RESUMO
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.).
Assuntos
Atenção à Saúde , Hospitalização , Erros Médicos , Dano ao Paciente , Segurança do Paciente , Humanos , Atenção à Saúde/normas , Atenção à Saúde/estatística & dados numéricos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/epidemiologia , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/prevenção & controle , Hospitalização/estatística & dados numéricos , Pacientes Internados , Erros Médicos/prevenção & controle , Erros Médicos/estatística & dados numéricos , Segurança do Paciente/normas , Estudos Retrospectivos , Dano ao Paciente/prevenção & controle , Dano ao Paciente/estatística & dados numéricosRESUMO
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.
Assuntos
Assistência Ambulatorial , Registros Eletrônicos de Saúde , Segurança do Paciente , Humanos , Feminino , Pessoa de Meia-Idade , Masculino , Estudos Retrospectivos , Adulto , Idoso , Massachusetts , Adolescente , Adulto JovemRESUMO
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.
Assuntos
Estenose da Valva Aórtica/epidemiologia , Estenose da Valva Aórtica/cirurgia , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/etiologia , Gerenciamento Clínico , Feminino , Pesquisas sobre Atenção à Saúde , Humanos , Masculino , Medidas de Resultados Relatados pelo Paciente , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Prognóstico , Sistema de Registros , Reprodutibilidade dos Testes , Índice de Gravidade de Doença , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/métodos , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
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.
Assuntos
Procedimentos Cirúrgicos Cardíacos , Bases de Dados Factuais , Cardiopatias Congênitas/mortalidade , Cardiopatias Congênitas/cirurgia , Mortalidade Hospitalar , Criança , Pré-Escolar , Feminino , Humanos , Lactente , Masculino , Estados Unidos/epidemiologiaRESUMO
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.
Assuntos
Estenose das Carótidas/cirurgia , Ponte de Artéria Coronária/efeitos adversos , Doença da Artéria Coronariana/cirurgia , Endarterectomia das Carótidas/efeitos adversos , Ataque Isquêmico Transitório/epidemiologia , Acidente Vascular Cerebral/epidemiologia , Idoso , Ponte Cardiopulmonar/efeitos adversos , Estenose das Carótidas/diagnóstico por imagem , Estenose das Carótidas/mortalidade , Ponte de Artéria Coronária/mortalidade , Ponte de Artéria Coronária sem Circulação Extracorpórea/efeitos adversos , Doença da Artéria Coronariana/diagnóstico por imagem , Doença da Artéria Coronariana/mortalidade , Bases de Dados Factuais , Endarterectomia das Carótidas/mortalidade , Feminino , Humanos , Incidência , Ataque Isquêmico Transitório/diagnóstico , Ataque Isquêmico Transitório/mortalidade , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Medição de Risco , Fatores de Risco , Acidente Vascular Cerebral/diagnóstico , Acidente Vascular Cerebral/mortalidade , Fatores de Tempo , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
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.
Assuntos
População Negra/estatística & dados numéricos , Ponte de Artéria Coronária/estatística & dados numéricos , Disparidades em Assistência à Saúde/estatística & dados numéricos , População Branca/estatística & dados numéricos , Comorbidade , Ponte de Artéria Coronária/mortalidade , Bases de Dados Factuais , Acessibilidade aos Serviços de Saúde/estatística & dados numéricos , Mortalidade Hospitalar , Hospitais/normas , Hospitais/estatística & dados numéricos , Humanos , Médicos/estatística & dados numéricos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etnologia , Qualidade da Assistência à Saúde , Risco , Fatores Socioeconômicos , Resultado do Tratamento , Estados Unidos/epidemiologiaRESUMO
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.
Assuntos
Marcha , Limitação da Mobilidade , Complicações Pós-Operatórias/epidemiologia , Substituição da Valva Aórtica Transcateter/mortalidade , Injúria Renal Aguda/epidemiologia , Idoso , Idoso de 80 Anos ou mais , Feminino , Idoso Fragilizado/estatística & dados numéricos , Mortalidade Hospitalar , Humanos , Masculino , Complicações Pós-Operatórias/mortalidade , Hemorragia Pós-Operatória/epidemiologia , Prognóstico , Estudos Prospectivos , Sistema de Registros/estatística & dados numéricos , Acidente Vascular Cerebral/epidemiologiaRESUMO
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.
