David M Shahian

Massachusetts General Hospital, Boston, Massachusetts, United States

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Publications (163)1095.62 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Introducing new medical devices into routine practice raises concerns because patients and outcomes may differ from those in randomized trials. To update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States. Data from the Society of Thoracic Surgeons/American College of Cardiology (STS/ACC) Transcatheter Valve Therapies Registry were linked with patient-specific Centers for Medicare & Medicaid Services (CMS) administrative claims data. At 299 US hospitals, 12 182 patients linked with CMS data underwent TAVR procedures performed from November 2011 through June 30, 2013, and the end of the follow-up period was June 30, 2014. Transcatheter aortic valve replacement. One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling. The median age of patients was 84 years and 52% were women, with a median STS Predicted Risk of Operative Mortality (STS PROM) score of 7.1%. Following the TAVR procedure, 59.8% were discharged to home and the 30-day mortality was 7.0% (95% CI, 6.5%-7.4%) (n = 847 deaths). In the first year after TAVR, patients were alive and out of the hospital for a median of 353 days (interquartile range, 312-359 days); 24.4% (n = 2074) of survivors were rehospitalized once and 12.5% (n = 1525) were rehospitalized twice. By 1 year, the overall mortality rate was 23.7% (95% CI, 22.8%-24.5%) (n = 2450 deaths), the stroke rate was 4.1% (95% CI, 3.7%-4.5%) (n = 455 stroke events), and the rate of the composite outcome of mortality and stroke was 26.0% (25.1%-26.8%) (n = 2719 events). Characteristics significantly associated with 1-year mortality included advanced age (hazard ratio [HR] for ≥95 vs <75 years, 1.61 [95% CI, 1.24-2.09]; HR for 85-94 years vs <75 years, 1.35 [95% CI, 1.18-1.55]; and HR for 75-84 years vs <75 years, 1.23 [95% CI, 1.08-1.41]), male sex (HR, 1.21; 95% CI, 1.12-1.31), end-stage renal disease (HR, 1.66; 95% CI, 1.41-1.95), severe chronic obstructive pulmonary disease (HR, 1.39; 95% CI, 1.25-1.55), nontransfemoral access (HR, 1.37; 95% CI, 1.27-1.48), STS PROM score greater than 15% vs less than 8% (HR, 1.82; 95% CI, 1.60-2.06), and preoperative atrial fibrillation/flutter (HR, 1.37; 95% CI, 1.27-1.48). Compared with men, women had a higher risk of stroke (HR, 1.40; 95% CI, 1.15-1.71). Among patients undergoing TAVR in US clinical practice, at 1-year follow-up, overall mortality was 23.7%, the stroke rate was 4.1%, and the rate of the composite outcome of death and stroke was 26.0%. These findings should be helpful in discussions with patients undergoing TAVR.
    JAMA The Journal of the American Medical Association 03/2015; 313(10):1019-1028. DOI:10.1001/jama.2015.1474 · 30.39 Impact Factor
  • David M Shahian, Sharon-Lise T Normand
    BMJ quality & safety 02/2015; 24(2):95-9. DOI:10.1136/bmjqs-2015-003934 · 3.28 Impact Factor
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    ABSTRACT: Risk-adjusted mortality (RAM) models are increasingly used to evaluate hospital performance, but the validity of the RAM method has been questioned. Providers are concerned that these methods might not adequately account for the highest levels of risk and that treating high-risk cases will have a negative impact on RAM rankings. Using cases of isolated coronary artery bypass grafting (CABG) performed at 1002 sites in the United States participating in The Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database from 2008 to 2010 (N = 494,955), the STS CABG RAM model performance in high-risk patients was assessed. The ratios of observed to expected (O/E) perioperative mortality were compared among groups of hospitals with varying expected risks. Finally, RAM rates during the overall study period for each site were compared with its performance in a simulated "nightmare year" in which the site's highest risk cases over a 3-year period were concentrated into a 1-year period of exceptional risk. The average predicted mortality for center risk groups ranged from 1.46% for the lowest risk quintile to 2.87% for the highest. The O/E ratios for center risk quintiles 1 to 5 during the overall period were 1.01 (95% confidence interval, 0.96% to 1.06%), 1.00 (0.95% to 1.04%), 0.98 (0.94% to 1.03%), 0.97 (0.93% to 1.01%), and 0.80 (0.77% to 0.84%), respectively. The sites' risk-adjusted mortality rates were not increased when the centers' highest risk cases were concentrated into a single "nightmare year." Our results show that the current risk-adjusted models accurately estimate CABG mortality and that hospitals accepting more high-risk CABG patients have equal or better outcomes than do those with predominately lower-risk patients. Copyright © 2015 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
