First-in-human: Leaflet laceration with balloon mediated annihilation to prevent coronary obstruction with radiofrequency needle (LLAMACORN) for valve-in-valve transcatheter aortic valve replacement.

Coronary obstruction (CO) is a potential pitfall for transcatheter aortic valve replacement (TAVR), especially in valve in valve procedures into degenerated surgical or transcatheter prostheses. Bioprosthetic leaflet modification techniques that incorporate electrosurgery are evolving as the preferred strategy to mitigate the risk of CO in high CO risk settings. The UNICORN method is proposed as a more predictable leaflet modification strategy than the earlier described BASILICA approach, but its proponents have hitherto mandated the use of a balloon-expandable valve (BEV) prosthesis. Many patients have small prostheses and therein face a significant risk of patient prosthesis mismatch with BEV in this setting. This risk may be curtailed if a self-expanding valve (SEV) prosthesis could be used. Herein described is a modified approach to allow for the utilization of SEV systems in this setting.

Third-Generation Transcatheter Aortic Heart Valve with Reverse Parachute Sealing Cuff in Patients with Aortic Valve Disease.

BACKGROUND: The Navitor (Abbott Inc, IL, USA) transcatheter heart valve is a novel third-generation self-expanding bioprosthesis with specific features to mitigate paravalvular regurgitation (PVR). Owing to its novelty, there is a paucity of data on its application in clinical practice. METHODS: Consecutive cohort analysis of the use of the Navitor system in an as-treated clinical setting at a quaternary heart hospital. RESULTS: Sixty consecutive non-clinical trial patients treated with Navitor were identified. All patients underwent a successful procedure. The mean age was 79.3 years (±SD 7.82), 56.67% (n=34) were female, and the mean STS score was 4.87 (±SD 5.70). At 30 days post-procedure, all patients were alive with no readmissions for heart failure. One patient had a major vascular complication (1.7%). Four patients (7.14% of patients without a pre-existing pacemaker) received a new permanent pacemaker. Two patients (3.4%) had a non-disabling stroke. PVR at 30 days was trivial or none in 75% of patients, and no patient had worse than mild PVR. CONCLUSIONS: The Navitor system in this as-treated cohort was associated with favourable clinical, haemodynamic, and safety outcomes.

30-Day Outcomes With the Portico Transcatheter Heart Valve: Insights From a Multi-Centre Australian Observational Study.

BACKGROUND: Transcatheter aortic valve implantation (TAVI) is an established therapy for the treatment of aortic valve disease in appropriately selected patients. Previous studies using the self-expanding Portico transcatheter heart valve (THV), (Abbott Structural Heart, St Paul, MN, USA) have demonstrated the technical feasibility of this system albeit in the hands of relatively inexperienced Portico users. The objective of this study was to assess the real-world safety and efficacy of the Portico THV (with and without the FlexNav delivery system, Abbott Structural Heart) at the 30-day timepoint in an Australian cohort. METHODS AND RESULTS: This study was a retrospective real-world cohort analysis of 269 consecutive patients with severe aortic valve disease who underwent TAVI at multiple centres within Australia between February 2015 and April 2021. Of the 269 patients, 51.7% were female, mean Society of Thoracic Surgeons (STS) score was 5.2 (±6.8) and 98.5% had successful implantations. Thirty (30)-day post-implantation all-cause mortality was observed in one (0.4%) patient, major vascular complications in two (0.7%) patients, more-than-mild paravalvular leak in six (2.2%) patients and requirement for new permanent pacemaker implantation in 27 (10.2%) patients. Haemodynamic parameters at 30 days included mean effective orifice area (EOA) of 2.3 (±0.9) cm2 and mean aortic valve gradient (AVG) of 9.6 (±6.2) mmHg. CONCLUSION: This analysis of the Portico THV in a real-world setting suggested that the system is associated with satisfactory safety and efficacy parameters. Previously published datasets may not have found similar findings owing to lower operator experience with the Portico THV system.

Complete revascularization in stable multivessel coronary artery disease: A real world analysis from the British Columbia Cardiac Registry.

