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Background: Renal denervation (RDN) is under investigation for treatment of uncontrolled hypertension and might represent an attractive treatment for patients with high cardiovascular (CV) risk. It is important to determine whether baseline CV risk affects the efficacy of RDN. Objectives: The purpose of this study was to assess blood pressure (BP) reduction and event rates after RDN in patients with various comorbidities, testing the hypothesis that RDN is effective and durable in these high-risk populations. Methods: BP reduction and adverse events over 3 years were evaluated for several high-risk subgroups in the GSR (Global proSpective registrY for syMPathetic renaL denervatIon in seleCted IndicatIons Through 3 Years Registry), an international registry of RDN in patients with uncontrolled hypertension (n = 2,652). Comparisons were made for patients age ≥65 years versus age <65 years, with versus without isolated systolic hypertension, with versus without atrial fibrillation, and with versus without diabetes mellitus. Baseline cardiovascular risk was estimated using the American Heart Association (AHA)/American College of Cardiology (ACC) atherosclerosis cardiovascular disease (ASCVD) risk score. Results: Reduction in 24-h systolic BP at 3 years was −8.9 ± 20.1 mm Hg for the overall cohort, and for high-risk subgroups, BP reduction was −10.4 ± 21.0 mm Hg for resistant hypertension, −8.7 ± 17.4 mm Hg in patients age ≥65 years, −10.2 ± 17.9 mm Hg in patients with diabetes, −8.6 ± 18.7 mm Hg in isolated systolic hypertension, −10.1 ± 20.3 mm Hg in chronic kidney disease, and −10.0 ± 19.1 mm Hg in atrial fibrillation (p < 0.0001 compared with baseline for all). BP reduction in patients with measurements at 6, 12, 24, and 36 months showed similar reductions in office and 24-h BP for patients with varying baseline ASCVD risk scores, which was sustained to 3 years. Adverse event rates at 3 years were higher for patients with higher baseline CV risk. Conclusions: B

BACKGROUND: Inflammation plays a crucial role in clinical manifestations and complications of acute coronary syndromes (ACS). Colchicine, a commonly used treatment for gout, has recently emerged as a novel therapeutic option in cardiovascular medicine owing to its anti-inflammatory properties. We sought to determine the potential usefulness of colchicine treatment in patients with ACS. METHOD(S): This was a multicenter, randomized, double-blind, placebo-controlled trial involving 17 hospitals in Australia that provide acute cardiac care service. Eligible participants were adults (18-85 years) who presented with ACS and had evidence of coronary artery disease on coronary angiography managed with either percutaneous coronary intervention or medical therapy. Patients were assigned to receive either colchicine (0.5 mg twice daily for the first month, then 0.5 mg daily for 11 months) or placebo, in addition to standard secondary prevention pharmacotherapy, and were followed up for a minimum of 12 months. The primary outcome was a composite of all-cause mortality, ACS, ischemia-driven (unplanned) urgent revascularization, and noncardioembolic ischemic stroke in a time to event analysis. RESULT(S): A total of 795 patients were recruited between December 2015 and September 2018 (mean age, 59.8+/-10.3 years; 21% female), with 396 assigned to the colchicine group and 399 to the placebo group. Over the 12-month follow-up, there were 24 events in the colchicine group compared with 38 events in the placebo group (P=0.09, log-rank). There was a higher rate of total death (8 versus 1; P=0.017, log-rank) and, in particular, noncardiovascular death in the colchicine group (5 versus 0; P=0.024, log-rank). The rates of reported adverse effects were not different (colchicine 23.0% versus placebo 24.3%), and they were predominantly gastrointestinal symptoms (colchicine, 23.0% versus placebo, 20.8%). CONCLUSION(S): The addition of colchicine to standard medical therapy did not significan

