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词条 Impella
释义

  1. Medical uses

  2. Technology

  3. Left-sided support

  4. Approval

  5. See also

  6. References

{{Multiple issues|{{COI|date=April 2017}}{{Advert|date=January 2017}}
}}Impella is a family of medical devices used for temporary ventricular support device in people with depressed heart function. Some versions of the device can provide right 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 a heart attack or an open heart surgery procedure. It is placed into the heart through a peripheral artery.[2] Once in place, it pumps blood for the left or right side of the heart, pumping blood into 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] According to Bloomberg, Abiomed "engages in the research, development, and sale of medical devices to assist or replace the pumping function of the failing heart. It also provides continuum of care to heart failure patients". Earlier in the year, the company had increased its 2019 revenue guidance to approximately $780 million. [6]

Medical uses

It results in similar results to veno-arterial extracorporeal life support and TandemHeart.[7]

The Impella pump is in 7 sets of practice guidelines:

  • 2014 AHA/ACC Guideline for the Management of Patients With Non–ST-Elevation Acute Coronary Syndromes[8]
  • 2013 ACCF/AHA Guidelines for the Management of ST-Elevation Myocardial Infarction[9]
  • 2013 ACCF/AHA Guidelines for the Management of Heart Failure[10]
  • 2013 International Society for Heart and Lung Transplantation Guidelines for Mechanical Circulatory Support[11]
  • 2012 AHA Scientific Statement: Use of Mechanical Circulatory Support[12]
  • 2011 American College of Cardiology Foundation (ACCF)/American Heart Association (AHA)/Society for Coronary Angiography Interventions (SCAI) Guideline for Percutaneous Coronary Intervention[13]

Technology

Impella heart pumps are percutaneous microaxial pumps that act as mechanical circulatory support (MCS) devices in patients in need of hemodynamic support. The pumps are mounted on a 9 Fr support catheter. The pumps are inserted by a physician typically through femoral artery access, although axillary and subclavian artery approaches are not uncommon.[14]

Left-sided support

The Impella heart pumps are designed to provide hemodynamic support when the patient's heart is unable to produce sufficient cardiac output. The Impella family of heart pumps can supply 1.0 L/min-5.0 L/min of blood flow, depending on the size and power setting of the individual pump.[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, which decreases ventricular wall stress. Subsequently, left ventricular work and myocardial oxygen demand decrease.[16][17][18][19] Second, Impella pump flow increases mean arterial pressure, diastolic pressure, and cardiac output. This increases cardiac power output and cardiac index.[17] The combined effects of the Impella 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 has secondary benefits related to right ventricular function. Impella support 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 6 hours during cardiac procedures not requiring cardiopulmonary bypass. In March 2015, the Impella 2.5 heart pump received FDA Premarket Approval (PMA) for elective and urgent high-risk PCI procedures,[25] and in December 2016, the FDA PMA was expanded to include the Impella CP heart pump.[26] In April 2009, the Impella 5.0 and Impella LD heart pumps received FDA 510(k) clearance for circulatory support for periods of up to 6 hours during cardiac procedures not requiring cardiopulmonary bypass.[27] In July 2010, the Automated Impella Controller received FDA 510(k) clearance for intended use by trained healthcare professionals in healthcare facilities and medical transport (ie, ambulance, helicopter, or fixed-wing aircraft) environments.[28]

In January 2015, the Impella RP was granted a humanitarian device exemption (HDE) to provide circulatory assistance for people who develop right heart failure.[29]

On 28 February 2018, the FDA approved the sale of the Impella Ventricular Support Systems - P140003/S018. The system consists of left-side heart pump models (listed earlier) "intended to help pump blood in patients who need short-term support (up to 6 days)... mounted at the end of a thin, flexible tube (catheter), a console that drives the pump, and an infusion system that flushes the pump". The FDA report added the following specifics about the system: "The Impella Ventricular Support System helps pump blood by drawing blood out of the heart and pumping it into the aorta, partially or fully bypassing the left ventricle. It is implanted into the left side of a patient's heart through a small incision in the femoral artery (major artery in the leg). It can also be implanted through a small incision in a subclavian artery (an artery in the chest)."[30]

