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.Effects of different intervention time of percutaneous transhepatic gallbladder catheterizing drainage on severe acute biliary pancreatitis
Jianjun ZHANG ; Hailong JU ; Bing ZHANG ; Lu LIANG
The Journal of Practical Medicine 2018;34(1):76-78
Objective To study the effects of different intervention time of percutaneous transhepatic gallbladder catheterizing drainage (PTGBD)on severe acute biliary pancreatitis Methods Totally 64 patients with severe acute biliary pancreatitis in Affiliated Hospital of Hebei University from July 2013 to July 2017were selected and divided into 3 groups according to the time from attack to PTGBD:group A (less than 72 hours,n =28),group B (from 72 hours to 120 hours,n =22),group C (from 120 hours to 148 hours,n =14).Intergroup comparison of level of WBC,CRP,TBIL,PLT and APACHE-Ⅱ Score,disappearance time of abdominal sign,incidence of pancreatic abscess,length of stay (LOS),mortality and patient satisfaction 48 hours before and after PTGBD were conducted.Results Compared with those in group B and C,all laboratory indexes,APACHE-ⅡScore,disappearance time of abdominal sign,incidence of pancreatic abscess,LOS,mortality and patient satisfaction in group A were all significantly different (P < 0.05).Conclusion Early PTGBD (within 72 hours)can be effective and safe for the treatment of severe acute biliary pancreatitis,and can shorten LOS and reduce the mortality.

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