Cardiogenic Shock
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
Insel Gruppe AG, University Hospital Bern
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of deceased participants at 1 month after cardiogenic shock | 30 days | All-cause mortality at 30 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Statistical and medical analysis of vascular complications (VARC) reported by participants | 6 months | Vascular complications (VARC) |
| Statistical and medical analysis of vascular surgery needed by participants | 6 months | Need for vascular surgery |
| Statistical and medical analysis of bleeding complications (minor, major) reported by participants | 6 months | Bleeding complications (minor, major) |
| Implantation time of MCS-device | 6 months | Implantation time of MCS-device |
| Statistical and medical analysis of major adverse cardiac and cerebrovascular events (MACCE) reported by participants | 6 months | Major adverse cardiac and cerebrovascular events (MACCE) |
| Analysis of New York Heart Association (NYHA) Classification for participants | 6 months | 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. |
| Modified rankin scale | 6 months | 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. |
| Number of deceased participants at 6 month after cardiogenic shock | 6 months | Mortality at 6 months |
| Support time under MCS | 6 months | Support time under MCS |
Countries
Switzerland
Contacts
Primary ContactLukas C Hunziker Munsch, Prof MD
Backup ContactMonika Fürholz, MD
Outcome results
None listed