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Joseph S Ross,1–4 Jonathan Bates,4 Craig S Parzynski,4 Joseph G Akar,4,5 Jeptha P Curtis,4,5 Nihar R Desai,4,5 James V Freeman,4,5 Ginger M Gamble,4 Richard Kuntz,6 Shu-Xia Li,4 Danica Marinac-Dabic,7 Frederick A Masoudi,8 Sharon-Lise T Normand,9,10 Isuru Ranasinghe,11 Richard E Shaw,12 Harlan M Krumholz2–5 1Section of General Medicine, Department of Medicine, 2Robert Wood Johnson Foundation Clinical Scholars Program, Yale School of Medicine, 3Department of Health Policy and Management, Yale School of Public Health, 4Center for Outcomes Research and Evaluation, Yale–New Haven Hospital, 5Section of Cardiovascular Medicine, Department of Medicine, Yale School of Medicine, New Haven, CT, 6Medtronic Inc, Minneapolis, MN, 7Division of Epidemiology, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD, 8Division of Cardiology, Department of Medicine, University of Colorado, Aurora, CO, 9Department of Health Care Policy, Harvard Medical School, 10Department of Biostatistics, Harvard TH Chan School of Public Health, Boston, MA, USA; 11Discipline of Medicine, University of Adelaide, Adelaide, SA, Australia; 12Department of Clinical Informatics, California Pacific Medical Center, San Francisco, CA, USA Background: Machine learning methods may complement traditional analytic methods for medical device surveillance.Methods and results: Using data from the National Cardiovascular Data Registry for implantable cardioverter–defibrillators (ICDs) linked to Medicare administrative claims for longitudinal follow-up, we applied three statistical approaches to safety-signal detection for commonly used dual-chamber ICDs that used two propensity score (PS) models: one specified by subject-matter experts (PS-SME), and the other one by machine learning-based selection (PS-ML). The first approach used PS-SME and cumulative incidence (time-to-event), the second approach used PS-SME and cumulative risk (Data Extraction and Longitudinal Trend Analysis [DELTA]), and the third approach used PS-ML and cumulative risk (embedded feature selection). Safety-signal surveillance was conducted for eleven dual-chamber ICD models implanted at least 2,000 times over 3 years. Between 2006 and 2010, there were 71,948 Medicare fee-for-service beneficiaries who received dual-chamber ICDs. Cumulative device-specific unadjusted 3-year event rates varied for three surveyed safety signals: death from any cause, 12.8%–20.9%; nonfatal ICD-related adverse events, 19.3%–26.3%; and death from any cause or nonfatal ICD-related adverse event, 27.1%–37.6%. Agreement among safety signals detected/not detected between the time-to-event and DELTA approaches was 90.9% (360 of 396, k=0.068), between the time-to-event and embedded feature-selection approaches was 91.7% (363 of 396, k=–0.028), and between the DELTA and embedded feature selection approaches was 88.1% (349 of 396, k=–0.042).Conclusion: Three statistical approaches, including one machine learning method, identified important safety signals, but without exact agreement. Ensemble methods may be needed to detect all safety signals for further evaluation during medical device surveillance. Keywords: implanted cardioverter–defibrillator, methodology, surveillance

Background: Coronary Artery Bypass Grafting (CABG) is the most common cardiac surgery, yet little is known about unplanned readmissions after CABG despite increasing clinical and policy focus on reducing readmissions. We assessed the incidence, timing, and reasons for unplanned readmission within 30 days of CABG and evaluated for variation in readmission rates across hospitals in Australia and New Zealand (ANZ)., Method: We identified isolated CABG procedures from 2013 to 2017 across all public and most private hospitals in ANZ. The primary outcome was unplanned (acute) readmissions within 30-days of discharge. Hospital specific risk standardised readmission rates (RSRRs) and 95% CI were estimated using a hierarchical generalized linear model accounting for differences in patient characteristics., Results: 52,104 patients (mean age 66.1 ± 9.9 years, 17.6 % female, 30.7 % acute) were included. The 30-day unplanned readmission rate was 12.7 % (n = 6,613) and was higher following urgent surgery (16.2 %, n = 2,595). Readmission rates peaked on days 2-4 with a median time to readmission of 9 (IQR: 4-17) days. Procedural complications and chest pain were the most common diagnoses on readmission. Risk adjustment model demonstrated satisfactory performance (C-statistic = 0.62). The median RSRR was 12.8 % (range: 6.1-20.3 %) across 37 hospitals. Only one hospital had its RSRR estimate lower than average and no hospitals had higher than average RSRR., Conclusion: One-in-8 patients undergoing CABG experienced an unplanned readmission within 30-day, rising to one-in-6 following urgent CABG. There was little statistically significant institutional variation in RSRR. Nevertheless, many readmissions are likely related to care quality and potentially preventable, highlighting scope for clinical and policy interventions to reduce readmissions., Competing Interests: The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: [Isuru Ranasinghe reports financial support was provided by National Heart Foundation of Australia. Isuru Ranasinghe reports a relationship with National Heart Foundation of Australia that includes: funding grants. If there are other authors, they declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper]., (© 2024 The Authors.)

Competing Interests: Nil.

Background: The incidence and type of complications following catheter ablation of atrial fibrillation have been extensively examined, but the impact associated with these complications on the length of stay and hospitalization costs is unknown., Methods and Results: This cohort study included 20 117 adult patients (mean age 62.6±11.4 years, 30.3% women, median length of stay 1 day [interquartile range 1-2 days]) undergoing atrial fibrillation ablation in financial years 2011 to 2017 in Australia with available cost data from the National Hospital Cost Data Collection, which determines government reimbursement of health services provided. The primary outcome was the costs associated with complications occurring up to 30 days postdischarge adjusted for inflation to 2021 Australian dollars. We used generalized linear models to estimate the increase in length of stay and cost associated with complications, adjusting for patient characteristics. Within 30 days of hospital discharge, 1151 (5.72%) patients experienced a complication with bleeding (3.35%) and pericardial effusion (0.75%) being the most common. On average, the occurrence of a complication was associated with an adjusted 3.3 (95% CI, 3.1-3.6) excess bed days of hospital care (totaling 3851 days), and a $7812 (95% CI, $6754-$8870) increase in hospitalization cost (totaling $9.0 million). Most of the total excess cost was attributable to bleeding ($3.8 million, 41.9% of total excess cost) and pericardial effusion ($1.6 million, 18.2%)., Conclusions: Complications following atrial fibrillation ablation were associated with significant increase in length of stay and hospitalization costs, most of which were attributable to bleeding and pericardial effusion. Strategies to improve procedural safety and reduce health care costs should focus on these complications.

