Rajan Patel, MD, FACC, FAHA, FSCAI, discusses clinical data supporting Impella® use in Protected PCI and cardiogenic shock. He presents data that established the safety and effectiveness of Impella and resulted in postmarket approval for Impella for high-risk PCI and cardiogenic shock. He also discusses data identifying and validating best practices as well as studies underway to strengthen guidelines. Dr. Patel is the interventional cardiology fellowship program director and medical director of the CTO PCI program at Ochsner Medical Center in New Orleans, LA. He gave this presentation as part of the Cardiovascular Research Technologies (CRT) virtual annual symposium in 2021.

Dr. Patel begins by reviewing data from the PROTECT II randomized controlled trial (RCT), highlighting the 29% relative reduction in MACCE (death, stroke, MI, repeat revascularization) in the Impella group at 90 days as well as the 47% reduction in adverse events post-discharge with Impella. He then discusses more recent results from the PROTECT III post-approval study showing even better patient outcomes with lower MACCE rates at 90 days in an even more complex patient population. “This is likely a result of more experience among these operators as well as better patient selection,” Dr. Patel notes.

“But to get that Class I indication, we’re going to need a large multicenter randomized controlled trial,” Dr. Patel explains, “and that’s where PROTECT IV comes in.” He discusses the PROTECT IV study design, explaining that it is a true randomized trial with no crossover and operators are required to document their planned revascularization strategy prior to randomization. All sites will use high volume complex PCI operators and require clinical and procedural best practices (eg, heart team consultation and large bore access best practices). The trial is empowered for superiority to determine whether complex high-risk PCI with Impella is superior to the same type of PCI without Impella support.

Dr. Patel also briefly discusses the Impella clinical evidence pathway to Class I recommendation in cardiogenic shock, mentioning best practices validated in the National Cardiogenic Shock Initiative (NCSI) study, in the Inova system, and in the ongoing DanGer Shock trial.

Dr. Patel then discusses work by Navin Kapur, MD, examining LV unloading in patients with stable MI without shock and demonstrating a decrease in infarct size with 30 minutes of Impella support prior to PCI in patients with large AMIs. The STEMI-DTU Pivotal study, he explains, is an RCT superiority study with an independent steering committee and independent angiographic and echo core labs.

Finally, Dr. Patel mentions the SMART Pump Early Feasibility Study, a small ongoing study by Amir Kaki, MD, and colleagues using the Impella CP® with SmartAssist®. The study tests whether cloud-based predictive artificial intelligence (AI) parameters can be safely calculated and can predict what will happen in a patient (eg, predict hemodynamic embarrassment or hemodynamic collapse) before it occurs so that operators can take preventative steps.

“And hopefully,” Dr. Patel concludes, referring to all the data he’s presented, “we’ll be seeing the fruits of this research in the next couple of years.”