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1.
N Engl J Med ; 388(2): 142-153, 2023 01 12.
Artículo en Inglés | MEDLINE | ID: mdl-36630622

RESUMEN

BACKGROUND: Adverse events during hospitalization are a major cause of patient harm, as documented in the 1991 Harvard Medical Practice Study. Patient safety has changed substantially in the decades since that study was conducted, and a more current assessment of harm during hospitalization is warranted. METHODS: We conducted a retrospective cohort study to assess the frequency, preventability, and severity of patient harm in a random sample of admissions from 11 Massachusetts hospitals during the 2018 calendar year. The occurrence of adverse events was assessed with the use of a trigger method (identification of information in a medical record that was previously shown to be associated with adverse events) and from review of medical records. Trained nurses reviewed records and identified admissions with possible adverse events that were then adjudicated by physicians, who confirmed the presence and characteristics of the adverse events. RESULTS: In a random sample of 2809 admissions, we identified at least one adverse event in 23.6%. Among 978 adverse events, 222 (22.7%) were judged to be preventable and 316 (32.3%) had a severity level of serious (i.e., caused harm that resulted in substantial intervention or prolonged recovery) or higher. A preventable adverse event occurred in 191 (6.8%) of all admissions, and a preventable adverse event with a severity level of serious or higher occurred in 29 (1.0%). There were seven deaths, one of which was deemed to be preventable. Adverse drug events were the most common adverse events (accounting for 39.0% of all events), followed by surgical or other procedural events (30.4%), patient-care events (which were defined as events associated with nursing care, including falls and pressure ulcers) (15.0%), and health care-associated infections (11.9%). CONCLUSIONS: Adverse events were identified in nearly one in four admissions, and approximately one fourth of the events were preventable. These findings underscore the importance of patient safety and the need for continuing improvement. (Funded by the Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.).


Asunto(s)
Atención a la Salud , Hospitalización , Errores Médicos , Daño del Paciente , Seguridad del Paciente , Humanos , Atención a la Salud/normas , Atención a la Salud/estadística & datos numéricos , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/epidemiología , Efectos Colaterales y Reacciones Adversas Relacionados con Medicamentos/prevención & control , Hospitalización/estadística & datos numéricos , Pacientes Internos , Errores Médicos/prevención & control , Errores Médicos/estadística & datos numéricos , Seguridad del Paciente/normas , Estudios Retrospectivos , Daño del Paciente/prevención & control , Daño del Paciente/estadística & datos numéricos
2.
Ann Intern Med ; 177(6): 738-748, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38710086

RESUMEN

BACKGROUND: Despite considerable emphasis on delivering safe care, substantial patient harm occurs. Although most care occurs in the outpatient setting, knowledge of outpatient adverse events (AEs) remains limited. OBJECTIVE: To measure AEs in the outpatient setting. DESIGN: Retrospective review of the electronic health record (EHR). SETTING: 11 outpatient sites in Massachusetts in 2018. PATIENTS: 3103 patients who received outpatient care. MEASUREMENTS: Using a trigger method, nurse reviewers identified possible AEs and physicians adjudicated them, ranked severity, and assessed preventability. Generalized estimating equations were used to assess the association of having at least 1 AE with age, sex, race, and primary insurance. Variation in AE rates was analyzed across sites. RESULTS: The 3103 patients (mean age, 52 years) were more often female (59.8%), White (75.1%), English speakers (90.8%), and privately insured (70.4%) and had a mean of 4 outpatient encounters in 2018. Overall, 7.0% (95% CI, 4.6% to 9.3%) of patients had at least 1 AE (8.6 events per 100 patients annually). Adverse drug events were the most common AE (63.8%), followed by health care-associated infections (14.8%) and surgical or procedural events (14.2%). Severity was serious in 17.4% of AEs, life-threatening in 2.1%, and never fatal. Overall, 23.2% of AEs were preventable. Having at least 1 AE was less often associated with ages 18 to 44 years than with ages 65 to 84 years (standardized risk difference, -0.05 [CI, -0.09 to -0.02]) and more often associated with Black race than with Asian race (standardized risk difference, 0.09 [CI, 0.01 to 0.17]). Across study sites, 1.8% to 23.6% of patients had at least 1 AE and clinical category of AEs varied substantially. LIMITATION: Retrospective EHR review may miss AEs. CONCLUSION: Outpatient harm was relatively common and often serious. Adverse drug events were most frequent. Rates were higher among older adults. Interventions to curtail outpatient harm are urgently needed. PRIMARY FUNDING SOURCE: Controlled Risk Insurance Company and the Risk Management Foundation of the Harvard Medical Institutions.


