The Pediatric Interagency Registry for Mechanical Circulatory Support (Pedimacs), a National Heart, Lung, and Blood Institute–supported North American registry of mechanical circulatory support in the pediatric population, has expanded significantly since its inception September 19, 2012. Developed as part of the Interagency Registry for Mechanically Assisted Circulatory Support (Intermacs) registry. Pedimacs was designed to prospectively collect data relevant to the unique aspects of ventricular assist device (VAD) support in patients aged younger than 19 years.

VAD could be implanted in patients with chronicle HF as bridge for HTx or in cases of acute HF as bridge to recovery. Currently VAD in children as bridge to destiny is not accepted worldwide.

INCLUSION CRITERIA FOR  MECHANICAL ASSISTING DEVICE IN PEDIATRIC HF

NYHA  IV (or Ross IV for subjects < 6 years) HF refractory to medical therapy, with at least one of the following criteria:

1. INTERMACS 1 or 1A : cardiogenic shock (low BP unresponsive to support, compromised end organ perfusion, < 24 hour survival expected without MCS; may be due to VTach/VF (1A)
2. INTERMACS 2 or 2A : (progressive decline): not in imminent danger, but worsening despite inotropic therapy; may be due to VT/VF (2A) AND at least one of the following criteria:
   Decline in renal function  (50% reduction in estimated GFR despite optimization of subject volume status
   Decline in nutritional status (sustained 7 days inability to tolerate an enteral nutritional intake sufficient to provide at least 75% of the prescribed caloric needs, or signs of nutritional compromise (cachexia, nutritional weight loss) despite appropriate intervention
   Decline in mobility/ambulation as defined by sustained bed confinement ( 7 days without prospect for improvement) attributable to heart failure symptoms or its treatment (e.g. intubation for pulmonary edema)
3. Support with ECMO without possibility of weaning after 2 weeks of support.
4. Unable to separate from CPB after 1-2 weeks of ECMO support and no surgical residuals lesions (must be listed for HTX)

EXCLUSION CRITERIA FOR  MECHANICAL ASSISTING DEVICE INSERTION

1. Intracranial hemorrhage or platelet disorders or contraindication to anticoagulant/anti-platelet therapy
2. Coagulopathy ( Factor VIII deficiency, disseminated intravascular coagulation) or thrombophilic disorder (Factor V Leiden mutation)
3. Hematologic disorder causing fragility of blood cells or hemolysis (sickle cell disease)
4. Active infection within 48 hours of implant demonstrated by: Positive blood culture OR  Temperature >38 degrees C and WBC >15, 000/ ml
5. HIV or AIDS or malignancy
6. Stroke within past 30 days prior to enrollment, or congenital CNS malformation syndrome associated with increased risk of bleeding (AV malformation, Moya Moya)
7. Psychiatric or behavioral disease (antisocial disorder) with high likelihood for non-compliance