Impact of Procedural Success Definitions on Long-Term Outcomes in Patients With Rheumatic Mitral Stenosis Treated With Percutaneous Balloon Mitral Valvuloplasty: A Multicenter, Retrospective Cohort Study.

BACKGROUND: It is uncertain which percutaneous balloon mitral valvuloplasty (PBMV) success definitions should be used because there are no studies comparing the effects of these definitions on subsequent outcomes. We evaluated the association between 3 success definitions and long-term clinical outcomes in patients with rheumatic mitral stenosis who underwent PBMV. METHODS AND RESULTS: This multicenter retrospective study included patients with severe rheumatic mitral stenosis who underwent PBMV. Three definitions were used as follows: (A) post-PBMV mitral valve area (MVA) ≥1.5 cm2 or ≥50% increase in MVA with MR <3+; (B) post-PBMV MVA ≥1.5 cm2 and MR ≤2+; and (C) post-PBMV MVA ≥1.5 cm2 or ≥50% increase in MVA, with no more than 1-grade increment in MR. Multivariable Cox regression analyses were performed to evaluate the associations between PBMV success and the composite of all-cause mortality, mitral surgery, and repeat PBMV. Successful PBMV, according to definitions A, B, and C was associated with a lower risk of the composite outcomes (definition A-hazard ratio [HR], 0.55 [95% CI, 0.43-0.69], definition B-HR, 0.55 [95% CI, 0.43-0.69], definition C-HR, 0.55 [95% CI, 0.44-0.69]). Patients meeting all 3 success definitions had the lowest risk compared with those who did not meet any definition or met 1 or 2 definitions. CONCLUSIONS: All 3 success definitions had a prognostic impact on outcomes. Patients who achieved post-PBMV MVA ≥1.5 cm2, irrespective of the percentage increase in MVA, and MR ≤grade 2, with no more than a 1-grade increment in MR, had the most favorable outcomes.

Clinical outcomes of patients with atrial fibrillation in relation to multimorbidity status changes over time and the impact of ABC pathway compliance: a nationwide cohort study.

Patients with atrial fibrillation (AF) commonly have associated comorbidities. The primary aim was to determine the effect of increasing numbers of comorbidity on clinical outcomes. The secondary aims were (1) the association of comorbidities with oral anticoagulants (OAC) discontinuation, and quality control, (2) the impact of holistic care based on the ABC pathway on clinical outcomes. The primary outcome was the composite of all-cause death, ischemic stroke/systemic embolism, major bleeding, and heart failure. A total of 3405 patients were enrolled; mean age 67.8 ± 11.3 years, 41.8% female. Compared to low comorbidity group [n = 897 (26.3%)], hazard ratios (HR) and 95% confidence intervals (CI) for the composite outcome in the high [n = 929 (27.3%)] and moderate comorbidity [n = 1579 (46.4%)] groups were 5.40 (4.20-6.94) and 2.54 (1.97-3.27), respectively. ABC pathway adherence was associated with reduction of the composite outcome overall (HR 0.63; 0.54-0.74). High comorbidity adversely impacted on OAC use, OAC discontinuation, and quality of warfarin control. If quality of anticoagulation control was included as part of the ABC pathway adherence, the reduction in composite outcome risk was greater (HR 0.46; 0.36-0.58). During 3-year follow-up, 33.9% changed from low- to the moderate-high comorbidity groups and 22.3% changed from moderate- to the high comorbidity group. In conclusion, comorbidity burden in AF patients is an important determinant of clinical outcomes, and changed over time. OAC use, OAC discontinuation, and quality of OAC control were impacted by comorbidity burden. ABC pathway adherence was associated with a reduced risk of adverse clinical outcomes.

Reassessing heart failure therapy in Thailand: Patient insights and treatment outcomes from the Thai heart failure registry.

