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Transthyretin amyloid cardiomyopathy (ATTR-CM) is a debilitating and life-threatening condition with a heterogeneous clinical presentation. Recent guidelines from the United States and Europe have been published to guide clinical practice and to facilitate management conformity by covering current diagnostic and treatment strategies for patients with ATTR-CM. These guidelines highlight the importance of an early diagnosis to optimize therapeutic outcomes, specifying the use of tests and imaging techniques to allow accurate, noninvasive diagnosis of ATTR-CM. However, as regional practice variations across Asia may limit access to healthcare, availability of specific tests, and expertise in assessing diagnostic images, there is an ongoing need to provide an Asian perspective on these clinical guidelines. This review article provides practical recommendations for the diagnosis and monitoring of patients with ATTR-CM in Asia, highlighting the need for additional guidelines to support a broad and diverse population, consider differing healthcare systems and diagnostic testing availability, and provide a flexible yet robust algorithm.

The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB).There is increasing clinical evidence for the treatment of coronary de novo disease using drug-coated balloons. However, it is unclear whether paclitaxel remains the drug of choice or if sirolimus is an alternative, in analogy to drug-eluting stents.Seventy patients with coronary de novo lesions were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, B. Braun Melsungen; 4 μg/mmQuantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment LLL was 0.01 ± 0.33 mm in the PCB group versus 0.10 ± 0.32 mm in the SCB group. The mean difference between SCB and PCB was 0.08 (95% CI: -0.07 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. However, negative LLL was more frequent in the PCB group (60% of lesions vs 32% in the SCB group; P = 0.019). Major adverse cardiovascular events up to 12 months also did not differ between the groups.This first-in-human comparison of a novel SCB with a crystalline coating showed similar angiographic outcomes in the treatment of coronary de novo disease compared with a clinically proven PCB. However, late luminal enlargement was more frequently observed after PCB treatment. (Treatment of Coronary De-Novo Stenosis by a Sirolimus Coated Balloon or a Paclitaxel Coated Balloon Catheter Malaysia [SCBDNMAL]; NCT04017364).

Background: Paclitaxel-coated balloons (PCBs) are a preferred treatment option for coronary in-stent restenosis. To date, data from randomized trials of alternative drug coatings are lacking. The aim of the randomized Malaysian and German-Swiss randomized trials was to investigate a novel sirolimus-coated balloon (SCB) compared with a PCB in in-stent restenosis. Methods: One hundred one patients with drug-eluting stent in-stent restenosis were enrolled in 2 identical randomized trials comparing the novel SCB (SeQuent SCB, 4 μg/mm²) with the clinically proven PCB (SeQuent Please, 3 μg/mm²). Primary end point was angiographic late lumen loss at 6 months. Secondary end points included procedural success, major adverse cardiac events, and individual clinical end points such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. Results: Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.25±0.57 mm in the PCB group versus 0.26±0.60 mm in the SCB group. Mean difference between SCB and PCB was 0.01 (95% CI, -0.23 to 0.24). Noninferiority at a predefined margin of 0.35 was shown. Clinical events up to 12 months did not differ between the groups. Conclusions: This first-in man comparison of a novel SCB with a crystalline coating showed similar angiographic and clinical outcomes in the treatment of coronary drug-eluting stent in-stent restenosis compared with PCB. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT02996318, NCT03242096.

Contains fulltext : 233810.pdf (Publisher’s version ) (Closed access) BACKGROUND AND AIMS: The impact of advanced age on the optimal duration of dual antiplatelet therapy (DAPT) in patients with acute coronary syndrome (ACS) undergoing percutaneous coronary revascularization (PCI) is still greatly debated. Therefore, the aim of the present sub-analysis of the REDUCE trial was to assess the impact of age on the comparison between a short 3 months vs standard 12 months DAPT in ACS patients treated with the COMBO Dual Stent Therapy. METHODS: The REDUCE trial is a prospective, multicenter, investigator-initiated study that randomized ACS patients undergoing PCI with the COMBO drug eluting stent to either 3 or 12 months of DAPT. The study population was divided according to age (

Background and objectives Data on population-level outcomes after heart failure (HF) hospitalisation in Asia is sparse. This study aimed to estimate readmission and mortality after hospitalisation among HF patients and examine temporal variation by sex and ethnicity. MethodsData for 105,399 patients who had incident HF hospitalisations from 2007 to 2016 were identified from a national discharge database and linked to death registration records. The outcomes assessed here were 30-day readmission, in-hospital, 30-day and one-year all-cause mortality. ResultsEighteen percent of patients (n = 16786) were readmitted within 30 days. Mortality rates were 5.3% (95% confidence interval (CI) 5.1–5.4%), 11.2% (11.0–11.4%) and 33.1% (32.9–33.4%) for in-hospital, 30-day and 1-year mortality after the index admission. Age, sex and ethnicity-adjusted 30-day readmissions increased by 2% per calendar year while in-hospital and 30-day mortality declined by 7% and 4% per year respectively. One-year mortality rates remained constant during the study period. Men were at higher risk of 30-day readmission (adjusted rate ratio (RR) 1.16, 1.13–1.20) and one-year mortality (RR 1.17, 1.15–1.19) than women. Ethnic differences in outcomes were evident. Readmission rates were equally high in Chinese and Indians relative to Malays whereas Others, which mainly comprised Indigenous groups, fared worst for in-hospital and 30-day mortality with RR 1.84 (1.64–2.07) and 1.3 (1.21–1.41) relative to Malays. ConclusionsShort-term survival was improving across sex and ethnic groups but prognosis at one year after incident HF hospitalisation remained poor. The steady increase in 30-day readmission rates deserves further investigation.

