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The fact that these changes have been made without a thorough Management of Change assessment is often due to a lack of understanding of the impact of the change, and a lack of an IIL that if in place would have identified the potential impact of the change.
A thorough corrosion degradation review of an operating unit by a Subject Matter Expert (SME) should include identification of operating conditions that can impact and change the degradation exposures through the unit.
In the trials included in this meta-analysis, the follow-up assessments of infarct size and LVEF were done at a mean of 36 days (range: from hospital discharge to 6 months) and involved a variety of methods, including echocardiography, radionuclide perfusion studies, and magnetic resonance imaging. Also, these relatively smaller infarcts and essentially normal LVEFs, coupled with the relatively lower mortalities, all suggest that stringent clinical selection allowed only less clinically ill patients into the trials. Finally, it is important and noteworthy that these authors extracted ischemic times, which they are careful to define as generally taken to be the time from onset of infarct symptoms until device activation.
Selection bias, survival bias, and incomplete follow-up no doubt interfered with the comparisons, and it is not surprising that there were no differences in infarct size (mean: 17.1% vs. Mean ischemic times in these studies ranged from 2.4 h to 7.6 h.
We and others have shown that total ischemic time is the correct focus of attention for reperfusion in STEMI (6,7).
To further illustrate its importance, we used the ischemic time and infarct size data reported in the present meta-analysis (Fig. Based on data from studies in animals and humans, it appears that a total ischemic time of Ischemic Time Versus Infarct Size The x-axis shows mean ischemic time in hours.
(1) reported that aspiration thrombectomy prior to percutaneous coronary intervention (PCI) in acute ST segment–elevation myocardial infarction (STEMI) can be beneficial.Similar to their previous findings, both TIMI blush grade 3 and STR were significantly better with aspiration thrombectomy compared with PCI only, and mortality at 6 months was lower (2.7% vs. Mechanical thrombectomy again did not exhibit benefit compared with PCI alone.The data extracted regarding infarct size and LVEF are interesting but not conclusive, and this further reinforces the need for larger randomized trials that address these clinical measures directly using uniform methods.What that finding might mean is unknown at present.Myocardial blush grades, STR, and clinical events also were not different, but the TROFI trial was not designed or powered for those secondary outcomes. (5) of the previous meta-analysis have now updated their work with several important additions.
“An established limit or standard operating range for other integrity parameters that are used primarily by SME’s (e.g., process engineer, inspector, corrosion specialist, etc.) to predict and/or control the longer term integrity/reliability of the equipment.