Dataset Information

Predictive Score of Adverse Events After Carotid Endarterectomy: The NSQIP Registry Carotid Endarterectomy Scale.

ABSTRACT: Background The goal of this study was to create a comprehensive, integer-weighted predictive scale of adverse events after carotid endarterectomy (CEA), which may augment risk stratification and patient counseling. Methods and Results The targeted carotid files from the prospective NSQIP (National Surgical Quality Improvement Program) registry (2011-2013) comprised the derivation population. Multivariable logistic regression evaluated predictors of a 30-day adverse event (stroke, myocardial infarction, or death), the effect estimates of which were used to build a weighted predictive scale that was validated using the 2014 to 2015 NSQIP registry release. A total of 10 766 and 8002 patients were included in the derivation and the validation populations, in whom 4.0% and 3.7% developed an adverse event, respectively. The NSQIP registry CEA scale included 14 variables; the highest points were allocated for insulin-dependent diabetes mellitus, high-risk cardiac physiological characteristics, admission source other than home, an emergent operation, American Society of Anesthesiologists' classification IV to V, modified Rankin Scale score ?2, and presentation with a stroke. NSQIP registry CEA score was predictive of an adverse event (concordance=0.67), stroke or death (concordance=0.69), mortality (concordance=0.76), an extended hospitalization (concordance=0.73), and a nonroutine discharge (concordance=0.83) in the validation population, as well as among symptomatic and asymptomatic subgroups (P<0.001). In the validation population, patients with an NSQIP registry CEA scale score >8 and 17 had 30-day stroke or death rates >3% and 6%, the recommended thresholds for asymptomatic and symptomatic patients, respectively. Conclusions The NSQIP registry CEA scale predicts adverse outcomes after CEA and can risk stratify patients with both symptomatic and asymptomatic carotid stenosis using different thresholds for each population.

SUBMITTER: Dasenbrock HH

PROVIDER: S-EPMC6898838 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Predictive Score of Adverse Events After Carotid Endarterectomy: The NSQIP Registry Carotid Endarterectomy Scale.

Dasenbrock Hormuzdiyar H HH Smith Timothy R TR Gormley William B WB Castlen Joseph P JP Patel Nirav J NJ Frerichs Kai U KU Aziz-Sultan M Ali MA Du Rose R

Journal of the American Heart Association 20191030 21

Background The goal of this study was to create a comprehensive, integer-weighted predictive scale of adverse events after carotid endarterectomy (CEA), which may augment risk stratification and patient counseling. Methods and Results The targeted carotid files from the prospective NSQIP (National Surgical Quality Improvement Program) registry (2011-2013) comprised the derivation population. Multivariable logistic regression evaluated predictors of a 30-day adverse event (stroke, myocardial infa ...[more]

