Impella

Impella is a family of medical devices used for temporary ventricular support in patients with depressed heart function. Some versions of the device can provide left heart support during other forms of mechanical circulatory support including ECMO and Centrimag.[1]

The device is approved for use in high-risk percutaneous coronary intervention (PCI) and cardiogenic shock following heart attack or open heart surgery. It is placed through a peripheral artery,[2] from which it pumps blood to the left or right heart via the ascending aorta or pulmonary artery, respectively.

The Impella technology was acquired by Abiomed in 2005.[3] As of March 2019, the Impella series included the Impella 2.5, Impella 5.0/LD, Impella CP and Impella RP.[4][5][6]

Medical uses

The Impella device is a simple solution to a very complex problem. Used alone or in tandem sets it utilizes the concept of magnetic levitation to reduce moving parts to an absolute minimum thus reducing anticoagulation requirements. Cardiogenic shock has been historically addressed by many devices, most notably the Intra Aortic Balloon Pump (IABP). The technology deployed by the Impella device similarly alters the fundamental characteristics of the human circulatory system. As the propeller is accelerated to give respite to an acutely injured myocardium the circulatory system transitions from a pulsatile mechanism to continuous flow. Cellular response to cardiogenic shock is poorly described by either method (counterpulsation or continuous flow). Control of directional flow of the device (magnetic vectors) is under investigation in pursuit of addressing right versus left sided heart failure. Transseptal intervention in addressing physiologic mismatch in perfusion between left and right sided heart failure is in experimental status.

Impella provides results similar to venoarterial extracorporeal life support and TandemHeart.[7]

The Impella pump is recommended in the following practice guidelines:

Technology

Impella heart pumps are percutaneous microaxial pumps that act as mechanical circulatory support devices in patients in need of hemodynamic support. The pumps are mounted on support catheters and typically inserted through the femoral artery, although axillary and subclavian artery approaches are not uncommon.[14]

Technology

The Impella Device is a generational extension of the Intra aortic balloon pump (IABP) in addressing cardiogenic shock. Tech has allowed a single moving piece floated by magnetically steered mechanisms to deploy an "Archimedes Pump" just north of the Aortic Valve that purports to reduce both preload and afterload. The same tech can apparently also be deployed just above the pulmonary (pulmonic) valve as a gate on right sided heart failure.

Left-sided support

Designed to provide hemodynamic support when the patient's heart is unable to produce sufficient cardiac output, Impella heart pumps can supply one to five liters per minute of blood flow.[15] The physiological consequences of left-sided support are threefold. First, it unloads the left ventricle by reducing left ventricular end-diastolic volume and pressure, thereby decreasing ventricular wall stress, work, and myocardial oxygen demand.[16][17][18][19] Second, it increases mean arterial pressure, diastolic pressure, and cardiac output, improving cardiac power output and cardiac index.[17] The combined effects on wall stress and perfusion pressure (especially diastolic pressure) augment coronary perfusion.[16][20] Lastly, augmented cardiac output and forward flow from the left ventricle decreases pulmonary capillary wedge pressure and reduces right ventricular afterload.[21][22][23]

Approval

In June 2008, the Impella 2.5 heart pump received FDA 510(k) clearance[24] for partial circulatory support for periods of up to six hours during cardiac procedures not requiring cardiopulmonary bypass. In March 2015, it received FDA premarket approval for elective and urgent high-risk percutaneous intervention procedures.[25] In December 2016, the premarket approval was expanded to include the Impella CP heart pump.[26]

In April 2009, the Impella 5.0 and Impella LD heart pumps received 510(k) clearance for circulatory support for periods of up to six hours during cardiac procedures not requiring cardiopulmonary bypass.[27] In July 2010, the automated Impella controller received FDA 510(k) clearance for use by trained healthcare professionals in healthcare facilities and medical transport.[28]

In January 2015, the Impella RP was granted a humanitarian device exemption to provide circulatory assistance for patients with right heart failure.[29]

In February 2018, the FDA approved the sale of the Impella ventricular support systems.[5]

