Implementation of Staging Guidelines in Early Esophageal Cancer: A Study of the Society of Thoracic Surgeons General Thoracic Surgery Database.

OBJECTIVE: To evaluate the adoption and clinical impact of endoscopic resection (ER) in early esophageal cancer. BACKGROUND: Staging for early esophageal cancer is largely inaccurate. Assessment of the impact of ER on staging accuracy is unknown, as is the implementation of ER. METHODS: We retrospectively reviewed 2608 patients captured in the Society of Thoracic Surgeons General Thoracic Surgery Database between 2015 and 2020. Patients with clinical T1 and T2 esophageal cancer without nodal involvement (N0) who were treated with upfront esophagectomy were included. Staging accuracy was assessed by clinical-pathologic concordance among patients staged with and without ER. We also sought to measure adherence to National Comprehensive Cancer Network staging guidelines for esophageal cancer staging, specifically the implementation of ER. RESULTS: For early esophageal cancer, computed tomography/positron emission tomography/endoscopic ultrasound (CT/PET/EUS) accurately predicts the pathologic tumor (T) stage 58.5% of the time. The addition of ER to staging was related to a decrease in upstaging from 17.6% to 10.8% ( P =0.01). Adherence to staging guidelines with CT/PET/EUS improved from 58.2% between 2012 and 2014 to 77.9% between 2015 and 2020. However, when ER was added as a staging criterion, adherence decreased to 23.3%. Increased volume of esophagectomies within an institution was associated with increased staging adherence with ER ( P =0.008). CONCLUSIONS: The use of CT/PET/EUS for the staging of early esophageal cancer is accurate in only 56.3% of patients. ER may increase staging accuracy as it is related to a decrease in upstaging. ER is poorly utilized in staging of early esophageal cancer. Barriers to the implementation of ER as a staging modality should be identified and corrected.

Outcomes of acute type A aortic dissection during the COVID-19 pandemic: An analysis of the Society of Thoracic Surgeons Database.

PURPOSE: There have been reported reductions of hospital presentation for acute cardiovascular conditions such as myocardial infarction and acute type A aortic dissection (ATAAD) in the United States during the COVID-19 pandemic. This study examined presentation patterns and outcomes of ATAAD in North America immediately before, and during, the COVID-19 pandemic. METHODS: The Society of Thoracic Surgeons Adult Cardiac Surgery Database (STS ACSD) was queried to identify patients presenting with ATAAD in the 12 months pre-pandemic (March 2019-February 2020), and during the early pandemic (March through June 2020). Demographics and operative characteristics were compared using χ² test and Wilcoxon Rank-sum test. The median annual case volume designated low-volume centers versus high-volume centers (>10 cases per month). Step-wise variable selection was used to create a risk set used for adjustment of all multivariable models. RESULTS: There were 5480 patients identified: 4346 pre-pandemic and 1134 during pandemic. There was significantly lower volume of median cases per month during the COVID-19 pandemic period (286 interquartile range [IQR]: 256-306 vs. 372 IQR: 291-433,p = .0152). In historically low-volume centers (<10 cases per year), there was no difference in volume between the two periods (142 IQR: 133-166 vs. 177 IQR: 139-209, p = NS). In high-volume centers, there was a decline during the pandemic (140 IQR: 123-148 vs. 212 IQR: 148-224, p = .0052). There was no difference in overall hospital-to-hospital transfers during the two time periods (54% of cases pre-pandemic, 55% during). Patient demographics, operative characteristics, malperfusion rates, and cardiac risk factors were similar between the two time periods. There was no difference in unadjusted operative mortality (19.01% pre-pandemic vs. 18.83% during, p = .9) nor major morbidity (52.42% pre-pandemic vs. 51.24% during, p = .5). Risk-adjusted multivariable models showed no difference in either operative mortality nor major morbidity between time periods. CONCLUSIONS: For patients presenting to the hospital with ATAAD during the first surge of the pandemic, operative outcomes were similar to pre-pandemic despite a 30% reduction in volume. Out-of-hospital mortality from ATAAD during the pandemic remains unknown. Further understanding these findings will inform management of ATAAD during future pandemics.

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.

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.

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.

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.

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.

Benchmarking Outcomes of Surgical Aortic Valve Replacement in Patients With Bicuspid Aortic Valves.

