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1.
To achieve rapid assessment of chest pain in emergency/cardiology departments, a short turnaround time for cardiac marker testing is necessary. Nevertheless, Total Quality Management principles must be incorporated into the management of point-of-care testing (POCT); in this setting we implemented the Stratus CS assay as POCT for cardiac markers in our emergency/cardiology department. The analytical performance of the troponin I method was evaluated; information connectivity between the Stratus CS data management system and the laboratory information system was implemented and practical training of testing personnel was carried out at the POCT site. A total of 41 non-ST-segment elevation patients admitted to the hospital were followed to evaluate the appropriateness of hospital admission, formulated on the basis of the cardiac troponin-I level measured at the POCT site by clinical staff. Our preliminary clinical data suggest that the high sensitivity of the Stratus CS troponin method could play an important role in the early identification of patients with acute myocardial infarction in a low to intermediate-risk population for acute coronary syndrome. Our POCT model suggests that the central laboratory could ensure that the POCT program remains in compliance with quality requirements. Nevertheless, our comparison studies suggest that the implementation of POCT requires a high level of integration between cardiologists and pathologists to guarantee appropriate interpretation of the monitoring results for suspected ACS patients.  相似文献   

2.
The progressive evolution of cardiac marker testing in patients with acute coronary syndromes has extended their role into risk stratification and guidance of therapeutic regimen. To provide utilization of cardiac markers around the clock and facilitate the diagnostic work-up of patients with acute chest pain in the emergency room, a point-of-care system for quantitative troponin T and myoglobin testing in whole blood samples was developed. Aim of this multicenter study was to evaluate bedside quantitative determination of myoglobin and troponin T in chest pain patients in a clinical routine setting. Five hospitals in Germany were contributing to blood sampling and 741 patients were included four hours (median) after onset of cardiac pain. Comparison between the rapid test and the established laboratory-based method showed a sufficient agreement of results with a correlation of r = 0.89 (Y = 0.856x + 0.029) for troponin T and r = 0.912 (Y= +1.145x + 3.457) for myoglobin. Diagnostic sensitivity and prognostic power of the troponin T results obtained in the emergency unit were thoroughly equivalent to the laboratory-based method. The results show that the cardiac reader system represents a promising alternative to central laboratory testing with an accuracy sufficiently for rapid decision making in the emergency room. Myoglobin results in this study did not add supplementary information to the cardiac reader troponin result. However, point-of-care testing of troponin T is advantageous whenever marker results could positively effect initial triage decisions and interventional management choices.  相似文献   

3.
IntroductionIn the emergency department, troponin assays are commonly used and essential in the evaluation of chest pain and diagnosis of acute coronary syndrome. This study was designed to assess the potential impact of implementing point-of-care troponin testing by comparing the time to point-of-care laboratory result and time to conventional laboratory result.MethodsThe study enrolled 60 ED patients deemed to need a troponin test in the evaluation of low-risk chest pain (HEART score <4 based on history, electrocardiogram, age, risk factors). Point-of-care troponin testing was performed with the same blood sample obtained for a conventional troponin assay. If the provider determined that the patient required 2 troponin tests, the second laboratory draw was used in the data collection. This was to correlate the time of laboratory result to time of disposition.ResultsOf the 60 subjects enrolled, 2 subjects were excluded because of user errors with the point-of-care testing equipment and 2 others for not meeting inclusion criteria on later review. The median times for the point-of-care troponin and conventional troponin assays were 11:00 minutes (interquartile range 10:00-15:30) and 40:00 minutes (interquartile range 31:30-52:30), respectively; P < 0.001. There were 3 extreme outliers from the conventional troponin assay that significantly skewed the distribution of the mean, making the median the more accurate assessment of the central tendency.DiscussionPoint-of-care troponin testing provided results in a median time 29 minutes quicker than the conventional troponin assay. This result is statistically significant and has the potential to greatly improve time to disposition in all patients with chest pain requiring a troponin assay.  相似文献   