Background: Bioresorbable scaffolds (BRS) are a novel technology in coronary intervention. However, recent trials demonstrate higher rates of device failure compared to contemporary drug-eluting stents. This study sought to utilise a clinical quality registry to assess the medium-term safety of the Abbott Absorb BRS (Abbott Vascular, Santa Clara, CA, USA), in an Australian context. Method(s): A prospective, observational study of 192 BRS percutaneous coronary interventions (PCI) compared to 31,773 non-BRS PCIs entered in the Victorian Cardiac Outcomes Registry from 2013 to 2017. The main outcome measure was patient-oriented composite endpoint (POCE) events comprising all-cause mortality, any myocardial infarction (MI), and any revascularisation. Result(s): Bioresorbable scaffolds patients (mean age 61.6+/-10.5 years, 79% male) were younger, had less comorbidity, less prior PCI, fewer ST elevation myocardial infarction (STEMI) presentations, lower rates of multi-lesion disease and more adjuvant devices compared to non-BRS PCI (all p<0.01). All-cause mortality was 2.1%, myocardial infarction (MI) 2.1%, scaffold thrombosis 3.1% and any revascularisation 14.1% (mean follow-up 27.4+/-8.9 months). POCE events occurred in 11.5% at 1 year and 16.9% at 2 years, comparable to pooled-trial data. Multivariate predictors of POCE were >1 scaffold used (odds ratio [OR] 4.6, 95% confidence interval [CI] 1.9-11.4, p<0.01) and scaffold diameter <=2.5 mm (OR 3.3, 95% CI 1.4-7.6, p=0.02). Over 95% guideline adherence was achieved in six of eight patient selection criteria and four of six device deployment criteria. Conclusion(s): In an Australian setting, BRS were used in non-complex patients. Most guidelines for use were adhered to and outcomes were comparable to pooled trial data. Clinical quality registries are effective in assessing novel treatments and technologies when potential safety concerns develop.Copyright © 2019 Australian and New Zealand Society of Cardiac and Thoracic Su

Background: The FAST Feasibility Study is a first-in-human, prospective, multicenter, single-arm study of the second-generation, thin-strut (105-mum thickness), everolimus-eluting Renuvia bioresorbable scaffold for the treatment of coronary artery disease. Method(s): To evaluate the acute device performance and long-term arterial response, serial intravascular ultrasound (IVUS) was performed at baseline (n = 31), 6 months (required, n = 31), and 2 years (optional, n = 16). Serial optical coherence tomography was recommended additionally with the aim of strut-level analysis. Result(s): Post-procedural device expansion (ratio of scaffold to reference lumen volume index on IVUS) of 99.4 +/- 14.7% was achieved. On optical coherence tomography, incomplete strut apposition was observed in a median of 1.3% (interquartile range: 0.0%, 3.1%) of all struts analyzed post-procedure, the majority of which had been resolved at 6 months (median: 0.0%; interquartile range: 0.0%, 0.2%) with nearly complete strut coverage (uncovered struts: median: 0.0%; interquartile range: 0.0%, 1.8%; n = 14). Neointimal volume obstruction by IVUS was 5.1 +/- 3.9% with minimal scaffold recoil (2.2 +/- 5.1%) at 6 months. Serial volumetric IVUS showed a plaque increase with a trend of adaptive remodeling over 6 months, followed by no significant change in vessel, plaque, or lumen from 6 months to 2 years (Figure). No thrombus or strut fracture including intraluminal dismantling was detected at any time point. [Formula presented] Conclusion(s): The data support clinical feasibility of thin-strut scaffolds without compromising radial strength and fracture resistance and with virtually stable arterial responses up to 2 years. Categories: CORONARY: Stents: Bioresorbable Vascular ScaffoldsCopyright © 2020

