Clinical Outcomes of Renal Transplant Recipients Undergoing Percutaneous Coronary Intervention.

BACKGROUND: Clinical outcomes of patients with renal transplant (RT) undergoing percutaneous coronary intervention (PCI) remain poorly elucidated. METHOD: Between 2014 and 2021, data were analysed for the following three groups of patients undergoing PCI enrolled in a multicentre Australian registry: (1) RT recipients (n=226), (2) patients on dialysis (n=992), and (3) chronic kidney disease (CKD) patients (estimated glomerular filtration rate [eGFR], 30‒60 mL/min per 1.73 m2) without previous RT (n=15,534). Primary outcome was 30-day major adverse cardiac and cerebrovascular events (MACCEs)-composite of mortality, myocardial infarction, stent thrombosis, target vessel revascularisation, and stroke. RESULTS: RT recipients were younger than dialysis and patients with CKD (61±10 vs 68±12 vs 78±8.2 years, p<0.001). Patients with RT less frequently had severe left ventricular dysfunction compared with dialysis and CKD groups (6.7% vs 14% and 8.5%); however more, often presented with acute coronary syndrome (58% vs 52% and 48%), especially STEMI (all p<0.001). Patients with RT and CKD had lower rates of 30-day MACCE (4.4% and 6.8% vs 11.6%, p<0.001) than the dialysis group. Three-year survival was similar between RT and CKD groups, however was lower in the dialysis group (80% and 83% vs 60%, p<0.001). After adjustment, dialysis was an independent predictor of 30-day MACCE (odds ratio [OR] 1.90, 95% confidence interval [CI] 1.44‒2.50, p<0.001), however RT was not (OR 0.91, CI 0.42‒1.96, p=0.802). Both RT (hazard ratio [HR] 2.07, CI 1.46‒2.95, p<0.001) and dialysis (HR 1.35, CI 1.02‒1.80, p=0.036) heightened the hazard of long-term mortality. CONCLUSIONS: RT recipients have more favourable clinical outcomes following PCI compared with patients on dialysis. However, despite having similar short-term outcomes to patients with CKD, the hazard of long-term mortality is significantly greater for RT recipients.

Electrocardiographic patterns and clinical outcomes of acute coronary syndrome cardiogenic shock in patients undergoing percutaneous coronary intervention - A propensity score analysis.

OBJECTIVES: To determine the influence of presenting electrocardiographic (ECG) changes on prognosis in acute coronary syndrome cardiogenic shock (ACS-CS) patients undergoing percutaneous coronary angiography (PCI). BACKGROUND: The effect of initial ECG changes such as ST-elevation myocardial infarction (STEMI) versus non-STEMI among patients ACS-CS on prognosis remains unclear. METHODS: We analysed data from consecutive patients with ACS-CS enrolled in the Victorian Cardiac Outcomes registry between 2014 and 2020. Inverse probability of treatment weighting analysis (IPTW) was used to assess the effect of ECG changes on 30-day mortality. RESULTS: Of 1564 patients with ACS-CS who underwent PCI, 161 had non-STEMI and 1403 had STEMI on ECG. The mean age was 66 ± 13 years, and 74 % (1152) were males. Patients with non-STEMI compared to STEMI were older (70 ± 12 vs 65 ± 13 years), had higher rates of diabetes (34 % vs 21 %), prior coronary artery bypass graft surgery (14 % vs 3.3 %), peripheral arterial disease (10.6 % vs 4.1 %, p < 0.01), and lower baseline eGFR (53.8 [37.1, 75.4] vs 65.3 [46.3, 87.8] ml/min/1.73m2), all p ≤ 0.01. Non-STEMI patients were more likely to have a culprit left circumflex artery (29 % vs 20 %) and more often underwent multivessel percutaneous coronary intervention (30 % vs 20 %) but had lower rates of out-of-hospital cardiac arrest (21 % vs 39 %), all p ≤ 0.01. Propensity score analysis with IPTW confirmed that non-STEMI ECG was associated with lower odds for 30-day all-cause mortality (OR 0.47 [0.32, 0.69], p < 0.001), and 30-day major adverse cardiovascular and cerebrovascular events (OR 0.48 [0.33, 0.70]). CONCLUSIONS: In patients undergoing PCI, Non-STEMI as compared to STEMI on index ECG was associated with approximately half the relative risk of both 30-day mortality and 30-day MACCE and could be a useful variable to integrate in ACS-CS risk scores.

