Prediction of hypoattenuating leaflet thickening in patients undergoing transcatheter aortic valves replacement based on clinical factors and 4D-computed tomography morphological characteristics: A retrospective cross-sectional study.

BACKGROUND: The rapid increase in the number of transcatheter aortic valve replacement (TAVR) procedures in China and worldwide has led to growing attention to hypoattenuating leaflet thickening (HALT) detected during follow-up by 4D-CT. It's reported that HALT may impact the durability of prosthetic valve. Early identification of these patients and timely deployment of anticoagulant therapy are therefore particularly important. METHODS: We retrospectively recruited 234 consecutive patients who underwent TAVR procedure in Fuwai Hospital. We collected clinical information and extracted morphological characteristics parameters of the transcatheter heart valve (THV) post TAVR procedure from 4D-CT. LASSO analysis was conducted to select important features. Three models were constructed, encapsulating clinical factors (Model 1), morphological characteristics parameters (Model 2), and all together (Model 3), to identify patients with HALT. Receiver operating characteristic (ROC) curves and decision curve analysis (DCA) were plotted to evaluate the discriminatory ability of models. A nomogram for HALT was developed and verified by bootstrap resampling. RESULTS: In our study patients, Model 3 (AUC = 0.738) showed higher recognition effectiveness compared to Model 1 (AUC = 0.674, p = 0.032) and Model 2 (AUC = 0.675, p = 0.021). Internal bootstrap validation also showed that Model 3 had a statistical power similar to that of the initial stepwise model (AUC = 0.723 95%CI: 0.661-0.786). Overall, Model 3 was rated best for the identification of HALT in TAVR patients. CONCLUSION: A comprehensive predictive model combining patient clinical factors with CT-based morphology parameters has superior efficacy in predicting the occurrence of HALT in TAVR patients.

Single-shot technique of cryoablation for atrial fibrillation has comparable effective and safety outcomes compared to standard technique: insights from multiple clinical studies.

Background: Although there are many freezing protocols available, the optimal freezing dose is still not determined. We aimed to evaluate the effectiveness and safety of different freeze strategies of CBA in the treatment of AF. Methods: PubMed, Cochrane Library, Web of Science, and Embase were searched up to 1st December 2022. Studies comparing the outcomes between single-shot technique and standard technique of cryoablation were included. Subgroup analysis identified potential determinants for single-shot technique procedure. Results: Our search resulted in 3407 records after deduplication. A total of 17 qualified studies met our inclusion criteria. Compared with standard technique, single-shot technique of cryoablation has a comparable rate of freedom from AF/AT(RR 1.00; P = 0.968), a trend for lower rate of procedure complications (RR 0.80; P = 0.069), a lower rate in transient phrenic paralysis (t-PNP) (RR 0.67; P = 0.038), a similar rate in persistent phrenic paralysis (per-PNP) (RR 1.15; P = 0.645), as well as a comparable procedure parameters. Importantly, potentially significant treatment covariable interactions in procedure complications were found in freeze strategy subgroup, male proportion subgroup and age subgroup, including single-shot freeze (RR 1.02; P = 0.915) and TTI-guided (RR 0.63; P = 0.007) with interaction P = 0.051, high male proportion (RR 0.54; P = 0.005) and a low male proportion (RR 0.94; P = 0.759) with interaction P = 0.074, as well as age ≥ 65 (RR0.91; P = 0.642) and age <65 (RR 0.54; P = 0.006),interaction P = 0.090. Meanwhile, only one significant treatment covariable interactions in procedure complications was found in the hypertension subgroup, including HT > 60% (RR 0.89; P = 0.549) and HT ≤ 60% (RR 0. 46; P < 0.01) with interaction P = 0.043. Conclusions: Our study suggested that single-shot technique of cryoablation has comparable effective and safety outcomes for AF ablation compared to standard technique.