Asunto(s)
Atención Ambulatoria , Registros Electrónicos de Salud , Seguridad del Paciente , Humanos , Femenino , Persona de Mediana Edad , Masculino , Estudios Retrospectivos , Adulto , Anciano , Massachusetts , Adolescente , Adulto Joven
3.
Circulation ; 144(3): 186-194, 2021 07 20.
Artículo en Inglés | MEDLINE | ID: mdl-33947202

RESUMEN

BACKGROUND: Transcatheter aortic valve replacement (TAVR) is a transformative therapy for aortic stenosis. Despite rapid improvements in technology and techniques, serious complications remain relatively common and are not well described by single outcome measures. The purpose of this study was to determine whether there is site-level variation in TAVR outcomes in the United States using a novel 30-day composite measure. METHODS: We performed a retrospective cohort study using data from the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapies Registry to develop a novel ranked composite performance measure that incorporates mortality and serious complications. The selection and rank order of the complications for the composite was determined by their adjusted association with 1-year outcomes. Sites with risk-adjusted outcomes significantly more or less frequent than the national average based on a 95% probability interval were classified as performing worse or better than expected. RESULTS: The development cohort consisted of 52 561 patients who underwent TAVR between January 1, 2015, and December 31, 2017. Based on associations with 1-year risk-adjusted mortality and health status, we identified 4 periprocedural complications to include in the composite risk model in addition to mortality. Ranked empirically according to severity, these included stroke, major, life-threatening or disabling bleeding, stage III acute kidney injury, and moderate or severe perivalvular regurgitation. Based on these ranked outcomes, we found that there was significant site-level variation in quality of care in TAVR in the United States. Overall, better than expected site performance was observed in 25/301 (8%) sites, performance as expected was observed in 242/301 sites (80%), and worse than expected performance was observed in 34/301 (11%) sites. Thirty-day mortality; stroke; major, life-threatening, or disabling bleeding; and moderate or severe perivalvular leak were each substantially more common in sites with worse than expected performance as compared with other sites. There was good aggregate reliability of the model. CONCLUSIONS: There are substantial variations in the quality of TAVR care received in the United States and 11% of sites were identified as providing care below the average level of performance. Further study is necessary to determine structural, process-related, and technical factors associated with high- and low-performing sites.


Asunto(s)
Estenosis de la Válvula Aórtica/epidemiología , Estenosis de la Válvula Aórtica/cirugía , Reemplazo de la Válvula Aórtica Transcatéter , Anciano , Anciano de 80 o más Años , Estenosis de la Válvula Aórtica/diagnóstico , Estenosis de la Válvula Aórtica/etiología , Manejo de la Enfermedad , Femenino , Encuestas de Atención de la Salud , Humanos , Masculino , Medición de Resultados Informados por el Paciente , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Pronóstico , Sistema de Registros , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Reemplazo de la Válvula Aórtica Transcatéter/métodos , Resultado del Tratamiento , Estados Unidos/epidemiología
4.
Circulation ; 142(14): 1351-1360, 2020 10 06.
Artículo en Inglés | MEDLINE | ID: mdl-33017214

RESUMEN

BACKGROUND: Optimal strategies to improve national congenital heart surgery outcomes and reduce variability across hospitals remain unclear. Many policy and quality improvement efforts have focused primarily on higher-risk patients and mortality alone. Improving our understanding of both morbidity and mortality and current variation across the spectrum of complexity would better inform future efforts. METHODS: Hospitals participating in the Society of Thoracic Surgeons Congenital Heart Surgery Database (2014-2017) were included. Case mix-adjusted operative mortality, major complications, and postoperative length of stay were evaluated using Bayesian models. Hospital variation was quantified by the interdecile ratio (IDR, upper versus lower 10%) and 95% credible intervals (CrIs). Stratified analyses were performed by risk group (Society of Thoracic Surgeons-European Association for Cardiothoracic Surgery [STAT] category) and simulations evaluated the potential impact of reductions in variation. RESULTS: A total of 102 hospitals (n=84 407) were included, representing ≈85% of US congenital heart programs. STAT category 1 to 3 (lower risk) operations comprised 74% of cases. All outcomes varied significantly across hospitals: adjusted mortality by 3-fold (upper versus lower decile 5.0% versus 1.6%, IDR 3.1 [95% CrI 2.5-3.7]), mean length of stay by 1.8-fold (19.2 versus 10.5 days, IDR 1.8 [95% CrI 1.8-1.9]), and major complications by >3-fold (23.5% versus 7.0%, IDR 3.4 [95% CrI 3.0-3.8]). The degree of variation was similar or greater for low- versus high-risk cases across outcomes, eg, ≈3-fold mortality variation across hospitals for STAT 1 to 3 (IDR 3.0 [95% CrI 2.1-4.2]) and STAT 4 or 5 (IDR 3.1 [95% CrI 2.4-3.9]) cases. High-volume hospitals had less variability across outcomes and risk categories. Simulations suggested potential reductions in deaths (n=282), major complications (n=1539), and length of stay (101 183 days) over the 4-year study period if all hospitals were to perform at the current median or better, with 37% to 60% of the improvement related to the STAT 1 to 3 (lower risk) group across outcomes. CONCLUSIONS: We demonstrate significant hospital variation in morbidity and mortality after congenital heart surgery. Contrary to traditional thinking, a substantial portion of potential improvements that could be realized on a national scale were related to variability among lower-risk cases. These findings suggest modifications to our current approaches to optimize care and outcomes in this population are needed.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Bases de Datos Factuales , Cardiopatías Congénitas/mortalidad , Cardiopatías Congénitas/cirugía , Mortalidad Hospitalaria , Niño , Preescolar , Femenino , Humanos , Lactante , Masculino , Estados Unidos/epidemiología
5.
J Vasc Surg ; 72(2): 589-596.e3, 2020 08.
Artículo en Inglés | MEDLINE | ID: mdl-32067876

