Clinical outcomes of an ultrathin-strut sirolimus-eluting stent in all-comers population: Thailand Orsiro registry.

BACKGROUND: Despite numerous studies supporting the outperformance of ultrathin-strut bioresorbable polymer sirolimus-eluting stent (Orsiro SES, Biotronik AG), the generalizability of the study results remains unclear in the Asian population. We sought to evaluate the clinical outcomes of the Orsiro SES in unselected Thai population. METHODS: The Thailand Orsiro registry was a prospective, open-label clinical study evaluating all patients with obstructive coronary artery disease implanted with Orsiro SES. The primary endpoint was target lesion failure (TLF) at 12 months. TLF is defined as a composite of cardiac death, target vessel myocardial infarction (TVMI), emergent coronary artery bypass graft (CABG), and clinically driven target lesion revascularization (CD-TLR). Patients with diabetes, small vessels (≤ 2.75 mm), chronic total occlusions (CTOs), and acute myocardial infarction (AMI) were pre-specified subgroups for statistical analysis. RESULT: A total of 150 patients with 235 lesions were included in the analysis. Half of the patients (53.3%) presented with AMI, and 24% had diabetes. Among 235 lesions, 93(39.4%) were small vessels, and 24(10.2%) were chronic total occlusions. The primary endpoint, TLF at 12 months, occurred in eight patients (5.3%), predominately caused by cardiac death. By contrast, the incidences of TVMI and CD-TLR were null. The outcomes in pre-specified subgroup were not different from the overall population (all p > 0.05). One definite late stent thrombosis(0.7%) was incidentally observed during primary percutaneous coronary intervention to the non-target vessel. CONCLUSION: The safety and efficacy of the ultrathin strut sirolimus-eluting stent in unselected cases are confirmed in the Thailand Orsiro registry. Despite the high proportion of pre-specified high-risk subgroups, the excellent stent performance was consistent with the overall population. Trial Registration TCTR20190325001.

Transcatheter aortic valve implantation during the COVID-19 pandemic: Clinical expert opinion and consensus statement for Asia.

OBJECTIVES: The impact of the COVID-19 pandemic on the treatment of patient with aortic valve stenosis is unknown and there is uncertainty on the optimal strategies in managing these patients. METHODS: This study is supported and endorsed by the Asia Pacific Society of Interventional Cardiology. Due to the inability to have face to face discussions during the pandemic, an online survey was performed by inviting key opinion leaders (cardiac surgeon/interventional cardiologist/echocardiologist) in the field of transcatheter aortic valve implantation (TAVI) in Asia to participate. The answers to a series of questions pertaining to the impact of COVID-19 on TAVI were collected and analyzed. These led subsequently to an expert consensus recommendation on the conduct of TAVI during the pandemic. RESULTS: The COVID-19 pandemic had resulted in a 25% (10-80) reduction of case volume and 53% of operators required triaging to manage their patients with severe aortic stenosis. The two most important parameters used to triage were symptoms and valve area. Periprocedural changes included the introduction of teleconsultation, preprocedure COVID-19 testing, optimization of protests, and catheterization laboratory set up. In addition, length of stay was reduced from a mean of 4.4 to 4 days. CONCLUSION: The COVID-19 pandemic has impacted on the delivery of TAVI services to patients in Asia. This expert recommendation on best practices may be a useful guide to help TAVI teams during this period until a COVID-19 vaccine becomes widely available.

Low-Density Lipoprotein Cholesterol Target Attainment in Patients Surviving an Acute Coronary Syndrome in Thailand: Results From the Dyslipidaemia International Study (DYSIS) II.

