The safety and efficacy of Firesorb bioresorbable scaffold in first-in-man study for coronary artery disease: the four-year outcomes / 中华心血管病杂志

Objective: To evaluate the 4-year clinical outcomes of patients following Firesorb bioresorbable scaffold (BRS) implantation. Methods: The study reported the 4-year follow-up results of the FUTURE I study. FUTURE I was a prospective, single-center, open-label, first-in-man study which evaluated the feasibility, preliminary safety, and efficacy of Firesorb stent in the treatment of coronary artery stenosis. A total of 45 patients with single de novo lesions in native coronary arteries ,who hospitalized in Fuwai Hospital from January to March 2016 were enrolled. After successfully stent implantation these patients were randomized in a 2∶1 ratio into cohort 1 (n=30) or cohort 2 (n=15). The patients in cohort 1 underwent angiographic, IVUS or OCT examination at 6 months and 2 years; and cohort 2 underwent angiographic, IVUS or OCT at 1 and 3 years. All patients underwent clinical follow-up at 1, 6 months and 1 year and annually thereafter up to 5 years. The primary endpoint was target lesion failure (TLF, including cardiac death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization). Secondary endpoints included patient-oriented composite endpoint (PoCE, defined as composite of all death, all miocardial infarction, or any revascularization). Results: A total of 45 patients were enrolled and implanted with Firesorb BRS, including 35 males (77.8%), and the age was (54.4±9.3) years. At 4 years, 10 patients in cohort 1 were reexamined by coronary angiography and OCT examination. Among them, 2 patients' stents were completely degraded and absorbed. Compared with the OCT images of the other 8 patients in cohort 2 at 3 years, the degree of stent degradation was increased, and no stent adherence was found. The 4-year clinical follow-up rate was 100%. In 4-year clinical following up, 2 patients suffered PoCE (4.4%): 1 patient underwent non-target vessel revascularization the day after index procedure and target vessel revascularization (Non-target lesion revascularization) at 2-year imaging follow-up; the other patient underwent target lesion revascularization during imaging follow-up at 4 years but not due to ischemic driven. There was no scaffold thrombosis or TLF events through 4 years. Conclusions: Four years after the implantation, complete degradation and absorption of the Firsorb stent are evidenced in some patients. Firesorb stent is feasible and effective in the treatment of patients with non-complex coronary lesions.

Effect of intracoronary infusion of bone marrow mononuclear cells or peripheral endothelial progenitor cells on myocardial ischemia-reperfusion injury in mini-swine / 中国医学科学杂志(英文版)

<p><b>OBJECTIVE</b>To simulate and assess the clinical effect of intracoronary infusion of bone marrow mononuclear cells or peripheral endothelial progenitor cells on myocardial reperfusion injury in mini-swine model.</p><p><b>METHODS</b>Twenty-three mini-swine with myocardial reperfusion injury were used as designed in the study protocol. About (3.54 +/- 0.90) x 10(8) bone marrow mononuclear cells (MNC group, n = 9) or (1.16 +/- 1.07) x 10(7) endothelial progenitor cells (EPC group, n = 7) was infused into the affected coronary segment of the swine. The other mini-swine were infused with phosphate buffered saline as control (n = 7). Echocardiography and hemodynamic studies were performed before and 4 weeks after cell infusion. Myocardium infarction size was calculated. Stem cell differentiation was analyzed under a transmission electromicroscope.</p><p><b>RESULTS</b>Left ventricular ejection fraction dropped by 0% in EPC group, 2% in MNC group, and 10% in the control group 4 weeks after cell infusion, respectively (P < 0.05). The systolic parameters increased in MNC and EPC groups but decreased in the control group. However, the diastolic parameters demonstrated no significant change in the three groups (P > 0.05). EPC decreased total infarction size more than MNC did (1.60 +/- 0.26 cm2 vs. 3.71 +/- 1.38 cm2, P < 0.05). Undermature endothelial cells and myocytes were found under transmission electromicroscope.</p><p><b>CONCLUSIONS</b>Transplantation of either MNC or EPC may be beneficial to cardiac systolic function, but might not has obvious effect on diastolic function. Intracoronary infusion of EPC might be better than MNC in controlling infarction size. Both MNC and EPC may stimulate angiogenesis, inhibit fibrogenesis, and differentiate into myocardial cells.</p>