Mortality and Clinical Predictors After Percutaneous Mitral Valve Repair for Secondary Mitral Regurgitation: A Systematic Review and Meta-Regression Analysis.

Background: Percutaneous mitral valve repair (PMVR) provides an available choice for patients suffering from secondary mitral regurgitation (SMR), especially those whose symptoms persist after optimal, conventional, heart-failure therapy. However, conflicting results from clinical trials have created a problem in identifying patients who will benefit the most from PMVR. Objective: To pool mortality data and assess clinical predictors after PMVR among patients with SMR. To this end, subgroup and meta-regression analyses were additionally performed. Methods: We searched PubMed, EMBASE, and Cochrane databases, and 13 studies were finally included for meta-analysis. Estimated mortality and 95% confidence intervals (CIs) were obtained using a random-effects proportional meta-analysis. We also carried out a meta-regression analysis to clarify the potential influence of important covariates on mortality. Results: A total of 1,259 patients with SMR who had undergone PMVR were enrolled in our meta-analysis. The long-term estimated pooled mortality of PMVR was 19.3% (95% CI: 13.6-25.1). Meta-regression analysis showed that mortality was directly proportional to cardiac resynchronization therapy (CRT) (ß = 0.009; 95% CI: 0.002-0.016; p = 0.009), an effective regurgitant orifice (ERO) (ß = 0.009; 95% CI: 0.000-0.018; p = 0.047), and a mineralocorticoid receptor antagonist (MRA) use (ß = -0.015; 95% CI: -0.023--0.006; p < 0.001). Subgroup analysis indicated that patients with preexisting AF (ß = -0.002; 95% CI: -0.005- -0.000; p = 0.018) were associated with decreased mortality if they received a mitral annuloplasty device. Among the edge-to-edge repair device group, a higher left ventricular (LV) ejection fraction, or lower LV end-systolic diameter, LV end-systolic volume, and LV end-diastolic volume were proportional to lower mortality. Conclusion and Relevance: The pooled mortality of PMVR was 19.3% (95% CI: 13.6-25.1). Further meta-regression indicated that AF was associated with a better outcome in conjunction with the use of a mitral annuloplasty device, while better LV functioning predicted a better outcome after the implantation of an edge-to-edge repair device.

The Clinical Impact of Proton Pump Inhibitors When Co-Administered With Dual Antiplatelet Therapy in Patients Having Acute Myocardial Infarction With Low Risk of Gastrointestinal Bleeding: Insights From the China Acute Myocardial Infarction Registry.

Background: The latest guidelines recommend the use of proton pump inhibitors (PPIs) to minimize gastrointestinal bleeding (GIB) in patients receiving dual antiplatelet therapy (DAPT), even though this co-administration may increase the risk of ischemia due to drug interactions. We have noticed that there are few studies conducted on patients with a lower risk of GIB. Therefore, we investigated the clinical effect of co-administration of PPI on DAPT patients with low GIB risk. Methods and Results: From January 2013 to September 2014, a total of 17,274 consecutive patients on DAPT from 108 hospitals with low risk for GIB in the China Acute Myocardial Infarction (CAMI) registry were analyzed. The primary endpoints were GIB and major adverse cardiovascular and cerebrovascular events (MACCE). Multivariate logistic regression analysis and Cox proportional hazard models were used to assess the effect of PPIs use. Of the analyzed patients, 66.6% (n = 11,487) were treated with PPIs. PPI use did not show an extra gastrointestinal protective effect in patients with low risk for GIB who were hospitalized and on follow-up after 2 years. Moreover, it was associated with an increased risk of stroke during the 2-year follow-up [hazard ratio (HR) 2.072, 95% confidence interval (CI) 1.388-3.091, p = 0.0003] and an increased risk of MI after 6 months (HR 1.580, 95% CI 1.102-2.265, p = 0.0119). We found the same results after propensity score matching. Conclusion: PPI use is prevalent in DAPT patients with low GIB risk. PPIs did not show an extra gastrointestinal protective effect, while an increased risk of stroke was observed during the 2-year follow-up. Clinical Trial Registration:www.clinicaltrials.gov, identifier NCT01874691.