BACKGROUND: Patients suffering an acute coronary syndrome (ACS) are at increased risk for future cardiovascular events. Effective management of hyperlipidaemia in such patients is essential. We aimed to document the use of lipid-lowering therapy (LLT) and low-density lipoprotein cholesterol (LDL-C) target achievement in patients hospitalised with an ACS in Thailand. METHODS: The Dyslipidemia International Study (DYSIS) II was a multinational, observational study that enrolled patients over 18 years of age who were hospitalised with an ACS in 2013-2014 and survived until discharge. Patients were analysed according to whether or not they were treated with LLT prior to hospital admission. A lipid profile was carried forward from blood taken within the first 24 hours after admission, and attainment of the LDL-C target of <70 mg/dL (1.8 mmol/L) for very high-risk subjects was reported. Details of LLTs were collected. Lipid levels, LLT use and cardiovascular events since discharge were collected at a follow-up interview 4 months later. RESULTS: A total of 320 ACS patients were enrolled from seven sites across Thailand, 188 (58.8%) of whom were being treated with LLT prior to the acute event. The mean LDL-C levels of the LLT and no LLT patients were 106.2 ± 39.4 mg/dL (2.75 ± 1.02 mmol/L) and 139.8 ± 46.6 mg/dL (3.62 ± 1.21), respectively, with 15.4% and 4.5% having an LDL-C level below 70 mg/dL (1.8 mmol/L). Lipid-lowering therapy consisted mainly of statins, with an atorvastatin-equivalent daily dosage of 17 ± 13 mg/day. At the 4-month follow-up, LDL-C target attainment remained low at 26.7% for the initial LLT group and 24.1% for the no LLT group. Although most patients were being treated with LLT at this point, the dosage was still low (28 ± 16 mg/day) and there was little use of combination therapy. CONCLUSION: In this cohort of Thai ACS patients, LDL-C levels were highly elevated, placing them at extreme risk of recurrent adverse cardiovascular events. Lipid-lowering therapy was widely used after the ACS; however, treatment was rarely optimised. Huge improvements are required in the management of hyperlipidaemia in Thailand.

Demographics and Outcomes of Percutaneous Coronary Intervention in Thailand: Data from Thai Percutaneous Coronary Intervention Registry.

Background: Percutaneous coronary intervention (PCI) has been and continues to be standard treatment in patients with coronary artery disease. The data for demographic and outcomes in Thailand are limited. Objective: To study data and characteristics relating to patients, the procedure, and outcomes of percutaneous coronary intervention in the Thai population. Material and Method: The Thai Percutaneous Coronary Intervention Registry (TPCIR) was established in 2006, consisting of 27 hospitals in Thailand that perform the PCI procedure. All patients who underwent PCI between May 2006 and October 2006 in participating hospitals were asked to participate in this registry. Data was recorded in case record form and then entered into the web-based registry. Key variables include demographic data, risk factors, indications for PCI, outcomes, and complications. Results: Four thousand one hundred fifty six patients were enrolled; 69.2% were male. Average age of PCI patients was 62.7 years. Indications for PCI were ST segment elevation myocardial infarction (14%), Non-ST segment elevation acute coronary syndrome (37.3%), and stable coronary artery disease (48.7%). PCI was successfully performed in 92.5% of lesions or 89.6% of cases with in-hospital complications reported in 12% of cases. Conclusion: This was the first nationwide multi-center study of PCI in Thailand. The overall PCI procedure success rate was 92.5%.

Machine learning-based predictive risk models for 30-day and 1-year mortality in severe aortic stenosis patients undergoing transcatheter aortic valve implantation.

BACKGROUND: Predictive risk score for mortality plays an important role in the decision-making in patient selection and risk stratification for TAVI. Existing established predictive risk scores had poor discrimination performance in the prediction of mortality after the TAVI. OBJECTIVES: The present study aimed to develop machine learning-based predictive models for 30-day and 1-year mortality in severe aortic stenosis patients undergoing TAVI. METHODS: A total of 186 patients in a retrospective cohort study were analyzed. The models were fitted by a decision tree. Each model was tested in 100 iterations of 80:20 stratified random splitting into training/testing samples and 10-fold cross-validation. RESULTS: Variables that predict 30-day mortality are a set of factors driven mainly by height, chronic lung disease, STS score, preoperative LVEF, age, and preoperative LVOT VTI. Variables that predict 1-year mortality are a set of factors consisting of preoperative LVEF, STS score, heart rate, systolic blood pressure, home oxygen use, serum creatinine level, and preoperative LVOT Vmax. This decision tree-generated predictive models for 30-day and 1- year mortality provided the most precise accuracy of 0.97 and 0.90 with the AUC-ROC curves of 0.83 and 0.71 on 30-day and 1-year mortality on testing data and had better discrimination performance compared to the existing established TAVI predictive risk scores. CONCLUSIONS: These machine learning models show excellent accuracy and have a better prediction for 30-day and 1-year mortality than the existing established TAVI predictive risk scores. A customized predictive model deems to be properly developed for better risk discrimination among cohorts.

Machine Learning-Based Predictive Model of Aortic Valve Replacement Modality Selection in Severe Aortic Stenosis Patients.