PMID: 31662028

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Project description:ObjectiveMost studies based on state and nationwide registries evaluating perioperative outcome after carotid endarterectomy (CEA) rely on hospital discharge data only. Therefore, the true 30-day complication risk after carotid revascularization may be underestimated.MethodsWe used the National Surgical Quality Improvement Program database 2005-2010 to assess the in-hospital and postdischarge rate of any stroke, death, cardiac event (new Q-wave myocardial infarction or cardiac arrest), and combined stroke/death and combined adverse outcome (S/D/CE) at 30 days following CEA. Multivariable analyses were used to identify predictors for in-hospital and postdischarge events separately, and in particular, those that predict postdischarge events distinctly.ResultsA total of 35,916 patients who underwent CEA during 2005-2010 were identified in the National Surgical Quality Improvement Program database; 59% were male, median age was 72 years, and 44% had a previous neurologic event. Thirty-day stroke rate was 1.6% (n = 591), death rate was 0.8% (n = 272), cardiac event rate was 1.0% (n = 350), stroke or death rate was 2.2% (n = 794), and combined S/D/CE rate was 2.9% (n = 1043); 33% of strokes, 53% of deaths, 32% of cardiac events, 40% of combined stroke/death, and 38% of combined S/D/CE took place after hospital discharge. Patients with a prior stroke or transient ischemic attack had similar proportions of postdischarge events compared with patients without prior symptoms. Independent predictors for postdischarge events, but not for in-hospital events were female sex (stroke [odds ratio (OR), 1.6; 95% confidence interval (CI), 1.2-2.1] and stroke/death [OR, 1.4; 95% CI, 1.1-1.7]), renal failure (stroke [OR, 3.0; 95% CI, 1.4-6.2]) and chronic obstructive pulmonary disease (death [OR, 2.5; 95% CI, 1.6-3.7], stroke/death [OR, 1.8; 95% CI, 1.4-2.4], and S/D/CE [OR 1.8, 95% CI 1.4-2.3]).ConclusionsWith 38% of perioperative adverse events after CEA happening posthospitalization, regardless of symptoms status, we need to be alert to the ongoing risks after discharge particularly in women, patients with renal failure, or chronic obstructive pulmonary disease. This emphasizes the need for reporting and comparing 30-day adverse event rates when evaluating outcomes for CEA, or comparing carotid stenting to CEA.

Project description:Background Carotid endarterectomy (CEA) is a major vascular operation for stroke prevention that carries significant perioperative risks; however, outcome prediction tools remain limited. The authors developed machine learning algorithms to predict outcomes following CEA. Methods and Results The National Surgical Quality Improvement Program targeted vascular database was used to identify patients who underwent CEA between 2011 and 2021. Input features included 36 preoperative demographic/clinical variables. The primary outcome was 30-day major adverse cardiovascular events (composite of stroke, myocardial infarction, or death). The data were split into training (70%) and test (30%) sets. Using 10-fold cross-validation, 6 machine learning models were trained using preoperative features. The primary metric for evaluating model performance was area under the receiver operating characteristic curve. Model robustness was evaluated with calibration plot and Brier score. Overall, 38 853 patients underwent CEA during the study period. Thirty-day major adverse cardiovascular events occurred in 1683 (4.3%) patients. The best performing prediction model was XGBoost, achieving an area under the receiver operating characteristic curve of 0.91 (95% CI, 0.90-0.92). In comparison, logistic regression had an area under the receiver operating characteristic curve of 0.62 (95% CI, 0.60-0.64), and existing tools in the literature demonstrate area under the receiver operating characteristic curve values ranging from 0.58 to 0.74. The calibration plot showed good agreement between predicted and observed event probabilities with a Brier score of 0.02. The strongest predictive feature in our algorithm was carotid symptom status. Conclusions The machine learning models accurately predicted 30-day outcomes following CEA using preoperative data and performed better than existing tools. They have potential for important utility in guiding risk-mitigation strategies to improve outcomes for patients being considered for CEA.