BACKGROUND: The relative roles for transcatheter and surgical aortic valve replacement (SAVR) for bicuspid aortic valve (AV) stenosis are debated. This study analyzes the 5-year longitudinal outcomes of isolated SAVR in bicuspid vs tricuspid AV patients, particularly in low-risk patients. METHODS: All patients undergoing isolated index SAVR at 1146 United States hospitals in The Society of Thoracic Surgeons (STS) Adult Cardiac database between July 1, 2011, and December 31, 2018, with linkage to Medicare claims, were analyzed. RESULTS: A total of 65,687 patients were analyzed, including of 9131 bicuspid patients (13.9%). Compared with tricuspid patients, bicuspid patients were significantly younger (median 70 vs 74 years, P < .001) with lower Society of Thoracic Surgeons predicted risk of mortality scores (mean 1.6% vs 2.3%, P < .001) and lower risk profile. Risk-adjusted 30-day mortality and major morbidity were similar, but risk-adjusted 5-year mortality was significantly lower in the bicuspid patients (adjusted hazard ratio, 0.72; 95% CI, 0.66-0.77), specifically in low-risk patients (adjusted hazard ratio, 0.69; 95% CI, 0.64-0.76). Additionally, the bicuspid cohort had a lower 5-year readmission risk of heart failure, stroke, bleeding, or other cardiovascular causes (all P < .05). CONCLUSIONS: In this nationally representative study, 30-day mortality was similar, but risk-adjusted 5-year mortality was significantly lower in bicuspid patients undergoing isolated SAVR compared with tricuspid patients, specifically low-risk and normal left ventricular ejection fraction patients. This analysis provides a much-needed 5-year longitudinal national-level benchmark to better inform the discussion of transcatheter vs SAVR in bicuspid patients.

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.

Impact of Transcatheter Mitral Valve Repair Availability on Volume and Outcomes of Surgical Repair.

BACKGROUND: The impact of transcatheter edge-to-edge repair (TEER) on national surgical mitral valve repair (MVr) volume and outcomes is unknown. OBJECTIVES: This study aims to assess the impact of TEER availability on MVr volumes and outcomes for degenerative mitral regurgitation. METHODS: MVr volume, 30-day and 5-year outcomes, including mortality, heart failure rehospitalization and mitral valve reintervention, were obtained from the Society of Thoracic Surgeons database linked with Medicare administrative claims and were compared within TEER centers before and after the first institutional TEER procedure. A difference-in-difference approach comparing parallel trends in coronary artery bypass grafting outcomes was used to account for temporal improvements in perioperative care. RESULTS: From July 2011 through December 2018, 13,959 patients underwent MVr at 278 institutions, which became TEER-capable during the study period. There was no significant change in median annualized institutional MVr volume before (32 [IQR: 17-54]) vs after (29 [IQR: 16-54]) the first TEER (P = 0.06). However, higher-risk (Society of Thoracic Surgeons predicted risk of mortality ≥2%) MVr procedures declined over the study period (P < 0.001 for trend). The introduction of TEER was associated with reduced risk-adjusted odds of mortality after MVr at 30 days (adjusted OR: 0.73; 95% CI: 0.54-0.99) and over 5 years (adjusted HR: 0.75; 95% CI: 0.66-0.86). These improvements in 30-day and 5-year mortality were significantly greater than equivalent trends in coronary artery bypass grafting. CONCLUSIONS: The introduction of TEER has not significantly changed overall MVr case volumes for degenerative mitral regurgitation but is associated with a decrease in higher-risk surgical operations and improved 30-day and 5-year outcomes within institutions adopting the technology.

Perioperative Anemia and Transfusions and Late Mortality in Coronary Artery Bypass Patients.

BACKGROUND: Perioperative anemia and transfusions are associated with adverse operative outcomes after coronary artery bypass graft surgery (CABG). Their individual association with long-term outcomes is unclear. METHODS: Patients aged 65 years and older who had undergone CABG and were in The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database (n = 504,596) from 2011 to 2018 were linked to Centers for Medicare and Medicaid Service data to assess long-term survival. The association of intraoperative anemia defined by intraoperative nadir hematocrit (nHct) and red blood cell (RBC) transfusions, and their interactions, on long-term mortality were assessed with Kaplan-Meier estimates and multivariable Cox regression. Restricted cubic splines were used to explore the association between nHct as a continuous variable and long-term mortality. RESULTS: 258,398 on-pump CABG STS Adult Cardiac Surgery Database patients surviving the perioperative period were linked to Centers for Medicare and Medicaid Service claims files. Per World Health Organization criteria, 41% had preoperative anemia. Mean intraoperative nHct was 24%; RBC transfusion rate was 43.7%. Univariable analysis associated both RBC transfusion and lower nHct with worse survival. Lower nHct was only marginally associated with risk-adjusted mortality: adjusted hazard ratio (AHR) 1.04 (95% CI, 1.01-1.06) and 1.07 (95% CI, 1.00-1.14) at nHct 20% and at nHct 14%, respectively. RBC transfusion was associated with significantly higher adjusted mortality irrespective of timing of transfusion: AHR intraoperative 1.21 (95% CI, 1.18-1.27); AHR postoperative 1.26 (95% CI, 1.22-1.30); AHR both 1.46 (95% CI, 1.40-1.52) and across all levels of nHct. RBC transfusion was not associated with improved survival at any level of nHct. CONCLUSIONS: Among Medicare CABG patients, RBC transfusions were associated with increased risk-adjusted late mortality across all levels of nHct whereas intraoperative anemia was only marginally so. Tolerance of lower intraoperative nHct than currently accepted may be preferable to transfusions.

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.