BACKGROUND: This research analyzed the demographics, management, and outcomes of patients with heart failure (HF) in Thailand. METHODS: The Thai Heart Failure Registry prospectively enrolled patients diagnosed with HF from 36 hospitals in Thailand. Follow-up data were recorded at 6, 12, 18, and 24 months. This study primarily focused on two outcomes: mortality and HF-related hospitalizations. RESULTS: The study included 2639 patients aged at least 18. Their mean age was 59.2 ± 14.5 years, and most were male (68.4%). Patients were classified as having HF with reduced ejection fraction (HFrEF, 80.7%), HF with preserved ejection fraction (HFpEF, 9.0%), or HF with mildly reduced ejection fraction (HFmrEF, 10.3%). Guideline-directed medical therapy utilization varied. Beta-blockers had the highest usage (93.2%), followed by mineralocorticoid receptor antagonists (65.7%), angiotensin-converting enzyme inhibitors (39.3%), angiotensin receptor blockers (28.2%), angiotensin receptor-neprilysin inhibitors (16.1%), and sodium-glucose cotransporter-2 inhibitors (8.0%). The study monitored a composite of mortality and HF incidents, revealing incidence rates of 11.74, 12.50, and 8.93 per 100 person-years for the overall, HFrEF, and HFmrEF/HFpEF populations, respectively. CONCLUSIONS: Despite high guideline-directed medical therapy adherence, the Thai Heart Failure Registry data revealed high mortality and recurrent HF rates. These findings underscore limitations in current HF treatment efficacy. The results indicate the need for further investigation and improvements of HF management to enhance patient outcomes.

Relation of changes in ABC pathway compliance status to clinical outcomes in patients with atrial fibrillation: A report from the COOL-AF registry.

AIM: The Atrial fibrillation Better Care (ABC) pathway provides a framework for holistic care management of atrial fibrillation (AF) patients. This study aimed to determine the impact of changes in compliance to ABC pathway management on clinical outcomes. METHODS: This is a prospective multicenter AF registry. Patients with non-valvular AF were enrolled and follow-up for 3 years. Baseline and follow-up compliance to the ABC pathway was assessed. The main outcomes were all-cause death, ischemic stroke/systemic embolism (SSE), major bleeding, and heart failure. RESULTS: There studied 3096 patients (mean age 67.6 ± 11.1 years, 41.8% female). Patients were categorized into 4 groups: Group 1: ABC compliant at baseline and 1 year [n = 1022 (33.0%)]; Group 2: ABC non-compliant at baseline but compliant at 1 year [n = 307 (9.9%)]; Group 3: ABC compliant at baseline and non-compliant at 1 year [n = 312 (10.1%)]; and Group 4: ABC non-compliant at baseline and also at 1 year [n = 1455 (47.0%)]. The incidence rates (95% confidence intervals, CI) of the composite outcome for Group 1 to 4 were 5.56 (4.54-6.74), 7.42 (5.35-10.03), 9.74 (7.31-12.70), and 11.57 (10.28-12.97), respectively. With Group 1 as a reference, Group 2-4 had hazard ratios (95% CI) of the composite outcome of 1.32 (0.92-1.89), 1.75 (1.26-2.43), and 2.07 (1.65-2.59), respectively. CONCLUSION: Re-evaluation of compliance status of the ABC pathway management is needed to optimize integrated care management and improve clinical outcomes. AF patients who were ABC pathway compliant at baseline and also at follow-up had the best clinical outcomes.

Systolic blood pressure visit-to-visit variability and outcomes in Asian patients with atrial fibrillation.