Older patients who undergo coronary interventions are at greater risk of ischemic events and less likely to tolerate prolonged dual antiplatelet therapy (DAPT) due to bleeding risk. The COMBO biodegradable polymer sirolimus-eluting stent promotes rapid endothelialization through endothelial progenitor cell capture technology which may be advantageous in elderly patients. We compared 1-year clinical outcomes and DAPT cessation events in patients >75 versus ≤75 years from the MASCOT registry. MASCOT was a prospective, multicenter cohort study of all-comers undergoing attempted COMBO stenting. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, myocardial infarction (MI) not clearly attributed to a nontarget vessel or clinically driven target lesion revascularization. Bleeding was adjudicated using the Bleeding Academic Research Consortium criteria. Adjusted outcomes were analyzed using Cox regression methods. The study included 18% (n = 479) patients >75 years and 72% (n = 2,135) patients ≤75 years. One-year TLF occurred in 4.6% patients >75 years versus 3.1% patients ≤75years of age, p = 0.10; adj hazard ratio 1.36, 95% confidence intervals 0.77 to 2.38, p = 0.29. There were no significant differences in cardiac death (1.7% vs 1.3%, p = 0.55), MI (2.1% vs 1.2%, p = 0.14), target lesion revascularization (1.7% vs 1.4%, p = 0.60) and definite stent thrombosis (0.8% vs 0.4%, p = 0.19). Major Bleeding Academic Research Consortium 3,5 bleeding (3.1% vs 1.5%, p = 0.01) and DAPT cessation rates (32.4% vs 23.0%, p 75 years treated with COMBO stents had similar TLF but significantly greater incidence of bleeding than younger patients and DAPT cessation in one-third of patients over 1 year.

Background The COMBO drug-eluting stent combines sirolimus-elution from a biodegradable polymer with an anti-CD34+ antibody coating for early endothelialization. Objective We investigated for geographical differences in outcomes after percutaneous coronary intervention (PCI) with the COMBO stent among Asians and Europeans. Methods The COMBO Collaboration is a pooled patient-level analysis of the MASCOT and REMEDEE registries of all-comers undergoing attempted COMBO stent PCI. The primary outcome was 1-year target lesion failure (TLF), composite of cardiac death, target vessel myocardial infarction (TV-MI) and target lesion revascularization (TLR). Results This study included 604 Asians (17.9%) and 2775 Europeans (82.1%). Asians were younger and included fewer females, with a higher prevalence of diabetes mellitus but lower prevalence of other comorbidities than Europeans. Asians had a higher prevalence of ACC/AHA C type lesions and received longer stent lengths. More Asians than Europeans were discharged on clopidogrel (86.5% vs 62.8%) rather than potent P2Y12 inhibitors. One-year TLF occurred in 4.0% Asians and 4.1% of Europeans, p = 0.93. The incidence of cardiac death was higher in Asians (2.8% vs. 1.3%, p = 0.007) with similar rates of TV-MI (1.5% vs. 1.2%, p = 0.54) and definite stent thrombosis (0.3% vs. 0.5%, p = 0.84) and lower incidence of TLR than Europeans (1.0% vs. 2.5%, p = 0.025). After adjustment, differences for cardiac death and TLR were no longer significant. Conclusions In the COMBO collaboration, although 1-year TLF was similar regardless of geography, Asians experienced higher rates of cardiac death and lower TLR than Europeans, while incidence of TV-MI and ST was similar in both regions. Adjusted differences did not reach statistical significance. Clinicaltrial.gov identifier-numbers NCT01874002 (REMEDEE Registry), NCT02183454 (MASCOT registry).

BACKGROUND: Guideline-recommended doses of angiotensin-converting-enzyme (ACE) inhibitors or angiotensin-receptor blockers (ARBs), and β blockers are similar for men and women with heart failure with reduced ejection fraction (HFrEF), even though there are known sex differences in pharmacokinetics of these drugs. We hypothesised that there might be sex differences in the optimal dose of ACE inhibitors or ARBs and β blockers in patients with HFrEF.METHODS: We did a post-hoc analysis of BIOSTAT-CHF, a prospective study in 11 European countries of patients with heart failure in whom initiation and up-titration of ACE inhibitors or ARBs and β blockers was encouraged by protocol. We included only patients with left ventricular ejection fraction less than 40%, and excluded those who died within the first 3 months. Primary outcome was a composite of time to all-cause mortality or hospitalisation for heart failure. Findings were validated in ASIAN-HF, an independent cohort of 3539 men and 961 women with HFrEF.FINDINGS: Among 1308 men and 402 women with HFrEF from BIOSTAT-CHF, women were older (74 [12] years vs 70 [12] years, pINTERPRETATION: This study suggests that women with HFrEF might need lower doses of ACE inhibitors or ARBs and β blockers than men, and brings into question what the true optimal medical therapy is for women versus men.FUNDING: European Commission.

