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1.
Circ Cardiovasc Interv ; 12(11): e008231, 2019 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-31694411

RESUMO

BACKGROUND: Cerebrovascular events (CVEs) are devastating complications after aortic valve replacement. We assessed whether billing claims accurately identify CVEs in place of clinical event adjudication in structural heart disease trials. METHODS: Adult participants in the US CoreValve High Risk and SURTAVI trials (Surgical or Transcatheter Aortic-Valve Replacement in Intermediate-Risk Patients) were linked to Medicare inpatient claims from January 1, 2006 to December 31, 2016. Claims consistent with CVEs within 14 days of a similar trial-adjudicated CVE were considered a match. The sensitivity, specificity, and positive and negative predictive values of International Classification of Diseases, Ninth and Tenth Revisions, Clinical Modification billing codes for cerebrovascular disease were determined against trial-defined CVEs as the criterion standard. Kaplan-Meier estimates of claims-defined versus trial-defined CVEs were compared. RESULTS: Among 4230 linked trial participants (linkage rate 79.8%), 550 (13.0%) sustained 630 adjudicated CVEs over a 5-year follow-up period. Linked and nonlinked individuals were similar. An algorithm using 4 International Classification of Diseases, Ninth Revision, Clinical Modification codes (434.91, 434.11, 433.11, and 997.02) had a sensitivity of 60.9%, specificity of 99.0%, positive predictive value of 86.5%, and negative predictive value of 95.8% for identifying a trial-adjudicated ischemic stroke. An algorithm using 3 International Classification of Diseases, Tenth Revision, Clinical Modification codes (I63.9, I63.40, I63.49) had a sensitivity of 66.7%, specificity of 99.4%, positive predictive value of 88.9%, and negative predictive value of 97.6%. CONCLUSIONS: In linked clinical trial and Medicare claims data, 4 International Classification of Diseases, Ninth Revision, Clinical Modification and 3 International Classification of Diseases, Tenth Revision, Clinical Modification billing codes identified half of trial-adjudicated CVEs during follow-up with high specificity and predictive value, but imperfect sensitivity. Although low sensitivity may limit the use of claims to substitute for traditional trial outcomes to identify CVEs, high specificity suggests claims could be used to trigger evaluation of neurological events, potentially improving the efficiency of the evaluation of techniques and devices designed to reduce such events.

2.
Am Heart J ; 218: 110-122, 2019 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-31726314

RESUMO

BACKGROUND: Medicare insurance claims may provide an efficient means to ascertain follow-up of older participants in clinical research. We sought to determine the accuracy and completeness of claims- versus site-based follow-up with clinical event committee (+CEC) adjudication of cardiovascular outcomes. METHODS: We performed a retrospective study using linked Medicare and Duke Database of Clinical Trials data. Medicare claims were linked to clinical data from 7 randomized cardiovascular clinical trials. Of 52,476 trial participants, linking resulted in 5,839 (of 10,497 linkage-eligible) Medicare-linked trial participants with fee-for-service A and B coverage. Death, myocardial infarction (MI), stroke, and revascularization incidences were compared using Medicare inpatient claims only, site-reported events (+CEC) only, or a combination of the 2. Randomized treatment effects were compared as a function of whether claims-based, site-based (+CEC), or a combined system was used for event detection. RESULTS: Among the 5,839 study participants, the annual event rates were similar between claims- and site-based (+CEC) follow-up: death (overall rate 5.2% vs 5.2%; adjusted κ 0.99), MI (2.2% vs 2.3%; adjusted κ 0.96), stroke (0.7% vs 0.7%; adjusted κ 0.99), and any revascularization (7.4% vs 7.9%; adjusted κ 0.95). Of events detected by claims yet not reported by CEC, a minority were reported by sites but negatively adjudicated by CEC (39% of MIs and 18% of strokes). Differences in individual case concordance led to higher event rates when claims- and site-based (+CEC) systems were combined. Randomized treatment effects were similar among the 3 approaches for each outcome of interest. CONCLUSIONS: Claims- versus site-based (+CEC) follow-up identified similar overall cardiovascular event rates despite meaningful differences in the events detected. Randomized treatment effects were similar using the 2 methods, suggesting claims data could be used to support clinical research leveraging routinely collected data. This approach may lead to more effective evidence generation, synthesis, and appraisal of medical products and inform the strategic approaches toward the National Evaluation System for Health Technology.