Objective: To define, improve and maintain the safety and quality of care for Australian patients undergoing TAVI procedures. Method(s): The National TAVI Registry was mandated by the Health Insurance Commission (HIC) for patients with severe aortic stenosis who are treated with a TAVI procedure. The HIC decision was based on the Commonwealth Medicare Benefits Scheme agreeing to reimburse TAVI procedures and the joint recommendations provided by CSANZ and ANZSCTS. These recommendations are the basis for hospitals and practitioners to initiate and maintain a TAVI programme and furthermore comply with the accreditation requirements outlined by the TAVI Accreditation Committee. The Australasian Cardiac Outcomes Registry (ACOR) was tasked with designing and implementing a national TAVI Registry. The South Australian Health and Medical Research Institute (SAHMRI) was appointed by ACOR as the Registry Operator to develop and manage the registry. All accredited Australian hospitals performing TAVI procedures are mandated to participate to ensure data is collected from the entire eligible population. Result(s): The TAVI Steering Committee agreed on a minimum data set, including information on demographics, diagnosis, treatment, outcomes and patient reported quality of life. As of February 2019, 39 hospitals (100%) have received ethics approval, 37 (95%) have local governance approval, 32 (82%) have received training and 30 (77%) are contributing data. Conclusion(s): The TAVI Registry will identify areas of excellence, opportunities for improvements in quality of care and provide an accurate and transparent assessment of the safety of the TAVI procedure and devices in the Australian population.Copyright © 2019

Objective: To evaluate the health status outcomes of TAVI patients using two standardised and validated patient-reported outcome measures (PROMs). Method(s): From April to October 2018, TAVI Registry patients were requested via phone, email, mail or direct contact to complete the PROMs at two timepoints: pre-procedure (416 patients) and 30-day follow-up (273 eligible patients). The PROMs include: a generic quality of life questionnaire, the EQ-5D and a disease specific instrument, the Kansas City Cardiomyopathy Questionnaire (KCCQ). Result(s): The cohort mean age was 83 years (range 59-87) and 57% male. For both PROMs there was a high completion rate: the pre-procedure timepoint (KCCQ n = 384 (92%), EQ5D n = 390 (94%)) was lower than at 30-days (KCCQ n = 262 (96%) EQ5D n = 264 (97%)). The mean KCCQ-overall score increased from 49.7 +/- 22.7 pre-procedure to 76.0 +/- 21.2 at 30-days (p value < 0.0001). All KCCQ domains increased when comparing pre-procedure and 30-day follow-up. The overall mean EQ5D visual analogue scale (score 0-100) increased from 59.8 +/- 18.9 to 72.9 +/- 17.0 at 30-days (p value < 0.001). A comparison of pre-procedure and 30-day follow-up data using EQ5D showed a significant increase in all five domains. Conclusion(s): A dramatic improvement at 30-days is being reported by patients supporting the clinical benefits of the TAVI procedure. This significance was demonstrated throughout all domain variables and as an overall score in both PROMs. As the TAVI Registry reaches its 1-year timepoint, it is expected the outcomes will continue to improve which aligns with the PROMs data reported from other international registries.Copyright © 2019

Objective: To examine Australian TAVI practice and early clinical outcomes with data from the TAVI Registry. Method(s): Australian TAVI Registry data were exported in February 2019 with incomplete cases subsequently excluded from the dataset. The following data variables were included in the review: age, gender, mortality, STS score, hospital type, length of stay (total LOS and post Procedure LOS) and adverse events. Results are aggregated for all contributing hospitals. Result(s): The TAVI Registry contains 865 in-hospital cases, 778 were eligible for follow-up at 30-days. The number of complete cases at these timepoints are: in-hospital 717 (83%) and 30-day follow-up 553 (71%). The cohort mean age was 83 years (range 45.8 - 97.3) and 60% were male. The majority (81%) of procedures were performed in the private sector. The median STS score was 4.47% with a mean STS score of 5.87% (range 1.0 - 39.4%). The 30-day mortality was 1.54% (n = 12). Of these, 7 patients (0.8%) died in-hospital. This mortality is consistent with the 1-2%% reported by other international registries. Median total length of stay (LOS) admission to discharge was 4 days. At 30-days an adverse event occurred in 199 patients (25%, 209 events), which includes 186 in-hospital events. Conclusion(s): The clinical characteristics of Australian TAVI patients are consistent with international practice. Early clinical outcomes are also consistent with international benchmarks.Copyright © 2019

