Publications by authors named "Fred H Edwards"

Background: Failure to rescue (FTR) focuses on the ability to prevent death among patients who have postoperative complications. The Society of Thoracic Surgeons (STS) Quality Measurement Task Force has developed a new, risk-adjusted FTR quality metric for adult cardiac surgery.

Methods: The study population was taken from 1118 STS Adult Cardiac Surgery Database participants including patients who underwent isolated CABG, aortic valve replacement with or without CABG, or mitral valve repair or replacement with or without CABG between January 2015 and June 2019.

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Background: Patients with bicuspid aortic valve (AV) stenosis were excluded from the pivotal evaluations of transcatheter AV replacement (TAVR) devices. We sought to evaluate the outcomes of TAVR in patients with bicuspid AV stenosis in comparison with those with tricuspid AV stenosis.

Methods: We used data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011 through November 2018) to determine device success, procedural outcomes, post-TAVR valve performance, and in-hospital clinical outcomes (mortality, stroke, and major bleeding) according to valve morphology (bicuspid versus tricuspid).

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Background: Patients undergoing post infarction ventricular septal defect repair are at high risk for early morbidity and mortality, but little is known about subsequent clinical events. This study uses short-term clinical data from The Society of Thoracic Surgeons National Database linked with Medicare data to examine longer term outcomes in these patients.

Methods: This was a retrospective review of The Society of Thoracic Surgeons National Database to link with Medicare data all adults (≥65 years) who underwent ventricular septal defect repair after a myocardial infarction between 2008 and 2012.

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Background: In patients with end-stage renal disease (ESRD), surgical aortic valve replacement is associated with higher early and late mortality, and adverse outcomes compared with patients without renal disease. Transcatheter aortic valve replacement (TAVR) offers another alternative, but there are limited reported outcomes.

Objectives: The purpose of this study was to determine the outcomes of TAVR in patients with ESRD.

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Background In older adults undergoing cardiac surgery, prediction of downstream risk is critical. Our objective was to determine the association of 5-m gait speed with 1-year mortality and repeat hospitalization following cardiac surgery. Methods and Results In this prospective cohort of patients undergoing cardiac surgery at centers participating in the Society of Thoracic Surgeons Database with gait speed recorded, we examined all-cause mortality using a landmark analysis at 0 to 30, 30 to 365, and >365 days, as well as repeat hospitalization.

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Background: Stroke is a serious complication after transcatheter aortic valve replacement (TAVR), yet predictive models are not available. A new risk model for in-hospital stroke after TAVR was developed and used to estimate site-specific performance.

Methods: We included 97,600 TAVR procedures from 521 sites in The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from July 2014 to June 2017.

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Background Among clinical trial patients at high surgical risk, a model has been developed and externally validated to estimate patient risk for poor outcomes after transcatheter aortic valve replacement (TAVR). How this model performs in lower risk and unselected patients is not known. We sought to examine and optimize the performance of the TAVR poor outcome risk model among patients in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry.

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Background: The Society of Thoracic Surgeons (STS) uses statistical models to create risk-adjusted performance metrics for Adult Cardiac Surgery Database (ACSD) participants. Because of temporal changes in patient characteristics and outcomes, evolution of surgical practice, and additional risk factors available in recent ACSD versions, completely new risk models have been developed.

Methods: Using July 2011 to June 2014 ACSD data, risk models were developed for operative mortality, stroke, renal failure, prolonged ventilation, mediastinitis/deep sternal wound infection, reoperation, major morbidity or mortality composite, prolonged postoperative length of stay, and short postoperative length of stay among patients who underwent isolated coronary artery bypass grafting surgery (n = 439,092), aortic or mitral valve surgery (n = 150,150), or combined valve plus coronary artery bypass grafting surgery (n = 81,588).

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Objectives: The aim of this study was to develop and validate a risk adjustment model for 30-day mortality after transcatheter aortic valve replacement (TAVR) that accounted for both standard clinical factors and pre-procedural health status and frailty.

Background: Assessment of risk for TAVR is important both for patient selection and provider comparisons. Prior efforts for risk adjustment have focused on in-hospital mortality, which is easily obtainable but can be biased because of early discharge of ill patients.

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The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS CHSD) is the largest congenital and pediatric cardiac surgical clinical data registry in the world. It contains data pertaining to more than 435,000 total operations. The most recent biannual feedback report to participants (Spring 2017, Report of the Twenty-Sixth Harvest) included analysis of data submitted from 127 hospitals in North America.

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Background: Randomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged.

Objectives: The aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort.