Clinical features of unexpected sudden death clustered in 7 families in Yunnan Province / 中华心血管病杂志

<p><b>OBJECTIVE</b>To investigate the clinical features of unexpected sudden death (SUD) clustered in families in Yunnan province.</p><p><b>METHODS</b>This retrospective study analyzed the clinical features of SUD occurred between July to September 2005 in 7 families in Yunnan province.</p><p><b>RESULTS</b>All 16 SUD patients shared common clinical features such as fatigue and repeated syncope and one group of SUD patients (n = 8 from 4 families) presented with the gastric intestinal tract manifestations including nausea, vomiting, abdominal pain and diarrhea with suspected dietary history and abnormal laboratory enzyme findings (GOT/GPT, CK/CKMB, LDH/LDH1 etc.). In SUD patients without gastric intestinal tract manifestations (n = 8 from 3 families), there were no clear symptoms before death and repeated ventricular tachycardia and ventricular fibrillation were recorded in one survivor. There was no clear evidence for the involvements of hereditary and infectious factors for observed SUD.</p><p><b>CONCLUSION</b>The reason for the unexpected sudden death clustered in 7 families in Yunnan remains unclear. Repeated syncope and fatigue served as the common clinical features in the presence or absence of gastric intestinal tract manifestations in all SUD cases. Further studies are needed to clarify the pathology and detailed clinical manifestations of SUD occurred in this area.</p>

Implantation of autologous bone marrow mononuclear cells into ischemic myocardium enhances coronary capillaries and systolic function in miniswine / 中国医学科学杂志(英文版)

<p><b>OBJECTIVE</b>To investigate the therapeutic effectiveness of intracoronary implantation of autologous bone marrow mononuclear cells (BM-MNC) in miniswine model of reperfused myocardial infarction.</p><p><b>METHODS</b>Sixteen miniswine myocardial ischemic reperfusion injury models made by ligation of the distal one third segment of left anterior descending artery for 90 minutes were randomized into 2 groups. In BM-MNC group (n = 9), (3.54 +/- 0.90) X 10(8) BM-MNC were intracoronary injected, and in the control group (n = 7), phosphate buffered saline was injected by the same way. Echocardiographic and hemodynamic results, vessel density, and myocardial infarction size were evaluated and compared before and 4 weeks after cell transplantation.</p><p><b>RESULTS</b>In BM-MNC group, there were no differences between before and 4 weeks after transplantation in aspects of left ventricular ejection fraction (LVEF), interventricular septal thickness, left ventricular lateral and anterior septal wall thickness, cardiac output, or +dp/dtmax. In control group, LVEF, interventricular septal thickness, left ventricular lateral and anterior septal wall thickness, cardiac output, and +dp/dtmax decreased significantly 4 weeks after transplantation (P < 0.05). Left ventricular end-diastolic pressure and -dp/dtmax, did not change significantly before and after cell transplantation in both groups. Capillary density in BM-MNC group was greater than that in control group [(13.39 +/- 6.96)/high power field vs. (3.50 +/- 1.90)/high power field, P < 0.05]. Infarction area assessed by tetrazolium red staining and the infarction percentage decreased in BM-MNC group compared with those in control group (P < 0.05).</p><p><b>CONCLUSIONS</b>Transplantation of BM-MNC into myocardium with ischemic reperfusion injury increases capillary density and decreases infarction area. It has significantly beneficial effect on cardiac systolic function rather than on diastolic function.</p>

Effect of intracoronary transplantation of autologous bone marrow mononuclear cells on myocardial ischemia reperfusion injury in mini-swine model / 中国医学科学院学报