4.
The emergency department (ED) evaluation of patients with potential acute coronary syndromes (ACS) has traditionally included initial cardiac marker testing for suspected acute myocardial infarction (AMI). While ED management decisions for patients with ACS have largely been based on history, physical examination, and a presenting 12-lead electrocardiogram (ECG), there is ample evidence that markers impact treatment decisions and provide risk stratification. Newer, more sensitive markers of myocardial necrosis have blurred the distinction between patients with and without classically defined AMI, and have focused attention on the continuum of ACS from angina to transmural Q-wave MI. Newer antiplatelet agents, the glycoprotein IIb/IIIa receptor blockers, are likely to receive increased ED utilization. This use will be partially driven by ED cardiac marker determination. Bedside, point-of-care testing is reliable technology that may shorten time to diagnosis and treatment of ACS in the emergency setting. The ED-based chest pain center (CPC) has become a popular tool to evaluate patients at low- to moderate-risk for ACS and a non-diagnostic ECG. Such centers use serial cardiac marker testing as a mainstay for evaluation and risk stratification. Cost issues have driven many diagnostic patient evaluations from the inpatient setting to such ED observation units. As this becomes more common for low- to moderate-risk patients with chest pain, serial assessment of cardiac markers, and their interpretation by emergency physicians, will become essential.  相似文献   

5.
A prospective multicenter study including 1410 chest pain patients with suspected acute coronary syndromes was carried out to examine the predictive value of biological cardiac markers for adverse events measured by a point-of-care system. Admission cardiac troponin T (cTnT) and myoglobin were measured in parallel on a point-of-care system in the emergency department and -- together with CK-MB mass -- on lab analyzers. In a one-year follow-up, cardiac and non-cardiac death, acute myocardial infarction, unstable angina pectoris and need for revascularization were registered. Median time between onset of symptoms and admission was 285 min; 172 patients (12.2%) had no event during follow-up. If the cTnT, measured either by the point-of-care system or a conventional lab analyzer, was >0.05 microg/L, then the chance of a cardiac event during the follow-up period was doubled (18% vs. 9%). Serial cTnT measurement did not add any further value to the predictive power of the admission cTnT. Myoglobin and CK-MB mass identified increasing risk with increasing concentration quartiles; cardiac event rates were 2.8- to 4.4-fold higher between the quartiles with the lowest and those with the highest analyte concentration, respectively. There was no difference in non-cardiac death rates between any concentration quartiles. In conclusion, the prediction of clinical events by cardiac troponin T and myoglobin measured with a point-of-care analyzer in the emergency department was as good as that of the same cardiac markers and CK-MB mass measured on lab analyzers.  相似文献   

6.
This study was undertaken to evaluate the diagnostic accuracy and practicality of Emergency Department (ED) testing for cardiac biomarkers in the diagnosis of acute coronary syndromes. All patients presenting with chest pain to the ED of a community-based tertiary care facility over a 16-day period (N = 205) had blood drawn and tested for cardiac troponin I, myoglobin, and CK-MB by a quantitative, point-of-care instrument system (Stratus CS). Point-of-care cardiac testing expedited diagnosis by decreasing the turn-around time by 55% compared to the central laboratory. The extreme sensitivity of the cardiac troponin I assay integral to this system was responsible for the high diagnostic accuracy (100% sensitivity; virtually 100% specificity, compared with the final assigned diagnosis). The assay also identified a clinically significant "high-risk" zone for near-future cardiac events: 17 patients were identified and four of these progressed to further cardiac events in the next 9 months. Further studies to explore the clinical implications of this high-risk zone are warranted.  相似文献   

7.
An early diagnosis of myocardial infarction in the emergency setting would be advantageous for both patients and the physicians treating these patients. Guidelines currently recommend serial samples that are drawn at presentation and 6-9 h later to be measured for cardiac troponin to aid in this diagnosis. However, much effort has been directed to decrease the time to make a diagnosis in this setting, and there has been renewed interest in shortening the time between serial measurements as well as the turnaround time for reporting the results. By eliminating the blood sample transit time to the central laboratory, point-of-care testing or near-patient testing can reduce the turnaround time for reporting the results, however this is possibly at the cost of decreased diagnostic performance. In this article, we discuss the recent results from the RATPAC study, which evaluated whether the combination of myoglobin, the MB isoenzyme of creatine kinase (CKMB) and a sensitive troponin assay would be superior to troponin alone.  相似文献   

8.
Evaluation of: Collinson P, Goodacre S, Gaze D et al. Very early diagnosis of chest pain by point-of-care testing: comparison of the diagnostic efficiency of a panel of cardiac biomarkers compared with troponin measurement alone in the RATPAC trial. Heart 98(4), 312–318 (2012).

