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- Rebeiz, A. G., et al.
(author)
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Comparison of ST-segment resolution with combined fibrinolytic and glycoprotein IIb/IIIa inhibitor therapy versus fibrinolytic alone (data from four clinical trials)
- 2005
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In: Am J Cardiol. - 0002-9149. ; 95:5, s. 611-4
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Journal article (peer-reviewed)abstract
- We compared combination fibrinolytic plus glycoprotein IIb/IIIa inhibitor therapy with stand-alone fibrinolysis with respect to speed and stability of reperfusion in patients who had acute ST-segment elevation myocardial infarction; data were obtained from 654 patients in 4 trials (Integrilin to Manage Platelet Aggregation to Combat Thrombosis in Acute Myocardial Infarction, Platelet Aggregation Receptor Antagonist Dose Investigation and Reperfusion Gain in Myocardial Infarction, Integrilin and Tenecteplase in Acute Myocardial Infarction, and the Fifth Global Use of Strategies to Open Occluded Coronary Arteries) that compared thrombolytics plus lamifiban, eptifibatide, or abciximab with standard thrombolysis. We found significantly faster and more stable ST-segment recovery with combination therapy starting at 60 minutes (56.7% vs 48.0% with >/=50% ST-segment resolution, p = 0.03) and sustained over 180 minutes after drug administration; this transient benefit may suggest a time frame when more optimal percutaneous coronary intervention can be performed.
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- Johanson, Per, 1963, et al.
(author)
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An academic ECG core lab perspective of the FDA initiative for digital ECG capture and data management in large-scale clinical trials
- 2005
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In: Drug Information Journal. - 0092-8615. ; 39:4, s. 345-351
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Journal article (peer-reviewed)abstract
- Maximal utility of accessible data is attractive to all partners in clinical research, whether it directly improves patient care or more accurately allows identification of the safety and efficacy of a new drug or procedure. The Food and Drug Administration (FDA) has presented a guideline draft addressing digitization of electrocardiogram (ECG) data in clinical trials to improve the standards for collection, analysis, and storage of safety information on new medical therapies. This FDA initiative has led to discussions and collaboration among the FDA, the pharmaceutical industry, the electrocardiographj, manufacturers, and the academic as well as the nonacademic EGG core labs. In this article, we present a broad-based viewpoint from two groups of academic EGG core labs, the Alliance of Academic EGG Core Labs and the Virtual Electronic EGG Corelab International Consortium. We have chosen to widen the perspective from using digitized EGG data in safety trials only, as addressed by the FDA guideline draft, to a discussion on the possibilities and the potential problems when using digitized EGG data also in large clinical trials focusing on efficacy measurements. We conclude that the benefit of digital data mining is probably well worth an initial incremental effort and expense.
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- Nelwan, S. P., et al.
(author)
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Assessment of derived 12-lead electrocardiograms using general and patient-specific reconstruction strategies at rest and during transient myocardial ischemia
- 2004
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In: Am J Cardiol. - 0002-9149. ; 94:12, s. 1529-33
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Journal article (peer-reviewed)abstract
- Twelve-lead ST-segment monitoring is a widely used tool for capturing focal ischemia and transient intermittent episodes. However, continuous registration of all 10 electrodes is impractical in clinical settings. This study investigated the accuracy of 2 derived 12-lead strategies that required 6 electrodes, including all limb leads, and 2 precordial leads by using population-based (generalized) and individualized (patient-specific) reconstruction coefficients to derive the additional 4 chest leads. A total of 26,880 simultaneous digital conventional 12-lead generalized and patient-specific electrocardiograms were monitored over 112 hours in 39 patients during percutaneous coronary intervention, including 159 balloon occlusions in 63 arteries, to test accuracy at rest and during ischemia. Occlusion duration was 78 seconds (range 42 to 96) in the left main coronary in 2 patients, the left anterior descending artery in 15, the right coronary artery in 10, the circumflex artery in 2, and graft segments in 5 patients. Average summated 12-lead ST deviation over the study population at baseline was 377 microV (range 104 to 1,718), which increased at peak ischemia to an average of 1,086 microV (range 282 to 4,099). Median absolute differences at peak ischemic ST deviation were 25 microV in lead V(1), 0 microV in lead V(2), 35 microV in lead V(3), 34 microV in lead V(4), 0 microV in lead V(5), 11 microV in lead V(6), and 114 microV for summated 12-lead ST deviation with the generalized method and 7 microV in lead V(1), 4 microV in lead V(2), 1 muV in lead V(3), 5 microV in lead V(4), 4 microV in lead V(5), 9 microV in lead V(6), and 83 microV for the summated 12-lead ST deviation with the patient-specific method. Limb leads (I, II, III, aVR, aVL, and aVF) were identical in all patients. Thus, generalized and patient-specific methods derived from 12-lead electrocardiography using actual limb and 2 precordial electrodes accurately derived the additional chest leads at rest and during ischemia. These approaches appear to be more practical than conventional 10-electrode monitoring but preserve high accuracy.
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- Hess, Connie N., et al.
