6.10
Instructions for Use & Clinical Reference Manual (US)
Figure 6.5 Right ventricular function changes from baseline to 30 days or discharge
Device Malfunctions:
During the RECOVER RIGHT trial, the clinical investigators reported seven (7) device malfunctions in 7
different patients: 5 were related to the Impella RP pump, one to the AIC and one to the off the shelf
introducer sheath. Only one affected patient had a device related AE, which was related to the initial
insertion of the Impella RP pump, which ultimately was successfully delivered for support.
TRIAL CONCLUSIONS
Safety:
The nature and types of risks associated with the Impella RP System are consistent with those expected
in the device treatment of this very sick patient population. Successful percutaneous insertion was
achieved in 97% of the patients. The number of device related AEs was low.
Effectiveness:
In the cohorts studied, use of the Impella RP System to provide percutaneous hemodynamic support for
right heart failure had a high survival rate. The 30-day survival rate in the 30 patients treated with the
Impella RP System was 73%, a substantial improvement over expected survival for medically treated
patients. Additional benefits relating to supplementation of right heart output, hemodynamic stability,
unloading of the RV, and RV recovery or bridge to another therapy were seen in this small trial.
Percutaneous insertion and removal allowed by the Impella RP design resulted in a very low incidence
of bleeding and vascular complications. Support durations were relatively short, ranging from 13 hours
to 8 days.
Risk Benefit:
The positive survival and hemodynamic benefits associated with use of the Impella RP System,
combined with the acceptable incidence of adverse events for the patient population being treated,
suggest the probable benefits of Impella RP use in the treatment of acute right or decompensation heart
failure outweigh its risks. This benefit-risk determination is also acceptable when taking into account the
