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Background Atmospheric changes in pollen concentration may affect human health by triggering various allergic processes. We sought to assess if changes in pollen concentrations were associated with different acute coronary syndrome (ACS) subtype presentations and short-term clinical outcomes. Methods and Results We analyzed data in consecutive patients presenting with ACS (unstable angina, non-ST-segment-elevation myocardial infarction, and ST-segment-elevation myocardial infarction) treated with percutaneous coronary intervention between January 2014 and December 2017 and enrolled in the VCOR (Victorian Cardiac Outcomes Registry). Baseline characteristics were compared among patients exposed to different grass and total pollen concentrations. The primary outcome was occurrence of ACS subtypes and 30-day major adverse cardiac and cerebrovascular events (composite of mortality, myocardial infarction, stent thrombosis, target vessel revascularization, or stroke). Of 15 379 patients, 7122 (46.3%) presented with ST-segment-elevation myocardial infarction, 6781 (44.1%) with non-ST-segment-elevation myocardial infarction, and 1476 (9.6%) with unstable angina. The mean age was 62.5 years, with men comprising 76% of patients. No association was observed between daily or seasonal grass and total pollen concentrations with the frequency of ACS subtype presentation. However, grass and total pollen concentrations in the preceding days (2-day average for grass pollen and 7-day average for total pollen) correlated with in-hospital mortality (odds ratio [OR], 2.17 [95% CI, 1.12-4.21]; P=0.021 and OR, 2.78 [95% CI, 1.00-7.74]; P=0.05), respectively, with a trend of 2-day grass pollen for 30-day major adverse cardiac and cerebrovascular events (OR, 1.50 [95% CI, 0.97-2.32]; P=0.066). Conclusions Increased pollen concentrations were not associated with differential ACS subtype presentation but were significantly related to in-hospital mortality following percutaneous coronary interve

BACKGROUND: Clinical quality registries (CQRs) monitor compliance against optimal practice and provide feedback to the clinical community and wider stakeholder groups. Despite a number of CQRs having incorporated the patient perspective to support the evaluation of healthcare delivery, no recommendations for inclusion of patient-reported outcome measures (PROMs) in CQRs exist. The aim of this study was to develop a core set of recommendations for PROMs inclusion of in CQRs. METHOD: An online two-round Delphi survey was performed among CQR data custodians, quality of life researchers, biostatisticians and clinicians largely recruited in Australia. A list of statements for the recommendations was identified from a literature and survey of the Australian registries conducted in 2019. The statements were grouped into the following domains: rationale, setting, ethics, instrument, administration, data management, statistical methods, and feedback and reporting. Eighteen experts were invited to participate, 11 agreed to undertake the first online survey (round 1). Of these, nine experts completed the online survey for round 2. RESULTS: From 117 statements presented to the Delphi panel in round 1, a total of 72 recommendations (55 from round 1 and 17 from round 2) with median importance (MI) ≥ 7 and disagreement index (DI) < 1 were proposed for inclusion into the final draft set and were reviewed by the project team. Recommendations were refined for clarity and to read as stand-alone statements. Ten overlapped conceptually and, therefore, were merged to reduce repetition. The final 62 recommendations were sent for review to the panel members for their feedback, which was incorporated into the final set. CONCLUSION: This is the first study to develop preliminary recommendations for PROMs inclusion in CQRs. Recommendations for PROMs implementation are critically important for registries to assure meaningful PROMs data capture, use, interpretation, and reporting to improve hea

OBJECTIVES: This study sought to assess the association between cardiac surgery availability and percutaneous coronary intervention (PCI) volume with clinical outcomes of cardiogenic shock (CS) complicating acute coronary syndrome (ACS). BACKGROUND: CS remains a grave complication of ACS with high mortality rates despite timely reperfusion and improved heart failure therapies. METHODS: The study analyzed data from consecutive patients with CS complicating ACS who underwent PCI and were prospectively enrolled in the VCOR (Victorian Cardiac Outcomes Registry) from 26 hospitals in Victoria. We compared patients treated at cardiac surgical centers (CSCs) versus non-CSCs as well as the annual CS PCI volume (stratified into tiers of <10, 10-25, and >25 cases) for in-hospital major adverse cardiac and cerebrovascular events (MACCE) and long-term mortality. RESULTS: Of 1,179 patients with CS, the mean age of patients was 65 years; males comprised 74%, and 22% had diabetes mellitus. Cardiac arrest occurred in 38% of patients, while 90% presented with ST-segment elevation myocardial infarction and 26% received intra-aortic balloon pump support. Overall, in-hospital and long-term mortality were 42% and 51%, respectively. There was no difference among patients treated non-CSCs compared with a CSCs for in-hospital MACCE and mortality (both P > 0.05). Similarly, there was no association between tiers of annual CS PCI volume with in-hospital MACCE and mortality (both P > 0.05). CONCLUSIONS: Comparable short- and long-term mortality rates among patients with ACS complicated by CS treated by PCI irrespective of cardiac surgery availability and CS PCI volume support the emergent treatment of these gravely ill patients at their presenting PCI-capable hospital.