Effect of Concomitant Cardiac Arrest on Outcomes in Patients With Acute Coronary Syndrome-Related Cardiogenic Shock.

Patients with acute coronary syndrome (ACS)-related cardiogenic shock (CS) with or without concomitant CA may have disparate prognoses. We compared clinical characteristics and outcomes of patients with CS secondary to ACS with and without cardiac arrest (CA). Between 2014 and 2020, 1,573 patients with ACS-related CS with or without CA who underwent percutaneous coronary intervention enrolled in a multicenter Australian registry were analyzed. Primary outcome was 30-day major adverse cardiovascular and cerebrovascular events (MACCE) (composite of mortality, myocardial infarction, stent thrombosis, target vessel revascularization and stroke). Long-term mortality was obtained through linkage to the National Death Index. Compared with the no-CA group (n = 769, 49%), the CA group (n = 804, 51%) was younger (62 vs 69 years, p <0.001) and had fewer comorbidities. Patients with CA more frequently had ST-elevation myocardial infarction (92% vs 86%), occluded left anterior descending artery (43% vs 33%), and severe preprocedural renal impairment (49% vs 42%) (all p <0.001). CA increased risk of 30-day MACCE by 45% (odds ratio 1.45, 95% confidence interval 1.05 to 2.00, p = 0.024) after adjustment. CA group had higher 30-day MACCE (55% vs 42%, p <0.001) and mortality (52% vs 37%, p <0.001). Three-year survival was lower for CA compared with no-CA patients (43% vs 52%, p <0.001). In Cox regression, CS with CA was associated with a trend toward greater long-term mortality hazard (hazard ratio 1.19, 95% confidence interval 1.00 to 1.41, p = 0.055). In conclusion, concomitant CA among patients with ACS-related CS conferred a particularly heightened short-term risk with a diminishing legacy effect over time for mortality. CS survivors continue to exhibit high sustained long-term mortality hazard regardless of CA status.

Estimating the cost-effectiveness and return on investment of the Victorian Cardiac Outcomes Registry in Australia: a minimum threshold analysis.

OBJECTIVES: We sought to establish the minimum level of clinical benefit attributable to the Victorian Cardiac Outcomes Registry (VCOR) for the registry to be cost-effective. DESIGN: A modelled cost-effectiveness study of VCOR was conducted from the Australian healthcare system and societal perspectives. SETTING: Observed deaths and costs attributed to coronary heart disease (CHD) over a 5-year period (2014-2018) were compared with deaths and costs arising from a hypothetical situation which assumed that VCOR did not exist. Data from the Australian Bureau of Statistics and published sources were used to construct a decision analytic life table model to simulate the follow-up of Victorians aged ≥25 years for 5 years, or until death. The assumed contribution of VCOR to the proportional change in CHD mortality trend observed over the study period was varied to quantify the minimum level of clinical benefits required for the registry to be cost-effective. The marginal costs of VCOR operation and years of life saved (YoLS) were estimated. PRIMARY OUTCOME MEASURES: The return on investment (ROI) ratio and the incremental cost-effectiveness ratio (ICER). RESULTS: The minimum proportional change in CHD mortality attributed to VCOR required for the registry to be considered cost-effective was 0.125%. Assuming this clinical benefit, a net return of $A4.30 for every dollar invested in VCOR was estimated (ROI ratio over 5 years: 4.3 (95% CI 3.6 to 5.0)). The ICER estimated for VCOR was $A49 616 (95% CI $A42 228 to $A59 608) per YoLS. Sensitivity analyses found that the model was sensitive to the time horizon assumed and the extent of registry contribution to CHD mortality trends. CONCLUSIONS: VCOR is likely cost-effective and represents a sound investment for the Victorian healthcare system. Our evaluation highlights the value of clinical quality registries in Australia.