The current recommendation for bioprosthetic valve replacement in severe aortic stenosis (AS) is either surgical aortic valve replacement (SAVR) or transcatheter aortic valve replacement (TAVR). We evaluated the performance of a machine learning-based predictive model using existing periprocedural variables for valve replacement modality selection. We analyzed 415 patients in a retrospective longitudinal cohort of adult patients undergoing aortic valve replacement for aortic stenosis. A total of 72 clinical variables including demographic data, patient comorbidities, and preoperative investigation characteristics were collected on each patient. We fit models using LASSO (least absolute shrinkage and selection operator) and decision tree techniques. The accuracy of the prediction on confusion matrix was used to assess model performance. The most predictive independent variable for valve selection by LASSO regression was frailty score. Variables that predict SAVR consisted of low frailty score (value at or below 2) and complex coronary artery diseases (DVD/TVD). Variables that predicted TAVR consisted of high frailty score (at or greater than 6), history of coronary artery bypass surgery (CABG), calcified aorta, and chronic kidney disease (CKD). The LASSO-generated predictive model achieved 98% accuracy on valve replacement modality selection from testing data. The decision tree model consisted of fewer important parameters, namely frailty score, CKD, STS score, age, and history of PCI. The most predictive factor for valve replacement selection was frailty score. The predictive models using different statistical learning methods achieved an excellent concordance predictive accuracy rate of between 93% and 98%.

High-Sensitivity Troponins and Subclinical Coronary Atherosclerosis Evaluated by Coronary Calcium Score Among Older Asians Living With Well-Controlled Human Immunodeficiency Virus.

Background: Elevated levels of high-sensitivity cardiac troponin (hs-cTn) are suggestive of myocardial cell injury and coronary artery disease. We explored the association between hs-cTn and subclinical arteriosclerosis using coronary artery calcification (CAC) scoring among 337 virally suppressed patients with human immunodeficiency virus (HIV) who were ≥50 years old and without evidence of known coronary artery disease. Methods: Noncontrast cardiac computed tomography and blood sampling for hs-cTn, both subunit I (hs-cTnI) and subunit T (hs-cTnT), were performed. The relationship between CAC (Agatston score) and serum hs-cTn levels was analyzed using Spearman correlation and logistic regression models. Results: The patients, of whom 62% were male, had a median age of 54 years and had been on antiretroviral therapy for a median of 16 years; the CAC score was >0 in 50% of patients and ≥100 in 16%. Both hs-cTn concentrations were positively correlated with the Agatston score, with correlation coefficients of 0.28 and 0.27 (P < .001) for hs-cTnI and hs-cTnT, respectively. hs-cTnI and hs-cTnT concentrations of ≥4 and ≥5.3 pg/mL, respectively, provided the best performance for discriminating patients with Agatston scores ≥100, with a sensitivity and specificity of 76% and 60%, respectively, for hs-cTnI and 70% and 50% for hs-cTnT. In multivariable logistic regression analysis, each log unit increase in hs-cTnI level was independently associated with increased odds of having an Agatston score ≥100 (odds ratio, 2.83 [95% confidence interval, 1.69-4.75]; P <.001). Although not an independent predictor, hs-cTnT was also associated with an increased odds of having an Agatston score ≥100 (odds ratio, 1.58 [95% confidence interval, .92-2.73]; P = .10). Conclusions: Among Asians aged ≥50 years with well-controlled HIV infection and without established cardiovascular disease, 50% had subclinical arteriosclerosis. Increasing hs-cTnI and hs-cTnT concentrations were associated with an increased risk of severe subclinical arteriosclerosis, and hs-cTn may be a potential biomarker to detect severe subclinical arteriosclerosis.

Comparison of original and generic clopidogrel 600 mg loading dose in the patients who planned undergoing coronary angiography.