3.
Ann Thorac Surg ; 2019 Sep 25.
Artigo em Inglês | MEDLINE | ID: mdl-31562839

RESUMO

BACKGROUND: Patients undergoing postinfarction ventricular septal defect (VSD) repair are at high risk for early morbidity and mortality, but little is known about subsequent clinical events. This study uses short-term clinical data from the Society of Thoracic Surgeons (STS) National Database linked with Medicare data to examine longer-term outcomes in these patients. METHODS: This was a retrospective review of the STS National Database to link with Medicare data all adults (≥65 years) who underwent VSD repair following a myocardial infarction between 2008-2012. The primary outcome was 1-year mortality. Risk factors for 1-year survival were modeled using a multivariable Cox regression. RESULTS: A total of 537 patients were identified using the STS database and medicare linkage. Median age was 74 years, and 277(52%) were men. 192(36%) were supported preoperatively with an intra-aortic balloon pump. Surgical status was emergent or salvage in 138(26%). 158(29%) died within 30-days and 207 (39%) patients died within 1-year. Among patients who survived to hospital discharge, 44% were discharged to a facility, and 172(32%) experienced at least one all-cause re-admission within 1-year. Unadjusted 1-year mortality rates were 13% for elective patients and 69% for emergency status (p<0.01). On multivariable analysis, emergency/salvage status, older age, and concomitant CABG were independently associated with worse 1-year survival. CONCLUSIONS: These data suggest the greatest mortality risk in this patient population occurs in the first 30-days. Emergency or salvage status strongly predicts 1-year mortality. Optimizing physiologic derangements prior to operative repair may be considered when possible in this subgroup of patients.

4.
Circ Cardiovasc Interv ; 12(5): e007451, 2019 May.
Artigo em Inglês | MEDLINE | ID: mdl-31084236

RESUMO

BACKGROUND: Clinical event committees are commonly employed for event validation in clinical studies, but little is known about the comparative performance of administrative claims data versus clinician-triggered event adjudication for ascertainment of adverse events in structural heart disease studies. METHODS AND RESULTS: Medicare claims were linked to 418 patients >65 years of age who underwent transcatheter mitral valve repair (MitraClip) for severe mitral regurgitation from 2007 to 2013 as part of the EVEREST II (Endovascular Valve Edge-to-Edge Repair Study II) High-Risk Registry or the REALISM (Real World Expanded Multicenter Study of the MitraClip System) Continued-Access Registry. Each registry adjudicated mortality, heart failure hospitalization, renal failure, ventilation, and bleeding/transfusion within 1 year. Concordance of claims-based outcomes with events was assessed in 3 ways: 1-year occurrence, cumulative incidence, and synchrony of first events. For event occurrence, positive predictive value (PPV) of claims versus adjudication was the highest for mortality (PPV=97%) and heart failure hospitalization (PPV=69%) but lower for bleeding (PPV=40%) and renal failure (PPV=19%). Whereas claims-based cumulative incidence for mortality, heart failure hospitalization, and renal failure were consistent with clinician-triggered adjudication, incidence curves for bleeding events and ventilation diverged, with claims identifying a greater number of events. When events were detected by both methods, however, over 75% of event dates matched exactly. Mitral valve reinterventions were identified through claims with perfect sensitivity and specificity relative to physician adjudication. CONCLUSIONS: Ascertainment of mortality, heart failure hospitalization, and renal failure was highly concordant between physician adjudication and administrative claims. Further work is necessary to determine the role of administrative claims in event ascertainment in both prospective and retrospective studies of structural heart disease.

6.
Am Heart J ; 212: 64-71, 2019 06.
Artigo em Inglês | MEDLINE | ID: mdl-30953936

RESUMO

BACKGROUND: Randomized controlled trials are the "gold standard" for comparing the safety and efficacy of therapies but may be limited due to high costs, lack of feasibility, and difficulty enrolling "real-world" patient populations. The Extending Trial-Based Evaluations of Medical Therapies Using Novel Sources of Data (EXTEND) Study seeks to evaluate whether data collected within procedural registries and claims databases can reproduce trial results by substituting surrogate non-trial-based variables for exposures and outcomes. METHODS AND RESULTS: Patient-level data from 2 clinical trial programs-the Dual Antiplatelet Therapy Study and the United States CoreValve Studies-will be linked to a combination of national registry, administrative claims, and health system data. The concordance between baseline and outcomes data collected within nontrial data sets and trial information, including adjudicated end point events, will be assessed. We will compare the study results obtained using these alternative data sources to those derived using trial-ascertained variables and end points using trial-adjudicated end points and covariates. CONCLUSIONS: Linkage of trials to registries and claims data represents an opportunity to use alternative data sources in place of and as adjuncts to randomized clinical trial data but requires further validation. The results of this research will help determine how these data sources can be used to improve our present and future understanding of new medical treatments.


Assuntos
/métodos , Registros Eletrônicos de Saúde/provisão & distribução , Isquemia Miocárdica/terapia , Revascularização Miocárdica/métodos , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Sistema de Registros , Idoso de 80 Anos ou mais , Bases de Dados Factuais , Feminino , Humanos , Masculino , Reprodutibilidade dos Testes
7.
Ann Thorac Surg ; 107(4): 1097-1103, 2019 04.
Artigo em Inglês | MEDLINE | ID: mdl-30529671

