[Transcatheter interventional therapy for heart valve disease: applications and challenges].

Heart valve disease (HVD) is one of the most common cardiovascular diseases, and its incidence increases gradually with the aging of population. Surgery has long been the main solution to treat HVD. In recent years, the transcatheter interventional therapy of HVD has made great progress with the continuous technology innovation and improvement of devices. This article mainly describes the applications and challenges of transcatheter interventional therapy in aortic valve, mitral valve, tricuspid valve and pulmonary valve.

[Risk factors related to coronary artery occlusion in female patients with ischemic angina pectoris].

Objective: To analyze the risk factors of coronary artery occlusion in female patients with ischemic angina pectoris. Methods: Clinical data of 1 600 patients (666 females and 934 males) who underwent coronary angiography from January 2013 to December 2015 due to angina pectoris in 6 major coronary intervention centers in China were retrospectively analyzed. The clinical characteristics were compared between the female and male groups, and between the non-obstructive coronary artery disease (INOCA) and ischemic obstructive coronary artery disease (IOCA) subgroups of female subjects with angina pectoris. The risk factors related to the degree of coronary artery occlusion in female patients were analyzed. Results: In the enrolled patients who underwent coronary angiography for angina pectoris, female group was older than the male group, and the proportion of patients with hypertension, diabetes and ischemia accompanied by IOCA was significantly higher than that of the male group (P<0.05). Univariate analysis showed that age≥65 years, hypertension, diabetes, and typical angina symptoms were associated with an increased risk of IOCA in female patients with angina pectoris. Multivariate regression analysis showed that age≥65 years old (OR=1.784, 95%CI: 1.146-2.776, P=0.010), hypertension (OR=1.782, 95%CI: 1.201-2.644, P=0.004) and typical angina symptoms (OR=1.642, 95%CI: 1.127-2.393, P=0.010) were independent risk factors for female patients with angina pectoris diagnosed as IOCA. The correlation analysis between the number of risk factors and the type of coronary artery disease obstruction showed that the incidence of INOCA decreased significantly with the increase of the number of risk factors, from 45.5% to 14.2%. The incidence of IOCA increased significantly with the number of risk factors, from 54.5% to 85.8% (P for trend<0.001). Conclusion: The incidence of INOCA in female patients with angina pectoris suspected of coronary heart disease is higher than that of male. The incidence of IOCA increased significantly, and the incidence of INOCA decreased significantly in proportion to the increase of the number of combined risk factors.

[Clinical characteristics and prognostic analysis of female patients with Stanford type B aortic dissection].

Objective: To explore the clinical characteristics and prognostic factors of female patients with Stanford type B aortic dissection. Methods: This is a single-centre retrospective study. Consecutive patients diagnosed with Stanford type B aortic dissection in General Hospital of Northern Theater Command from June 2002 to August 2021 were enrolled, and grouped based on sex. According to the general clinical conditions and complications of aortic dissection tear, patients were treated with thoracic endovascular aortic repair, surgery, or optimal medication. The clinical characteristics and aortic imaging data of the patients at different stages were collected, adverse events including all-cause deaths, stroke, and occurrence of aortic-related adverse events were obtained during hospitalization and within 30 days and at 1 and 5 years after discharge. According to the time of death, death was classified as in-hospital death, out-of-hospital death, and in-hospital death was divided into preoperative death, intraoperative death and postoperative death. According to the cause of death, death was classified as aortic death, cardiac death and other causes of death. Aortic-related adverse events within 30 days after discharge included new paraplegia, post-luminal repair syndrome, and aortic death; long-term (≥1 year after discharge) aortic-related adverse events included aortic death, recurrent aortic dissection, endoleak and distal ulcer events. The clinical characteristics, short-term and long-term prognosis was compared between the groups. Logistic regression analysis was used to explore the association between different clinical factors and all-cause mortality within 30 days in female and male groups separately. Results: A total of 1 094 patients with Stanford type B aortic dissection were enrolled, mean age was (53.9±12.1) years, and 861 (78.7%) were male and 233 (21.3%) were female. (1) Clinical characteristics: compared with male patients, female patients were featured with older average age, higher proportion of aged≥60 years old, back pain, anemia, optimal medication treatment, and higher cholesterol level; while lower proportion of smoking and drinking history, body mass index, calcium antagonists use, creatine kinase level, and white blood cell count (all P<0.05). However, there was no significant difference in dissection tear and clinical stage, history of coronary heart disease, diabetes, hypertension, and cerebrovascular disease between female and male patients (all P>0.05). (2) Follow-up result: compared with male patients, female patients had a higher rate of 30-day death [6.9% (16/233) vs. 3.8% (33/861), P=0.047], in-hospital death (5.6% (13/233) vs. 2.7% (23/861), P=0.027), preoperative death (3.9% (9/233) vs. 1.5% (12/861), P=0.023) and aorta death (6.0% (14/233) vs. 3.1% (27/861), P=0.041). The 1-year and 5-year follow-up results demonstrated that there were no significant differences in death, cerebrovascular disease, and aorta-related adverse events between the two groups (all P>0.05). (3) Prognostic factors: the results of the univariate logistic regression analysis showed that body mass index>24 kg/m2 (HR=1.087, 95%CI 1.029-1.149, P=0.013), history of anemia (HR=2.987, 95%CI 1.054-8.468, P=0.032), hypertension (HR=1.094, 95%CI 1.047-1.143, P=0.040) and troponin-T>0.05 µg/L (HR=5.818, 95%CI 1.611-21.018, P=0.003)were associated with an increased risk of all-cause mortality within 30 days in female patients. Conclusions: Female patients with Stanford type B aortic dissection have specific clinical characteristics, such as older age at presentation, higher rates of anemia and combined back pain, and higher total cholesterol levels. The risk of death within 1 month is higher in female patients than in male patients, which may be associated with body mass index, hypertension, anemia and troponin-T, but the long-term prognosis for both female and male patients is comparable.

