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

Humans ; Male ; Middle Aged ; Pacemaker, Artificial ; adverse effects ; Tricuspid Valve Stenosis ; etiology

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

Complete atrioventricular (AV) block is frequently regarded as a cause of informed syncopal attacks, even though the escape rhythm is maintained. Torsade de pointes (TdP) may be a significant complication of AV block associated with QT prolongation. Here, we report the case of a 42-year-old female who was referred to our hospital due to recurrent seizure-like attacks while taking anti-convulsant drugs at a psychiatric hospital. TdP with a long QT interval (corrected QT = 0.591 seconds) was observed on an electrocardiogram (ECG) taken in the emergency department. The patient's drug history revealed olanzapine as the suspicious agent. Even after the medication was stopped, however, the QT interval remained within an abnormal range and multiple episodes of TdP and related seizure-like symptoms were found via ECG monitoring. A permanent pacemaker was thus implanted, and the ventricular rate was set at over 80 beats/min. There was no recurrence of tachyarrhythmia or other symptoms.
Adult ; Atrioventricular Block/*complications ; Benzodiazepines/adverse effects ; Electrocardiography ; Epilepsy/*etiology ; Female ; Humans ; Pacemaker, Artificial ; Torsades de Pointes/*etiology/therapy

Adult ; Aged ; Aged, 80 and over ; Female ; Humans ; Lead ; isolation & purification ; Male ; Middle Aged ; Pacemaker, Artificial ; adverse effects

BACKGROUNDMany recipients of implantable cardiac electronic devices have atrial fibrillation (AF) occurrences after device implantation, even if there is no previous history of AF, and some of the episodes are asymptomatic. The purpose of this study was to evaluate trends in AF burden following early AF detection in patients treated with pacemakers equipped with automatic, daily Home Monitoring function.

METHODSBetween February 2009 and December 2010, the registry recruited 701 pacemaker patients (628 dual-chamber, 73 biventricular devices) at 97 clinical centers in China. Daily Home Monitoring data transmissions were analyzed to screen for the AF burden. In-office follow-ups were scheduled for 3 and 6 months after implantation. Upon first AF (i.e., mode-switch) detection in a patient, screening of AF burden by Home Monitoring was extended for the next 180 days.

RESULTSAt least one episode of AF was observed in 22.9% of patients with dual-chamber pacemakers and in 28.8% of patients with biventricular pacemakers. The first AF detection in a patient occurred, on average, about 2 months before scheduled follow-up visits. In both pacemaker groups, mean AF burden decreased significantly (P < 0.05) over 180 days following first AF detection: from 12.0% to 2.5% in dual-chamber and from 12.2% to 0.5% in biventricular pacemaker recipients. The number of patients with an AF burden >10% per month was significantly reduced over 6 months of implantation in both dual chamber (38 patients in the first month vs. 21 patients in month 6, P < 0.05) and biventricular (7 patients in the first month vs. 0 patient in months 4-6, P < 0.05) pacemaker recipients.

CONCLUSIONSAutomatic, daily Home Monitoring of patients treated with cardiac pacemakers allows early detection of AF, and there is a gradual and significant decrease in AF burden.

Aged ; Aged, 80 and over ; Atrial Fibrillation ; prevention & control ; Female ; Humans ; Male ; Middle Aged ; Pacemaker, Artificial ; adverse effects

Pacemaker lead infections are rare. There are only about 0.4%-1.1% of the patients who have been implanted permanent pacemakers suffering from serious infections which lead to endocarditis. Generally, removal of the infected pacemaker wire and lead, long-term anti-infection therapy, and implantation of a new pacemaker to another anatomic site are accepted approaches for these patients.
Device Removal ; Endocarditis ; drug therapy ; Humans ; Male ; Middle Aged ; Mycoses ; drug therapy ; Pacemaker, Artificial ; adverse effects ; Scopulariopsis

Aged, 80 and over ; Blood Vessel Prosthesis Implantation ; adverse effects ; methods ; Humans ; Male ; Pacemaker, Artificial ; Subclavian Artery ; surgery