: Among the 58,353 tPA-treated patients, median age was 72 years, 50.3% were women, median OTT time was 144 minutes (interquartile range, 115-170), 9.3% (5404) had OTT time of 0 to 90 minutes, 77.2% (45,029) had OTT time of 91 to 180 minutes, and 13.6% (7920) had OTT time of 181 to 270 minutes. Median pretreatment National Institutes of Health Stroke Scale documented in 87.7% of patients was 11 (interquartile range, 6-17). Patient factors most strongly associated with shorter OTT included greater stroke severity (odds ratio [OR], 2.8; 95% CI, 2.5-3.1 per 5-point increase), arrival by ambulance (OR, 5.9; 95% CI, 4.5-7.3), and arrival during regular hours (OR, 4.6; 95% CI, 3.8-5.4). Overall, there were 5142 (8.8%) in-hospital deaths, 2873 (4.9%) patients had intracranial hemorrhage, 19,491 (33.4%) patients achieved independent ambulation at hospital discharge, and 22,541 (38.6%) patients were discharged to home. Faster OTT, in 15-minute increments, was associated with reduced in-hospital mortality (OR, 0.96; 95% CI, 0.95-0.98; P < .001), reduced symptomatic intracranial hemorrhage (OR, 0.96; 95% CI, 0.95-0.98; P < .001), increased achievement of independent ambulation at discharge (OR, 1.04; 95% CI, 1.03-1.05; P < .001), and increased discharge to home (OR, 1.03; 95% CI, 1.02-1.04; P < .001). CONCLUSIONS AND RELEVANCE: In a registry representing US clinical practice, earlier thrombolytic treatment was associated with reduced mortality and symptomatic intracranial hemorrhage, and higher rates of independent ambulation at discharge and discharge to home following acute ischemic stroke. These findings support intensive efforts to accelerate hospital presentation and thrombolytic treatment in patients with stroke.

Long-term outcomes of aortic root operations in the United States among Medicare beneficiaries.

OBJECTIVE: The best method of aortic root repair in older patients remains unknown given a lack of comparative effectiveness of long-term outcomes data. The objective of this study was to compare long-term outcomes of different surgical approaches for aortic root repair in Medicare patients using The Society of Thoracic Surgeons Adult Cardiac Surgery Database-Centers for Medicare & Medicaid Services-linked data. METHODS: A retrospective cohort study was performed by querying the Society of Thoracic Surgeons Adult Cardiac Surgery Database for patients aged 65 years or more who underwent elective aortic root repair with or without aortic valve replacement. Primary long-term end points were mortality, any stroke, and aortic valve reintervention. Short-term outcomes and long-term survival were compared among each root repair strategy. Additional risk factors for mortality after aortic root repair were assessed with a multivariable Cox proportional hazards model. RESULTS: A total of 4173 patients aged 65 years or more underwent elective aortic root repair. Patients were stratified by operative strategy: mechanical Bentall, stented bioprosthetic Bentall, stentless bioprosthetic Bentall, or valve-sparing root replacement. Mean follow-up was 5.0 (±4.6) years. Relative to mechanical Bentall, stented bioprosthetic Bentall (adjusted hazard ratio, 0.80; confidence interval, 0.66-0.97) and stentless bioprosthetic Bentall (adjusted hazard ratio, 0.70; confidence interval, 0.59-0.84) were associated with better long-term survival. In addition, stentless bioprosthetic Bentall (adjusted hazard ratio, 0.64; confidence interval, 0.47-0.80) and valve-sparing root replacement (adjusted hazard ratio, 0.51; confidence interval, 0.29-0.90) were associated with lower long-term risk of stroke. Aortic valve reintervention risk was 2-fold higher after valve-sparing root replacement compared with other operative strategies. CONCLUSIONS: In the Medicare population, there was poorer late survival and greater late stroke risk for patients undergoing mechanical Bentall and a higher rate of reintervention for valve-sparing root replacement. Bioprosthetic Bentall may be the procedure of choice in older patients undergoing aortic root repair, particularly in the era of transcatheter aortic valve replacement.

Timeliness of tissue-type plasminogen activator therapy in acute ischemic stroke: patient characteristics, hospital factors, and outcomes associated with door-to-needle times within 60 minutes.

BACKGROUND: The benefits of intravenous tissue-type plasminogen activator (tPA) in acute ischemic stroke are time dependent, and guidelines recommend an arrival to treatment initiation (door-to-needle) time of ≤60 minutes. METHODS AND RESULTS: Data from acute ischemic stroke patients treated with tPA within 3 hours of symptom onset in 1082 hospitals participating in the Get With the Guidelines-Stroke Program from April 1, 2003, to September 30, 2009 were studied to determine frequency, patient and hospital characteristics, and temporal trends in patients treated with door-to-needle times ≤60 minutes. Among 25 504 ischemic stroke patients treated with tPA, door-to-needle time was ≤60 minutes in only 6790 (26.6%). Patient factors most strongly associated with door-to-needle time ≤60 minutes were younger age, male gender, white race, or no prior stroke. Hospital factors associated with ≤60 minute door-to-needle time included greater annual volumes of tPA-treated stroke patients. The proportion of patients with door-to-needle times ≤60 minutes varied widely by hospital (0% to 79.2%) and increased from 19.5% in 2003 to 29.1% in 2009 (P<0.0001). Despite similar stroke severity, in-hospital mortality was lower (adjusted odds ratio, 0.78; 95% confidence interval, 0.69 to 0.90; P<0.0003) and symptomatic intracranial hemorrhage was less frequent (4.7% versus 5.6%; P<0.0017) for patients with door-to-needle times ≤60 minutes compared with patients with door-to-needle times >60 minutes. CONCLUSIONS: Fewer than one-third of patients treated with intravenous tPA had door-to-needle times ≤60 minutes, with only modest improvement over the past 6.5 years. These findings support the need for a targeted initiative to improve the timeliness of reperfusion in acute ischemic stroke.

