Safety of External Electrocardioversion in Device Patients

Study Overview
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Brief Summary
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Arrhythmias of the atria of the heart are a common comorbidity in patients with cardiac rhythm management devices, such as pacemakers and implantable cardioverter/defibrillators (ICD). External electrical cardioversion is an established method to achieve rhythm control (restore normal sinus rhythm) in patients with atrial arrhythmia. Little data on safety and efficacy of external electrical cardioversion in patients with cardiac rhythm management devices exists. Thus, available data on the safety of external electrical cardioversion in cardiac rhythm management patients lacks statistical power to accurately reflect the true hazard of external electrical cardioversion in patients with cardiac rhythm management devices. The aim is to systematically include and follow all patients with cardiac rhythm management devices presenting for external electrical cardioversion, to analyse the effects of external electrical cardioversion on leads and devices.

Detailed Description
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Introduction Atrial arrhythmias are a common comorbidity in patients with cardiac rhythm management (CRM) devices, such as pacemakers and ICD. External electrical cardioversion is an established method to achieve rhythm control in patients with atrial arrhythmia. A paucity of data on safety and efficacy of external electrical cardioversion in patients with cardiac rhythm management devices exists. Most publications are of older date and predominantly case reports or case collections. Few prospective studies with a population of cardiac rhythm management patients after external electrical cardioversion have been published in recent years. Thus, available data on the safety of external electrical cardioversion in cardiac rhythm management patients lacks statistical power to accurately reflect the true hazard of external electrical cardioversion in patients with cardiac rhythm management devices. Rationale Electrocardioversion in Propofol sedation for atrial or ventricular tachyarrhythmia is an established therapy. It is routinely used for patients with cardiac rhythm management devices and the risk of device and lead affectation is deemed to be low. This assumption is currently not supported by substantial and current scientific data, mostly relying on older reports. No large, prospective trials with a population of patients with modern cardiac rhythm management devices exists. Aim of the study The aim is to systematically include and follow all patients with cardiac rhythm management devices presenting for external electrical cardioversion, to analyse the effects of external electrical cardioversion on leads and devices. Thereby, providing reliable evidence and detecting possible SAE with a low incidence. Furthermore, to gather information on efficacy and recurrence rate in this population, to examine the value of external electrical cardioversion for rhythm control in these patients.

Official Title
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Safety of External Electrocardioversion in Device Patients - the SEED Registry

Conditions
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Atrial Arrhythmia

Intervention / Treatment
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* Procedure: Cardioversion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Informed, written consent Atrial or ventricular arrhythmia with indication for CV Status post CRM implantation, including CRT-D Exclusion Criteria: Age < 18 years Patients under guardianship or with mental disorders / disabilities lead implantation < 4 weeks prior to CV contraindications for eCV or transoesophageal echocardiographie (TOE)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pacemaker patients<br>Patients with pacemaker, presenting for cardioversion. | Procedure: Cardioversion<br> <br> |
| ICD patients<br>Patients with ICD, presenting for cardioversion. | Procedure: Cardioversion<br> <br> |
| CRT patients<br>Patients with CRT device, presenting for cardioversion. | Procedure: Cardioversion<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite safety endpoint: Changes of lead and device parameters | assessed by device interrogation, if any of the following criteria is met: a rise in threshold (at constant pulse duration) of >1V exit block of any of the pacing leads loss of programming of the device rise in shock impedance by 50% rise in charge time by 50% drop in battery voltage of ≥0.2V within < 6 weeks | 2 weeks after CV | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy Endpoint | Assessed by device interrogation and 12-lead ECG: - restoration of normal sinus rhythm after CV | within 15 minutes after CV | 
| Late changes of lead parameters | Any of the below, assessed by device interrogation: Lead impedance > 1000 Ohm a rise in lead impedance by 50% ventricular lead sensing < 2mV atrial lead sensing < 1mV | 2 weeks after CV | 
| Inadvertent induction of ventricular fibrillation | Assessed by 3 lead monitoring ECG | 10 seconds after CV | 
| Composite endpoint: Early lead changes | assessed by device interrogation, if any of the following criteria is met: a rise in threshold (at constant pulse duration) of >1V exit block of any of the pacing leads Lead impedance > 1000 Ohm a rise in lead impedance by 50% ventricular lead sensing < 2mV atrial lead sensing < 1mV | within 15 minutes after CV | 
| Loss of programming | assessed by device interrogation: - loss of programming of the device | within 15 minutes after CV | 
| Change of shock impedance | assessed by device interrogation: - rise in shock impedance by 50% | within 15 minutes after CV | 
| Change of charge time | assessed by device interrogation: - rise in charge time by 50% | within 15 minutes after CV |