Background: Little is known regarding the impact of socioeconomic factors on the use of evidence-based therapies and outcomes in patients with heart failure with reduced ejection fraction across Asia. Methods: We investigated the association of both patient-level (household income, education levels) and country-level (regional income level by World Bank classification, income disparity by Gini index) socioeconomic indicators on use of guideline-directed therapy and clinical outcomes (composite of 1-year mortality or HF hospitalization, quality of life) in the prospective multinational ASIAN-HF study (Asian Sudden Cardiac Death in Heart Failure). Results: Among 4540 patients (mean age: 60±13 years, 23% women) with heart failure with reduced ejection fraction, 39% lived in low-income regions; 34% in regions with high-income disparity (Gini ≥42.8%); 64.4% had low monthly household income (P interaction Conclusions: These findings highlight the importance of socioeconomic determinants among patients with heart failure in Asia and suggest that attention should be paid to address disparities in access to care among the poor and less educated, including those from wealthy regions. Registration: URL: https://clinicaltrials.gov ; Unique Identifier: NCT01633398.

Item does not contain fulltext BACKGROUND: Gender differences in the thrombotic and bleeding risk have been suggested to condition the benefits of antithrombotic therapies in Acute Coronary Syndrome (ACS) patients, and mainly among those undergoing percutaneous coronary interventions with drug eluting stents (DES). The impact of gender on the optimal duration of dual antiplatelet therapy (DAPT) in ACS patients is still unexplored and was, therefore, the aim of the present sub-study. METHODS: REDUCE was a prospective, multicenter, randomized investigator-initiated study designed to enroll 1500 ACS patients after treatment with the COMBO Dual Stent Therapy, based on a noninferiority design. Patients were randomized in a 1:1 fashion to either 3 or 12 months of DAPT. Primary study endpoint was a composite of all-cause mortality, myocardial infarction, definite/probable stent thrombosis (ST), stroke, target-vessel revascularization (TVR) and bleedings (BARC II, III, V) at 12 months. Secondary endpoints were cardiovascular mortality and the individual components of the primary endpoint within 24 months. RESULTS: From June 2014 to May 2016 300 women and 1196 men were included in the study. Among them, 43.7% of females and 51.9% of males were assigned to the 3 months DAPT treatment. Baseline characteristics were well matched between the two arms, with the exception of a lower rate of TIMI flow

Background Data comparing outcomes in heart failure ( HF ) across Asia are limited. We examined regional variation in mortality among patients with HF enrolled in the ASIAN ‐HF (Asian Sudden Cardiac Death in Heart Failure) registry with separate analyses for those with reduced ejection fraction ( EF ; Methods and Results The ASIAN ‐ HF registry is a prospective longitudinal study. Participants with symptomatic HF were recruited from 46 secondary care centers in 3 Asian regions: South Asia (India), Southeast Asia (Thailand, Malaysia, Philippines, Indonesia, Singapore), and Northeast Asia (South Korea, Japan, Taiwan, Hong Kong, China). Overall, 6480 patients aged >18 years with symptomatic HF were recruited (mean age: 61.6±13.3 years; 27% women; 81% with HF and reduced r EF ). The primary outcome was 1‐year all‐cause mortality. Striking regional variations in baseline characteristics and outcomes were observed. Regardless of HF type, Southeast Asians had the highest burden of comorbidities, particularly diabetes mellitus and chronic kidney disease, despite being younger than Northeast Asian participants. One‐year, crude, all‐cause mortality for the whole population was 9.6%, higher in patients with HF and reduced EF (10.6%) than in those with HF and preserved EF (5.4%). One‐year, all‐cause mortality was significantly higher in Southeast Asian patients (13.0%), compared with South Asian (7.5%) and Northeast Asian patients (7.4%; P Conclusions This first multinational prospective study shows that the outcomes in Asian patients with both HF and reduced or preserved EF are poor overall and worst in Southeast Asian patients. Region‐specific risk factors and gaps in guideline‐directed therapy should be addressed to potentially improve outcomes. Clinical Trial Registration URL : https://www.clinicaltrials.gov/ . Unique identifier: NCT 01633398.

Background Chronic total occlusions remain one of the biggest challenges for interventional cardiologists and the high risk of restenosis and stent thrombosis is still a major problem. Drug-coated balloons showed favorable results for the treatment of in-stent restenosis and other lesion types. The aim of this study was to evaluate the feasibility and outcome of a drug-coated balloon only approach for chronic total occlusion. Methods We included 34 patients with a native chronic total occlusion treated only by drug-coated balloons. A visual residual stenosis of 30% or less without major dissection was considered a satisfactory percutaneous intervention result according to the German Consensus Group recommendations for drug-coated balloon use. We collected clinical and procedural data. Angiograms were conducted during the procedure and at follow-up. Quantitative coronary analysis was performed and mean and minimal lumen diameter and late luminal changes were assessed. Results The recanalization was considered satisfactory in 79.4% (n=27). Restenosis occurred in 11.8% (n=4) and reocclusion in 5.9% (n=2). Out of the 27 patients with a satisfactory initial result, 3.7% (n=1) had reocclusion and 3.7% (n=1) had restenosis. In the subgroup without satisfactory result (n=7), restenosis occurred in 3 patients (42.9%) and reocclusion in 1 patient (14.3%). A luminal increase was found in 67.6% (n=23) and mean late luminal gain was 0.11±0.49mm. Angina class improved significantly (p Conclusions Drug-coated balloon angioplasty without stenting is a feasible and well-tolerated treatment method for chronic total occlusions if the predilatation result is good.