An early diagnosis of myocardial infarction in the emergency setting would be advantageous for both patients and the physicians treating these patients. Guidelines currently recommend serial samples that are drawn at presentation and 6–9 h later to be measured for cardiac troponin to aid in this diagnosis. However, much effort has been directed to decrease the time to make a diagnosis in this setting, and there has been renewed interest in shortening the time between serial measurements as well as the turnaround time for reporting the results. By eliminating the blood sample transit time to the central laboratory, point-of-care testing or near-patient testing can reduce the turnaround time for reporting the results, however this is possibly at the cost of decreased diagnostic performance. In this article, we discuss the recent results from the RATPAC study, which evaluated whether the combination of myoglobin, the MB isoenzyme of creatine kinase (CKMB) and a sensitive troponin assay would be superior to troponin alone.  相似文献   

9.
BACKGROUND: Validation of whole blood, point-of-care testing devices for monitoring cardiac markers to aid clinicians in ruling in and ruling out myocardial infarction (MI) is necessary for both laboratory and clinical acceptance. METHODS: This study evaluated the clinical diagnostic sensitivity and specificity of the First Medical Cardiac Test device operated by nursing and laboratory personnel that simultaneously measures cardiac troponin I (cTnI), creatine kinase (CK) MB, myoglobin, and total CK on the Alpha Dx analyzer in whole blood for detection of MI. Over a 6-month period, 369 patients initially presenting to the emergency department with chest pain were evaluated for MI using modified WHO criteria. Eighty-nine patients (24%) were diagnosed with MI. RESULTS: In whole blood samples collected at admission and at 3- to 6-h intervals over 24 h, ROC curve-determined MI decision limits were as follows: cTnI, 0.4 microgram/L; CKMB, 7.0 microgram/L; myoglobin, 180 microgram/L; total CK, 190 microgram/L. Based on peak concentrations within 24 h after presentation, the following sensitivities (+/- 95% confidence intervals) were found: cTnI, 93% +/- 5.5%; myoglobin, 81% +/- 9.7%; CKMB, 90% +/- 6.3%; total CK, 86% +/- 7.5%. Sensitivities were maximal at >90% for both cTnI and CKMB at >12 h in MI patients, without differences between ST-segment elevation and non-ST-segment elevation MI patients. CONCLUSIONS: The First Medical point-of-care device provides cardiac marker assays that can be used by laboratories and clinicians in a variety of hospital settings for ruling in and ruling out MI.  相似文献   

10.

Background

Cardiac markers are a cornerstone for assessment of suspected acute coronary syndrome (ACS) patients. The National Academy for Clinical Biochemistry has recently developed practice guidelines for clinical, analytical and point-of-care (POC) testing in the context of ACS. Several technologies have become available for POC applications.

Setting

Cardiac troponin is the preferred biochemical marker for diagnosis, risk stratification and guiding management of suspected ACS patients. Samples must be collected with proper timing, typically on presentation and then 6 to 9 h later. Assays should work toward a goal of total CV < 10% at the 99th percentile cutpoint, and should adhere to specifications defined by professional organizations. A 1-h or less turnaround time is specified; quantitative POC testing should be implemented if this timing cannot be met consistently by the central laboratory. The same quality criteria for assays apply regardless of testing venue.

Implementation/management

Laboratory medicine personnel must have active role in implementation, choice of technology and management of POC cardiac marker testing.

Conclusions

Cardiac troponin measurements at POC are a viable alternative when testing needs cannot be met by the central laboratory. Laboratory medicine must be involved in implementation and ongoing service. Quality of testing must not be compromised by performance at POC.  相似文献   

11.
As part of a symposium on laboratory medicine, a colloquium on point-of-care testing was held in June 1999 where four experts were invited to produce recommendations and opinions on the use of point-of-care testing under various clinical venues. Each commented on costs for providing POCT services. A total of eleven recommendations and four opinions were rendered and discussed in an open forum. While one expert concluded that some forms of POCT are less expensive than central laboratory testing if entire laboratory workstations are eliminated, another expert suggested that POCT offered little advantage if rapid transport systems are available. A recommendation was made that POCT be considered for analytes that have a required reporting turnaround time of <30 min, and that the goals for precision and accuracy should be dictated by the clinical need and not by analytical limitations. Recommendations for POCT in specific clinical situations include use of glycated hemoglobin and urine albumin testing with personal glucose monitoring at the time of consultation, use of glycated albumin for gestational diabetes, leukocyte esterase and nitrite testing in urine to screen for urinary tract infections, coagulation tests for monitoring patients on oral anticoagulant therapy and in the operating room, testing for H. pylori for patients with dyspepsia, and cardiac markers and urine drugs-of-abuse testing in the emergency department.  相似文献   