Registry randomised trials: a methodological perspective.

Registry randomised clinical trials (RRCTs) have the potential to provide pragmatic answers to important clinical questions. RRCTs can be embedded into large population-based registries or smaller single site registries to provide timely answers at a reduced cost compared with traditional randomised controlled trials. RRCTs can take a number of forms in addition to the traditional individual-level randomised trial, including parallel group trials, platform or adaptive trials, cluster randomised trials and cluster randomised stepped-wedge trials. From an implementation perspective, initially it is advantageous to embed RRCT into well-established registries as these have typically already overcome any issues with end point validation and adjudication. With advances in data linkage and data quality, RRCTs can play an important role in answering clinical questions in a pragmatic, cost-effective way.

Characteristics of Radial Artery Coronary Bypass Graft Failure and Outcomes Following Subsequent Percutaneous Coronary Intervention.

BACKGROUND: When patients with prior coronary artery bypass grafting (CABG) undergo percutaneous coronary intervention (PCI), targeting the native vessel is preferred. Studies informing such recommendations are based predominantly on saphenous vein graft (SVG) PCI. There are few data regarding arterial graft intervention, particularly to a radial artery (RA) graft. OBJECTIVES: The aim of this study was to report the characteristics of arterial graft stenoses and evaluate the feasibility of RA PCI. METHODS: This study included 2,780 consecutive patients with prior CABG undergoing PCI between 2005 and 2018 who were prospectively enrolled in the MIG (Melbourne Interventional Group) registry. Data were stratified by PCI target vessel. RA graft PCI was compared with both native vessel (native PCI) and SVG PCI. Internal mammary graft PCI data were reported. The primary outcome was 3-year mortality. RESULTS: Overall, 1,928 patients (69.4%) underwent native PCI, 716 (25.6%) SVG PCI, 86 (3.1%) RA PCI, and 50 (1.8%) internal mammary graft PCI. Compared with SVG PCI, the RA PCI cohort presented earlier after CABG, less frequently had acute coronary syndrome, and more commonly had ostial or distal anastomosis intervention (P < 0.005 for all). Compared with patients who underwent native PCI, those who underwent RA PCI were more likely to have diabetes and peripheral vascular disease (P < 0.001 for both) and to present with non-ST-segment elevation myocardial infarction (P = 0.010). The RA PCI group had no perforations or in-hospital myocardial infarctions, though no significant difference was found in periprocedural outcomes compared with either native or SVG PCI. No differences were found between RA PCI and either native or SVG PCI in 30-day outcomes or 3-year mortality. CONCLUSIONS: Presenting and lesion characteristics differed between patients undergoing arterial compared with SVG PCI, implying a varied pathogenesis of graft stenosis. RA PCI appears feasible, safe, and where anatomically suitable, may be a viable alternative to native PCI.

Regional differences in percutaneous coronary intervention outcomes in STEMI patients with diabetes: The Asia-Pacific evaluation of cardiovascular therapies (ASPECT) collaboration.

