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Objectives: We examined the appropriateness of prehospital cardiac catheter laboratory activation (CCL-A) in ST-segment elevation myocardial infarction (STEMI) utilizing the University of Glasgow algorithm (UGA) and remote interventional cardiologist consultation., Background: The incremental benefit of prehospital electrocardiogram (PH-ECG) transmission on the diagnostic accuracy and appropriateness of CCL-A has been examined in a small number of studies with conflicting results., Methods: We identified consecutive PH-ECG transmissions between June 2, 2010 and October 6, 2016. Blinded adjudication of ECGs, appropriateness of CCL-A, and index diagnoses were performed using the fourth universal definition of MI. The primary outcome was the appropriate CCL-A rate. Secondary outcomes included rates of false-positive CCL-A, inappropriate CCL-A, and inappropriate CCL nonactivation., Results: Among 1088 PH-ECG transmissions, there were 565 (52%) CCL-As and 523 (48%) CCL nonactivations. The appropriate CCL-A rate was 97% (550 of 565 CCL-As), of which 4.9% (n = 27) were false-positive. The inappropriate CCL-A rate was 2.7% (15 of 565 CCL-As) and the inappropriate CCL nonactivation rate was 3.6% (19 of 523 CCL nonactivations). Reasons for appropriate CCL nonactivation (n = 504) included nondiagnostic ST-segment elevation (n = 128, 25%), bundle branch block (n = 132, 26%), repolarization abnormality (n = 61, 12%), artefact (n = 72, 14%), no ischemic symptoms (n = 32, 6.3%), severe comorbidities (n = 26, 5.2%), transient ST-segment elevation (n = 20, 4.0%), and others., Conclusions: PH-ECG interpretation utilizing UGA with interventional cardiologist consultation accurately identified STEMI with low rates of inappropriate and false-positive CCL-As, whereas using UGA alone would have almost doubled CCL-As. The benefits of cardiologist consultation were identifying "masquerading" STEMI and avoiding unnecessary CCL-As., (© 2022 The Authors. Catheterization and Cardiovascular Interventions published by Wiley Periodicals LLC.)

Background Patients with suspected ST-segment-elevation myocardial infarction (STEMI) and cardiac catheterization laboratory nonactivation (CCL-NA) or cancellation have reportedly similar crude and higher adjusted risks of death compared with those with CCL activation, though reasons for these poor outcomes are not clear. We determined late clinical outcomes among patients with prehospital ECG STEMI criteria who had CCL-NA compared with those who had CCL activation. Methods and Results We identified consecutive prehospital ECG transmissions between June 2, 2010 to October 6, 2016. Diagnoses according to the Fourth Universal Definition of myocardial infarction (MI), particularly rates of myocardial injury, were adjudicated. The primary outcome was all-cause death. Secondary outcomes included cardiovascular death/MI/stroke and noncardiovascular death. To explore competing risks, cause-specific hazard ratios (HRs) were obtained. Among 1033 included ECG transmissions, there were 569 (55%) CCL activations and 464 (45%) CCL-NAs (1.8% were inappropriate CCL-NAs). In the CCL activation group, adjudicated index diagnoses included MI (n=534, 94%, of which 99.6% were STEMI and 0.4% non-STEMI), acute myocardial injury (n=15, 2.6%), and chronic myocardial injury (n=6, 1.1%). In the CCL-NA group, diagnoses included MI (n=173, 37%, of which 61% were non-STEMI and 39% STEMI), chronic myocardial injury (n=107, 23%), and acute myocardial injury (n=47, 10%). At 2 years, the risk of all-cause death was higher in patients who had CCL-NA compared with CCL activation (23% versus 7.9%, adjusted risk ratio, 1.58, 95% CI, 1.24-2.00), primarily because of an excess in noncardiovascular deaths (adjusted HR, 3.56, 95% CI, 2.07-6.13). There was no significant difference in the adjusted risk for cardiovascular death/MI/stroke between the 2 groups (HR, 1.23, 95% CI, 0.87-1.73). Conclusions CCL-NA was not primarily attributable to missed STEMI, but attributable to "masquerading" with high rates of non-STEMI and myocardial injury. These patients had worse late outcomes than patients who had CCL activation, mainly because of higher rates of noncardiovascular deaths.