We aimed to assess the association between SBP-VVV and outcomes in Asian patients with atrial fibrillation (AF). AF patients in the COOL-AF registry with SBP measured at baseline, and at least two other visits were studied. We defined SBP-VVV using the standard deviation (SD) of average SBP. Patients were categorized according to the quartiles of SBP SD. The associations between SBP-VVV and outcomes were assessed in the adjusted Cox model. We studied 3172 patients (mean age 67.7 years; 41.8% female), with the prevalence of hypertension being 69%. Warfarin was used in 69% of patients, whereas 7% received non-vitamin K antagonist oral anticoagulants. The minimum and maximum SD of average SBP in the study population was 0.58 and 56.38 mmHg respectively. The cutoff of SD of average SBP for each quartile in our study were 9.09, 12.15, and 16.21 mmHg. The rates of all-cause mortality, ischemic stroke or systemic embolization (SSE), major bleeding, and intracranial hemorrhage (ICH) were 3.10, 1.42, 2.09, and 0.64 per 100 person-years, respectively. Compared with the first quartile, patients in the fourth quartile had a significantly higher risk of mortality (adjusted HR 1.60, 95%CI 1.13-2.25), bleeding (aHR 1.92, 95%CI 1.25-2.96) and ICH (aHR 3.51, 95%CI 1.40-8.76). The risk of SSE was not significantly different among the quartiles. SBP-VVV had a significant impact on the long-term outcomes of Asian patients with AF, particularly mortality and bleeding. Adequate SBP control and maintaining SBP stability over time may improve outcomes for AF patients.

Time in target range of systolic blood pressure and clinical outcomes in atrial fibrillation patients: results of the COOL-AF registry.

We aimed to investigate the relationship between time in target range of systolic blood pressure (SBP-TTr) and clinical outcomes in patients with atrial fibrillation (AF). We analyzed the results from multicenter AF registry in Thailand. Blood pressure was recorded at baseline and at every 6 monthly follow-up visit. SBP-TTr were calculated using the Rosendaal method, based on a target SBP 120-140 mmHg. The outcomes were death, ischemic stroke/systemic embolism (SSE), major bleeding, and heart failure. A total of 3355 patients were studied (mean age 67.8 years; 41.9% female). Average follow-up time was 32.1 ± 8.3 months. SBP-TTr was classified into 3 groups according to the tertiles. The incidence rates of all-cause death, SSE, major bleeding, and heart failure were 3.90 (3.51-4.34), 1.52 (1.27-1.80), 2.2 (1.90-2.53), and 2.83 (2.49-3.21) per 100 person-years, respectively. Patients in the 3rd tertile of SBP-TTr had lower rates of death, major bleeding and heart failure with adjusted hazard ratios 0.62 (0.48-0.80), p < 0.001, 0.64 (0.44-0.92), p = 0.016, and 0.61 (0.44-0.84), p = 0.003, respectively, compared to 1st SBP-TTr tertile. In conclusion, high SBP-TTr was associated with better clinical outcomes compared to other groups with lower SBP-TTr. This underscores the importance of good blood pressure control in AF patients.

Updated CRUSADE score to predict in-hospital bleeding: External validation in the Thai percutaneous coronary intervention registry.

BACKGROUND: The Can Rapid Risk Stratification of Unstable Angina Patients Suppress Adverse Outcomes with Early Implementation of the ACC/AHA Guidelines (CRUSADE) score has been recommended to predict in-hospital bleeding risk in non-ST segment elevation myocardial infarction (NSTEMI) patients. The evaluation of the CRUSADE risk score in Asian patients undergoing contemporary percutaneous coronary intervention (PCI) for NSTEMI is necessary. AIMS: We aimed to validate and update the CRUSADE score to predict in-hospital major bleeding in NSTEMI patients treated with PCI. METHOD: The Thai PCI registry is a large, prospective, multicenter PCI registry in Thailand enrolling patients between May 2018 and August 2019. The CRUSADE score was calculated based on 8 predictors including sex, diabetes, prior vascular disease (PVD), congestive heart failure (CHF), creatinine clearance (CrCl), hematocrit, systolic blood pressure, and heart rate (HR). The score was fitted to in-hospital major bleeding using the logistic regression. The original score was revised and updated for simplification. RESULTS: Of 19,701 patients in the Thai PCI registry, 5976 patients presented with NSTEMI. The CRUSADE score was calculated in 5882 patients who had all variables of the score available. Thirty-five percent were female, with a median age of 65.1 years. The proportion of diabetes, PVD, and CHF was 46%, 7.9%, and 11.2%, respectively. The original and revised models of the CRUSADE risk score had C-statistics of 0.817 (95% CI: 0.762-0.871) and 0.839 (95% CI: 0.789-0.889) respectively. The simplified CRUSADE score which contained only four variables (hematocrit, CrCl, HR, and CHF), had C-statistics of 0.837 (0.787-0.886). The calibration of the recalibrated, revised, and simplified model was optimal. CONCLUSIONS: The full and simplified CRUSADE scores performed well in NSTEMI treated with PCI in Thai population.