<p><b>OBJECTIVE</b>To investigate the therapeutic effectiveness of intracoronary transplantation of autologous bone marrow mononuclear cells (BM-MNC) on myocardial ischemia reperfusion injury in mini-swine model.</p><p><b>METHODS</b>Myocardial ischemia reperfusion injury model was established by ligating in 16 mini-swines, which were further randomized into two groups: (3.54 +/- 0.90) x 10(8) BM-MNC was intracoronarily transplanted in BM-MNC group (n = 9), and phosphate buffer saline was intracoronarily applied in the control group (n = 7). Ultrasonic cardiograhpy, hemodynamics, neovascular density, and myocardium infarction size were evaluated before and 4 weeks after transplantation.</p><p><b>RESULTS</b>In BM-MNC group, left ventricular ejection fraction (LVEF), intra-ventricular septa, lateral wall and anterior wall, cardiac output (CO) and + dp/dt(max) had no significant differences before and 4 weeks after transplantation (P > 0.05). In the control group, LVEF, intraventricular septa, lateral wall and anterior wall, CO, and + dp/dt(max) significantly decreased 4 weeks after transplantation (P < 0.05). Left ventricular end-diastolic pressure and- dp/dt(max) had no significant differences before and after cell transplantation. Capillary density was significantly larger in the BM-MNC group than in the control group [(13.39 +/- 6.96) /HP vs. (3.50 +/- 1.90) /HP]. The percentage and size of myocardial infarction was significantly lower in the BM-MNC group than in the control group.</p><p><b>CONCLUSION</b>Transplantation of BM-MNC into the myocardial ischemic reperfusion-injury area can increase capillary density and decrease infarction area, and thus remarkably improve cardiac systolic function.</p>

Effects of intracoronary transplantation of autologous bone marrow mononuclear cells or endothelial progenitor cells in mini-swine model of myocardial ischemia-reperfusion / 中华心血管病杂志

<p><b>OBJECTIVE</b>To compare the effects of intracoronary transplantation of autologous bone marrow mononuclear cells (BM-MNC) or peripheral endothelial progenitor cells (EPC) in mini-swine model of myocardial ischemia-reperfusion.</p><p><b>METHODS</b>The Mini-swine acute myocardial infarction and reperfusion model was created with 90 min occlusion of the left anterior descending coronary artery followed by reperfusion and the animals were then divided into BM-MNC group (3.54 x 10(8) +/- 0.90 x 10(8), n = 9), EPC group (1.16 x 10(7) +/- 1.07 x 10(7), n = 7) and control group (saline, n = 7). Echocardiography, hemodynamic measurements and myocardium infarction size were evaluated before and 4 weeks after intracoronary cell transplantations.</p><p><b>RESULTS</b>The net decrease from baseline to 4 weeks after transplantation of left ventricular ejection fraction (LVEF), left ventricular end systolic pressure, cardiac output and +dp/dt(max) were significantly attenuated post BM-MNC and EPC therapy compared to control group (all P < 0.05) and were similar between BM-MNC and EPC groups. Transplantation of BM-MNC and EPC also significantly decreased myocardial infarction size compared to control group.</p><p><b>CONCLUSION</b>Autologous intracoronary transplantation of BM-MNC or EPC in this model equally improved cardiac systolic function and reduced infarction area.</p>

Electrocardiogram analysis in high risk population of unexplained sudden death in Yunnan province / 中华心血管病杂志

<p><b>OBJECTIVE</b>The purpose of this study was to analyze the electrocardiographic features of the people living in the area with high incidence of unexplained sudden deaths in Yunnan province.</p><p><b>METHOD</b>The electrocardiograms of 338 residents from three villages (Dayao, Ninglang, Heqing) with high incidence of unexplained sudden deaths and one control village (Dali) were analyzed [averaged age was (33.4 +/- 11.7) years, 175 men and 163 women].</p><p><b>RESULTS</b>The incidence of cardiac arrhythmias was similar low in all groups. The left ventricular hypertrophy was observed in 34.6% of residents from Dayao. QTc significantly prolonged in the residents from all 3 high incidence areas compare the control area of Dali [control (386.8 +/- 27.22) ms, Ninglang (428.92 +/- 25.71) ms, Heqing (440.67 +/- 28.03) ms, Dayao (417.7 +/- 24.00) ms, P < 0.05 vs. control]. Incidence of U wave was significantly higher in Heqing village than that in control village (P < 0.05). The QUc of these 3 villages was: (613.67 +/- 37.34) ms, (597.19 +/- 46.47) ms, (608.59 +/- 39.59) ms respectively, and also significantly longer than the control village of Dali (589.33 +/- 41.27) ms (P < 0.05). The typical pattern of U wave presents as enlarged U wave and apparent T-U complex. In the 7 residents who have the family history of unexplained sudden death, 6 residents have U wave, and 4 of them present typical U wave pattern.</p><p><b>CONCLUSION</b>The significant ECG changes in villages with high incidence of unexplained sudden death in Yunnan province were prolonged QTc, enlarged U wave and apparent T-U complex and these ECG features suggested the repolarization abnormalities of the heart in these subjects.</p>

