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Carl J. Pepine - One of the best experts on this subject based on the ideXlab platform.
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Revisiting the culprit lesion in non–Q-wave myocardial infarction: Results from the VANQWISH trial angiographic Core Laboratory
Journal of the American College of Cardiology, 2002Co-Authors: Richard A Kerensky, Michael J. Wade, Prakash Deedwania, William E. Boden, Carl J. PepineAbstract:Abstract Objectives We sought to determine the underlying coronary anatomy and characterize the culprit lesion after non–Q-wave myocardial infarction (NQWMI). Background Although the culprit lesion and infarct-related artery often are easily identified with coronary angiography after Q-wave MI, the culprit lesion after NQWMI has not been well characterized. Small retrospective studies have suggested that the absence of Q-waves on an electrocardiogram is due to incomplete occlusion of the infarct-related artery. Methods Coronary angiograms from 350 patients randomized to the early invasive strategy in the Veterans Affairs Non–Q-Wave Infarction Strategies in-Hospital (VANQWISH) trial were systematically analyzed in an angiographic Core Laboratory. A consensus panel identified the culprit lesion and the infarct-related artery using prespecified criteria for complex lesion morphology and acute versus chronic occlusions. Severity of angiographic disease and left ventricular function also were analyzed. Patients with a single identified culprit lesion were compared with those who had multiple apparent culprits and those without an identifiable culprit lesion. Results A single culprit lesion was identified in only 49% of patients undergoing early angiography after NQWMI. The majority of patients either had no identifiable culprit (37%) or multiple apparent culprit lesions (14%). A single incomplete occlusion of the infarct-related artery was found in only 36% of patients, and an isolated acute occlusion of the infarct-related artery occurred in 13%. Patients without an identifiable culprit lesion had severe coronary disease (obstructive coronary artery disease [CAD] in 84%) but no complex lesion morphology. There was no difference in angiographic severity of disease comparing patients with and without identifiable culprit lesions. Patients with a single incomplete occlusion of the infarct-related artery were more likely to undergo percutaneous transluminal coronary angioplasty than other patients, whereas patients with multiple culprit lesions were more frequently treated with coronary artery bypass grafting. Conclusions Coronary angiography early after NQWMI frequently identifies severe obstructive CAD, but a single identifiable culprit lesion was identified in
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revisiting the culprit lesion in non q wave myocardial infarction results from the vanqwish trial angiographic Core Laboratory
Journal of the American College of Cardiology, 2002Co-Authors: Richard A Kerensky, Prakash Deedwania, William E. Boden, Michael Wade, Carl J. PepineAbstract:Abstract Objectives We sought to determine the underlying coronary anatomy and characterize the culprit lesion after non–Q-wave myocardial infarction (NQWMI). Background Although the culprit lesion and infarct-related artery often are easily identified with coronary angiography after Q-wave MI, the culprit lesion after NQWMI has not been well characterized. Small retrospective studies have suggested that the absence of Q-waves on an electrocardiogram is due to incomplete occlusion of the infarct-related artery. Methods Coronary angiograms from 350 patients randomized to the early invasive strategy in the Veterans Affairs Non–Q-Wave Infarction Strategies in-Hospital (VANQWISH) trial were systematically analyzed in an angiographic Core Laboratory. A consensus panel identified the culprit lesion and the infarct-related artery using prespecified criteria for complex lesion morphology and acute versus chronic occlusions. Severity of angiographic disease and left ventricular function also were analyzed. Patients with a single identified culprit lesion were compared with those who had multiple apparent culprits and those without an identifiable culprit lesion. Results A single culprit lesion was identified in only 49% of patients undergoing early angiography after NQWMI. The majority of patients either had no identifiable culprit (37%) or multiple apparent culprit lesions (14%). A single incomplete occlusion of the infarct-related