Cardiac Pacing, Artificial ; adverse effects ; Diaphragm ; Female ; Humans ; Muscular Diseases ; etiology ; Pacemaker, Artificial ; Young Adult

Humans ; Bradycardia/therapy* ; Tricuspid Valve Insufficiency ; Pacemaker, Artificial/adverse effects* ; Cardiac Pacing, Artificial

Arrhythmias, Cardiac ; etiology ; prevention & control ; Cardiac Pacing, Artificial ; adverse effects ; methods ; Humans

Aged ; Cardiac Pacing, Artificial ; adverse effects ; Echocardiography ; methods ; Heart Failure ; diagnostic imaging ; etiology ; Humans ; Male

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

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 ; Aged, 80 and over ; Cardiac Pacing, Artificial ; *Defibrillators, Implantable/adverse effects ; Female ; Humans ; Male ; Middle Aged ; *Pacemaker, Artificial/adverse effects ; *Radiography, Thoracic ; *Tomography, X-Ray Computed

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

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

Cardiac resynchronization therapy (CRT) has been proven its value in adult patients with congestive heart failure of low ejection fraction and wide QRS duration. Contrast to adult patients, CRT has been rarely applied for young patients. We report on a 9-yr-old boy with progressive left ventricular (LV) dilatation and dysfunction following chronic VVI pacemaker therapy for congenital complete atrioventricular block associated with maternal anti-SSA/Ro and SSB/La antibody. His LV dysfunction was improved after epicardially established CRT.
Antibodies, Antinuclear/metabolism ; Atrioventricular Block/congenital/therapy ; Cardiac Pacing, Artificial/*adverse effects ; *Cardiac Resynchronization Therapy ; Child ; Chronic Disease ; Electrocardiography ; Heart Ventricles ; Humans ; Male ; Natriuretic Peptide, Brain/blood ; Sjogren's Syndrome/immunology ; Ventricular Dysfunction, Left/etiology/radiography/*therapy

Angioplasty, Balloon, Coronary ; Bradycardia ; etiology ; Cardiac Pacing, Artificial ; adverse effects ; Carotid Artery, Common ; abnormalities ; Heart Block ; etiology ; Humans ; Jugular Veins ; abnormalities ; Male ; Middle Aged ; Shock, Cardiogenic ; etiology ; Thromboembolism ; complications ; Torsades de Pointes ; etiology