PumpKINJarvik 2015 VAD para Insuficiencia Cardíaca Pediátrica

Surgical placement of the Jarvik 2015 VAD

Surgical Placement of Jarvik 2015 VAD

Clinical Feasibility

Adverse Events

Technical, surgical, and clinical milestones assessed by feasibility milestones

Pivotal Trial continuation assessed by exploratory primary and secondary endpoints

Paralytics discontinuation

Inotropic agents

Sedation

MRI

King's Outcome Scale for Childhood Head Injury score (0 -5 scale, higher = worse outcome)

Incidence of Adverse Events per patient days of VAD support

Incidence of Adverse Events related to device

Neurological dysfunction

Pediatric Stroke Outcome Measure Neurological Exam (PSOM-NE) score (0 - 10 scale, higher = worse outcome)

Pediatric Stroke Recurrence and Recovery Questionnaire score (0 -10 scale, higher = worse outcome)

Vineland Adaptive Behavior Scales score (scoring and scale different by domain)

Pediatric Quality of Life score (0-4 scale per domain, higher = worse outcome)

Ventricular Assist Device Quality of Life score (scoring and scale different per question)

TPN discontinuation

Extubation

Survival in absence of severe neurological impairment

Overall survival in the absence of device failure

Survival at 30 days post-implant

Survival at 180 days post-implant

Survival at 12 months post-explant

Time to pump failure

Incidence rate of pump failure

Time to first pump exchange

Incidence rate of pump exchange

Creatinine level

ALT level