artery was found in only 36% of patients, and an isolated acute occlusion of the infarct-related artery occurred in 13%. Patients without an identifiable culprit lesion had severe coronary disease (obstructive coronary artery disease [CAD] in 84%) but no complex lesion morphology. There was no difference in angiographic severity of disease comparing patients with and without identifiable culprit lesions. Patients with a single incomplete occlusion of the infarct-related artery were more likely to undergo percutaneous transluminal coronary angioplasty than other patients, whereas patients with multiple culprit lesions were more frequently treated with coronary artery bypass grafting. Conclusions Coronary angiography early after NQWMI frequently identifies severe obstructive CAD, but a single identifiable culprit lesion was identified in
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detailed angiographic analysis of women with suspected ischemic chest pain pilot phase data from the nhlbi sponsored women s ischemia syndrome evaluation wise study angiographic Core Laboratory
American Journal of Cardiology, 2001Co-Authors: Arry L Sharaf, Carl J. Pepine, Richard A Kerensky, Steve E Reis, Nathaniel Reichek, William J Rogers, George Sopko, Sheryl F Kelsey, Richard Holubkov, Maria OlsoAbstract:Abstract The purpose of this study is to provide a contemporary qualitative and quantitative analysis of coronary angiograms from a large series of women enrolled in the Women’s Ischemia Syndrome Evaluation (WISE) study who had suspected ischemic chest pain. Previous studies have suggested that women with chest pain have a lower prevalence of significant coronary artery disease (CAD) compared with men. Detailed analyses of angiographic findings relative to risk factors and outcomes are not available. All coronary angiograms were reviewed in a central Core Laboratory. Quantitative measurement of percent stenosis was used to assess the presence and severity of disease. Of the 323 women enrolled in the pilot phase, 34% had no detectable, 23% had measurable but minimal, and 43% had significant (>50% diameter stenosis) CAD. Of those with significant CAD, most had multivessel disease. Features suggesting complex plaque were identified in
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Digital assessment of the epicardial electrocardiogram: novel methodology for a Core Laboratory for clinical studies.
Clinical cardiology, 1999Co-Authors: J. Willis Hurst, Barry E. Bertolet, Alice F. Boyette, Eileen M. Handberg‐thurmond, Robert A. Wolf, David Deitchman, Mel Blumenthal, Carl J. PepineAbstract:Background: The epicardial electrocardiogram (ECG) is a sensitive marker for cardiac ischemia and has been used as a measure of ischemia in clinical trials. We sought to examine the utility of a central ECG Laboratory for determining ischemic-type ST-segment shifts from epicardial ECG recordings obtained from multiple clinical sites. Hypothesis: We speculated that an operator-assisted digital ECG Core Laboratory is feasible, reliable, and efficient, with the ability for rapid and accurate interpretation of the epicardial ECG. Methods: The epicardial ECG was recorded via an angioplasty guidewire placed in a coronary artery of a patient undergoing angioplasty. Site investigators visually determined the time-to-onset of 0.1 and 0.3 mm ST-segment elevation, and the maximal ST-segment elevation during balloon inflation, and then compared the measurements with those made at an operator-assisted digital ECG Core Laboratory. Results: Agreement between the two methods occurred in 78% of the time-to-onset measurements, but in only 39% of the maximal ST-segment measurements. Overall, the visual measurements of the clinical investigators of time-to-onset differed from the digital Core Laboratory by 11.8 ± 11.6 s for 0.1 mV, and 15.8 ± 20.6 s for 0.3 mV. Recorded maximal ST-segment shifts differed by a mean of 0.47 ± 0.69 mV. Conclusion: The magnitude of inconsistency between the ECG Core Laboratory results using an operator-assisted digital method and the interpretations of clinical investigators using manual caliper-type analysis was surprisingly large. These results support the need for an ECG Core Laboratory in clinical trials where ECG ST-segment shifts are used as a response variable.
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A detailed angiographic analysis of patients with ambulatory electrocardiographic ischemia: results from the Asymptomatic Cardiac Ischemia Pilot (ACIP) study angiographic Core Laboratory.