RESUMO

BACKGROUND: Stroke is a serious complication after transcatheter aortic valve replacement (TAVR), yet predictive models are not available. A new risk model for in-hospital stroke after TAVR was developed and used to estimate site-specific performance. METHODS: We included 97,600 TAVR procedures from 521 sites in The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry from July 2014 to June 2017. Association between baseline covariates and in-hospital stroke was estimated by logistic regression. Discrimination was evaluated by C-statistic. Calibration was tested internally via cross-validation. Hierarchical modeling was used to estimate risk-adjusted site-specific performance. RESULTS: Median age was 82 years, 44,926 (46.0%) were women, and 1,839 (1.9%) had in-hospital stroke. Covariates associated with stroke (odds ratio) included transapical access (1.44), access excluding transapical and transfemoral (1.77), prior stroke (1.57), prior transient ischemic attack (1.50), preprocedural shock, inotropes or mechanical assist device (1.48), smoking (1.28), porcelain aorta (1.23), peripheral arterial disease (1.21), age per 5 years (1.11), glomerular filtration rate per 5 mL/min (0.97), body surface area per m2 (0.55 male; 0.43 female), and prior aortic valve (0.78) and nonaortic valvular (0.42) procedures. The C-statistic was 0.622. Calibration curves demonstrated agreement between observed and expected stroke rates. Hierarchical modeling showed 10 (1.9%) centers with significantly higher odds ratios for in-hospital stroke than their peers. CONCLUSIONS: A risk model for in-hospital stroke after TAVR was developed from The Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry and used to estimate site-specific stroke performance. This model can serve as a valuable resource for quality improvement, clinical decision making, and patient counseling.


Assuntos
Estenose da Valva Aórtica/cirurgia , Mortalidade Hospitalar , Sistema de Registros , Acidente Vascular Cerebral/epidemiologia , Substituição da Valva Aórtica Transcateter/efeitos adversos , Idoso , Idoso de 80 Anos ou mais , Estenose da Valva Aórtica/diagnóstico por imagem , Feminino , Humanos , Masculino , Valor Preditivo dos Testes , Prevalência , Reprodutibilidade dos Testes , Medição de Risco , Gestão de Riscos , Sociedades Médicas , Acidente Vascular Cerebral/etiologia , Cirurgia Torácica , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/mortalidade , Estados Unidos
8.
Artigo em Inglês | MEDLINE | ID: mdl-31952824

RESUMO

BACKGROUND: This study compares outcomes of patients with preoperative atrial fibrillation undergoing coronary artery bypass grafting (CABG) with or without concomitant atrial fibrillation ablation in a nationally representative Medicare cohort. OBJECTIVES: This study examined early and late outcomes in CABG patients with a preoperative history of atrial fibrillation to determine the correlation between surgical atrial fibrillation ablation to mortality and stroke or systemic embolization. METHODS: In the Medicare-linked Society of Thoracic Surgeons database, 361,138 patients underwent isolated CABG from 2006 to 2013; 34,600 (9.6%) had preoperative atrial fibrillation; 10,541 (30.5%) were treated with surgical ablation (ablation group), and 23,059 were not (no ablation group). Propensity score matching was performed using a hierarchical mixed model. Long-term survival was summarized using Kaplan-Meier curves and Cox regression models with robust variance estimation. The stroke or systemic embolization incidence was modeled using the Fine-Gray model. Median follow-up was 4 years. RESULTS: Long-term mortality in propensity score-matched CABG patients (mean age 74 years; Society of Thoracic Surgeons risk score, 2.25) receiving ablation versus no ablation was similar (log-rank P = .30). Stroke or systemic embolization occurred in 2.2% versus 2.1% at 30 days and 9.9% versus 12.0% at 5 years (Gray P = .0091). Landmark analysis from 2 to 5 years showed lower mortality (hazard ratio, 0.89; 95% confidence interval 0.82-0.97; P = .0358) and lower risk of stroke or systemic embolization (hazard ratio, 0.73; 95% confidence interval, 0.61-0.87; P = .0006) in the ablation group. CONCLUSIONS: Concomitant ablation in CABG patients with preoperative atrial fibrillation is associated with lower stroke or systemic embolization and mortality in patients who survive more than 2 years.

9.
J Am Heart Assoc ; 7(23): e010139, 2018 12 04.
Artigo em Inglês | MEDLINE | ID: mdl-30571598

RESUMO

Background In older adults undergoing cardiac surgery, prediction of downstream risk is critical. Our objective was to determine the association of 5-m gait speed with 1-year mortality and repeat hospitalization following cardiac surgery. Methods and Results In this prospective cohort of patients undergoing cardiac surgery at centers participating in the Society of Thoracic Surgeons Database with gait speed recorded, we examined all-cause mortality using a landmark analysis at 0 to 30, 30 to 365, and >365 days, as well as repeat hospitalization. The cohort consisted of 8287 patients (median age, 74 years; 32% females). At 1 year, survival was 90% in the slow (<0.83 m/s), 95% in the middle (0.83-1.00 m/s), and 97% in the fast (>1.00 m/s) gait speed tertiles, and risk of hospitalization was 45%, 33%, and 27%, respectively (both P<0.0001). After adjustment, gait speed remained predictive of mortality (hazard ratio, 2.16 per 0.1-m/s decrease in gait speed; 95% confidence interval, 1.59-2.93) and rehospitalization (hazard ratio, 1.71 per 0.1-m/s decrease in gait speed; 95% confidence interval, 1.45-2.0). In a landmark analysis, the effect of slow gait speed on mortality was most marked from 30 to 365 days after surgery, where each decline in 0.1 m/s of gait speed conferred a 2-fold increased risk of mortality. Conclusions Gait speed is a simple tool to screen for frailty and identify older adults at risk for adverse events in the early and midterm postoperative periods.