Background: Constrictive pericarditis associated with actinomycosis infection is a rare and challenging diagnosis due to its insidious manifestation. We describe the successful treatment of pericardial infiltration and constriction due to actinomycosis., Case Summary: A 50-year-old Aboriginal man presented with insidious onset of fatigue, dyspnoea, pleuritic chest pain, fever, drenching sweats, severe exercise intolerance to 50 m, and recurrent itchy skin lesions over 8 months. Prior investigations, including serial fluorodeoxyglucose (FDG)-Positron emission tomography scans, found a progressively enlarging, metabolically active anterior mediastinal mass with two biopsies on separate occasions showing no malignancy, granulomas, tuberculosis, or other pathology. Screening for infective, autoimmune, and connective tissue disease was negative. A transthoracic echocardiogram (TTE) showed fibrinous pericarditis with extensive myocardial tethering and constrictive physiology confirmed on heart catheterization. A pericardial biopsy showed inflammatory tissue only. Biopsy of a skin lesion on the buttock showed abscess formation with Splendore Hoeppli phenomenon with Gram-positive and Grocott-positive filamentous bacteria suggestive of actinomyces, confirmed by 16S rRNA gene sequencing. He was diagnosed with cardiac actinomycosis, likely due to mediastinal infiltration from a lung infection, with haematogenous spread and treated with Penicillin G with adjunctive high-dose steroid therapy with resolution of symptoms and marked improvement in TTE features of constriction after 6 weeks., Discussion: Actinomycosis is an extremely rare cause of pericardial infiltration and constriction yet highly sensitive to penicillin, highlighting the importance of accurate diagnosis. Corticosteroids are a useful adjunct to prevent chronic constrictive pericarditis and to avoid the high morbidity and mortality associated with pericardiectomy., Competing Interests: Conflict of interest: Dr Linh Ngo is a junior reviewer for EHj case report., (© The Author(s) 2023. Published by Oxford University Press on behalf of the European Society of Cardiology.)

Background Prehospital activation of the cardiac catheter laboratory is associated with significant improvements in ST-segment-elevation myocardial infarction (STEMI) performance measures. However, there are equivocal data, particularly within Australia, regarding its influence on mortality. We assessed the association of prehospital activation on performance measures and mortality in patients with STEMI treated with primary percutaneous coronary intervention from the Queensland Cardiac Outcomes Registry (QCOR). Methods and Results Consecutive ambulance-transported patients with STEMI treated with primary percutaneous coronary intervention were analyzed from January 1, 2017 to December 31, 2020 from the QCOR. The total and direct effects of prehospital activation on the primary outcomes (30-day and 1-year cardiovascular mortality) were estimated using logistic regression analyses. Secondary outcomes were STEMI performance measures. Among 2498 patients (mean age: 62.2±12.4 years; 79.2% male), 73% underwent prehospital activation. Median door-to-balloon time (34 minutes [26-46] versus 86 minutes [68-113]; P <0.001), first-electrocardiograph-to-balloon time (83.5 minutes [72-98] versus 109 minutes [81-139]; P <0.001), and proportion of patients meeting STEMI targets (door-to-balloon <60 minutes 90% versus 16%; P <0.001), electrocardiograph-to-balloon time <90 minutes (62% versus 33%; P <0.001) were significantly improved with prehospital activation. Prehospital activation was associated with significantly lower 30-day (1.6% versus 6.6%; P <0.001) and 1-year cardiovascular mortality (2.9% versus 9.5%; P <0.001). After adjustment, no prehospital activation was strongly associated with increased 30-day (odds ratio [OR], 3.6 [95% CI, 2.2-6.0], P <0.001) and 1-year cardiovascular mortality (OR, 3.0 [95% CI, 2.0-4.6]; P <0.001). Conclusions Prehospital activation of cardiac catheterization laboratory for primary percutaneous coronary intervention was associated with significantly shorter time to reperfusion, achievement of STEMI performance measures, and lower 30-day and 1-year cardiovascular mortality.

Background: High-sensitivity cardiac troponin (hs-cTn) laboratory assays are used to rule out myocardial infarction (MI) on presentation, but prolonged result turnaround times can delay patient management. Our primary aim was to identify patients at low risk of index MI using a rapid point-of-care (POC) whole-blood hs-cTnI assay at presentation with potential early patient discharge., Methods: Consecutive patients presenting to the emergency department from 2 prospective observational studies with suspected acute coronary syndrome were enrolled. A POC hs-cTnI assay (Atellica VTLi) threshold using whole blood at presentation, which resulted in a negative predictive value of ≥99.5% and sensitivity of >99% for index MI, was derived (SEIGE [Safe Emergency Department Discharge Rate]) and validated with plasma (SAMIE [Suspected Acute Myocardial Infarction in Emergency]). Event adjudications were established with hs-cTnI assay results from routine clinical care. The primary outcome was MI at 30 days., Results: A total of 1086 patients (8.1% with MI) were enrolled in a US derivation cohort (SEIGE) and 1486 (5.5% MI) in an Australian validation cohort (SAMIE). A derivation whole-blood POC hs-cTnI concentration of <4 ng/L provided a sensitivity of 98.9% (95% CI, 93.8%-100%) and negative predictive value of 99.5% (95% CI, 97.2%-100%) for ruling out MI. In the validation cohort, the sensitivity was 98.8% (95% CI, 93.3%-100%), and negative predictive value was 99.8% (95% CI, 99.1%-100%); 17.8% and 41.8%, respectively, were defined as low risk for discharge. The 30-day adverse cardiac events were 0.1% (n=1) for SEIGE and 0.8% (n=5) for SAMIE., Conclusions: A POC whole-blood hs-cTnI assay permits accessible, rapid, and safe exclusion of MI and may expedite discharge from the emergency department., Registration: URL: https://www., Clinicaltrials: gov; Unique identifier: NCT04772157. URL: https://www.australianclinicaltrials.gov.au/anzctr&#95;feed/form; Unique identifier: 12621000053820.