OBJECTIVE: To compare the efficacy and safety of original (Plavix) and generic (Apolets) clopidogrel 600 mg loading in patients planning to undergo coronary angiography. MATERIAL AND METHOD: This is an experimental design, parallel, randomized-controlled study. Coronary artery disease patients planned for cardiac catheterization were recruited Patients were randomized to receive either original or generic clopidogrel 600 mg loading dose. Platelet aggregation induced by 5 micromol/L and 20 micromol/L adenosine diphosphate (ADP) was measured by light transmission aggregometry (LTA) at baseline and 6 hours after clopidogrel 600 mg administration. RESULTS: Forty-nine patients were enrolled, 24 patients received original clopidogrel, and 25 patients received generic clopidogrel. After six hours of loading, there was significantly reduction in platelet aggregation induced by adenosine 5 micromol/L from 41.08 +/- 3.04% to 19.50 +/- 1.68% (p < 0.001) in original group compared to 36.76 +/- 2.66% to 21.32 +/- 2.60% (p < 0.001) in generic group. When induced by 20 micromol/L, the platelet aggregation was reduced from 58.50 +/- 2.09% to 32.25 +/- 2.30% (p < 0.001) in original group and from 61.12 +/- 2.54% to 30.04 +/- 3.14% (p < 0.001) in generic group. There was no significant difference between original and generic clopidogrel in reducing platelet aggregation induced by both adenosine 5 and 20 micromol/L. Groin hematoma was found in one case (4.2%) in the original clopidogrel group. CONCLUSION: Generic clopidogrel (Apolets) 600 mg loading dose is as effective as original clopidogrel (Plavix) in term of platelet aggregation inhibition.

In-hospital outcomes of primary percutaneous coronary intervention in King Chulalongkorn Memorial Hospital: 11 years of experience.

BACKGROUND: Primary percutaneous coronary intervention (PCI) appears to be the preferred reperf usion methodfor patients with ST-segment elevation myocardial infarction (STEMI). This method was introduced in our hospital before the year 2000. In Thailand, data showing long experience results in patients with STEMI who underwent primary percutaneous coronary intervention remain limited. OBJECTIVE: To demonstrate 11-yr experience of primary percutaneous coronary intervention at King Chulalongkorn Memorial Hospital. MATERIAL AND METHOD: This retrospective descriptive single-center study analyses clinical characteristics, angiographic features and in-hospital outcomes of 772 patients with STEMI who underwent primary percutaneous coronary intervention between 2000 and 2010. RESULTS: Seven hundred seventy two consecutive patients with STEMI were enrolled in the study. Three-fourth of the patients were male. Mean age was 60.13 years (range 28 to 96 years) and 12.6% were older than 75 years old. Forty-eight percent of patients were referred from hospital without cardiac catheterization facilities. Of these patients 94.4% underwent primary PCI and rescue PCI was done in 5.6% of patients. There were 27% ofpatients with left ventricular ejection fraction less than 40%, 21% of patients with Killip's class IV and 12% suffered cardiac arrest prior to angiography. Median door-to-balloon time in referred and non-referred patients was 28 and 104.5 minutes, respectively. Ninety-two percent of referred patients and 36% of non-referred patients, door to balloon time were within 90 minutes. About half ofthe patients had multi-vessels disease at that time of diagnosis. The overall angiographic success rate was 96%. Platelet glycoprotein llb/lla inhibitors were used in two-third ofpatients and stent placement in 82%. Post procedural thrombolysis in myocardial infarction (TII) 3 flow was documented in 87%. Intra-aortic balloon pump was used in 15% and thrombus aspiration device in 47%. During hospital stay, in-hospital mortality was 8.5% and 80% of those cases died from cardiac cause. One-third of patients died if they had Killip's class IV at presentation compared with 1.6% in patients with Killip's class I-III. In-hospital major adverse cardiovascular event was 10.4%. CONCLUSION: During 11 years of primary PCI experience in King Chulalongkorn Memorial Hospital, the angiographic success rate was high with acceptable in-hospital mortality and major adverse cardiac event. This strategy of treatment should be the treatment of choice for patients with STEMI in experienced PCI capable center with 24 hours/7 days availability.

Cost-utility analysis of transcatheter aortic valve implantation versus surgery in severe aortic stenosis patients with intermediate surgical risk in Thailand.