    The Annals of Thoracic Surgery 01/2015; DOI:10.1016/j.athoracsur.2014.09.048 · 3.63 Impact Factor
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    ABSTRACT: ASCERT (American College of Cardiology Foundation and the Society of Thoracic Surgeons Collaboration on the Comparative Effectiveness of Revascularization Strategies) was a large observational study designed to compare the long-term effectiveness of coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) to treat coronary artery disease (CAD) over 4 to 5 years. This study examined the cost-effectiveness of CABG versus PCI for stable ischemic heart disease. The Society of Thoracic Surgeons and American College of Cardiology Foundation databases were linked to the Centers for Medicare and Medicaid Services claims data. Costs for the index and observation period (2004 to 2008) hospitalizations were assessed by diagnosis-related group Medicare reimbursement rates; costs beyond the observation period were estimated from average Medicare participant per capita expenditure. Effectiveness was measured via mortality and life-expectancy data. Cost and effectiveness comparisons were adjusted using propensity score matching with the incremental cost-effectiveness ratio expressed as cost per quality-adjusted life-year gained. CABG patients (n = 86,244) and PCI patients (n = 103,549) were at least 65 years old with 2- or 3-vessel coronary artery disease. Adjusted costs were higher for CABG for the index hospitalization, study period, and lifetime by $10,670, $8,145, and $11,575, respectively. Patients undergoing CABG gained an adjusted average of 0.2525 and 0.3801 life-years relative to PCI over the observation period and lifetime, respectively. The life-time incremental cost-effectiveness ratio of CABG compared to PCI was $30,454/QALY gained. Over a period of 4 years or longer, patients undergoing CABG had better outcomes but at higher costs than those undergoing PCI. Copyright © 2015 American College of Cardiology Foundation. Published by Elsevier Inc. All rights reserved.
    Journal of the American College of Cardiology 01/2015; 65(1):1-11. DOI:10.1016/j.jacc.2014.09.078 · 15.34 Impact Factor
  • JAMA Internal Medicine 01/2015; DOI:10.1001/jamainternmed.2014.7129 · 13.25 Impact Factor
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    ABSTRACT: Whether the introduction of transcatheter aortic valve replacement (TAVR) has affected hospitals' surgical aortic valve replacement (SAVR) and overall aortic valve replacement (AVR) case volumes and outcomes in the United States is unknown. We utilized data from The Society of Thoracic Surgeons (STS) adult cardiac surgery database and the STS/American College of Cardiology (ACC) transcatheter valve therapies registry to examine SAVR and TAVR procedures. Temporal trends in total case volume (SAVR plus TAVR), and observed and risk-adjusted in-hospital mortality rates were assessed among low-risk cases (STS predicted risk of operative mortality < 4%), intermediate-risk cases (4% to 8%), and high-risk cases (> 8%). A contemporary control was provided by non-TAVR centers. From 2008 to 2013, the total annual volume of AVR among 246 TAVR-performing hospitals increased from 19,578 to 33,004, with a 22% growth in SAVR volumes; non-TAVR hospital (n = 555) increases were more modest (16,563 to 19,134; 16% growth). Expanded volumes at TAVR hospitals included increased SAVR use in low- and intermediate-risk cases, and TAVR use in high-risk cases. In parallel, in-hospital mortality for all AVR procedures at TAVR sites declined from 3.4% to 2.9% (observed to expected [O:E] ratio 0.75 to 0.58, p < 0.001); the greatest declines were among intermediate- and high-risk SAVR patients. Owing to reduced SAVR mortality, TAVR centers experienced a significantly greater decline in O:E ratio for high-risk patient in-hospital mortality than non-TAVR centers (TAVR center O:E ratio, 0.81 to 0.61; non-TAVR center O:E ratio, 0.85 to 0.76; p < 0.001). After approval of TAVR for clinical use, a trend toward higher in-hospital mortality rates and O:E ratios for TAVR procedures was observed at new (but not at established) TAVR centers (O:E ratio, 0.41 to 0.67; p = 0.08). Since the introduction of TAVR, the total volume of AVR procedures, including higher overall use of SAVR, at TAVR sites has significantly increased in the United States. Overall, in-hospital survival of patients undergoing treatment for aortic valve stenosis continues to improve. Copyright © 2014 The Society of Thoracic Surgeons. Published by Elsevier Inc. All rights reserved.
