Impella RP Flex^TM Insertion: Medical Science Office Discussion

“We’ve heard from most of our customers, it’s the easiest device we have to implant,” Bobbi Chapman, MD, states during this discussion about insertion of the Impella RP Flex^TM with SmartAssist^TM. “If it were any easier it would implant itself.”

The Impella RP Flex is a percutaneously inserted right-sided mechanical circulatory support device that can be placed in either the cath lab or operating room, typically via the femoral vein or internal jugular (IJ) vein. “The Flex has been a significant advance in terms of the ease of insertion,” Navin Kapur, MD, explains, as he talks about femoral versus IJ insertion. “Both are very doable. In terms of selecting one or the other, honestly, it’s a timing and practicality issue. If I think the patient’s going to be on support for more than 24-48 hours, then we’ll tend to favor the IJ approach. Or if it’s going to be a pretty short run then we’ll go ahead with the femoral approach.”

“And obviously if we can have an insertion site above the diaphragm,” Dr. Chapman adds, “patients can get up and walk around, which allows patients to not only have better nutrition after a procedure, but also to rehab and improve their frailty.”

The physicians discuss the importance of early identification of right heart failure to improve patient outcomes. “Unmasking right heart failure is something that requires a little bit of maneuvering in the cath lab,” Dr. Kapur explains. He describes giving volume load and observing CVP. “We’ll watch the CVP go from 5 up to 15, and that tells you right away that this RV cannot tolerate volume overload.” He highlights that the time to intervene is when patients are hypotensive, have elevated CVP, or are experiencing suction on left-sided support.

Dr. Kapur highlights a key lesson from the RECOVER RIGHT trial: “the longer you waited, the worse the outcome.” He emphasizes, “If you can get to the patients in the first 24 hours, before they deteriorate in their shock condition, those are the patients who do well with the RP device. Once you have multiorgan dysfunction, it is really hard, no matter what device you’re using, to pull that patient out of that scenario.”

The physicians also discuss special considerations when inserting the Impella RP Flex with SmartAssist in a patient who already has a durable left ventricular assist device (LVAD). Dr. Kapur expresses a preference for the IJ approach in these patients—even though a femoral approach may be easier, faster, and more readily accessible—because the goal is to get patients to sit up and ambulate.

The discussion concludes with the topic of hemostasis after device placement. Dr. Kapur emphasizes that it is important to think about closure and hemostasis before inserting the device. Hemostasis is less of an issue in the low-pressure environment of the venous side compared to the arterial side and in his experience purse-string or mattress sutures typically suffice.