Thursday, December 12, 2019
Breaking Medical Device Industry News

Abiomed Announces a Comprehensive Publication Review of Cost and Comparative Effectiveness of Impella in High-Risk PCI and Cardiogenic Shock

Thursday, December 12, 2019

To mark the five year anniversary of the study by Stretch, et al., on cost and outcomes trends for short-term mechanical circulatory support, Abiomed announced a comprehensive publication review of cost and comparative effectiveness of Impella in high-risk PCI and cardiogenic shock. The data, from a robust body of US and European evidence from 2004 – 2019, includes the PROTECT II FDA randomized controlled trial, data from the Centers for Medicare & Medicaid Services MedPAR database and more than 20 peer-reviewed clinical publications on cost-effectiveness. It demonstrates that Impella use in high-risk PCI (Protected PCI) and cardiogenic shock when compared to intra-aortic balloon pump (IABP) or other therapies, is associated with improved patient outcomes and reduced costs. The review will be presented at upcoming meetings of interventional cardiologists and cardiac surgeons in Munich, Germany, and Phoenix, Arizona.

Key evidence of Impella’s cost-effectiveness includes data on how:

  • Impella reduces mortality and cost
  • Impella reduces the length of stay and readmissions
  • Impella reduces long-term health care costs

Impella Reduces Mortality and Cost

Several studies show that the use of percutaneous ventricular assist devices (PVADs), including Impella, is particularly cost-effective in cases of cardiogenic shock:

  • A study conducted by Yale University colleagues Stretch, et al., found that in cases of cardiogenic shock in coronary atherosclerosis and other heart diseases, PVADs reduced costs by $45,000 and $54,000 per case, respectively, and reduced mortality by 58% (Stretch, et al., Journal of the American College of Cardiology, 2014)
  • For patients in cardiogenic shock requiring emergent hemodynamic support, PVAD therapy (and Impella 2.5 in particular) resulted in better outcomes, shorter length of stay, lower costs and a survival benefit when compared with surgical hemodynamic support alternatives (Maini, et al., Journal of Catheterization and Cardiovascular Interventions, 2014)
  • Research by Vetrovec, et al, found that use of PVADs, including Impella, is associated with reduced mortality rates, shorter length of stay and lower hospital costs compared to ECMO. Their data showed that PVAD use compared to ECMO resulted in total episode-of-care (EOC) savings of $54,571 (Vetrovec, et al., Journal of Catheterization and Cardiovascular Interventions, 2019)

Impella Reduces Length of Stay and Readmissions

Several studies, including systematic reviews of multiple cost-effectiveness publications, demonstrate that Impella use is associated with a reduction in length of stay for patients, with a greater opportunity for benefit as the illness level increases1.

According to peer-reviewed published data, Impella use is associated with:

  • A 52% reduction in repeated admission for revascularization at 90 days, as demonstrated in an independent economic analysis of the PROTECT II Randomized Controlled Trial (Gregory, et al., American Health & Drug Benefits Journal, 2013)
  • A reduction in hospital stays ranging from 2-12 days (Maini, et al., Expert Review of Pharmacoeconomics & Outcomes Research, 2014)
  • Shorter ablation times and reduced hospital length of stay in patients with unstable ventricular tachycardia (Aryana, et al., Heart Rhythm Society, 2014)
  • A reduction in acute kidney injury, with average cost savings of $22,023 per case (Silver, et al., Journal of Hospital Medicine, 2016)

These findings are consistent in the United States and Europe. A retrospective cost-effectiveness analysis based on the USPella and Europella databases concluded that Impella is a cost-effective intervention compared with IABP for high-risk PCI patients (Roos, et al., Journal of Medical Economics, 2013).

As an example of Impella’s cost-effectiveness, the United Kingdom’s National Institute for Health Care and Excellence (NICE), one of the world’s most conservative regulatory bodies, confirmed the use of Impella in certain high-risk PCI patients.