RESUMEN

OBJECTIVE: The timing of operative revascularization for patients with concomitant carotid artery stenosis and coronary artery disease remains controversial. We examined the Society of Thoracic Surgeons (STS) Adult Cardiac Surgery Database to evaluate the association of combined carotid endarterectomy (CEA) and coronary artery bypass grafting (CABG) with postoperative outcomes. METHODS: All patients undergoing CABG with known carotid stenosis of >80% were identified from 2011 to 2016. Individuals were stratified by use of cardiopulmonary bypass and whether a concomitant CEA was performed at the time of CABG. Multivariate logistic regression was used to model the probability of combined CABG and CEA. The resulting propensity scores were used to match individuals on the basis of clinical and operative characteristics to evaluate primary (30-day mortality and in-hospital transient ischemic attack and stroke) and secondary (STS morbidity composite events and length of stay) end points, with P < .05 required to declare statistical significance. RESULTS: After propensity score matching, 994 off-pump CABG patients (497 CABG only and 497 CABG-CEA) and 5952 on-pump CABG patients (2976 CABG only and 2976 CABG-CEA) were identified. For patients who received on-pump operations, those undergoing CABG-CEA had no observed difference in rate of in-hospital stroke (odds ratio [OR], 0.93; 95% confidence interval [CI], 0.72-1.21; P = .6), higher incidence of STS morbidity composite events (OR, 1.15, 95% CI, 1.01-1.31; P = .03), longer length of stay (7.0 [interquartile range, 5.0-9.0] days vs 6.0 [interquartile range, 5.0-9.0] days; P < .005), and no observed difference in 30-day mortality (OR, 1.28; 95% CI, 0.97-1.69; P = .08) compared with those undergoing CABG only. For off-pump procedures, CABG-CEA patients had no observed difference in rate of in-hospital stroke (OR, 0.80; 95% CI, 0.37-1.69; P = .56) compared with those undergoing CABG only. CONCLUSIONS: Whereas the differences are relatively small, these data suggest that a combined CABG-CEA approach is unlikely to provide significant stroke reduction benefit compared with CABG only. However, comparison with staged approaches merits further investigation.


Asunto(s)
Estenosis Carotídea/cirugía , Puente de Arteria Coronaria/efectos adversos , Enfermedad de la Arteria Coronaria/cirugía , Endarterectomía Carotidea/efectos adversos , Ataque Isquémico Transitorio/epidemiología , Accidente Cerebrovascular/epidemiología , Anciano , Puente Cardiopulmonar/efectos adversos , Estenosis Carotídea/diagnóstico por imagen , Estenosis Carotídea/mortalidad , Puente de Arteria Coronaria/mortalidad , Puente de Arteria Coronaria Off-Pump/efectos adversos , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Enfermedad de la Arteria Coronaria/mortalidad , Bases de Datos Factuales , Endarterectomía Carotidea/mortalidad , Femenino , Humanos , Incidencia , Ataque Isquémico Transitorio/diagnóstico , Ataque Isquémico Transitorio/mortalidad , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Medición de Riesgo , Factores de Riesgo , Accidente Cerebrovascular/diagnóstico , Accidente Cerebrovascular/mortalidad , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos/epidemiología
6.
Circulation ; 133(2): 124-30, 2016 Jan 12.
Artículo en Inglés | MEDLINE | ID: mdl-26603032

