Registry of Device Implantation
Registry of Device Implantation
The implantable device therapy for cardiac arrhythmias has been an established therapy, and
 one of the common standard procedures in cardiac clinical practice.

 Pacemakers, implantable cardioverter-defibrillators, and cardiac resynchronization therapy
 have been developed since 1960s, and the technologies in this field are still progressively
 developing. Not only these "traditional" implantable devices, there are multiple new devices
 for cardiac diseases, such as implantable loop recorder, vagal nerve stimulator and
 barostimulator.

 The aim of this registry is to demonstrate the efficacy and the safety of standard device
 implantation procedures and to evaluate/ identify specific factors, including clinical
 characteristics, laboratory data and procedural data, which predict the
 prognosis/complication of the patients. These identification will result in further
 improvement of patients' care.
The implantation of cardiac devices has been one of the common standard procedures in the
 cardiac clinical practice.

 Pacemakers are implanted for patients with symptomatic bradyarrhythmias. Implantable
 cardioverter-defibrillators are implanted in order to avoid sudden cardiac death (SCD) in
 high risk patients such as after myocardial infarction and reduced ejection fraction.

 Cardiac resynchronization therapy was introduced to improve the prognosis in patients with
 reduced EF and left bundle branch block. This therapy demonstrated the efficacy in severe
 heart failure patients.

 Recently a new implantable device has been developed also to improve the prognosis of
 patients with severe heart failure refractory to the maximal therapies at present. This
 barostimulator activates the baro-reflex and results in higher parasympathetic activity and
 better outcome in those patients, in whom the sympathetic function is overactivated.

 In patients with cryptogenic stroke or syncope, the implantable loop recorder enables us to
 monitor the cardiac rhythm continuously for 3 years. With this device, the occult arrhythmias
 can be revealed and lead patients to the adequate therapy.

 Above mentioned device therapies have been developed since 1960s, and the technologies in
 this field are still progressively developing. To catch up these advancements, the quality
 management including the efficacy, safety aspects and the prognosis of the patients should be
 carefully monitored.

 The aim of the present study is, therefore, to demonstrate the efficacy and the safety of
 standard device implantation procedures. The patient specific and procedural factors are
 evaluated to test if those factors predict the prognosis of the patients. These
 identifications will eventually result in the improvement of future patients' care.

 The data of patients who underwent device implantation since 2011 and those who undergo
 device implantation till 2019 will be collected, including the basic demographic data,
 comorbidities, results of laboratory and functional tests. In the latter patients, the
 peri-procedural data and post-procedural data are also prospectively collected.

 The present study is essentially an observational study. The inclusion in this study does not
 affect the decision of device implantation itself. The post-procedural therapies, such as
 medications and device therapies are not due to this registry affected.

 As a sub-project in this registry, biomarkers and thyroid hormone are evaluated to
 investigate the predictable value of those indices.
Inclusion Criteria:

 1. pre-operative clinical history taking

 2. pre-operative functional investigations (cardiac echo, electrocardiograms)

 3. pre-operative laboratory data evaluation (kidney function, liver function, biomarkers,
 thyroid hormone, CBC)

 Exclusion Criteria:

 １. no written informed consent