Net clinical benefit of oral anticoagulants in Asian patients with atrial fibrillation based on a CHA2DS2-VASc score.

BACKGROUND: This study was conducted to assess the net clinical benefit (NCB) for oral anticoagulant (OAC) in atrial fibrillation (AF) patients according to the CHA2DS2-VASc score. METHODS: Patients with AF were prospectively recruited in the COOL AF Thailand registry from 2014 to 2017. The incidence rate of thromboembolic (TE) events and major bleeding (MB) was calculated. Cox proportional hazards model was used to compare the TE and MB rate in patients with and without OACs in CHA2DS2-VASc score of 0-1 and ≥ 2, respectively. The survival analysis was performed based on CHA2DS2-VASc score. The NCB of OACs was defined as the TE rate prevented minus the MB rate increased multiplied by a weighting factor. RESULTS: A total of 3,402 AF patients were recruited. An average age of patients was 67.38 ± 11.27 years. Compared to non-anticoagulated patients, the Kaplan Meier curve showed anticoagulated patients with CHA2DS2-VASc score of 2 or more had the lower thromboembolic events with statistical significance (p = 0.043) and the higher MB events with statistical significance (p = 0.018). In overall AF patients, there were positive NCB in warfarin patients with CHA2DS2-VASc score of 3 or more while there were positive NCB in DOACs patients regardless of CHA2DS2-VASc score. Females with CHA2DS2-VASc score of 3 or more had a positive NCB regardless of OACs type. Good anticoagulation control (TTR ≥65%) improved an NCB in males with CHA2DS2-VASc score of 3 or more. CONCLUSIONS: AF patients with CHA2DS2-VASc score of 3 or more regardless warfarin or DOACs had a positive NCB. The NCB of OACs was more positive for DOACs compared to warfarin and for females compared to males.

Diagnostic Performance of a Mnemonic for Warning Symptoms in Predicting Acute Coronary Syndrome Diagnosis: A Retrospective Cross-Sectional Study.

Objectives: We aimed to create a mnemonic for acute coronary syndrome (ACS) warning symptoms and determine its diagnostic performance. Methods: This retrospective cross-sectional study included patients visiting the emergency room with symptoms of suspected ACS during 2020-2021. The mnemonic was created using symptoms with an odds ratio (OR) for predicting ACS >1.0. The mnemonic with the highest OR and sensitivity was identified. Sensitivity analysis was performed to test the diagnostic performance of the mnemonic by patient subgroups commonly exhibiting atypical symptoms. Results: ACS prevalence was 12.2% (415/3,400 patients). The mnemonic, "RUSH ChesT" [if you experience referred pain (R), unexplained sweating (U), shortness of breath (S), or heart fluttering (H) together with chest pain (C), visit the hospital in a timely (T) manner] had the best OR [7.81 (5.93-10.44)] and sensitivity [0.81 (0.77-0.85)]. This mnemonic had equal sensitivity in men and women, the elderly and adults, smokers and non-smokers, and those with and without diabetes or hypertension. Conclusion: The "RUSH ChesT" mnemonic shows good diagnostic performance for patient suspected ACS. It may effectively help people memorize ACS warning symptoms.

Validation of the academic research consortium high bleeding risk definition in Thai PCI registry.