BACKGROUND: More than half of patients undergoing percutaneous coronary intervention (PCI) have multivessel disease (MVD). The prognostic significance of PCI in stable patients has recently been debated, but little data exists about the potential benefit of complete revascularization (CR) in stable MVD. We investigated the prognostic benefit of CR in patients undergoing PCI for stable disease. METHODS: We compared CR versus incomplete revascularization (IR) in 8,436 patients with MVD. The primary outcome was all-cause mortality at 5 years. RESULTS: A total of 1,399 patients (17%) underwent CR during the index PCI procedure for stable disease. CR was associated with lower mortality (6.2 vs. 10.7%, p < .001) and lower repeat revascularization at 5 years (12.7 vs. 18.4%, p < .001). Multivariable-adjusted analyses indicated that CR was associated with lower mortality (HR = 0.73, 95% CI: 0.58-0.91, p = .005) and repeat revascularization at 5 years (HR = 0.78, 95% CI: 0.66-0.93, p = .005). These findings were also confirmed in propensity-matched cohorts. Subgroup analyses indicated that CR conferred survival in older patients, male patients, absence of renal disease, greater angina (CCS Class III-IV) and heart failure (NYHA Class III-IV) symptoms, and greater burden of coronary disease. In sensitivity analyses where patients with subsequent repeat revascularization events were excluded, CR remained a strong predictor for lower mortality (HR = 0.69, 95% CI: 0.54-0.89, p = .004). CONCLUSIONS: In this study of stable patients with MVD, CR was an independent predictor of long-term survival. This benefit was specifically seen in higher risk patient groups and indicates that CR may benefit selected stable patients with MVD.

The Cone Flare Crush Modified-T (CFCT) stenting technique for coronary artery bifurcation lesions.

BACKGROUND: The present study is a prospective observational single arm clinical investigation, with parallel bench test interrogation, aimed at investigating the technical feasibility, safety and clinical outcomes with the cone flare crush modified-T (CFCT) bifurcation stenting technique. Bifurcation percutaneous coronary intervention (PCI) remains an area of ongoing procedural evolution. More widely applicable and reproducible techniques are required. METHODS: From April 2018 until March 2019, 20 consecutive patients underwent bifurcation PCI using the CFCT technique with a Pt-Cr everolimus drug-eluting stent with a bioresorbable polymer. Exercise stress echocardiography was performed at 12-month follow-up. The primary outcome was a composite of cardiac related mortality, myocardial infarction, target lesion/vessel revascularization and stroke. Safety secondary endpoints included bleeding, all-cause mortality and stent thrombosis. RESULTS: All patients underwent a successful CFCT bifurcation procedure with no complications to 30-day follow-up. One patient met the primary endpoint requiring target lesion revascularization at 9 months for stable angina. There were no other primary or secondary outcome events in the cohort. There were no strokes, deaths, stent thrombosis or myocardial infarction during the follow-up period. The mean CCS score improved from 2.25 to 0.25 (p < 0.0001). Optical coherence tomography (OCT) and bench test findings indicated optimal side branch ostial coverage and minimal redundant strut material crowding the neo-carina. CONCLUSIONS: The CFCT technique appears to be a safe, efficacious and feasible strategy for managing coronary artery bifurcation disease. Expanded and randomized datasets with longer term follow-up are required to further explore confirm this feasibility data. (ANZCTR ID: ACTRN12618001145291).

Coronary Angiography and Revascularization Following Coronary Artery Bypass Grafting in British Columbia: Incidence, Predictors and Longer-term Outcomes.

BACKGROUND: Coronary artery bypass grafting (CABG) is established treatment for subsets of coronary artery disease (CAD). Observational data have characterised significant progression of native coronary as well as graft vessel disease during longer-term follow-up, potentially reducing the benefit of CABG. We sought to assess longer-term outcomes following CABG by determining rates of repeat coronary angiography, revascularization procedures, and survival. METHODS: Data for all patients undergoing isolated CABG in British Columbia between 2001 and 2009 inclusive, and with follow-up until the end of 2013, were retrieved from the British Columbia Cardiac Registry. Cox proportional hazard regression and competing risk regression were performed for survival and subsequent cardiac procedures (coronary angiography, percutaneous coronary intervention [PCI] or repeat CABG). RESULTS: Data were available from 17,316 patients with a mean age at index CABG of 65.7 ± 9.8 years. At a median follow-up of 8.5 (range 4.0 to 12.9) years, 3185 patients (18.4%) had died, 3135 (18.1%) underwent repeat coronary angiography with or without PCI or repeat CABG, and 11,557 (66.7%) had survived without additional procedures. Of those who underwent angiography, 1459 patients (46.5%) underwent further revascularization. In multivariate analysis, the strongest predictors of long-term mortality were dialysis dependency and age >75, whereas left internal mammary artery utilization and aspirin therapy were protective. Repeat revascularization predicted survival (adjusted hazard ratio 0.76; 95% confidence interval, 0.63-0.92; P = 0.004), whereas angiography alone did not. CONCLUSIONS: Following CABG, patients frequently undergo repeat coronary angiography. Although only a minority of patients receive further revascularization, this appears to be associated with longer-term survival.

The Utility of 99mTc-DPD Scintigraphy in the Diagnosis of Cardiac Amyloidosis: An Australian Experience.