Background: When compared to left ventricular ejection fraction (LVEF), previous studies have suggested the superiority of wall motion score index (WMSI) in predicting cardiac events in patients who have suffered acute myocardial infarction. However, there are limited studies assessing WMSI and mortality in ST-segment elevation myocardial infarction (STEMI). We aimed to compare the prognostic value of WMSI in a cohort of STEMI patients treated with primary percutaneous coronary intervention (PCI)., Methods: A comparison of WMSI, LVEF, and all-cause mortality in STEMI patients treated with primary PCI between January 2008 and December 2020 was performed. The prognostic value of WMSI, LVEF, and traditional risk scores (TIMI, GRACE) were compared using multivariable logistic regression modelling., Results: Among 1181 patients, 27 died within 30-days (2.3%) and 49 died within 12 months (4.2%). WMSI ≥1.8 was associated with poorer survival at 12-months (9.2% vs 1.5%; p < 0.001). When used as the only classifier for predicting 12-month mortality, the discriminatory ability of WMSI (area under the curve (AUC): 0.77; 95% CI: 0.68-0.84) was significantly better than LVEF (AUC: 0.71; 95% CI: 0.61-0.79; p =0.034). After multivariable modelling, the AUC was comparable between models with either WMSI (AUC: 0.89; 95% CI: 0.85-0.94) or LVEF (AUC: 0.87; 95% CI: 0.83-0.92; p < 0.08) yet performed significantly better than TIMI (AUC: 0.71; 95% CI: 0.62-0.79; p < 0.001), or GRACE (AUC: 0.63; 95% CI: 0.54-0.71; p < 0.001) risk scores., Conclusions: When examined individually, WMSI is a superior predictor of 12-month mortality over LVEF in STEMI patients treated with primary PCI. When examined in multivariable predictive models, WMSI and LVEF perform very well at predicting 12-month mortality, especially when compared to existing STEMI risk scores., Competing Interests: The authors declare that there are no conflicts of interest regarding the publication of this article., (Copyright © 2022 Michael L. Savage et al.)

Aims: Contemporary long-term survival following a heart failure (HF) hospitalization is uncertain. We evaluated survival up to 10 years after a HF hospitalization using national data from Australia and New Zealand, identified predictors of survival, and estimated the attributable loss in life expectancy., Methods and Results: Patients hospitalized with a primary diagnosis of HF from 2008-2017 were identified and all-cause mortality assessed by linking with Death Registries. Flexible parametric survival models were used to estimate survival, predictors of survival and loss in life expectancy. A total of 283 048 patients with HF were included (mean age 78.2 ± 12.3 years, 50.8% male). Of these, 48.3% (48.1-48.5) were surviving by 3 years, 34.1% (33.9-34.3) by 5 years and 17.1% (16.8-17.4) by 10 years (median survival 2.8 years). Survival declined with age with 53.4% of patients aged 18-54 years and 6.2% aged ≥85 years alive by 10 years (adjusted hazard ratio [aHR] for mortality 4.84, 95% confidence interval [CI] 4.65-5.04 for ≥85 years vs. 18-54 years) and was worse in male patients (aHR 1.14, 95% CI 1.13-1.15). Prior HF (aHR 1.20, 95% CI 1.18-1.22), valvular and rheumatic heart disease (aHR 1.11, 95% CI 1.10-1.13) and vascular disease (aHR 1.07, 95% CI 1.04-1.09) were cardiovascular comorbidities most strongly associated with long-term death. Non-cardiovascular comorbidities and geriatric syndromes were common and associated with higher mortality. Compared with the general population, HF was associated with a loss of 7.3 years in life expectancy (or 56.6% of the expected life expectancy) and reached 20.5 years for those aged 18-54 years., Conclusion: Less than one in five patients hospitalized for HF were surviving by 10 years with patients experiencing almost 60% loss in life expectancy compared with the general population, highlighting the considerable persisting societal burden of HF. Concerted multidisciplinary efforts are needed to improve post-hospitalization outcomes of HF., (© 2022 The Authors. European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.)

Background: Data on long-term outcomes following an acute stroke are sparse. We assessed survival, risk of recurrent stroke and loss in life expectancy following an acute stroke using population-wide data from Australia and New Zealand., Methods: We included all adults with the first stroke hospitalization during 2008 and 2017 at all public and most private hospitals. Patients were followed up to 10 years after the stroke by linkage to each region's Registry of Deaths and subsequent hospitalizations. Flexible parametric survival modeling was used to estimate all-cause mortality, stroke recurrence, and loss in life expectancy. Competing risk model was used when estimating the risk of stroke recurrence., Results: Three hundred thirteen thousand one hundred sixty-two patients were included (mean age 73.0±14.6 y, 52.0% males) with ischemic stroke (175 547, 56.1%) being the most common, followed by hemorrhagic stroke (77 940, 24.9%) and unspecified stroke (59 675, 19.1%). The overall survival probability was 79.4% at 3 months, 73.0% at 1 year, 52.8% at 5 years, and 36.4% at 10 years. Cumulative incidence of stroke recurrence was 7.8% at 3 months, 11.0% at 1 year, 19.8% at 5 years, and 26.8% at 10 years. Hemorrhagic stroke was associated with greater mortality (hazard ratio, 2.02 [95% CI, 1.99-2.04]) and recurrent stroke (hazard ratio, 1.63 [95% CI, 1.59-1.67]) compared with ischemic stroke. Female sex (hazard ratio, 1.10 [95% CI, 1.09-1.11]) and increasing age (≥85 years versus 18-54 years: hazard ratio, 7.36 [95% CI, 7.15-7.57]) were also associated with increased mortality. Several risk factors including atherosclerotic coronary and noncoronary vascular disease, cardiac arrhythmia, and diabetes were associated with increased risk of mortality and recurrent stroke. Compared with the general population, an acute stroke was associated with a loss of 5.5 years of life expectancy, or 32.7% of the predicted life expectancy, and was pronounced in patients with a hemorrhagic stroke (7.4 years and 38.5% of predicted life expectancy lost)., Conclusions: In this population-wide study, death and recurrence of stroke were common after an acute stroke and an acute stroke was associated with considerable loss in life expectancy. Further improvements in treatment and secondary prevention of stroke are needed to reduce these risks.