Objectives: The management of heart failure (HF) is most effective when established treatment guidelines and recommendations are followed. We aimed to develop a “Toolbox” of resources to facilitate the care of patients with acute HF and chronic HF with reduced ejection fraction delivered by healthcare professionals across Asia-Pacific, the Middle East and Africa (henceforth referred to as the “Region”). Methods: We convened a group of cardiologists from across the Region to develop a set of checklists, algorithms, and other practical resources. These resources are based on our experiences, current evidence, and international guidelines. Results: The HF Toolbox comprises three simplified sets of resources for use in the Emergency Room (ER), hospital and outpatient settings. Resources include admission and discharge checklists, treatment algorithms, recommendations for forming a multidisciplinary team, patient education, and self-management materials, and key performance indicators to monitor whether standards of care are met or maintained, or should be improved. Conclusions: The HF Toolbox provides practical resources to simplify the management of patients with HF and to support the formation of HF programs in the Region. The Toolbox is aligned with current guideline recommendations and can support the management of patients from presentation in the ER, through hospital admission to outpatient care.

Objectives. We analyzed the efficacy of drug coated balloons (DCB) as a stand-alone-therapy in de novo lesions of large coronary arteries. DCBs seem to be an attractive alternative for the stent-free interventional treatment of de novo coronary artery disease (CAD). However, data regarding a DCB-only approach in de novo CAD are currently limited to vessels of small caliber. Methods. By means of propensity score (PS) matching 234 individuals with de novo CAD were identified with similar demographic characteristics. This patient population was stratified in a 1:1 fashion according to a reference vessel diameter cut-off of 2.75 mm in small and large vessel disease. The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) at 9 months. Results. Patients with small vessel disease had an average reference diameter of 2.45 ± 0.23 mm, while the large vessel group averaged 3.16 ± 0.27 mm. Regarding 9-month major adverse cardiac event (MACE), 5.7% of the patients with small and 6.1% of the patients with large vessels had MACE (p=0.903). Analysis of the individual MACE components revealed a TLR rate of 3.8% in small and 1.0% in large vessels (p=0.200). Of note, no thrombotic events in the DCB treated coronary segments occurred in either group during the 9-month follow-up. Conclusions. Our data demonstrate for the first time that DCB-only PCI of de novo lesions in large coronary arteries (>2.75 mm) is safe and as effective. Interventional treatment for CAD without permanent or temporary scaffolding, demonstrated a similar efficacy for large and small vessels.

Objectives The aim of this randomized controlled trial was to investigate a novel sirolimus-coated balloon (SCB) compared with the best investigated paclitaxel-coated balloon (PCB). Background Treatment of coronary in-stent restenosis (ISR) remains challenging. PCBs are an established treatment option outside the United States with a Class I, Level of Evidence: A recommendation in the European guidelines. However, their efficacy is better in bare-metal stent (BMS) ISR compared with drug-eluting stent (DES) ISR. Methods Fifty patients with DES ISR were enrolled in a randomized, multicenter trial to compare a novel SCB (SeQuent SCB, 4 μg/mm2) with a clinically proven PCB (SeQuent Please Neo, 3 μg/mm2) in coronary DES ISR. The primary endpoint was angiographic late lumen loss at 6 months. Secondary endpoints included procedural success, major adverse cardiovascular events, and individual clinical endpoints such as stent thrombosis, cardiac death, target lesion myocardial infarction, clinically driven target lesion revascularization, and binary restenosis. Results Quantitative coronary angiography revealed no differences in baseline parameters. After 6 months, in-segment late lumen loss was 0.21 ± 0.54 mm in the PCB group versus 0.17 ± 0.55 mm in the SCB group (p = NS; per-protocol analysis). Clinical events up to 12 months also did not differ between the groups. Conclusions This first-in-man comparison of a novel SCB with a crystalline coating shows similar angiographic outcomes in the treatment of coronary DES ISR compared with a clinically proven PCB. (Treatment of Coronary In-Stent Restenosis by a Sirolimus [Rapamycin] Coated Balloon or a Paclitaxel Coated Balloon [FIM LIMUS DCB]; NCT02996318)

Objectives This prospective, observational all-comers registry assessed the safety and efficacy of a Drug Coated Balloon-only strategy (DCB-only) in patients with coronary lesions. Background Data regarding the performance of a DCB-only approach, especially in patients with previously untreated de-novo coronary artery disease (CAD), are still limited. Methods This study was conducted as an international, multicenter registry primarily enrolling patients with de-novo CAD. However, it was also possible to include patients with in-stent restenosis (ISR). The primary endpoint was the rate of clinically driven target lesion revascularization (TLR) after 9 months. Results A total of 1,025 patients with a mean age of 64.0 ± 11.2 years were enrolled. The majority of treated lesions were de-novo (66.9%), followed by drug-eluting-stent ISR (DES-ISR; 22.6%) and bare-metal-stent ISR (BMS-ISR; 10.5%). The TLR rate was lower in the de-novo group (2.3%) when compared to BMS- (2.9%) and DES-ISR (5.8%) (P = 0.049). Regarding MACE, there was a trend toward fewer events in the de-novo group (5.6%) than in the BMS- (7.8%) and DES-ISR cohort (9.6%) (P = 0.131). Subgroup analyses revealed that lesion type (95% CI 1.127-6.587); P = 0.026) and additional stent implantation (95% CI 0.054-0.464; P = 0.001) were associated with higher TLR rates. Conclusions Our results show that DCB-only angioplasty of de-novo coronary lesions is associated with low MACE and TLR rates. Thus, DCBs appear to be an attractive alternative for the interventional, stentless treatment of suitable de-novo coronary lesions.