Protein A resins are often reused for multiple cycles to improve process economy during mAb purification. Significant reduction in binding capacity and product recovery are typically observed due to the presence of unwanted materials (foulants) deposited on the resin upon reuse. In this paper, we have used a wide spectrum of qualitative and quantitative analytical tools (particle size analysis, HPLC, fluorescence, SEM, MS, and FTIR) to compare the strengths and shortcomings of different analytical tools in terms of their capability to detect the fouling of the resin and relate it to chromatographic cycle performance. While each tool offers an insight into this complex phenomena, fluorescence is the only one that can be used for real-time monitoring of resin fouling. A correlation could be established between fluorescence intensity and the process performance attributes (like yield or binding capacity) impacted upon resin reuse. This demonstration of the application of fluorescence for real-time monitoring correlated empirically with process performance attributes and the results support its use as a PAT tool as part of a process control strategy. While the focus of this paper is on fouling of protein A chromatography resin, the approach and strategy are pertinent to other modes of chromatography as well., (© 2019 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.)

Background: Periodontal disease is a risk factor for atherosclerotic cardiovascular disease and it is recommended internationally that patients with cardiovascular disease should engage in preventative oral health practices and attend regular dental care visits. This study aimed to explore the oral health status, behaviours and knowledge of patients with cardiovascular disease., Methods: A cross-sectional questionnaire containing 31 items was administered to patients with cardiovascular disease from cardiac rehabilitation and outpatient clinics in Sydney Australia in 2016-2017., Results: Of the 318 patients surveyed, 81.1% reported having at least one oral health problem. Over a third (41.2%) of participants had not seen a dentist in the preceding 12 months and 10.7% had received any oral healthcare information in the cardiac setting. Those with valvular conditions were more likely to have received information compared to those with other cardiovascular conditions (40.6% versus 7.4%, p < 0.001). Only half of the participants had adequate oral health knowledge., Conclusions: Despite a high incidence of reported oral health problems, many patients lacked knowledge about oral health, were not receiving oral health information from cardiac care providers and had difficulty accessing dental services. Further research is needed to develop oral health strategies in this area.

Background: There are continuing bed constraints in percutaneous coronary intervention centres (PCI) so efficient patient triage from referral hospitals is pivotal. To evaluate a strategy of PCI centre (PCIC) bed-sparing we examined return of patients to referral hospitals screened by the RETRIEVE (REverse TRIage EVEnts) criteria and validated its use as a tool for screening suitability for same day transfer of non-ST-elevation acute coronary syndrome (NSTEACS) patients post PCI to their referring non-PCI centre (NPCIC)., Methods: From May 2008 to May 2011, 433 NSTEACS patients were prospectively screened for suitability for same day transfer back to the referring hospital at the completion of PCI. Of these patients, 212 were excluded from same day transfer using the RETRIEVE criteria and 221 patients met the RETRIEVE criteria and were transferred back to their NPCIC., Results: Over the study period, 218 patients (98.6%) had no major adverse events. The primary endpoint (death, arrhythmia, myocardial infarction, major bleeding event, cerebrovascular accident, major vascular site complication, or requirement for return to the PCIC) was seen in only three transferred patients (1.4%)., Conclusions: The RETRIEVE criteria can be used successfully to identify NSTEACS patients suitable for transfer back to NPCIC following PCI. Same day transfer to a NPCIC using the RETRIEVE criteria was associated with very low rates of major complications or repeat transfer and appears to be as safe as routine overnight observation in a PCIC., (Copyright © 2017 Australian and New Zealand Society of Cardiac and Thoracic Surgeons (ANZSCTS) and the Cardiac Society of Australia and New Zealand (CSANZ). All rights reserved.)

