1.Rationale and Study Design for Evaluating the Efficacy and Safety of Intracardiac Echocardiography-Guided Minimal-Fluoroscopy Ablation in Patients with Paroxysmal Atrial Fibrillation: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial (PAF-ICE Trial)
Jiang RUHONG ; Liu XINGPENG ; Zhang JIDONG ; Chen YU ; Wang RUI ; Wu MENGZUO ; Long DEYONG ; Li JIA ; Wang HAIXIONG ; Fan JIE ; Ju WEIZHU ; Ge WEILI ; Liu XU ; Deng HAI ; Wang WEIJIAN ; Yang PINGZHEN ; Li DING ; Huang XIAOBO ; Liu XIONGTAO ; Tao HAILONG ; Paul C. ZEI ; Tung RODERICK ; Wang XUNZHANG ; Jiang CHENYANG
Cardiology Discovery 2021;01(4):228-232
The feasibility and safety of intracardiac echocardiography (ICE)-guided catheter ablation for atrial fibrillation (AF) using a minimal/zero-fluoroscopy approach have recently been reported. This approach helps to reduce ionizing radiation exposure and orthopedic complications resulting from using lead aprons. The objectives of this planned prospective, multicenter randomized controlled trial (RCT) (paroxysmal AF (PAF)-ICE trial; ChiCTR2000033624) are to evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF and the impact on occupational hazards among lab staff.Patients will be randomized in a 1:1 ratio to 2 groups: minimal fluoroscopy group ( n = 216) and traditional approach group ( n = 216). In the minimal fluoroscopy group, an ICE catheter will be used for geometry/anatomic construction, transseptal puncture, catheter tracking, and effusion monitoring. Pulmonary vein isolation (PVI) will be performed using an open-irrigated radiofrequency SmartTouch Surround Flow or SmartTouch catheter (Biosense Webster, Diamond Bar, California, USA), and confirmed by a multipolar Lasso or PentaRay catheter (Biosense Webster). In the traditional approach group, an ICE catheter will not be used. Transseptal puncture will be performed under fluoroscopic guidance, with all geometries constructed by mapping the catheters. The primary efficacy endpoint is freedom from AF recurrence (without antiarrhythmic medications) at 12 months after ablation. Other endpoints include duration of lead apron use, measures of intra-procedural efficiency, and peri-procedural complications. This RCT will evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF, also evaluate the benefits to lab staff (regarding reducing occupational hazards) related to this "minimal/zero-fluoroscopy" and "leadless" mode.
2.Rationale and Study Design for Evaluating the Efficacy and Safety of Intracardiac Echocardiography-Guided Minimal-Fluoroscopy Ablation in Patients with Paroxysmal Atrial Fibrillation: A Non-Inferior, Multi-Center, Prospective Randomized Controlled Trial (PAF-ICE Trial)
Jiang RUHONG ; Liu XINGPENG ; Zhang JIDONG ; Chen YU ; Wang RUI ; Wu MENGZUO ; Long DEYONG ; Li JIA ; Wang HAIXIONG ; Fan JIE ; Ju WEIZHU ; Ge WEILI ; Liu XU ; Deng HAI ; Wang WEIJIAN ; Yang PINGZHEN ; Li DING ; Huang XIAOBO ; Liu XIONGTAO ; Tao HAILONG ; Paul C. ZEI ; Tung RODERICK ; Wang XUNZHANG ; Jiang CHENYANG
Cardiology Discovery 2021;01(4):228-232
The feasibility and safety of intracardiac echocardiography (ICE)-guided catheter ablation for atrial fibrillation (AF) using a minimal/zero-fluoroscopy approach have recently been reported. This approach helps to reduce ionizing radiation exposure and orthopedic complications resulting from using lead aprons. The objectives of this planned prospective, multicenter randomized controlled trial (RCT) (paroxysmal AF (PAF)-ICE trial; ChiCTR2000033624) are to evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF and the impact on occupational hazards among lab staff.Patients will be randomized in a 1:1 ratio to 2 groups: minimal fluoroscopy group ( n = 216) and traditional approach group ( n = 216). In the minimal fluoroscopy group, an ICE catheter will be used for geometry/anatomic construction, transseptal puncture, catheter tracking, and effusion monitoring. Pulmonary vein isolation (PVI) will be performed using an open-irrigated radiofrequency SmartTouch Surround Flow or SmartTouch catheter (Biosense Webster, Diamond Bar, California, USA), and confirmed by a multipolar Lasso or PentaRay catheter (Biosense Webster). In the traditional approach group, an ICE catheter will not be used. Transseptal puncture will be performed under fluoroscopic guidance, with all geometries constructed by mapping the catheters. The primary efficacy endpoint is freedom from AF recurrence (without antiarrhythmic medications) at 12 months after ablation. Other endpoints include duration of lead apron use, measures of intra-procedural efficiency, and peri-procedural complications. This RCT will evaluate the efficacy and safety of ICE-guided minimal-fluoroscopy ablation in patients with PAF, also evaluate the benefits to lab staff (regarding reducing occupational hazards) related to this "minimal/zero-fluoroscopy" and "leadless" mode.
