Impella® RP with the Automated Impella® Controller
6.1
PIVOTAL CLINICAL STUDY DESIGN – RECOVER RIGHT
RECOVER RIGHT was a prospective, multi-center, non-randomized study. The primary objective for the
study was to assess safety and effectiveness of the use of the Impella RP device in patients with RVF
refractory to medical treatment who require hemodynamic support. The intent of therapy was to restore
normal right heart hemodynamics, reduce right ventricular work, and allow the right heart time to
potentially recover adequate contractile function or to be bridged to the next therapy.
The primary endpoint was the survival rate at 30 days post device explant or hospital discharge
(whichever is longer), or at induction of anesthesia for a longer term therapy, including heart transplant
or implant of a surgical RVAD (as a bridge-to-recovery or bridge-to-transplant).
Secondary effectiveness endpoint was determined by the following:
•
Central venous pressure (CVP) and cardiac index (CI) improvement post initiation of Impella
RP support
•
Decreased use of inotropes during support
•
Improvement in LVAD flow or left ventricle pumping function secondary to the increased
venous return by the Impella RP within 48 hours post implant
Secondary safety endpoint was determined by the rates of the following adverse events at 30 days or
discharge (whichever is longer), or at induction of anesthesia for a longer term therapy, including heart
transplant or implant of a surgical RVAD (as a bridge-to-recovery or bridge-to-transplant:
•
Death (any cause of death and cardiac death)
•
Major bleeding
•
Hemolysis
•
Pulmonary embolism
•
Tricuspid/pulmonary valve dysfunction (defined as tricuspid/pulmonic valve injury resulting in
increased valve regurgitation versus baseline)
INCLUSION AND EXCLUSION CRITERIA
The study population consisted of consented patients (
≥ 18 years of age) who developed RVF either a)
during or after durable LVAD implantation (Cohort A) or b) subsequent to post-cardiotomy cardiogenic
shock or post myocardial infarction (Cohort B).
RVF was defined as:
•
A CI <2.2 l/min/m
2
despite continuous infusion of high dose of inotropes and any of the following:
•
CVP >15 mmHg or
•
CVP/PCWP or LAP >0.63 or
•
Moderate to severe global RV dysfunction on echocardiography defined as one of the following
criteria: global RV hypokinesis, a TAPSE score of ≤14 mm, right ventricular diameter at base >42mm,
right ventricular short axis (or mid cavity) diameter >35mm)
•
High dose of inotropes was defined as Dobutamine of ≥10µg/kg/min or equivalent for more than 15
minutes (120 minutes for milrinone) and/or administration of more than one inotrope/vasopressor
medication