Assuntos
Procedimentos Cirúrgicos Cardíacos/mortalidade , Velocidade de Caminhada , Idoso , Idoso de 80 Anos ou mais , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Bases de Dados como Assunto , Feminino , Fragilidade/diagnóstico , Humanos , Estimativa de Kaplan-Meier , Masculino , Readmissão do Paciente/estatística & dados numéricos , Modelos de Riscos Proporcionais , Fatores de Risco , Sociedades Médicas , Análise de Sobrevida , Estados Unidos
10.
Circ Cardiovasc Qual Outcomes ; 11(10): e004693, 2018 10.
Artigo em Inglês | MEDLINE | ID: mdl-30354575

RESUMO

Background Among clinical trial patients at high surgical risk, a model has been developed and externally validated to estimate patient risk for poor outcomes after transcatheter aortic valve replacement (TAVR). How this model performs in lower risk and unselected patients is not known. We sought to examine and optimize the performance of the TAVR poor outcome risk model among patients in the US Society of Thoracic Surgeons/American College of Cardiology Transcatheter Valve Therapy Registry. Methods and Results Among 13 351 patients who underwent TAVR at 252 US sites between November 9, 2011 and June 30, 2015, the rate of poor outcome at 1 year after TAVR was 38.9%, which was because of death in 20.7% and poor quality of life or quality of life decline in 18.2%. The rate of poor outcome has decreased slightly over time, from 42.0% in 2012 to 37.8% in 2015 ( P for trend=0.076). The original TAVR poor outcome risk model did not calibrate well on this population. We then reestimated the intercept and coefficients in the model and retested model performance, after which it performed well (both overall and in subgroups), with a C index 0.65 and excellent calibration. Conclusions In a large cohort of unselected patients in the United States, we found that while a substantial minority of patients continue to have a poor outcome after TAVR, outcomes have slowly improved over time. After recalibration, the TAVR poor outcome risk model performed well. This model could potentially be used before TAVR to help patients have appropriate expectations of recovery.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica/cirurgia , Qualidade de Vida , Substituição da Valva Aórtica Transcateter , Idoso , Idoso de 80 Anos ou mais , Valva Aórtica/fisiopatologia , Estenose da Valva Aórtica/diagnóstico , Estenose da Valva Aórtica/mortalidade , Estenose da Valva Aórtica/fisiopatologia , Feminino , Nível de Saúde , Humanos , Masculino , Sistema de Registros , Medição de Risco , Fatores de Risco , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Estados Unidos
11.
J Am Coll Cardiol ; 72(4): 370-382, 2018 07 24.
Artigo em Inglês | MEDLINE | ID: mdl-30025572

RESUMO

BACKGROUND: Valve-in-valve (ViV) transcatheter aortic valve replacement (TAVR) has been shown to be feasible, yet the safety and efficacy in relation to native valve (NV) TAVR are not known. OBJECTIVES: This study sought to evaluate the safety and effectiveness of ViV TAVR for failed surgical aortic valve replacement (SAVR) by comparing it with the benchmark of NV TAVR. METHODS: Patients who underwent ViV-TAVR (n = 1,150) were matched 1:2 (on sex, high or extreme risk, hostile chest or porcelain aorta, 5-m-walk time, and Society of Thoracic Surgeons Predicted Risk of Mortality for reoperation) to patients undergoing NV-TAVR (n = 2,259). Baseline characteristics, procedural data, and in-hospital outcomes were obtained from the Transcatheter Valve Therapy Registry. The 30-day and 1-year outcomes were obtained from linked Medicare administrative claims data. RESULTS: Unadjusted analysis revealed lower 30-day mortality (2.9% vs. 4.8%; p < 0.001), stroke (1.7% vs. 3.0%; p = 0.003), and heart failure hospitalizations (2.4% vs. 4.6%; p < 0.001) in the ViV-TAVR compared with NV-TAVR group. Adjusted analysis revealed lower 30-day mortality (hazard ratio: 0.503; 95% confidence interval: 0.302 to 0.839; p = 0.008), lower 1-year mortality (hazard ratio: 0.653; 95% confidence interval: 0.505 to 0.844; p = 0.001), and hospitalization for heart failure (hazard ratio: 0.685; 95% confidence interval: 0.500 to 0.939; p = 0.019) in the ViV-TAVR group. Patients in the ViV-TAVR group had higher post-TAVR mean gradient (16 vs. 9 mm Hg; p < 0.001), but less moderate or severe aortic regurgitation (3.5% vs. 6.6%; p < 0.001). Post-TAVR gradients were highest in small SAVRs and stenotic SAVRs. CONCLUSIONS: Comparison with the benchmark NV-TAVR shows ViV-TAVR to be a safe and effective procedure in patients with failed SAVR who are at high risk for repeat surgery.