BACKGROUND: Bleeding following percutaneous coronary intervention (PCI) has important prognostic implications. The Academic Research Consortium (ARC) have identified a set of clinical criteria to standardize the definition of a high bleeding risk (HBR). Current study sought to externally validate the ARC definition for HBR patients in a contemporary real-world cohort. METHOD: This post hoc analysis included 22,741 patients undergoing PCI between May 2018 and August 2019 enrolled in Thai PCI Registry. The primary endpoint was the incidence of major bleeding at 12 months post index PCI. RESULTS: In total, 8678 (38.2%) and 14,063 (61.8%) patients were stratified to the ARC-HBR and non-ARC-HBR groups, respectively. Incidence of major bleeding was 3.3 and 1.1 per 1000 patients per month in the ARC-HBR group and the non-ARC-HBR group (HR 2.84 [95% CI: 2.39-3.38]; p < 0.001). Advanced age and heart failure met the 1-year major criteria performance goal of ≥4% major bleeding. The impact of HBR risk factors was incremental. HBR patients also experienced significantly higher rates of all-cause mortality (19.1% versus 5.2%, HR 4.00 [95% CI: 3.67-4.37]; p < 0.001) and myocardial infarction. The ARC-HBR score fairly performed in discriminating bleeding with C-statistic (95% CI) of 0.674 (0.649, 0.698). Updating the ARC-HBR by adding heart failure, prior myocardial infarction, non-radial access, female in the model significantly improved C-statistic of 0.714 (0.691, 0.737). CONCLUSIONS: The ARC-HBR definition could identify patients at increased risk not only for bleeding but also for thrombotic events, including all-cause mortality. Coexistence of multiple ARC-HBR criteria unveiled additive prognostic value.

Comparative validation of HAS-BLED, GARFIELD-AF and ORBIT bleeding risk scores in Asian people with atrial fibrillation treated with oral anticoagulant: A report from the COOL-AF registry.

AIMS: Comparative data between the HAS-BLED, GARFIELD-AF and ORBIT score are limited in anticoagulated Asian patients with atrial fibrillation (AF). We compared the performance of the 3 scores in a nationwide registry. METHODS: AF patients treated with oral anticoagulants in the COOL-AF registry were studied. We fitted the variables of the HAS-BLED, GARFIELD-AF and ORBIT score to major bleeding in Cox model. We explored a modified HAS-BLED by addition of sex and body weight. Discrimination, calibration, net reclassification index (NRI) and decision curve analysis were used to compare the performance of the 3 models. RESULTS: Of 3402 patients in the registry, 2568 patients who received oral anticoagulant at baseline were studied. Majority of patients (91.1%) received warfarin. The rate of major bleeding was 2.11 per 100 person-years. The C-statistics of the GARFIELD-AF, HAS-BLED, modified HAS-BLED and ORBIT score were 0.65 (95% confidence interval [CI] 0.63-0.67), 0.66 (95%CI 0.64-0.68), 0.69 (95%CI 0.67-0.71) and 0.64 (95%CI 0.62-0.66) respectively. There was good agreement between predicted and observed bleeding in the deciles of HAS-BLED and GARFIELD-AF scores, while the modified HAS-BLED score and ORBIT score overestimated the risk in the last decile. The modified HAS-BLED score had superior NRI than the HAS-BLED score (26.9%, 95%CI 9.7%-42.2%) and the ORBIT score (31.9%, 95%CI 9.0-53.6%). The NRI between the modified HAS-BLED and GARFIELD-AF score was similar. The net benefit curve of the 4 models were overlapping among different thresholds. CONCLUSIONS: The clinical utility for bleeding prediction of GARFIELD-AF, HAS-BLED, modified HAS-BLED and ORBIT scores were similar in anticoagulated Asian patients with AF participating in the COOL-AF registry. We found no advantage of the ORBIT over HAS-BLED score for bleeding risk prediction, even in direct oral anticoagulant users.

