SAN FRANCISCO—The Impella device has been shown to reduce major adverse events in patients undergoing extensive revascularization with PCI. Now, results of an economic study have shown that using the Impella device during PCI can reduce adverse events at a decent price tag, according to results presented Nov. 8 at the 23rd annual Transcatheter Cardiovascular Therapeutics (TCT) conference.
The cost-effective analysis was based on the results of the PROTECT II trial, the first randomized clinical trial to compare a hemodynamic support device in patients with reduced left ventricular function and a complex anatomy. The outcomes of the Impella (Abiomed) device were compared to those outcomes of intra-aortic balloon pump (IABP) devices."This high-risk patient population has never been studied before due to the increased risk of revascularization," Brijeshwar Maini, MD, chair of the structural heart program at PinnacleHealth and cardiologist at the Moffitt Heart & Vascular Group in Wormleysburg, Pa., told Cardiovascular Business .
The aim of the study was to evaluate the cost-effectiveness for Impella patients versus IABP patients. To do so, Maini et al measured resource utilization during episodes of care and incremental cost per quality-adjusted life-years (ICERs).
During PROTECT II, it was reported that patients who received the Impella device saw a decrease in major adverse event rates by 56 percent. "These results are extremely significant," Maini offered. Additionally, these patients saw a 52 percent reduction in repeat revascularization procedures.
"Where will the dollar signs come in to play?" Maini asked. "Starting in 2012 hospitals will be fined for readmission procedures, so it will become even more important that we are using therapies that will help to decrease readmissions." According to Maini, results showed that patients who received the Impella device saw an increase in quality-of-life with an incremental cost-effectiveness ratio of $39,400, a number that is well below the current $100,000 threshold used in the U.S.
The cost-effectiveness of the Impella device is somewhat similar to both transcatheter aortic valve implantation procedures ($50,200 ICERs) and dialysis, Maini noted.
"What really led to the decreased costs was the decrease in readmissions," Maini said.
The total hospital costs and index hospital costs were similar for Impella and IABPs, $172,583 vs. $173,403, respectively. "The differences in costs really came from the reduction in repeat hospitalizations seen with Impella," according to Maini.
Despite the fact that Impella devices are much more costly than balloon pumps, $22,000 (Impella 2.5) compared with $800-$1,000 (estimations), in terms of quality of life, Impella patients may fair better.
According to Maini, the results were two-fold. While Impella patients saw less hospital readmissions, when these patients were readmitted they also saw shorter length of stay when compared with balloon pump patients who were readmitted to the hospital--seven days vs. five days.
In comparison, using a left ventricular assist device (LVAD) has previously been shown to have an incremental cost per life year between $199,000 and $274,000.
"We are not comparing apples to apples here," Maini said. "These patient populations in the comparative devices are completely different, but if you look at the other therapies that are considered standard of care (like dialysis), the results are slightly better."
The quality of life improvements seen during the trial resulted in a 22 percent improvement in ejection fraction and a 58 percent reduction in NYHA Class III and Class IV heart failure, Maini said. Because patients who received the Impella device saw reduced adverse outcomes, the patients also incurred lower hospital costs when compared with patients who received an intra-aortic balloon pump.
"The reductions in repeat revascularizations, readmission costs, and length of stay have significant policy implications in the new era of health reform," Maini concluded.