See also

References
  1. Shishehbor, MH; Moazami, N; Tong, MZ; Unai, S; Tang, WH; Soltesz, EG (April 2017). "Cardiogenic shock: From ECMO to Impella and beyond". Cleveland Clinic Journal of Medicine. 84 (4): 287–295. doi:10.3949/ccjm.84gr.17002. PMID 28388392.
  2. Bansal, A; Bhama, JK; Patel, R; et al. (2016). "Using the minimally invasive Impella 5.0 via the right subclavian artery cutdown for acute on chronic decompensated heart failure as a bridge to decision". Ochsner Journal. 16 (3): 210–216. PMC 5024800. PMID 27660567.
  3. https://www.medicaldesignandoutsourcing.com/abiomed-cracked-big-100/
  4. http://www.abiomed.com/impella
  5. https://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/recently-approveddevices/ucm598801.htm
  6. https://www.bloomberg.com/research/stocks/private/snapshot.asp?privcapId=247589
  7. Ouweneel, DM; Schotborgh, JV; Limpens, J; Sjauw, KD; Engström, AE; Lagrand, WK; Cherpanath, TG; Driessen, AH; de Mol, BA; Henriques, JP (December 2016). "Extracorporeal life support during cardiac arrest and cardiogenic shock: a systematic review and meta-analysis". Intensive Care Medicine. 42 (12): 1922–1934. doi:10.1007/s00134-016-4536-8. PMC 5106498. PMID 27647331.
  8. Amsterdam, EA; Wenger, NK; Brindis, RG; et al. (2014). "2014 AHA/ACC guideline for the management of patients with non-ST-elevation acute coronary syndromes: a report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines". Circulation. 130 (25): e344–e426. doi:10.1161/CIR.0000000000000134. PMID 25249585.
  9. O'Gara, PT; Kushner, FG; Ascheim, DD; et al. (2013). "ACCF/AHA guideline for the management of ST-elevation myocardial infarction: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines". Journal of the American College of Cardiology. 61 (4): e78–e140. doi:10.1016/j.jacc.2012.11.019. PMID 23256914.
  10. Yancy, CW; Jessup, M; Bozkurt, B; et al. (2013). "ACCF/AHA guideline for the management of heart failure: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines". Journal of the American College of Cardiology. 62 (16): e147–e239. doi:10.1016/j.jacc.2013.05.019. PMID 23747642.
  11. Feldman, D; Pamboukian, SV; Teuteberg, JJ; et al. (2013). "The 2013 International Society for Heart and Lung Transplantation guidelines for mechanical circulatory support: executive summary". The Journal of Heart and Lung Transplantation. 32 (2): 157–187. doi:10.1016/j.healun.2012.09.013. PMID 23352391.
  12. Peura, JL; Colvin-Adams, M; Francis, GS; et al. (2012). ""; American Heart Association Heart Failure and Transplantation Committee of the Council on Clinical Cardiology; Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Cardiovascular Disease in the Young; Council on Cardiovascular Nursing; Council on Cardiovascular Radiology and Intervention, and Council on Cardiovascular Surgery and Anesthesia. Recommendations for the use of mechanical circulatory support " device strategies and patient selection: a scientific statement from the American Heart Association". Circulation. 126 (22): 2648–2667. doi:10.1161/CIR.0b013e3182769a54. PMID 23109468.
  13. Levine, GN; Bates, ER; Blankenship, JC; et al. (2011). "ACCF/AHA/SCAI Guideline for Percutaneous Coronary Intervention: A report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines and the Society for Cardiovascular Angiography and Interventions". Journal of the American College of Cardiology. 58 (24): e44–e122. doi:10.1016/j.jacc.2011.08.007. PMID 22070834.
  14. Tayal, R; Barvalia, M; Rana, Z; et al. (2016). "Totally percutaneous insertion and removal of Impella device using axillary artery in the setting of advanced peripheral artery disease". Journal of Invasive Cardiology. 28 (9): 374–380. PMID 27430667.
  15. "Impella".
  16. Sauren, LD; Accord, RE; Hamzeh, K; et al. (2007). ""Combined Impella and intra-aortic balloon pump support to improve both ventricular unloading and coronary blood flow for myocardial recovery " an experimental study". Artificial Organs. 31 (11): 839–842. doi:10.1111/j.1525-1594.2007.00477.x. PMID 18001394.
  17. Seyfarth, M; Sibbing, D; Bauer, I; et al. (2008). "A randomized clinical trial to evaluate the safety and efficacy of a percutaneous left ventricular assist device versus intra-aortic balloon pumping for treatment of cardiogenic shock caused by myocardial infarction". Journal of the American College of Cardiology. 52 (19): 1584–1588. doi:10.1016/j.jacc.2008.05.065. PMID 19007597.
  18. Kawashima, D; Gojo, S; Nishimura, T; et al. (2011). "Left ventricular mechanical support with Impella provides more ventricular unloading in heart failure than extracorporeal membrane oxygenation". ASAIO Journal. 57 (3): 169–176. doi:10.1097/MAT.0b013e31820e121c. PMID 21317769.
  19. Meyns, B; Stolinski, J; Leunens, V; Verbeken, E; Flameng, W (2003). "Left ventricular support by catheter-mounted axial flow pump reduces infarct size". Journal of the American College of Cardiology. 41 (7): 1087–1095. doi:10.1016/S0735-1097(03)00084-6. PMID 12679206.
  20. Remmelink, M; Sjauw, KD; Henriques, JP; et al. (2007). "Effects of left ventricular unloading by Impella recover LP2.5 on coronary hemodynamics". Catheterization and Cardiovascular Interventions. 70 (4): 532–537. doi:10.1002/ccd.21160. PMID 17896398.
  21. Spiro, J; Doshi, SN (2014). "Use of left ventricular support devices during acute coronary syndrome and percutaneous coronary intervention". Current Cardiology Reports. 16 (12): 544. doi:10.1007/s11886-014-0544-x. PMID 25326728.
  22. La Torre, MW; Centofanti, P; Attisani, M; Patanè, F; Rinaldi, M (2011). "Posterior ventricular septal defect in presence of cardiogenic shock: early implantation of the Impella recover LP 5.0 as a bridge to surgery". Texas Heart Institute Journal. 38 (1): 42–49. PMC 3060738. PMID 21423467.
  23. Cheng, JM; den Uil, CA; Hoeks, SE; et al. (2009). ""Percutaneous left ventricular assist devices vs. intra-aortic balloon pump counterpulsation for treatment of cardiogenic shock " a meta-analysis of controlled trials". European Heart Journal. 30 (17): 2102–2108. doi:10.1093/eurheartj/ehp292. PMID 19617601.
  24. "FDA 510(k) clearance".
  25. "FDA approves blood pump system to help patients maintain stable heart function during certain high-risk cardiac procedures [press release]. Rockville, MD: US Food and Drug Association. March 23, 2015. Updated March 27, 2015".
  26. "FDA approves blood pump system to help patients maintain stable heart function during certain high-risk cardiac procedures [press release]. Rockville, MD: US Food and Drug Association. March 23, 2015. Updated March 27, 2015".
  27. "US Food and Drug Association. 510(k) Summary – Impella 5.0" (PDF).
  28. "US Food and Drug Association. 510(k) Summary – Impella Controller" (PDF).
  29. "Humanitarian Device Exemption (HDE). US Food and Drug Administration".
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