Association of myosteatosis with treatment response and survival in patients with hepatocellular carcinoma undergoing chemoembolization: a retrospective cohort study.

Patients with hepatocellular carcinoma (HCC) have poor prognosis and have frequent treatment-related toxicities resulting in cancer-associated cachexia. This study aimed to determine the association of myosteatosis and sarcopenia on mortality in patients with HCC treated with transarterial chemoembolization (TACE). Six hundred and eleven patients diagnosed with HCC and underwent TACE at a tertiary care center between 2008 and 2019 were included. Body composition was assessed using axial CT slices at level L3 to calculate the skeletal muscle density for myosteatosis and skeletal muscle index for sarcopenia. The primary outcome was overall survival while the secondary outcome was TACE response. Patients with myosteatosis had a poorer TACE response than patients without myosteatosis (56.12% vs. 68.72%, adjusted odds ratio [OR] 0.49, 95% confidence interval [CI] 0.34-0.72). The rate of TACE response in patients with sarcopenia was not different from those without sarcopenia (60.91% vs. 65.22%, adjusted OR 0.79, 95% CI 0.55-1.13). Patients with myosteatosis had shorter overall survival than without myosteatosis (15.9 vs. 27.1 months, P < 0.001). In the multivariable Cox regression analysis, patients with myosteatosis or sarcopenia had higher risk of all-cause mortality than their counterparts (adjusted hazard ratio [HR] for myosteatosis versus no myosteatosis 1.66, 95% CI 1.37-2.01, adjusted HR for sarcopenia versus no sarcopenia 1.26, 95% CI 1.04-1.52). Patients with both myosteatosis and sarcopenia had the highest 7 year mortality rate at 94.45%, while patients with neither condition had the lowest mortality rate at 83.31%. The presence of myosteatosis was significantly associated with poor TACE response and reduced survival. Identifying patients with myosteatosis prior to TACE could allow for early interventions to preserve muscle quality and might improve prognosis in HCC patients.

Predicting Heart Failure in Patients with Atrial Fibrillation: A Report from the Prospective COOL-AF Registry.

BACKGROUND: This study aimed to determine risk factors and incidence rate and develop a predictive risk model for heart failure for Asian patients with atrial fibrillation (AF). METHODS: This is a prospective multicenter registry of patients with non-valvular AF in Thailand conducted between 2014 and 2017. The primary outcome was the occurrence of an HF event. A predictive model was developed using a multivariable Cox-proportional model. The predictive model was assessed using C-index, D-statistics, Calibration plot, Brier test, and survival analysis. RESULTS: There were a total of 3402 patients (average age 67.4 years, 58.2% male) with mean follow-up duration of 25.7 ± 10.6 months. Heart failure occurred in 218 patients during follow-up, representing an incidence rate of 3.03 (2.64-3.46) per 100 person-years. There were ten HF clinical factors in the model. The predictive model developed from these factors had a C-index and D-statistic of 0.756 (95% CI: 0.737-0.775) and 1.503 (95% CI: 1.372-1.634), respectively. The calibration plots showed a good agreement between the predicted and observed model with the calibration slope of 0.838. The internal validation was confirmed using the bootstrap method. The Brier score indicated that the model had a good prediction for HF. CONCLUSIONS: We provide a validated clinical HF predictive model for patients with AF, with good prediction and discrimination values.

Impact of the adjunctive use criteria for intravascular ultrasound-guided percutaneous coronary intervention and clinical outcomes.

