Cardiogenic Shock, Mechanical Circulatory Support, PCI Patients
Conditions
Keywords
IMPELLA, CARDIOGENIC SHOCK, COMPLEX PCI
Brief summary
The IMMERGE registry is an observational, international multicentric study, including patients underwent IMPELLA implantation in the participating centers both for cardiogenic shock and high-risk PCI. Only IMPELLA CP, 5.0 and 5.5 devices will be included. Consecutive patients with CS and CHIPs implanted with Impella® CP, 5.0 and 5.5 with at least 6 months of follow-up completed will be enrolled in the registry. Baseline clinical and echocardiographic variables, peri-procedural haemodynamic parameters, laboratoristic findings and complications, together with follow-up outcomes data will be recorded in a dedicated database.
Interventions
DEVICEImpella implantation
To implante Impella
Sponsors
A.O.U. Città della Salute e della Scienza
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Males or females ≥ 18 years-old with CS or CHIPs * Impella® device implanted (CP, 5, 5.5)
Exclusion criteria
* Age \< 18 years * No Impella implanted
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| long-term overall mortality | 12 months |
Secondary
| Measure | Time frame |
|---|---|
| 30-day overall and cardiovascular mortality | 30 day |
| Rate of acute kidney injury (AKIN classification) and need for renal replacement therapy (RRT) | 12 months |
| Rate of bleedings according to the BARC classification | 12 months |
| Rate of vascular complications, limb-ischemia, hemolysis (INTERMACS definition) | 12 months |
| Rate of neurological events (stroke and TIA) | 12 months |
Countries
Italy
Outcome results
None listed