[Efficacy and safety of extracorporeal membrane oxygenation-supported percutaneous coronary intervention in chronic coronary total occlusion patients with reduced left ventricular ejection fraction].

Objective: To investigate the feasibility and safety of extracorporeal membrane oxygenation (ECMO)-supported percutaneous coronary intervention (PCI) in chronic coronary total occlusion (CTO) patients with reduced left ventricular ejection fraction (LVEF). Methods: The CTO patients with LVEF≤35% and undergoing CTO-PCI assisted by ECMO in the General Hospital of Northern Theater Command from December 2018 to March 2022 were enrolled in this study. The post-procedure complications, changes of LVEF from pre-procedure to post-procedure during hospitalization, and the incidence of all-cause mortality and changes of LVEF after discharge were assessed. Results: A total of 17 patients aged (59.4±11.8) years were included. There were 14 males. The pre-procedure LVEF of these patients were (29.00±4.08)%. Coronary angiography results showed that there were 29 CTO lesions in these 17 patients. There was 1 in left main coronary artery, 7 in left anterior descending artery, 11 in left circumflex artery, and 10 in right coronary artery. ECMO was implanted in all patients before procedure. Among 25 CTO lesions attempted to cross, 24 CTO were successfully implanted with stents. All patients underwent successful PCI for at least one CTO lesion. The number of drug-eluting stents implantation per patient were 4.6±1.3. After procedure, there were 8 patients with hemoglobin decreased>20 g/L, and 1 patient with ECMO-access-site related bleeding. The LVEF value at a median duration of 2.5 (2.0-5.5) days after procedure significantly increased to (38.73±7.01)% (P<0.001 vs. baseline). There were no in-hospital deaths. Patients were followed up for 360 (120, 394) days after discharge, 3 patients died (3/17). The LVEF value was (41.80±7.32)% at 155 (100, 308) days after discharge, which was significantly higher than the baseline value (P<0.001). Conclusion: The results of present study demonstrate that it is feasible, efficient and safe to perform ECMO)-supported CTO-PCI in CTO patients with reduced LVEF.

[Study on the status of turnover intention and its influencing factors of 382 hemato-oncology nurses].

Objective: To explore the status of turnover intention and its influencing factors of hemato-oncology nurses. Methods: From September to November 2021, the convenience sampling method was used to select 382 hemato-oncology nurses from 8 tertiary grade A general hospitals in Shandong Province. The general information questionnaire, the Chinese Nurses' Work Stressor Scale, the Psychological Capital Questionnaire and the Turnover Intention Questionnaire were used to investigate the general situation, occupational stress, psychological capital and turnover intention of the objects. The correlations between the turnover intention, occupational stress and psychological capital of the objects were analyze by Pearson correlation. And the multiple linear regression was used to analyze the influencing factors of turnover intention. A structural equation model was used to analyze the effect path of occupational stress and psychological capital on turnover intention. Results: The total turnover intention score of hemato-oncology nurses was (14.25±4.03), with the average item score of (2.38±0.67). The occupational stress score of hemato-oncology nurses was (71.57±14.43), and the psychological capital score was (91.96±15.29). The results of correlation analysis showed that the turnover intention of hemato-oncology nurses was positively correlated with occupational stress, and was negatively correlated with psychological capital (r=0.599, -0.489, P<0.001). Multiple linear regression analysis showed that married (ß=-0.141), psychological capital (ß=-0.156) and occupational stress (ß=0.493) were the influencing factors of turnover intention of hemato-oncology nurses (P<0.05). The path analysis of structural equation model showed that the direct effect of occupational stress on turnover intention of hemato-oncology nurses was 0.522, and the intermediary effect of psychological capital on turnover intention was 0.143 (95%CI: 0.013-0.312, P<0.05), accounting for 21.5% of the total effect. Conclusion: The turnover intention of hemato-oncology nurses is at a high level, hospital and administrators should focus on the psychological state of unmarried nurses. By improving the psychological capital of nurses, to reduce occupational stress and turnover intention.

[One-year follow-up results of atrial fibrillation patients who undergoing transcatheter aortic valve implantation].