RESUMEN

BACKGROUND: Previous studies have reported that black patients undergoing coronary artery bypass surgery had worse outcomes than white patients, even after accounting for patient factors. The degree to which clinician, hospital, and care factors account for these outcome differences remains unclear. METHODS AND RESULTS: We evaluated procedural outcomes in 11,697 blacks and 136,362 whites undergoing isolated coronary artery bypass surgery at 663 Society of Thoracic Surgery Database participating sites (January 1, 2010 to June 30, 2011) adjusted for patients' clinical and socioeconomic features, hospital and surgeon effects, and care processes (internal mammary artery graft and perioperative medications use). Relative to whites, blacks undergoing coronary artery bypass surgery were younger, yet had higher comorbidities and more adverse presenting features. Blacks were also more likely to be treated at hospitals with higher risk-adjusted mortality. The use of internal mammary artery was marginally lower in blacks than in whites (93.3% versus 92.2%, P<0.0001). Unadjusted mortality and major morbidity rates were higher in blacks than in whites (1.8% versus 2.5%, P<0.0001) and (13.6% versus 19.4%, P<0.0001), respectively. These racial differences in outcomes narrowed but still persisted after adjusting for surgeon, hospital, and care processes in addition to patient and socioeconomic factors (odds ratio, 1.17; 95% confidence interval, 1.00-1.36 and odds ratio, 1.26; 95% confidence interval, 1.19-1.34, respectively). CONCLUSIONS: The risks of procedural mortality and morbidity after coronary artery bypass surgery were higher among black patients than among white patients. These differences were in part accounted for by patient comorbidities, socioeconomic status, and surgeon, hospital, and care factors, as well, as suggested by the reduction in the strength of the race-outcomes association. However, black race remained an independent predictor of outcomes even after accounting for these differences.


Asunto(s)
Población Negra/estadística & datos numéricos , Puente de Arteria Coronaria/estadística & datos numéricos , Disparidades en Atención de Salud/estadística & datos numéricos , Población Blanca/estadística & datos numéricos , Comorbilidad , Puente de Arteria Coronaria/mortalidad , Bases de Datos Factuales , Accesibilidad a los Servicios de Salud/estadística & datos numéricos , Mortalidad Hospitalaria , Hospitales/normas , Hospitales/estadística & datos numéricos , Humanos , Médicos/estadística & datos numéricos , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etnología , Calidad de la Atención de Salud , Riesgo , Factores Socioeconómicos , Resultado del Tratamiento , Estados Unidos/epidemiología
7.
Circulation ; 133(14): 1351-9, 2016 Apr 05.
Artículo en Inglés | MEDLINE | ID: mdl-26920495

RESUMEN

BACKGROUND: Surgical risk scores do not include frailty assessments (eg, gait speed), which are of particular importance for patients with severe aortic stenosis considering transcatheter aortic valve replacement. METHODS AND RESULTS: We assessed the association of 5-m gait speed with outcomes in a cohort of 8039 patients who underwent transcatheter aortic valve replacement (November 2011-June 2014) and were included in the Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. We evaluated the association between continuous and categorical gait speed and 30-day all-cause mortality before and after adjustment for Society of Thoracic Surgeons-predicted risk of mortality score and key variables. Secondary outcomes included in-hospital mortality, bleeding, acute kidney injury, and stroke. The overall median gait speed was 0.63 m/s (25th-75th percentile, 0.47-0.79 m/s), with the slowest walkers (<0.5 m/s) constituting 28%, slow walkers (0.5-0.83 m/s) making up 48%, and normal walkers (>0.83 m/s) constituting 24% of the population. Thirty-day all-cause mortality rates were 8.4%, 6.6%, and 5.4% for the slowest, slow, and normal walkers, respectively (P<0.001). Each 0.2-m/s decrease in gait speed corresponded to an 11% increase in 30-day mortality (adjusted odds ratio, 1.11; 95% confidence interval, 1.01-1.22). The slowest walkers had 35% higher 30-day mortality than normal walkers (adjusted odds ratio, 1.35; 95% confidence interval, 1.01-1.80), significantly longer hospital stays, and a lower probability of being discharged to home. CONCLUSIONS: Gait speed is independently associated with 30-day mortality after transcatheter aortic valve replacement. Identification of frail patients with the slowest gait speeds facilitates preprocedural evaluation and anticipation of a higher level of postprocedural care. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01737528.


Asunto(s)
Marcha , Limitación de la Movilidad , Complicaciones Posoperatorias/epidemiología , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad , Lesión Renal Aguda/epidemiología , Anciano , Anciano de 80 o más Años , Femenino , Anciano Frágil/estadística & datos numéricos , Mortalidad Hospitalaria , Humanos , Masculino , Complicaciones Posoperatorias/mortalidad , Hemorragia Posoperatoria/epidemiología , Pronóstico , Estudios Prospectivos , Sistema de Registros/estadística & datos numéricos , Accidente Cerebrovascular/epidemiología
8.
Circulation ; 130(5): 399-409, 2014 Jul 29.
Artículo en Inglés | MEDLINE | ID: mdl-24916208