See also

{{portal|Medicine}}
  • Protected percutaneous coronary intervention

References

1. ^{{cite journal|last1=Shishehbor|first1=MH|last2=Moazami|first2=N|last3=Tong|first3=MZ|last4=Unai|first4=S|last5=Tang|first5=WH|last6=Soltesz|first6=EG|title=Cardiogenic shock: From ECMO to Impella and beyond.|journal=Cleveland Clinic Journal of Medicine|date=April 2017|volume=84|issue=4|pages=287–295|pmid=28388392|doi=10.3949/ccjm.84gr.17002}}
2. ^Bansal A, Bhama JK, Patel R, et al. 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. 2016;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. ^{{cite journal|last1=Ouweneel|first1=DM|last2=Schotborgh|first2=JV|last3=Limpens|first3=J|last4=Sjauw|first4=KD|last5=Engström|first5=AE|last6=Lagrand|first6=WK|last7=Cherpanath|first7=TG|last8=Driessen|first8=AH|last9=de Mol|first9=BA|last10=Henriques|first10=JP|title=Extracorporeal life support during cardiac arrest and cardiogenic shock: a systematic review and meta-analysis.|journal=Intensive Care Medicine|date=December 2016|volume=42|issue=12|pages=1922–1934|pmid=27647331|doi=10.1007/s00134-016-4536-8|pmc=5106498}}
8. ^Amsterdam EA, Wenger NK, Brindis RG, et al; ACC/AHA Task Force Members. 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. 2014;130(25):e344-e426. {{DOI|10.1161/CIR.0000000000000134}}. {{PMID|25249585}}.
9. ^O’Gara PT, Kushner FG, Ascheim DD, et al; American College of Emergency Physicians; Society for Cardiovascular Angiography and Interventions. 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. 2013;61(4):e78-e140. {{DOI|10.1016/j.jacc.2012.11.019}}. {{PMID|23256914}}.
10. ^Yancy CW, Jessup M, Bozkurt B, et al; American College of Cardiology Foundation; American Heart Association Task Force on Practice Guidelines. 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. 2013;62(16):e147-e239. {{DOI|10.1016/j.jacc.2013.05.019}} {{PMID|23747642}}
11. ^{{cite journal | last1 = Feldman | first1 = D | last2 = Pamboukian | first2 = SV | last3 = Teuteberg | first3 = JJ |display-authors=etal | year = 2013 | title = The 2013 International Society for Heart and Lung Transplantation guidelines for mechanical circulatory support: executive summary | url = | journal = The Journal of Heart and Lung Transplantation: The Official Publication of the International Society for Heart Transplantation | volume = 32 | issue = 2| pages = 157–187 | doi = 10.1016/j.healun.2012.09.013 | pmid = 23352391 }}
12. ^{{cite journal | last1 = Peura | first1 = JL | last2 = Colvin-Adams | first2 = M | last3 = Francis | first3 = GS |display-authors=etal | year = 2012 | title = "; 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 | url = | journal = Circulation | volume = 126 | issue = 22| pages = 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. 2011;58(24):e44-e122. {{DOI|10.1016/j.jacc.2011.08.007}}. {{PMID|22070834}}.
14. ^{{cite journal | last1 = Tayal | first1 = R | last2 = Barvalia | first2 = M | last3 = Rana | first3 = Z |display-authors=etal | year = 2016 | title = Totally percutaneous insertion and removal of Impella device using axillary artery in the setting of advanced peripheral artery disease | url = | journal = Journal of Invasive Cardiology | volume = 28 | issue = 9| pages = 374–380 | pmid = 27430667 }}
15. ^{{Cite web|url=http://www.abiomed.com/impella|title=Impella|last=|first=|date=|website=|publisher=|access-date=}}