Objective: To investigate whether atrial fibrillation (AF) before transcatheter aortic valve implantation (TAVI) will affect the prognosis of patients post TAVI. Methods: This is a single center retrospective study. A total of 115 patients with severe aortic stenosis (AS) who were admitted to General Hospital of Northern Theater Command from May 2016 to November 2020 and successfully received TAVI treatment were included. According to absence or accompaniment of AF pre-TAVI, they were divided into AF group (21 cases) and non-AF group (94 cases). The patients were followed up for postoperative antithrombotic treatment and the occurrence of the net adverse clinical and cerebrovascular events (NACCE) at 12 months post TAVI, including cardiogenic death, readmission to hospital for heart failure, nonfatal myocardial infarction, ischemic stroke and severe bleeding (BARC levels 3-5). Univariate logistic regression was used to analyze the related factors of NACCE. Results: Among the 115 selected patients, age was (73.8±6.9) years, there were 63 males. And 21 cases (18.2%) were diagnosed as AFbefore TAVI. In terms of postoperative antithrombotic therapy, 48.9% (46/94) of the patients in the non-AF group received monotherapy and 47.9% (45/94) received dual antiplatelet therapy. In the AF group, 47.6% (10/21) received anticoagulants and 33.3% (7/21) received dual antiplatelet therapy. The proportion of patients in the AF group taking non-vitamin K antagonist oral anticoagulants (NOAC) was higher than that in the non-AF group (38.1% (8/21) vs. 2.1% (2/94), P<0.001). Patients in both groups were followed up to 12 months after TAVI. During the 12 months follow-up, the incidence of NACCE after TAVI was 14.3% (3/21) in the AF group, which was numerically higher than that in the non-AF group (6.4% (6/94)), but the difference was not statistically significant (P=0.441). The incidence of severe bleeding was significantly higher in the AF group than in the non-AF group (9.5% (2/21) vs. 0, P=0.032). Univariate logistic regression analysis showed that hypertension was associated with the risk of NACCE (OR=8.308, P=0.050), while AF was not associated with the risk of NACCE (P=0.235). Conclusion: The incidence of severe bleeding after TAVI is higher in patients with AF than in patients without AF prior TAVI, and there is a trend of increased risk of NACCE post TAVI in AF patients.

[The efficacy and safety of ticagrelor versus clopidogrel in elderly patients with acute coronary syndrome undergoing percutaneous coronary intervention].

Objective: To compare the efficacy and safety of ticagrelor and clopidogrel in elderly Chinese patients with acute coronary syndrome (ACS) underwent percutaneous coronary intervention (PCI) in the real world. Methods: This study is a post-hoc analysis of a single center, retrospective cohort study. Between March 2016 and March 2018, elderly (age≥65) ACS patients who underwent PCI in the General Hospital of Northern Theater Command were included in the study. The patients were grouped according to P2Y12 receptor inhibitor. The primary endpoints of this study were ischemic events during the 2-year follow-up, which were defined as the composite of cardiac death, myocardial or stroke. The secondary efficiency endpoints included all-cause death and BARC 2, 3, 5 bleeding events. Results: A total of 4 022 elderly (mean age: (71.5±5.3) years) ACS patients were included in this study. Based on the choice of P2Y12 receptor inhibitor, patients were divided into clopidogrel (n=3 201) and ticagrelor (n=821) groups. Incidences of ischemic events (3.2% (26/821) vs. 5.6% (179/3 201), P=0.005) at 2 years were significantly lower in ticagrelor group compared to clopidogrel group. BARC 2, 3, 5 bleeding events (1.7% (14/821) vs. 1.6% (52/3 201), P=0.818) were comparable between the two groups. The incidence of all-cause death (1.5% (12/821) vs. 4.1% (132/3 201), P=0.005) were also lower in the ticagrelor group compared to the clopidogrel group. Clinical outcomes were consistent after adjusting for confounding factors, the incidence of ischemic events (HR= 0.637, 95%CI 0.409-0.991, P=0.046) and all-cause mortality (HR=0.402, 95%CI 0.213-0.758, P=0.005) was significantly lower in the ticagrelor group compared with the clopidogrel group. Risk of BARC 2, 3, 5 bleeding events were similar between the two groups (HR=0.957, 95%CI 0.496-1.848, P=0.897). Conclusion: In real-world clinical practice, for elderly patients with ACS undergoing PCI, ticagrelor use might reduce the incidence of long-term ischemic events and all-cause death without increasing the risk of bleeding.

[Five-year clinical outcomes of the second generation biodegradable polymer sirolimus-eluting stent (EXCROSSAL) in treating patients with de novo coronary lesions].

