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OBJECTIVE:
The primary objective was to evaluate the biocompatibility and operating performance of the Impella RP, a novel transvalvular endovascular right heart assist system, for a period of 14 days in a bovine model.
METHODS:
Impella RP pump was surgically inserted into the right heart through the caudal vena cava (CVC) after the vessel was surgically exposed through a right retroperitoneal approach. Correct Impella catheter orientation across the tricuspid and pulmonic valves was facilitated and documented by fluoroscopy. At the completion of the minimum 14-day period of pump operation, the animals were anesthetized and the pump was surgically removed. ICE was performed prior to and immediately after pump implantation and explantation. The animals were survived for a period of at least 14 days after pump removal at which time the animals were euthanatized and underwent necropsy.
RESULTS: All animals (n=6) were successfully maintained on device support for 14 days. The average flow was 2.2 L/min at the mid range of device support, or P4. All animals survived 14 days post explant. There were no clinically significant adverse events from implant through euthanasia. The ICE imaging showed no valve or heart structure injuries. Hematologic and serum chemistries as well as plasma free hemoglobin levels were normal in all animals throughout the support period. The necropsies showed no abnormalities of the pulmonary valves and only a minor healed abrasion on the septal leaflet of the tricuspid valve in one animal. Gross and microscopic evaluation of the pulmonary parenchyma showed no evidence of pulmonary embolization.
CONCLUSIONS: The use of Impella RP in this animal model was safe with no acute or short term device related adverse events. All pumps operated to 14 days and provided flows that were within expected ranges. A novel implant technique allowing chronic right heart access in a bovine model is described.