Background: The subcutaneous (S-) implantable cardioverter-defibrillator (ICD) is an alternative to the transvenous (TV-) ICD that is increasingly implanted in younger patients; data on the safety and effectiveness of the S-ICD in older patients are lacking., Objectives: The purpose of this study was to compare outcomes among older patients who received an S- or TV-ICD., Methods: The authors compared S-ICD and single-chamber TV-ICD implants in Fee-For-Service Medicare beneficiaries using the National Cardiovascular Data Registry ICD Registry. Outcomes were ascertained from Medicare claims data. Cox regression or competing-risk models (with TV-ICD as reference) with overlap weights were used to compare death and nonfatal outcomes (device reoperation, device removal for infection, device reoperation without infection, and cardiovascular admission), respectively. Recurrent all-cause readmissions were compared using Anderson-Gill models., Results: A total of 16,063 patients were studied (age 72.6 ± 5.9 years, 28.4% women, ejection fraction 28.3 ± 8.9%). Compared with TV-ICD patients (n = 15,072), S-ICD patients (n = 991, 6.2% overall) were more often Black, younger, and dialysis dependent and less likely to have history of atrial fibrillation or flutter. In adjusted analyses, there were no differences between device type and risk of all-cause mortality (HR: 1.020; 95% CI: 0.819-1.270), device reoperation (subdistribution [s] HR: 0.976; 95% CI: 0.645-1.479), device removal for infection (sHR: 0.614; 95% CI: 0.138-2.736), device reoperation without infection (sHR: 0.975; 95% CI: 0.632-1.506), cardiovascular readmission (sHR: 1.087; 95% CI: 0.912-1.295), or recurrent all-cause readmission (HR: 1.072; 95% CI: 0.990-1.161)., Conclusions: In a large representative national cohort of older patients undergoing ICD implantation, risk of death, device reoperation, device removal for infection, device reoperation without infection, and cardiovascular and all-cause readmission were similar among S- and TV-ICD recipients., Competing Interests: Funding Support and Author Disclosures This research was supported by the American College of Cardiology’s National Cardiovascular Data Registry (NCDR). The views expressed in this paper represent those of the author(s), and do not necessarily represent the official views of the NCDR or its associated professional societies identified at CVQuality.ACC.org/NCDR. The ICD Registry is an initiative of the American College of Cardiology with partnering support from the Heart Rhythm Society. Dr Heist has received consulting fees from Abbott, Boston Scientific, Medtronic, and Pfizer; has received research grants from Abbott, Biotronik, and Pfizer; and has received honoraria from Medtronic, Biotronik, and Abbott. Dr Russo has received research support from Boston Scientific and Medilynx; and serves on research steering committees for Apple and Boston Scientific (no honoraria). Dr Ranasinghe has received research grants from the National Heart Foundation and the National Health and Medical Research Council of Australia. Dr Zeitler has received consulting fees from Medtronic Inc; and has received research grants from Boston Scientific and the NCDR. Dr Minges has received salary support from the American College of Cardiology for analytic services performed. Dr Freeman has received salary support from the American College of Cardiology, NCDR, and the National Heart, Lung, and Blood Institute; has received consulting/advisory board fees (modest) from Boston Scientific, Medtronic, Janssen Pharmaceuticals, Pacemate, and Biosense Webster; has equity in Pacemate; has received research grants from the American Heart Association, NCDR, Boston Scientific, Abbott, Medtronic, Merit Medical, and Biosense Webster; and has received consulting fees from Abbott and AtriCure. Dr Curtis has received an institutional contract with the American College of Cardiology for his role as Senior Scientific Advisor of the NCDR; and has equity interest in Medtronic. Dr Al-Khatib has received research fees from Medtronic, Boston Scientific, and Abbott; and has received speaker fees from Medtronic. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose., (Published by Elsevier Inc.)

Background Complications are a measure of procedural quality, yet variation in complication rates following catheter ablation of atrial fibrillation (AF) among hospitals has not been systematically examined. We examined institutional variation in the risk-standardized 30-day complication rates (RSCRs) following AF ablation which may suggest variation in care quality. Methods and Results This cohort study included all patients >18 years old undergoing AF ablations from 2012 to 2017 in Australia and New Zealand. The primary outcome was procedure-related complications occurring during the hospital stay and within 30 days of hospital discharge. We estimated the hospital-specific risk-standardized complication rates using a hierarchical generalized linear model. A total of 25 237 patients (mean age, 62.5±11.4 years; 30.2% women; median length of stay 1 day [interquartile range, 1-2 days]) were included. Overall, a complication occurred in 1400 (5.55%) patients (4.34% in hospital, 1.46% following discharge, and 0.25% experienced both). Bleeding (3.31%), pericardial effusion (0.74%), and infection (0.44%) were the most common complications while stroke/transient ischemic attack (0.24%), cardiorespiratory failure and shock (0.19%), and death (0.08%) occurred less frequently. Among 46 hospitals that performed ≥25 ablations during the study period, the crude complication rate varied from 0.00% to 21.43% (median, 5.74%). After adjustment for differences in patient and procedural characteristics, the median risk-standardized complication rate was 5.50% (range, 2.89%-10.31%), with 10 hospitals being significantly different from the national average. Conclusions Procedure-related complications occur in 5.55% of patients undergoing AF ablations, although the risk of complications varies 3-fold among hospitals, which suggests potential disparities in care quality and the need for efforts to standardize AF ablation practices among hospitals.