Objective: To evaluate the five-year safety and efficacy of the second generation biodegradable polymer sirolimus-eluting stent (EXCROSSAL) in treating patients with de novo coronary artery diseases. Methods: Patients with coronary artery disease (CAD)who were implanted with EXTROSSAL stents in CREDIT Ⅱ and CREDIT Ⅲ study were included. CREDIT Ⅱ was a randomized trial, and CREDIT Ⅲ was a single-arm study. From November 2013 to December 2014, 833 CAD patients with de novo coronary lesions implanted with EXTROSSAL stents were selected from 33 centers in China. The primary outcome was 5-year target lesion failure (TLF), a composite of cardiac death, target vessel myocardial infarction and clinically indicated target lesion revascularization. Secondary endpoints was patient-oriented composite endpoint (PoCE), including all-cause death, all myocardial infarction, or any revascularization within 5 years post stenting and stent thrombosis according to Academic Research Consortium's (ARC) definition. Kaplan Meier method was used to calculate the incidence of TLF and PoCE within 5 years after operation. Univariate Cox regression analysis was used to analyze the impacts of diabetes, small vessel disease (vessel diameter ≤ 2.74 mm), lesion length ≥ 16.7 mm and multivessel disease on the incidence of TLF within 5 years after operation. Results: A total of 833 patients were included in this study including 579 males (69.5%), the age was (59.3±9.1) years. And 832 (99.9%) patients completed 5-year clinical follow-up. The incidence of TLF and PoCE in the 5-year follow-up were 10.6%(86/811) and 15.5%(126/811), respectively. Stent thrombosis occurred in 1.0%(8/811) of patients. Univariate Cox regression analysis showed that vessel diameter ≤ 2.74 mm (HR=3.20,95%CI 1.90-5.39,P<0.001), lesion length ≥ 16.7 mm (HR=1.88,95%CI 1.18-2.99,P=0.007) and multivessel disease (HR=2.44,95%CI 1.60-3.72,P<0.001) were related factors of TLF within 5 years after operation. Conclusion: EXCROSSAL stent is effective and safe in treating CAD patients with de novo coronary lesions, with low incidence of TLF and PoCE within 5 years after operation.

[Key data elements for clinical management and outcomes of patients with coronary artery disease: definitions from Coronary Artery Disease and Creative Antithrombotic Clinical Research Collaboration (CardiaCare)].

Objective: To develop a set of data elements and standardized definitions of Coronary Artery Disease and Creative Antithrombotic Clinical Research Collaboration (CardiaCare), aiming to facilitate the exchange of disparate data sources, enhance the abilities to support multicenter researches, and subsequently ensure the databases use under standardized process and criteria. Methods: The Cardiacare writing committee members reviewed data elements and definitions from published guidelines, clinical trials, databases, and standardized documents, then determined the data elements and standardized definitions, which should be included in CardiaCare. The writing committee also considered the specific domestic clinical management strategies during the establishment of Cardiacare. The resulting documents provide a series of key data elements and standardized definitions used in the management of coronary artery disease patients. Key data elements from CardiaCare could be sorted by clinical management flowsheet and outcome from hospitalization to long-term follow-up. Results: The Cardiacare standardized set comprised 864 data elements from admission to post-hospital follow-up visit. There were 8 tables in the documents, including demographic and admission information (23 elements), medical history and risk factors (102 elements), clinical presentations and diagnosis (22 elements), diagnostic and laboratory tests (111 elements), interventional diagnosis and treatment (118 elements), pharmacological therapy (213 elements), clinical outcomes (161 elements), and special subpopulations (114 elements: 87 elements for transcatheter valve replacement and 27 elements with cardiac rehabilitation). Conclusions: The Cardiacare standardized data elements set could provide support for real-world clinical research in consecutive data collection and databases mining. A wider applicability in various settings of CardiaCare needs to be explored further.

[Medication compliance for secondary prevention and long-term outcome among patients with acute coronary syndrome after percutaneous coronary intervention in different regions].

Objective: To explore the medication compliance for secondary prevention drugs and long-term prognosis of patients with acute coronary syndrome (ACS) undergoing percutaneous coronary intervention (PCI) between hospitals in different regions of China. Methods: The Optimal Antiplatelet Therapy for Chinese Patients with Coronary Artery Disease (OPT-CAD) study was a prospective, multi-center and registered study. Patients diagnosed as ACS and underwent PCI in OPT-CAD study were selected. Taking the Yangtze River as the dividing line between the south and the north of China, these patients were divided into two groups according to the hospitals where the patients visited, namely the southerns region group (n=1 958) and the northerns region group (n=5 091). In order to reduce selection bias and potential confounding factors, the patients in the two groups were matched by the tendency score, and the patients in the two groups were matched by the 1: 1 nearest match method according to the tendency score. The main endpoint of this study was the major adverse cardiovascular and cerebrovascular events (MACCE) occurring within 5 years after discharge, namely the composite endpoint of cardiac death, myocardial infarction, and/or ischemic stroke. Secondary endpoints were all-cause death, cardiac death, myocardial infarction, ischemic stroke, and type 2, 3, and 5 bleeding events defined by the Academic Research Consortium on Hemorrhage (BARC) within 5 years. The secondary preventive drugs was recorded, including antiplatelet drugs, statins, beta blockers, angiotensin converting enzyme inhibitors/angiotensinⅡreceptor blockers (ACEI/ARB), etc. Before and after the matching, the secondary preventive medication and the incidence of clinical events of the two groups were compared. Results: A total of 7 049 ACS patients, including 1 958 patients in the southern region group and 5 091 patients in the northern region group were enrolled in this study. There were 5 319 males (37.9%), and the aged was (60.7±6.7) years. After propensity score matching, there were 1 324 cases in each group. Before matching, in the northern region group, the proportion of smoking, hypertension and diabetes, previous history (myocardial infarction, PCI and stroke) and family history of coronary heart disease were higher (all P<0.05). The proportion of complex lesions, diffuse lesions, small vessel lesions and thrombotic lesions in the northern region group was higher than that in the southern region group (all P<0.05). Sixty months after discharge, the antiplatelet patterns were quite different between patients in the northern and southern region group (P<0.001). The proportion of clopidogrel monotherapy in the southern region group was higher than that in the northern region group (9.8% (130/1324) vs. 1.1% (14/1324)), while the proportion of aspirin monotherapy in the northern region group was higher than that in the southern region group (67.4% (893/1324) vs. 46.5% (616/1324)). As for the use of other secondary prophylactic drugs, the proportion of patients in southern region group receiving beta blockers (24.5% (325/1324) vs. 16.8% (222/1324), P<0.001) and ACEI/ARB (19.4% (257/1324) vs. 10.0% (133/1324), P<0.001) was higher than that in northern region group. After matching, the incidence of MACCE (8.4%(111/1 324) vs.6.2% (82/1 324), P=0.030) and BARC 2, 3 and 5 bleeding (6.0% (80/1 324) vs. 4.0% (53/1 324), P=0.020) was higher in patients in northern region group. Conclusions: ACS patients who undergo PCI in northern area hospital is at higher prevalence of comorbidities and complicated coronary artery lesions compared to patients in the southern area hospital, and the drug compliance is worse than that in southern area, and the prognosis is also relatively poor.

