May 11, 2011 – The Impella percutaneously deployed ventricular assist device showed an overall average hospital charge savings when compared to the standard-of-care intra-aortic balloon pump (IABP). The economic analyses is based on data from the PROTECT II study, which compares Impella to IABP hemodynamic support.
The data analyses showed a significant reduction of 29 percent in the major adverse cardiac and cerebrovascular event (MACCE) rate for the Impella arm at 90 days. Additionally, the Impella patient population had overall average hospital charge savings of $19,000 (all patients) to $22,000 (survivors only) without device costs included. With the device costs included, hospital charges with Impella ranged from being equivalent to $3,000 less than the IABP.
The analyses were presented by William O’Neill, M.D., executive dean for clinical affairs at the University of Miami Miller School of Medicine and principal investigator of the PROTECT II study, last week at the Society for Cardiovascular Angiography Interventions (SCAI) 2011 Scientific Sessions in Baltimore. The PROTECT II study was a prospective, multicenter, randomized trial, designed to measure a composite of major adverse events at 30 days, with 90-day follow-up in high-risk percutaneous coronary intervention (PCI) patients requiring hemodynamic support, comparing the Impella 2.5 to the IABP.
Economic Study Analysis
In PROTECT II, Impella significantly reduced out-of-hospital major adverse events by 56 percent (p=0.002) over the IABP arm. As of today’s latest release, the economic study includes additional patients and readmission data (n=249) from the initial PROTECT II presentation at the American College of Cardiology (ACC) Scientific Session in April 2011.
Hospital charges for all PROTECT II patients at 90 days averaged approximately $165,000 per patient for the IABP and approximately $146,000 for Impella, resulting in $19,000 lower charges with Impella support. Hospital charges for survivors only averaged approximately $156,000 per patient for IABP and approximately $134,000 for Impella, resulting in $22,000 lower charges with Impella support, excluding device costs.
Reduction in Hospital Charges
Impella’s reduction of overall hospital charges were driven by the following:
- - 47 percent reduction in repeat revascularization for Impella patients at 90 days;
- - 67 percent lower charges per readmission for Impella patients at 90 days.
The device costs were subtracted out of the economic study data and added back in at hospital cost assumptions. With device costs included ($20,000 for Impella, $800 for IABP), the hospital charges become equivalent at 90 days. Additional economic study information will be presented at a later date. This economic study was conducted by Presscott Associates Ltd., an independent health economics organization. Analysis included third-party collection and analysis of medical billing data from actual claims submitted to payers.
“National delivery and payment reforms will accelerate the need for healthcare providers to show that clinical therapies improve quality and the use of healthcare resources,” said David A. Gregory, MPA, FACHE, executive vice president, Presscott Associates. “These economic findings demonstrate that the Impella therapy as compared to the IABP are powerful, in that they show Impella reduced the need for the patient to repeat the PCI procedure, which is a benefit to hospitals, payers, and certainly to the patient from a quality of life perspective.”
These data reported have been collected, monitored and analyzed by a third-party academic research organization and Presscott Associates.
Conclusion of PROTECT II
Positive overall outcomes for the Impella arm over the IABP arm in the entire study cohort at 90 days, resulting in a 21 percent reduction in major adverse events over the IABP (p=0.029).
In the pre-specified high-risk PCI without atherectomy subgroup (88 percent of study), Impella provided a significant benefit over the IABP at 30 days (p=0.009) and at 90 days (p=0.003) with a 29 percent reduction of major adverse events.
There was a significant 29 percent reduction of the MACCE¹ rate at 90-day follow-up per protocol in the Impella arm compared to the IABP arm (p=0.038).
“The PROTECT II data continues to be clinically relevant, particularly at the 90-day mark,” O’Neill said. “Our most recent analysis, presented today at SCAI, shows a significant reduction in MACCE in favor of Impella. This important finding provides new guidance for interventional cardiologists in selecting the appropriate type of support and its impact on patient care in high-risk PCI.”
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1. MACCE is defined as Composite of Major Adverse Cardiac and Cerebrovascular Events, including Death/Stroke or TIA/MI/Repeat Revascularization in the PROTECT II study, using 8xULN for biomarkers or Q-wave for Peri-procedural MI (Stone et al Circulation 2001;104:642-647) and 2xULN for Spontaneous MI (PROTECT II definition).
2. The PROTECT II study was a prospective, multi-center, randomized controlled study of the Impella 2.5 versus the intra-aortic balloon pump (IABP) in patients undergoing non-emergent high-risk PCI requiring hemodynamic support. The purpose of the PROTECT II study was to determine the safety and effectiveness of the Impella 2.5 as compared to optimal medical management with an IABP during “high-risk” angioplasty procedures. The study protocol was for low ejection fraction (EF) patients with unprotected left main (EF < 35 percent) or with triple vessel disease (EF < 30 percent). The primary endpoint of the study is a composite of the following ten Major Adverse Events at 30 days or discharge: death, myocardial infarction, stroke, repeat revascularization (PCI/CABG), need for any cardiovascular operation, acute renal dysfunction, increase in aortic insufficiency, severe hypotension, CPR or arrhythmia requiring Trt, failure to adequately reopen the vessel. The thesis assumed major adverse event rates of >20 percent for Impella and > 30 percent for IABP.
3. Coronary atherectomy, commonly referred to as rotablation, is a catheter-based procedure that includes a high-speed rotating metallic burr that abrades calcified (hardened) plaque that is blocking an artery and blood supply to the heart, rotating at speeds of up to 200,000 RPM. Complications listed per FDA labeling include: ventricular perforation, contrast media reaction, stroke, slow flow, no flow, myocardial infarction (Q-wave and non Q-wave), arrhythmia requiring treatment, cardiac tamponade, and death.
4. All of the adverse events of the study have been independently adjudicated by the third party academic research organization (ARO). However, the database is not locked as of the Society of Angiographic Cardiovascular Interventions (SCAI) Scientific Sessions in May 2011.
5. All economic data has been collected by Presscott Associates, Ltd. in unison with the ARO. Additional patients may be added in the future to the economic report. As of this press release, n=249 is comprised of patients that consented to the economic study and were in the United States.
6. Statistically Significant p value of p<0.05 means that the likelihood that the phenomena tested occurred by chance alone is less than or equal to 5 percent.