5.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.
Mei-Xiang XIANG ; Dong-Qi WANG ; Jing XU ; Zheng ZHANG ; Jian-Xin HU ; Dong-Mei WANG ; Xiang GU ; He-Ping LIU ; Tao GUO ; Xiang-Jun YANG ; Feng LING ; Jia-Feng LIN ; Shang-Lang CAI ; Guo-Bin ZHU ; Jian-An WANG
Chinese Medical Journal 2016;129(22):2659-2665
BACKGROUNDHigh 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.
METHODSA 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.
RESULTSA 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%).
CONCLUSIONSThis 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.
Aged ; Bradycardia ; therapy ; Cardiac Pacing, Artificial ; methods ; China ; Female ; Humans ; Male ; Middle Aged ; Pacemaker, Artificial ; adverse effects ; Prospective Studies
6.Where Does It Lead? Imaging Features of Cardiovascular Implantable Electronic Devices on Chest Radiograph and CT.
Rotem S LANZMAN ; Joachim WINTER ; Dirk BLONDIN ; Gunter FURST ; Axel SCHERER ; Falk R MIESE ; Suhny ABBARA ; Patric KROPIL
Korean Journal of Radiology 2011;12(5):611-619
Pacemakers and implantable cardioverter defibrillators (ICDs) are being increasingly employed in patients suffering from cardiac rhythm disturbances. The principal objective of this article is to familiarize radiologists with pacemakers and ICDs on chest radiographs and CT scans. Therefore, the preferred lead positions according to pacemaker types and anatomic variants are introduced in this study. Additionally, the imaging features of incorrect lead positions and defects, as well as complications subsequent to pacemaker implantation are demonstrated herein.
Aged
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Aged, 80 and over
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Cardiac Pacing, Artificial
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*Defibrillators, Implantable/adverse effects
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Female
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Humans
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Male
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Middle Aged
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*Pacemaker, Artificial/adverse effects
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*Radiography, Thoracic
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*Tomography, X-Ray Computed
7.The efficacy of permanent epicardial pacing in the treatment of pacing-dependent patients with cardiac device related endocarditis.
Gang LIU ; Dezhi ZHENG ; Xuebin LI ; Jihong GUO ; Yu CHEN ; Shenglong CHEN ; Dayi HU
Chinese Journal of Cardiology 2014;42(1):35-37
OBJECTIVEPermanent epicardial pacemaker is seldom used clinically and it is even less likely to be used for the treatment of seriously ill pacing-dependent patients with cardiac electronic device related endocarditis.
METHODWe retrospectively analyzed the feasibility and efficacy of permanent epicardial pacing for the treatment of 3 pacing-dependent patients with cardiac electronic device related endocarditis, who were treated by removal of all pacemaker devices and reimplantation of permanent epicardial pacing system combined with antibiotics. The reason of using epicardial pacing system was as follows: uncontrolled sepsis (case 1); big vegetation on the electrode of pacemaker and tricuspid valve but not a candidate for open heart surgery because of high operative risk (case 2); occlusion of superior vena cava (case 3).
RESULTSAll 3 patients were cured with the treatment of extraction of infected pacing system, re-implanted permanent epicardial pacing system and antibiotics. The permanent epicardial pacemaker worked well during the 2-12 months follow-up period and there was no recurrence of infection.
CONCLUSIONSPermanent epicardial pacing is useful and efficient in treatment of seriously ill and high risk pacing-dependent patients with cardiac device related endocarditis.
Aged, 80 and over ; Cardiac Pacing, Artificial ; methods ; Endocarditis ; etiology ; therapy ; Female ; Follow-Up Studies ; Humans ; Male ; Middle Aged ; Pacemaker, Artificial ; adverse effects ; Retrospective Studies ; Treatment Outcome
8.Effect of catheter-based renal sympathetic denervation in pigs with rapid pacing induced heart failure.
Yun XIE ; Qiliang LIU ; Youlong XU ; Junqing GAO ; Pengyong YAN ; Wenquan ZHANG ; Jianguang SUN ; Mingyu WANG ; Huigen JIN ; Jinfa JIANG ; Zongjun LIU
Chinese Journal of Cardiology 2014;42(1):48-52
OBJECTIVEThis study investigated the effect of catheter-based renal sympathetic denervation (RDN) in pigs with rapid pacing induced heart failure.
METHODSHeart failure was induced by rapid right ventricular pacing in 12 pigs and pigs were randomly divided into RDN group (n = 6): pacing+RDN at 7 days post pacing; control group (n = 6): pacing only. Echocardiography examination (LVEF, LVEDD and LVESD) was performed before pacing and at 1 and 2 weeks post pacing. Serum biochemical markers including renin, aldosterone and creatinine were also measured at baseline, 1 and 2 weeks after pacing. Repeated renal artery angiography was performed at 1 week after RDN. All pigs were sacrificed to examine the heart and renal pathology and renal artery sympathetic nerve staining at 2 weeks post pacing.