    The Annals of Thoracic Surgery 12/2014; 98(6):2016-22. DOI:10.1016/j.athoracsur.2014.07.051 · 3.63 Impact Factor
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    ABSTRACT: Background The most common forms of risk adjustment for pediatric and congenital heart surgery used today are based mainly on the estimated risk of mortality of the primary procedure of the operation. The goals of this analysis were to assess the association of patient-specific preoperative factors with mortality and to determine which of these preoperative factors to include in future pediatric and congenital cardiac surgical risk models. Methods All index cardiac operations in The Society of Thoracic Surgeons Congenital Heart Surgery Database (STS-CHSD) during 2010 through 2012 were eligible for inclusion. Patients weighing less than 2.5 kg undergoing patent ductus arteriosus closure were excluded. Centers with more than 10% missing data and patients with missing data for discharge mortality or other key variables were excluded. Rates of discharge mortality for patients with or without specific preoperative factors were assessed across age groups and were compared using Fisher’s exact test. Results In all, 25,476 operations were included (overall discharge mortality 3.7%, n = 943). The prevalence of common preoperative factors and their associations with discharge mortality were determined. Associations of the following preoperative factors with discharge mortality were all highly significant (p < 0.0001) for neonates, infants, and children: mechanical circulatory support, renal dysfunction, shock, and mechanical ventilation. Conclusions Current STS-CHSD risk adjustment is based on estimated risk of mortality of the primary procedure of the operation as well as age, weight, and prematurity. The inclusion of additional patient-specific preoperative factors in risk models for pediatric and congenital cardiac surgery could lead to increased precision in predicting risk of operative mortality and comparison of observed to expected outcomes.
    The Annals of Thoracic Surgery 09/2014; DOI:10.1016/j.athoracsur.2014.07.029 · 3.63 Impact Factor
  • David M Shahian, Frederick L Grover
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    ABSTRACT: Early risk models in cardiac surgery focused exclusively on coronary artery bypass grafting surgery (CABG), using pre-procedural variables to estimate the likelihood of in-hospital or 30-day mortality. These models were initially developed to assess provider performance, but they have subsequently been used for patient counseling, shared decision-making, and a variety of other applications. For provider profiling, the expected outcomes for all patients of a given hospital or surgeon, estimated from regional or national benchmarks, are aggregated to calculate the expected outcomes for their overall practice. These expected rates are compared with the observed outcomes to calculate standardized mortality ratios or rates.
    Circulation 08/2014; 130(12). DOI:10.1161/CIRCULATIONAHA.114.011983 · 14.95 Impact Factor
  • David M Shahian
    JAMA Internal Medicine 06/2014; 174(8). DOI:10.1001/jamainternmed.2014.155 · 13.25 Impact Factor
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    ABSTRACT: -Reducing readmissions is a major healthcare reform goal, and reimbursement penalties are imposed for higher than expected readmission rates. Most readmission risk models and performance measures are based on administrative rather than clinical data.
    Circulation 06/2014; 130(5). DOI:10.1161/CIRCULATIONAHA.113.007541 · 14.95 Impact Factor
  • Infection Control and Hospital Epidemiology 06/2014; 35(6):737-40. DOI:10.1086/676436 · 4.02 Impact Factor
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    ABSTRACT: Recent observational studies show that patients with multivessel coronary disease have a long-term survival advantage with coronary artery bypass grafting (CABG) compared with percutaneous coronary intervention (PCI). Important nonfatal outcomes may also affect optimal treatment recommendation. CABG was compared with percutaneous catheter intervention by using a composite of death, myocardial infarction (MI), or stroke. Medicare patients undergoing revascularization for stable multivessel coronary disease from 2004 through 2008 were identified in national registries. Short-term clinical information from the registries was linked to Medicare data to obtain long-term follow-up out to 4 years from the time of the procedure. Propensity scoring with inverse probability weighting was used to adjust for baseline risk factors. There were 86,244 CABG and 103,549 PCI patients. The mean age was 74 years, with a median 2.67 years of follow-up. At 4 years, the propensity-adjusted adjusted cumulative incidence of MI was 3.2% in CABG compared with 6.6% in PCI (risk ratio, 0.49; 95% confidence interval, 0.45 to 0.53). At 4 years, the cumulative incidence of stroke was 4.5% in CABG compared with 3.1% in PCI patients (risk ratio, 1.43; 95% confidence interval, 1.31 to 1.54). This difference was primarily due to the higher 30-day stroke rate for CABG (1.55% vs 0.37%). For the composite of death, MI, or stroke, the 4-year adjusted cumulative incidence was 21.6% for CABG and 26.7% for PCI (risk ratio, 0.81; 95% confidence interval, 0.78 to 0.83). The 4-year composite event rate of death, MI, and stroke favored CABG, whereas the risk of stroke alone favored PCI.