Assuntos
Ponte de Artéria Coronária/estatística & dados numéricos , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/cirurgia , Readmissão do Paciente/estatística & dados numéricos , Sistema de Registros/estatística & dados numéricos , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Feminino , Humanos , Classificação Internacional de Doenças , Modelos Logísticos , Masculino , Medicaid/estatística & dados numéricos , Medicare/estatística & dados numéricos , Valor Preditivo dos Testes , Risco Ajustado/estatística & dados numéricos , Fatores de Risco , Estados Unidos/epidemiologiaRESUMO
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 (â¼1000 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.
Assuntos
Acesso à Informação , Mortalidade Hospitalar/tendências , Disseminação de Informação , Garantia da Qualidade dos Cuidados de Saúde , Cirurgia Torácica/organização & administração , Adulto , Idoso , Ponte de Artéria Coronária/métodos , Ponte de Artéria Coronária/mortalidade , Ponte de Artéria Coronária/estatística & dados numéricos , Bases de Dados Factuais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Medição de Risco , Sociedades Médicas , Análise de Sobrevida , Fatores de Tempo , Resultado do Tratamento , Estados UnidosRESUMO
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.).
Assuntos
Angioplastia Coronária com Balão , Ponte de Artéria Coronária , Doença das Coronárias/terapia , Idoso , Pesquisa Comparativa da Efetividade , Fatores de Confusão Epidemiológicos , Doença das Coronárias/mortalidade , Doença das Coronárias/cirurgia , Bases de Dados Factuais , Feminino , Seguimentos , Humanos , Masculino , Observação , Modelos de Riscos Proporcionais , Análise de Sobrevida , Estados UnidosRESUMO
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.
Assuntos
Acidente Vascular Cerebral/etiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/cirurgia , Feminino , Seguimentos , Insuficiência Cardíaca/epidemiologia , Insuficiência Cardíaca/etiologia , Doenças das Valvas Cardíacas/cirurgia , Humanos , Incidência , Masculino , Avaliação de Resultados em Cuidados de Saúde , Readmissão do Paciente/estatística & dados numéricos , Vigilância de Produtos Comercializados , Sistema de Registros , Fatores de Risco , Acidente Vascular Cerebral/epidemiologia , Substituição da Valva Aórtica Transcateter/mortalidadeRESUMO
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.
Assuntos
Ponte de Artéria Coronária/estatística & dados numéricos , Reestenose Coronária/cirurgia , Intervenção Coronária Percutânea/estatística & dados numéricos , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Comorbidade , Reestenose Coronária/terapia , Bases de Dados Factuais/estatística & dados numéricos , Feminino , Humanos , Incidência , Nefropatias/epidemiologia , Nefropatias/terapia , Masculino , Medicaid/estatística & dados numéricos , Medicare/estatística & dados numéricos , Obesidade/epidemiologia , Complicações Pós-Operatórias/mortalidade , Modelos de Riscos Proporcionais , Diálise Renal/estatística & dados numéricos , Reoperação/estatística & dados numéricos , Estudos Retrospectivos , Fatores de Risco , Fumar/epidemiologia , Sociedades Médicas , Taxa de Sobrevida , Cirurgia Torácica , Estados Unidos/epidemiologiaRESUMO
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.
Assuntos
Ponte de Artéria Coronária , Doença da Artéria Coronariana/epidemiologia , Doença da Artéria Coronariana/mortalidade , Ecocardiografia , Cuidados Pré-Operatórios , Idoso , Idoso de 80 Anos ou mais , Canadá , Estudos de Coortes , Doença da Artéria Coronariana/diagnóstico por imagem , Feminino , Seguimentos , Humanos , Hipertensão Pulmonar/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Morbidade , Valor Preditivo dos Testes , Prognóstico , Estudos Retrospectivos , Fatores de Risco , Taxa de Sobrevida , Estados Unidos , Disfunção Ventricular Direita/diagnóstico por imagemRESUMO
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.