Adsorbent lifetime during protein A chromatography is not readily predicted or understood, representing a key challenge to be addressed for biopharmaceutical manufacturers. This article focuses on the impact of feed composition on the performance of a typical agarose-based protein A resin across a lifetime of 50 cycles. Cycling studies were performed using three different feed materials with varying levels of feed components including proteases, histones, DNA, and nonhistone proteins. Changes in the process and quality attributes were measured. The DBCs were not seen to vary between conditions although there was a reduction in particle porosity in all cases. Fluorescence spectroscopy and LC-MS/MS were used to identify the contribution and extent of fouling to the observed capacity loss. Residual protein A ligand density and deposition of foulants (HCP, residual mAb, and DNA) varied between the three feed materials. Resins cycled in feed materials containing high concentrations of HCP and histones were seen to have greater extents of capacity loss. The mode of performance loss, capacity loss, or impact on product quality was seen to vary depending on the feed material. The results indicate that feed material composition may be correlated to the rate and mode of resin aging as a basis for improved process understanding. © 2018 American Institute of Chemical Engineers Biotechnol. Prog., 34:412-419, 2018., (© 2018 American Institute of Chemical Engineers.)

Main Objective: The aim of this study was to explore the perception of patients with cardiovascular disease towards oral health and the potential for cardiac care clinicians to promote oral health., Method: A needs assessment was undertaken with twelve patients with cardiovascular disease attending cardiac rehabilitation between 2015 and 2016, in three metropolitan hospitals in Sydney, Australia. These patients participated in face-to-face semi-structured interviews. Data was analysed using thematic analysis., Results: Results suggested that while oral health was considered relevant there was high prevalence of poor oral health among participants, especially those from socioeconomic disadvantaged background. Awareness regarding the importance of oral health care its impact on cardiovascular outcomes was poor among participants. Oral health issues were rarely discussed in the cardiac setting. Main barriers deterring participants from seeking oral health care included lack of awareness, high cost of dental care and difficulties in accessing the public dental service. Findings also revealed that participants were interested in receiving further information about oral health and suggested various mediums for information delivery. The concept of cardiac care clinicians, especially nurses providing education, assessment and referrals to ongoing dental care was well received by participants who felt the post-acute period was the most appropriate time to receive oral health care advice. The issues of oral health training for non-dental clinicians and how to address existing barriers were highlighted by participants., Relevance to Clinical Practice: The lack of oral health education being provided to patients with cardiovascular disease offers an opportunity to improve care and potentially, outcomes. In view of the evidence linking poor oral health with cardiovascular disease, cardiac care clinicians, especially nurses, should be appropriately trained to promote oral health in their practice. Affordable and accessible dental care services for people with cardiovascular disease should be considered and offered by health services in Australia.

Background: The provision of equitable acute coronary syndrome (ACS) care in Australia and New Zealand requires an understanding of the sources of variation in the provision of this care., Objective: The aim of this study was to compare the variation in care and outcomes between ACS patients with limited English proficiency (LEP) and English proficiency (EP) admitted to Australian and NZ hospitals., Methods: Data were collected from 4387 suspected/confirmed ACS patients from 286 hospitals between May 14 and 27, 2012, who were followed for 18 months. We compared hospital care and outcomes according to the proficiency of English using logistic regressions., Results: The 294 LEP patients were older (70.9 vs 66.3 years; P < .001) and had higher prevalence of hypertension (71.1% vs 62.8%; P = .004), diabetes (40.5% vs 24.3%; P < .001), and renal impairment (16.3% vs 11.1%; P = .007) compared with the 4093 EP patients. Once in hospital, there was no difference in receipt of percutaneous coronary intervention (57.0% vs 55.4%; P = .78) or coronary artery bypass graft surgery (10.5% vs 11.5%; P = .98). After adjustment for medical history, there were no significant differences (P > .05) between the 2 groups in the risk of major adverse cardiovascular events and/or all-cause death during the index admission and from index admission to 18 months., Conclusions: These results suggest that LEP patients admitted to Australian or New Zealand hospitals with suspected ACS may not experience inequity in hospital care and outcomes.