BACKGROUND: Patient factors, such as sex and body mass index (BMI), are known to influence patient radiation exposure. Body surface area (BSA) and its association with patient radiation exposure has not been well studied. METHODS AND RESULTS: We analysed height, weight, BMI and BSA in consecutive patients undergoing cardiac catheterisation and percutaneous coronary intervention (PCI) at a high-volume Australian centre between September 2016 and April 2020 to assess their association with dose-area product (DAP, Gycm2). The mean age of the cohort was 64.5 ± 12.3 years with males comprising 68.8% (n = 8100, 5124 diagnostic cardiac catheterisation cases and 2976 PCI cases). Median male BMI was 28.4 kg/m2 [IQR 25.2-32.1] versus 28.8 kg/m2 [24.7-33.7] for females, p = 0.01. Males had higher BSA (2.0 ± 0.2 m2) than females (1.78 ± 0.2 m2), p = 0.001. Each 0.4 m2 increase in BSA conferred a 1.32x fold change in DAP (95% CI 1.29-1.36, p ≤ 0.001). Each 5 kg/m2 increase in BMI was linked to a 1.13x DAP fold change (1.12-1.14, p ≤ 0.001). Male sex conferred a 1.23x DAP fold change (1.20-1.26, p ≤ 0.001). Multivariable modelling with BMI or BSA explained 14% of DAP variance (R2 0.67 vs. 0.53 for both, p ≤ 0.001). CONCLUSIONS: BSA is an important anthropometric measure between the sexes and a key predictor of radiation dose and radiation exposure beyond sex, BMI, and weight.

ObjectivesIn this study, we sought to evaluate the costs of percutaneous coronary intervention (PCI) across a variety of indications in Victoria, Australia, using a direct per-person approach, as well as to identify key cost drivers.DesignA cost-burden study of PCI in Victoria was conducted from the Australian healthcare system perspective.SettingA linked dataset of patients admitted to public hospitals for PCI in Victoria was drawn from the Victorian Cardiac Outcomes Registry (VCOR) and the Victorian Admitted Episodes Dataset. Generalised linear regression modelling was used to evaluate key cost drivers. From 2014 to 2017, 20 345 consecutive PCIs undertaken in Victorian public hospitals were captured in VCOR.Primary outcome measuresDirect healthcare costs attributed to PCI, estimated using a casemix funding method.ResultsKey cost drivers identified in the cost model included procedural complexity, patient length of stay and vascular access site. Although the total procedural cost increased from $A55 569 740 in 2014 to $A72 179 656 in 2017, mean procedural costs remained stable over time ($A12 521 in 2014 to $A12 185 in 2017) after adjustment for confounding factors. Mean procedural costs were also stable across patient indications for PCI ($A9872 for unstable angina to $A15 930 for ST-elevation myocardial infarction) after adjustment for confounding factors.ConclusionsThe overall cost burden attributed to PCIs in Victoria is rising over time. However, despite increasing procedural complexity, mean procedural costs remained stable over time which may be, in part, attributed to changes in clinical practice.

OBJECTIVES: In this study, we sought to evaluate the costs of percutaneous coronary intervention (PCI) across a variety of indications in Victoria, Australia, using a direct per-person approach, as well as to identify key cost drivers. DESIGN: A cost-burden study of PCI in Victoria was conducted from the Australian healthcare system perspective. SETTING: A linked dataset of patients admitted to public hospitals for PCI in Victoria was drawn from the Victorian Cardiac Outcomes Registry (VCOR) and the Victorian Admitted Episodes Dataset. Generalised linear regression modelling was used to evaluate key cost drivers. From 2014 to 2017, 20 345 consecutive PCIs undertaken in Victorian public hospitals were captured in VCOR. PRIMARY OUTCOME MEASURES: Direct healthcare costs attributed to PCI, estimated using a casemix funding method. RESULTS: Key cost drivers identified in the cost model included procedural complexity, patient length of stay and vascular access site. Although the total procedural cost increased from $A55 569 740 in 2014 to $A72 179 656 in 2017, mean procedural costs remained stable over time ($A12 521 in 2014 to $A12 185 in 2017) after adjustment for confounding factors. Mean procedural costs were also stable across patient indications for PCI ($A9872 for unstable angina to $A15 930 for ST-elevation myocardial infarction) after adjustment for confounding factors. CONCLUSIONS: The overall cost burden attributed to PCIs in Victoria is rising over time. However, despite increasing procedural complexity, mean procedural costs remained stable over time which may be, in part, attributed to changes in clinical practice.