BACKGROUND: Transcatheter Aortic Valve Implantation (TAVI) has been shown to provide comparable survival benefit and improvement in quality of life to surgical aortic valve replacement (SAVR) for treating patients with severe aortic stenosis (AS) at intermediate surgical risk. This study aimed to evaluate the cost-utility of TAVI compared with SAVR for severe aortic stenosis with intermediate surgical risk in Thailand. METHODS: A two-part constructed model was used to analyze lifetime costs and quality-adjusted life-years (QALYs) from societal and healthcare perspectives. The study cohort comprised severe AS patients at intermediate surgical risk with an average age of 80 years. The landmark trials were used to populate the model in terms of mortality and adverse event rates. All cost-related data and quality of life were based on Thai population. Costs and QALYs were discounted at 3% annually and presented as 2021 values. Incremental cost-effectiveness ratios (ICERs) were calculated. Deterministic and probabilistic sensitivity analyses were conducted. RESULTS: In comparison to SAVR, TAVI resulted in higher total cost (THB 1,717,132 [USD 52,415.51] vs. THB 893,524 [USD 27,274.84]) and higher QALYs (4.88 vs. 3.98) in a societal perspective. The estimated ICER was THB 906,937/QALY (USD 27,684.27/QALY). From a healthcare system perspective, TAVI also had higher total cost than SAVR (THB 1,573,751 [USD 48,038.79] vs. THB 726,342 [USD 22,171.63]) with similar QALYs gained to the societal perspective. The estimated ICER was THB 933,145/QALY (USD 933,145/QALY). TAVI was not cost-effective at the Thai willingness to pay (WTP) threshold of THB 160,000/QALY (USD 4,884/QALY). The results were sensitive to utility of either SAVR or TAVI treatment and cost of TAVI valve. CONCLUSION: In patients with severe AS at intermediate surgical risk, TAVI is not a cost-effective strategy compared with SAVR at the WTP of THB 160,000/QALY (USD 4,884/QALY) from the perspectives of society and healthcare system.

Clinical Characteristics and In-Hospital Mortality in Patients with STEMI during the COVID-19 Outbreak in Thailand.

Background: Nowadays, current evidence on the effects of the COVID-19 outbreak on ST-elevation myocardial infarction (STEMI) patients is discrepant. The aim of this study was to compare and identify any changes in STEMI patients between the pre-COVID-19 period and during the COVID-19 outbreak. Methods: We conducted a retrospective cohort study to evaluate consecutive STEMI patients admitted from 1 September 2018 to 30 September 2021. We designated 14 March 2020 as the commencement of the COVID-19 outbreak in Thailand. Results: A total of 513 consecutive STEMI patients were included in this study: 330 (64%) admitted during the pre-COVID-19 outbreak period and 183 (36%) admitted during the COVID-19 outbreak. There was a significant 45% decline in the number of STEMI cases admitted during the COVID-19 outbreak period. During the outbreak, STEMI patients had significantly increased intra-aortic balloon pump (IABP) insertion (23% vs. 15%, p-value = 0.004), higher high-sensitivity troponin T level (11,150 vs. 5213, p-value < 0.001), and lower pre- and post-PCI TIMI flow. The time-to-diagnosis (59 vs. 7 min, p-value < 0.001), pain-to-first medical contact (FMC) time (250 vs. 214 min, p-value = 0.020), FMC-to-wire-crossing time (39 vs. 23 min, p-value < 0.001), and pain-to-wire-crossing time (292 vs. 242 min, p-value = 0.005) were increased in STEMI patients during the outbreak compared with pre-outbreak. There was no statistical difference in in-hospital mortality between both periods (p-value = 0.639). Conclusions: During the COVID-19 outbreak, there was a significant decline in the total number of admitted STEMI cases. Unfortunately, the time-to-diagnosis, pain-to-FMC time, FMC-to-wire-crossing time, and pain-to-wire-crossing time were significantly delayed during the COVID-19 outbreak. However, in-hospital mortality showed no significant differences between these two time periods. Highlights: 45% decline in the number of STEMI cases admitted and a significant delay in the treatment timeline during the COVID-19 outbreak. In-hospital mortality showed no significant difference between these two periods. Our study will motivate healthcare professionals to optimize treatments, screenings, and infectious control protocols to reduce the time from the onset of chest pain to wire crossing in STEMI patients during the outbreak.

Cost-Utility Analysis of Transcatheter Aortic Valve Implantation versus Surgery in High-Risk Severe Aortic Stenosis Patients in Thailand.