[Perioperative serious complications in patients undergoing transcatheter aortic valve replacement: a single-center experience].

Objective: To observe the incidence of perioperative severe complications in aortic stenosis (AS) patients undergoing transcatheter aortic valve implantation (TAVR), and to explore the influence of the accumulated experience of the operators on the incidence of complications. Methods: This is a single-center retrospective study. Patients with AS who underwent TAVR from May 2016 to November 2020 in General Hospital of Northern Theater Command were included. The occurrence of severe complications during perioperative period was recorded. Severe complications included all-cause death, surgical transfer to thoracotomy, coronary artery occlusion, peripheral vascular approach complications, severe cerebrovascular events, moderate or above perivalvular leakage, valve displacement (implanted valve middle valve), pacemaker implantation, etc. In order to observe the influence of the accumulated experience of the operators on the occurrence of postoperative complications, the complications in each stage of the patients were counted and the bar chart was drawn with interval of every 30 patients. Results: A total of 119 patients were included, including 64 males and 55 females, the mean age was (73.9±6.9) years. The valve implantation was unsuccessful in 3 out of 119 patients (2.5%). There were 39 cases of severe complications during perioperative period, including 1 death (0.8%), 2 cases of thoracotomy (1.7%), 2 cases of coronary artery occlusion (1.7%), 8 cases of peripheral vascular approach complications (6.7%), and 1 case of new severe cerebrovascular event (0.8%), 3 cases of moderate or higher perivalvular leakage (2.5%), 8 cases of valve displacement leads to midvalvular implantation (6.7%), 14 cases of permanent pacemaker implantation due to new atrioventricular block (11.8%). The bar chart showed that the incidence of permanent pacemaker implantation and in-valve implantation did not significantly decrease with the accumulation of experience, while the incidence of other complications showed a decreasing trend after 30 cases. Conclusions: Most serious complications occurred in the early stage of TAVR in our center. The incidence of all cause death, coronary artery occlusion and peripheral vascular approach complications in the perioperative period post TAVR could be reduced in the TAVR center in the learning stage through the accumulation of procedure-related experience, but the incidence of pacemaker placement and the implanted valve within the valve dose not significantly decrease over time.

[Clinical analysis of 12 cases of acute myeloid leukemia complicated with synchronous primary solid tumor].

Objective: To explore the clinical characteristics of acute myeloid leukemia (AML) complicated with simultaneous multiple primary cancer (SMPC). Methods: The data of 12 AML patients with SMPC hospitalized in the Affiliated Cancer Hospital of Zhengzhou University, the First Affiliated Hospital of Nanyang Medical College, the Xinhua District Hospital of Pingdingshan City and the First People's Hospital of Pingdingshan City from March 2014 to July 2019 were analyzed retrospectively, and their clinical features, treatment and prognosis were summarized. Results: Among the 12 patients, there were 6 males and 6 females, with a median age of 58 years (39-70 years). AML classification: according to French-American-British (FAB) classification, the 12 AML patients were classified as M0 1, M1 1, M2a 5, M2b 1, M3 2, M5 2; according to National Comprehensive Cancer Network (NCCN) prognosis stratified, low risk group 1 case, medium risk group 4 cases, high risk group 7 cases; classification of solid tumors: 3 cases of lung cancer, 1 case of breast cancer, 2 cases of gastric cancer, 3 cases of esophageal cancer, 1 case of rectal neuroendocrine tumor, 1 case of invasive hydatidiform mole and 1 case of sigmoid colon cancer. The median time interval for the diagnosis of two primary malignant tumors was 4 (from 2.6 to 5.6) months. Results of gene mutation detection: AML prognostic gene detection results: a total of 12 kinds of gene abnormalities including ASXL1, JAK2, TET2, U2AF1, ABCB1, FLT3-ITD, RUNX1, SETBPIT, TET2 (single nucleotide polymorphism, SNP), p53, IKZF1 and IDH2 were detected, and solid tumor related genes were detected: a total of 4 kinds of gene abnormalities including Her-2, EGFR, K-RAS and MSI were detected. Survival: among the 12 patients, 1 case was lost during follow-up, 2 cases were still in treatment, 3 cases ended treatment and the condition was stable, 6 cases died. The median overall survival of 12 patients was 12.5 (from 3.8 to 48.0) months. Conclusions: It is not clear whether there is a certain correlation between the simultaneous occurrence of AML and solid tumors. Patients with AML and synchronous solid tumors are not unusual. Both tumors should be treated aggressively at the same time.