Assuntos
Estenose da Valva Aórtica/cirurgia , Valva Aórtica , Bioprótese , Falha de Prótese , Substituição da Valva Aórtica Transcateter , Idoso , Valva Aórtica/patologia , Valva Aórtica/cirurgia , Bioprótese/efeitos adversos , Bioprótese/estatística & dados numéricos , Feminino , Humanos , Masculino , Mortalidade , Sistema de Registros/estatística & dados numéricos , Reoperação/métodos , Reoperação/estatística & dados numéricos , Medição de Risco , Substituição da Valva Aórtica Transcateter/efeitos adversos , Substituição da Valva Aórtica Transcateter/instrumentação , Substituição da Valva Aórtica Transcateter/métodos , Substituição da Valva Aórtica Transcateter/mortalidade , Resultado do Tratamento , Estados Unidos/epidemiologia
12.
Ann Thorac Surg ; 106(5): 1388-1393, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-29966592

RESUMO

BACKGROUND: National outcomes of robotic mitral valve repair (rMVr) compared with sternotomy (sMVr) in older patients are currently unknown. METHODS: From 2011 to 2014, all patients aged 65 years and older undergoing MVr in The Society of Thoracic Surgeons Adult Cardiac Surgery Database linked to Medicare claims data were identified. Patients who underwent rMVr were propensity matched to patients who underwent sMVr. Standard differences and falsification outcome of baseline characteristics were tested to ensure a balanced match. Cox models were used to calculate 3-year mortality, heart failure readmission, and mitral valve reintervention, adjusting for competing risks where appropriate. RESULTS: After matching, 503 rMVr patients from 65 centers and 503 sMVr from 251 centers were included. There were no significant differences in comorbidities or falsification outcome. Cardiopulmonary bypass and cross-clamp times were longer with rMVr versus sMVr at 125 versus 102 minutes (p < 0.0001) and 85 versus 75 minutes (p < 0.0001), respectively. The rMVr patients had shorter intensive care unit (27 vs 47 hours, p < 0.0001) and hospital stay (5 vs 6 days, p < 0.0001), less frequent transfusion (21% vs 35%, p < 0.0001), and less atrial fibrillation (28% vs 40%, p < 0.0001). Three-year mortality (hazard ratio, 1.21; 95% confidence interval, 0.68 to 2.16; p = 0.52), heart failure readmission (hazard ratio, 1.42; 95% confidence interval, 0.80 to 2.52, p = 0.10), and mitral valve reintervention (hazard ratio, 0.42; 95% confidence interval, 0.15 to 1.18; p = 0.22) did not differ between the groups. CONCLUSIONS: The rMVr procedure was associated with less atrial fibrillation, less frequent transfusion requirement, and shorter intensive care unit and hospital stay, without a significant difference in 3-year mortality, heart failure readmission, or mitral valve reintervention. In older patients, rMVr confers short-term advantages without a detriment to midterm outcomes.


Assuntos
Doenças das Valvas Cardíacas/cirurgia , Valva Mitral/cirurgia , Procedimentos Cirúrgicos Robóticos/métodos , Esternotomia/métodos , Idoso , Idoso de 80 Anos ou mais , Ponte Cardiopulmonar/métodos , Ponte Cardiopulmonar/mortalidade , Estudos de Coortes , Bases de Dados Factuais , Procedimentos Cirúrgicos Eletivos/efeitos adversos , Procedimentos Cirúrgicos Eletivos/métodos , Feminino , Avaliação Geriátrica , Doenças das Valvas Cardíacas/diagnóstico por imagem , Doenças das Valvas Cardíacas/mortalidade , Mortalidade Hospitalar , Humanos , Tempo de Internação , Masculino , Valva Mitral/fisiopatologia , Duração da Cirurgia , Prognóstico , Pontuação de Propensão , Estudos Retrospectivos , Medição de Risco , Procedimentos Cirúrgicos Robóticos/mortalidade , Sociedades Médicas , Esternotomia/mortalidade , Análise de Sobrevida , Cirurgia Torácica , Resultado do Tratamento
13.
Ann Thorac Surg ; 106(1): 14-22, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29630873

RESUMO

BACKGROUND: The goal of this study was to determine the relationship of prosthesis-patient mismatch (PPM) with long-term survival and to assess whether growing concern about PPM has resulted in a decreased incidence over time. METHODS: Using The Society of Thoracic Surgeons Adult Cardiac Surgery Database, we identified 59,779 patients ≥65 years old who underwent isolated surgical aortic valve replacement (AVR) between 2004 and 2014. The degree of PPM was calculated using literature-derived effective orifice areas for commonly used valves. Outcomes to 10 years were stratified by degree of PPM. RESULTS: The distribution of PPM was as follows: 35%, none (n = 21,053); 54%, moderate (n = 32,243); and 11%, severe (n = 6,483). Compared with patients with no PPM, patients with moderate or severe PPM had a significantly increased risk of readmission for heart failure (hazard ratio [HR], 1.15; 95% confidence interval [CI], 1.09 to 1.21; HR, 1.37; 95% CI, 1.26 to 1.48) and redo AVR (HR, 1.41; 95% CI, 1.13 to 1.77; HR, 2.68; 95% CI, 2.01 to 3.56) for moderate or severe PPM, respectively. Survival was significantly worse for any degree of PPM (moderate to none: HR, 1.08; 95% CI, 1.05 to 1.12; severe to none: HR, 1.32; 95% CI, 1.25 to 1.39), with 10-year adjusted survival rates of 46%, 43%, and 35% for none, moderate, and severe, respectively (p < 0.001). The incidence of severe PPM decreased by 55% over the study period, from 13.8% in 2004 to 6.2% in 2014. CONCLUSIONS: Any degree of PPM significantly decreased long-term survival and increased readmission rates for both heart failure and reoperation for AVR. Temporal trends show a significant decrease in the incidence of PPM over the past decade.