    The Annals of thoracic surgery 04/2014; DOI:10.1016/j.athoracsur.2014.01.087 · 3.45 Impact Factor
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    ABSTRACT: In 2011 The Society of Thoracic Surgeons (STS) Workforce on National Databases established the International Database Task Force devoted to expanding participation in the STS National Database internationally. The vision for this initiative was to assist in the globalization of outcomes data and share knowledge, facilitating a worldwide quality collaborative in cardiac surgery. The Department of Cardiothoracic Surgery at Hadassah Medical Center, Jerusalem, Israel, was among the first of several international sites to join the collaborative. This report outlines the rationale behind clinical databases outside of North America submitting data to the STS National Database and reviews the unique challenges and practical steps of integration through experiences by Hadassah Medical Center. Our hope is that this procedural learning will serve as a template to assist future international program integration.
    The Annals of thoracic surgery 04/2014; 97(4):1127-30. DOI:10.1016/j.athoracsur.2013.12.038 · 3.45 Impact Factor
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    ABSTRACT: The Society of Thoracic Surgeons (STS) is developing a portfolio of composite performance measures for the most commonly performed adult cardiac procedures. This manuscript describes the third composite measure in this series, aortic valve replacement (AVR) combined with coronary artery bypass grafting surgery (CABG). We identified all patients in the STS Adult Cardiac Surgery Database who underwent AVR + CABG during recent 3-year (July 1, 2009, through June 30, 2012) and 5-year (July 1, 2007, through June 30, 2012) periods. Variables from the STS risk model for AVR + CABG were used to adjust morbidity and mortality outcomes. Evidence for internal mammary artery use in AVR + CABG was examined. We compared composite measures constructed using 3 or 5 years of outcomes with Bayesian credible intervals of 90%, 95%, or 98%. The final STS AVR + CABG composite performance measure is based on 3 years of data and 95% credible intervals. It includes risk-adjusted mortality and morbidity but not internal mammary artery use. Median composite score is 91.0% (interquartile range, 89.5% to 92.2%). There were 2.6% (24 of 915) one-star (lower performing) and 6.5% (59 of 915) three-star (higher performing) programs. Morbidity and mortality decrease monotonically as star ratings increase. The percentage of three-star programs increased substantially among programs that performed more than 150 procedures over 3 years compared with those performing 25 to 50 procedures (32.8% versus 1.6 %). Measure reliability was 0.51. The STS has developed a composite performance measure for AVR + CABG based on 3-year data samples and 95% credible intervals. This composite measure identified 9.1% of STS participants as having higher or lower than expected performance.
    The Annals of thoracic surgery 03/2014; 97(5). DOI:10.1016/j.athoracsur.2013.10.114 · 3.45 Impact Factor
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    ABSTRACT: Recent national trends in off-pump versus on-pump coronary artery bypass grafting have not been reported.
    Journal of Thoracic and Cardiovascular Surgery 01/2014; DOI:10.1016/j.jtcvs.2013.12.047 · 3.99 Impact Factor
  • The Annals of thoracic surgery 01/2014; 97(1 Suppl):S48-54. DOI:10.1016/j.athoracsur.2013.10.015 · 3.45 Impact Factor
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    ABSTRACT: Under the Affordable Care Act, health care reimbursement will increasingly be linked to quality and costs. In this environment, teaching hospitals will be closely scrutinized, as their care is often more expensive. Furthermore, although they serve vital roles in education, research, management of complex diseases, and care of vulnerable populations, debate continues as to whether teaching hospitals deliver better outcomes for common conditions. To determine the association between risk-standardized mortality and teaching intensity for 3 common conditions. Using CMS models, 30-day risk-standardized mortality rates were compared among US hospitals classified as Council of Teaching Hospital (COTH) members, non-COTH teaching hospitals, or nonteaching hospitals. These analyses were repeated using ratios of interns and residents to beds to classify teaching intensity. The study cohort included Medicare fee-for-service beneficiaries aged 66 years or older hospitalized in acute care hospitals during 2009-2010 for acute myocardial infarction (N=342,145), heart failure (N=647,081), or pneumonia (N=598,366). The 30-day risk-standardized mortality rates for each condition, stratified by teaching intensity. For each diagnosis, compared with nonteaching hospitals there was a 10% relative reduction in the adjusted odds of mortality for patients admitted to COTH hospitals and a 6%-7% relative reduction for patients admitted to non-COTH teaching hospitals. These findings were insensitive to the method of classifying teaching intensity and only partially explained by higher teaching hospital volumes. Health care reimbursement strategies designed to increase value should consider not only the costs but also the superior clinical outcomes at teaching hospitals for certain common conditions.