Objective: To determine if STS score alone can predict which patients proceed to a TAVI procedure Method: When evaluating a patient's suitability for a TAVI procedure, Australian multidisciplinary heart teams (MDT) also assess the perioperative risk of surgical mortality (PROM). The STS PROM is calculated based on the patient demographics, history and clinical variables weighted against outcomes for surgical Atrial Valve Replacement (sAVR). However, it does not include many factors deemed important for decision of TAVI vs sAVR. The TAVI Registry commenced mandatory STS scoring in August 2018. Three STS risk levels are included in the cohort of data exported from the TAVI Registry in February 2019. Result(s): Out of 677 cases in the TAVI registry with completed STS score, 274 were low risk (STS <4%), 264 "intermediate risk" (STS 4-7%) and 139 "high risk" (STS >=8%). TAVI was performed as recommended by an MDT, indicating there are other factors which must be considered during risk assessment of patients such as: previous cardiac surgery; porcelain aorta, frailty score, mental state (dementia), mobility, social situation and BMI. Conclusion(s): The majority of patients in the TAVI Registry were the "low-risk" for sAVR suggesting deficiency of using STS score alone for TAVI. Many other factors precluding sAVR are not included in the STS risk calculation. Currently the criteria used by the MDT to determine TAVI risk is not uniform and could be viewed as subjective. An opportunity exists to develop a TAVI-specific risk-prediction model incorporating other factors.Copyright © 2019

BACKGROUND: There is still limited data on the very long term clinical outcomes after ABSORB BRS in daily practice. We sought to evaluate the 3 year-performance of the Absorb bioresorbable vascular scaffolds for the treatment of low/moderate complexity patients enrolled in the ABSORB EXTEND trial. METHODS: ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. This study allowed the treatment of lesions ≤28 mm in length and reference vessel diameter of 2.0-3.8 mm (as assessed by on-line QCA). To determine the independent predictors of MACE, a multivariable logistic regression model was built using a stepwise (forward/backward) procedure. RESULTS: Average population age was 61 years and 26.5% had diabetes. Most patients had single target lesion (92.4%). Adequate scaffold deployment (PSP) was achieved in 14.2% of the cases. At three years, the composite endpoints of MACE and ischemia-driven target vessel failure were 9.2% and 10.6%, respectively. The cumulative rate of ARC definite/probable thrombosis was 2.2%, with 1.2% of the cases occurring after the 1st year. Independent predictors of MACE were hypertension and the need for "bail out" stent. CONCLUSION: At three-year follow-up, the use of ABSORB in low/moderate complex PCI was associated with low and acceptable rates of major adverse clinical events, despite the infrequent use of the recommended contemporary scaffold deployment technique. However, scaffold thrombosis rate was higher than reported with current generation of metallic DES. The study is registered on clinicaltrials.gov (unique identifier NCT01023789).

BACKGROUND: Spontaneous coronary artery dissection (SCAD) is an infrequent but potentially life-threatening condition in patients with acute myocardial infarction. Conservative medical therapy is recommended in patients with SCAD. However, very little evidence exists in the management of recurrent SCAD when conservative medical therapy fails. CASE SUMMARY: A 48-year-old woman presented with non-ST-elevation myocardial infarction (NSTEMI) on a background of cigarette smoking. Her coronary angiogram showed the first diagonal artery (D1) and right marginal branch (RM) occlusion with angiographic appearance that is consistent with SCAD. She was medically managed. She represented 2 months later with another NSTEMI, and her coronary angiogram showed healing SCAD in the D1 and RM, but a new SCAD in the first obtuse marginal artery (OM1). She was managed medically. She represented 4 months later complaining of angina every 2 days. This time her coronary angiogram showed healed SCAD in OM1 and RM, but the recurrence of SCAD in D1. Given that she had recurrent events despite medical therapy, we decided to proceed with percutaneous coronary intervention (PCI) to D1. She presented with an atypical chest pain 10 months later and her coronary angiogram showed complete healing of all coronary arteries and a patent stent in D1. She has remained symptom free. DISCUSSION: The management of SCAD is contentious given the lack of randomized clinical trials to assess optimal treatment strategy. In most patients with SCAD, conservative medical therapy is recommended after the diagnosis is secured. We believe that PCI may be beneficial in patients with recurrent SCAD.