In-hospital gastrointestinal bleeding in patients with acute myocardial infarction: incidence, outcomes and risk factors analysis from China Acute Myocardial Infarction Registry.

OBJECTIVE: To investigate the incidence of gastrointestinal bleeding (GIB) in patients with acute myocardial infarction (AMI), clarify the association between adverse clinical outcomes and GIB and identify risk factors for in-hospital GIB after AMI. DESIGN: Retrospective cohort study. SETTING: 108 hospitals across three levels in China. PARTICIPANTS: From 1 January 2013 to 31 August 2014, after excluding 2659 patients because of incorrect age and missing GIB data, 23 794 patients with AMI from 108 hospitals enrolled in the China Acute Myocardial Infarction Registry were divided into GIB-positive (n=282) and GIB-negative (n=23 512) groups and were compared. PRIMARY AND SECONDARY OUTCOME MEASURES: Major adverse cardiovascular and cerebrovascular events (MACCEs) are a composite of all-cause death, reinfarction and stroke. The association between GIB and endpoints was examined using multivariate logistic regression and Cox proportional hazards models. Independent risk factors associated with GIB were identified using multivariate logistic regression analysis. RESULTS: The incidence of in-hospital GIB in patients with AMI was 1.19%. GIB was significantly associated with an increased risk of MACCEs both in-hospital (OR 2.314; p<0.001) and at 2-year follow-up (HR 1.407; p=0.0008). Glycoprotein IIb/IIIa (GPIIb/IIIa) receptor inhibitor, percutaneous coronary intervention (PCI) and thrombolysis were novel independent risk factors for GIB identified in the Chinese AMI population (p<0.05). CONCLUSIONS: GIB is associated with both in-hospital and follow-up MACCEs. Gastrointestinal prophylactic treatment should be administered to patients with AMI who receive primary PCI, thrombolytic therapy or GPIIb/IIIa receptor inhibitor. TRIAL REGISTRATION NUMBER: NCT01874691.

The benefit of exercise-based rehabilitation programs in patients with pulmonary hypertension: a systematic review and meta-analysis of randomized controlled trials.

Several studies have suggested that exercise capacity and quality of life are reduced in patients with pulmonary hypertension, and exercise-based rehabilitation can improve exercise capacity and quality of life in patients with pulmonary hypertension. The aim of this study is to assess the efficacy and safety of exercise-based rehabilitation in patients with pulmonary hypertension through a meta-analysis of randomized controlled trials. We searched PubMed, Embase, Medline, and the Cochrane Central Register of Controlled Trials up to November 2018. All randomized controlled trials comparing exercise capacity and quality of life between patients undergoing exercise-based rehabilitation and those undergoing non-exercise training were included. Data were extracted separately and independently by two investigators, and discrepancies were arbitrated by the third investigator. We used the random-effects model to analyze the results, the GRADE to assess the risk of bias in the included studies, and I2 statistic to estimate the degree of heterogeneity. Nine randomized controlled trials are included; however, only seven randomized controlled trials were able to extract data. Including inpatients and outpatients, the total number of participants was 234, most of whom were diagnosed as pulmonary artery hypertension. The study duration ranged from 3 to 15 weeks. The mean six-minute walking distance after exercise training was 51.94 m higher than control (27.65-76.23 m, n = 234, 7 randomized controlled trials, low quality evidence), the mean peak oxygen uptake was 2.96 ml/kg/min higher (2.49-3.43 ml/kg/min, n = 179, 4 randomized controlled trials, low-quality evidence) than in the control group. In conclusion, our finding suggests that an exercise-based training program positively influences exercise capacity in patients with pulmonary hypertension.