BACKGROUND: The uptake of bone-seeking radiotracers in the amyloid heart is well recognised. 99mTc-DPD has been shown to be highly sensitive for cardiac transthyretin (ATTR) amyloid in an overseas population, but is not registered for use in Australia. We explored its utility as a diagnostic tool within our population. METHODS: Patients diagnosed with AL and ATTR (wild-type and inherited) cardiac amyloidosis were prospectively recruited from the Princess Alexandra Hospital Amyloidosis Centre. Patients underwent injection with 99mTc-DPD then planar whole body imaging was performed at 5 minutes post-injection (soft tissue phase) and 3 hours (bone phase). A myocardial SPECT and low amperage CT were acquired after the late whole-body scan. Scans were analysed by two nuclear imaging specialists. Intensity of cardiac 99mTc-DPD uptake was graded as 0 to 3 in accordance with previous criteria, and semiquantitative analysis was performed using a heart to whole body ratio (H:WB) on the 3-hour scan. Patients also underwent electrocardiography and transthoracic echocardiography, and blood samples were taken for troponin I and brain natriuretic peptide levels, to assess for any correlation with DPD uptake. RESULTS: Twenty-one patients (8 AL and 13 ATTR) completed the study. Median age was 58 and 70 years for AL and ATTR patients respectively, and 19 (90.5%) were male. 99mTc-DPD scintigraphy was positive in 2 (25%) of AL, and 13 (100%) of ATTR patients. Grade of cardiac uptake, and mean H:WB (0.1249 v. 0.0794) was greater in the ATTR cohort (p-value<0.001 and 0.001 respectively). No statistically significant correlation was identified between H:WB and echocardiographic parameters. There was a significant positive correlation between H:WB and the PR interval on ECG (p=0.026). CONCLUSIONS: 99mTc-DPD scintigraphy is highly sensitive for the diagnosis of cardiac ATTR amyloid, but less so for AL amyloid.

A quasi-Monte-Carlo comparison of parametric and semiparametric regression methods for heavy-tailed and non-normal data: an application to healthcare costs.

We conduct a quasi-Monte-Carlo comparison of the recent developments in parametric and semiparametric regression methods for healthcare costs, both against each other and against standard practice. The population of English National Health Service hospital in-patient episodes for the financial year 2007-2008 (summed for each patient) is randomly divided into two equally sized subpopulations to form an estimation set and a validation set. Evaluating out-of-sample using the validation set, a conditional density approximation estimator shows considerable promise in forecasting conditional means, performing best for accuracy of forecasting and among the best four for bias and goodness of fit. The best performing model for bias is linear regression with square-root-transformed dependent variables, whereas a generalized linear model with square-root link function and Poisson distribution performs best in terms of goodness of fit. Commonly used models utilizing a log-link are shown to perform badly relative to other models considered in our comparison.

Cardiac Amyloid Imaging with 18F-Florbetaben PET: A Pilot Study.

Our aim was to determine the feasibility of 18F-florbetaben PET in diagnosing cardiac amyloidosis. METHODS: 18F-florbetaben PET was performed on 14 patients: 5 amyloid light chain, 5 amyloid transthyretin, and 4 control with hypertensive heart disease. Qualitative and quantitative assessments of 18F-florbetaben activity were performed using the SUVmean of the left ventricular myocardium and blood pool and calculation of target-to-background SUV ratio. Myocardial 18F-forbetaben retention was also calculated as the percentage mean myocardial SUV change between 0 and 5 min and 15 and 20 min after radiotracer injection. Global left ventricular longitudinal and right ventricular free wall longitudinal strain were calculated using 2-dimensional speckle-tracking echocardiography. RESULTS: Target-to-background SUV ratio and percentage myocardial 18F-forbetaben retention were higher in amyloid patients than in hypertensive controls. A cutoff of 40% was able to differentiate between cardiac amyloid patients and hypertensive controls. Percentage myocardial 18F-forbetaben retention was an independent determinant of both global left ventricular longitudinal and right ventricular free wall longitudinal strain via an inverse curve relationship. CONCLUSION: 18F-florbetaben PET imaging can accurately identify and differentiate between cardiac amyloidosis and hypertensive heart disease. Percentage myocardial 18F-florbetaben retention was an independent determinant of myocardial dysfunction in cardiac amyloidosis.

An Unusual Cause of Out-of-Hospital Cardiac Arrest Recorded on a Heartrate Monitor.

Coronary vasospasm is an uncommon, but perhaps under-recognised, cause of cardiac arrest. We present a novel case of an exercise-induced out-of-hospital cardiac arrest due to coronary vasospasm, captured on a heartrate monitor, and discuss the management options for this condition.

Medical Graduates, Tertiary Hospitals, and Burnout: A Longitudinal Cohort Study.