Journal of the American College of Cardiology, 1997Co-Authors: Barry L. Sharaf, David O. Williams, Nicholas J. Miele, Robert P. Mcmahon, Peter H. Stone, Preben Bjerregaard, Richard F. Davies, A.david Goldberg, Michael J Parks, Carl J. PepineAbstract:Abstract Objectives. The purpose of this Asymptomatic Cardiac Ischemia Pilot (ACIP) data bank study was to characterize angiographic features of coronary pathology of patients enrolled in the ACIP study. Background. Ischemia during ambulatory electrocardiographic (AECG) monitoring is associated with increased morbidity and mortality. Reports relating AECG ischemia to severity or complexity of coronary artery disease are few in number and small in size and have produced conflicting results. Methods. Coronary angiograms from patients with asymptomatic AECG ischemia enrolled in the ACIP study were reviewed at a central Core Laboratory. Quantitative measurement of percent stenosis and Thrombolysis in Myocardial Infarction flow grades were used to assess the severity of coronary artery disease. Lesions were also evaluated for the presence of intracoronary thrombus, ulceration and lumen contour as indicators of stenosis complexity. In addition, comparisons were made with 27 patients screened for the ACIP study, but who were found ineligible because they did not have AECG ischemia on 48-h Holter monitoring. Results. A total of 329 (75%) of 439 patients with AECG ischemia had multivessel coronary artery disease. Proximal stenoses ≥50% diameter reduction were common in patients with AECG ischemia (62.2%), as were proximal stenoses ≥70% (38.7%). Features suggesting complex plaque were found in 50.1% of patients with AECG ischemia. Conclusions. Multivessel coronary artery disease, severe proximal stenoses and features of complex plaque were observed frequently in patients who exhibited AECG ischemia. The presence of severe and complex coronary artery disease may explain, in part, the increased risk for adverse outcome associated with ischemia during activities of daily life. (J Am Coll Cardiol 1997;29:78–84)>
Richard A Kerensky - One of the best experts on this subject based on the ideXlab platform.
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revisiting the culprit lesion in non q wave myocardial infarction results from the vanqwish trial angiographic Core Laboratory
Journal of the American College of Cardiology, 2002Co-Authors: Richard A Kerensky, Prakash Deedwania, William E. Boden, Michael Wade, Carl J. PepineAbstract:Abstract Objectives We sought to determine the underlying coronary anatomy and characterize the culprit lesion after non–Q-wave myocardial infarction (NQWMI). Background Although the culprit lesion and infarct-related artery often are easily identified with coronary angiography after Q-wave MI, the culprit lesion after NQWMI has not been well characterized. Small retrospective studies have suggested that the absence of Q-waves on an electrocardiogram is due to incomplete occlusion of the infarct-related artery. Methods Coronary angiograms from 350 patients randomized to the early invasive strategy in the Veterans Affairs Non–Q-Wave Infarction Strategies in-Hospital (VANQWISH) trial were systematically analyzed in an angiographic Core Laboratory. A consensus panel identified the culprit lesion and the infarct-related artery using prespecified criteria for complex lesion morphology and acute versus chronic occlusions. Severity of angiographic disease and left ventricular function also were analyzed. Patients with a single identified culprit lesion were compared with those who had multiple apparent culprits and those without an identifiable culprit lesion. Results A single culprit lesion was identified in only 49% of patients undergoing early angiography after NQWMI. The majority of patients either had no identifiable culprit (37%) or multiple apparent culprit lesions (14%). A single incomplete occlusion of the infarct-related artery was found in only 36% of patients, and an isolated acute occlusion of the infarct-related artery occurred in 13%. Patients without an identifiable culprit lesion had severe coronary disease (obstructive coronary artery disease [CAD] in 84%) but no complex lesion morphology. There was no difference in angiographic severity of disease comparing patients with and without identifiable culprit lesions. Patients with a single incomplete occlusion of the infarct-related artery were more likely to undergo percutaneous transluminal coronary angioplasty than other patients, whereas patients with multiple culprit lesions were more frequently treated with coronary artery bypass grafting. Conclusions Coronary angiography early after NQWMI frequently identifies severe obstructive CAD, but a single identifiable culprit lesion was identified in