A real time monitoring of fouling in liquid chromatography has been presented. The versatility of the approach has been proven by successful implementation in three case studies with an error <1%. The first application demonstrates the monitoring of protein A ligand density and foulant concentration for assessing performance of protein A chromatography resin during purification of monoclonal antibodies. The observations have been supported from LC-MS/MS studies that were independently performed. The second application involves monitoring of foulant deposition during multimode cation exchange chromatography based purification of human serum albumin. Finally, in the third application, monitoring of foulants during multimodal hydrophobic interaction chromatography of recombinant human granulocyte colony stimulating factor is demonstrated. In all three cases, it is observed that the fluorescence intensity consistently increases with resin reuse as more foulants are deposited over time. The proposed approach can be readily used for real time monitoring of fouling and process control.

Capacity reduction in protein A affinity chromatography with extended cycling during therapeutic antibody manufacture is well documented. Identification of which residual proteins remain from previous cycles during the lifetime of these adsorbent materials is required to understand their role in this ageing process, but represents a significant metrological challenge. Scanning electron microscopy (SEM) and liquid chromatography mass spectrometry (LC-MS/MS) are combined to detect and map this phenomenon of protein carry-over. We show that there is a morphological change at the surface of the agarose resin, revealing deposits on the polymer fibres increasing with cycle number. The amount of residual host cell proteins (HCPs) by LC-MS/MS present on the resin is shown to increase 10-fold between 50 and 100 cycles. During this same period the functional class of the predominant HCPs associated with the resin increased in diversity, with number of proteins identified increasing 5-fold. This ageing is observed in the context of the product quality of the eluate HCP and protein A leachate concentration remaining constant with cycle number., (Copyright © 2016 The Author(s). Published by Elsevier B.V. All rights reserved.)

Objective: To evaluate the proportion of patients hospitalised with acute coronary syndrome (ACS) in Australia and New Zealand who received optimal inpatient preventive care and to identify factors associated with preventive care., Methods: All patients hospitalised bi-nationally with ACS were identified between 14-27 May 2012. Optimal in-hospital preventive care was defined as having received lifestyle advice, referral to rehabilitation, and prescription of secondary prevention pharmacotherapies. Multilevel multivariable logistic regression was used to determine factors associated with receipt of optimal preventive care., Results: For the 2299 ACS survivors, mean (SD) age was 69 (13) years, 46% were referred to rehabilitation, 65% were discharged on sufficient preventive medications, and 27% received optimal preventive care. Diagnosis of ST elevation myocardial infarction (OR: 2.64 [95% CI: 1.88-3.71]; p<0.001) and non-ST elevation myocardial infarction (OR: 1.99 [95% CI: 1.52-2.61]; p<0.001) compared with a diagnosis of unstable angina, having a percutaneous coronary intervention (PCI) (OR: 4.71 [95% CI: 3.67-6.11]; p<0.001) or coronary bypass (OR: 2.10 [95% CI: 1.21-3.60]; p=0.011) during the admission or history of hypertension (OR:1.36 [95% CI: 1.06-1.75]; p=0.017) were associated with greater exposure to preventive care. Age over 70 years (OR:0.53 [95% CI: 0.35-0.79]; p=0.002) or admission to a private hospital (OR:0.59 [95% CI: 0.42-0.84]; p=0.003) were associated with lower exposure to preventive care., Conclusions: Only one-quarter of ACS patients received optimal secondary prevention in-hospital. Patients with UA, who did not have PCI, were over 70 years or were admitted to a private hospital, were less likely to receive optimal care., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.)