BACKGROUND: Burnout among junior doctors can affect patient care. We conducted a longitudinal cohort study designed to explore the incidence of burnout in medical interns and to examine the changes in burnout during the course of the intern year. METHODS: Interns were recruited at two tertiary hospitals in Brisbane, Australia (n=180). Participants completed surveys at four time points during their internship year. All interns (100%) completed the baseline survey during their orientation. Response rates were 85%, 88%, and 79%, respectively, at 5-week, 6-month, and 12-month follow-up. RESULTS: Interns reported high levels of personal and work-related burnout throughout the year that peaked at 6 months with mean scores of 42.53 and 41.81, respectively. Increases of 5.1 points (confidence interval [CI] 2.5,7.7; P=0.0001) and 3.5 points (CI 1.3,5.6; P=0.0015) were seen at 6 months for personal and work-related burnout, respectively. The mean score for patient-related burnout at 12 months was 25.57, and this number had increased significantly by 5.8 points (CI 3.2,8.5; P<0.0001) throughout the year. Correlation with demographic variables (age, sex) were found. The total incidence of burnout was 55.9%. CONCLUSION: Our study showed that burnout is a common problem among interns. The high incidence of burnout demonstrates the need for appropriate strategies to prevent adverse effects on doctors' quality of life and on the quality of care patients receive.

Economic evaluation of a fluocinolone acetonide intravitreal implant for patients with DME based on the FAME study.

INTRODUCTION: Diabetic macular edema (DME) is the most common cause of visual impairment in patients with diabetes. DME is a complex disease characterized by the deposition of fluid and proteins within the intraretinal layers, and the disease is recognized as being mediated by multiple cytokines, requiring a multifactorial therapeutic approach. Iluvien (fluocinolone acetonide intravitreal implant) 0.19 mg contains a corticosteroid, fluocinolone acetonide [FAc], and is indicated for the treatment of DME in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure. METHODS: A Markov model was constructed in Microsoft Excel with a 15-year time horizon comparing the healthcare and productivity costs with health outcomes from treatment. The model was structured around 13 best corrected visual acuity states using Early Treatment Diabetic Retinopathy Study scores. Observations and extrapolations from the Fluocinolone Acetonide for Diabetic Macular Edema study were applied to determine observed and ongoing treatment effects. RESULTS: The expected incremental cost-effectiveness ratio for treatment with an FAc implant is $38,763, assuming 40% of patients are treated unilaterally; when 100% of patients receive unilateral treatment with an FAc implant, it is cost-saving. CONCLUSION: Administering an FAc implant to patients with DME previously treated with a corticosteroid is a cost-effective treatment option for ophthalmologists.

Seven years experience of a nurse-led elective cardioversion service in a tertiary referral centre: an observational study.

BACKGROUND: Traditionally the provision of elective external direct current cardioversion (EDCCV) for patients with atrial arrhythmias has been doctor-led. Increasing demands on hospital beds and time pressures for doctors has driven the desire for an alternative approach. We established a nurse-led cardioversion service in 2006 and present our experience. METHODS: A prospective database of patients undergoing elective EDCCV between July 2006 and July 2013 was collected. Demographic data, arrhythmia, success and immediate complications of cardioversion were recorded. RESULTS: A total of 974 EDCCV were performed on 772 patients. The mean patient age was 62.7 years, 564 (73.1%) were male. In 530 patients (69.0%) AF was the primary arrhythmia, in 242 (31.0%) atrial flutter. All EDCCVs were performed in a high dependency unit. Sinus rhythm was obtained in 692 patients (89.6%). Of 640 outpatients, 629 (98.3%) were discharged on the same day of their procedure. Eleven patients (1.7%) required admission to hospital. No patients required urgent temporary transvenous or permanent pacing, and there were no deaths in association with this procedure. CONCLUSIONS: Nurse-led elective EDCCV is a safe and effective way of restoring sinus rhythm in patients with AF or atrial flutter, with additional benefits to resource provision.

Economic impact of primary open-angle glaucoma in Australia.

BACKGROUND: Glaucoma is the World's leading cause of irreversible blindness, and poses serious public health and economic concerns. DESIGN: Review. SAMPLES: Published randomized trials and population-based studies since 1985. METHODS: We report the economic impact of primary open-angle glaucoma and model the effect of changes in detection rates and management strategies. MAIN OUTCOME MEASURES: The cost-effectiveness of different interventions to prevent vision loss from primary open-angle glaucoma was measured in terms of financial cost (Australian dollars) and disability-adjusted life years. RESULTS: The prevalence of glaucoma in Australia is expected to increase from 208 000 in 2005 to 379 000 in 2025 because of the aging population. Health system costs over the same time period are estimated to increase from $AU355 million to $AU784 million. Total costs (health system costs, indirect costs and costs of loss of well-being) will increase from $AU1.9 billion to $AU4.3 billion in Australia. CONCLUSION: Primary open-angle glaucoma poses a significant economic burden, which will increase substantially by 2025. This dynamic model provides a valuable tool for ongoing policy formulation and determining the economic impact of interventions to better prevent visual impairment and blindness from glaucoma.