Background: Transcatheter aortic valve implantation (TAVI) has been shown to be effective in treating patients with severe symptomatic AS who are high-risk population for conventional surgical aortic valve replacement (SAVR). This study aimed to evaluate the cost-utility of TAVI compared with SAVR for severe aortic stenosis with high surgical risk in Thailand. Methods: Lifetime costs and quality-adjusted life years (QALYs) from societal and healthcare perspectives were estimated using a two-part constructed model. The study population consisted of 80-year-old severe AS patients with high surgical risk. Mortality and complication rates were obtained from landmark trials. All cost-related and utility data were based on Thai population. Costs and QALYs were discounted at a rate of 3% annually and presented as 2021 values. Incremental cost-effectiveness ratios (ICERs) were computed. Sensitivity analyses were performed both deterministically and probabilistically. Results: The findings from a societal perspective revealed that TAVI treatment was associated with higher cost (THB 1,551,895 [USD 47,371.64] vs THB 548,438 [USD 16,741.09] and higher QALYs than SAVR treatment (3.15 vs 2.31 QALYs). The estimated ICER was THB 1,196,191/QALY (USD 36,513.78 QALY). For the healthcare system perspective, TAVI treatment resulted in a higher total cost than SAVR treatment (THB 1,451,317 [USD 44,301.49] vs THB 432,398 [USD 13,198.95]) with comparable gains in LY and QALYs from a societal perspective. The ICER was calculated to be THB 1,214,624/QALY (USD 37,076.42/QALY). TAVI was not cost-effective at the Thai willingness to pay (WTP) threshold of THB 160,000/QALY (USD 4884/QALY). The model was the most sensitive to changes in TAVI valve cost and TAVI or SAVR treatment utilities. Conclusion: TAVI is not a cost-effective strategy in patients with severe AS who are at high surgical risk when compared to SAVR at the WTP of THB 160,000/QALY (USD 4884/QALY) from the perspectives of society and the healthcare system.

Dose-dependent effect of impaired renal function on all-cause mortality in patients following percutaneous coronary intervention.

OBJECTIVE: To determine the risk prediction of various degrees of impaired renal function on all-cause mortality in patients following percutaneous coronary intervention (PCI). BACKGROUND: Patients with chronic kidney disease (CKD) are at high risk of all-cause mortality after PCI. However, there are less data of various degrees of impaired renal function to predict those risks. METHODS: This was a subgroup analysis of nationwide PCI registry of 22 045 patients. Patients were classified into six CKD stages according to preprocedure estimated glomerular filtration rate (eGFR) (ml/min/1.73 m2 ): I (≥90), II (60-89), III (30-59), IV (15-29), or V (<15) without or with dialysis. Baseline clinical and angiographic characteristics were compared among patients in each stage. One-year all-cause mortality was reported with risk prediction based on CKD stages and other risk factors. RESULTS: Patients with CKD stage I-V without and with on dialysis were found in 26.9%, 40.8%, 23.2%, 3.9%, 1.5%, and 3.7%, respectively. PCI procedural success and complication rates ranged from 94.0% to 96.2% and 2.8% to 6.1%, respectively. One-year overall survival among CKD stages I-V was 96.3%, 93.1%, 84.4%, 65.2%, 68.0%, and 69.4%, respectively (p < .001 by log-rank test). After adjusting covariables, the hazard ratios of all-cause mortality for CKD stages II-V as compared to stage I by multivariate Cox regression analysis were 1.5, 2.6, 5.3, 5.9, and 7.0, respectively, (p < .001). CONCLUSION: Among patients undergoing PCI, lower preprocedure eGFR is associated in a dose-dependent effect with decreased 1-year survival. This finding may be useful for risk classification and to guide decision-making.

30-Day and 1-Year Outcomes With HYDRA Self-Expanding Transcatheter Aortic Valve: The Hydra CE Study.

OBJECTIVES: This study sought to evaluate the 30-day and 1-year safety and performance of the Hydra transcatheter aortic valve (THV) (in the treatment of symptomatic severe aortic stenosis in patients at high or extreme surgical risk. BACKGROUND: The Hydra THV is a novel repositionable self-expanding system with supra-annular bovine pericardial leaflets. METHODS: The Hydra CE study was a premarket, prospective, multicenter, single-arm study conducted across 18 study centers in Europe and Asia-Pacific countries. The primary endpoint was all-cause mortality at 30 days. All endpoints were adjudicated by an independent clinical events committee. RESULTS: A total of 157 patients (79.2 ± 7.1 years of age, 58.6% female; Society of Thoracic Surgeons score 4.7 ± 3.4%) were enrolled. Successful implantation was achieved in 94.3% cases. At 30 days, there were 11 (7.0%) deaths, including 9 (5.7%) cardiovascular deaths, of which 5 (3.2%) were device related. At 1 year, there were 23 (14.6%) deaths, including 13 (8.3%) cardiovascular deaths. At 30 days, there were significant improvement of effective orifice area (from 0.7 ± 0.2 cm2 to 1.9 ± 0.6 cm2) and mean aortic valve gradient (from 49.5 ± 18.5 mm Hg to 8.1 ± 3.7 mm Hg), which were sustained up to 1 year. Moderate or severe paravalvular leak was observed in 6.3% of patients at 30 days and 6.9% of patients at 1 year. The rate of new permanent pacemaker implantation was 11.7% at 30 days and 12.4% at 1 year. CONCLUSIONS: The Hydra CE study demonstrated that transcatheter aortic valve replacement with Hydra THV offered favorable efficacy at 1 year, providing large effective orifice area and low transvalvular gradient as well as acceptable complication rates with regard to new permanent pacemaker and paravalvular leak. (A Clinical Evaluation of the HYDRA Self Expanding Transcatheter Aortic Valve; NCT02434263).