Assuntos
Valva Aórtica/cirurgia , Implante de Prótese de Valva Cardíaca , Próteses Valvulares Cardíacas/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Ajuste de Prótese , Idoso , Idoso de 80 Anos ou mais , Índice de Massa Corporal , Estudos de Coortes , Comorbidade , Feminino , Insuficiência Cardíaca/epidemiologia , Humanos , Incidência , Masculino , Pessoa de Meia-Idade , Readmissão do Paciente/estatística & dados numéricos , Complicações Pós-Operatórias/etiologia , Modelos de Riscos Proporcionais , Desenho de Prótese , Falha de Prótese , Sistema de Registros , Reoperação/estatística & dados numéricos , Volume Sistólico , Análise de Sobrevida , Resultado do Tratamento
14.
J Thorac Cardiovasc Surg ; 155(6): 2358-2367.e1, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29523404

RESUMO

BACKGROUND: This study compares early and late outcomes in patients undergoing coronary artery bypass grafting with and without preoperative atrial fibrillation in a contemporary, nationally representative Medicare cohort. METHODS: In the Medicare-Linked Society of Thoracic Surgeons database, 361,138 patients underwent isolated coronary artery bypass from 2006 to 2013, of whom 37,220 (10.3%) had preoperative atrial fibrillation; 13,161 (35.4%) were treated with surgical ablation and were excluded. Generalized estimating equations were used to compare 30-day mortality and morbidity. Long-term survival was summarized using Kaplan-Meier curves and Cox regression models. Stroke and systemic embolism incidence was modeled using the Fine-Gray model and the CHA2DS2-VASc score was used to analyze stroke risk. Median follow-up was 4 years. RESULTS: Preoperative atrial fibrillation was associated with a higher adjusted in-hospital mortality (odds ratio [OR], 1.5; P < .0001) and combined major morbidity including stroke, renal failure, prolonged ventilation, reoperation, and deep sternal wound infection (OR, 1.32; P < .0001). Patients with preoperative atrial fibrillation experienced a higher adjusted long-term risk of all-cause mortality and cumulative risk of stroke and systemic embolism compared to those without atrial fibrillation. At 5 years, the survival probability in the preoperative atrial fibrillation versus no atrial fibrillation groups stratified by CHA2DS2-VASc scores was 74.8% versus 86.3% (score 1-3), 56.5% versus 73.2% (score 4-6), and 41.2% versus 57.2% (score 7-9; all P < .001). CONCLUSIONS: Preoperative atrial fibrillation is independently associated with worse early and late postoperative outcomes. CHA2DS2-VASc stratifies risk, even in those without preoperative atrial fibrillation.


Assuntos
Fibrilação Atrial , Ponte de Artéria Coronária , Complicações Pós-Operatórias , Idoso , Idoso de 80 Anos ou mais , Fibrilação Atrial/epidemiologia , Fibrilação Atrial/etiologia , Fibrilação Atrial/mortalidade , Ponte de Artéria Coronária/efeitos adversos , Ponte de Artéria Coronária/mortalidade , Ponte de Artéria Coronária/estatística & dados numéricos , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Razão de Chances , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/mortalidade , Estudos Retrospectivos
15.
Eur J Cardiothorac Surg ; 54(4): 710-716, 2018 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-29554232

RESUMO

OBJECTIVES: Previous studies have demonstrated a 20% mortality rate among patients undergoing isolated coronary artery bypass grafting (CABG) for cardiogenic shock. However, outcomes following CABG for cardiogenic shock in patients who are neurologically unresponsive preoperatively are unknown. METHODS: Utilizing the Society of Thoracic Surgeons Adult Cardiac Surgery Database between July 2011 and December 2013, patients undergoing urgent or emergent CABG within 7 days of an acute myocardial infarction complicated by cardiogenic shock were identified. Patients were stratified on the basis of whether they had a non-medically induced unresponsive state within 24 h of surgery. RESULTS: Of the 5259 patients with acute myocardial infarction complicated by cardiogenic shock who underwent CABG during the study period, 243 (4.62%) patients had an unresponsive preoperative neurological state. The unresponsive cohort had a higher 30-day operative mortality than the responsive cohort (33.74% vs 16.91%, P < 0.001). Unresponsive neurological state was associated with increased odds for mortality (adjusted odds ratio 1.81, 95% confidence interval 1.37-2.4; P < 0.001), postoperative stroke (adjusted odds ratio 2.17, 95% confidence interval 1.27-3.73; P = 0.0048) and encephalopathy (adjusted odds ratio 2.08, 95% confidence interval 1.44-3.01; P < 0.001). Among survivors in the unresponsive cohort, 78 (46.15%) were discharged home and 62 (36.69%) were discharged to extended care facilities. CONCLUSIONS: Although cardiac surgery in unresponsive patients in the setting of acute myocardial infarction complicated by cardiogenic shock is associated with considerable neurological disability and mortality, the majority survive to discharge. These findings may help guide patient and family discussions regarding goals of care.