Project description:BACKGROUND:Carotid artery stenting (CAS) and carotid endarterectomy (CEA) are alternative strategies for stroke prevention in patients with atherosclerotic carotid disease. CEA has been considered the first-line treatment for carotid stenosis worldwide, and the safety and efficacy of CAS compared to CEA remains in question. OBJECTIVE:The purpose of this study is to compare the practice and outcomes of CAS and CEA in a real-world setting within public university hospitals in Brazil. METHODS:This study will be a prospective 5-year analysis of treatment for atherosclerotic carotid stenosis with CEA and CAS performed at 5 centers affiliated with the Vascular Study Group at public university hospitals in Brazil. The indications for the procedures will be determined by each surgeon's individual discretion, in accordance with preoperative risk evaluation. The primary outcome measures will be (1) any in-hospital stroke or death, and (2) any per-procedural stroke, death, or myocardial infarction (MI). Patients undergoing CEA in conjunction with cardiac surgery will be excluded from the study. Multivariate logistic regression will be performed to identify predictors of stroke or death in patients undergoing CEA and CAS. All tests of significance will be performed at the .05 level. This study was approved by the Committee of Ethics in Research at the University Hospital of Ribeirao Preto Medical School, and in all other participating institutions linked to National Research System and National Board of Health in Brazil (Process 15695/2011). RESULTS:This study is currently in the recruitment phase, and the final patient is expected to be enrolled by the end of 2018. We hope to recruit approximately 800 patients to the study. Analyses will focus on primary end points for patients that are allocated to each treatment group. During the per-procedural period, the occurrence of the primary end point components (stroke, MI, or death) for CAS and CEA will be analyzed for symptomatic or asymptomatic subjects. CONCLUSIONS:The analyses of the primary endpoints (and all others variables of the study) are expected to be published in 2019 in a peer reviewed journal, and results will be presented at scientific meetings, with summary results published online. This study will obtain new data related to the quality of treatment for carotid disease in Brazil at the primary training centers of future vascular surgeons, but the initial data that will be obtained and published (with the outcomes and complications) are restricted to the first 30 days postprocedure. This time restriction limits the comparison of the results that relate to the main goal of treatment, which is to decrease the risk of stroke over 5 years. The purpose of the study group is to continue the monitoring of patient records, and evaluate the follow-up data in the 5 years following the initial evaluation. This study protocol will contribute very significantly to improving the care of patients with carotid disease, in addition to qualifying the level of assistance provided in public university hospitals in the state of São Paulo, Brazil. TRIAL REGISTRATION:Clinicaltrials.gov NCT02538276; https://www.clinicaltrials.gov/ct2/show/NCT02538276 (Archived by WebCite at http://www.webcitation.org/6m7APnFLD).

Project description:Background and Purpose- Patients undergoing surgery on the weekend may experience worse outcomes, but this weekend effect has not been studied in carotid endarterectomy (CEA). Methods- We identified patients undergoing isolated CEA in the Vascular Quality Initiative between 2003 and 2018. Our primary outcome was in-hospital stroke or perioperative death (stroke/death), stratified by symptom status. For asymptomatic patients, we also compared rates of the Centers for Medicare and Medicaid Services quality metric prolonged length of stay (>2 days or failed discharge home). We calculated propensity scores and used multilevel, inverse probability weighted logistic regression clustering at the hospital level. Results- There were 86?123 repairs during the study period, 53% asymptomatic lesions and 47% symptomatic. Only 0.7% of asymptomatic patients underwent CEA on the weekend, compared with 3.1% of symptomatic patients. Patients undergoing weekend repairs were more often white, with lower rates of most comorbidities. In asymptomatic patients, weekend operations were associated significantly higher odds of stroke/death (odds ratio [OR], 2.3 [1.1-4.8]; P=0.02), and prolonged length of stay (OR, 3.6 [2.7-4.7]; P<0.001). In symptomatic patients, weekend operations were associated with significantly higher adjusted odds of stroke/death (OR, 1.7 [1.2-2.4]; P=0.007) and longer postoperative length of stay (3.3 days versus 2.0 days, P=0.002). However, the difference in stroke/death was driven by patients presenting with stroke (OR, 2.2 [1.5-2.3]; P<0.001), rather than those presenting with transient ischemic attack (OR, 1.2 [0.6-2.1]; P=0.56). Conclusions- We found evidence of a significant weekend effect in CEA, as weekend operations in asymptomatic patients and patients who presented with stroke were associated with higher rates of stroke/death and prolonged length of stay. However, there was no evidence of such an effect in patients with transient ischemic attack. These data suggest that weekend CEA should be avoided except in the case of expedited revascularization after transient ischemic attack.