12.
Cardiac troponin is the standard marker for diagnosis of acute myocardial infarction and risk stratification of patients who present to an emergency department with signs and symptoms of acute cardiac ischemia. Over the past few years, the analytical sensitivity of assays for cardiac troponin has improved significantly to the point where a detectable amount of troponin can be measured in essentially all healthy subjects. Recent studies have shown that use of a highly sensitive troponin assays may provide value to traditional markers of primary disease risk for patients, i.e., for those who have no history of heart disease. There are barriers to the adoption of cardiac troponin for screening high risk cohorts such as the elderly, diabetics and perhaps even the asymptomatic population. Strategies used for the assignment of cutoff concentrations in acute care, i.e., the 99th percentile, may not be appropriate for primary care as changes over baseline levels may provide more accurate information of risk than cross-sectional results. A review of biological variation has shown that cardiac troponin as a biomarker has low index of individuality, indicating that reference values are of little utility. Whether or not cardiac troponin can be released in reversible injury is a debate that could have significance for detecting minor myocardial injury. A major hurdle for use of troponin in primary care is the lack of assay standardization and nomenclature for the different generations of troponin assays. Standardization requires knowledge of what is released after cardiac injury and what the various cardiac troponin assays are measuring. Currently it is not clear if the cardiac troponin release after ischemic injury is identical to that in circulation of healthy individuals. This may affect the design of future assays and standardization approaches. There is potential that a marker of myocardial injury such as troponin can add to the value of existing indicators and biomarkers of cardiovascular disease risk. Additional analytical and clinical validations are needed to fully elucidate cardiac troponin metabolism and resolve ongoing clinical and laboratory issues. While these issues are directed to the use of troponin in primary care, most of these concepts are relevant to the use of troponin in acute coronary syndromes as well.  相似文献   

13.

Objectives

We examined the use of point-of-care (POC) testing of cardiac biomarkers against standard core laboratory testing to determine the time-savings and estimate a cost-benefit ratio at our institution.

Methods

We prospectively enrolled 151 patients presenting to the emergency department undergoing evaluation for acute coronary syndrome and conducted both central laboratory troponin T (TnT) testing at baseline and 6 hours as well as POC assays of creatine kinase MB, troponin I (TnI), and myoglobin at baseline and 2 hours. Sensitivity/specificity was calculated to measure the ability of the POC-accelerated pathway to identify enzyme elevations at rates parallel to our core laboratory. The time-savings were calculated as the difference between the median of the current protocol and the accelerated POC pathway.

Results

Troponin T tests were elevated in 12 patients, which were all detected by the accelerated pathway yielding a relative sensitivity of 100%. Time-saving between the accelerated pathway and core laboratory showed a saving of 390 minutes (6.5 hours). The accelerated POC pathway would have benefited 60% (95% confidence interval [CI], 52%-68%) of our patients with an estimated cost of $7.40 (95% CI, $6.40-$8.70) per direct patient care hour saved.

Conclusion

Our data suggest that the use of an accelerated cardiac POC pathway could have dramatically impacted the care provided to a large percentage of our patients at a minimal cost per direct patient care hour saved.  相似文献   

14.
OBJECTIVE: Major challenges for physicians include selection of effective tests in the time-sensitive identification and management of patients with acute coronary syndromes (ACS). We review whether cardiac marker testing performed at the point-of-care (POC) has an impact on clinical management and guidance of intervention for ACS patients. DESIGN AND METHODS: Evidence from recently published studies and meta-analyses supports the efficacy of cardiac markers. Technologies and specifications of all currently available POC tests for monitoring cardiac markers are surveyed. Finally, a series of questions to investigate the utility of cardiac markers, and their measurement by POC tests, for clinical management and guidance of therapy for ACS patients, are addressed. RESULTS: Cardiac troponins are clearly the best markers for the definitive detection of myocardial infarction. Compelling evidence for the utility of troponins in risk stratification and guidance of intervention for ACS patients has resulted in inclusion of cardiac markers in clinical guidelines. Rapid multi-analyte POC tests, few of which exhibit harmony with central laboratory assays, have facilitated the use of cardiac markers for clinical management and guidance of therapy. CONCLUSIONS: Given the need to minimize vein-to-brain time, it is expected that point-of-care testing of cardiac markers will take a leading role in management of ACS patients.  相似文献   

