Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by ECMO-VA for Refractory Cardiogenic Shock

Study Overview
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Brief Summary
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Brief Summary : Rhythm disorders are a frequent and potentially serious complication of critical patients in the ICU and postoperative cardiac surgery. In particular, atrial fibrillation (AF) is the most common rhythm disorder in patients admitted to the ICU and is associated with excess mortality during acute circulatory failure. In postoperative cardiac surgery, AF affects 15 to 45% of patients. In addition to hemodynamic effects, AF increases the risk of stroke, bleeding, respiratory or renal failure, and doubles mortality at 30 days and 6 months. In the longer term, the recurrence rate of AF within 1 year after hospital discharge is about 50%. Similarly, other rhythm disorders, supraventricular or ventricular, can be life-threatening in ICU patients. While the incidence and complications of rhythm disorders are well documented during sepsis, cardiogenic shock or after cardiac surgery, there are to our knowledge no data on the frequency and complications of rhythm disorders in patients assisted by VA ECMO. The primary objective is to describe the incidence of supraventricular rhythm disorders in patients assisted by VA ECMO.

Detailed Description
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This study is an observational study to describe the conditions of occurrence of arrhythmias, particularly atrial fibrillation, in patients supported by VA ECMO, as well as their short-term and long-term prognosis. Patients will be recruited from the intensive care units and CRFs will be completed by the investigators at each of the participating centers. Data will be collected directly from the medical records, except for vital status at 1 year, which may be collected by telephone from the patient by the investigator at the center in the absence of data in the medical record. Atrial fibrillation episodes will be recorded on a 12-lead electrocardiogram and securely transmitted to the coordinating center. In addition, investigators will send weekly data to the principal investigator for incidence calculation. Patients or their relatives will be informed about the study by an information sheet presented and explained by the investigator or another person authorized to conduct the research. The investigator will record the patient's consent in the patient's medical record.

Official Title
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Incidence and Morbidity of Cardiac Rhythm Disorders in Patients Assisted by Extra Corporeal Membrane Oxygenation Veno-arterial (ECMO VA) for Refractory Cardiogenic Shock

Conditions
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Cardiac Rhythm Disorder

Intervention / Treatment
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* Other: Follow up by phone call


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient 18 years of age or older Assistance with VA ECMO Exclusion Criteria: Opposition to the use of data. Persons under legal protection (curators, guardianship), judicially safeguarded. VA ECMO for refractory cardiac arrest.

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Patients with refractory cardiogenic shock assisted with ECMO VA<br> | Other: Follow up by phone call<br>* Centralized review of ECGs by the Pitié-Salpêtrière rhythmology department and collection of vital status at 12 months (if information not available, telephone call to the patient)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of atrial fibrillation in patients assisted by veno-arterial ECMO. | Atrial fibrillation will be defined as an episode of AF ≥ 30 minutes or requiring pharmacological or electrical cardioversion. | day 30 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventricular rhythm disorders | ventricular tachycardia, ventricular fibrillation | day 30 | 
| duration of VA ECMO support | duration of VA ECMO support | day 30 | 
| duration of ICU stay | duration of ICU stay | day 30 | 
| duration of mechanical ventilation | duration of mechanical ventilation | day 30 | 
| Number of living patient | Number of living patient | day 28, day 360 | 
| Number of thrombo-embolic complications | acute limb ischemia, circuit thrombosis, membrane thrombosis | day 30 | 
| Number of neurological complications | ischemic and hemorrhagic stroke | day 30 | 
| Number of bleeding complications | bleeding requiring transfusion of packed red blood cells (> 3 units / 24h) or requiring surgical intervention or interventional procedure (digestive or implantation site bleeding, need for revision surgery | day 30 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Arrhythmia, Veno-arterial Extra Corporeal Membrane, Oxygenation (VA ECMO), Cardiogenic shock.