The use of Abiomed’s Impella 2.5, a left ventricular assist device (LVAD) used periprocedurally, is a safe and feasible mechanism for hemodynamic support, a study published in the Dec. 15 issue of the Journal of the American College of Cardiology found.
“Although, the exact role of mechanical cardiac assistance in peri-procedural risk management of complex and high-risk PCI procedures remains a matter of debate, the recently introduced percutaneous LVADs might be a superior alternative to intra-aortic balloon pump (IABP),” wrote the authors.
Krischan D. Sjauw, MD, of the Academic Medical Center at the University of Amsterdam, and colleagues studied 144 patients who received prophylactic circulatory support with the Impella 2.5 during high-risk PCI between July 2004 and December 2007.
Of the patients, 62 percent were 70 years of age or older, and 54 percent had a reduced LV ejection fraction.
According to the researchers, the purpose of the study was to investigate safety and feasibility measures of the Impella 2.5, a “minimally invasive percutaneous LVAD” that provides flow support of up to 2.5 l/min with maximum rotation speeds of 51,000 rpm. The Impella device is a catheter-mounted micro-axial rotary blood pump, which is positioned across the aortic valve into the LV with fluoroscopy using a femoral approach.
“Because peri-procedureal hemodynamic compromise and complications can occur rapidly, a growing number of high-risk PCI procedures are being performed with mechanical cardiac assistance, particularly in patients with poor left ventricular function,” the authors wrote.
During the study, the researchers measured primary safety end points at 30 days; this included the incident rates of major adverse cardiac and cerebral events such as death and major bleeding. Device malfunction, rates of infection and vascular complications were also gauged.
Researchers found that 12.4 percent of the patients implanted with the device reached the primary safety end points. No cases of reported device malfunction were reported, but incidents of major bleeding occurred in nine patients. While eight patients died (5.5 percent) during the study, these deaths were unrelated to device implantation.
In addition, results showed that device implantation and explantation were considered “easy” or “suitable” in more than 99 percent of patient cases.
Patients were studied from the Europella registry from 10 tertiary PCI centers throughout Europe.
According to the authors, the guidelines for mechanical cardiac assist device in elective PCI are “conservative,” because the procedure is only recommended “in patients with very poor LV dysfunction or those considered at high risk of peri-procedural hemodynamic collapse.”
Currently, the reported usage of IABP in PCI patients is between 4.9 to 64 percent, according to the authors. Although numbers illustrate that survival rates improve when the IABP approach is used, the authors said that the safety and feasibility of percutaneous LVADs show the capability of them providing better cardiac support compared to IABP.
Presently, a large number of these percutaneous LAVDs is being developed, which the authors said will increase the treatment possibilities, especially in high-risk PCI procedures.
The Impella 2.5 is CE marked for periods of five days and has received FDA 510(k) clearance for periods of up to six hours. The registry was supported by Abiomed Europe.