“Sometimes trying to save costs by avoiding or delaying the use of innovative technologies sounds good, but you delay safe and effective therapy. Then the patients are sicker, and their outcomes are worse, which ends up being more costly for the patient and the healthcare system. Using a better therapy upfront can give you a better long-term outcome while reducing total costs,” said George Vetrovec, MD, professor, emeritus, at Virginia Commonwealth University.

Case Studies: Impella Reduces Long-term Health Care Costs

Because Impella enables the heart to rest and recover – while helping to restore native heart function – it may prevent the need for an implantable left ventricular assist device (LVAD) or a heart transplant, leading to an estimated $887,000 reduction in hospital charges over the period from 30 days pre-transplant to 180 days post-transplant discharge2. This makes native heart recovery one of the most cost-effective therapies in healthcare.

The case of Adam Millar illustrates the real-world benefit of native heart recovery. In 2018, Millar was 18 years old when Nima Aghili, MD, an interventional cardiologist at St. Anthony’s Central in Lakewood, Colorado, placed an Impella CP and Impella RP to recover Adam’s heart after he was diagnosed with atrial fibrillation and developed cardiogenic shock. At the time, Millar was a junior hockey player, and native heart recovery proved to be the best outcome for his health and future quality of life. Adam’s treatment was covered by United Healthcare.

“Before Impella recovered my heart, physicians considered me as a candidate for an implantable LVAD and a heart transplant. Both would have drastically decreased my quality of life,” said Millar. “If I received a heart transplant, I would have had a long recovery and taken auto-immune medication to avoid the rejection of the transplanted heart for the rest of my life.”

Impella also enables high-risk PCI patients to improve their native heart function through Impella-supported Protected PCI. The story of Jim Hoag illustrates how Protected PCI with Impella and complete revascularization enable better outcomes and improved quality of life for patients.

Jim, a 67-year-old grandfather, struggled with such extreme weakness and fatigue that he could barely walk from the parking lot to the athletic field to watch his grandsons play sports. He went to Spectrum Health in Grand Rapids, Michigan, where a diagnostic catheterization revealed severe blockages and poor heart function with an ejection fraction of 25%. Jim was referred to the advanced heart failure clinic where he was identified by the heart team as an appropriate candidate for Protected PCI. Drs. David Wohns and Kevin Wolschleger implanted the Impella 2.5 to support Jim’s weak heart while they placed multiple stents.

Jim was discharged home one day later, and within two months his heart function had returned to near normal with an ejection fraction of 55%. Jim’s treatment was reimbursed by Medicare. Today, Jim feels better than he has in years, attended Abiomed’s patient summit in Danvers, Massachusetts, this summer, and now climbs to the top of the stands to cheer on his grandchildren.

Cost-Effectiveness Compared to Other Therapies

Impella’s cost-effectiveness when compared to other related treatments, including LVADs, is validated based on an incremental cost-effectiveness ratio — or ICER. ICER is a standard economic metric that represents the additional cost of one unit of a healthcare outcome, such as a quality-adjusted life year, gained by a healthcare intervention or strategy when compared with the next best alternative or standard of care. Amounts less than $100,000 are considered cost effective in the U.S., and less than $50,000 in most other countries. Impella’s ICER shows a reduction in costs of $135,000 per year in an emergent population3.


References

1 Nalluri, et al, Expert Review of Medical Devices, 2017; Aryana, et al, Heart Rhythm Society, 2014; Krenn, et al, SCAI, 2014; Maini, et al, Journal of Catheterization and Cardiovascular Interventions, 2014; Maini, et al, Expert Review of Pharmacoeconomics & Outcomes Research, 2014; Wohns et al, International Society for Minimally Invasive Cardiothoracic Surgery, 2014; Gregory, et al, American Health & Drug Benefits Journal, 2013; Gregory, et al, Journal of Managed Care Medicine, 2013; O’Neil,l et al, Journal of American College of Cardiology. USPella, 2013; Roos, et al, Journal of Medical Economics, 2013; Lamarche, et al, Journal of Thoracic and Cardiovascular Surgery, 2010

2 Milliman 2017 US Organ and Tissue Transplant Cost Estimates and Discussion

3 Maini et al, Journal of Catheterization and Cardiovascular Interventions, 2014

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