Comparison of the effect of glucose-lowering agents on the risk of atrial fibrillation: A network meta-analysis.

BACKGROUND: Diabetes is associated with the progression of atrial fibrillation (AF) and atrial flutter (AFL). However, whether glucose-lowering agents could reduce AF/AFL remains unclear. We hypothesized that different glucose-lowering agents exhibit different characteristic effects on the risk of AF/AFL. OBJECTIVES: The goals of this study were to evaluate the effect of different glucose-lowering agents and identify the optimal treatment that can reduce AF/AFL events in patients with diabetes. METHODS: We searched PubMed, Embase, and the Cochrane Library from their inception to September 30, 2020. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were used in this network meta-analysis. The primary end point of our study was AF or AFL. Only studies that reported AF/AFL as clinical end points with a follow-up period of at least 12 months were included. The results from trials were presented as odds ratios (ORs) with 95% confidence intervals (CIs). The results were pooled using a Bayesian random-effects model. RESULTS: Five eligible studies (9 glucose-lowering agents, including thiazolidinedione, metformin, sulfonylurea, insulin, dipeptidyl peptidase-4 inhibitor, glucagon-like peptide-1 receptor agonist [GLP-1RA], sodium-glucose cotransporter 2 inhibitor, alpha-glucosidase inhibitor, and non-sulfonylurea) consisting of 263,583 patients with type 2 diabetes mellitus were included. Based on the pooled results, GLP-1RA significantly reduced AF/AFL events compared with metformin (OR 0.17; 95% CI 0.04-0.61), sulfonylurea (OR 0.23; 95% CI 0.07-0.73), insulin (OR 0.20; 95% CI 0.07-0.86), and non-sulfonylurea (OR 0.18; 95% CI 0.04-0.66). CONCLUSION: Compared with other glucose-lowering agents, GLP-1RA could reduce the risk of AF/AFL in patients with diabetes.

Ethnic variance on long term clinical outcomes of concomitant use of proton pump inhibitors and clopidogrel in patients with stent implantation: A PRISMA-complaint systematic review with meta-analysis.

BACKGROUND: Pharmacokinetic and pharmacodynamic study showed a lower clopidogrel response when coprescribed with proton pump inhibitors (PPIs). Despite this, PPIs is necessary for patients treated with long term dual antiplatelet therapy (DAPT). Ethnic variance also played a different effect on clopidogrel response. Our study evaluated the effect of concomitant use of DAPT and PPIs and assessed whether ethnic variance exert different effect on clinical outcomes. METHODS: We carefully searched EMBASE, PubMed/Medline databases, and the Cochrane library in April 2019. The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE) and individual endpoints reported. We also focused on bleeding events. Studies were excluded if the follow-up were <12 months and patients were not treated with clopidogrel after stent implantation. RESULTS: A total of 18 studies were included in the systematic review (involving 79,670 patients). No randomized controlled trials (RCTs) were included. PPIs comedication were associated with increased MACCE (odds ratio [OR] = 1.38; 95% confidence interval [CI] = 1.28-1.49) while not associated with decreased bleeding risks, such as gastrointestinal bleeding (OR = 1.05; 95% CI = 0.53-2.11). PPIs comedication were associated with increased risk for all endpoints among Caucasian population while not with increased risk for MACE (OR = 1.20; 95% CI = 0.99-1.39), all-cause death (OR = 1.24; 95% CI = 0.74-2.06), cardiac-death (OR = 1.29; 95% CI = 0.64-2.57) among Asian population. CONCLUSION: PPIs comedication were associated with adverse clinical outcomes, and ethnic variance may exert different effect on clinical outcomes. Subgroup analysis indicated that concomitant use of PPI might be suitable for Asian patients after stent implantation.

Appropriateness of gastrointestinal prophylaxis use during hospitalization in patients with acute myocardial infarction: Analysis from the China Acute Myocardial Infarction Registry.