Project description:BackgroundThe Carotid Revascularization Endarterectomy Versus Stenting Trial (CREST) found a higher risk of stroke after carotid artery stenting and a higher risk of myocardial infarction (MI) after carotid endarterectomy.Methods and resultsCardiac biomarkers and ECGs were performed before and 6 to 8 hours after either procedure and if there was clinical evidence of ischemia. In CREST, MI was defined as biomarker elevation plus either chest pain or ECG evidence of ischemia. An additional category of biomarker elevation with neither chest pain nor ECG abnormality was prespecified (biomarker+ only). Crude mortality and risk-adjusted mortality for MI and biomarker+ only were assessed during follow-up. Among 2502 patients, 14 MIs occurred in carotid artery stenting and 28 MIs in carotid endarterectomy (hazard ratio, 0.50; 95% confidence interval, 0.26 to 0.94; P=0.032) with a median biomarker ratio of 40 times the upper limit of normal. An additional 8 carotid artery stenting and 12 carotid endarterectomy patients had biomarker+ only (hazard ratio, 0.66; 95% confidence interval, 0.27 to 1.61; P=0.36), and their median biomarker ratio was 14 times the upper limit of normal. Compared with patients without biomarker elevation, mortality was higher over 4 years for those with MI (hazard ratio, 3.40; 95% confidence interval, 1.67 to 6.92) or biomarker+ only (hazard ratio, 3.57; 95% confidence interval, 1.46 to 8.68). After adjustment for baseline risk factors, both MI and biomarker+ only remained independently associated with increased mortality.ConclusionsIn patients randomized to carotid endarterectomy versus carotid artery stenting, both MI and biomarker+ only were more common with carotid endarterectomy. Although the levels of biomarker elevation were modest, both events were independently associated with increased future mortality and remain an important consideration in choosing the mode of carotid revascularization or medical therapy.Clinical trial registrationURL: http://www.ClinicalTrials.gov. Unique identifier: NCT00004732.

Project description:ObjectivesThe purpose of this study was to compare health-related quality of life (HRQOL) outcomes in patients treated with carotid artery stenting (CAS) versus carotid endarterectomy (CEA).BackgroundIn CREST (Carotid Revascularization Endarterectomy versus Stenting Trial), the largest randomized trial of carotid revascularization to date, there was no significant difference in the primary composite endpoint, but rates of stroke and myocardial infarction (MI) differed between CAS and CEA. To help guide individualized clinical decision making, we compared HRQOL among patients enrolled in the CREST study. We also performed exploratory analyses to evaluate the association between periprocedural complications and HRQOL.MethodsWe measured HRQOL at baseline, and after 2 weeks, 1 month, and 1 year among 2,502 patients randomly assigned to either CAS or CEA in the CREST study. The HRQOL was assessed using the Medical Outcomes Study Short-Form 36 (SF-36) and 6 disease-specific scales designed to study HRQOL in patients undergoing carotid revascularization.ResultsAt both 2 weeks and 1 month, CAS patients had better outcomes for multiple components of the SF-36, with large differences for role physical function, pain, and the physical component summary scale (all p < 0.01). On the disease-specific scales, CAS patients reported less difficulty with driving, eating/swallowing, neck pain, and headaches but more difficulty with walking and leg pain (all p < 0.05). However, by 1 year, there were no differences in any HRQOL measure between CAS and CEA. In the exploratory analyses, periprocedural stroke was associated with poorer 1-year HRQOL across all SF-36 domains, but periprocedural MI or cranial nerve palsy were not.ConclusionsAmong patients undergoing carotid revascularization, CAS is associated with better HRQOL during the early recovery period as compared with CEA-particularly with regard to physical limitations and pain-but these differences diminish over time and are not evident after 1 year. Although CAS and CEA are associated with similar overall HRQOL at 1 year, event-specific analyses confirm that stroke has a greater and more sustained impact on HRQOL than MI. (Carotid Revascularization Endarterectomy versus Stenting Trial [CREST]; NCT00004732)

Dataset Information

Predictive Score of Adverse Events After Carotid Endarterectomy: The NSQIP Registry Carotid Endarterectomy Scale.

Publications

Predictive Score of Adverse Events After Carotid Endarterectomy: The NSQIP Registry Carotid Endarterectomy Scale.

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