Evaluation of Safety and Efficacy of Qinming8631 DR Implantable Cardiac Pacemaker in Chinese Patients: A Prospective, Multicenter, Randomized Controlled Trial of the First Domestically Developed Pacemaker of China / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>High cost of imported pacemakers is a main obstacle for Chinese patients suffering from bradyarrhythmia, and a domestically developed pacemaker will help lower the burden. This study aimed to evaluate the safety and efficacy of Qinming8631 DR (Qinming Medical, Baoji, China), the first domestically developed dual-chamber pacemaker of China, compared with a commercially available pacemaker Talos DR (Biotronik, Berlin, Germany) in Chinese patients.</p><p><b>METHODS</b>A prospective randomized trial was conducted at 14 centers in China. Participants were randomized into trial (Qinming8631 DR) and control (Talos DR) groups. Parameters of the pacing systems were collected immediately after device implantation and during follow-ups. The effective pacing rate at 6-month follow-up was recorded as the primary end point. Electrical properties, magnet response, single- and double-pole polarity conversion, rate response function, and adverse events of the pacing system were analyzed. The Cochran-Mantel-Haenszel Chi-square test, paired t-test, and Wilcoxon signed-rank test were used for measuring primary qualitative outcomes and comparing normally and abnormally distributed measurement data.</p><p><b>RESULTS</b>A total of 225 patients with a diagnosis of bradyarrhythmia and eligible for this study were randomly enrolled into the trial (n = 113) and control (n = 112) groups. They underwent successful pacemaker implantation with acceptable postoperative pacing threshold and sensitivity. Effective pacing rates of trial and control groups were comparable both in the full analysis set and the per protocol set (81.4% vs. 79.5%, P = 0.712 and 95.4% vs. 89.5%, P = 0.143, respectively). In both data sets, noninferiority of the trial group was above the predefined noninferiority limit(-9.5%).</p><p><b>CONCLUSIONS</b>This study established the noninferiority of Qinming8631 DR to Talos DR. The safety and efficacy of Qinming8631 DR pacemaker were comparable to those of Talos DR in treating patients with cardiac bradyarrhythmia.</p>

Status of glucose metabolism in Chinese essential hypertensive patients / 中华心血管病杂志

<p><b>OBJECTIVE</b>To investigate glucose metabolism status and its relationship with blood pressure, obesity, renal function and cardio-cerebral vascular events in Chinese essential hypertensive patients.</p><p><b>METHODS</b>Essential hypertensive patients without diabetic history were enrolled in this cross-sectional survey. All patients filled in questionnaires and received physical examination and laboratory tests. Oral glucose tolerance test (OGTT, fasting and 2 hours glucose level after drinking the 75 g glucose solution) was performed in patients who signed the informed consent.</p><p><b>RESULTS</b>(1) The control rate of systolic BP was lower in patients with dysglycemia than in patients without dysglycemia (41.0% vs. 46.4%, P = 0.000). (2) The albuminuria detection rate and the abnormal rate of estimated glumerular filtration rate (eGFR) increased significantly with the deterioration of glucose metabolism. (3) Multifactor-analysis showed that abnormal waist circumference, decreased eGFR and presence of albuminuria were independent risk factors for abnormal glucose metabolism. Cardiovascular events was significantly higher in patients with abnormal glucose metabolism than patients with normal glucose metabolism.</p><p><b>CONCLUSION</b>Abnormal glucose metabolism is common in Chinese essential hypertensive patients. When complicated with abnormal glucose metabolism, essential hypertensive patients had poor blood pressure control rate and were related to higher cardiovascular risk.</p>