Heart failure with preserved ejection fraction (HFpEF) is a global public health problem. Unfortunately, little is known about HFpEF across Asia.We prospectively studied clinical characteristics, echocardiographic parameters and outcomes in 1204 patients with HFpEF (left ventricular ejection fraction ≥50%) from 11 Asian regions, grouped as Northeast Asia (Hong Kong, Taiwan, China, Japan, Korea, n = 543), South Asia (India, n = 252), and Southeast Asia (Malaysia, Thailand, Singapore, Indonesia, Philippines, n = 409). Mean age was 68 ±12 years (37% were 65 years) and 50% were women. Seventy per cent of patients had ≥2 co-morbidities, most commonly hypertension (71%), followed by anaemia (57%), chronic kidney disease (50%), diabetes (45%), coronary artery disease (29%), atrial fibrillation (29%) and obesity (26%). Southeast Asian patients had the highest prevalence of all co-morbidities except atrial fibrillation, South Asians had the lowest prevalence of all co-morbidities except anaemia and obesity, and Northeast Asians had more atrial fibrillation. Left ventricular hypertrophy and concentric remodelling were most prominent among Southeast and South Asians, respectively (P 0.001). Overall, 12.1% of patients died or were hospitalized for heart failure within 1 year. Southeast Asians were at higher risk for adverse outcomes, independent of co-morbidity burden and cardiac geometry.These first prospective multinational data from Asia show that HFpEF affects relatively young patients with a high burden of co-morbidities. Regional differences in types of co-morbidities, cardiac remodelling and outcomes of HFpEF across Asia have important implications for public health measures and global HFpEF trial design.

A 62-year old male underwent treatment of a bifurcation lesion in the left anterior descending coronary artery using provisional stenting with a jailed wire technique. Severe longitudinal stent deformation and unravelment of the stent part proximal of the bifurcation occurred when we tried to pull the jailed wire from the side branch. The described case poses a caution on the use of this specific stent(-design) in bifurcation lesions.

Introduction The increasing disease burden of coronary artery disease (CAD) calls for sustainable cardiac service. Teaching hospitals and general hospitals in Malaysia are main providers of percutaneous coronary intervention (PCI), a common treatment for CAD. Few studies have analyzed the contemporary data on local cardiac facilities. Service expansion and budget allocation require cost evidence from various providers. We aim to compare the patient characteristics, procedural outcomes, and cost profile between a teaching hospital (TH) and a general hospital (GH). Methods This cross-sectional study was conducted from the healthcare providers’ perspective from January 1st to June 30th 2014. TH is a university teaching hospital in the capital city, while GH is a state-level general hospital. Both are government-funded cardiac referral centers. Clinical data was extracted from a national cardiac registry. Cost data was collected using mixed method of top-down and bottom-up approaches. Total hospitalization cost per PCI patient was summed up from the costs of ward admission and cardiac catheterization laboratory utilization. Clinical characteristics were compared with chi-square and independent t-test, while hospitalization length and cost were analyzed using Mann-Whitney test. Results The mean hospitalization cost was RM 12,117 (USD 3,366) at GH and RM 16,289 (USD 4,525) at TH. The higher cost at TH can be attributed to worse patients’ comorbidities and cardiac status. In contrast, GH recorded a lower mean length of stay as more patients had same-day discharge, resulting in 29% reduction in mean cost of admission compared to TH. For both hospitals, PCI consumables accounted for the biggest proportion of total cost. Conclusions The high PCI consumables cost highlighted the importance of cost-effective purchasing mechanism. Findings on the heterogeneity of the patients, treatment practice and hospitalization cost between TH and GH are vital for formulation of cost-saving strategies to ensure sustainable and equitable cardiac service in Malaysia.

Objectives Limitations in the quality and access of cost data from low-income and middle-income countries constrain the implementation of economic evaluations. With the increasing prevalence of coronary artery disease in Malaysia, cost information is vital for cardiac service expansion. We aim to calculate the hospitalisation cost of percutaneous coronary intervention (PCI), using a data collection method customised to local setting of limited data availability. Design This is a cross-sectional costing study from the perspective of healthcare providers, using top-down approach, from January to June 2014. Cost items under each unit of analysis involved in the provision of PCI service were identified, valuated and calculated to produce unit cost estimates. Setting Five public cardiac centres participated. All the centres provide full-fledged cardiology services. They are also the tertiary referral centres of their respective regions. Participants The cost was calculated for elective PCI procedure in each centre. PCI conducted for urgent/emergent indication or for patients with shock and haemodynamic instability were excluded. Primary and secondary outcome measures The outcome measures of interest were the unit costs at the two units of analysis, namely cardiac ward admission and cardiac catheterisation utilisation, which made up the total hospitalisation cost. Results The average hospitalisation cost ranged between RM11 471 (US$3186) and RM14 465 (US$4018). PCI consumables were the dominant cost item at all centres. The centre with daycare establishment recorded the lowest admission cost and total hospitalisation cost. Conclusions Comprehensive results from all centres enable comparison at the levels of cost items, unit of analysis and total costs. This generates important information on cost variations between centres, thus providing valuable guidance for service planning. Alternative procurement practices for PCI consumables may deliver cost reduction. For countries with limited data availability, costing method tailored based on country setting can be used for the purpose of economic evaluations. Registration Malaysian MOH Medical Research and Ethics Committee (ID: NMRR-13-1403-18234 IIR).