Assuntos
Ponte de Artéria Coronária/métodos , Infarto do Miocárdio/cirurgia , Sistema de Registros , Choque Cardiogênico/cirurgia , Sociedades Médicas , Cirurgia Torácica , Idoso , Bases de Dados Factuais , Feminino , Seguimentos , Mortalidade Hospitalar/tendências , Humanos , Masculino , Pessoa de Meia-Idade , Infarto do Miocárdio/complicações , Infarto do Miocárdio/mortalidade , Estudos Retrospectivos , Fatores de Risco , Choque Cardiogênico/etiologia , Taxa de Sobrevida/tendências , Resultado do Tratamento , Estados Unidos/epidemiologia
16.
JACC Cardiovasc Interv ; 11(6): 581-589, 2018 03 26.
Artigo em Inglês | MEDLINE | ID: mdl-29566805

RESUMO

OBJECTIVES: The aim of this study was to develop and validate a risk adjustment model for 30-day mortality after transcatheter aortic valve replacement (TAVR) that accounted for both standard clinical factors and pre-procedural health status and frailty. BACKGROUND: Assessment of risk for TAVR is important both for patient selection and provider comparisons. Prior efforts for risk adjustment have focused on in-hospital mortality, which is easily obtainable but can be biased because of early discharge of ill patients. METHODS: Using data from patients who underwent TAVR as part of the Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry (June 2013 to May 2016), a hierarchical logistic regression model to estimate risk for 30-day mortality after TAVR based only on pre-procedural factors and access site was developed and internally validated. The model included factors from the original TVT Registry in-hospital mortality model but added the Kansas City Cardiomyopathy Questionnaire (health status) and gait speed (5-m walk test). RESULTS: Among 21,661 TAVR patients at 188 sites, 1,025 (4.7%) died within 30 days. Independent predictors of 30-day death included older age, low body weight, worse renal function, peripheral artery disease, home oxygen, prior myocardial infarction, left main coronary artery disease, tricuspid regurgitation, nonfemoral access, worse baseline health status, and inability to walk. The predicted 30-day mortality risk ranged from 1.1% (lowest decile of risk) to 13.8% (highest decile of risk). The model was able to stratify risk on the basis of patient factors with good discrimination (C = 0.71 [derivation], C = 0.70 [split-sample validation]) and excellent calibration, both overall and in key patient subgroups. CONCLUSIONS: A clinical risk model was developed for 30-day death after TAVR that included clinical data as well as health status and frailty. This model will facilitate tracking outcomes over time as TAVR expands to lower risk patients and to less experienced sites and will allow an objective comparison of short-term mortality rates across centers.


Assuntos
Técnicas de Apoio para a Decisão , Indicadores Básicos de Saúde , Nível de Saúde , Doenças das Valvas Cardíacas/cirurgia , Substituição da Valva Aórtica Transcateter/mortalidade , Idoso , Idoso de 80 Anos ou mais , Cardiomiopatias/diagnóstico , Cardiomiopatias/mortalidade , Tomada de Decisão Clínica , Feminino , Fragilidade/diagnóstico , Fragilidade/mortalidade , Doenças das Valvas Cardíacas/diagnóstico , Doenças das Valvas Cardíacas/mortalidade , Mortalidade Hospitalar , Humanos , Masculino , Aptidão Física , Valor Preditivo dos Testes , Sistema de Registros , Reprodutibilidade dos Testes , Medição de Risco , Fatores de Risco , Sociedades Médicas , Inquéritos e Questionários , Fatores de Tempo , Substituição da Valva Aórtica Transcateter/efeitos adversos , Resultado do Tratamento , Estados Unidos/epidemiologia , Teste de Caminhada , Velocidade de Caminhada
17.
Ann Thorac Surg ; 105(6): 1790-1796, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29391145

RESUMO

BACKGROUND: Surgical ablation (SA) for atrial fibrillation (AF) concomitant to mitral valve repair/replacement (MVRR) improves longitudinal sinus rhythm. However, the risk of adding SA remains a clinical question. This study examined whether the addition of contemporary SA for AF has an impact on operative outcomes. METHODS: The study cohort included 88,765 MVRR patients with or without SA, coronary artery bypass grafting (CABG), septal defect, and tricuspid repair in The Society of Thoracic Surgeons Database between 2011 and 2014. Group 1 did not have AF (No-AF) and did not receive SA (No-SA); group 2 had No-AF immediately preoperatively but received SA; group 3 had AF but No-SA; and group 4 had AF with SA. Groups 3 and 4 were stratified into paroxysmal versus nonparoxysmal AF. With the use of logistic regression, with group 1 as reference, risk-adjusted odds ratios (OR) for mortality were compared for SA performance, AF type, and SA technique. RESULTS: Group 3 had higher age, New York Heart Association class, redo operations, and unadjusted mortality than group 4. Relative to group 1, group 3 had an OR for mortality of 1.15 (95% confidence interval: 1.04 to 1.27, p < 0.01). OR increments were similar for paroxysmal and nonparoxysmal AF. In group 4, concomitant SA was independently associated with lower AF-related relative risk (OR 1.08), to a level that was not different from group 1 (p = 0.13). Observed treatment effects were equivalent for paroxysmal and nonparoxysmal AF and across all levels of baseline risk. CONCLUSIONS: For patients with AF at the time of mitral operation, the performance of SA seems associated with a lower risk-adjusted operative mortality compared with patients who do not undergo ablation.