One-stop hybrid cardiac surgery for adults with complex heart disease / 中华心血管病杂志

<p><b>OBJECTIVE</b>To evaluate the efficacy and security of one-stop hybrid cardiac surgery for the treatment of adult patients with complex heart disease.</p><p><b>METHODS</b>From November 2011 to March 2012, a total of 5 patients [4 male, mean age: (58.8 ± 14.7) years] underwent one-stop hybrid approach in the hybrid operating room. Two patients suffered from multi-coronary lesions, 2 patients were diagnosed with both valvular heart disease and coronary disease, and another 1 patient had valve disease and congenital heart disease (patent ductus arteriosus). Minimally invasive cardiac surgery (coronary artery bypass grafting for the left anterior descending or valvular surgery) and percutaneous intervention were performed in an enhanced operative unit. The efficacy and security of one-stop hybrid cardiac surgery were evaluated after the procedure.</p><p><b>RESULTS</b>The one-stop hybrid procedure was successful in all patients. Left internal mammary artery grafts were unobstructed. A total of 6 non-left anterior descending coronary lesions were treated by percutaneous coronary intervention and 6 drug-eluting stents were implanted. There was no death, perioperative myocardial infarction, heart failure, prosthetic valve dysfunction, respiratory failure, stroke or repeat surgery during the procedure period. All patients remained free from angina, prosthetic valve dysfunction and patent ductus arteriosus recanalisation during the 3.2 months (rang 1 to 5 months) follow-up period.</p><p><b>CONCLUSION</b>One-stop hybrid cardiac surgery provides a reasonable, feasible and safe alternative for treating adult patients with complex heart disease.</p>

Clinical outcomes of serolimus-eluting stents versus bare metal stents in ST-segment elevation myocardial infarction patients: a meta-analysis / 中华医学杂志(英文版)

<p><b>BACKGROUND</b>The benefits and safety of sirolimus-eluting stent (SES) have not been systematically quantified in different trials in ST-segment elevation myocardial infarction (STEMI) patients with primary or rescue percutaneous coronary intervention (PCI). A meta-analysis of randomised trials comparing SES and bare-metal stent (BMS) was performed.</p><p><b>METHODS</b>A systematic literature search was conducted to identify all randomized clinical trials. The primary outcome was the rate of major adverse cardiac events (MACEs). The secondary outcomes included death, recurrent myocardial infarction, recurrent revascularization, and stent thrombosis.</p><p><b>RESULTS</b>Totally, 1973 STEMI patients were enrolled in seven eligible randomized trials comparing SES with BMS. The pooled rate of major adverse cardiac events was significantly lower in the SES group than in the BMS group (9.7% vs 20.3%, OR 2.45, 95% CI 1.88-3.19, P < 0.00001). No significant difference in all causes of death was found between the SES and BMS groups, as well as in the pooled recurrent myocardial infarction rates. The pooled recurrent revascularization rate was significantly lower in the SES group than in the BMS group (5.1% vs 14.8%, OR 3.30, 95% CI 2.37-4.60, P < 0.00001). No significant difference was found between the pooled rates of stent thrombosis (1.2% in the SES group and 2.0% in the BMS group, OR 1.61, 95% CI 0.79-3.26, P = 0.19).</p><p><b>CONCLUSIONS</b>SES is associated with a decreased risk of major adverse cardiac events compared with BMS by the greater reduction in repeat revascularization in STEMI patients. Larger trials with longer follow up are warranted to better define the role of SES in STEMI.</p>

Effect of matrine and carvedilol on collagen and MMPs activity of hypertrophy myocardium induced by pressure overload / 浙江大学学报（英文版）（B辑：生物医学和生物技术）

<p><b>OBJECTIVE</b>To explore the effect and mechanism of matrine (Mt.) on myocardial interstitial fibrosis induced by pressure overload.</p><p><b>METHODS</b>Pressure overloaded myocardial hypertrophy was produced by banding of aorta abdominalis in 67 male Sprague-Dawley rats weighing (200+/-15) g. The rats were assigned into one of the following groups: sham-operation control, operation control, operation group treated with matrine (15 mg/(kg.d)) and treated with carvedilol (Car.) (3.6 mg/(kg.d)) group. The rats were given drugs one day after operation. Five weeks after treatment, the left ventricular weight (LVW) was measured and the volume of myocardial cells was detected with Hematoxylin-Eosin (H-E) stain and Masson stain was used to assess the level of fibrosis of the myocardial matrix. Myocardial metalloproteinase activity was quantified with zymography, and survival rate was calculated.</p><p><b>RESULTS</b>Survival rate significantly decreased (P<0.05), LVW/BW (body weight), MMP-2 (matrix metalloproteinase-2) activity (P<0.05), size of cardiomyocytes and interstitial fibrosis obviously increased in the operation group compared with sham control group. Mt. and Car. treatment can significantly increase survival rate (P<0.05), decrease LVW/BW (P<0.05) and MMP-2 activity (P<0.05), decrease size of cardiomyocytes and interstitial fibrosis compared with operation group. But there was difference compared with sham group.</p><p><b>CONCLUSION</b>Matrine was shown to be able to prevent cardiac remodelling of hypertrophy cardium induced by pressure overload including myocardial hypertrophy and fibrosis which may be associated with the decrease in MMP-2 activity of heart.</p>

