Cost scrutiny and comparative effectiveness research are playing a growing role in shaping healthcare delivery. In light of that, Abiomed Inc. (Danvers, MA) has recently announced the results of a study that showed the company’s Impella heart pump significantly reduced major adverse events at an incremental cost per quality-adjusted life year. “The cost-effective message is directly tied to the financial impact of these better clinical outcomes for patients treated with Impella,” Jeffrey Popma, MD, the director of the angiographic Core Laboratory at Beth Israel Deaconess told Medgadget. Popma was responsible for the planned analysis of the angiographic results.
The device, which the company describes as the “world’s smallest heart pump,” demonstrated an increase in ejection fraction of more than 20% and an improvement in New York Heart Association (NYHA) Class III and Class IV heart failure of more than 50%. “For patients who have this very complex coronary disease with reduced left ventricular ejection fraction (LVEF), there is a benefit to complete revascularization,” Popma explained. “If one is to do extensive revascularization, there is an additional advantage for the Impella device compared with the balloon pump. We want to fix as much as we can, and we can do that more safely with the Impella device.”
From the announcement:
This study was performed by Prescott Associates and the Harvard Clinical Research Institute (HCRI), utilizing data on patients enrolled in the PROTECT II trial, which is the first randomized trial comparing prophylactic use of hemodynamic support in patients with depressed left ventricular function and complex anatomy. The study demonstrated a gain in quality of life for Impella patients over the current standard of care, the intra-aortic balloon pump (IABP), at an incremental cost-effectiveness ratio (ICER) of $39,400, below the $100,000 threshold commonly used in the United States.
The economic study results were consistent with overall PROTECT II 90 day clinical outcomes previously released. In the 90 days following initial hospitalization, Impella patients experienced:
- 50% lower re-hospitalization costs compared to the IABP (p=0.023);
- 58% reduction in hospitalizations due to repeat revascularization (p=0.024);
- Two fewer days in the hospital (p=0.001)
Press release: Economic Study Demonstrates Cost-Effectiveness of Impella Presented at TCT 2011