A multicenter prospective feasibility study of the Impella 2.5 temporary cardiac assist device (The PROTECT I Trial), published in Journal of the American College of Cardiology, has found that the device is “easy to implant, and provides excellent hemodynamic support during high-risk PCI.” That is good news for Abiomed, the manufacturer of the device which is designed to pump blood out of the left ventricle and augment cardiac output by up to 2.5 liters per minute, to provide assistance to patients with severely compromised, depressed hearts. The big trick is now for the company to convince cardiologists that its device is better, and maybe even safer, than commonly used Intra Aortic Baloon Pumps (IABPs). We, of course, have been following the Impella system for many years now, ever since it was a German invention.
From the current study abstract:
The PROTECT I trial enrolled 20 patients undergoing high-risk PCI at seven centers between July 2006 and April 2007. Eligible patients had left ventricular ejection fraction (EF) of less than 35% and were required to undergo PCI on either an unprotected left main coronary artery or the last patent coronary conduit
Methods: In a prospective, multicenter study, 20 patients underwent high-risk PCI with minimally invasive circulatory support employing the Impella 2.5 system. All patients had poor left ventricular function (ejection fraction ≤35%) and underwent PCI on an unprotected left main coronary artery or last patent coronary conduit. Patients with recent ST-segment elevation myocardial infarction or cardiogenic shock were excluded. The primary safety end point was the incidence of major adverse cardiac events at 30 days. The primary efficacy end point was freedom from hemodynamic compromise during PCI (defined as a decrease in mean arterial pressure below 60 mm Hg for >10 min).
Results: The Impella 2.5 device was implanted successfully in all patients. The mean duration of circulatory support was 1.7 ± 0.6 h (range: 0.4 to 2.5 h). Mean pump flow during PCI was 2.2 ± 0.3 l/min. At 30 days, the incidence of major adverse cardiac events was 20% (2 patients had a periprocedural myocardial infarction; 2 patients died at days 12 and 14). There was no evidence of aortic valve injury, cardiac perforation, or limb ischemia. Two patients (10%) developed mild, transient hemolysis without clinical sequelae. None of the patients developed hemodynamic compromise during PCI.
Conclusions: The Impella 2.5 system is safe, easy to implant, and provides excellent hemodynamic support during high-risk PCI. (The PROTECT I Trial; NCT00534859)
Animation demonstrating the functioning of the pump…
Press release: Journal of the American College of Cardiology Publishes PROTECT I Study Results for Abiomed Impella 2.5
Abstract in Journal of the American College of Cardiology…
Product page: Impella 2.5
Flashbacks: Impella 2.5 Heart Pump Given Green Light in US; Impella Percutaneous VAD to be Studied for Acute MI Patients; impella® recover LV