Aims: Peripheral artery disease (PAD) revascularization can be performed by either endovascular or open surgical approach. Despite increasing use of endovascular revascularization, it is still uncertain which strategy yields better long-term outcomes., Methods and Results: This retrospective cohort study evaluated patients hospitalized with PAD in Australia and New Zealand who underwent either endovascular or surgical revascularization between 2008 and 2015, and compared procedures using a propensity score-matched analysis. Hybrid interventions were excluded. The primary endpoint was mortality or major adverse limb events (MALE), defined as a composite endpoint of acute limb ischaemia, urgent surgical or endovascular reintervention, or major amputation, up to 8 years post-hospitalization using time-to-event analyses 75 189 patients fulfilled eligibility (15 239 surgery and 59 950 endovascular), from whom 14 339 matched pairs (mean ± SD age 71 ± 12 years, 73% male) with good covariate balance were identified. Endovascular revascularization was associated with an increase in combined MALE or mortality [hazard ratio (HR) 1.13, 95% confidence interval (CI): 1.09-1.17, P < 0.001]. There was a similar risk of MALE (HR 1.04, 95% CI: 0.99-1.10, P = 0.15), and all-cause urgent rehospitalizations (HR 1.01, 95% CI: 0.98-1.04, P = 0.57), but higher mortality (HR 1.16, 95% CI: 1.11-1.21, P < 0.001) when endovascular repair was compared to surgery. In subgroup analysis, these findings were consistent for both claudication and chronic limb-threatening ischaemia presentations., Conclusion: Although the long-term risk of MALE was comparable for both approaches, enduring advantages of surgical revascularization included lower long-term mortality. This is at odds with some prior PAD studies and highlights contention in this space., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Objective: To assess whether hypertension is an independent risk factor for mortality among patients hospitalised with COVID-19, and to evaluate the impact of ACE inhibitor and angiotensin receptor blocker (ARB) use on mortality in patients with a background of hypertension., Method: This observational cohort study included all index hospitalisations with laboratory-proven COVID-19 aged ≥18 years across 21 Australian hospitals. Patients with suspected, but not laboratory-proven COVID-19, were excluded. Registry data were analysed for in-hospital mortality in patients with comorbidities including hypertension, and baseline treatment with ACE inhibitors or ARBs., Results: 546 consecutive patients (62.9±19.8 years old, 51.8% male) hospitalised with COVID-19 were enrolled. In the multivariable model, significant predictors of mortality were age (adjusted OR (aOR) 1.09, 95% CI 1.07 to 1.12, p<0.001), heart failure or cardiomyopathy (aOR 2.71, 95% CI 1.13 to 6.53, p=0.026), chronic kidney disease (aOR 2.33, 95% CI 1.02 to 5.32, p=0.044) and chronic obstructive pulmonary disease (aOR 2.27, 95% CI 1.06 to 4.85, p=0.035). Hypertension was the most prevalent comorbidity (49.5%) but was not independently associated with increased mortality (aOR 0.92, 95% CI 0.48 to 1.77, p=0.81). Among patients with hypertension, ACE inhibitor (aOR 1.37, 95% CI 0.61 to 3.08, p=0.61) and ARB (aOR 0.64, 95% CI 0.27 to 1.49, p=0.30) use was not associated with mortality., Conclusions: In patients hospitalised with COVID-19, pre-existing hypertension was the most prevalent comorbidity but was not independently associated with mortality. Similarly, the baseline use of ACE inhibitors or ARBs had no independent association with in-hospital mortality., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

During the COVID-19 pandemic many IBD units chose Budesonide MMX (Cortiment) as the first-line treatment for flares of ulcerative colitis (UC) in outpatients for its favourable side effect profile. This retrospective study of all UC patients treated with oral steroids between 1 March 2019-30 June 2019 and 1 March 2020-30 June 2020 aimed to compare Cortiment with Prednisolone in routine clinical practice. Outcomes included the need for hospitalisation for acute severe ulcerative colitis, symptoms at four weeks and end of treatment, and the need for rescue Prednisolone. The 2019 and 2020 cohorts did not differ at the baseline. Cortiment prescriptions rose from 24.5% in 2019 to 70.1% in 2020 ( p < 0.001). At week four there were significant differences between 2019 and 2020 in mean bowel frequency (3.49 vs. 5.85, p = 0.001), rectal bleeding <50% (89.7% vs. 73.1% of patients, p = 0.039), and physician global assessment (PGA) (39.2% vs. 19.8% in remission, p = 0.045). There was no significant difference in hospital admissions, rectal bleeding, and PGA at week eight. Rescue Prednisolone was required in 10% of Cortiment patients in 2019 vs. 31.3% in 2020 ( p = 0.058). Active IBD is associated with worse COVID-19 outcomes prompting the careful evaluation of the choice of first-line steroid for UC, as Cortiment was associated with worse outcomes at four weeks.

Background: Little is known about the utilisation and safety of catheter ablation of atrial fibrillation (AF) among public and private sector hospitals., Aims: To examine the uptake of AF ablations and compare procedural safety between the sectors., Method: Hospitalisation data from all public and private hospitals in four large Australian states (NSW, QLD, VIC and WA) were used to identify patients undergoing AF ablation from 2012 to 17. The primary endpoint was any procedure-related complications up to 30-days post-discharge. Logistic regression was used to evaluate the association between treatment at a public hospital and risk of complications adjusting for covariates., Results: Private hospitals performed most of the 21,654 AF ablations identified (n = 16,992, 78.5 %), on patients who were older (63.5 vs. 59.9y) but had lower rates of heart failure (7.9 % vs. 10.4 %), diabetes (10.2 % vs. 14.1 %), and chronic kidney diseases (2.4 % vs. 5.2 %) (all p < 0.001) than those treated in public hospitals. When compared with private hospitals, public hospitals had a higher crude rate of complications (7.25 % vs. 4.70 %, p < 0.001). This difference remained significant after adjustment (OR 1.74 [95 % CI 1.54-2.04]) and it occurred with both in-hospital (OR 1.83 [1.57-2.14]) and post-discharge (OR 1.39 [1.06-1.83]) complications, with certain complications including acute kidney injury (OR 5.31 [3.02-9.36]), cardiac surgery (OR 5.18 [2.19-12.27]), and pericardial effusion (OR 2.18 [1.50-3.16])., Conclusions: Private hospitals performed most of AF ablations in Australia with a lower rate of complications when compared with public hospitals. Further investigations are needed to identify the precise mechanisms of this observed difference., (© 2021. The Author(s).)