Application of intraaortic balloon counterpulsation during primary percutaneous coronary intervention in patients with cardiogenic shock complicating with acute myocardial infarction / 中华急诊医学杂志

Objective To investigate the safety,efficacy and effects of emergent percutaneous coronary intervention (PCI) in patients from Second Affiliated Hospital,Medical College,Zhejiang University with cardiogenic shock (CS) complicating acute myocardial infarction (AMI).Method Twenty-seven patients with CS complicating with AMI were treated by PCI with intraaortic balloon counterpulsation (IABP) support.The change of hemodynamics before and after IABP and PCI,the characteristics of PCI,the mortality during hospitalization, the major adverse cardiac events (MACE) and left ventricular ejection fraction at 30-day follow-up were observed.Results The hemodynamics were significantly improved after IABP.No patients died during PCI.Two patients died after PCI and the total mortality was 7.4% in hospital.During the period of 30-day follow-up, one patient died of heart failure.The left ventricular ejection fraction greatly improved at 30 days after PCI. Conclusions The data suggested that the use of IABP during PCI in patients with CS complicating AMI was safe, decreased mortality and improved prognosis.

Intravenous administration of embryonic stem cells home into injured hearts and improve cardiac function post myocardial infarction in rats / 中华急诊医学杂志

Objective To clarify whether the intravenous administration of embryonic stem cells(ESCs)could home in on injured myocardium caused by acute myocardial infarction(MI)in rats and to improve the cardiac function afterwards,and to explore the possible effect of inflammatory factor TNF-?on it.Methods ESCs were cultured in vitro and transfected with green fluorescence protein(GFP).The model of heart failure post MI in rats was established by permanent ligation of left coronary anterior descend artery.After operation the rats were administered with 10~7 ESC via tail vein every other day for 6 days.The sham and MI without ESCs infusion groups served as control.Six weeks later,the hemodynamic measurement was employed to evaluate the cardiac function.Immunohistochemistry assay was used to detect the GFP expression in heart and other organs,and the cardiac specific protein Tropinin I(Tn I)expression in GFP positive spot of heart.Meanwhile,the co-culture in vitro of ESC and neonatal rat cardiomyocytes was used to observe the effect of overexpression of TNF-?in cardiomyocytes on ESC migration.Results Six weeks after MI,cardiac function was significantly improved in rats administered with ESC in comparison with those of MI group.Histological changes demonstrated that infused ESCs formed GFP-positive grafts in infracted myocardium.Alternatively,the positive immunostaining for Tn I was found in the area corresponding to GRP positive staining.In regard to other organs,only in spleen a few GFP positive cells were found.This would indicate that circulating ESC could translocate to infracted myocardium and to form cardiac tissue.Migration assay of ESC in vitro indicated that cultured cardiomyocytes with overexpression of TNF-aobviously enhanced the migration of ESCs in comparison with cardiomyocytes without transfection. Conclusion Intravenously infused ESC could home in on infarcted myocurdium and futher differentiate into cardiomyocytes which led to the improvement of cardiac function.In the setting of acute MI the homing mechanism Could be associated with locally released inflammatory factors such as TNF-?which may play as a chemotactic agent on circulating ESC.