Home Blood Pressure Control and Drug Prescription Patterns among Thai Hypertensives: A 1-Year Analysis of Telehealth Assisted Instrument in Home Blood Pressure Monitoring Nationwide Pilot Project.

BACKGROUND: Several interventions have been proposed to improve hypertension control with various outcomes. The home blood pressure (HBP) measurement is widely accepted for assessing the response to medications. However, the enhancement of blood pressure (BP) control with HBP telemonitoring technology has yet to be studied in Thailand. OBJECTIVE: To evaluate the attainment of HBP control and drug prescription patterns in Thai hypertensives at one year after initiating the TeleHealth Assisted Instrument in Home Blood Pressure Monitoring (THAI HBPM) nationwide pilot project. METHODS: A multicenter, prospective study enrolled treated hypertensive adults without prior regular HBPM to obtain monthly self-measured HBP using the same validated, oscillometric telemonitoring devices. The HBP reading was transferred to the clinic via a cloud-based system, so the physicians can adjust the medications at each follow-up visit on a real-life basis. Controlled HBP is defined as having HBP data at one year of follow-up within the defined target range (<135/85 mmHg). RESULTS: A total of 1,177 patients (mean age 58 ± 12.3 years, 59.4% women, 13.1% with diabetes) from 46 hospitals (81.5% primary care centers) were enrolled in the study. The mean clinic BP was 143.9 ± 18.1/84.3 ± 11.9 mmHg while the mean HBP was 134.4 ± 15.3/80.1 ± 9.4 mmHg with 609 (51.8%) patients having HBP reading <135/85 mmHg at enrollment. At one year of follow-up after implementing the HBP telemonitoring, 671 patients (57.0%) achieved HBP control. Patients with uncontrolled HBP had a higher prevalence of dyslipidemia and greater waist circumference than the controlled group. The majority of uncontrolled patients were still prescribed only one (36.0%) or two drugs (34.4%) at the end of the study. The antihypertensive drugs were not uptitrated in 136 (24%) patients with uncontrolled HBP at baseline. Calcium channel blocker was the most prescribed drug class (63.0%) followed by angiotensin-converting enzyme inhibitor (44.8%) while the thiazide-type diuretic was used in 18.9% of patients with controlled HBP and 16.4% in uncontrolled patients. CONCLUSION: With the implementation of HBP telemonitoring, the BP control rate based on HBP analysis was still low. This is possibly attributed to the therapeutic inertia of healthcare physicians. Calcium channel blocker was the most frequently used agent while the diuretic was underutilized. The long-term clinical benefit of overcoming therapeutic inertia alongside HBP telemonitoring needs to be validated in a future study.

Asia Pacific TAVI registry (an APSIC initiative): initial report of early outcomes: Asia Pacific TAVI registry.

AIMS: The aim of the study was to report the clinical experience, 30-day mortality and acute outcomes of patients undergoing transcatheter aortic valve implantation (TAVI) in the Asia Pacific region. METHODS AND RESULTS: The Asia Pacific TAVI registry is an international, multicentre, prospective, observational registry managed under the auspices of the Asian Pacific Society of Interventional Cardiology (APSIC). Patients undergoing TAVI in seven centres from Hong Kong, Japan, Philippines, Singapore and Taiwan, treated with TAVI devices for severe symptomatic aortic stenosis, were assessed. This first review presents the acute results and 30-day mortality. A multivariable analysis was also performed to identify independent predictors of early all-cause mortality. The enrolment was from 2009 to 2017 and a total of 1,125 patients were recruited. The 30-day mortality rate was 2.5%. Baseline logistic EuroSCORE more than 16 was independently associated with a 2.8-times increased risk of 30-day all-cause mortality (p=0.016). Post-procedural stroke (HR 4.9, p=0.008) was also associated with increased mortality. CONCLUSIONS: This initial report of the Asia Pacific TAVI registry demonstrated good acute success and low 30-day mortality. The preprocedural logistic EuroSCORE and post-procedural stroke incidence were strongly associated with acute mortality. Further attempts to reduce post-procedural stroke should be explored.