    Medical care 01/2014; 52(1):38-46. DOI:10.1097/MLR.0000000000000005 · 2.94 Impact Factor
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    ABSTRACT: To quantify the role of teaching hospitals in direct patient care, the authors compared characteristics of patients served by hospitals of varying teaching intensity. The authors studied Medicare beneficiaries ≥ 66 years old, hospitalized in 2009-2010 for acute myocardial infarction, heart failure, or pneumonia. They categorized hospitals as nonteaching, teaching, or Council of Teaching Hospitals and Health Systems (COTH) members and performed secondary analyses using intern and resident-to-bed ratios. The authors used descriptive statistics, adjusted odds ratios, and linear propensity scores to compare patient characteristics among teaching intensity levels. They supplemented Medicare mortality model variables with race, transfer status, and distance traveled. Adjusted for comorbidities, black patients had 2.44 (95% confidence interval [CI] 2.36-2.52), 2.56 (95% CI 2.51-2.60), and 2.58 (95% CI 2.51-2.65) times the odds of COTH hospital admission compared with white patients for acute myocardial infarction, heart failure, and pneumonia, respectively. For patients transferred from another hospital's inpatient setting, the corresponding adjusted odds ratios of COTH hospital admission were 3.99 (95% CI 3.85-4.13), 4.60 (95% CI 4.34-4.88), and 4.62 (95% CI 4.16-5.12). Using national data, distributions of propensity scores (probability of admission to a COTH hospital) varied markedly among teaching intensity levels. Data from Massachusetts and California illustrated between-state heterogeneity in COTH utilization. Major teaching hospitals are significantly more likely to provide care for minorities and patients requiring transfer from other institutions for advanced care. Both are essential to an equitable and high-quality regional health care system.
    Academic medicine: journal of the Association of American Medical Colleges 11/2013; DOI:10.1097/ACM.0000000000000050 · 2.34 Impact Factor
  • David M Shahian
    Annals of surgery 10/2013; 259(2). DOI:10.1097/SLA.0000000000000282 · 7.19 Impact Factor
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    ABSTRACT: This review investigates three fundamental issues in health care performance measurement: selection of a homogeneous target population, risk adjustment, and assignment of quality rating categories. Many but not all organizations involved in quality measurement have adopted similar approaches to these important methodological issues. To illustrate the practical implications of different profiling strategies, we use The Society of Thoracic Surgeons' data to compare profiling results derived using prevailing analytical methodologies with those obtained from alternative approaches, exemplified by those of a well-known health care performance rating organization. We demonstrate the differences in provider classification that may result from these methodologic decisions.
    The Annals of thoracic surgery 06/2013; DOI:10.1016/j.athoracsur.2013.03.029 · 3.45 Impact Factor

Publication Stats

5k Citations
1,095.62 Total Impact Points

Institutions

  • 2001–2015
    • Massachusetts General Hospital
      • • Department of Surgery
      • • Division of Thoracic Surgery
      • • Division of Cardiac Surgery
      Boston, Massachusetts, United States
  • 1984–2015
    • Harvard Medical School
      • Department of Health Care Policy
      Boston, Massachusetts, United States
  • 2007–2014
    • Harvard University
      Cambridge, Massachusetts, United States
    • University of Massachusetts Boston
      Boston, Massachusetts, United States
  • 2013
    • Duke University
      Durham, North Carolina, United States
    • Children's Hospitals and Clinics of Minnesota
      Minneapolis, Minnesota, United States
  • 2012
    • Christiana Care Health System
      Wilmington, Delaware, United States
  • 2008–2011
    • The Society of Thoracic Surgeons
      Chicago, Illinois, United States
    • Tufts University
      Бостон, Georgia, United States
  • 2010
    • FACC Aerostructures Engines & Nacelles Interiors
      Neuhofen, Lower Austria, Austria
  • 2009
    • North Carolina Clinical Research
      Raleigh, North Carolina, United States
  • 2005–2006
    • St. Elizabeth's Medical Center
      Boston, Massachusetts, United States
  • 1986–2003
    • Lahey Hospital and Medical Center
      Burlington, Massachusetts, United States
  • 1996
    • Dartmouth–Hitchcock Medical Center
      LEB, New Hampshire, United States