BACKGROUND: Pregnancy-associated spontaneous coronary artery dissection (P-SCAD) is defined as SCAD occurring during pregnancy or within 3 months post-partum. Earlier systematic reviews have suggested a high maternal and foetal mortality rate. We undertook a structured systematic review of P-SCAD demographics, management and maternal and foetal outcomes. METHODS: Case study identification was conducted according to PRISMA guidelines, with screening of all published P-SCAD cases not meeting pre-defined exclusion criteria. Of two hundred and seventy-three publications screened, one hundred and thirty-eight cases met inclusion criteria. Cases were allocated to one of three time periods; 1960-85 (twenty cases) reflecting early management of P-SCAD, 1986-2005 (forty-two cases) reflecting recent management, and 2006-16 (seventy-six cases), reflecting contemporary management. RESULTS: The only significant demographic change in women experiencing P-SCAD over the last 50 years was an increasing proportion of primigravidas (p = 0.02). Management and outcomes, however, have altered significantly. Emergent angiography (p < 0.0001), reduced thrombolysis (p = 0.006) and increasingly conservative or percutaneous management (p < 0.0001) are associated with dramatic reductions in maternal mortality (85% in earliest reports to 4% in the last decade, p < 0.0001) and foetal mortality (50% in earliest reports to 0.0% in the last decade, p = 0.023). CONCLUSION: This systematic review of temporal changes in presentation, management and outcomes of P-SCAD represents the widest range of variables analysed in the largest cohort of P-SCAD patients to date. In the setting of earlier coronary angiography and increasingly conservative management, maternal and foetal survival rates continue to improve.

BACKGROUND: Preclinical data showed that overlapping (OVP) scaffolds might result in delayed healing and strut coverage compared to nonOVP scaffold segments. Furthermore, OVP in patients could result in increased periprocedure myocardial infarction (MI) rate secondary to side branch occlusion; however, little is known whether this may have an impact on long-term clinical outcomes. METHODS: ABSORB EXTEND is a prospective, single-arm, open-label clinical study in which 812 patients were enrolled at 56 sites. In this study, we compared the immediate and 2-year clinical outcomes of patients with OVP scaffolds (n = 115) to those of patients with nonOVP scaffolds (n = 697). The primary objective was the comparison of major adverse cardiac event (MACE) (cardiac death, MI and ischemic-driven target lesion revascularization [TLR]) and scaffold thrombosis (ST) rates up to 2 years. RESULTS: Baseline clinical and angiographic characteristics were comparable between cohorts except for longer lesions in the OVP patients as expected (16.7 ± 7.3 vs. 11.6 ± 4.4 mm, P < 0.0001), higher lesion complexity (B2) and numerically smaller vessel size. In-hospital, there was a marked increase in MACE in the OVP cohort (7.0 vs. 0.9%, P = 0.002), exclusively driven by a higher rate of periprocedure MI (7.0 vs. 0.9%, P = 0.002). Long-term MACE did not significantly differ between groups (10.4% in the OVP cohort vs. 6.6% in the no-OVP group, P = 0.1) with comparable rates of cardiac death (0.9 vs. 1.2%, P = 1.0) and ischemia-driven TLR (1.7 vs. 2.5%, P = 1.0). Cumulative incidence of MI was higher in the OVP cohort (7.8 vs. 3.0%, P = 0.02). Of note, the rate of MI between hospital discharge and 2-year follow-up was lower in the OVP cohort (0.8 vs. 2.1%, P = 0.04). Cumulative incidence of definite/probable ST was relatively low and comparable between groups (1.8 vs. 1.5%, P = 0.7). CONCLUSIONS: In this low-to-moderate complex population treated with the ABSORB scaffold the OVP group showed a high