BACKGROUND: Diabetes is associated with poorer outcomes and increased complication rates in STEMI patients undergoing percutaneous coronary intervention (PCI). Data are notably lacking in the Asia-Pacific region. We report the overall association of Diabetes with clinical characteristics and outcomes in STEMI patients undergoing PCI across the Asia-Pacific, with a particular focus on regional differences. METHODOLOGY: The Asia Pacific Evaluation of Cardiovascular Therapies (ASPECT) collaboration consists of data from various PCI registries across Australia, Hong Kong, Singapore, Malaysia, Indonesia and Vietnam. Clinical characteristics, lesion characteristics, and outcomes were provided for STEMI patients. Key outcomes included 30-day overall mortality and major adverse cardiovascular events (MACE). RESULTS: A total of 12,144 STEMI patients (mean(SD) age 59.3(12.3)) were included, of which 3912 (32.2%) had diabetes. Patients with diabetes were likely to have a higher baseline risk profile, poorer clinical presentation, and more complex lesion patterns (all p < 0.05). Across all regions, patients with diabetes had a higher rate of 30-day mortality and MACE (all p < 0.05). After multivariable adjustment, diabetes was significantly associated with both increased 30-day mortality (9.6%vs 5.5%, OR 1.79 [95% CI 1.40-2.30]) and MACE (13.3% vs 8.6%, R 1.73 [1.44-2.08]). The association between diabetes and 30-day MACE varied by region (pinteraction = 0.041), with the association (OR) ranging from 1.34 [1.08-1.67] in Malaysia, to 2.39 [1.66-3.45] in Singapore. CONCLUSIONS: Diabetes portends poorer clinical outcomes in STEMI patients undergoing PCI in the Asia-Pacific with regional variations noted. The development of effective preventative measures and interventional strategies targetted at this high-risk group is crucial.

Harmonising Individual Patient Level Cardiac Registry Data Across the Asia Pacific Region-A Feasibility Study of In-Hospital Outcomes of STEMI Patients From the Asia Pacific Evaluation of Cardiovascular Therapies (ASPECT) Network.

OBJECTIVE: The Asia-Pacific Evaluation of Cardiovascular Therapies (ASPECT) collaboration was established to inform on percutaneous coronary intervention (PCI) in the Asia-Pacific Region. Our aims were to (i) determine the operational requirements to assemble an international individual patient dataset and validate the processes of governance, data quality and data security, and subsequently (ii) describe the characteristics and outcomes for ST-elevation myocardial infarction (STEMI) patients undergoing PCI in the ASPECT registry. METHODS: Seven (7) ASPECT members were approached to provide a harmonised anonymised dataset from their local registry. Patient characteristics were summarised and associations between the characteristics and in-hospital outcomes for STEMI patients were analysed. RESULTS: Six (6) participating sites (86%) provided governance approvals for the collation of individual anonymised patient data from 2015 to 2017. Five (5) sites (83%) provided >90% of agreed data elements and 68% of the collated elements had <10% missingness. From the registry (n=12,620), 84% were male. The mean age was 59.2±12.3 years. The Malaysian cohort had a high prevalence of previous myocardial infarction (34%), almost twice that of any other sites (p<0.001). Adverse in-hospital outcomes were the lowest in Hong Kong whilst in-hospital mortality varied from 2.7% in Vietnam to 7.9% in Singapore. CONCLUSIONS: Governance approvals for the collation of individual patient anonymised data was achieved with a high level of data alignment. Secure data transfer process and repository were established. Patient characteristics and presentation varied significantly across the Asia-Pacific region with this likely to be a major predictor of variations in the clinical outcomes observed across the region.

Effect of Different Anthropometric Body Indexes on Radiation Exposure in Patients Undergoing Cardiac Catheterisation and Percutaneous Coronary Intervention.

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.

Adverse Impact of Peri-Procedural Stroke in Patients Who Underwent Percutaneous Coronary Intervention.