Assuntos
Fibrilação Atrial/cirurgia , Ablação por Cateter/mortalidade , Implante de Prótese de Valva Cardíaca/mortalidade , Mortalidade Hospitalar/tendências , Insuficiência da Valva Mitral/cirurgia , Idoso , Fibrilação Atrial/mortalidade , Ablação por Cateter/métodos , Causas de Morte , Terapia Combinada , Feminino , Seguimentos , Implante de Prótese de Valva Cardíaca/métodos , Humanos , Modelos Logísticos , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Estudos Retrospectivos , Medição de Risco , Análise de Sobrevida , Resultado do Tratamento
20.
JAMA ; 319(4): 365-374, 2018 01 23.
Artigo em Inglês | MEDLINE | ID: mdl-29362794

RESUMO

Importance: The left atrial appendage is a key site of thrombus formation in atrial fibrillation (AF) and can be occluded or removed at the time of cardiac surgery. There is limited evidence regarding the effectiveness of surgical left atrial appendage occlusion (S-LAAO) for reducing the risk of thromboembolism. Objective: To evaluate the association of S-LAAO vs no receipt of S-LAAO with the risk of thromboembolism among older patients undergoing cardiac surgery. Design, Setting, and Participants: Retrospective cohort study of a nationally representative Medicare-linked cohort from the Society of Thoracic Surgeons Adult Cardiac Surgery Database (2011-2012). Patients aged 65 years and older with AF undergoing cardiac surgery (coronary artery bypass grafting [CABG], mitral valve surgery with or without CABG, or aortic valve surgery with or without CABG) with and without concomitant S-LAAO were followed up until December 31, 2014. Exposures: S-LAAO vs no S-LAAO. Main Outcomes and Measures: The primary outcome was readmission for thromboembolism (stroke, transient ischemic attack, or systemic embolism) at up to 3 years of follow-up, as defined by Medicare claims data. Secondary end points included hemorrhagic stroke, all-cause mortality, and a composite end point (thromboembolism, hemorrhagic stroke, or all-cause mortality). Results: Among 10 524 patients undergoing surgery (median age, 76 years; 39% female; median CHA2DS2-VASc score, 4), 3892 (37%) underwent S-LAAO. Overall, at a mean follow-up of 2.6 years, thromboembolism occurred in 5.4%, hemorrhagic stroke in 0.9%, all-cause mortality in 21.5%, and the composite end point in 25.7%. S-LAAO, compared with no S-LAAO, was associated with lower unadjusted rates of thromboembolism (4.2% vs 6.2%), all-cause mortality (17.3% vs 23.9%), and the composite end point (20.5% vs 28.7%) but no significant difference in rates of hemorrhagic stroke (0.9% vs 0.9%). After inverse probability-weighted adjustment, S-LAAO was associated with a significantly lower rate of thromboembolism (subdistribution hazard ratio [HR], 0.67; 95% CI, 0.56-0.81; P < .001), all-cause mortality (HR, 0.88; 95% CI, 0.79-0.97; P = .001), and the composite end point (HR, 0.83; 95% CI, 0.76-0.91; P < .001) but not hemorrhagic stroke (subdistribution HR, 0.84; 95% CI, 0.53-1.32; P = .44). S-LAAO, compared with no S-LAAO, was associated with a lower risk of thromboembolism among patients discharged without anticoagulation (unadjusted rate, 4.2% vs 6.0%; adjusted subdistribution HR, 0.26; 95% CI, 0.17-0.40; P < .001), but not among patients discharged with anticoagulation (unadjusted rate, 4.1% vs 6.3%; adjusted subdistribution HR, 0.88; 95% CI, 0.56-1.39; P = .59). Conclusions and Relevance: Among older patients with AF undergoing concomitant cardiac surgery, S-LAAO, compared with no S-LAAO, was associated with a lower risk of readmission for thromboembolism over 3 years. These findings support the use of S-LAAO, but randomized trials are necessary to provide definitive evidence.


Assuntos
Apêndice Atrial/cirurgia , Fibrilação Atrial , Procedimentos Cirúrgicos Cardíacos/efeitos adversos , Readmissão do Paciente/estatística & dados numéricos , Tromboembolia/prevenção & controle , Idoso , Valva Aórtica/cirurgia , Ponte de Artéria Coronária/efeitos adversos , Seguimentos , Humanos , Estimativa de Kaplan-Meier , Valva Mitral/cirurgia , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Dispositivo para Oclusão Septal , Tromboembolia/epidemiologia , Tromboembolia/etiologia
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