Evaluation of Long-term Incidence of Ventricular Arrhythmias in Patients With Acute Myocarditis
Evaluation of Long-term Incidence of Ventricular Arrhythmias in Patients With Acute Myocarditis
Myocarditis is an inflammatory disease of the heart muscle which is mostly caused by viruses,
 bacteria, parasites, toxic substances/drugs or by primary autoimmune mechanisms. Signs of
 heart failure (dyspnea, reduced resilience, tendency to edema), thoracic pain, palpitations /
 arrhythmias / syncope, as well as (potentially) lethal clinical conditions in the sense of a
 cardiogenic shock or sudden cardiac death can be found.

 In 2015, the European Society of Cardiology (ESC) gave a IIa recommendation for the
 indication of an ICD vest restoration as "bridging" until the acute phase subsides (possibly
 normalisation of the left ventricular pump function with reduced probability of malignant
 cardiac arrhythmia) or until ICD implantation in cases of severe LV dysfunction and/or
 ventricular electrical instability. The Monitoring and analysis of malignant cardiac
 arrhythmias are therefore crucial in the treatment of acute myocarditis.

 The aim of this study is to observe the long-term incidence of ventricular arrhythmias in
 patients diagnosed with myocarditis and to analyze the MRI and echocardiographic data
 obtained as potential predictive factors for the occurrence of ventricular arrhythmias.
Myocarditis is an inflammatory disease of the heart muscle, which is mostly caused by
 viruses, bacteria, parasites, toxic substances/drugs or by primary autoimmune mechanisms. In
 the first phase of acute myocarditis direct cell damage, in a second phase myocardial
 inflammation with additional myocardial damage can be observed. Symptoms vary widely and may
 include signs of heart failure (dyspnoea, reduced exercise capacity, edema tendency), chest
 pain, palpitations / arrhythmias / syncope, and (potentially) lethal clinical conditions such
 as cardiogenic shock or sudden cardiac death. Predictors of increased mortality are syncopes,
 malignant arrhythmias EF≤35% or heart failure NYHA III-IV. ICD implantation is recommended <3
 months after manifestation only in exceptional situations (e.g. following resuscitation). The
 European Society of Cardiology (ESC) issued a IIa recommendation in 2015 for the indication
 of ICD vest fitting as "bridging" until the acute phase subsides (possible normalization of
 left ventricular pumping function with reduced probability of malignant cardiac arrhythmias)
 or until ICD implantation in cases of severe LV dysfunction and/or ventricular electrical
 instability is necessary. The observation, monitoring and analysis of malignant cardiac
 arrhythmias are therefore crucial in the treatment of acute myocarditis.

 The aim of this study is to observe the long-term incidence of ventricular arrhythmias in
 patients with diagnosed myocarditis and to analyze the MRI and echocardiographic data
 obtained as potential predictive factors for the occurrence of ventricular arrhythmias.

 The study is a prospective multicenter registry study. All potentially stressful measures and
 examinations such as blood sampling and echocardiography - except for follow-up MRI
 examinations - are carried out at our centre as standard clinical progress assessment, even
 independently of participation in the registry. The indication for biomonitor implantation is
 given after initial screening by means of a 24h-LZ-ECG with positive results (detection of
 ventricular arrhythmias). The registry study is performed with approved IECDs (Implantable
 electronic cardiovascular devices: Biomonitor (BioMonitor 2-AF, BioMonitor 3-AF (after
 release)), Biotronik® ICD) as well as WCD (Wearable Cardioverter Defibrillator, Zoll®
 LifeVest) and Biotronik® Cardio Messenger. The implantation is carried out exclusively
 according to the indication/testing guidelines. Thus, there are no risks or disadvantages for
 the participating patient.

 The primary aim of the study is to monitor the long-term incidence of ventricular arrhythmias
 in patients with diagnosed myocarditis and to identify potential predictive factors for their
 occurrence.

 Secondary goal is to analyze the long-term survival and need for heart transplantation and to
 identify MRI/echocardiographic parameters as determinants of arrhythmias.
Inclusion Criteria:

 -  secured myocarditis via MRT / endomyocardial biopsy

 -  ventricular arrhythmias (≥ 5 beats) in the ECG / LZ ECG with clinical indication for a
 WCD system/ biomonitor/ or the indication for primary/secondary prophylactic ICD
 implantation

 -  presence of informed consent

 -  age >18 and <85 years

 Exclusion Criteria:

 -  Participation in another study with an active treatment group

 -  Pregnant or breastfeeding women