Peri-procedural stroke (PPS) is an important complication in patients who underwent percutaneous coronary intervention (PCI). The extent to which PPS impacts mortality and outcomes remains to be defined. Consecutive patients who underwent PCI enrolled in the Victorian Cardiac Outcomes Registry (2014 to 2018) were categorized into PPS and no PPS groups. The primary outcome was 30-day major adverse cardiovascular events (MACEs) (composite of mortality, myocardial infarction, stent thrombosis, and unplanned revascularization). Of 50,300 patients, PPS occurred in 0.26% patients (n = 133) (71% ischemic, and 29% hemorrhagic etiology). Patients who developed PPS were older (69 vs 66 years) compared with patients with no PPS, and more likely to have pre-existing heart failure (59% vs 29%), chronic kidney disease (33% vs 20%), and previous cerebrovascular disease (13% vs 3.6%), p <0.01. Among those with PPS, there was a higher frequency of presentation with ST-elevation myocardial infarction (49% vs 18%) and out-of-hospital cardiac arrest (14% vs 2.2%), PCI by way of femoral access (59% vs 46%), and adjunctive thrombus aspiration (12% vs 3.6%), all p = <0.001. PPS was associated with incident 30-day MACE (odds ratio [OR] 2.97, 95% confidence intervals [CIs] 1.86 to 4.74, p <0.001) after multivariable adjustment. Utilizing inverse probability of treatment weighting analysis, PPS remained predictive of 30-day MACE (OR 1.91, 95% CI 1.31 to 2.80, p = 0.001) driven by higher 30-day mortality (OR 2.0, 95% CI 1.35 to 2.96, p = 0.001). In conclusion, in this large, multi-center registry, the incidence of PPS was low; however, its clinical sequelae were significant, with a twofold increased risk of 30-day MACE and all-cause death.

Trends and Predictors of Cardiac Rehabilitation Referral Following Percutaneous Coronary Intervention: A Prospective, Multi-Site Study of 41,739 Patients From the Victorian Cardiac Outcomes Registry (2017-2020).

BACKGROUND: Following percutaneous coronary intervention (PCI), outpatient cardiac rehabilitation (CR) is essential for secondary prevention. However uptake of CR is suboptimal, despite strong evidence demonstrating benefits. The aim of this study was to identify contemporary trends and predictors of CR referral of PCI patients in Victoria. METHODS: A prospective, observational study using data extracted from the Victorian Cardiac Outcomes Registry was undertaken. A total of 41,739 patients were discharged following PCI over the study period (2017-2020) and included for analysis. RESULTS: Cardiac rehabilitation referral was 85%, with an increasing trend over time (p<0.001). Multivariable modelling identifying the independent predictors of CR referral included hospitals with high volumes of ST-elevation myocardial infarction patients (STEMI) (OR 4.89, 95% CI 4.41-5.20), STEMI diagnosis (OR 1.90, 95% CI 1.69-2.14), or treatment in a private hospital (OR 1.45, 95% CI 1.33-1.57). Predictors of non-referral included cardiogenic shock (OR 0.54, 95% CI 0.41-0.71), aged over 75 years (OR 0.62, 95% CI 0.57-0.68) and previous PCI (OR 0.66, 95% CI 0.62-0.70). Percutaneous coronary intervention patients with an acute coronary syndrome who were referred to CR were also more likely to be prescribed four or more major preventive pharmacotherapies, compared to those who were not referred (90% vs 82.1%, p<0.001). CONCLUSION: Our contemporary multicentre analysis showed generally high CR referral rates which have increased over time. However, more effort is needed to target patients treated in the public sector, low volume STEMI hospitals or with short lengths of stay.

Percutaneous Coronary Intervention Volume and Cardiac Surgery Availability Effect on Acute Coronary Syndrome-Related Cardiogenic Shock.

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.

Temporal Changes in Pollen Concentration Predict Short-Term Clinical Outcomes in Acute Coronary Syndromes.

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 intervention, underscoring a potential biologic link between pollen exposure and clinical outcomes.

Differences in outcomes of patients with in-hospital versus out-of-hospital ST-elevation myocardial infarction: a registry analysis.