RESUMEN

BACKGROUND: 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. METHODS AND RESULTS: We examined rates and predictors of 30-day all-cause readmission following coronary artery bypass grafting surgery by using nationally representative clinical data (2008-2010) from the Society of Thoracic Surgeons National Database linked to Medicare claims records. Among 265 434 eligible Medicare records, 226 960 (86%) were successfully linked to Society of Thoracic Surgeons records; 162 572 (61%) isolated coronary artery bypass grafting admissions constituted the study cohort. Logistic regression was used to identify readmission risk factors; hierarchical regression models were then estimated. Risk-standardized readmission rates ranged from 12.6% to 23.6% (median, 16.8%) among 846 US hospitals with ≥30 eligible cases and ≥90% of eligible Centers for Medicare and Medicaid Services records linked to the Society of Thoracic Surgeons database. Readmission predictors (odds ratios [95% confidence interval]) included dialysis (2.02 [1.87-2.19]), severe chronic lung disease (1.58 [1.49-1.68]), creatinine (2.5 versus 1.0 or lower:1.49 [1.41-1.57]; 2.0 versus 1.0 or lower: 1.37 [1.32-1.43]), insulin-dependent diabetes mellitus (1.45 [1.39-1.51]), obesity in women (body surface area 2.2 versus 1.8: 1.44 [1.35-1.53]), female sex (1.38 [1.33-1.43]), immunosuppression (1.38 [1.28-1.49]), preoperative atrial fibrillation (1.36 [1.30-1.42]), age per 10-year increase (1.36 [1.33-1.39]), recent myocardial infarction (1.24 [1.08-1.42]), and low body surface area in men (1.22 [1.14-1.30]). C-statistic was 0.648. Fifty-two hospitals (6.1%) had readmission rates statistically better or worse than expected. CONCLUSIONS: A coronary artery bypass grafting surgery readmission measure suitable for public reporting was developed by using the national Society of Thoracic Surgeons clinical data linked to Medicare readmission claims.


Asunto(s)
Puente de Arteria Coronaria/estadística & datos numéricos , Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/cirugía , Readmisión del Paciente/estadística & datos numéricos , Sistema de Registros/estadística & datos numéricos , Anciano , Anciano de 80 o más Años , Comorbilidad , Femenino , Humanos , Clasificación Internacional de Enfermedades , Modelos Logísticos , Masculino , Medicaid/estadística & datos numéricos , Medicare/estadística & datos numéricos , Valor Predictivo de las Pruebas , Ajuste de Riesgo/estadística & datos numéricos , Factores de Riesgo , Estados Unidos/epidemiología
10.
Ann Surg ; 262(3): 526-35; discussion 533-5, 2015 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-26258322

RESUMEN

OBJECTIVES: To evaluate participant characteristics and outcomes during the first 4 years of the Society of Thoracic Surgeons (STS) public reporting program. BACKGROUND: This is the first detailed analysis of a national, voluntary, cardiac surgery public reporting program using STS clinical registry data and National Quality Forum-endorsed performance measures. METHODS: The distributions of risk-adjusted mortality rates, multidimensional composite performance scores, star ratings, and volumes for public reporting versus nonreporting sites were studied during 9 consecutive semiannual reporting periods (2010-2014). RESULTS: Among 8929 unique observations (∼1000 STS participant centers, 9 reporting periods), 916 sites (10.3%) were classified low performing, 6801 (76.2%) were average, and 1212 (13.6%) were high performing. STS public reporting participation varied from 22.2% to 46.3% over the 9 reporting periods. Risk-adjusted, patient-level mortality rates for isolated coronary artery bypass grafting were consistently lower in public reporting versus nonreporting sites (P value range: <0.001-0.0077). Reporting centers had higher composite performance scores and star ratings (23.2% high performing and 4.5% low performing vs 7.6% high performing and 13.8% low performing for nonreporting sites). STS public reporting sites had higher mean annualized coronary artery bypass grafting volumes than nonreporting sites (169 vs 145, P < 0.0001); high-performing programs had higher mean coronary artery bypass grafting volumes (n = 241) than average (n = 139) or low-performing (n = 153) sites. Risk factor prevalence (except reoperation) and expected mortality rates were generally stable during the study period. CONCLUSIONS: STS programs that voluntarily participate in public reporting have significantly higher volumes and performance. No evidence of risk aversion was found.


Asunto(s)
Acceso a la Información , Mortalidad Hospitalaria/tendencias , Difusión de la Información , Garantía de la Calidad de Atención de Salud , Cirugía Torácica/organización & administración , Adulto , Anciano , Puente de Arteria Coronaria/métodos , Puente de Arteria Coronaria/mortalidad , Puente de Arteria Coronaria/estadística & datos numéricos , Bases de Datos Factuales , Femenino , Humanos , Masculino , Persona de Mediana Edad , Medición de Riesgo , Sociedades Médicas , Análisis de Supervivencia , Factores de Tiempo , Resultado del Tratamiento , Estados Unidos
11.
N Engl J Med ; 366(16): 1467-76, 2012 Apr 19.
Artículo en Inglés | MEDLINE | ID: mdl-22452338

RESUMEN

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.).