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Revisiting the culprit lesion in non–Q-wave myocardial infarction: Results from the VANQWISH trial angiographic Core Laboratory
Journal of the American College of Cardiology, 2002Co-Authors: Richard A Kerensky, Michael J. Wade, Prakash Deedwania, William E. Boden, Carl J. PepineAbstract:Abstract Objectives We sought to determine the underlying coronary anatomy and characterize the culprit lesion after non–Q-wave myocardial infarction (NQWMI). Background Although the culprit lesion and infarct-related artery often are easily identified with coronary angiography after Q-wave MI, the culprit lesion after NQWMI has not been well characterized. Small retrospective studies have suggested that the absence of Q-waves on an electrocardiogram is due to incomplete occlusion of the infarct-related artery. Methods Coronary angiograms from 350 patients randomized to the early invasive strategy in the Veterans Affairs Non–Q-Wave Infarction Strategies in-Hospital (VANQWISH) trial were systematically analyzed in an angiographic Core Laboratory. A consensus panel identified the culprit lesion and the infarct-related artery using prespecified criteria for complex lesion morphology and acute versus chronic occlusions. Severity of angiographic disease and left ventricular function also were analyzed. Patients with a single identified culprit lesion were compared with those who had multiple apparent culprits and those without an identifiable culprit lesion. Results A single culprit lesion was identified in only 49% of patients undergoing early angiography after NQWMI. The majority of patients either had no identifiable culprit (37%) or multiple apparent culprit lesions (14%). A single incomplete occlusion of the infarct-related artery was found in only 36% of patients, and an isolated acute occlusion of the infarct-related artery occurred in 13%. Patients without an identifiable culprit lesion had severe coronary disease (obstructive coronary artery disease [CAD] in 84%) but no complex lesion morphology. There was no difference in angiographic severity of disease comparing patients with and without identifiable culprit lesions. Patients with a single incomplete occlusion of the infarct-related artery were more likely to undergo percutaneous transluminal coronary angioplasty than other patients, whereas patients with multiple culprit lesions were more frequently treated with coronary artery bypass grafting. Conclusions Coronary angiography early after NQWMI frequently identifies severe obstructive CAD, but a single identifiable culprit lesion was identified in
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detailed angiographic analysis of women with suspected ischemic chest pain pilot phase data from the nhlbi sponsored women s ischemia syndrome evaluation wise study angiographic Core Laboratory
American Journal of Cardiology, 2001Co-Authors: Arry L Sharaf, Carl J. Pepine, Richard A Kerensky, Steve E Reis, Nathaniel Reichek, William J Rogers, George Sopko, Sheryl F Kelsey, Richard Holubkov, Maria OlsoAbstract:Abstract The purpose of this study is to provide a contemporary qualitative and quantitative analysis of coronary angiograms from a large series of women enrolled in the Women’s Ischemia Syndrome Evaluation (WISE) study who had suspected ischemic chest pain. Previous studies have suggested that women with chest pain have a lower prevalence of significant coronary artery disease (CAD) compared with men. Detailed analyses of angiographic findings relative to risk factors and outcomes are not available. All coronary angiograms were reviewed in a central Core Laboratory. Quantitative measurement of percent stenosis was used to assess the presence and severity of disease. Of the 323 women enrolled in the pilot phase, 34% had no detectable, 23% had measurable but minimal, and 43% had significant (>50% diameter stenosis) CAD. Of those with significant CAD, most had multivessel disease. Features suggesting complex plaque were identified in
William E. Boden - One of the best experts on this subject based on the ideXlab platform.