Assuntos
Insuficiência Cardíaca/mortalidade , Hospitais de Ensino/estatística & dados numéricos , Infarto do Miocárdio/mortalidade , Pneumonia/mortalidade , Idoso , Idoso de 80 Anos ou mais , Feminino , Mortalidade Hospitalar , Humanos , Internato e Residência/estatística & dados numéricos , Masculino , Medicare/estatística & dados numéricos , Transferência de Pacientes/estatística & dados numéricos , Estados Unidos/epidemiologiaAssuntos
Cateterismo Cardíaco/normas , Cardiologia/normas , Prestação Integrada de Cuidados de Saúde/normas , Doenças das Valvas Cardíacas/cirurgia , Implante de Prótese de Valva Cardíaca/normas , Valvas Cardíacas/cirurgia , Equipe de Assistência ao Paciente/normas , Cateterismo Cardíaco/efeitos adversos , Cateterismo Cardíaco/instrumentação , Consenso , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/fisiopatologia , Implante de Prótese de Valva Cardíaca/efeitos adversos , Implante de Prótese de Valva Cardíaca/instrumentação , Valvas Cardíacas/diagnóstico por imagem , Valvas Cardíacas/fisiopatologia , Humanos , Melhoria de Qualidade/normas , Indicadores de Qualidade em Assistência à Saúde/normas , Resultado do TratamentoAssuntos
Valva Aórtica/cirurgia , Medicina Baseada em Evidências/normas , Doenças das Valvas Cardíacas/cirurgia , Próteses Valvulares Cardíacas/normas , Padrões de Prática Médica/normas , Substituição da Valva Aórtica Transcateter/normas , Valva Aórtica/diagnóstico por imagem , Valva Aórtica/fisiopatologia , Técnicas de Imagem Cardíaca/normas , Competência Clínica/normas , Tomada de Decisão Clínica , Consenso , Credenciamento/normas , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/fisiopatologia , Hemodinâmica , Humanos , Curva de Aprendizado , Seleção de Pacientes , Valor Preditivo dos Testes , Desenho de Prótese/normas , Fatores de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Resultado do Tratamento , Carga de Trabalho/normasRESUMO
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.
Assuntos
Procedimentos Cirúrgicos Cardíacos , Bases de Dados Factuais , Cardiopatias Congênitas , Mortalidade Hospitalar , Sociedades Médicas , Humanos , Cardiopatias Congênitas/cirurgia , Cardiopatias Congênitas/mortalidade , Mortalidade Hospitalar/tendências , Procedimentos Cirúrgicos Cardíacos/mortalidade , Feminino , Masculino , Lactente , Cirurgia Torácica , Estados Unidos/epidemiologia , Recém-Nascido , Estudos Retrospectivos , Pré-EscolarRESUMO
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.
RESUMO
BACKGROUND: Atrial fibrillation (AF) occurs commonly following cardiac surgery and is associated with multiple adverse outcomes. Older randomized trials suggested that perioperative beta blockade reduced postoperative AF, and the Society of Thoracic Surgeons (STS) CABG composite measure includes beta blocker administration preoperatively within 24 hours of surgery and at discharge. However, some more recent studies suggest preoperative beta blockade has limited value and question its continuation as an STS quality measure. METHODS: In 2022, an STS Preoperative Beta Blocker Working Group was formed with representatives from the STS and the Society of Cardiovascular Anesthesiologists. Published randomized trials, observational studies, societal guidelines, and the current state of available data from the STS Adult Cardiac Surgery Database (ACSD) were reviewed. RESULTS: Review of existing studies reveals substantial heterogeneity or insufficient detail regarding specific beta blockers used; timing of initiation; management of patients on chronic beta blockade; and whether other pro- or anti-arrhythmic drugs were used concurrently. Further, beta blocker data currently collected in the STS ACSD lack sufficient granularity. CONCLUSIONS: As a new randomized trial seems unlikely, the working group believes that more granular data on real-world practice would facilitate assessment of the value of preoperative beta blockade in the current era, development of best practice recommendations, and evaluation of their continued appropriateness as an STS quality metric. STS ACSD participants have been invited to participate in a voluntary survey whose additional data, when linked to STS ACSD records, will better delineate contemporary beta blocker practice and outcomes.