OBJECTIVES: Patients with ST-elevation myocardial infarction (STEMI) that occur while already in hospital ('in-hospital STEMI') face high mortality. However, data about this patient population are scarce. We sought to investigate differences in reperfusion and outcomes of in-hospital versus out-of-hospital STEMI. DESIGN, SETTING AND PARTICIPANTS: Consecutive patients with STEMI all treated with percutaneous coronary intervention (PCI) across 30 centres were prospectively recruited into the Victorian Cardiac Outcomes Registry (2013-2018). PRIMARY AND SECONDARY OUTCOMES: Patients with in-hospital STEMI were compared with patients with out-of-hospital STEMI with a primary endpoint of 30-day major adverse cardiovascular events (MACE). Secondary endpoints included ischaemic times, all-cause mortality and major bleeding. RESULTS: Of 7493 patients with PCI-treated STEMI, 494 (6.6%) occurred in-hospital. Patients with in-hospital STEMI were older (67.1 vs 62.4 years, p<0.001), more often women (32% vs 19.9%, p<0.001), with more comorbidities. Patients with in-hospital STEMI had higher 30-day MACE (20.4% vs 9.8%, p<0.001), mortality (12.1% vs 6.9%, p<0.001) and major bleeding (4.9% vs 2.3%, p<0.001), than patients with out-of-hospital STEMI. According to guideline criteria, patients with in-hospital STEMI achieved symptom-to-device times of ≤70 min and ≤90 min in 29% and 47%, respectively. Patients with out-of-hospital STEMI achieved door-to-device times of ≤90 min in 71%. Occurrence of STEMI while in hospital independently predicted higher MACE (adjusted OR 1.77, 95% CI 1.33 to 2.36, p<0.001) and 12-month mortality (adjusted OR 1.49, 95% CI 1.08 to 2.07, p<0.001). CONCLUSIONS: Patients with in-hospital STEMI experience delays to reperfusion with significantly higher MACE and mortality, compared with patients with out-of-hospital STEMI, after adjustment for confounders. Focused strategies are needed to improve recognition and outcomes in this high-risk and understudied population.

Preliminary development of recommendations for the inclusion of patient-reported outcome measures in clinical quality registries.

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 health outcomes and healthcare value.

Long-term mortality in asymptomatic patients with stable ischemic heart disease undergoing percutaneous coronary intervention.

OBJECTIVES: Patients with stable ischemic heart disease (SIHD) may present with a variety of symptoms including typical angina, angina equivalents such as dyspnea or no symptoms. We sought to determine whether symptom status affects periprocedural safety and long-term mortality in patients undergoing PCI. METHODS: Prospectively enrolled consecutive patients undergoing PCI for SIHD at six hospitals in Australia between 2005 to 2018 as part of the Melbourne Interventional Group registry. Symptom status was recorded at the time of PCI and patients undergoing staged PCI were excluded. RESULTS: Overall, 11,730 patients with SIHD were followed up for a median period of 5 years (maximum 14.0 years, interquartile range 2.2-9.0 years) with 1,317 (11.2%) being asymptomatic. Asymptomatic patients were older, and more likely to be male, have triple-vessel disease, with multiple comorbidities including renal failure, diabetes and heart failure (all P < .01). These patients had significantly higher rates of periprocedural complications and major adverse cardiovascular events at 30-days. Long-term mortality was significantly higher in asymptomatic patients (27.2% vs 18.0%, P < .001). On cox regression for long-term mortality, after adjustment for more important clinical variables, asymptomatic status was an independent predictor (Hazard ratio (HR) 1.39 95% CI 1.16-1.66, P < .001). CONCLUSIONS: In a real-world cohort of patients undergoing revascularization for SIHD, absence of symptoms was associated with higher rates of periprocedural complications and, after adjustment for more important clinical variables, was an independent predictor of long-term mortality. As the primary goal of revascularization in SIHD remains angina relief, the appropriateness of PCI in the absence of symptoms warrants justification.