(author)
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Relationship Between Cancer and Cardiovascular Outcomes Following Percutaneous Coronary Intervention
- 2015
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In: Journal of the American Heart Association. - 2047-9980. ; 4:7
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Journal article (peer-reviewed)abstract
- Background-Cardiovascular disease and cancer increasingly coexist, yet relationships between cancer and long-term cardiovascular outcomes post-percutaneous coronary intervention (PCI) are not well studied. Methods and Results-We examined stented PCI patients at Duke (1996-2010) using linked data from the Duke Information Systems for Cardiovascular Care and the Duke Tumor Registry (a cancer treatment registry). Our primary outcome was cardiovascular mortality. Secondary outcomes included composite cardiovascular mortality, myocardial infarction, or repeat revascularization and all-cause mortality. We used adjusted cause-specific hazard models to examine outcomes among cancer patients (cancer treatment pre-PCI) versus controls (no cancer treatment pre-PCI). Cardiovascular mortality was explored in a cancer subgroup with recent (within 1 year pre-PCI) cancer and in post-PCI cancer patients using post-PCI cancer as a time-dependent variable. Among 15 008 patients, 3.3% (n=496) were cancer patients. Observed rates of 14-year cardiovascular mortality (31.4% versus 27.7%, P=0.31) and composite cardiovascular death, myocardial infarction, or revascularization (51.1% versus 55.8%, P=0.37) were similar for cancer versus control groups; all-cause mortality rates were higher (79.7% versus 49.3%, P<0.01). Adjusted risk of cardiovascular mortality was similar for cancer patients versus controls (hazard ratio 0.95; 95% CI 0.76 to 1.20) and for patients with versus without recent cancer (hazard ratio 1.46; 95% CI 0.92 to 2.33). Post-PCI cancer, present in 4.3% (n=647) of patients, was associated with cardiovascular mortality (adjusted hazard ratio 1.51; 95% CI 1.11 to 2.03). Conclusions-Cancer history was present in a minority of PCI patients but was not associated with worse long-term cardiovascular outcomes. Further investigation into PCI outcomes in this population is warranted.
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- Johanson, Per, 1963, et al.
(author)
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A dynamic model forecasting myocardial infarct size before, during, and after reperfusion therapy: an ASSENT-2 ECG/VCG substudy
- 2005
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In: Eur Heart J. - : Oxford University Press (OUP). - 0195-668X. ; 26:17, s. 1726-33
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Journal article (peer-reviewed)abstract
- AIMS: Serial forecasts of final myocardial infarct (MI) size during fibrinolytic treatment (Rx) of ST-elevation MI would allow the identification of high-risk patients with a predicted major loss of viable myocardium, at a point when treatment may still be modified. We investigated a model for such forecasting, using time and the ECG. METHODS AND RESULTS: We collected 234 patients with ST-elevation MI, without signs of previous MI, bundle branch block, or hypertrophy. MI size was determined by the Selvester score and was "forecasted" at: admission with patients stratified by delay time and an ECG acuteness score into three groups (EARLY, DISCORDANT, and LATE); 90 min after Rx by > or =70% ST-recovery or not and occurrence of "reperfusion peaks"; 4 h after Rx by ST re-elevations. EARLY patients had smaller final infarct sizes than LATE (9.4 vs. 20%, P=0.01). EARLY patients with > or =70% ST-recovery without a reperfusion peak had smaller infarct sizes than those with (3.1 vs. 12.5%, P=0.001). EARLY patients without ST re-elevations had smaller infarct sizes (1.5%) than those with some (9%) or many re-elevations (12%), P<0.001. CONCLUSION: Final infarct size can be forecasted using delay time and serial ECGs. Serially updated forecasts seem especially important when both clock-time and initial ECG- signs indicate earliness.
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- Simonato, Matheus, et al.
(author)
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Minimum Core Data Elements for Evaluation of TAVR : A Scientific Statement by PASSION CV, HVC, and TVT Registry
- 2022
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In: Academic pediatrics. - : Elsevier. - 1876-2859 .- 1876-2867. ; 22:3, s. 685-697
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Journal article (peer-reviewed)abstract
- Transcatheter aortic valve replacement (TAVR) is the standard of care for severe, symptomatic aortic stenosis. Real-world TAVR data collection contributes to benefit/risk assessment and safety evidence for the U.S. Food and Drug Administration, quality evaluation for the Centers for Medicare and Medicaid Services and hospitals, as well as clinical research and real-world implementation through appropriate use criteria. The essential minimum core dataset for these purposes has not previously been defined but is necessary to promote efficient, reusable real-world data collection supporting quality, regulatory, and clinical applications. The authors performed a systematic review of the published research for high-impact TAVR studies and U.S. multicenter, multidevice registries. Two expert task forces, one from the Predictable and Sustainable Implementation of National Cardiovascular Registries/Heart Valve Collaboratory and another from The Society of Thoracic Surgeons/American College of Cardiology TVT (Transcatheter Valve Therapy) Registry convened separately and then met to reconcile a final list of essential data elements. From 276 unique data elements considered, unanimous consensus agreement was achieved on 132 "core" data elements, with the most common reasons for exclusion from the minimum core dataset being burden or difficulty in accurate assessment (36.9%), duplicative information (33.3%), and low likelihood of affecting outcomes (10.7%). After a systematic review and extensive discussions, a multilateral group of academicians, industry representatives, and regulators established 132 interoperable, reusable essential core data elements essential to supporting more efficient, consistent, and informative TAVR device evidence for regulatory submissions, safety surveillance, best practice, and hospital quality assessments.
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