Autologous bone marrow mononuclear cells and peripheral endothelial progenitor cells differentiation in myocardial ischemia reperfusion injury region in swine / 中华心血管病杂志

<p><b>OBJECTIVE</b>To investigate the differentiation status of autologous bone marrow mononuclear cells (BM-MNC) and peripheral endothelial progenitor cells (EPC) transplanted into myocardial ischemia reperfusion injury region in swine.</p><p><b>METHODS</b>BM-MNC marked with PKH26 (n = 9), EPC marked with CM-DiI (n = 7), phosphate buffer saline (control, n = 7) were transplanted into myocardial ischemia reperfusion injury region of swine by intracoronary artery injection. Specimens were harvested 4 weeks after injection for histological analysis (HE, immunochemical stain for vWF, alpha-sarcomeric-actin and fibronectin antibody). Cell differentiation was observed under transmission electronmicroscope.</p><p><b>RESULTS</b>The number of small blood vessels was similar between BM-MNC group and EPC group (13.39 +/- 6.96/HP vs.12.39 +/- 4.72/HP, P < 0.05), but was significantly higher than that of control group (P < 0.05). Responsive intensity of immunochemical stain for fibronectin antibody was significantly lower in BM-MNC and EPC groups than that in control group. Responsive intensity of immunochemical stain for alpha-sarcomeric-actin antibody was similar among the three groups. Cluster cells were observed in one swine from BM-MNC group which might relate to the proliferation of stem cells in situ. Immature endothelial cells and myocytes were also detected by transmission electronmicroscope in BM-MNC and EPC group.</p><p><b>CONCLUSION</b>BM-MNC and EPC transplanted into myocardial ischemia reperfusion injury region in swine stimulated the formation of blood vessels and inhibited fibrogenesis.</p>

The influence of diabetes mellitus on the procedural and in-hospital outcomes after selective percutaneous coronary intervention / 中华心血管病杂志

<p><b>OBJECTIVE</b>To compare the procedural and in-hospital outcomes in a large series of diabetic and non-diabetic patients undergoing selective percutaneous coronary intervention (PCI) and to evaluate the influence of diabetes mellitus on the procedural and in-hospital outcomes.</p><p><b>METHODS</b>1294 consecutive patients underwent selective PCI from January to December 2002 in this institution were analyzed retrospectively. Baseline clinical, in-lab and in-hospital outcome information were recorded. Rates of procedural success, device success and clinical success were analyzed and logistic regression was performed to model the association between diabetes status and outcomes.</p><p><b>RESULTS</b>Two hundred and sixty-nine patients (20.8%) complicated with diabetes. Type C lesion, double and triple vessel diseases were more prevalent in diabetics than those in non-diabetics. The pre-PCI diameter stenosis of diabetics was significantly more severe than that of non-diabetics (91.00 +/- 6.62 vs 89.81 +/- 6.64, P < 0.01). The balloon length, maximum balloon diameter and maximum balloon inflation pressure, maximum inflation duration were larger in diabetics than those in non-diabetics [(17.07 +/- 6.31) mm vs (16.07 +/- 7.28) mm, (2.30 +/- 1.11) mm vs (2.12 +/- 0.94) mm, (9.86 +/- 4.40) atm vs (9.05 +/- 4.75) atm, (20.94 +/- 14.69) s vs (18.26 +/- 14.65) s, respectively, P < 0.05]. The stent diameter was smaller in diabetics than that in non-diabetics [(3.15 +/- 0.47) mm vs (3.23 +/- 0.43) mm, P < 0.05]. The procedural success rate showed no significant difference between two groups (89.6% vs 90.3%, P > 0.05). But a higher incidence of acute/subacute stent thrombosis was observed in diabetics compared with that in non-diabetics (1.9% vs 0.5%, P < 0.05). The rate of clinical success was similar between diabetics and non-diabetics (99.3% vs 99.2%, P > 0.05). Diabetes was not an independent predictor of acute outcomes in the regression model.</p><p><b>CONCLUSIONS</b>A higher incidence of acute/subacute stent thrombosis was observed in diabetics. The incidence of procedural and in-hospital major adverse cardiac events and the rate of clinical success were similar between diabetics and non-diabetics. Diabetes was not an independent predictor of in-hospital outcomes after selective PCI.</p>