OBJECTIVES: We aimed to assess the outcomes of cardiogenic shock (CS) complicating acute coronary syndromes (ACS). BACKGROUND: CS remains the leading cause of mortality in patients presenting with ACS despite advances in care. METHODS: We studied 13,184 patients undergoing percutaneous coronary intervention (PCI) for all subtypes of ACS enrolled prospectively in a large multicentre Australian registry (Melbourne Interventional Group registry) from 2005 to 2013. All-cause mortality was obtained via linkage to the National Death Index. Patients were divided into those with and those without CS. RESULTS: Compared to the non-CS group (n = 12,548, 95.2%), the CS group (n = 636, 4.8%) had a higher proportion of out-of-hospital cardiac arrest (OHCA) (31.1 vs. 2.2%) and ST-elevation myocardial infarction (STEMI) presentation (89 vs. 34%), both p < .01. Patients in the CS group had higher rates of in-hospital (40.4 vs. 1.2%) and 30-day (41 vs. 1.7%) mortality compared to the non-CS group. Long-term mortality over a median follow-up of 4.2 years was higher in the CS group (50.6 vs. 13.8%), p < .001. Trends of in-hospital and 30-day mortality rates of CS complicating ACS were relatively stable from 2005 to 2013. Predictors of long-term NDI-linked mortality within the CS group include severe left ventricular systolic dysfunction (HR 3.0), glomerular filtration rate (GFR) <30 (HR 2.56), GFR 30-59 (HR 1.94), OHCA (HR 1.46), diabetes (HR 1.44), and age (HR 1.02), all p < .05. CONCLUSIONS: Rates of CS-related mortality complicating ACS have remained very high and steady over nearly a decade despite progress in STEMI systems of care, PCI techniques, and medical therapy.

Bleeding severity in patients undergoing percutaneous coronary intervention (PCI), defined by the Bleeding Academic Research Consortium (BARC), portends adverse prognosis. We analysed data from 37,866 Australian patients undergoing PCI enrolled in the Victorian Cardiac Outcomes Registry (VCOR), and investigated the association between increasing BARC severity and in-hospital and 30-day major adverse cardiac and cerebrovascular events (MACCE) (a composite of mortality, myocardial infarction, stent thrombosis, target vessel revascularisation, or stroke). Independent predictors associated with major bleeding (BARC groups 3&5), and MACCE were also assessed. There was a stepwise increase in in-hospital and 30-day MACCE with greater severity of bleeding. Independent predictors of bleeding included female sex (Odds Ratio (OR) 1.34), age (OR 1.02), fibrinolytic therapy (OR 1.77), femoral access (OR 1.51), and ticagrelor (OR 1.42), all significant at the p < 0.001 level. Following adjustment of clinically important variables, BARC 3&5 bleeds (OR 4.37) were still predictive of cumulative in-hospital and 30-day MACCE. In conclusion, major bleeding is an uncommon but potentially fatal PCI complication and was independently associated with greater MACCE rates. Efforts to mitigate the occurrence of bleeding, including radial access and judicious use of potent antiplatelet therapies, may ameliorate the risk of short-term adverse clinical outcomes.