Assessing health-related quality of life (HRQoL) in patients with heart failure (HF) is an important goal of clinical care and HF research. We sought to investigate ethnic differences in perceived HRQoL and its association with mortality among patients with HF and left ventricular ejection fraction ≤35%, controlling for demographic characteristics and HF severity.We compared 5697 chronic HF patients of Indian (26%), white (23%), Chinese (17%), Japanese/Koreans (12%), black (12%), and Malay (10%) ethnicities from the HF-ACTION and ASIAN-HF multinational studies using the Kansas City Cardiomyopathy Questionnaire (KCCQ; range 0-100; higher scores reflect better health status). KCCQ scores were lowest in Malay (58±22) and Chinese (60±23), intermediate in black (64±21) and Indian (65±23), and highest in white (67±20) and Japanese or Korean patients (67±22) after adjusting for age, sex, educational status, HF severity, and risk factors. Self-efficacy, which measures confidence in the ability to manage symptoms, was lower in all Asian ethnicities (especially Japanese/Koreans [60±26], Malay [66±23], and Chinese [64±28]) compared to black (80±21) and white (82±19) patients, even after multivariable adjustment (P.001). In all ethnicities, KCCQ strongly predicted 1-year mortality (HR 0.45, 95% CI 0.30-0.67 for highest vs lowest quintile of KCCQ; P for interaction by ethnicity .101).Overall, HRQoL is inversely and independently related to mortality in chronic HF but is not modified by ethnicity. Nevertheless, ethnic differences exist independent of HF severity and comorbidities. These data may have important implications for future global clinical HF trials that use patient-reported outcomes as endpoints.

Objectives The primary objective of this study was to evaluate the safety and effectiveness of the Mirage (Manli Cardiology, Singapore) bioresorbable microfiber sirolimus-eluting scaffold compared with the Absorb (Abbott Vascular, Santa Clara, California) bioresorbable vascular scaffold in the treatment of stenotic target lesions located in native coronary arteries, ranging from ≥2.25 to ≤4.0 mm in diameter. Secondary objectives were to establish the medium-term safety, effectiveness, and performance of the Mirage device. Background The current generation of bioresorbable scaffolds has several limitations, such as thick square struts with large footprints that preclude their deep embedment into the vessel wall, resulting in protrusion into the lumen with microdisturbance of flow. The Mirage sirolimus-eluting bioresorbable microfiber scaffold is designed to address these concerns. Methods In this prospective, single-blind trial, 60 patients were randomly allocated in a 1:1 ratio to treatment with a Mirage sirolimus-eluting bioresorbable microfiber scaffold or an Absorb bioresorbable vascular scaffold. The clinical endpoints were assessed at 30 days and at 6 and 12 months. In-device angiographic late loss at 12 months was quantified. Secondary optical coherence tomographic endpoints were assessed post–scaffold implantation at 6 and 12 months. Results Median angiographic post-procedural in-scaffold minimal luminal diameters of the Mirage and Absorb devices were 2.38 mm (interquartile range [IQR]: 2.06 to 2.62 mm) and 2.55 mm (IQR: 2.26 to 2.71 mm), respectively; the effect size (d) was −0.29. At 12 months, median angiographic in-scaffold minimal luminal diameters of the Mirage and Absorb devices were not statistically different (1.90 mm [IQR: 1.57 to 2.31 mm] vs. 2.29 mm [IQR: 1.74 to 2.51 mm], d = −0.36). At 12-month follow-up, median in-scaffold late luminal loss with the Mirage and Absorb devices was 0.37 mm (IQR: 0.08 to 0.72 mm) and 0.23 mm (IQR: 0.15 to 0.37 mm), respectively (d = 0.20). On optical coherence tomography, post-procedural diameter stenosis with the Mirage was 11.2 ± 7.1%, which increased to 27.4 ± 12.4% at 6 months and remained stable (31.8 ± 12.9%) at 1 year, whereas the post-procedural optical coherence tomographic diameter stenosis with the Absorb was 8.4 ± 6.6%, which increased to 16.6 ± 8.9% and remained stable (21.2 ± 9.9%) at 1-year follow-up (Mirage vs. Absorb: dpost-procedure = 0.41, d6 months = 1.00, d12 months = 0.92). Angiographic median in-scaffold diameter stenosis was significantly different between study groups at 12 months (28.6% [IQR: 21.0% to 40.7%] for the Mirage, 18.2% [IQR: 13.1% to 31.6%] for the Absorb, d = 0.39). Device- and patient-oriented composite endpoints were comparable between the 2 study groups. Conclusions At 12 months, angiographic in-scaffold late loss was not statistically different between the Mirage and Absorb devices, although diameter stenosis on angiography and on optical coherence tomography was significantly higher with the Mirage than with the Absorb. The technique of implantation was suboptimal for both devices, and future trials should incorporate optical coherence tomographic guidance to allow optimal implantation and appropriate assessment of the new technology, considering the novel mechanical properties of the Mirage.