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Revisiting the culprit lesion in non–Q-wave myocardial infarction: Results from the VANQWISH trial angiographic Core Laboratory
Journal of the American College of Cardiology, 2002Co-Authors: Richard A Kerensky, Michael J. Wade, Prakash Deedwania, William E. Boden, Carl J. PepineAbstract:Abstract Objectives We sought to determine the underlying coronary anatomy and characterize the culprit lesion after non–Q-wave myocardial infarction (NQWMI). Background Although the culprit lesion and infarct-related artery often are easily identified with coronary angiography after Q-wave MI, the culprit lesion after NQWMI has not been well characterized. Small retrospective studies have suggested that the absence of Q-waves on an electrocardiogram is due to incomplete occlusion of the infarct-related artery. Methods Coronary angiograms from 350 patients randomized to the early invasive strategy in the Veterans Affairs Non–Q-Wave Infarction Strategies in-Hospital (VANQWISH) trial were systematically analyzed in an angiographic Core Laboratory. A consensus panel identified the culprit lesion and the infarct-related artery using prespecified criteria for complex lesion morphology and acute versus chronic occlusions. Severity of angiographic disease and left ventricular function also were analyzed. Patients with a single identified culprit lesion were compared with those who had multiple apparent culprits and those without an identifiable culprit lesion. Results A single culprit lesion was identified in only 49% of patients undergoing early angiography after NQWMI. The majority of patients either had no identifiable culprit (37%) or multiple apparent culprit lesions (14%). A single incomplete occlusion of the infarct-related artery was found in only 36% of patients, and an isolated acute occlusion of the infarct-related artery occurred in 13%. Patients without an identifiable culprit lesion had severe coronary disease (obstructive coronary artery disease [CAD] in 84%) but no complex lesion morphology. There was no difference in angiographic severity of disease comparing patients with and without identifiable culprit lesions. Patients with a single incomplete occlusion of the infarct-related artery were more likely to undergo percutaneous transluminal coronary angioplasty than other patients, whereas patients with multiple culprit lesions were more frequently treated with coronary artery bypass grafting. Conclusions Coronary angiography early after NQWMI frequently identifies severe obstructive CAD, but a single identifiable culprit lesion was identified in
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revisiting the culprit lesion in non q wave myocardial infarction results from the vanqwish trial angiographic Core Laboratory
Journal of the American College of Cardiology, 2002Co-Authors: Richard A Kerensky, Prakash Deedwania, William E. Boden, Michael Wade, Carl J. PepineAbstract:Abstract Objectives We sought to determine the underlying coronary anatomy and characterize the culprit lesion after non–Q-wave myocardial infarction (NQWMI). Background Although the culprit lesion and infarct-related artery often are easily identified with coronary angiography after Q-wave MI, the culprit lesion after NQWMI has not been well characterized. Small retrospective studies have suggested that the absence of Q-waves on an electrocardiogram is due to incomplete occlusion of the infarct-related artery. Methods Coronary angiograms from 350 patients randomized to the early invasive strategy in the Veterans Affairs Non–Q-Wave Infarction Strategies in-Hospital (VANQWISH) trial were systematically analyzed in an angiographic Core Laboratory. A consensus panel identified the culprit lesion and the infarct-related artery using prespecified criteria for complex lesion morphology and acute versus chronic occlusions. Severity of angiographic disease and left ventricular function also were analyzed. Patients with a single identified culprit lesion were compared with those who had multiple apparent culprits and those without an identifiable culprit lesion. Results A single culprit lesion was identified in only 49% of patients undergoing early angiography after NQWMI. The majority of patients either had no identifiable culprit (37%) or multiple apparent culprit lesions (14%). A single incomplete occlusion of the infarct-related artery was found in only 36% of patients, and an isolated acute occlusion of the infarct-related artery occurred in 13%. Patients without an identifiable culprit lesion had severe coronary disease (obstructive coronary artery disease [CAD] in 84%) but no complex lesion morphology. There was no difference in angiographic severity of disease comparing patients with and without identifiable culprit lesions. Patients with a single incomplete occlusion of the infarct-related artery were more likely to undergo percutaneous transluminal coronary angioplasty than other patients, whereas patients with multiple culprit lesions were more frequently treated with coronary artery bypass grafting. Conclusions Coronary angiography early after NQWMI frequently identifies severe obstructive CAD, but a single identifiable culprit lesion was identified in
Bassam A Nassar - One of the best experts on this subject based on the ideXlab platform.
