FDA acknowledges high-risk PCI population, gives nod to blood pump system

by Srihari S. Naidu, MD

PCI has had its ups and downs, and unfortunately mostly downs in recent years. After the exuberance of the 90s and early 2000s, the field was hit first by concerns regarding stent thrombosis and then by concerns regarding overutilization. Cumulative evidence continues to support PCI for revascularization in subsets of patients who clearly benefit, such as those with ongoing angina despite medications, significant ischemic burden or CAD-related reductions in ejection fraction. However, until now, one population was not fully defined or acknowledged: the high-risk PCI subgroup.

High-risk PCI was always thought of as a small group of fringe patients who could be revascularized without support, or as such a small group so as not to matter. Well, no longer! After the PROTECT 2 trial showed improvements in per–protocol-determined adverse events at 90 days and hemodynamic superiority to the intra-aortic balloon pump (IABP), despite ending early for presumed futility, the FDA has now looked at the trial and the totality of the evidence and voted in favor of a premarket approval (PMA) to label and market the miniature blood pump system (Impella 2.5, Abiomed Inc.) as both safe and effective in supported high-risk PCI. A heart team is required in such patients, and although the device is labeled for 6 hours, there is a provision for longer use if medically necessary.

Srihari S. Naidu

This is big news. It means that there are now enough data to state that this support system should be used in such patients to improve outcome and make the procedure safer.

All interventional cardiologists should become familiar with the device, including implantation and explantation, and large bore access site pre-closure techniques. Hospitals should also gain familiarity with physician and hospital billing for such procedures. Importantly, this approval means that IABP and extracorporeal membrane oxygenation can no longer be considered the preferred strategy in such patients. If support is deemed necessary, the Impella 2.5 system should be used, as it is the only device with an on-label indication. Practice guidelines will need to acknowledge this when updated.

But there is another big win here. This FDA indication for the first time acknowledges that there is a population of patients out there who are in need of high-risk PCI — those who might typically get bypass surgery but who are deemed too high risk. This is not a small group of patients, and we should be out there looking for them. They are the recurrent HF admissions and the chronically low ejection fraction patients in whom we keep titrating meds. They are the patients in whom the coronary anatomy has either not been fully defined or has not been redefined in the past few years. These patients should all pass through our hands so that high-risk PCI can be performed safely if found, and these tough patients can reap the benefits of complete or near-complete revascularization.

What is your experience with this device? What wisdom would you share about patient selection, techniques and/or approaches to the high-risk patient? Let us know your thoughts on this Eye on Intervention blog by submitting a comment.

Srihari S. Naidu, MD, FACC, FSCAI, is director of the cardiac catheterization laboratory, interventional cardiology fellowship program and Hypertrophic Cardiomyopathy Treatment Center at Winthrop University Hospital in Long Island, New York. He is a past trustee of SCAI and a current trustee of Brown University.

Disclosure: Naidu reports serving on the scientific advisory board for Abbott Vascular, Abiomed, Gilead and The Medicines Company.