Objectives: To compare clinical outcomes between patients with ST-elevation myocardial infarction (STEMI) presenting to a hospital with facilities for primary percutaneous coronary intervention (PCI) and patients transferred from a non-PCI- capable unit, and to determine the success rate of meeting clinical guidelines for management of STEMI. Design, setting and participants: Prospective study of patients with STEMI who underwent PCI at Box Hill Hospital (BHH), Melbourne, between 1 July 2002 and 30 June 2008. We compared two patient groups: "BHH patients", who were admitted directly to BHH (a hospital with PCI capability), and "SHIPEM (Shipping Infarcts for Primary Angioplasty in Eastern Melbourne Registry) patients", who were transferred from other hospitals without PCI capability. Main outcome measures: Clinical outcomes; symptom-to-first-door time (time between symptom onset and arrival at first hospital); first-door-to-balloon time (time between arrival at the first hospital and inflation of the angioplasty balloon); compliance with Cardiac Society of Australia and New Zealand/National Heart Foundation of Australia (CSANZ/NHFA) guidelines for management of patients with STEMI. Results: There were 598 patients in the BHH group and 189 in the SHIPEM group. The median first-door-to-balloon time was 89 minutes (interquartile range [IQR], 69-107 minutes) for BHH patients and 128 minutes (IQR, 104-157 minutes) for SHIPEM patients. These figures did not vary significantly over the 6 years of the registry. In the BHH group, 180 patients (30.1 %) had a symptom-to-first-door time of ≤ 60 minutes, with 32 (17.8%) receiving PCI in ≤ 60 minutes. The corresponding figure for the SHIPEM group was 48 patients (25.4%), with 1 (2.1%) receiving PCI within 60 minutes. In the BHH group, 304 patients (50.8%) had a symptom-to-first-door time of 61-180 minutes, with 166(54.6%) receiving PCI in ≤ 90 minutes. In the SHIPEM group, 50 patients (26.5%) had a symptom-to-first-door time of > 180 minutes, with 21 (42.0%) receiving PCI in ≤ 120 minutes. Conclusion: Our study demonstrates that transfer for PCI is feasible and safe in selected patients, with outcomes comparable to those of patients presenting to a PCI- capable unit. However, the CSANZ/NHFA targets, predicated by symptom-to-first-door time, are not being met and have not improved over time, which suggests that strategies to improve symptom-to-first-door, first-door-to-balloon and transfer times need to be addressed.

Background and Objective: We hypothesized that a "culprit" lesion in acute coronary syndrome (ACS) should have low overall vessel lumen and plaque density on multidetector computed tomography-assisted coronary angiography (MDCTA) because of lower calcification and the presence of occlusive thrombus. However, thrombi and calcification both can themselves blur the demarcation between vessel wall and lumen. If we calculated a "vessel density ratio" (VDR) obtained by measuring the mean density of contrast-enhancement within a region of interest (ROI), which includes the vessel wall, lumen, plaque, and thrombus, and comparing that with the aortic root mean density acting as a reference point, this ratio may be more convenient, standardized, and reproducible to test the feasibility of VDR in identifying "culprit" lesions in ACS. Methods: Sixty-four patients-21 exertional angina; 17 unstable angina/non-ST elevation myocardial infarction (NSTEMI); 26 ST elevation myocardial infarction (STEMI)-provided 188 diseased segments on conventional angiography. All underwent MDCTA within a week of angiography. ROI was mapped out from maximum intensity projections of diseased segments in planar view. Results: One hundred seventy-four segments were evaluated. Patients who presented with ACS (STEMI and unstable angina/ non-ST elevation myocardial infarction) had lower mean VDR compared to patients with exertional angina (0.58 vs. 0.66 vs. 0.81; P < 0.001). Culprit lesions in ACS patients also had the lowest mean VDR when compared to nonculprit lesions and lesions in patients without ACS (0.51 vs. 0.68 vs. 0.81; P < 0.001). Conclusions: VDR is a new, convenient, and standardized approach in identifying "culprit" lesions by MDCTA.

Background: Sex differences in acute coronary syndrome (ACS) have been well studied in major registries and clinical trials in Western populations. Limited studies have examined the sex differences in ACS using a large number of Asian women as the subjects.Objectives: The aim was to study the sex differences in ACS using the NCVD-ACS (National Cardiovascular Disease Database—Acute Coronary Syndrome) registry.Methods: We analyzed 13,591 ACS patients, of which 75.8% were men and 24.2% were women, from March 2006 to February 2010. Data were collected on demographic characteristics, risk factors, anthropometrics, treatments, procedures, mortalities, and complications. The results were compared among 3 cohorts of ACS (ST-segment elevation myocardial infarction [STEMI], non–STEMI, and unstable angina).Results: Women were older and more likely to have diabetes, hypertension, previous heart failure, and cerebral vascular accidents than men were. Women were less likely to receive in-hospital administration of aspirin, beta-blockers, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers, and they were less likely to undergo angiography and percutaneous coronary intervention. In STEMI, a significantly lower proportion of women than men received primary percutaneous coronary intervention (6.2% vs. 6.7%, respectively, p = 0.000) and fibrinolysis (64.4% vs. 74.6%, respectively, p = 0.000). In addition, with regard to STEMI, women had a significantly higher unadjusted in-hospital mortality rate than men did (15.0% vs. 8.1%, respectively, p < 0.000). There was no statistically significant in-hospital mortality difference between sexes for non-STEMI and unstable angina. After adjustment for age and other covariates, a multivariate analysis showed no sex differences in the in-hospital mortality in all spectrums of ACS.Conclusions: Our study showed significant sex differences in the demographic characteristics, risk factors, treatments, and outcomes of ACS. More importantly, in ACS patients, we found evidence of suboptimal treatments and interventions in women versus men. Our findings provide an opportunity to narrow the sex gap in the care of women with ACS in Malaysia.HighlightsWe studied the sex differences in acute coronary syndrome in Malaysia using the National Cardiovascular Disease Database—Acute Coronary Syndrome Registry.Demographic data, risk factors, anthropometrics, treatments, procedures, and outcomes were compared between sexes.Women were older, had more comorbidities, and were less likely to receive evidence-based treatment than men were.After adjustment for covariates, a multivariate analysis showed no sex differences in the in-hospital mortality among all spectrums of acute coronary syndromes.We found evidence of suboptimal treatments and interventions in women with acute coronary syndromes.