The impact of the adherence to the adjunctive use criteria (AUC) for intravascular ultrasound (IVUS) guided percutaneous coronary intervention (PCI) and clinical outcomes in low IVUS volume countries are limited. The current study compared the procedural success and complication rates between used and not used IVUS catheter in the patients who were met (C +) and were not met (C-) the AUC for IVUS-guided PCI. From June 2018 through June 2019, a total of 21,066 patients were included in the Thai PCI registry. Among the study population, 15,966 patients (75.8%) have met the IVUS-AUC. The IVUS-guided PCI rates were 14.5% and 11.3% in the C + and C - groups, respectively. After adjusting for covariables by propensity model, IVUS-guided PCI was identified as an independent predictor of the procedural success rate regardless of whether the AUC were met with the relative risk [RR (95% confidence interval (CI)] of 1.033(1.026-1.040) and 1.012(1.002-1.021) in C + and C- groups, respectively. IVUS-guided PCI increased the procedural complication risks in both groups but were not significant with corresponding RRs of 1.171(0.915-1.426) and 1.693(0.959-2.426). Procedural success was achieved with IVUS-guided PCI regardless of whether the AUC were met. IVUS-guided PCI did not lead to an increase in procedural complications.

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.

External Validation of the ACUITY/HORIZON Bleeding Risk Score among Acute Coronary Syndrome Patients in Thai PCI Registry.

BACKGROUND: External validation is essential before implementing a predictive model in clinical practice. This analysis validated the performance of the ACUITY/HORIZON risk score in the most contemporary Thai PCI registry. METHODS: The ACUITY/HORIZON model was applied and validated externally in 12,268 ACS (acute coronary syndrome) patients. For revision and updating models, the regression coefficientd of all predictors were re-estimated and then additional predictors were stepwise selected from multivariate analysis. RESULTS: In-hospital bleeding defined by the BARC (Bleeding Academic Research Consortium) criteria was 1.3% (161 patients) and 2.3% (285 patients) by the ACUITY criteria. The calibration of both scales demonstrated overestimation of the original model with C-statistic values of 0.704 for ACUITY major bleeding and 0.793 for BARC 3 or 5 bleeding. For ACUITY major bleeding, the discriminatory power of the update model improved substantially when congestive heart failure (CHF), prior vascular disease as well as body mass index were considered. The update model demonstrated good calibration and C-statistic of 0.747 and 0.745 with no white blood cell (WBC) count. For BARC 3 or 5 bleeding, good calibration and discriminatory capacity could be observed when CHF and prior vascular disease were added in the update models, with an excellent C-statistic of 0.838, and a lower C-statistic value of 0.835 was obtained in the absence of WBC count. CONCLUSION: The ACUITY/HORIZON score was successfully validated in contemporary predictive and risk-adjustment models for PCI-related bleeding. The update models had good operating characteristics in patients from a real-world ACS population irrespective of bleeding definitions.

Predicting Infection Related Complications After Endovascular Repair of Infective Native Aortic Aneurysms.

OBJECTIVE: Endovascular aortic repair (EVAR) as surgical treatment for infective native aortic aneurysm (INAA) is associated with superior survival compared with open surgery, but with the risk of infection related complications (IRCs). This study aimed to assess the association between baseline clinical and computed tomography (CT) features and the risk of post-operative IRCs in patients treated with EVAR for INAA. It also sought to develop a model to predict long term IRCs in patients with abdominal INAA treated with EVAR. METHODS: All initial clinical details and CT examinations of INAAs between 2005 and 2020 at a major referral hospital were reviewed retrospectively. The images were scrutinised according to aneurysm features, as well as peri-aortic and surrounding organ involvement. Data on post-operative IRCs were found in the patient records. Cox regression analysis was used to derive predictors for IRCs and develop a model to predict five year IRCs after EVAR in abdominal INAA. RESULTS: Of 3 780 patients with the diagnosis of aortic aneurysm or aortitis, 98 (3%) patients were treated with EVAR for abdominal INAAs and were thus included. The mean follow up time was 52 months (range 0 ‒ 163). The mean transaxial diameter was 6.5 ± 2.4 cm (range 2.1 ‒14.7). In the enrolled patients, 38 (39%) presented with rupture. The five year IRC rate in abdominal INAAs was 26%. Female sex, renal insufficiency, positive blood culture, aneurysm diameter, and psoas muscle involvement were predictive of five year IRC in abdominal INAA after EVAR. The model had a C-index of 0.76 (95% CI 0.66 - 0.87). CONCLUSION: Pre-operative clinical and CT features have the potential to predict IRC after endovascular aortic repair in INAA patients. These findings stress the importance of rigorous clinical, laboratory, and radiological follow up in these patients.