Objectives: We sought to assess the rate of unplanned hospital visits among patients undergoing ambulatory surgery., Summary Background Data: The majority of surgeries performed in the United States now take place in outpatient settings. Post-discharge hospital visit rates have been shown to vary widely, suggesting variation in surgical or discharge care quality. Complicating efforts to address quality, most facilities and surgeons are unaware of their patients' hospital visits after surgery since patients may present to a different hospital., Methods: We used state-level, administrative data from the Agency for Healthcare Research and Quality's Healthcare Cost and Utilization Project from California to assess unplanned hospital visits after ambulatory surgery. To compare rates across centers, we determined the age, sex, and procedure-adjusted rates of hospital visits for each facility using 2-level, hierarchical, generalized linear models using methods similar to existing Centers for Medicare and Medicaid Services measures., Results: Among a total of 1,260,619 ambulatory same-day surgeries from 440 surgical facilities, the risk adjusted 30-day rate of unplanned hospital visits was 4.8%, with emergency department visits of 3.1% and hospital admissions of 1.7%. Several patient characteristics were associated with increased risk of unplanned hospitals visits, including increased age, increased number of comorbidities (using the Elixhauser score), and type of procedure (p<0.001)., Conclusions: The overall rate unplanned hospital visits within 30 days after same-day surgery is low but variable, suggesting a difference in the quality of care provided. Further, these rates are higher among specific patient populations and procedure types, suggesting areas for targeted improvement., Competing Interests: JSR has received research support through Yale University from Johnson and Johnson for other work not related to this study. The other authors have no competing interests to declare.

Background Leadless pacemaker is a novel technology, and evidence supporting its use is uncertain. We performed a systematic review and meta-analysis to examine the safety and efficacy of leadless pacemakers implanted in the right ventricle. Methods and Results We searched PubMed and Embase for studies published before June 6, 2020. The primary safety outcome was major complications, whereas the primary efficacy end point was acceptable pacing capture threshold (≤2 V). Pooled estimates were calculated using the Freedman-Tukey double arcsine transformation. Of 1281 records screened, we identified 36 observational studies of Nanostim and Micra leadless pacemakers, with most (69.4%) reporting outcomes for the Micra. For Micra, the pooled incidence of complications at 90 days (n=1608) was 0.46% (95% CI, 0.08%-1.05%) and at 1 year (n=3194) was 1.77% (95% CI, 0.76%-3.07%). In 5 studies with up to 1-year follow-up, Micra was associated with 51% lower odds of complications compared with transvenous pacemakers (3.30% versus 7.43%; odds ratio [OR], 0.49; 95% CI, 0.34-0.70). At 1 year, 98.96% (95% CI, 97.26%-99.94%) of 1376 patients implanted with Micra had good pacing capture thresholds. For Nanostim, the reported complication incidence ranged from 6.06% to 23.54% at 90 days and 5.33% to 6.67% at 1 year, with 90% to 100% having good pacing capture thresholds at 1 year (pooled result not estimated because of the low number of studies). Conclusions Most studies report outcomes for the Micra, which is associated with a low risk of complications and good electrical performance up to 1-year after implantation. Further data from randomized controlled trials are needed to support the widespread adoption of these devices in clinical practice.

Aims: National 30-day mortality and readmission rates after heart failure (HF) hospitalisations are a focus of US policy intervention and yet have rarely been assessed in other comparable countries. We examined the frequency, trends and institutional variation in 30-day mortality and unplanned readmission rates after HF hospitalisations in Australia and New Zealand., Methods and Results: We included patients >18 years hospitalised with HF at all public and most private hospitals from 2010-15. The primary outcomes were the frequencies of 30-day mortality and unplanned readmissions, and the institutional risk-standardised mortality rate (RSMR) and readmission rate (RSRR) evaluated using separate cohorts. The mortality cohort included 153 592 patients (mean age 78.9 ± 11.8 years, 51.5% male) with 16 442 (10.7%) deaths within 30 days. The readmission cohort included 148 704 patients (mean age 78.6 ± 11.9 years, 51.7% male) with 33 158 (22.3%) unplanned readmission within 30 days. In 392 hospitals with at least 25 HF hospitalisations, the median RSMR was 10.7% (range 6.1-17.3%) with 59 hospitals significantly different from the national average. Similarly, in 391 hospitals with at least 25 HF hospitalisations, the median RSRR was 22.3% (range 17.7-27.1%) with 24 hospitals significantly different from the average. From 2010-15, the adjusted 30-day mortality [odds ratio (OR) 0.991/month, 95% confidence interval (CI) 0.990-0.992, P < 0.01] and unplanned readmission (OR 0.998/month, 95% CI 0.998-0.999, P < 0.01) rates declined., Conclusion: Within 30 days of a HF hospitalisation, one in 10 patients died and almost a quarter of those surviving experienced an unplanned readmission. The risk of these outcomes varied widely among hospitals suggesting disparities in HF care quality. Nevertheless, a substantial decline in 30-day mortality and a modest decline in readmissions occurred over the study period., (© 2020 European Society of Cardiology.)