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multiple pre and post analytical lean approaches to the improvement of the Laboratory turnaround time in a large Core Laboratory
Clinical Biochemistry, 2017Co-Authors: Manal O Elnenaei, Irene Sadek, Shauna Thompson, Bryan D Crocker, Bassam A NassarAbstract:Abstract Background Core Laboratory (CL), as a new business model, facilitates consolidation and integration of Laboratory services to enhance efficiency and reduce costs. This study evaluates the impact of total Laboratory automation system (TLA), electric track vehicle (ETV) system and auto-verification (AV) of results on overall turnaround time (TAT) (phlebotomy to reporting TAT: PR-TAT) within a CL setting. Methods Mean, median and percentage of outlier (OP) for PR-TAT were compared for pre- and post-CL eras using five representative tests based on different request priorities. Comparison studies were also carried out on the intra-Laboratory TAT (in-lab to reporting TAT: IR-TAT) and the delivery TAT (phlebotomy to in-lab TAT: PI-TAT) to reflect the efficiency of the TLA (both before and after introducing result AV) and ETV systems respectively. Results Median PR-TATs for the urgent samples were reduced on average by 16% across all representative analytes. Median PR-TATs for the routine samples were curtailed by 51%, 50%, 49%, 34% and 22% for urea, potassium, thyroid stimulating hormone (TSH), complete blood count (CBC) and prothrombin time (PT) respectively. The shorter PR-TAT was attributed to a significant reduction of IR-TAT through the TLA. However, the median PI-TAT was delayed when the ETV was used. Application of various AV rules shortened the median IR-TATs for potassium and urea. However, the OP of PR-TAT for the STAT requests exceeding 60 min were all higher than those from the pre-CL era. Conclusions TLA and auto-verification rules help to efficiently manage substantial volumes of urgent and routine samples. However, the ETV application as it stands shows a negative impact on the PR-TAT.
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evaluation of the impact of a total automation system in a large Core Laboratory on turnaround time
Clinical Biochemistry, 2016Co-Authors: Amy Lou, Manal O Elnenaei, Irene Sadek, Shauna Thompson, Bryan D Crocker, Bassam A NassarAbstract:Abstract Background Growing financial and workload pressures on laboratories coupled with user demands for faster turnaround time (TAT) has steered the implementation of total Laboratory automation (TLA). The current study evaluates the impact of a complex TLA on Core Laboratory efficiency through the analysis of the In-lab to Report TAT (IR-TAT) for five representative tests based on the different requested priorities. Methods Mean, median and outlier percentages (OP) for IR-TAT were determined following TLA implementation and where possible, compared to the pre-TLA era. Results The shortest mean IR-TAT via the priority lanes of the TLA was 22 min for Complete Blood Count (CBC), followed by 34 min, 39 min and 40 min for Prothrombin time (PT), urea and potassium testing respectively. The mean IR-TAT for STAT CBC loaded directly on to the analyzers was 5 min shorter than that processed via the TLA. The mean IR-TATs for both STAT potassium and urea via offline centrifugation were comparable to that processed by the TLA. The longest mean IR-TAT via regular lanes of the TLA was 62 min for Thyroid-Stimulating Hormone (TSH) while the shortest was 17 min for CBC. All parameters for IR-TAT for CBC and PT tests decreased significantly post- TLA across all requested priorities in particular the outlier percentage (OP) at 30 and 60 min. Conclusions TLA helps to efficiently manage substantial volumes of samples across all requested priorities. Manual processing for small STAT volumes, at both the initial centrifugation stage and front loading directly on to analyzers, is however likely to yield the shortest IR-TAT.
Wael A Jaber - One of the best experts on this subject based on the ideXlab platform.