3. Prognostic value of total cholesterol content of erythrocyte membranes in patients with acute coronary syndrome
Jianhua ZHANG ; Changhui WANG ; Jia XU ; Li YE ; Xiaochen WANG ; Banglong XU ; Xuhua CHEN ; Mengzuo WU ; Ziping CHENG ; Yan XU
Chinese Journal of Cardiology 2019;47(4):305-310
Objective:
Previous cross-sectional studies suggested that elevated levels of total cholesterol content of erythrocyte membrane (CEM) could significantly increase the risk of acute coronary syndrome (ACS). The purpose of the present study was to assess the predictive value of baseline CEM levels for the risk of clinical endpoint events in patients with ACS through prospective follow-up studies.
Methods:
This study is a prospective follow-up study, which consisted of 859 patients with first ACS (698 patients with unstable angina pectoris and 161 patients with acute myocardial infarction), diagnosed and hospitalized in the First and Second Affiliated Hospital of Anhui Medical University. The routine blood lipid levels and CEM were measured. Patients were divided into two groups according to the median of baseline CEM: CEM≤131.56 μg/mg group (
4.The predictive value of mild renal insufficiency on the prognosis of patients with acute coronary syndrome
Jianhua ZHANG ; Yan XU ; Xuhua CHEN ; Mengzuo WU ; Ziping CHENG ; Bin CHEN
Chinese Journal of Internal Medicine 2013;52(12):1033-1036
Objective To investigate the predictive value of mild renal insufficiency on the endpoint events in patients with acute coronary syndrome (ACS).Methods A total of 552 patients with ACS were enrolled in the present study.According to the levels of estimated glomerular filtration rate (eGFR),patients were divided into two groups,normal renal function (eGFR≥90 ml · min-1 · 1.73 m-2) and mild renal insufficiency (60≤eGFR <90 ml · min-1 · 1.73 m-2).The primary and secondary events were collected and analyzed through the present prospective follow-up study.Results The patients in mild renal insufficiency group had a higher incidence of the primary endpoint events than normal renal function group [31 cases (12.6%) vs 15 cases (4.9%),P =0.001].There was no difference of the secondary endpoint events incidence in the two groups.The incidence rate of all-cause mortality [8.9% (22 cases) vs 2.2% (7 cases),P <0.001] and cardiac death [6.5% (16 cases) vs 1.3% (4 cases),P =0.001] was higher in mild renal insufficiency group,but there was no statistical difference of incidence rate of no fatal stroke and myocardial infarction in the two groups.The results of COX regression analysis showed that the incidence of primary endpoint events in patients with mild renal dysfunction was 2.265 folds (95% CI 1.076-4.771,P=0.031) of patients with normal renal function.Further analysis indicated that the predictive value of mild renal insufficiency was only for all-cause mortality (HR 3.118,95% CI 1.197-8.125,P =0.020),not for heart failure and revascularization.According to the Kaplan-Meier curves results,the incidences of the primary endpoint events (P =0.004) and all-cause mortality (P =0.001) were higher in mild renal insufficiency group than in normal renal function group.Conclusion Mild renal insufficiency has important predictive value for primary endpoint events in patients with ACS.
5.Clinical analysis of the correlation between serum IL-10 and testosterone with coronary artery disease.
Xiaochen WANG ; Yan XU ; Ziping CHENG ; Banglong XU ; Bin CHEN ; Xuhua CHEN ; Mengzuo WU ; Xianhe LIN ; Runshuo ZHU
Clinical Medicine of China 2009;25(9):935-938
Objective To evaluate the correlation between seram interleukin-10 (IL-10) and testosterone with coronary heart disease (CHD). Methods 387 patients were divided into CHD group (n = 239) and control group ( n = 148 ) according to the results of coronary angiography. CHD patients were divided into subgroups accord-ing to the numbers, Gensini score of lesions in the coronary arteries and clinical severity ( statue of stable coronary artery disease, unstable angina or acute myocardial infarction). Serum IL-10 and testosterone levels were measured by ELASA. Logistic regression and partial correlation were used to evaluate the correlation of serum IL-10 and testoster-one with CHD. Results IL-10 was significantly lower in the CHD group than in the control group[ (39.08 ± 14.22) ng/L vs (49.27 ± 24.67)ng/L, P < 0. 001 ]. The partial correlation analysis results in subgroups showed that the correlation coefficient of IL-10 with number of lesions,gensini score and clinical severity of CHD was - 0.25, P < 0.001, -0.25 ,P <0.05 and -0.25 ,P <0.001 ,respectively. Serum testosterone had no difference in control group and CHD group (P >0.05 ). Logistic regression analysis found that only smoking (OR = 3.79,95% CI 2.09~ 6.84,P<0.01) ,diabetes mellitus (OR =2.48,95% CI 1.05 ~5.88,P <0. 05) ,apoB ( OR = 14.3,95% CI 4.29~46.61 ,P <0.01 ) and IL-10 ( OR =0.74,95%, CI 0.57~0.89 ,P <0.01 ) entered the model. Conclusions Serum IL-10 is not only significantly correlated with CHD but also with its severity. IL-10 is an independent pro-tective factor for CHD.

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