Impella

The Impella is an FDA approved, percutaneous ventricular assist device designed to provide a patient’s heart with hemodynamic support.

The catheter-based heart pump is manufactured by Abiomed, headquartered in Danvers, Massachusetts.

The Impella is currently the world's smallest heart pump. The whole device is less than the width of a pencil, and the pump is thinner than an eraser.[1] This tiny device acts like a temporary artificial heart as it maintains blood flow through the body during a cardiac procedure. It works by pumping blood throughout the body when the heart is too weak to do it itself – providing time for the heart to rest and heal.[1]

Doctors insert the Impella, a minimally invasive mechanical circulatory support (MCS) device, into the heart percutaneously, through a small hole in the leg, to provide hemodynamic support for patients. The procedure is typically performed in a catheterization lab (cath lab). This is different than traditional heart therapies which require doctors to open the chest.[1]

A recent study by Yale University published in the Journal of the American College of Cardiology, entitled “National Trends in the Utilization of Short-term Mechanical Support,” found a significant increase – more than 1,500 percent – in the use of minimally invasive percutaneous MCS devices – between 2007 and 2011.[2] As of 2016, 1,000 hospitals in the United States have acquired Impella products, helping more than 37,000 patients.[3]

Impella is now included in six sets of clinical practice guidelines:

1) 2011 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Society for Coronary Angiography Interventions (SCAI) guidelines for Percutaneous Coronary Intervention, JACC 2011;

2) 2013 ACCF/AHA Guidelines for the Management of ST-Elevation Myocardial Infarction, Circulation 2012;

3) 2013 ACCF/AHA guidelines for the Management of Heart Failure, Journal of American College of Cardiology 2013;

4) 2012 AHA guidelines for mechanical circulatory support, Circulation 2012; and

5) 2013 International Society for Heart & Lung Transplantation (ISHLT) guidelines for Mechanical Circulatory Support, The Journal of Heart and Lung Transplantation 2013. [4]

6) 2014 AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation Acute Coronary Syndromes, Circulation 2014.[5]

Abiomed received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps to provide treatment of cardiogenic shock in 2016. In this setting, the Impella heart pumps stabilize the patient’s hemodynamics, unload the left ventricle, perfuse the end organs and allow for recovery of the native heart.[6]

This latest FDA approval adds to the prior FDA indication of Impella 2.5 for elective or urgent high risk percutaneous coronary intervention (PCI) received in March 2015.[7] A 2016 study in the Journal of Interventional Cardiology also showed that a “survival benefit was significantly greater in women” who receive early initiation of hemodynamic support from the Impella 2.5 prior to percutaneous coronary intervention.[8]

In January 2015, Abiomed’s Impella RP system received FDA approval under the Humanitarian Device Exemption (HDE) to provide circulatory assistance for patients who develop acute right heart failure.[9] As of 2016, the Impella RP is the first and only single access right sided percutaneous ventricular assist device available to patients in the U.S.

Cited in more than 300 publications, Impella is the most extensively used and studied percutaneous circulatory support device available today. A self-contained motor drives the "Impeller" at 50,000 revolutions per minute and drives forward blood flow to support the heart and the rest of the body.[4]

The Impella CP is a more powerful version of its Impella 2.5 pump, delivering up to 3.5 liters of blood per minute percutaneously. The Impella CP device originally received FDA 510(k) clearance in September 2010.

The Impella 5.0 can be inserted into the left ventricle by femoral cut down or through the axillary artery and provides up to five liters of flow per minute. The Impella 5.0 originally received FDA 510(k) clearance in April 2009.[4]

In 2015, an association of clinical and basic research scientists formed a working group dedicated to capitalizing on the hemodynamic and pleiotropic effects of Impella support. The Acute Cardiac Unloading and Recovery (A-CURE) Working Group mission is to advance the science and mechanistic understanding of acute cardiac unloading by supporting the translation of basic and clinical research into therapies aimed at heart muscle recovery.[10]

See also

References

  1. 1 2 3 "World's smallest heart pump reaches thousands of patients across US". WCVB Boston. September 6, 2013.
  2. ↑ "National trends in the Utilization of Short-Term Mechanical Circulatory Support". Journal of the American College of Cardiology. October 2014.
  3. ↑ "A mobile lab about heart pumps stops in Lincoln". Retrieved 2016-08-09.
  4. 1 2 3 "Products". Abiomed. Retrieved 2015-01-13.
  5. ↑ Amsterdam, Ezra A.; Wenger, Nanette K.; Brindis, Ralph G.; Casey, Donald E.; Ganiats, Theodore G.; Holmes, David R.; Jaffe, Allan S.; Jneid, Hani; Kelly, Rosemary F. (2014-12-23). "2014 AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation Acute Coronary Syndromes". Circulation. 130 (25): e344–e426. doi:10.1161/CIR.0000000000000134. ISSN 0009-7322. PMID 25249585.
  6. ↑ "U.S. Food & Drug Administration -- Pre-Market Approval". Retrieved August 9, 2016.
  7. ↑ "U.S. Food & Drug Administration -- Pre-Market Approval". Retrieved August 9, 2016.
  8. ↑ Joseph, Susan M.; Brisco, Meredith A.; Colvin, Monica; Grady, Kathleen L.; Walsh, Mary Norine; Cook, Jennifer L.; for the genVAD Working Group (2016-06-01). "Women With Cardiogenic Shock Derive Greater Benefit From Early Mechanical Circulatory Support: An Update From the cVAD Registry". Journal of Interventional Cardiology. 29 (3): 248–256. doi:10.1111/joic.12298. ISSN 1540-8183.
  9. ↑ "U.S. Food & Drug Administration -- Humanitarian Device Exemption". Retrieved August 9, 2016.
  10. ↑ "Journal of Cardiovascular Pharmacology and Therapeutics publication on the A-CURE Working Group.".
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