Objectives To assess whether gender differences exist in the clinical presentation, angiographic severity, management and outcomes in patients with coronary artery disease (CAD). Methods The study comprised of 1,961 women and 8,593 men who underwent percutaneous coronary intervention (PCI) and were included in the Malaysian NCVD-PCI Registry from 2007–2009. Significant stenosis was defined as ≥70% stenosis in at least one of the epicardial vessels. Results Women were significantly older and had significantly higher rates of diabetes mellitus, hypertension, chronic renal failure, new onset angina and prior history of heart failure whereas smokers and past history of myocardial infarction were higher in men. In the ST-elevation myocardial infarction (STEMI) cohort, more women were in Killip class III-IV, had longer door-to-balloon time (169.5 min. vs 127.3 min, p

Objectives: To examine the prevalence of radiation-associated lens opacities among interventional cardiologists and nurses and correlate with occupational radiation exposure. Background: Interventional cardiology personnel are exposed to relatively high levels of X-rays and based on recent findings of radiation-associated lens opacities in other cohorts, they may be at risk for cataract without use of ocular radiation protection. Methods: Eyes of interventional cardiologists, nurses, and age-and sex-matched unexposed controls were screened by dilated slit lamp examination and posterior lens changes graded using a modified Merriam-Focht technique. Individual cumulative lens X-ray exposure was calculated from responses to a questionnaire and personal interview. Results: The prevalence of radiation-associated posterior lens opacities was 52% (29/56, 95% CI: 35-73) for interventional cardiologists, 45% (5/11, 95% CI: 15-100) for nurses, and 9% (2/22, 95% CI: 1-33) for controls. Relative risks of lens opacity was 5.7 (95% CI: 1.5-22) for interventional cardiologists and 5.0 (95% CI: 1.2-21) for nurses. Estimated cumulative ocular doses ranged from 0.01 to 43 Gy with mean and median values of 3.4 and 1.0 Gy, respectively. A strong dose-response relationship was found between occupational exposure and the prevalence of radiation-associated posterior lens changes. Conclusions: These findings demonstrate a dose dependent increased risk of posterior lens opacities for interventional cardiologists and nurses when radiation protection tools are not used. While study of a larger cohort is needed to confirm these findings, the results suggest ocular radio-protection should be utilized. (C) 2010 Wiley-Liss, Inc.

To compare the assessment of global and regional left ventricular (LV) function using 64-slice multislice computed tomography (MSCT), 2D echocardiography (2DE) and cardiac magnetic resonance (CMR).Thirty-two consecutive patients (mean age, 56.5+/-9.7 years) referred for evaluation of coronary artery using 64-slice MSCT also underwent 2DE and CMR within 48h. The global left ventricular function which include left ventricular ejection fraction (LVEF), left ventricular end diastolic volume (LVdV) and left ventricular end systolic volume (LVsV) were determine using the three modalities. Regional wall motion (RWM) was assessed visually in all three modalities. The CMR served as the gold standard for the comparison between 64-slice MSCT with CMR and 2DE with CMR. Statistical analysis included Pearson correlation coefficient, Bland-Altman plots and kappa-statistics.The 64-slice MSCT agreed well with CMR for assessment of LVEF (r=0.92; p0.0001), LVdV (r=0.98; p0.0001) and LVsV (r=0.98; p0.0001). In comparison with 64-slice MSCT, 2DE showed moderate correlation with CMR for the assessment of LVEF (r=0.84; p0.0001), LVdV (r=0.83; p0.0001) and LVsV (r=0.80; p0.0001). However in RWM analysis, 2DE showed better accuracy than 64-slice MSCT (94.3% versus 82.4%) and closer agreement (kappa=0.89 versus 0.63) with CMR.64-Slice MSCT correlates strongly with CMR in global LV function however in regional LV function 2DE showed better agreement with CMR than 64-slice MSCT.

The new 64-row multidetector computed tomography (CT)-assisted angiography can now detect coronary artery disease with shorter breath-hold time and at faster heart rates for symptomatic patients. We aim to determine if the 64-row scanner can also overcome limitations due to mild to moderate calcification.Scheduled for conventional coronary angiography, 134 symptomatic patients underwent multidetector CT-assisted angiography within 3 months. Patients were divided into those with low or high calcium score (median score 142) by modified Agatston formula: group A calcium score142 Agatston score (68 patients, mean age 53 years, heart rate 62 beat/min) and group B calcium scoreor = 142 Agatston score (66 patients, mean age 57 years, heart rate 62 beat/min). Eleven major coronary segments were evaluated.In group A, 93.6% of segments were evaluable with 97.3% correlation. Segment-by-segment analyses for sensitivity, specificity, and positive and negative predictive values were 85.4%, 98.1%, 76.7%, and 99.2%, respectively. For group B, 86.9% of segments were evaluable with 90.5% correlation. Sensitivity, specificity, and positive and negative predictive values were 79.9%, 92.8%, 78.8%, and 93.5%, respectively.The 64-slice multidetector CT coronary angiography can reliably detect the presence of significant coronary stenosis in symptomatic patients with mild calcification, but remains limited by moderate to heavy calcification.