Sex differences in in-hospital mortality in acute decompensated heart failure with reduced and preserved ejection fraction.

BACKGROUND: There are no sex-specific survival comparisons between patients with heart failure (HF) with reduced and those with preserved ejection fraction. Large registries noting women have better survival than men combined HF patients with reduced and preserved EF. Other registries that compared patients with reduced and preserved EF did not analyze their data by sex. We sought to evaluate sex/EF differences in mortality and risk factors for survival in hospitalized patients with HF. METHODS: We included hospitals fully participating in Get With The Guidelines-Heart Failure that admitted HF patients with reduced (EF <40%) or preserved (EF ≥50%) EF. The primary end point was in-hospital mortality. Multivariate generalized estimating equation logistic models were used to compute odds ratios accounting for hospital clustering. RESULTS: The study cohort consisted of 51,428 patients with EF <40% (36% women, 64% men) and 37,699 patients with EF ≥50% (65% women, 35% men). Women compared with men with reduced and preserved EF were older and more likely to have hypertension, depression, or valvular heart disease and less likely to have coronary artery disease or peripheral vascular disease. There were no sex differences in in-hospital mortality (EF <40%, 2.69% women vs 2.89% men, P = .20; EF ≥50%, 2.61% women vs 2.62% men, P = .96), and risk factors such as age, systolic blood pressure, heart rate, and history of renal failure/dialysis were highly predictive of death for each sex/EF subgroup. CONCLUSIONS: In a large, multicenter registry, we found that despite differences in baseline characteristics, women and men with reduced and preserved EF have similar in-hospital mortality and risk factors predicting death.

Risk of Each of the Five Lung Lobectomies: A Society of Thoracic Surgeons Database Analysis.

BACKGROUND: The perioperative risk of pulmonary lobectomy as a solitary procedure has been extensively studied, yet the differences in outcomes between lobes, which have unique anatomy and a different amount of lung parenchyma, are entirely unknown. The purpose of this study was to define the risk of each of the 5 lobectomies. METHODS: The Society of Thoracic Surgeons Database was queried for patients undergoing lobectomy between 2008 and 2018. Patient and disease characteristics, operative variables, major morbidity, and 30-day mortality were examined. A multivariable logistic regression model (using the same variables in the current Society of Thoracic Surgeons lobectomy risk model) was developed to assess the contribution of lobectomy site to adverse outcomes. RESULTS: There were 65 006 patients analyzed. Adjusted perioperative mortality rate is lowest for right middle lobe (RML), 0.63%; intermediate for right upper lobe (RUL), left upper lobe (LUL), and left lower lobe (LLL), 1.08 to 1.24%; and highest for right lower lobe (RLL), 1.63%. The adjusted major morbidity rate is lowest for RML, 5.36%; intermediate for LLL and LUL, 7.82% to 8.33%; and highest for RUL and RLL, 8.94% to 9.32%. Adjusted intraoperative transfusion rate is lowest for RML, 1.37%; intermediate for RLL and LLL, 1.81% to 1.94%; and highest for RUL and LUL, 2.47% to 2.72%. CONCLUSIONS: There are clear differences in postoperative outcomes by lobectomy location. Mortality, major morbidity, and transfusion rate are lowest for RML but vary across other lobectomies. These differences should be appreciated in evaluating risk of operation, deciding on best therapy, counseling patients, and comparing outcomes.

The STS Participant-Level, Multiprocedural Composite Measure for Adult Cardiac Surgery.

BACKGROUND: Composite performance measures for the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database participants (typically hospital departments or practice groups) are currently available only for individual procedures. To assess overall participant performance, STS has developed a composite metric encompassing the most common adult cardiac procedures. METHODS: Analyses included 1-year (July 1, 2018 to June 30, 2019) and 3-year (July 1, 2016 to June 30, 2019) time windows. Operations included isolated coronary artery bypass grafting (CABG), isolated aortic valve replacement (AVR), isolated mitral valve repair (MVr) or replacement (MVR), AVR + CABG, MVr or MVR + CABG, AVR + MVr or MVR, and AVR + (MVr or MVR) + CABG. The composite was estimated using Bayesian hierarchical models with risk-adjusted mortality and morbidity end points. Star ratings were based upon whether the 95% credible interval of a participant's score was entirely lower than (1 star), overlapping (2 star), or higher than (3 star) the STS average composite score. RESULTS: The North American procedural mix in the 3-year study cohort was as follows: 448 569 CABG, 72 067 AVR, 35 708 MVr, 29 953 MVR, 45 254 AVR + CABG, 12 247 MVr + CABG, 10 118 MVR + CABG, 3743 AVR + MVr, 6846 AVR + MVR, and 3765 AVR + (MVr or MVR) + CABG. Mortality and morbidity weightings were similar for 1- and 3-year analyses (76% and 24% [3-year]), as were composite score distributions (median, 94.7%; interquartile range, 93.6% to 95.6% [3-year]). The 3-year time frame was selected for operational use because of higher model reliability (0.81 [0.78-0.83]) and better outlier discrimination (26%, 3 star; 16%, 1 star). Risk-adjusted outcomes for 1-, 2-, and 3-star programs were 4.3%, 3.0%, and 1.8% mortality and 18.4%, 13.4%, and 9.7% morbidity, respectively. CONCLUSIONS: The STS participant-level, multiprocedural composite measure provides comprehensive, highly reliable, overall quality assessment of adult cardiac surgery practices.