Predictive value of Systematic Coronary Risk Evaluation 2-Diabetes risk model and arterial stiffness for cardiovascular events in the Asian population with type 2 diabetes mellitus.

AIMS/INTRODUCTION: Individuals with diabetes are at high risk of developing cardiovascular events. The present study investigated the predictive value of the cardio-ankle vascular index (CAVI) when added to the Systematic Coronary Risk Evaluation 2-Diabetes (SCORE2-Diabetes) risk algorithm to predict cardiovascular events in the Asian population. MATERIALS AND METHODS: The SCORE2-Diabetes risk was assessed in 1,502 patients with diabetes, aged 40-69 years. Then, we further stratified each 10-year risk category with a CAVI value of 9.0. The primary outcomes (composite of all causes of death, myocardial infarction, stroke and hospitalization for heart failure) were assessed over 5 years. RESULTS: The mean age of the population was 59.8 ± 6.4 years. The proportion of 10-year risk according to the SCORE2-Diabetes risk of low, moderate, high and very high risk identified at 7.2, 30.0, 27.2 and 35.6%, respectively. The mean CAVI value was 8.4 ± 1.4, and approximately 35.4% of the patients had CAVI ≥9.0. The SCORE2-Diabetes risk algorithm independently predicted the primary outcomes in patients with diabetes (hazard ratio 1.18, 95% confidence interval [CI] 1.13-1.22), whereas CAVI did not (hazard ratio 1.03, 95% CI 0.89-1.18). The C-index for the primary outcomes of the SCORE2-Diabetes risk algorithm alone was 0.72 (95% CI 0.67-0.77). The combination of SCORE2-Diabetes and CAVI, both in the continuous value and risk groups, did not improve discrimination (C-index 0.72, 95% CI 0.67-0.77 and 0.68, 95% CI 0.64-0.74, respectively). CONCLUSIONS: Adding the CAVI to the SCORE2-Diabetes risk algorithm did not improve individual risk stratification in patients with diabetes.

Prognostic Value of Ankle-Brachial Index in Prediction of Cardiovascular Events in an Asian Population with Multiple Atherosclerotic Risk Factors.

We aimed to evaluate the incremental prognostic value after incorporation of the ankle-brachial index (ABI) into the 10-year pool cohort equation (PCE) risk model in patients with multiple risk factors (MRFs). A total of 4332 MRFs patients were divided into 2 groups as ABI ≤.9 or >.9. The primary outcome was hard cardiovascular events (hCVE: including cardiovascular death, myocardial infarction, or ischemic stroke) over a median follow-up of 36 months. The Cox proportional hazards survival model, C-statistic, and net reclassification indices (NRI) were used. The occurrence of the primary outcome in the ABI ≤.9 group (3.7%) was significantly greater than in the ABI > .9 group (1.3%), P < .001. ABI is an independent predictor of hCVE in addition to the variables in the standard risk model (age, gender, and smoking status). ABI modestly improved the C-index when added to the PCE risk model (PCE .70 vs ABI+PCE .74). The addition of ABI to the PCE risk model did not significantly improve the classification of patients (NRI -.029; 95% CI: -.215 to .130). Despite ABI being one of the independent predictors of hCVE, integration of ABI into the PCE model did not improve the efficacy of risk reclassification in patients with MRFs.

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.

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.

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.

Standardized distances for placement of REBOA in patients with aortic stenosis.

Resuscitative endovascular balloon occlusion of the aorta (REBOA) is a technique where a balloon is advanced through the common femoral artery and temporarily inflated for treatment of cardiac arrest or non-compressible haemorrhage. The aim of this study was to measure intravascular distances relevant for correct placement of the REBOA catheter using computer tomographic (CT) scans. In a series of CT scans of the aorta from 100 patients diagnosed with severe aortic stenosis planned for transcatheter aortic valve implantation, we measured the intravascular distance from the insertion site in the common femoral artery to two potential zones for placement of the REBOA catheter; between the left subclavian artery and the celiac trunk (Zone 1), as well as between the aortic bifurcation and the distal take-off of the renal arteries (Zone 3). The mean (± SD) intravascular distance from the femoral artery to intra-aortic Zone 1 was 36 (± 2.5) cm for the lower border and 60 (± 4.1) cm for the upper border, respectively. For intra-aortic Zone 3, the mean (± SD) intravascular distance was 21 (± 2.1) cm to the lower border and 31 (± 2.3) cm to the upper border. Calculated potentially safe intervals for placement of the REBOA in Zone 1 was with 99.7% likelihood between 43 and 48 cm. No similar potentially safe interval could be calculated for Zone 3. According to this cohort study of patients with severe aortic stenosis, the balloon of the REBOA catheter should travel intraarterially between 43 (lower limit) and 48 cm (upper limit) from the site of insertion into the common femoral artery, which would lead to correct placement in intra-aortic Zone 1 in 99.7% of cases. In contrast, no potential safety interval could be similarly defined for insertion in Zone 3.