15.
Objective. The use of point-of-care technology has increased faster than efforts to validate its effectiveness compared to standard laboratory testing modalities. To address this issue with a current point-of-care coagulation system (HEMOCHRON® Jr, International Technidyne Corporation (ITC), Edison, NJ), we designed a study to test the hypothesis that data obtained from point-of-care coagulation equipment correlates with data obtained from standard laboratory coagulation equipment. One of the potential advantages gained using point-of-care testing is the ability to obtain more rapid results. To address this issue, turnaround time, defined as the elapsed time (in minutes) from when the sample was acquired from the patient until the investigators knew the results, was also determined. Methods. Following Human Investigation Committee approval and informed consent, a prospective study was conducted to compare results obtained from point-of-care coagulation equipment with those results obtained from standard laboratory coagulation equipment. The study was performed in three groups of patients undergoing cardiovascular surgery, each requiring different levels of anticoagulation. Results. Of the 83 patients who met the inclusion criteria, the correlation (combining data from groups 1–3) between results obtained from point-of-care and standard laboratory prothrombin time was r = 0.867, p < 0.001. The correlation (group 3) between point-of-care and standard laboratory international normalized ratio was r = 0.943, p < 0.001. The correlation (combining data from groups 1 & 2) between point-of-care and standard laboratory activated partial thromboplastin time was r = 0.825, p < 0.001. Median turnaround time for the standard laboratory was 90 minutes, with a mean turnaround time of 74 to 78 minutes, depending upon the group. In contrast, the median turnaround time for point-of-care testing was two minutes and 14 seconds. Conclusions.The results from this study population reveal that data obtained from point-of-care prothrombin time, international normalized ratio and activated partial thromboplastin time results correlate with results obtained from standard laboratory coagulation testing. The value of obtaining reliable results in a timely fashion offers a potential advantage for point-of-care testing in clinical situations, such as in the operating room, where saving time may translate into financial savings.  相似文献   

16.
BACKGROUND: The objective of this study was to evaluate a portable clinical analyzer (PCA) in the pediatric emergency department (ED), examining (1) turnaround time, (2) cost, and (3) sample amounts for PCA versus standard laboratory. METHODS: Twenty children were studied. Laboratory measurements were taken from the study group using PCA and central laboratory as the control. RESULTS: The PCA turnaround times were 54.2 minutes faster than the central laboratory. Cost was $1.65 less for the PCA. The PCA sample size was smaller (0.29 mL vs 2.62 mL). CONCLUSIONS: Laboratory values obtained by PCA were available to treating physicians significantly faster than those from the central laboratory. The PCA costs less and uses a smaller blood sample than the central laboratory. Use of PCA technology has the potential to decrease laboratory turnaround time and cost. Further investigation on the influence of patient care is needed.  相似文献   

17.
The emergency departments (ED) at many medical centers are experiencing increased crowding and prolonged ED patient length of stay. During periods of heavy patient volume, the ED may go on divert status and be unable to care for new patients except for life-threatening illness. As part of a larger interdepartmental effort to improve ED operations, we implemented an ED satellite laboratory (kiosk) in the ED of Massachusetts General Hospital. The tests performed included cardiac markers, urinalysis, urine pregnancy testing, and whole blood glucose testing. The resulting average test turnaround time decreased by 51.5 minutes (87%) compared with the central laboratory, and physician satisfaction increased markedly. ED patient length of stay decreased by an average of 41 minutes for each patient tested, and the number of ED divert hours has steadily decreased. We therefore have concluded that point-of-care testing in an ED satellite laboratory may improve ED operations and contribute to improved outcomes when implemented as part of a larger interdepartmental effort.  相似文献   