[Efficacy and safety of alirocumab versus ezetimibe in high cardiovascular risk Chinese patients with hyperlipidemia: ODYSSEY EAST Study-Chinese sub-population analysis].

Objective: To compare the efficacy and safety profile of alirocumab (PCSK9 inhibitor) versus ezetimibe on top of maximally tolerated statin dose in high cardiovascular risk Chinese patients with hyperlipidemia. Methods: The ODYSSEY EAST study was a randomized, double-blinded, double dummy, active-control, parallel group, multi-centers clinical trial, the Chinese sub-population included 456 patients with hyperlipidemia and high cardiovascular risk on maximally tolerated statin dose. Patients were randomized (2∶1) to receive the subcutaneous injection of alirocumab (75 mg Q2W; with dose up titration to 150 mg Q2W at week 12 if low-density lipoprotein cholesterol (LDL-C) was ≥1.81 mmol/L at week 8) or the oral administration of ezetimibe (10 mg daily) for 24 weeks. The primary endpoint was percentage change in calculated LDL-C from baseline to week 24. Key secondary efficacy endpoints included percentage change from baseline to week 12 or 24 in LDL-C (week 12) and other lipid parameters, including apolipoprotein (Apo) B, non-high-density lipoprotein cholesterol (non-HDL-C), TC, lipoprotein(a) (Lp(a)), HDL-C, fasting triglycerides (TG), and Apo A1, and the proportion of patients reaching LDL-C<1.81 mmol/L at week 24. Safety profile of therapeutic drugs was also assessed during the treatment period. Results: The mean age of 456 Chinese patients was (59.5±10.9) years, 341(74.8%) patients were male, 303 patients (66.4%) in alirocumab group and 153 patients (33.5%) in ezetimibe group. Demographic characteristics, disease characteristics, and lipid parameters at baseline were similar between the two groups. LDL-C was reduced more from baseline to week 12 and 24 in alirocumab group versus ezetimibe group, the difference of their least-squares mean (standard error) percent change were(-35.2±2.2)% and (-36.9±2.5)% (both P<0.001). At 12 weeks, alirocumab had significant reduction on Lp(a), Apo B, total cholesterol and non HDL-C, the difference of their least-squares mean (standard error) percent change were (-40.3±2.8)%, (-27.7±1.8)%, (-19.6±1.5)% and (-27.7±1.9)%, respectively (all P<0.001). At 24 weeks, the percent of patients who reached LDL-C<1.81 mmol/L and LDL-C<1.42 mmol/L was significantly higher in alirocumab group (85.3% and 70.5%) than in ezetimibe group (42.2% and 17.0%, both P<0.001), and alirocumab use was also associated with significant reduction on Lp(a), Apo B, total cholesterol and non HDL-C, the difference of their least-squares mean (standard error) percent change were (-37.2±2.8)%, (-29.1±2.0)%, (-21.6±1.6)% and (-29.6±2.2)%, respectively (all P<0.001). The incidence of treatment related adverse events was similar between the two treatment groups (223/302 patients (73.8%) in alirocumab group and 109/153 patients (71.2%) in ezetimibe group). Respiratory infection, urinary infection, dizziness and local injection-site reactions were the most frequently reported adverse events. Conclusions: In high cardiovascular risk patients with hyperlipidemia from China on maximally tolerated statin dose, the reduction of LDL-C induced by alirocumab is more significant than that induced by ezetimibe. Both treatments were generally safe during the observation period of study.

[Safety and efficacy of bivalirudin versus unfractionated heparin during perioperative period of percutaneous coronary intervention].

Objective: To compare the safety and efficacy of bivalirudin versus unfractionated heparin during perioperative period of percutaneous coronary intervention(PCI) in real-world. Methods: A total of 13 097 serial patients who underwent PCI from January 2016 to November 2018 in the Northern Theater Command were enrolled in the present study. Patients were stratified as the bivalirudin group or the heparin group according to antithrombotic therapy during PCI. The primary efficiency endpoint was 30-day net adverse clinical event(NACE), defined as all-cause death, re-infarction, urgent target lesion revascularization (uTLR), stroke or any bleeding. The second efficiency endpoint was 30-day major cardiac and cerebral events (MACCE), defined as all-cause death, re-infarction, uTLR and stroke. Additional end points included the rates of stent thrombosis at 30 days. Propensity scores included clinical and demographic variables, with 1∶2 matching. Compared the incidence of events above between the two groups before and after matching. Results: Among the 13 097 included patients(age was (61±10) years old), 3 421 (26.1%) were female. And 2 734 patients were divided into the bivalirudin group, and 10 363 patients to the heparin group(5 468 after matching). Before propensity score matching, patients in bivalirudin group were older and received higher levels of CRUSADE score than heparin group. These patients were more likely to have hypertension and more with ST-segment elevation acute coronary syndromes（all P＜0.05）. After propensity score matching, the incidence of 30-day NACE(3.8%(103/2 734) vs.5.0%(271/5 468), P=0.015) and any bleeding (2.0%(54/2 734) vs. 2.8%(151/5 468), P=0.032) in the bivalirudin group were lower than that in the heparin group, but the incidence of MACCE (1.9%(51/2 734) vs. 2.3%(127/5 468), P=0.180) and stent thrombosis (0.1%(2/2 734) vs. 0.1%(3/5 468), P=1.000) were comparable between the two groups. Conclusion: The risk of bleeding and the incidence of NACE are significantly lower for patients using bivalirudin during perioperative period of PCI compared to heparin, without significant differences in ischemic events.