Transcatheter aortic valve implantation with the self-expanding Portico valve system in an all-comers population: procedural and clinical outcomes.

AIMS: Transcatheter aortic valve implantation (TAVI) is an established therapy for patients with severe aortic stenosis (AS). The aim of this study was to evaluate the newer-generation Portico TAVI system in an all-comers population. METHODS AND RESULTS: This single-centre study included 216 patients with severe AS (Society of Thoracic Surgeons [STS] score 4.3±3.0%). The Portico valve was implanted using the transfemoral (91.2%), transsubclavian (5.6%) and transcaval (3.2%) access. Device success was achieved in 94.4% of cases. At 30 days, mortality and stroke rates were 2.3% and 0.5%, respectively. Early safety was achieved in 91.7% of cases. More-than-mild paravalvular leak (PVL), as assessed by echocardiogram, was observed in 3.4% of the patients, with rates of 4.9% and 1.9% in the first and second half of the cohort, respectively. A permanent pacemaker was implanted in 15.8% of those without prior pacemaker, with a rate of 11.1% in the second half of the cohort. At one year, incidence rates for all-cause mortality and stroke were 12.3% and 2.3%, respectively. In the low-risk group (STS <4%; n=128), Kaplan-Meier estimates at 30 days and one year were 0% and 7.5% for all-cause mortality and 0.8% and 2.2% for stroke, respectively. Haemodynamic improvements persisted over time with a mean transvalvular gradient of 7.0±3.0 mmHg at one-year follow-up. CONCLUSIONS: The Portico TAVI system was safe to implant and achieved a high device success rate. With learning curve effects, the device achieves lower rates of PVL and pacemaker implantation and provides adequate clinical and haemodynamic outcomes up to one year.

Comprehensive update on the new indications for transcatheter aortic valve replacement in the latest 2017 European guidelines for the management of valvular heart disease.

New European guidelines on the management of valvular heart disease-supported by the European Society of Cardiology (ESC) and European Association of CardioThoracic Surgery (EACTS)-were recently published. Although these guidelines are very comprehensive, these typically are not very inviting to read. In this document, we aimed to distil all the information about transcatheter aortic valve replacement (TAVR) in the new 2017 ESC/EACTS guidelines to the essential and give additional comments on the position of TAVR in 2017.

Vascular access site complication in transfemoral coronary angiography between uninterrupted warfarin and heparin bridging.

BACKGROUND: Warfarin discontinuation with heparin bridging is a common practice in patients receiving warfarin prior to elective coronary angiography (CAG). The uninterrupted warfarin strategy has been suggested to be alternative option for patients with high thromboembolic risk. Therefore, we aimed to assess the safety of elective transfemoral CAG during uninterrupted warfarin therapy compared to heparin bridging. METHODS: This study was a randomized open-label design with blinded event evaluation. The 110 consecutive patients (age ≥ 18 years) receiving warfarin before the planned transfemoral CAG were randomly assigned to either heparin bridging or uninterrupted warfarin with targeted INR (2.0-3.0). The primary outcome was the incidence of major vascular access site complications. RESULTS: The baseline characteristics were comparable between two groups (mean age was 60.1 ± 7.8 years, 49 males). The mean INR on the day of CAG of heparin bridging and uninterrupted warfarin groups was 1.2 ± 0.3 and 2.2 ± 0.5 (P < 0.001). The major vascular access site complications occurred in 3 of 55 (5.5%) heparin-bridging patients and in none of 55 uninterrupted warfarin patients (P = 0.243). The total vascular access site complications occurred in 6 (10.9%) heparin-bridging and one (1.8%) uninterrupted warfarin patients (P = 0.113). No patient developed either other bleeding or thromboembolic events during 7 days after CAG. CONCLUSIONS: We demonstrated that an uninterrupted warfarin strategy did not increase vascular access site complications in patients undergoing transfemoral CAG compared to heparin bridging therapy. Due to the safety and the ease of uninterrupted warfarin strategy, this approach should be encouraged in patients receiving long-term warfarin who undergo elective transfemoral CAG.