Maquet Cardiovascular USA has announced the publication of a manuscript comparing the clinical and economic impact of percutaneous ventricular assist devices (pVAD) with intraaortic balloon pumps for high-risk patients undergoing percutaneous coronary intervention (PCI). The paper, titled "Clinical and Economic Effectiveness of Percutaneous Ventricular Assist Devices for High-Risk Patients Undergoing Percutaneous Coronary Intervention," appears in the March, 2015 volume of the Journal of Invasive Cardiology.

The study, led by Atman P. Shah, MD, Associate Professor of Medicine, Director, Coronary Care Unit and Co-Director, Cardiac Catheterization Laboratory at The University of Chicago, conducted a review of all comparative randomized control trials of the pVADS (Impella and TandemHeart) vs IABP for patients undergoing high-risk percutaneous coronary intervention (PCI). A retrospective analysis of the 2010 and 2011 Medicare MEDPAR data files was also performed to compare procedural costs and hospital length of stay (LOS). Readmission rates between the devices were also studied.

From a clinical standpoint, the study demonstrated no conclusive clinical benefit in trial patients treated with pVADs compared with IABP--despite the additional costs of pVADs. pVADs were not shown to be associated with improved clinical outcomes, reduced hospital length of stay, or reduced readmission rates. Economically, first-line management of high-risk PCI and cardiogenic shock patients with IABP was shown to be more cost effective than routine use of pVADS. Use of IABP as initial therapy in high-risk PCI and cardiogenic shock patients may result in savings of up to $2.5 billion annually of incremental costs to the hospital system.

"The cath lab has a long tradition of implementing therapies to take care of patients quickly and effectively," said Dr. Shah. "Using IABP as a first-line strategy for cardiogenic shock and high-risk PCI patients with an escalating approach toward pVADs for refractory patients makes clinical sense in that IABP is easy and quick to deploy in addition to being cost effective."

Dr. Pierluca Lombardi, Chief Medical Officer, Maquet Cardiovascular said, "Intraaortic balloon pumps remain the most studied and most used devices for high-risk patients undergoing percutaneous coronary intervention because of their ease ,speed of use and low complication rates. Comparative effectiveness research influences hospital treatment protocols and health-care coverage policies by showing health-care providers the impact of new devices on costs and outcomes. We're pleased to offer doctors a first-line option that is cost-effective and clinically beneficial."