BACKGROUND: The current status of gastrointestinal prophylaxis (GIP) usage and its effects on hospitalized acute myocardial infarction (AMI) patients is not clear. We investigate the appropriateness of GIP usage and its relationship with clinical events in China. HYPOTHESIS: Appropriate use of GIP is not associated with increased adverse outcomes. METHODS: From January 2013 to September 2014, a total of 24 001 consecutive patients from 108 hospitals with AMI in China Acute Myocardial Infarction (CAMI) registry were analyzed. The appropriateness of GIP was evaluated using the current American College of Cardiology Foundation/American Heart Association (ACCF/AHA) and European Society of Cardiology (ESC) guidelines. The primary endpoint was in-hospital gastrointestinal bleeding (GIB), while the secondary endpoints were in-hospital and 2-year follow-up net adverse cardiovascular and cerebrovascular events (NACCE). Multivariate logistic regression analysis and Cox proportional hazard models were used to assess the effect of appropriate GIP. RESULTS: There were 16 413 (68.38%) AMI patients co-medicated with GIP. Among 108 involved hospitals, only 35 (32.4%) hospitals prescribed more than 50% appropriate GIP. Totally, 59.7% (14 340) AMI patients received inappropriate GIP. Inappropriate GIP use was independently associated with use of GPIIb/IIIa receptor inhibitor and primary percutaneous coronary intervention (PCI). Moreover, appropriate GIP use was associated with decreased GIB risk (OR: 0.692, 95% CI: 0.507-0.944, P = .0202) during hospitalization, while not with increased in-hospital and 2-year follow-up NACCE. CONCLUSION: The use of GIP is prevalent in patients with AMI in China but only 40% of hospitalized patients received appropriate GIP. Appropriate prophylactic therapy was associated with decreased GIB risk during hospitalization.

Impact of proton pump inhibitors on clinical outcomes in patients after acute myocardial infarction: a propensity score analysis from China Acute Myocardial Infarction (CAMI) registry.

BACKGROUND: Proton pump inhibitors (PPIs) are recommended by the latest guidelines to reduce the risk of bleeding in acute myocardial infarction (AMI) patients treated with dual antiplatelet therapy (DAPT). However, previous pharmacodynamic and clinical studies have reported controversial results on the interaction between PPI and the P2Y12 inhibitor clopidogrel. We investigated the impact of PPIs use on in-hospital outcomes in AMI patients, aiming to provide a new insight on the value of PPIs. METHODS: A total of 23, 380 consecutive AMI patients who received clopidogrel with or without PPIs in the China Acute Myocardial Infarction (CAMI) registry were analyzed. The primary endpoint was major adverse cardiovascular and cerebrovascular events (MACCE) defined as a composite of in-hospital cardiac death, re-infarction and stroke. Propensity score matching (PSM) was used to control potential baseline confounders. Multivariate logistic regression analysis was performed to evaluate the effect of PPIs use on MACCE and gastrointestinal bleeding (GIB). RESULTS: Among the whole AMI population, a large majority received DAPT and 67.5% were co-medicated with PPIs. PPIs use was associated with a decreased risk of MACCE (Before PSM OR: 0.857, 95% CI: 0.742-0.990, P = 0.0359; after PSM OR: 0.862, 95% CI: 0.768-0.949, P = 0.0245) after multivariate adjustment. Patients receiving PPIs also had a lower risk of cardiac death but a higher risk of complicating with stroke. When GIB occurred, an alleviating trend of GIB severity was observed in PPIs group. CONCLUSIONS: Our study is the first nation-wide large-scale study to show evidence on PPIs use in AMI patients treated with DAPT. We found that PPIs in combination with clopidogrel was associated with decreased risk for MACCE in AMI patients, and it might have a trend to mitigate GIB severity. Therefore, PPIs could become an available choice for AMI patients during hospitalization.