Cardiovascular disease has been the number one cause of death in the United States since 1920.1 In 2016, cardiovascular disease cost $555 billion and is expected to grow to $1.1 trillion by 2035, according to the American Heart Association.1 Heart failure and recurrent cardiac symptoms are the leading causes of medical readmissions among the Medicare population,2 with rates > 50% at 6 months.3

Over the last decade, there has been an increase in the use of percutaneous ventricular assist devices (pVADs), specifically the Impella 2.5® and Impella CP® (Abiomed, Inc.), which have demonstrated significant reductions in major adverse clinical events in patients undergoing high-risk percutaneous coronary intervention (PCI).4 This has resulted in cost savings and cost-effectiveness for payers and providers in multiple studies and economic models, namely in reduced length of stay (LOS) and reduced readmissions from repeat procedures.5-8

The PROTECT II Economic Study concluded that for patients with severe left ventricular dysfunction and complex anatomy, Impella-assisted high-risk PCI significantly reduced major adverse events at an incremental cost per quality-adjusted life-year (QALY), referred to as ICER (incremental cost-effectiveness ratio), of $39,000/QALY, which is considered to be cost-effective for advanced cardiovascular technologies.4

In the 90 days after initial hospitalization, Impella patients experienced:

  • Two fewer days in the hospital (P = .008)4 (Figure 1)
  • A 52% reduction in hospitalizations due to repeat revascularization (P = .024)4
  • 50% lower rehospitalization costs compared to the intra-aortic balloon pump (IABP) (P < .001)4

Figure 1. LOS reduction observed in PROTECT II randomized controlled trial.

The national upward trend in the utilization of pVADs and other short-term mechanical support reported by Stretch et al5 observed a correlation between increased utilization of pVADs and decreased costs.

REDUCTION IN LOS

A systematic review by Maini et al8 reported the findings of several cost-effectiveness studies of pVADs. Reductions in LOS were observed in all studies (Figure 2), with a clinically relevant observation of fewer days in the intensive care unit and fewer readmissions. As such, they concluded pVAD use, specifically Impella 2.5, is a high-value technology in an era of accountable care.

A budget impact model supports these and other studies showing patients receiving Impella support had a 2-day reduction in LOS, or 18% in the nonemergent care model, compared to those in the IABP arm. In the emergent setting, patients in the pVAD arm demonstrated an average of 10.5 days’ reduction in LOS, or 34% (Figure 3).6

Figure 2. Hospital LOS findings associated with pVAD use.

Figure 3. Impella demonstrates reduced LOS.

COST SAVINGS

Research published by Maini and colleagues also evaluated the cost-effectiveness of pVADs in an emergent setting compared with traditional surgical hemodynamic support alternatives. For patients in cardiogenic shock requiring emergent hemodynamic support, Impella 2.5 resulted in better outcomes, shorter LOS, lower costs, and a survival benefit when compared with surgical hemodynamic support alternatives (Table 1).9

With a negative, or dominant, ICER of -$134,932/life-year gained, Impella therapy not only improved outcomes but resulted in a cost savings in acute myocardial infarction patients with cardiogenic shock in this study.8

Most recently, Vetrovec and colleagues demonstrated that the use of the Impella pVAD is associated with reduced mortality rates, shorter LOS, and lower hospital costs compared to extracorporeal membrane oxygenation (ECMO) in patients with acute myocardial infarction and cardiogenic shock. pVAD use compared to ECMO resulted in total episode-of-care savings of $54,571.10

CONCLUSION

It is possible that new, minimally invasive technologies, such as the Impella pVAD, can provide the opportunity to concomitantly improve clinical outcomes, quality of care, and shared savings opportunities for patients and providers. As the heart failure population grows due to longer survival of patients with ischemic heart disease after revascularization procedures such as PCI, understanding the need to balance short-term costs of procedures versus the long-term savings associated with ongoing care and long-term improvement in outcomes will be key.

1. American Heart Association CVD Burden Report. 2017. https://www.heart.org/-/media/files/get-involved/advocacy/burden-report-consumer-report.pdf?la=en&hash=0A2A75E9FE82F7BEAE6A6A0FDB64E3FCE2BD8669

2. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics—2012 update: a report from the American Heart Association. Circulation. 2012;125:e2-e220. doi: 10.1161/CIR.0b013e31823ac046

3. Jencks SF, Williams MV, Coleman EA. Rehospitalizations among patients in the Medicare fee-for-service program. N Engl J Med. 2009;360:1418-1428. doi: 10.1056/NEJMsa0803563

4. O’Neill WW, Kleiman NS, Moses J, et al. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: the PROTECT II study. Circulation. 2012;126:1717-1727. doi: 10.1161/CIRCULATIONAHA.112.098194

5. Gregory D, Scotti DJ, de Lissovoy G, et al. A value-based analysis of hemodynamic support strategies for high-risk heart failure patients undergoing a percutaneous coronary intervention. Am Health Drug Benefits. 2013;6:88-99.

6. Stretch R, Sauer CM, Yuh DD, et al. National trends in the utilization of short-term mechanical circulatory support. incidence, outcomes and cost analysis. J Am Coll Cardiol. 2014;64:1407-1415. doi: 10.1016/j.jacc.2014.07.958

7. Gregory D, Scotti DJ. A budget impact model to estimate the cost dynamics of treating high-risk heart failure pa-tients with advanced percutaneous cardiac assist devices: the payer perspective. J Manag Care Med. 2013;16:61-69.

8. Maini B, Scotti DJ, Gregory D. Health economics of percutaneous hemodynamic support in the treatment of high-risk cardiac patients: a systematic appraisal of the literature. Expert Rev Pharmacoecon Outcomes Res. 2014;14:403-416. doi: 10.1586/14737167.2014.908714

9. Maini B, Gregory D, Scotti DJ, Buyantseva L. Percutaneous cardiac assist devices compared with surgical hemody-namic support alternatives: cost-effectiveness in the emergent setting. Catheter Cardiovasc Interv. 2014;83:E183-E192. doi: 10.1002/ccd.25247

10. Vetrovec GW, Lim MJ, Seeger KA, Needham KA. Cost savings for pVAD compared to ECMO in the management of acute myocardial infarction complicated by cardiogenic shock: an episode-of-care analysis. Poster presented at the Society for Cardiovascular Angiography & Interventions (SCAI) 2019 Scientific Sessions; May 19-22; Las Vegas, Nevada.

Charles Simonton, MD
Medical and Clinical Advisor, Abiomed
csimonton@abiomed.com
Disclosures: None.