OBJECTIVES: To assess the clinical outcomes of patients presenting with ST-elevation myocardial infarction (STEMI) secondary to stent thrombosis (ST) compared to those presenting with STEMI secondary to a de novo culprit lesion and treated by percutaneous coronary intervention (PCI). BACKGROUND: ST is an infrequent but serious complication of PCI with substantial associated morbidity and mortality, however with limited data. METHODS: We studied consecutive patients who underwent PCI for STEMI from 2005 to 2013 enrolled prospectively in the Melbourne Interventional Group registry. Patients were divided into two groups: the ST group comprised patients where the STEMI was due to ST and the de novo group formed the remainder of the STEMI cohort and all patients were treated by PCI. The primary endpoint was 30-day all-cause mortality. RESULTS: Compared to the de novo group (n = 3,835), the ST group (n = 128; 3.2% of STEMI) had higher rates of diabetes, hypertension and dyslipidemia, established cardiovascular diseases, myocardial infarction, and peripheral vascular disease, all p < .01. Within the ST group, very-late ST was the most common form of ST, followed by late and early ST (64, 19, and 17%, respectively). There was no significant difference in the primary outcome between the ST group and the de novo group (4.7 vs. 7.1%, p = .29). On multivariate analysis, ST was not an independent predictor of 30-day mortality (odds ratio: 0.62, 95% confidence interval: 0.07-1.09, p = .068). CONCLUSION: The short-term prognosis of patients with STEMI secondary to ST who were treated by PCI was comparable to that of patients with STEMI due to de novo lesions.

Unplanned readmissions to hospital after percutaneous coronary intervention (PCI) pose a significant burden to the healthcare system and are potentially preventable. In this study, we sought to determine the incidence of, and risk factors for, unplanned hospital readmissions within 30 days following PCI. We prospectively collected data on 28,488 patients undergoing PCI between 2013 and 2019, who were enrolled in the state-wide multi-centre Victorian Cardiac Outcomes Registry. Patients' data were then linked to data from the Victorian Department of Health administrative database that records statewide hospital admissions. Disease diagnosis codes were used to identify cause of readmission. Patients who had an unplanned readmission were further divided into those who had a cardiac vs. non-cardiac cause for readmission. Overall, 3059 patients (10.7%) had an unplanned hospital readmission within 30 days of PCI, of which 1848 patients (60.4%) were readmitted for primarily cardiac diagnoses. Independent predictors of both 30-day unplanned cardiac and non-cardiac readmissions post-PCI were female sex, having ≥1 admission in the 12 months prior to PCI, acute coronary syndrome presentation, having any in-hospital complication and being discharged on an oral anticoagulant (all p < 0.05). A stepwise increase in readmission risk was observed with increasing number of admissions from 1 to ≥4 admissions in the 12 months prior to PCI. In conclusion, a substantial proportion of patients undergoing PCI have unexpected readmissions to hospital in the 30 days following PCI. Targeted strategies for patients with risk factors for readmission may be useful to reduce this significant burden to the healthcare system.

ObjectivesThe objective of this systematic review was to examine the existing evidence base for the cost-effectiveness or cost-benefit of clinical quality registries (CQRs).DesignSystematic review and narrative synthesis.Data sourcesNine electronic bibliographic databases, including MEDLINE, EMBASE and CENTRAL, in the period from January 2000 to August 2019.Eligibility criteriaAny peer-reviewed published study or grey literature in English which had reported on an economic evaluation of one or more CQRs.Data extraction and synthesisData were screened, extracted and appraised by two independent reviewers. A narrative synthesis was performed around key attributes of each CQR and on key patient outcomes or changes to healthcare processes or utilisation. A narrative synthesis of the cost-effectiveness associated with CQRs was also conducted. The primary outcome was cost-effectiveness, in terms of the estimated incremental cost-effectiveness ratio (ICER), cost savings or return-on-investment (ROI) attributed to CQR implementation.ResultsThree studies and one government report met the inclusion criteria for the review. A study of the National Surgical Quality Improvement Programme (NSQIP) in the USA found that the cost-effectiveness of this registry improved over time, based on an ICER of US$8312 per postoperative event avoided. A separate study in Canada estimated the ROI to be US$3.43 per US$1.00 invested in the NSQIP. An evaluation of a post-splenectomy CQR in Australia estimated that registry cost-effectiveness improved from US$234 329 to US$18 358 per life year gained when considering the benefits accr