Asunto(s)
Angioplastia Coronaria con Balón , Puente de Arteria Coronaria , Enfermedad Coronaria/terapia , Anciano , Investigación sobre la Eficacia Comparativa , Factores de Confusión Epidemiológicos , Enfermedad Coronaria/mortalidad , Enfermedad Coronaria/cirugía , Bases de Datos Factuales , Femenino , Estudios de Seguimiento , Humanos , Masculino , Observación , Modelos de Riesgos Proporcionales , Análisis de Supervivencia , Estados Unidos
12.
JAMA ; 313(10): 1019-28, 2015 Mar 10.
Artículo en Inglés | MEDLINE | ID: mdl-25756438

RESUMEN

IMPORTANCE: Introducing new medical devices into routine practice raises concerns because patients and outcomes may differ from those in randomized trials. OBJECTIVE: To update the previous report of 30-day outcomes and present 1-year outcomes following transcatheter aortic valve replacement (TAVR) in the United States. DESIGN, SETTING, AND PARTICIPANTS: 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. EXPOSURE: Transcatheter aortic valve replacement. MAIN OUTCOMES AND MEASURES: One-year outcomes including mortality, stroke, and rehospitalization were evaluated using multivariate modeling. RESULTS: 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). CONCLUSIONS AND RELEVANCE: 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.


Asunto(s)
Accidente Cerebrovascular/etiología , Reemplazo de la Válvula Aórtica Transcatéter/efectos adversos , Anciano , Anciano de 80 o más Años , Válvula Aórtica/cirugía , Femenino , Estudios de Seguimiento , Insuficiencia Cardíaca/epidemiología , Insuficiencia Cardíaca/etiología , Enfermedades de las Válvulas Cardíacas/cirugía , Humanos , Incidencia , Masculino , Evaluación de Resultado en la Atención de Salud , Readmisión del Paciente/estadística & datos numéricos , Vigilancia de Productos Comercializados , Sistema de Registros , Factores de Riesgo , Accidente Cerebrovascular/epidemiología , Reemplazo de la Válvula Aórtica Transcatéter/mortalidad
13.
Circulation ; 127(16): 1656-63, 2013 Apr 23.
Artículo en Inglés | MEDLINE | ID: mdl-23532630

RESUMEN

BACKGROUND: A major advantage of coronary artery bypass graft surgery (CABG) relative to percutaneous coronary intervention is its durability, yet there is a paucity of information on rates and predictors of repeat coronary revascularization after CABG in the modern era. METHODS AND RESULTS: We included patients ≥65 years from the Society of Thoracic Surgeons' National Adult Cardiac Surgery Database who were undergoing first-time isolated CABG from 1991 to 2007 (n=723 134, median age 73 years). After linking to Medicare claims data, long-term outcomes of CABG (up to 18 years after surgery) were examined by use of cumulative incidence curves. Multivariable Cox proportional hazard analysis was used to identify factors associated with 1- and 5-year repeat revascularization trends and variability. We found that the overall 18-year survival rate was 20%. Cumulative incidences of any repeat revascularization (percutaneous coronary intervention or CABG, yet most often percutaneous coronary intervention) were 2%, 7%, 13%, and 16% at 1, 5, 10, and 18 years after surgery, respectively. The rates of repeat CABG procedures were quite low for all time points (0.1%, 0.6%, 1.3%, and 1.7%, respectively). Female sex, disease severity represented by a history of percutaneous coronary intervention, preoperative dialysis, and partial revascularization were strongly associated with a higher revascularization rate, whereas advanced age, left main disease, and smoking were associated with a lower rate. There was approximately a 2-fold variation in repeat revascularization rates across centers at 1 year (interquartile range 1.7-3.6%) and 5 years (interquartile range 6.7-12.0%). CONCLUSIONS: Repeat revascularization is performed infrequently among older patients who undergo CABG; however, these rates vary substantially by patient subgroups and among providers.


Asunto(s)
Puente de Arteria Coronaria/estadística & datos numéricos , Reestenosis Coronaria/cirugía , Intervención Coronaria Percutánea/estadística & datos numéricos , Factores de Edad , Anciano , Anciano de 80 o más Años , Comorbilidad , Reestenosis Coronaria/terapia , Bases de Datos Factuales/estadística & datos numéricos , Femenino , Humanos , Incidencia , Enfermedades Renales/epidemiología , Enfermedades Renales/terapia , Masculino , Medicaid/estadística & datos numéricos , Medicare/estadística & datos numéricos , Obesidad/epidemiología , Complicaciones Posoperatorias/mortalidad , Modelos de Riesgos Proporcionales , Diálisis Renal/estadística & datos numéricos , Reoperación/estadística & datos numéricos , Estudios Retrospectivos , Factores de Riesgo , Fumar/epidemiología , Sociedades Médicas , Tasa de Supervivencia , Cirugía Torácica , Estados Unidos/epidemiología
14.
Circulation ; 127(3): 356-64, 2013 Jan 22.
Artículo en Inglés | MEDLINE | ID: mdl-23239840