Estimating the economic impacts of percutaneous coronary intervention in Australia: a registry-based cost burden study.

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.

Comparison of Outcomes of Coronary Artery Disease Treated by Percutaneous Coronary Intervention in 3 Different Age Groups (<45, 46-65, and >65 Years).

There is paucity of data examining long-term outcomes of premature coronary artery disease (CAD). We aimed to investigate the short- and long-term clinical outcomes of patients with premature CAD treated by percutaneous coronary intervention (PCI) compared to older cohorts. We analyzed data from 27,869 patients who underwent PCI from 2005-2017 enrolled in a multicenter PCI registry. Patients were divided into three age groups: young group (≤ 45 years), middle-age group (46-65 years) and older group (>65 years). There were higher rates of current smokers in the young (n = 1,711) compared to the middle-age (n = 12,830) and older groups (n = 13,328) (54.2% vs 34.6% vs 11%) and the young presented more frequently with acute coronary syndrome (ACS) (78% vs 66% vs 62%), all p <0.05. There were also greater rates of cardiogenic shock (CS), out-of-hospital cardiac arrest (OHCA) and ST-elevation myocardial infarction (STEMI) in the young, all p <0.05. The young cohort with STEMI had higher rates of in-hospital, 30-day death, and long-term mortality (3.8% vs 0.2%, 4.3% vs 0.2% and 8.6% vs 3.1%, all p <0.05, respectively) compared to the non-STEMI subgroup. There was a stepwise increase in long-term mortality from the young, to middle-age, to the older group (6.1% vs 9.9% vs 26.8%, p <0.001). Younger age was an independent predictor of lower long-term mortality (HR 0.66, 95% CI 0.52-0.84, p = 0.001). In conclusion, younger patients presenting with STEMI had worse prognosis compared to those presenting with non-STEMI. Despite higher risk presentations among young patients, their overall prognosis was favorable compared to older age groups.

Comparison of Long-Term Mortality in Patients With Single Coronary Narrowing and Diabetes Mellitus to That of Patients With Multivessel Coronary Narrowing Without Diabetes Mellitus.

It is well recognized that patients with diabetes mellitus (DM) and multivessel coronary artery disease (MVD) undergoing percutaneous coronary intervention (PCI) have poorer long-term outcomes compared with those undergoing coronary artery bypass grafting. However, the relative impact of DM status and extent of coronary artery disease on long term mortality in patients undergoing PCI is unknown. We sought to compare patients with DM undergoing PCI for single and multivessel disease to their non-DM counterparts. Overall, 34,690 consecutive patients undergoing PCI from the Melbourne Interventional Group registry (2005 to 2017) were included (mean age 64.5 ± 12 years, 76.6% male). Our cohort was stratified by the presence of DM and extent of CAD (DM-SVD [single-vessel disease] [n = 2,669], DM-MVD [n = 6,118], no-DM-SVD [n = 10,993], no-DM-MVD [n = 14,910]). DM-SVD and no-DM-MVD cohorts demonstrated comparable baseline cardiovascular risk profiles, although the no-DM-MVD cohort had higher rates of prior myocardial infarction, while the DM-SVD cohort had a higher proportion of patients with renal impairment. Over a median follow-up of 4.8 (IQR 2.0 to 8.2) years, 6,031 (17.5%) patients died. Using the no-DM-SVD group as the reference category, adjusted risk of mortality was highest in the MVD-DM cohort (HR 1.90; 95% CI 1.71 to 2.09). Similar adjusted risk of long-term mortality was observed in the DM-SVD (HR 1.32, 95%CI 1.15 to 1.51) and no-DM-MVD (HR 1.30, 95%CI 1.20 to 1.40) groups. In conclusion, we found that the long-term mortality of patients with DM and SVD undergoing PCI was the risk equivalent of non-DM patients with MVD.

Incidence and Predictors of Unplanned Hospital Readmission after Percutaneous Coronary Intervention.

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.