OBJECTIVES: The objective of this study was to investigate the association of proximal and nonproximal location of culprit coronary lesions with clinical outcomes of patients presenting with ST-elevation myocardial infarction (STEMI) treated by primary percutaneous coronary intervention (PCI). BACKGROUND: Proximal culprit lesion location in patients presenting with STEMI is associated with increased mortality when compared to distal culprit lesions in the thrombolytic era. The impact of lesion location on clinical outcomes in the era of PCI remains unclear. METHODS: We analyzed 3,283 patients with STEMI who enrolled in the Victorian Cardiac Outcomes Registry. We compared outcomes in those with proximal lesion location versus patients with nonproximal location. RESULTS: Of 3,283 participants, 1,376 (41.9%) had a proximal lesion location. Patients with proximal lesion location presented with greater rates of cardiogenic shock and out-of-hospital cardiac arrest, and left ventricular systolic dysfunction, all P < .01. Procedural success rates were similar (96% vs. 95%, P = .08). Patients with proximal lesion location had higher rates of in-hospital and 30-day mortality, major adverse cardiac events (MACE; mortality, myocardial infarction, stent thrombosis, and unplanned revascularization) and major adverse cardiac and cerebrovascular events (MACCE; MACE, and stroke) compared to the nonproximal group, all P < .001. However, on multivariable regression analysis, proximal lesion location was not independently associated with MACE during in-hospital stay or at 30-days (OR 1.32, 95% CI 0.95-1.83, P = .09 and OR 1.23, 95% CI 0.92-1.65, P = .15) respectively. CONCLUSIONS: Patients with proximal lesion location had greater hemodynamic instability and higher-risk features; however, proximal lesions per se were not independently associated with worse clinical outcomes compared to nonproximal lesions.

Objective We aim to ascertain the prognostic significance of persistent smoking and smoking cessation after an acute coronary syndrome (ACS) in the era of percutaneous coronary intervention (PCI) and optimal secondary prevention pharmacotherapy. Methods Consecutive patients from the Melbourne Interventional Group registry (2005-2013) who were alive at 30 days post-ACS presentation were included in our observational cohort study. Patients were divided into four categories based on their smoking status: non-smoker; ex-smoker (quit >1 month before ACS); recent quitter (smoker at presentation but quit by 30 days) and persistent smoker (smoker at presentation and at 30 days). The primary endpoint was survival ascertained through the Australian National Death Index linkage. A Cox-proportional hazards model was used to estimate the adjusted HR and 95% CI for survival. Results Of the 9375 patients included, 2728 (29.1%) never smoked, 3712 (39.6%) were ex-smokers, 1612 (17.2%) were recent quitters and 1323 (14.1%) were persistent smokers. Cox-proportional hazard modelling revealed, compared with those who had never smoked, that persistent smoking (HR 1.78, 95% CI 1.36 to 2.32, p<0.001) was an independent predictor of increased hazard (mean follow-up 3.9±2.2 years) while being a recent quitter (HR 1.27, 95% CI 0.96 to 1.68, p=0.10) or an ex-smoker (HR 1.03, 95% CI 0.87 to 1.22, p=0.72) were not. Conclusions In a contemporary cohort of patients with ACS, those who continued to smoke had an 80% risk of lower survival while those who quit had comparable survival to lifelong non-smokers. This underscores the importance of smoking cessation in secondary prevention despite the improvement in management of ACS with PCI and pharmacotherapy.

Despite the guidelines, a "treatment gap" exists in the delivery of pharmacotherapy for secondary prevention. We aimed to analyze the trend in guideline-based medication usage following percutaneous coronary intervention (PCI) using the Melbourne Interventional Group (MIG) registry over a 6-year period (2005-2010).

The no reflow phenomenon is reported to occur in >2% of all percutaneous coronary interventions (PCIs) and portends a poor prognosis. We analyzed data from 5,286 consecutive patients who underwent PCI from the Melbourne Interventional Group (MIG) registry from April 2004 through January 2008 who had 30-day follow-up completed. Patients without no reflow (normal reflow, n = 5,031) were compared to 255 (4.8%) with no reflow (n = 217 for transient no reflow, n = 38 for persistent no reflow). Patients with transient or persistent no reflow were more likely to present with ST-elevation myocardial infarction (MI) or cardiogenic shock (p <0.0001 for the 2 comparisons). They were also more likely to have complex lesions (American College of Cardiology/American Heart Association type B2/C), have lesions within a bypass graft, require an intra-aortic balloon pump, receive glycoprotein IIb/IIIa inhibition, and have a longer mean stent length (p <0.0001 for all comparisons). In-hospital outcomes were significantly worse in those patients with transient or persistent no reflow, with increased death, periprocedural MI, renal impairment, and major adverse cardiac events (p <0.0001 for all comparisons). Similarly, transient and persistent no reflow portended worse 30-day clinical outcomes, with a progressive increase in mortality (normal reflow 1.7% vs transient no reflow 5.5% vs persistent no reflow 13.2%, p <0.0001), MI, target vessel revascularization, and major adverse cardiac events (p <0.0001 for all comparisons) compared to patients with normal flow. In conclusion, transient or persistent no reflow complicates approximately 1 in 20 PCIs and results in stepwise increases in in-hospital and 30-day adverse outcomes.