Procedural success and outcomes after percutaneous balloon mitral valvuloplasty in rheumatic mitral stenosis with moderate mitral regurgitation: a retrospective cohort study.

Background: Percutaneous balloon mitral valvuloplasty (PBMV) is contraindicated in mitral stenosis (MS) with moderate mitral regurgitation (MR) according to the European guidelines. However, small-sized studies have demonstrated the feasibility and safety of PBMV in these patients. We aimed to study the procedural success and mid-term outcomes of PBMV in MS patients with moderate MR. Methods: The present study was a retrospective cohort study in consecutive patients with severe rheumatic MS who underwent PBMV with the Inoue technique in Songklanagarind hospital. The severity of mitral regurgitation was assessed with qualitative Doppler. The patients were grouped according to their MR severity before PBMV into moderate MR or less-than-moderate MR. Procedural success and a composite of all-cause death, mitral valve surgery or re-PBMV were compared between the two groups. Results: Of 618 patients with rheumatic MS who underwent PBMV in Songklanagarind hospital between January 2003 and October 2020, 598 patients (96.8%) had complete information of pre-PBMV MR severity and procedural success. Forty-nine patients (8.2%) had moderate MR before PBMV. Moderate MR before PBMV was not associated with a lower chance of PBMV success (moderate MR vs. less-than-moderate MR before PBMV; adjusted OR 0.65, 95% CI: 0.32-1.29, P=0.22). Survival probability of all-cause death, MV surgery or re-PBMV in the group with moderate MR before PBMV was not different from the group with less-than-moderate MR (adjusted HR 1.30, 95% CI: 0.98-1.62, P=0.10). Conclusions: PBMV is an effective and safe treatment in rheumatic MS with moderate MR.

Ticagrelor Monotherapy or Dual Antiplatelet Therapy After Drug-Eluting Stent Implantation: Per-Protocol Analysis of the GLOBAL LEADERS Trial.

Background In the GLOBAL LEADERS trial, ticagrelor monotherapy beyond 1 month compared with standard antiplatelet regimens after coronary stent implantation did not improve outcomes at intention-to-treat analysis. Considerable differences in treatment adherence between the experimental and control groups may have affected the intention-to-treat results. In this reanalysis of the GLOBAL LEADERS trial, we compared the experimental and control treatment strategies in a per-protocol analysis of patients who did not deviate from the study protocol. Methods and Results Baseline and postrandomization information were used to classify whether and when patients were deviating from the study protocol. With logistic regressions, we derived time-varying inverse probabilities of nondeviation from protocol to reconstruct the trial population without protocol deviation. The primary end point was a composite of all-cause mortality or nonfatal Q-wave myocardial infarction at 2 years. At 2-year follow-up, 1103 (13.8%) of 7980 patients in the experimental group and 785 (9.8%) of 7988 patients in the control group qualified as protocol deviators. At per-protocol analysis, the rate ratio for the primary end point was 0.88 (95% CI, 0.75-1.03; P=0.10) on the basis of 274 versus 325 events in the experimental versus control group. The rate ratio for the key safety end point of major bleeding was 1.00 (95% CI, 0.79-1.26; P=0.99). The per-protocol and intention-to-treat effect estimates were overall consistent. Conclusions Among patients who complied with the study protocol in the GLOBAL LEADERS trial, ticagrelor plus aspirin for 1 month followed by ticagrelor monotherapy was not superior to 1-year standard dual antiplatelet therapy followed by aspirin alone at 2 years after coronary stenting. Registration URL: https://www.clinicaltrials.gov; Unique identifier: NCT01813435.