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assessment of paravalvular aortic regurgitation after transcatheter aortic valve replacement intra Core Laboratory variability
Journal of The American Society of Echocardiography, 2015Co-Authors: Rebecca T Hahn, Philippe Pibarot, Neil J Weissman, Leonardo L Rodriguez, Wael A JaberAbstract:Background There is significant disparity in the reported incidence of moderate and severe paravalvular aortic regurgitation (PAR) between the Placement of Aortic Transcatheter Valves (PARTNER) I and PARTNER II trials, which may be related to the echocardiographic methodologies used by separate Core laboratories. To further explore the variability in echocardiographic interpretation of PAR, agreement between the grading of PAR by the Core Laboratory of PARTNER IIB was compared with that by a consortium of echocardiography Core Laboratory directors. Methods The PARTNER IIB Core Laboratory reevaluated patients using primarily the circumferential extent of the regurgitant jet for PAR. A consortium of echocardiography Core Laboratory directors was formed to evaluate the echocardiographic images and to grade PAR and central and total aortic regurgitation in a randomly chosen subset of the randomized patients in the PARTNER IIB trial using a multiwindow, multiparametric approach. Both a four-class scale (none or trace, mild, moderate, and severe) and a seven-class (none, trace, mild, mild to moderate, moderate, moderate to severe, and severe) scale were used. Levels of grading agreement between the consortium and original Core Laboratory in both scales were determined using weighted κ statistics. Results Only 87 patients assessed for PAR by the consortium could be paired with readings by the PARTNER IIB Core Laboratory. Using the four-class grading scheme the weighted κ statistic for PAR was 0.481 (95% confidence limits, 0.367, 0.595). Using the seven-class scale, the weighted κ statistic for PAR was 0.517 (95% confidence limits, 0.431, 0.607). For either grading scheme, 15.9% of patients graded by the PARTNER IIB Core Laboratory as having moderate PAR would have been graded as having mild PAR using the multiparametric approach. Similar results were seen for central and total aortic regurgitation assessments. Conclusions Using primarily the circumferential extent criteria, the PARTNER IIB Core Laboratory overestimated the severity of PAR compared to the consortium using a multi-parametric approach. Although a more granular classification scheme for PAR may slightly improve concordance between Core laboratories, differences in the incidence of moderate or severe PAR are likely related to differences in grading methodology. A multiparametric approach is advocated, and other echocardiographic methods for assessing PAR deserve further study.
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Assessment of Paravalvular Aortic Regurgitation after Transcatheter Aortic Valve Replacement: Intra–Core Laboratory Variability
Journal of the American Society of Echocardiography : official publication of the American Society of Echocardiography, 2015Co-Authors: Rebecca T Hahn, Philippe Pibarot, Neil J Weissman, Leonardo L Rodriguez, Wael A JaberAbstract:Background There is significant disparity in the reported incidence of moderate and severe paravalvular aortic regurgitation (PAR) between the Placement of Aortic Transcatheter Valves (PARTNER) I and PARTNER II trials, which may be related to the echocardiographic methodologies used by separate Core laboratories. To further explore the variability in echocardiographic interpretation of PAR, agreement between the grading of PAR by the Core Laboratory of PARTNER IIB was compared with that by a consortium of echocardiography Core Laboratory directors. Methods The PARTNER IIB Core Laboratory reevaluated patients using primarily the circumferential extent of the regurgitant jet for PAR. A consortium of echocardiography Core Laboratory directors was formed to evaluate the echocardiographic images and to grade PAR and central and total aortic regurgitation in a randomly chosen subset of the randomized patients in the PARTNER IIB trial using a multiwindow, multiparametric approach. Both a four-class scale (none or trace, mild, moderate, and severe) and a seven-class (none, trace, mild, mild to moderate, moderate, moderate to severe, and severe) scale were used. Levels of grading agreement between the consortium and original Core Laboratory in both scales were determined using weighted κ statistics. Results Only 87 patients assessed for PAR by the consortium could be paired with readings by the PARTNER IIB Core Laboratory. Using the four-class grading scheme the weighted κ statistic for PAR was 0.481 (95% confidence limits, 0.367, 0.595). Using the seven-class scale, the weighted κ statistic for PAR was 0.517 (95% confidence limits, 0.431, 0.607). For either grading scheme, 15.9% of patients graded by the PARTNER IIB Core Laboratory as having moderate PAR would have been graded as having mild PAR using the multiparametric approach. Similar results were seen for central and total aortic regurgitation assessments. Conclusions Using primarily the circumferential extent criteria, the PARTNER IIB Core Laboratory overestimated the severity of PAR compared to the consortium using a multi-parametric approach. Although a more granular classification scheme for PAR may slightly improve concordance between Core laboratories, differences in the incidence of moderate or severe PAR are likely related to differences in grading methodology. A multiparametric approach is advocated, and other echocardiographic methods for assessing PAR deserve further study.