RESUMEN

BACKGROUND: Although echocardiography is commonly performed before coronary artery bypass surgery, there has yet to be a study examining the incremental prognostic value of a complete echocardiogram. METHODS AND RESULTS: Patients undergoing isolated coronary artery bypass surgery at 2 hospitals were divided into derivation and validation cohorts. A panel of quantitative echocardiographic parameters was measured. Clinical variables were extracted from the Society of Thoracic Surgeons database. The primary outcome was in-hospital mortality or major morbidity, and the secondary outcome was long-term all-cause mortality. The derivation cohort consisted of 667 patients with a mean age of 67.2±11.1 years and 22.8% females. The following echocardiographic parameters were found to be optimal predictors of mortality or major morbidity: severe diastolic dysfunction, as evidenced by restrictive filling (odds ratio, 2.96; 95% confidence interval, 1.59-5.49), right ventricular dysfunction, as evidenced by fractional area change <35% (odds ratio, 3.03; 95% confidence interval, 1.28-7.20), or myocardial performance index >0.40 (odds ratio, 1.89; 95% confidence interval, 1.13-3.15). These results were confirmed in the validation cohort of 187 patients. When added to the Society of Thoracic Surgeons risk score, the echocardiographic parameters resulted in a net improvement in model discrimination and reclassification with a change in c-statistic from 0.68 to 0.73 and an integrated discrimination improvement of 5.9% (95% confidence interval, 2.8%-8.9%). In the Cox proportional hazards model, right ventricular dysfunction and pulmonary hypertension were independently predictive of mortality over 3.2 years of follow-up. CONCLUSIONS: Preoperative echocardiography, in particular right ventricular dysfunction and restrictive left ventricular filling, provides incremental prognostic value in identifying patients at higher risk of mortality or major morbidity after coronary artery bypass surgery.


Asunto(s)
Puente de Arteria Coronaria , Enfermedad de la Arteria Coronaria/epidemiología , Enfermedad de la Arteria Coronaria/mortalidad , Ecocardiografía , Cuidados Preoperatorios , Anciano , Anciano de 80 o más Años , Canadá , Estudios de Cohortes , Enfermedad de la Arteria Coronaria/diagnóstico por imagen , Femenino , Estudios de Seguimiento , Humanos , Hipertensión Pulmonar/diagnóstico por imagen , Masculino , Persona de Mediana Edad , Morbilidad , Valor Predictivo de las Pruebas , Pronóstico , Estudios Retrospectivos , Factores de Riesgo , Tasa de Supervivencia , Estados Unidos , Disfunción Ventricular Derecha/diagnóstico por imagen
15.
Med Care ; 52(1): 38-46, 2014 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-24322988

RESUMEN

BACKGROUND: 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. OBJECTIVE: To determine the association between risk-standardized mortality and teaching intensity for 3 common conditions. RESEARCH DESIGN: 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. SUBJECTS: 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). OUTCOME MEASURE: The 30-day risk-standardized mortality rates for each condition, stratified by teaching intensity. RESULTS: 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. CONCLUSIONS: 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.


Asunto(s)
Insuficiencia Cardíaca/mortalidad , Hospitales de Enseñanza/estadística & datos numéricos , Infarto del Miocardio/mortalidad , Neumonía/mortalidad , Anciano , Anciano de 80 o más Años , Femenino , Mortalidad Hospitalaria , Humanos , Internado y Residencia/estadística & datos numéricos , Masculino , Medicare/estadística & datos numéricos , Transferencia de Pacientes/estadística & datos numéricos , Estados Unidos/epidemiología
16.
Catheter Cardiovasc Interv ; 94(1): 3-26, 2019 Jul 01.
Artículo en Inglés | MEDLINE | ID: mdl-31002751
17.
Catheter Cardiovasc Interv ; 93(3): E153-E184, 2019 02 15.
Artículo en Inglés | MEDLINE | ID: mdl-30265423
18.
Ann Thorac Surg ; 118(4): 834-842, 2024 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-38950724

RESUMEN

BACKGROUND: The Society of Thoracic Surgeons General Thoracic Surgery Database (STS-GTSD) previously reported short-term risk models for esophagectomy for esophageal cancer. We sought to update existing models using more inclusive contemporary cohorts, with consideration of additional risk factors based on clinical evidence. METHODS: The study population consisted of adult patients in the STS-GTSD who underwent esophagectomy for esophageal cancer between January 2015 and December 2022. Separate esophagectomy risk models were derived for 3 primary end points: operative mortality, major morbidity, and composite morbidity or mortality. Logistic regression with backward selection was used, with predictors retained in models if P < .10. All derived models were validated using 9-fold cross-validation. Model discrimination and calibration were assessed for the overall cohort and specified subgroups. RESULTS: A total of 18,503 patients from 254 centers underwent esophagectomy for esophageal cancer. Operative mortality, morbidity, and composite morbidity or mortality rates were 3.4%, 30.5%, and 30.9%, respectively. Novel predictors of short-term outcomes in the updated models included body surface area and insurance payor type. Overall discrimination was similar or superior to previous STS-GTSD models for operative mortality (C statistic = 0.72) and for composite morbidity or mortality (C statistic = 0.62), Model discrimination was comparable across procedure- and demographic-specific subcohorts. Model calibration was excellent in all patient subgroups. CONCLUSIONS: The newly derived esophagectomy risk models showed similar or superior performance compared with previous models, with broader applicability and clinical face validity. These models provide robust preoperative risk estimation and can be used for shared decision making, assessment of provider performance, and quality improvement.