Methods: Using data from the Transcatheter Valve Therapy Registry and Society of Thoracic Surgeons National Database linked to Medicare administrative claims for follow-up, 9,464 propensity-matched intermediate- and high-risk (Society of Thoracic Surgeons Predicted Risk of Mortality score ≥3%) U.

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Containing more than 6 million cumulative operative records and accounting for 90% to 95% of adult cardiac surgery performed in the United States, The Society of Thoracic Surgeons Adult Cardiac Surgery Database is an invaluable resource for performance assessment, quality improvement, and clinical research. This article reviews the seven major research efforts published in 2016 that utilized the Adult Cardiac Surgery Database. Two studies evaluated national trends in clinical practice, three assessed the effect of several risk factors on postoperative morbidity and mortality, and two developed new models to evaluate quality of care.

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Background: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services.

Objectives: This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States.

Methods: We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry.

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Background: The Society of Thoracic Surgeons (STS)/American College of Cardiology Transcatheter Valve Therapy (TVT) Registry captures all procedures with Food and Drug Administration-approved transcatheter valve devices performed in the United States, and is mandated as a condition of reimbursement by the Centers for Medicaid & Medicare Services.

Objectives: This annual report focuses on patient characteristics, trends, and outcomes of transcatheter aortic and mitral valve catheter-based valve procedures in the United States.

Methods: We reviewed data for all patients receiving commercially approved devices from 2012 through December 31, 2015, that are entered in the TVT Registry.

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Established in 1989, The Society of Thoracic Surgeons Adult Cardiac Surgery Database is one of the most comprehensive clinical data registries in health care. It is widely regarded as the gold standard for benchmarking risk-adjusted outcomes in cardiac surgery and is the foundation for all quality measurement and improvement activities of The Society of Thoracic Surgeons. This is the second in a series of annual reports that summarizes current aggregate national outcomes in cardiac surgery and reviews database-related activities in the areas of quality measurement and performance improvement during the past year.

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The art and science of outcomes analysis, quality improvement, and patient safety continue to evolve, and cardiothoracic surgery leads many of these advances. The Society of Thoracic Surgeons (STS) National Database is one of the principal reasons for this leadership role, as it provides a platform for the generation of knowledge in all of these domains. Understanding these topics is a professional responsibility of all cardiothoracic surgeons.

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The Society of Thoracic Surgeons General Thoracic Surgery Database has grown to more than 500,000 case records. Clinical research supported by the database is increasingly used to advance patient outcomes. This research review from the General Thoracic Surgery Database in 2014 and 2015 discusses 6 recent publications and an ongoing study on longitudinal outcomes in lung cancer surgery from The Society of Thoracic Surgeons Task Force for Linked Registries and Longitudinal Follow-up.

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Background: The use of transcatheter aortic valve replacement (TAVR) to treat aortic stenosis in the United States is growing, yet little is known about the variation in procedural outcomes in community practice. We developed a TAVR in-hospital mortality risk model and used it to quantify variation in mortality rates across United States (US) TAVR centers.

Methods And Results: We analyzed data from 22 248 TAVR procedures performed at 318 sites participating in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry (November 2011 to October 2014).

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The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS CHSD) is the largest congenital and pediatric cardiac surgical clinical data registry in the world. With more than 400,000 total operations from nearly all centers performing pediatric and congenital heart operations in North America, the STS CHSD is an unparalleled platform for clinical investigation, outcomes research, and quality improvement activities in this subspecialty. In 2015, several major original publications reported analyses of data in the CHSD pertaining to specific diagnostic and procedural groups, age-defined cohorts, or the entire population of patients in the database.

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Importance: Prediction of operative risk is a critical step in decision making for cardiac surgery. Existing risk models may be improved by integrating a measure of frailty, such as 5-m gait speed, to better capture the heterogeneity of the older adult population.

Objective: To determine the association of 5-m gait speed with operative mortality and morbidity in older adults undergoing cardiac surgery.

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Importance: Patient selection for transcatheter aortic valve replacement (TAVR) should include assessment of the risks of TAVR compared with surgical aortic valve replacement (SAVR). Existing SAVR risk models accurately predict the risks for the population undergoing SAVR, but comparable models to predict risk for patients undergoing TAVR are currently not available and should be derived from a population that underwent TAVR.

Objective: To use a national population of patients undergoing TAVR to develop a statistical model that will predict in-hospital mortality after TAVR.

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Background: Failure to rescue (FTR) is increasingly recognized as an important quality indicator in surgery. The Society of Thoracic Surgeons National Database was used to develop FTR metrics and a predictive FTR model for coronary artery bypass grafting (CABG).

Methods: The study included 604,154 patients undergoing isolated CABG at 1,105 centers from January 2010 to January 2014.

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