User's Manual

5
CPR4 – UA10821A
 Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or
unstable.
 Patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained
VT or ventricular fibrillation induced at electrophysiological study.
 Patients with reduced LVEF due to prior myocardial infarction who are at least 40 days post-myocardial
infarction and with symptomatic heart failure or LV dysfunction.
 Patients with non-ischemic dilated cardiomyopathy and reduced LVEF with symptomatic heart failure.
 Patients with non-sustained VT due to prior myocardial infarction, reduced LVEF and inducible ventricular
fibrillation or sustained VT at electrophysiological study. For further details, please refer to “2008
ACCF/AHA/HRS Guidelines for Device-Based Therapy of Cardiac Rhythm Abnormalities” and its 2012
Focused Update or “2017 AHA/ACC/HRS Guidelines for management of patients with ventricular
arrhythmias and the prevention of sudden cardiac death” or “2015 ESC Guidelines for management of
patients with ventricular arrhythmias and the prevention of sudden cardiac death”.
According to the guidelines specified above, ventricular antitachycardia pacing and ventricular defibrillation for
automated treatment of life-threatening ventricular arrhythmia with resynchronization is indicated in:
 Patients who are survivors of cardiac arrest due to ventricular fibrillation or hemodynamically unstable
sustained VT after evaluation to define the cause of the event and to exclude any completely reversible
causes.
 Patients with structural heart disease and spontaneous sustained VT, whether hemodynamically stable or
unstable.
 Patients with syncope of undetermined origin with clinically relevant, hemodynamically significant sustained
VT or ventricular fibrillation induced at electrophysiological study.
 Patients with reduced LVEF due to prior myocardial infarction who are at least 40 days post-myocardial
infarction and with symptomatic heart failure or LV dysfunction.
 Patients with non-ischemic dilated cardiomyopathy and reduced LVEF with symptomatic heart failure.
 Patients with non-sustained VT due to prior myocardial infarction, reduced LVEF and inducible ventricular
fibrillation or sustained VT at electrophysiological study.
Biventricular pacing therapy is indicated in patients with symptomatic heart failure despite optimal pharmacological
therapy, with reduced LVEF and wide QRS.
For further details, please refer to “2008 ACCF/AHA/HRS Guidelines for Device-Based Therapy of Cardiac Rhythm
Abnormalities” and its 2012 Focused Update or “2017 AHA/ACC/HRS Guidelines for management of patients with
ventricular arrhythmias and the prevention of sudden cardiac death” or “2015 ESC Guidelines for management of
patients with ventricular arrhythmias and the prevention of sudden cardiac death”. For biventricular pacing therapy,
please also refer to “2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy”.
1.2.2 Target population(s)
The target populations are patient groups indicated for the implantation of either a pacemaker or a defibrillator, with
or without resynchronization, and implanted with a MicroPort CRM device. For further details regarding pacemaker
indications, please refer to the "2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy", or the
“2012 ACCF/AHA/HRS Focused Update of the 2008 Guidelines for Device-Based Therapy of Cardiac Rhythm
Abnormalities”. For further details regarding defibrillator indications, please refer to “ACC/AHA/HRS 2008 Guidelines
for Device-Based Therapy of Cardiac Rhythm Abnormalities” or “ACC/AHA/ESC 2006 Guidelines for management of
patients with ventricular arrhythmias and the prevention of sudden cardiac death”. For biventricular pacing therapy,
please also refer to “2013 ESC Guidelines on cardiac pacing and cardiac resynchronization therapy”.
1.2.3 Intended user(s)
The CPR4 is intended to be used by electrophysiologists, cardiologists, or specialized nurses and/or technicians
trained or experienced in device implant and/or follow- up procedures in order to interrogate and program
implantable cardiac devices in a cardiology practice (hospital, clinic, outpatient practice…).