[Evaluating the long-term prognosis of coronary artery disease patients undergoing percutaneous coronary intervention by risk stratification with ACC/AHA classification of coronary lesions].

Objective: To evaluate the long-term prognosis of coronary artery disease (CAD) patients undergoing percutaneous coronary intervention (PCI) by risk stratification with American College of Cardiology (ACC)/American Heart Association (AHA) classification of coronary lesions. Methods: Data used in this study derived from the I-LOVE-IT 2 trial. I-LOVE-IT 2 trial was a prospective, multicenter, randomized, assessor-blinded, noninferiority study. A total of 1 255 patients in I-LOVE-IT 2 trial with only one lesion and underwent biodegradable polymer drug-eluting stent implantation were included and grouped according to ACC/AHA classification of coronary lesions, namely type A/B1 lesion group (n=184), type B2 lesion group (n=457) and type C lesion group (n=614). The primary endpoint was 48-month patient-oriented composite endpoint (PoCE), a composite of all-cause mortality, all myocardial infarction, stroke, and/or any revascularization. The secondary endpoints were target lesion failure (TLF), components of PoCE, major bleeding (bleeding academic research consortium(BARC) type 3-5) and definite/probable stent thrombosis within 48 months. The incidences of endpoint events were compared in the three groups. The multivariable Cox hazard ratio model was used to analyze the independent predictors of PoCE and TLF at 48 months. Results: Incidences of PoCE at 48 months were significantly higher in patients with type C lesion compared with patients with type A/B1 (24.43%(150/614) vs. 14.13%(26/184), P<0.05) or B2 lesion (24.43%(150/614) vs. 15.97%(73/457), P<0.05). The multivariable Cox hazard ratio model showed that the type C lesion were the independent predictors of 48-month PoCE (HR=1.59, 95%CI 1.21-2.08, P<0.001) and TLF (HR=2.31, 95%CI 1.53-3.49, P<0.001). After multivariable adjustment, the HRs of PoCE for patients with type C lesion versus type A/B1 and type B2 were 1.91 (95%CI 1.25-2.92, P=0.003) and 1.64 (95%CI 1.23-2.20, P<0.001), respectively. Meanwhile, the HRs of TLF for patients with type C lesion versus type A/B1 and type B2 were 2.45 (95%CI 1.29-4.64, P=0.006) and 2.55 (95%CI 1.62-4.02, P=0.001), respectively. Conclusions: The ACC/AHA classification of coronary lesions has good discrimination with long-term outcomes for CAD patients undergoing PCI. The type C lesion is associated with a worse prognosis, enough attention should be paid in these patients during routine clinical management.

[Impact of femoral or radial approach on acute renal injury induced by repeated contrast medium in patients with coronary heart disease].

Objective: To investigate the effects of femoral approach versus radial approach on the incidence of contrast-induced acute kidney injury (CI-AKI) in patients with coronary heart disease, who received twice contrast agents within a short interval. Methods: A total of 322 patients with coronary heart disease, who admitted to the General Hospital of Northern Theater Command from January 2010 to January 2015, were included in this retrospective analysis. All patients exposed to contrast agents twice within 30 days. The patients were divided into two groups according to the approach of interventional operation: radial artery group (n=235) and femoral artery group (n=87). Serum creatinine (SCr) values were detected at 48 and 72 hours post procedure. Endpoint events were CI-AKI, which was defined as SCr increased>0.5 mg/dl (44.2 µmol/L) or relative ratio ((postoperative SCr-preoperative SCr)/preoperative SCr×100%>25%) within 72 hours after contrast agent use after excluding other causes. Clinical characteristics and the incidence of CI-AKI were compared between the two groups, multivariate logistic regression analysis was used to detect the risk factors of postoperative CI-AKI in these patients. Results: The proportion of smoking, PCI history, STEMI patients and levels of fibrinogen, fasting blood glucose, troponin T was significantly higher in femoral artery group than in radial artery group (all P<0.05). The interval between two procedure sessions was significantly longer in the femoral artery group than in the radial artery group (P=0.001). The incidence of CI-AKI tended to be higher in femoral artery group than in radial artery group after the first operation (18.6% (16/87) vs. 11.9% (28/235), P=0.133). CI-AKI incidence after the second operation was similar between the two groups (P>0.05). Multivariate logistic regression analysis showed that interventional approach was not an independent risk factor for postoperative CI-AKI in patients with coronary heart disease undergoing interventional procedures twice within 30 days (P>0.05);STEMI (OR=2.854, 95%CI 1.100-7.404, P=0.031) and diuretics use (OR=4.002, 95%CI 1.470-10.893, P=0.007) were independent risk factors for CI-AKI after the first operation. Conclusion: There is no correlation between the risk of CI-AKI and interventional approaches in patients with coronary heart disease who undergo interventional surgery twice within 30 days.

