CARDSUP - SWISS Circulatory Support Registry

Study Overview
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Brief Summary
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The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.

Detailed Description
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This prospective data collection is made up of an all-comers design, including all eligible consecutive patients receiving an Impella (2.5, 5, CP, or RP) or VA-ECMO device via femoral access who gave their consent (or, if not possible, their relative). The project's main goal is to collect baseline clinical and procedural data as well as to assess clinical outcomes for all patients undergoing ECMO or Impella implantation at all included sites. All patients undergoing ECMO and/or IMPELLA implantation will be prospectively registered. Device use is according to the decision of the treating physician and independent of this registry.

Official Title
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Clinical Outcomes in Patients in Need of a Non-permanent Extracorporeal Cardiocirculatory Support System (Peripheral Extracorporeal Membrane Oxygenation (ECMO) or Axial Flow Pump IMPELLA)

Conditions
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Cardiogenic Shock

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Medical indication for implantation of a peripheral cannulated VA-ECMO or microaxial flow pump (IMPELLA) or newer LV / LA-Ascending Aorta devices. Signed informed consent by patient or relative or waived consent by EC Exclusion Criteria: None

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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of deceased participants at 1 month after cardiogenic shock | All-cause mortality at 30 days | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants | Major adverse cardiac and cerebrovascular events (MACCE) | 6 months | 
| Statistical and medical analysis of vascular complications (VARC) reported by participants | Vascular complications (VARC) | 6 months | 
| Statistical and medical analysis of vascular surgery needed by participants | Need for vascular surgery | 6 months | 
| Statistical and medical analysis of bleeding complications (minor, major) reported by participants | Bleeding complications (minor, major) | 6 months | 
| Implantation time of MCS-device | Implantation time of MCS-device | 6 months | 
| Support time under MCS | Support time under MCS | 6 months | 
| Analysis of New York Heart Association (NYHA) Classification for participants | The New York Heart Association (NYHA) Classification provides a way of classifying the extent of heart failure. It classifies patients in one of four categories based on their limitations during physical activity; the limitations/symptoms are in regards to normal breathing and varying degrees in shortness of breath and or angina pain. Class I is defined as no symptoms and no limitation in ordinary physical activity worsening to Class IV defined as severe limitations. | 6 months | 
| Modified rankin scale | Modified rankin scale measures the degree of disability or dependence in the daily activities of people who have suffered a stroke or other causes of neurological Disability. The scale ranges form 0-6 with 0 defined as no Symptoms and 5 being severe Symptoms and 6 defined as death. | 6 months | 
| Number of deceased participants at 6 month after cardiogenic shock | Mortality at 6 months | 6 months |