18.
This study evaluated the role of serum cardiac troponin I as a biochemical marker for the diagnosis of acute coronary syndromes in the presence of noncardiac diseases. Diagnostic characteristics were examined in 102 consecutive patients who were found to have serum cardiac troponin I levels higher than the upper reference limit of 0.6 ng/mL. Of 102 patients with cardiac troponin I levels of >0.6 ng/mL, 35 did not have the final diagnoses of acute coronary syndromes (myocardial infarction or unstable angina) but had various other final diagnoses, including nonischemic dilated cardiomyopathy, muscular disorders, central nervous system disorders, HIV disease, chronic renal failure, sepsis, lung diseases, and endocrine disorders. The mean value of serum cardiac troponin I in the patients with diseases other than acute coronary syndromes was significantly lesser than in those with acute coronary syndromes (2.0+/-1.9 [SD] v. 24.7+/-28.2 ng/mL; P<.0001). There were significantly fewer histories of chest pain and prior myocardial infarction in patients with diseases other than acute coronary syndromes than in those with acute coronary syndromes (history of chest pain, 3 v. 48 patients [P<.001]; history of prior myocardial infarction, 0 v. 30 patients [P<.001]). In conclusion, elevated serum levels of cardiac troponin I, especially in the lower ranges, should be interpreted with caution, particularly in patients suffering from acute illnesses who lack other diagnostic features suggestive of acute coronary ischemic events.  相似文献   

19.
BACKGROUND: The need to rapidly evaluate patients presenting to emergency departments and cardiology services for ruling in and ruling out acute myocardial infarction (AMI) is widely recognized as a clinical challenge. We determined the impact of incorporating point-of-care (POC) cardiac troponin I (cTnI) testing into a cardiology service regarding assay turn around time (TAT), patient length of stay (LOS), financial matrixes and patient outcomes compared to central laboratory cTnI testing. METHODS: Patients presenting with symptoms suggestive of acute coronary syndrome (ACS) were enrolled pre-POC (PreCS, n=271) and post-POC (PostCS, n=274). POC cTnI determinations were performed at the bedside on the Dade Behring Stratus CS by nursing staff. Routine cTnI determinations were performed in the central laboratory (Dade Behring Dimension) by laboratory staff. Data were collected and analyzed on each patient per hospital stay by review of electronic medical and financial records. In addition, risk stratification outcomes for all cause death were determined at 30 days and 1 y following baseline sampling based on the 99th percentile cutoff concentrations of <0.1 microg/l for both assays. RESULTS: There was a decrease in time from blood draw to result to healthcare provider (PreCS mean 76 min; PostCS mean 19.5 min; p<0.001) as well as a decrease trend in charge per patient admission (4281 dollars savings) following implementation of POC testing. Total charges per patient admission decreased by 25% PostCS vs. PreCS (17,163 dollars vs. 12,882 dollars); a composite of lower charges for: boarding (-21%), other departments (-58%), pharmacy (-28%), labs (-22%), non-cardiac procedures (-28%), cardiac procedures (-14%). The mean LOS also decreased 8% (p=0.05) from PreCS (2.36 days) to PostCS (2.19 days). cTnI reagents charges to the laboratory were higher for the POC assay, 10.54 dollars, vs. the central lab assay, 3.83 dollars. One year survival was greater in the <0.1 microg/l patients (PreCS 96.2%, PostCS 97.2%) compared to the >0.1 microg/l patients (PreCS 77.7%, PostCS 75.5%); both p<0.001. Kaplan-Meier survival curves showed early separation by 30 days in each group. CONCLUSIONS: Our study demonstrates the cost effectiveness and clinical effectiveness of implementation of POC whole blood, cTnI testing for assisting clinicians with diagnostic and risk assessment of ACS patients.  相似文献   

20.
Stratifying risk of patients with acute coronary syndrome (ACS) in the emergency department (ED) remains a frequent challenge. When ST-elevation criteria are absent, current recommendations rely upon insensitive and time-intensive methods such as the electrocardiogram and cardiac enzyme testing. Here, we report on a series of cases, where emergency physicians used a simplified model for identifying regional wall motion abnormalities by point-of-care echocardiography in patients presenting with chest pain to the ED. With the use of a simplified model described herein, high-risk patients with ACS were identified rapidly in a cohort usually difficult to risk stratify.  相似文献   

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