2020 Asian Pacific Society of Cardiology Consensus Recommendations on Antithrombotic Management for High-risk Chronic Coronary Syndrome.

The unique characteristics of patients with chronic coronary syndrome (CCS) in the Asia-Pacific region, heterogeneous approaches because of differences in accesses and resources and low number of patients from the Asia-Pacific region in pivotal studies, mean that international guidelines cannot be routinely applied to these populations. The Asian Pacific Society of Cardiology developed these consensus recommendations to summarise current evidence on the management of CCS and provide recommendations to assist clinicians treat patients from the region. The consensus recommendations were developed by an expert consensus panel who reviewed and appraised the available literature, with focus on data from patients in Asia-Pacific. Consensus statements were developed then put to an online vote. The resulting recommendations provide guidance on the assessment and management of bleeding and ischaemic risks in Asian CCS patients. Furthermore, the selection of long-term antithrombotic therapy is discussed, including the role of single antiplatelet therapy, dual antiplatelet therapy and dual pathway inhibition therapy.

2021 Asian Pacific Society of Cardiology Consensus Recommendations on the Use of P2Y12 Receptor Antagonists in the Asia-Pacific Region: Special Populations.

Advanced age, diabetes, and chronic kidney disease not only increase the risk for ischaemic events in chronic coronary syndromes (CCS) but also confer a high bleeding risk during antiplatelet therapy. These special populations may warrant modification of therapy, especially among Asians, who have displayed characteristics that are clinically distinct from Western patients. Previous guidance has been provided regarding the classification of high-risk CCS and the use of newer-generation P2Y12 inhibitors (i.e. ticagrelor and prasugrel) after acute coronary syndromes (ACS) in Asia. The authors summarise evidence on the use of these P2Y12 inhibitors during the transition from ACS to CCS and among special populations. Specifically, they present recommendations on the roles of standard dual antiplatelet therapy, shortened dual antiplatelet therapy and single antiplatelet therapy among patients with coronary artery disease, who are either transitioning from ACS to CCS; elderly; or with chronic kidney disease, diabetes, multivessel coronary artery disease and bleeding events during therapy.

Sex differences in patients undergoing transcatheter aortic valve replacement in Asia.

OBJECTIVES: Transcatheter aortic valve replacement (TAVR) is increasingly performed. Physically small Asians have smaller aortic root and peripheral vessel anatomy. The influence of gender of Asian patients undergoing TAVR is unknown and may affect outcomes. The aim of this study was to assess sex differences in Asian patients undergoing TAVR. METHODS: Patients undergoing TAVR from eight countries were enrolled. In this retrospective analysis, we examined differences in characteristics, 30-day clinical outcomes and 1-year survival between female and male Asian patients. RESULTS: Eight hundred and seventy-three patients (54.4% women) were included. Women were older, smaller and had less coronary artery and lung disease but tended to have higher logistic EuroSCOREs. Smaller prostheses were used more often in women. Major vascular complications occurred more frequently in women (5.5% vs 1.8%, p<0.01); however, 30-day stroke and mortality (women vs men: 1.5% vs 1.6%, p=0.95% and 4.3% vs 3.4%, p=0.48) were similar. Functional status improvement was significant and comparable between the sexes. Conduction disturbance and permanent pacemaker requirements (11.2% vs 9.0%, p=0.52) were also similar as was 1-year survival (women vs men: 85.6% vs 88.2%, p=0.25). The only predictors of 30-day mortality were major vascular injury in women and age in men. CONCLUSIONS: Asian women had significantly smaller stature and anatomy with some differences in clinical profiles. Despite more frequent major vascular complications, women had similar 30-day stroke or mortality rates. Functional status improvement was significant and comparable between the sexes. Conduction disturbance and permanent pacemaker requirements were similar as was 1-year survival.