Introduction: Despite global concerns about the safety and quality of health care, population-wide studies of hospital outcomes are uncommon. The SAFety, Effectiveness of care and Resource use among Australian Hospitals (SAFER Hospitals) study seeks to estimate the incidence of serious adverse events, mortality, unplanned rehospitalisations and direct costs following hospital encounters using nationwide data, and to assess the variation and trends in these outcomes., Methods and Analysis: SAFER Hospitals is a cohort study with retrospective and prospective components. The retrospective component uses data from 2012 to 2018 on all hospitalised patients age ≥18 years included in each State and Territories' Admitted Patient Collections. These routinely collected datasets record every hospital encounter from all public and most private hospitals using a standardised set of variables including patient demographics, primary and secondary diagnoses, procedures and patient status at discharge. The study outcomes are deaths, adverse events, readmissions and emergency care visits. Hospitalisation data will be linked to subsequent hospitalisations and each region's Emergency Department Data Collections and Death Registries to assess readmissions, emergency care encounters and deaths after discharge. Direct hospital costs associated with adverse outcomes will be estimated using data from the National Cost Data Collection. Variation in these outcomes among hospitals will be assessed adjusting for differences in hospitals' case-mix. The prospective component of the study will evaluate the temporal change in outcomes every 4 years from 2019 until 2030., Ethics and Dissemination: Human Research Ethics Committees of the respective Australian states and territories provided ethical approval to conduct this study. A waiver of informed consent was granted for the use of de-identified patient data. Study findings will be disseminated via presentations at conferences and publications in peer-reviewed journals., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Background: Readmissions within 30 days of discharge are prominent among patients with cardiovascular disease. Post hospital syndrome hypothesizes that sleep disturbance during the index admission contributes to an acquired transient vulnerability, leading to increased risk of readmission. This study evaluated the association of in-hospital sleep (a) duration and (b) quality with 30-day all-cause unplanned readmission. Methods: This prospective observational cohort study included patients admitted to the coronary care unit of a South Australian hospital between 2016-2018. Study participants were invited to wear an ActiGraph GT3X+ for the duration of their admission and for two weeks post-discharge. Validated sleep and quality of life questionnaires, including the Pittsburgh Sleep Quality Index (PSQI), were administered. Readmission status and questionnaires were assessed at 30 days post-discharge via patient telephone interview and a review of hospital records. Results: The final cohort consisted of 75 patients (readmitted: n = 15, non-readmitted: n = 60), of which 72% were male with a mean age 66.9 ± 13.1 years. Total sleep time (TST), both in hospital (6.9 ± 1.3 vs. 6.8 ± 2.9 h, p = 0.96) and post-discharge (7.4 ± 1.3 h vs. 8.9 ± 12.6 h, p = 0.76), was similar in all patients. Patient's perception of sleep, reflected by PSQI scores, was poorer in readmitted patients (9.13 ± 3.6 vs. 6.4 ± 4.1, p = 0.02). Conclusions: Although an association between total sleep time and 30-day readmission was not found, patients who reported poorer sleep quality were more likely to be readmitted within 30 days. This study also highlighted the importance of improving sleep, both in and out of the hospital, to improve the outcomes of cardiology inpatients., Competing Interests: Conflicts of InterestThe authors declare no conflict of interest., (© 2020 by the authors.)

Background Patients undergoing implantable cardioverter-defibrillator (ICD) implantations have high rates of long-term device-related complications and reoperations. Whether physician specialty training is associated with differences in long-term outcomes following ICD implantation is unclear. Methods and Results We linked data from the National Cardiovascular Data Registry ICD Registry with Medicare fee-for-service claims to identify physicians who performed ≥10 index ICDs from 2006 to 2009. We used data from the American Board of Medical Specialties to group the specialty of the implanting physician into mutually exclusive categories: electrophysiologists, interventional cardiologists, general cardiologists, thoracic surgeons, and other specialties. Primary outcomes were long-term device-related complications requiring reoperations or hospitalizations and reoperations for reasons other than complications. We compared the cumulative incidence rates and case-mix adjusted rates of long-term outcomes of index ICD implantations across physician specialties. Our analysis had a median follow-up of 47 months and included 107 966 index ICD implantations. Electrophysiologists had the lowest rates of incident long-term device-related complications (14.1%; interventional cardiologists, 15.3%; general cardiologists, 15.4%; thoracic surgeons, 16.4%; other specialists, 15.2%; P<0.001) and reoperations for reasons other than complications (electrophysiologists, 16.7%; interventional cardiologists, 17.0%; general cardiologists, 18.0%; thoracic surgeons, 18.4%; other specialists, 18.0%; P<0.001). Compared with patients whose ICDs were implanted by electrophysiologists, patients with implantations performed by nonelectrophysiologists were at higher risk of having long-term device-related complications (relative risk for interventional cardiologists: 1.16 [95% CI, 1.08-1.25]; general cardiologists: 1.13 [1.08-1.18]; thoracic surgeons: 1.20 [1.06-1.37]; all P<0.001, but not other specialists: 1.08 [0.99-1.17]; P=0.07). Compared to patients with implantations performed by electrophysiologists, patients with implantations performed by general cardiologists and thoracic surgeons were at higher risk of reoperation for noncomplication causes (relative risk for general cardiologists: 1.10 [1.05-1.15]; thoracic surgeons: 1.16 [1.00-1.33]; both P<0.05). Conclusions Patients with ICD implantations performed by electrophysiologists had the lowest risks of having long-term device-related complications and reoperations for noncomplication causes. Consideration of physician specialty before ICD implantation may represent an opportunity to minimize long-term adverse outcomes.

Background To date, limited population-level studies have examined the impact of sex on the acute complications of cardiac implantable electronic devices ( CIED) , including permanent pacemakers, implantable cardioverter defibrillators, and cardiac resynchronization therapy devices. Methods and Results We studied all patients aged >18 years from 2010 to 2015 who were a resident of Australia or New Zealand, undergoing a new permanent pacemaker, implantable cardioverter defibrillator, or cardiac resynchronization therapy implant. Standardized variables were collected including patient demographic characteristics, primary and secondary diagnoses, procedures performed and discharge status. Diagnoses and procedures were coded as per the International Classification of Diseases, Tenth Revision ( ICD-10) and the Australian Classification of Health Interventions. The primary end point was the incidence of major CIED -related complications in-hospital or within 90 days of discharge, with the effect of sex evaluated using multiple logistic regression. A total of 81 304 new CIED (61 658 permanent pacemakers, 12 097 implantable cardioverter defibrillators, 7574 cardiac resynchronization therapy) implants were included (38% women). Overall, 8.5% of women and 8.0% of men experienced a CIED complication ( P=0.008). Differences between women and men remained significant after adjustment for age, procedural acuity, and comorbidities (odds ratio 1.10, 95% CI: 1.04-1.16, P<0.001). Differences in CIED complication rates were primarily driven by excess rate of in-hospital pleural drainage (1.2% women versus 0.6% men, P<0.001; adjusted odds ratio 1.86, 95% CI: 1.59-2.17, P<0.001) and pericardial drainage (0.3% women versus 0.1% men, P<0.001; adjusted odds ratio 2.17, 95% CI: 1.48-3.18, P<0.001). Conclusions Women are at higher risk of acute CIED complications. Improvements in implant technique and technologies are required to minimize the risk of implant-related complications in women.