Asunto(s)
Neoplasias Esofágicas , Esofagectomía , Sociedades Médicas , Cirugía Torácica , Humanos , Neoplasias Esofágicas/cirugía , Neoplasias Esofágicas/mortalidad , Masculino , Femenino , Medición de Riesgo/métodos , Persona de Mediana Edad , Anciano , Calibración , Estados Unidos/epidemiología , Estudios Retrospectivos , Factores de Riesgo , Factores de Tiempo , Bases de Datos Factuales , Complicaciones Posoperatorias/epidemiología
19.
Ann Thorac Surg ; 118(2): 478-483, 2024 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-38401767

RESUMEN

BACKGROUND: Mortality after congenital heart surgery is an important metric across benchmarking, quality, and reporting initiatives. All rely on estimates from prior years, and how well these reflect current outcomes is unclear. METHODS: Index operations from The Society of Thoracic Surgeons Congenital Database (2014-2019) were included. Adjusted operative mortality in "past" 4-year and 1-year intervals vs the most recent year ("present") was evaluated using Bayesian hierarchical logistic regression with results presented as odds ratios and 95% credible intervals (CrI). RESULTS: Among 115,699 operations (106 hospitals), overall present observed mortality was 2.5%. Regression to the mean was evident, and individual hospital's present vs past adjusted mortality were only weakly correlated (-0.11 vs past 1-year data, 0.22 vs past 4-year data). A significant relationship was found between past and present mortality only for the group of hospitals in the highest mortality quartile, most prominent for past 4-year data (adjusted odds ratio vs lowest mortality quartile, 2.04; 95% CrI, 1.44-2.80). The proportion of present hospital mortality variation explained by past mortality quartile was 52% (95% CrI, 20%-90%) using past 4-year data and only 27% (95% CrI, 92%-83%) using past 1-year data. Overall 66% of hospitals changed mortality quartiles from past to present (30% by ≥2 quartiles). CONCLUSIONS: Past mortality relates to present primarily for groups of hospitals at the extremes, with past 4-year data more informative than past 1-year data. For individual hospitals, past may differ from present, regression to the mean is common, and many change quartiles. Past mortality should be used thoughtfully and not as the sole factor informing present decision making.


Asunto(s)
Procedimientos Quirúrgicos Cardíacos , Bases de Datos Factuales , Cardiopatías Congénitas , Mortalidad Hospitalaria , Sociedades Médicas , Humanos , Cardiopatías Congénitas/cirugía , Cardiopatías Congénitas/mortalidad , Mortalidad Hospitalaria/tendencias , Procedimientos Quirúrgicos Cardíacos/mortalidad , Femenino , Masculino , Lactante , Cirugía Torácica , Estados Unidos/epidemiología , Recién Nacido , Estudios Retrospectivos , Preescolar
20.
Ann Thorac Surg ; 2024 Aug 26.
Artículo en Inglés | MEDLINE | ID: mdl-39197635

RESUMEN

BACKGROUND: The Society of Thoracic Surgeons General Thoracic Surgery Database (STS GTSD) has been used to develop risk models for patients undergoing pulmonary resection for cancer. Leveraging a contemporary and more inclusive cohort, we sought to refine these models. METHODS: The study population consisted of adult patients in the STS GTSD who underwent pulmonary resection for cancer between 2015 and 2022. Unlike previous models, non-elective operations were included. Separate risk models were derived for operative mortality, major morbidity, and composite morbidity or mortality. Logistic regression with backward selection was used with predictors retained in models if p<0.10. All derived models were validated using 9-fold cross validation. Model discrimination and calibration were assessed for the overall cohort and for surgical procedure, demographic, and risk factor subgroups. RESULTS: Data from 140,927 patients at 337 participating centers were included in the study. Overall operative mortality rate was 1.1%, major morbidity 7.3%, and composite morbidity or mortality 7.6%. Novel predictors of short-term outcomes included interstitial lung disease, DLCO, and payor status. Overall discrimination was superior to previous STS pulmonary resection models for operative mortality [C-statistic = 0.80] and for composite morbidity or mortality [C-statistic = 0.70]. Model discrimination was comparable and model calibration was excellent across all procedure- and demographic-specific sub-cohorts. CONCLUSIONS: Among STS GTSD participants, major morbidity and operative mortality rates remain low following pulmonary resection. The newly derived pulmonary resection risk models demonstrate superior performance compared to previous models, with broader real-life applicability and clinical face validity.

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