Back to Annual Meeting Program
First Clinical Experience with a Novel Percutaneous Short-Term Right Ventricular Assist Device: The Impella RP
Anson Cheung1, Pascal Leprince2, Dan Raess3, Darren Freed4.
1St. Paul's Hospital, Vancouver, BC, Canada, 2Pitie-Salpetriere Hospital, Paris, France, 3Abiomed Inc, Danver, MA, USA, 4St. Paul's HospitalSt. Boniface Hospital, Winnipeg, MB, Canada.
Background: Right ventricular (RV) failure is a clinical problem associated with a high mortality in the setting of post-cardiotomy cardiogenic shock, cardiac transplant, right ventricular infarction, pulmonary embolism and after left ventricular assist device (LVAD) implantation. Temporary mechanical right ventricular support could be a reasonable option in these patients. We report the initial first clinical evaluation of a novel minimally invasive percutaneous right ventricular assist device, Impella RP.
Methods: Impella RP is a new, minimally invasive, 3D catheter-based percutaneous microaxial pump that is designed for short-term right ventricular support. The device is inserted percutaneously via the femoral vein using Seldinger techniques. The device (22 Fr microaxial pump mounted on an 11 Fr catheter) is positioned under fluoroscopic and echocardiographic guidance. It delivers up to 4.4 liters/min of blood flow from the inferior vena cava into the pulmonary artery transversing the tricuspid and pulmonary valve. A First in Man pre-market clinical feasibility evaluation has been initiated at several sites in Canada and Europe.
Results: Five patients received the device for cardiogenic shock primary from RV failure (2- post cardiac transplant, 2-post LVAD and 1-RV infarct) in three centres. Successful implantation occurred in all patients. The support time ranged from 1 to 7 days with a median of 6 days. The average flow was 3.7 L/min. Three patients were successfully weaned and had the device explanted. There was no major device-related morbidity. Overall thirty-day survival was 80%.
Conclusion: Impella RP is a novel percutaneous right ventricular assist device. The design was enhanced after the first human implant to improve torque-ability and push-ability, resulting in ease of placement for the subsequent patients. It delivers sufficient flow and allows RV recovery in cardiogenic shock patients with RV failure. The preliminary clinical experience is very encouraging and further evaluation is ongoing.
Back to Annual Meeting Program