Clinical evaluation of risk factors for coronary heart disease / 中华预防医学杂志

<p><b>OBJECTIVE</b>To explore the relationship between risk factors for coronary heart disease (CHD) and coronary artery lesions.</p><p><b>METHOD</b>Potential risk factors were studied in 341 patients underwent coronary angiography.</p><p><b>RESULTS</b>(1) Coronary angiography showed coronary artery lesions in 214 patients (lesion group), and no lesion in 127 patients (non-lesion group). There was significant difference in age, past history of diabetes, family history of CHD, smoking history, high-density lipoprotein cholesterol (HDL-C), lower-density lipoprotein cholesterol (LDL-C), ratio of total cholesterol to HDL-C (TC/HDL-C), lipoprotein(a) [Lp(a)], fibrinogen (Fbg) and high-sensitivity C-reactive protein (hs-CRP) between two groups (P < 0.05). (2) There was significant correlation between severity of coronary artery lesions and hs-CRP, Lp(a), TC/HDL-C, Fbg, hyperlipidemia, TC, LDL-C and TG (with coefficients of correlation of 0.338, 0.250, 0.241, 0.207, 0.167, 0.147, 0.140 and 0.139; respectively, P < 0.05). (3) Analysis of receiver operating characteristics (ROC) curve for patients with coronary angiography and risk factors for CHD showed that the areas under ROC curve were 0.810, 0.669, 0.626, 0.625, 0.619 and 0.618 for hs-CRP, TC/HDL-C, Lp(a), Fbg, LDL-C and past history of hyperlipidemia, respectively.</p><p><b>CONCLUSIONS</b>Past history of hyperlipidemia was a predictor for occurrence of CHD. Ratio of TC/HDL-C and blood level of Lp(a) could be used as predictors in screening for high blood lipid, which were much stronger than others. It is suggested that hs-CRP had an excellent predictive value in current coronary inflammatory lesions.</p>

Oxidative stress in patients with acute coxsackie virus myocarditis / 生物医学与环境科学（英文）

<p><b>OBJECTIVE</b>To study the state of oxidative stress in patients with acute coxsackie virus myocarditis (ACM), and to investigate the pathological chain reactions of a series of free radicals and oxidative and lipoperoxidative damages in their bodies.</p><p><b>METHODS</b>Eighty ACM patients and 80 healthy adult volunteers (HAV) were enrolled in a case-control study, in which concentrations of nitric oxide (NO) in plasma, lipoperoxides (LPO) in plasma and LPO in erythrocytes (RBC), vitamin C (VC), vitamin E (VE) and beta-carotene (beta-CAR) in plasma as well as activities of superoxide dismutase (SOD), catalase (CAT) and glutathione peroxidase (GSH-Px) in RBC were determined by using spectrophotometric assays.</p><p><b>RESULTS</b>Compared with the average values (AV) of the above biochemical parameters (BP) in the HAV group, the AV of NO in plasma, and LPO in plasma and RBC in the ACM group were significantly increased (P = 0.0001), while the AV of VC, VE, beta-CAR, SOD, CAT and GSH-Px in the ACM group were significantly decreased (P = 0.0001). The values of the above BP were used to estimate the relative risk ratio (RR) between the ACM group and the HAV group; the RR and its 95% confidence interval were 12.467 (5.745-27.051), 4.333 (2.126-8.834), 6.517 (3.225-13.618), 3.310 (1.598-6.858), 31.000 (12.611-76.201), 4.663 (2.228-9.759), 11.769 (5.440-25.462), 3.043 (1.486-6.229) and 6.594 (3.045-14.281) respectively, and their P levels ranged from 0.002 to 0.0001. The results were as follows: D = 22.143 - 0.017SOD + 0.008NO + 0.244LPO in RBC, Eigenvalue = 13.659, Canonical correlation = 0.965, Wilks' lambda = 0.068, chi 2 = 420.212, P = 0.0001. The correct rate of discrimination to the ACM group and to the HAV group was 87.5% and 95.0%, respectively, and 91.3% of originally grouped cases was correctly classified.</p><p><b>CONCLUSION</b>The findings in this study suggested that the oxidative stress in bodies of ACM patients was severely aggravated, and marked high oxidative constituents and low antioxidants and antioxidases in the human body might increase the relative risk of inducing acute coxsackie virus myocarditis, and measuring the values of NO in plasma, SOD and LPO in RBC might increase the correct rates of discriminatory analysis of the ACM.</p>