Background: Studies of chronic diseases are associated with a financial burden on households. We aimed to determine if survivors of acute coronary syndrome (ACS) experience household economic burden and to quantify any potential burden by examining level of economic hardship and factors associated with hardship., Methods: Australian patients admitted to hospital with ACS during 2-week period in May 2012, enrolled in SNAPSHOT ACS audit and who were alive at 18 months after index admission were followed-up via telephone/paper survey. Regression models were used to explore factors related to out-of-pocket expenses and economic hardship., Results: Of 1833 eligible patients at baseline, 180 died within 18 months, and 702 patients completed the survey. Mean out-of-pocket expenditure (n = 614) in Australian dollars was A$258.06 (median: A$126.50) per month. The average spending for medical services was A$120.18 (SD: A$310.35) and medications was A$66.25 (SD: A$80.78). In total, 350 (51 %) of patients reported experiencing economic hardship, 78 (12 %) were unable to pay for medical services and 81 (12 %) could not pay for medication. Younger age (18-59 vs ≥80 years (OR): 1.89), no private health insurance (OR: 2.04), pensioner concession card (OR: 1.80), residing in more disadvantaged area (group 1 vs 5 (OR): 1.77), history of CVD (OR: 1.47) and higher out-of-pocket expenses (group 4 vs 1 (OR): 4.57) were more likely to experience hardship., Conclusion: Subgroups of ACS patients are experiencing considerable economic burden in Australia. These findings provide important considerations for future policy development in terms of the cost of recommended management for patients.

Background: The availability of hospital cardiac services may vary between hospitals and influence care processes and outcomes. However, data on available cardiac services are restricted to a limited number of services collected by the American Hospital Association (AHA) annual survey. We developed an alternative method to identify hospital services using individual patient discharge data for acute myocardial infarction (AMI) in the Premier Healthcare Database., Methods and Results: Thirty-five inpatient cardiac services relevant for AMI care were identified using American Heart Association/American College of Cardiology guidelines. Thirty-one of these services could be defined using patient-level administrative data codes, such as International Classification of Diseases, Ninth Revision, Clinical Modification and Current Procedural Terminology codes. A hospital was classified as providing a service if it had ≥5 instances for the service in the Premier database from 2009 to 2011. Using this system, the availability of these services among 432 Premier hospitals ranged from 100% (services such as chest X-ray) to 1.2% (heart transplant service). To measure the accuracy of this method using administrative data, we calculated agreement between the AHA survey and Premier for a subset of 16 services defined by both sources. There was a high percentage of agreement (≥80%) for 11 of 16 (68.8%) services, moderate agreement for 3 of 16 (18.8%) services, and low agreement (≤50%) for 2 of 16 services (12.5%)., Conclusions: The availability of cardiac services for AMI care varies widely among hospitals. Using individual patient discharge data is a feasible method to identify these cardiac services, particularly for those services pertaining to inpatient care., (© 2016 The Authors and Premier Inc. Published on behalf of the American Heart Association, Inc., by Wiley Blackwell.)

Background & Aims: Colonoscopy is a common procedure, yet little is known about variations in colonoscopy quality among outpatient facilities. We developed an outcome measure to profile outpatient facilities by estimating risk-standardized rates of unplanned hospital visits within 7 days of colonoscopy., Methods: We used a 20% sample of 2010 Medicare outpatient colonoscopy claims (331,880 colonoscopies performed at 8140 facilities) from patients ≥65 years or older, and developed a patient-level logistic regression model to estimate the risk of unplanned hospital visits (ie, emergency department visits, observation stays, and inpatient admissions) within 7 days of colonoscopy. We then used the patient-level risk model variables and hierarchical logistic regression to estimate facility rates of risk-standardized unplanned hospital visits using data from the Healthcare Cost and Utilization Project (325,811 colonoscopies at 992 facilities), from 4 states containing 100% of colonoscopies per facility., Results: Outpatient colonoscopies were followed by 5412 unplanned hospital visits within 7 days (16.3/1000 colonoscopies). Hemorrhage, abdominal pain, and perforation were the most common causes of unplanned hospital visits. Fifteen variables were independently associated with unplanned hospital visits (c = 0.67). A history of fluid and electrolyte imbalance (odds ratio [OR] = 1.43; 95% confidence interval [CI]: 1.29-1.58), psychiatric disorders (OR = 1.34; 95% CI: 1.22-1.46), and, in the absence of prior arrhythmia, increasing age past 65 years (aged >85 years vs 65-69 years: OR = 1.87; 95% CI: 1.54-2.28) were most strongly associated. The facility risk-standardized unplanned hospital visits calculated using Healthcare Cost and Utilization Project data showed significant variation (median 12.3/1000; 5th-95th percentile, 10.5-14.6/1000). Median risk-standardized unplanned hospital visits were comparable between ambulatory surgery centers and hospital outpatient departments (each was 10.2/1000), and ranged from 16.1/1000 in the Northeast to 17.2/1000 in the Midwest., Conclusions: We calculated a risk-adjusted measure of outpatient colonoscopy quality, which shows important variation in quality among outpatient facilities. This measure can make transparent the extent to which patients require follow-up hospital care, help inform patient choices, and assist in quality-improvement efforts., (Copyright © 2016 AGA Institute. Published by Elsevier Inc. All rights reserved.)