Influence of fluvastatin on left ventricular remodeling after myocardial infarction in rats / 浙江大学学报·医学版

<p><b>OBJECTIVE</b>To investigate the effect of long-term administration of fluvastatin on improvement of ventricular remodeling of rats after myocardial infarction and its mechanism.</p><p><b>METHODS</b>Sprague-Dawley rats were subjected to ligation in anterior descending branch of coronary artery and treated with fluvastatin (20 mg.kg(-1) d(-1)) or distilled water for 8 weeks. Doppler echocardiography, hemodynamic study and cardiac histomorphometry were used to estimate the ventricular remodeling and cardiac function. Laser scanning confocal microscope was used to definite the distribution of superoxide anion (O(2)(*-)) and nitrogen monoxide. RT-PCR and immunohistochemistry were used to detect the expression of NOS2 and p22phox in mRNA and protein level. The level of lipid peroxidation, glutathione peroxidase, nitrogen monoxide and total cholesterol were detected too.</p><p><b>RESULTS</b>Administration of fluvastatin ameliorated left ventricular remodeling without affecting the infarct size [(40 +/- 6 vs 42 +/-5)%, P>0.05]. The level of left ventricular end-diastolic pressure [(18.24 +/-6.58 vs 10.74 +/-4.71) mmHg, P<0.05], right ventricular ameliorated relative weight [(0.92 +/-0.19 vs 0.71 +/-0.13) g/kg, P<0.05], the thickness of left ventricular posterior wall [(3.04 +/-0.28 vs 2.60 +/-0.36) mm, P<0.05] decreased after fluvastatin treatment. The left ventricular ejection fraction was not influenced, the relative lung weight and the left atrium diameter reduced [(5.79 +/-2.92 vs 3.69 +/-0.68) g/kg, (0.55 +/-0.12 vs 0.45 +/-0.04) mm, P<0.05]; the expressions of LPO in the plasma and myocardium [(8.64 +/-0.59 vs 7.71 +/-0.66) U/dl, P<0.05; (3.12 +/-0.38 vs 1.93 +/-0.40) ng/microg.pro, P<0.01] were reduced, and the overexpressed NO was inhibited [(436.87 +/-47.22 vs 313.78 +/-34.35) mg/dl, P<0.01], but the expression of GPx increased [(66.13 +/-8.31 vs 79.78 +/-2.38) mg/dl, P<0.01]. The expression of O(2)(*-) and the activity of NADPH oxidase subunit p22phox increased; NOS2 and its products NO were over-expressed too.</p><p><b>CONCLUSION</b>Ventricular remodeling and hemodynamics are improved profoundly in MI rats treated with fluvastatin. The effect of antioxidative stress of fluvastatin might be involved in the mechanism.</p>

Effect of PP60c-Src on angiotensin II-induced signal transduction in rat vascular smooth muscle cells / 浙江大学学报·医学版

<p><b>OBJECTIVE</b>To further clarify the mechanism of Ang II-induced intracellular signal transduction in vascular smooth muscle cells(VSMCs) proliferation by observing the effect of c-Src on Ang II-mediated MAPK activation and c-fos protein expressions in rat VSMCs.</p><p><b>METHODS</b>Aortic VSMCs from SD rats were cultured primarily and subcultured, which were transfected with anti-sense c-Src oligodeoxynucleotides(ODNs) wrapped with lipofectin to inhibit c-Src activity and protein production. Untransfected VSMCs were used as control, to observe the role of Ang II stimulation in MAPK activation and c-fos protein expression in VSMC. Protein immunoprecipitation and kinase phosphorylation were employed to measure c-Src kinase activity; MAPK kinase activity was assessed by the phosphorylation rate of the substrate MBP(Myelin Basic Protein); Western blot was used to assess the protein expression of c-Src and c-fos.</p><p><b>RESULTS</b>c-Src protein expressions in VSMC, which were transfected with different concentrations of anti-sense c-Src ODNs, were significantly decreased in a negative dose-effect manner (0.2 microm, 0.5 microm, 1.0 microm and 2.0 microm were 68.2%, 34.7%, 30.3% and 15.8% respectively compared with control). c-Src kinase activity was also obviously inhibited. Following stimulation of Ang II on VSMC transfected with anti-sense c-Src ODNs, the increase of c-Src activity was only 8.7% of control,the activity of MAPK only 1.6% compared with control, and the increase in c-fos protein expression 30.3% as control.</p><p><b>CONCLUSION</b>Ang II can induce c-Src activation and intracellular signal transduction in VSMC which depend on c-Src activation, indicating that c-Src is a pivotal signal factor in VSMC proliferation.</p>