[Prospective controlled observation ofeffect of adjuvant chemotherapy onsurvival and prognosis ofhigh-risk upper tract urothelial carcinoma patients underwent radical nephroureterectomy].

Objective: To assess the oncologic outcomes of radical nephroureterectomy (RNU) combined with adjuvant chemotherapy (ACT) in patients with high risk upper tract urothelial carcinoma (UTUC). Methods: From January 2014, all high-risk UTUC patients after RNU surgery were enrolled in this prospective comparative trial. And these patients were randomized to ACT group (Gemcitabine+Cisplatin three weeks regimen) and observing group. Cox proportional hazard modeling and Kaplan-Meier analysis were used to determine overall survival (OS), cancer specific survival (CSS) and disease-free survival (PFS) in the cohort. Results: The median follow-up duration was36 months (range: 6-54) in the ACT group (n=94) and 30 months (range: 6-54) in the observing group (n=82). Oncologic outcomes of RNU treated high-risk UTUC patients were improved much significantly by ACT: OS [P=0.0397, HR: 1.39(0.91-1.75)], CSS [P=0.0255, HR: 1.26(1.07-1.45)] and PFS [P=0.0033, HR: 3.78(3.13-4.55)]. The further analysis in lymph node positive cohort displayed that median times of oncologic events were prolonged in the ACT group compared with the observing group: OS (26.8mon vs 36.3mon, P=0.0255), CSS (28.2mon vs39.3mon, P=0.0197) and PFS (11.4mon vs 31.9mon, P=0.0018). Additionally in T3/4 cohort, the significant growth in the median times of OS (20.6mon vs 32.2mon, P=0.0183), CSS (21.9mon vs 38.4mon, P=0.0226) and PFS (13.9mon vs 36.3mon, P=0.0217) were observed in ACT group. Conclusion: ACT could play the important synergistic role in improving the OS, CSS and PFS of high-risk UTUC patients after RNU.

[Derepression of CXCR7 indicates resistance to enzalutamide in castration resistant prostate cancer].

Objective: To investigate the effect of the derepression of chemokine receptor-7 (CXCR7) in prostatic tissues from patients with Castration Resistant Prostate Cancer (CRPC) on the resistance to enzalutamide (Enza). Methods: During the period of January 2015 to December 2017 all CRPC cases who underwent radical radiotherapy or androgen deprivation therapy (ADT) were evaluated. After prostatic puncture biopsy, the tissues were treated for immunostaining with CXCR7. Cox proportional hazard modeling and Kaplan-Meier analysis were used to determine PSA Progression-Free Survival (PSAP-FS) and Clinical or Radiographic Progression-Free Survival (CRP-FS) in the cohort. At last, PSA response rates and progression outcomes in CXCR7 negative cases and CXCR7 positive cases were analyzed. Results: Total 39 CRPC patients were enrolled in this study. And 23 cases derepress CXCR7, 16 cases negatively express CXCR7. The median follow-up duration was 12 months (range: 6-18) in the cohort. Chi-square analysis confirmed that PSA response rates after Enza treatment were significantly associated with CXCR7 derepression (χ(2)=22.129, P=0.000 06). Compared with CXCR7 positive expression group, CXCR7 negative expression group displayed improved median PSAP-FS (4.4 mon vs 11.7 mon, P=0.040 8) and CRP-FS (5.2 mon vs 13.1 mon, P=0.036 2) after Enza treatment. Conclusion: Derepression of CXCR7 in CRPC patients may be associated with resistance to enzalutamide. This protein may be novel target for treatment of CRPC.

[Oncologic outcomes of high-risk upper tract urothelial carcinoma patients undergoing radical nephroureterectomy combined with adjuvant chemotherapy].

Objective: To assess the oncologic outcomes of radical nephroureterectomy (RUN) combined with adjuvant chemotherapy (ACT) in patients with high risk upper tract urothelial carcinoma (UTUC). Methods: One-hundred-thirty-four individuals with high-risk UTUC who underwent RUN with or without ACT were evaluated. Cox proportional hazard model and Kaplan-Meier analysis were used to determine overall and cancer specific survival in the cohort. Results: The median follow-up duration was 24 months (range: 6-36) in the RUN group (n=61) and 18 months (range: 6-36) in the RUN+ACT group (n=73). Median time of overall survival (OS) and cancer specific survival (CSS) showed much better in RUN+ACT group than in RUN group, but the differences were not reached the significant standard. The further analysis in lymph node positive cohort displayed that median times of oncologic events were prolonged in the RUN+ACT group compared with the RUN group: OS (30.1 mon vs 18.0 mon, P=0.083) and CSS (29.2 mon vs 18.6 mon, P=0.047). Additionally in T3/T4 cohort, the significant growth in the median times of OS (25.2 mon vs 12.6 mon, P=0.038) and CSS (31.3 mon vs 18.9 mon, P=0.044) were observed in combination treatment group. Conclusion: ACT could play the important synergistic role in improving the OS and CSS of RUN treated UTUC patients with lymph node-positive or stage of T3/T4.