Item does not contain fulltext, BACKGROUND: The long-term fate of Absorb bioresorbable vascular scaffold (Abbott Vascular, Santa Clara, CA) struts jailing side branch ostia has not been clarified. We therefore evaluate serially (post-procedure and at 6 months, 1, 2, 3, and 5 years) the appearance and fate of jailed Absorb bioresorbable vascular scaffold struts. METHODS AND RESULTS: We performed 3-dimensional optical coherence tomographic analysis of the ABSORB Cohort B trial (A Clinical Evaluation of the Bioabsorbable Everolimus Eluting Coronary Stent System in the Treatment of Patients With De Novo Native Coronary Artery Lesions) up to 5 years using a novel, validated cut-plane analysis method. We included 29 patients with a total of 85 side branch ostia. From the 12 ostia which could be assessed in true serial fashion, 7 showed a pattern of initial decrease in the ostial area free from struts, followed by an increase in strut-free ostial area toward the end of the 5 years of follow-up. In a repeated-measures analysis with time as fixed variable and ostial area free from struts as dependent variable, we showed a numeric decrease in the estimated ostial area free from struts from 0.75 mm(2) (baseline) to 0.68 mm(2) (first follow-up visit at 6 months or 1 year) and 0.63 mm(2) (second follow-up visit at 2 or 3 years). However, from the second visit to the 5-year follow-up visit, there was a statistically significant increase from 0.63 to 0.89 mm(2) (P=0.001). Struts overlying an ostium divided the ostium into compartments, and the number of these compartments decreased over time. CONCLUSIONS: This study showed that in most cases, the side branch ostial area free from struts initially decreased. However, with full scaffold bioresorption, the ostial area free from scaffold increased between 2 to 3 years and 5 years in the vast majority of patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00856856.

Importance: Early cardiovascular and bleeding events after coronary stenting are associated with high risk of morbidity and mortality. Objective(s): To assess the prognosis of cardiovascular and bleeding events occurring beyond 1 year after coronary stenting. Design, Setting, and Participant(s): This secondary analysis is derived from data from the Dual Antiplatelet Therapy (DAPT) Study, a multi center trial involving 220 US and in ternational clinical sites from 11 countries. The study dateswere August 2009 to May 2014. Individuals who underwent coronary stenting and completed 12 months of thienopyridine plus aspirin therapy without ischemic or bleeding events remained on an aspirin regimen and were randomized to continued thienopyridine therapy vs placebo for 18 additional months. Individuals were then followed up for 3 additional months while receiving aspirin therapy alone. The analysis began in August 2015. Exposures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (Global Utilization of Streptokinase and Tissue Plasminogen Activator for Occluded Arteries [GUSTO] classification moderate or severe bleeding). Main Outcomes and Measures: Ischemic events (myocardial infarction not related to stent thrombosis, stent thrombosis, and ischemic stroke) and bleeding events (GUSTO classification moderate or severe bleeding). Death at 21 months after randomization (33 months after coronary stenting). Result(s): Intotal, 25 682 individuals older than 18 years with an indication for coronarystentingwere enrolled, and 11 648(meanage,61.3 years; 25.1%female)were randomized. After randomization, 478 individuals (4.1%) had 502 ischemic events (306 with myocardial infarction, 113 with stent thrombosis, and 83 with ischemic stroke), and 232 individuals (2.0%) had 235 bleeding events (155 with moderate and 80 with severe bleeding). Among individuals with ischemic events, 52(10.9%) died. The annualize