RESULTSLVEF decreased 1 week after rapid pacing from (60.5 ± 6.0)% to (35.3 ± 9.8)%. LVEF was significantly higher [(42.8 ± 5.9) % vs. (33.4 ± 9.7)%, P = 0.001 8] while LVESD was significantly lower [(28.4 ± 3.7) mm vs. (33.0 ± 2.0) mm, P = 0.001 6] in the RDN group than in the control group at 2 weeks post pacing. At 2 weeks after pacing, plasma concentrations of renin and aldosterone were significantly lower in RDN group compared to the control group (all P < 0.05) . Kidney function and blood pressure were comparable between the two groups at 2 weeks post pacing. There were no signs of renal damages such as renal artery stenosis, dissection and thrombus in all pigs after 2 weeks pacing. Sympathetic neurons of adventitia were injured in RND group.
CONCLUSIONRDN could significantly improve cardiac function and attenuate left ventricular remodeling via inhibiting renin-angiotensin-aldosterone system in this pacing induced pig heart failure model.
Animals ; Cardiac Pacing, Artificial ; adverse effects ; Catheter Ablation ; methods ; Disease Models, Animal ; Female ; Heart Failure ; etiology ; surgery ; Kidney ; innervation ; Male ; Swine ; Sympathectomy ; methods
9.Complications of cardiac resynchronization therapy in patients with congestive heart failure.
Hong-xia NIU ; Wei HUA ; Fang-zheng WANG ; Shu ZHANG ; Ke-ping CHEN ; Xin CHEN
Chinese Medical Journal 2006;119(6):449-453
BACKGROUNDPrevious clinical studies have suggested that patients with congestive heart failure and intraventricular conduction delay could benefit from cardiac resynchronization therapy (CRT). Implantation of left ventricular lead is a complex procedure with some potential for complications. This study was conducted to analyse the complications of CRT in patients with congestive heart failure.
METHODSTotally 117 patients, 86 males and 31 females, mean age of 53 years, with congestive heart failure and intraventricular conduction delay were enrolled in this study. Venography was performed on all patients. Different types of coronary sinus leads were used to pace the left ventricle.
RESULTSLeft ventricular lead was attempted to implant through coronary sinus for all the 117 patients and was successfully implanted in 111 patients. The success rate was 94.9%. Main complications rate was 6.8%, including coronary sinus dissection in 4 patients, phrenic nerve stimulation required lead repositioning in 2 patients and lead dislodgement in 2 patients.
CONCLUSIONSIt is feasible and safe to pace left ventricle through coronary sinus. However, there are some procedural complications.
Angioplasty, Balloon, Coronary ; Cardiac Pacing, Artificial ; adverse effects ; Defibrillators, Implantable ; Female ; Heart Failure ; complications ; therapy ; Heart Ventricles ; Humans ; Male ; Middle Aged
10.Right ventricular desynchronization in patients with pacemaker syndrome.
De-Zhen ZHOU ; Fan-Ping WEI ; Gao-Hui YUAN
Chinese Journal of Cardiology 2007;35(12):1108-1110
OBJECTIVETo observe the incidence of ventricular desynchronization in patients with or without pacemaker syndrome (PMS).
METHODSThe systolic peak velocity, the acceleration and the time to peak velocity of the interventricular septum (IVS), left ventricular (LV) and right ventricular (RV) lateral wall were detected by tissue Doppler imaging (TDI) in 14 atrial fibrillation patients without pacemaker implantation (control), 18 atrial fibrillation patients without PMS and 16 atrial fibrillation patients with PMS. All patients were free of valve disease, myocardial infarction, severe pulmonary hypertension, low left ventricular eject fraction (< or = 50%), significant segmental hypokinesis of ventricular wall or complete bundle branch block.
RESULTSCompared to the control patients, the systolic peak velocity and the accelerations on lateral walls of the LV and RV reduced significantly in patients with implanted pacemakers (P < 0.05). The intervals to peak velocity of the IVS and LV lateral walls were significantly prolonged [PMS group (80.13 +/- 26.92) ms vs. (25.60 +/- 4.30) ms, P < 0.01; without PMS group (76.22 +/- 23.32) ms vs. (25.60 +/- 4.30) ms, P < 0.01] and the intervals to peak velocity of the IVS and RV lateral walls significantly shortened [PMS group (16.33 +/- 6.85) ms vs. (40.70 +/- 7.60) ms, P < 0.01; without PMS group (21.20 +/- 7.34) ms vs. (40.70 +/- 7.60) ms, P < 0.01]. The systolic peak velocities, the accelerations of the IVS and bilateral walls and the intervals to peak velocity of the IVS and LV lateral wall were similar in patients with and without PMS (P > 0.05), however, the intervals to peak velocity of the IVS and RV lateral wall was significant shorter in patients with PMS compared to that of patients without PMS [(16.33 +/- 6.85) ms vs. (21.20 +/- 7.34) ms, P < 0.01].
CONCLUSIONRV desynchronization but not LV desynchronization might play an important role in patients with PMS.
Adult ; Aged ; Aged, 80 and over ; Atrial Fibrillation ; therapy ; Cardiac Pacing, Artificial ; adverse effects ; Echocardiography, Doppler, Pulsed ; Female ; Heart Ventricles ; diagnostic imaging ; physiopathology ; Humans ; Male ; Middle Aged ; Ventricular Septum