16. ^1 {{cite journal | last1 = Sauren | first1 = LD | last2 = Accord | first2 = RE | last3 = Hamzeh | first3 = K |display-authors=etal | year = 2007 | title = "Combined Impella and intra-aortic balloon pump support to improve both ventricular unloading and coronary blood flow for myocardial recovery " an experimental study | url = | journal = Artificial Organs | volume = 31 | issue = 11| pages = 839–842 | doi = 10.1111/j.1525-1594.2007.00477.x | pmid = 18001394 }}
17. ^1 {{cite journal | last1 = Seyfarth | first1 = M | last2 = Sibbing | first2 = D | last3 = Bauer | first3 = I |display-authors=etal | year = 2008 | title = 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 | url = | journal = Journal of the American College of Cardiology | volume = 52 | issue = 19| pages = 1584–1588 | doi = 10.1016/j.jacc.2008.05.065 | pmid = 19007597 }}
18. ^{{cite journal | last1 = Kawashima | first1 = D | last2 = Gojo | first2 = S | last3 = Nishimura | first3 = T |display-authors=etal | year = 2011 | title = Left ventricular mechanical support with Impella provides more ventricular unloading in heart failure than extracorporeal membrane oxygenation | url = | journal = ASAIO Journal | volume = 57 | issue = 3| pages = 169–176 | doi = 10.1097/MAT.0b013e31820e121c | pmid = 21317769 }}
19. ^{{cite journal | last1 = Meyns | first1 = B | last2 = Stolinski | first2 = J | last3 = Leunens | first3 = V | last4 = Verbeken | first4 = E | last5 = Flameng | first5 = W | year = 2003 | title = Left ventricular support by catheter-mounted axial flow pump reduces infarct size | url = | journal = Journal of the American College of Cardiology | volume = 41 | issue = 7| pages = 1087–1095 | doi = 10.1016/S0735-1097(03)00084-6 | pmid = 12679206 }}
20. ^{{cite journal | last1 = Remmelink | first1 = M | last2 = Sjauw | first2 = KD | last3 = Henriques | first3 = JP |display-authors=etal | year = 2007 | title = Effects of left ventricular unloading by Impella recover LP2.5 on coronary hemodynamics | url = | journal = Catheterization and Cardiovascular Interventions | volume = 70 | issue = 4| pages = 532–537 | doi = 10.1002/ccd.21160 | pmid = 17896398 }}
21. ^{{cite journal | last1 = Spiro | first1 = J | last2 = Doshi | first2 = SN | year = 2014 | title = Use of left ventricular support devices during acute coronary syndrome and percutaneous coronary intervention | url = | journal = Current Cardiology Reports | volume = 16 | issue = 12| page = 544 | doi = 10.1007/s11886-014-0544-x | pmid = 25326728 }}
22. ^La Torre MW, Centofanti P, Attisani M, Patanè F, Rinaldi M. 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. 2011;38(1):42-49. {{PMC|3060738}}. {{PMID|21423467}}.
23. ^{{cite journal | last1 = Cheng | first1 = JM | last2 = den Uil | first2 = CA | last3 = Hoeks | first3 = SE |display-authors=etal | year = 2009 | title = "Percutaneous left ventricular assist devices vs. intra-aortic balloon pump counterpulsation for treatment of cardiogenic shock " a meta-analysis of controlled trials | url = | journal = European Heart Journal | volume = 30 | issue = 17| pages = 2102–2108 | doi = 10.1093/eurheartj/ehp292 | pmid = 19617601 }}
24. ^{{Cite web|url=http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/510kClearances/default.htm|title=FDA 510(k) clearance|last=|first=|date=|website=|publisher=|access-date=}}
25. ^{{Cite web|url=http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm439529.htm|title=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.|last=|first=|date=|website=|publisher=|access-date=}}
26. ^{{Cite web|url=http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm439529.htm.|title=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.|last=|first=|date=|website=|publisher=|access-date=}}
27. ^{{Cite web|url=http://www.accessdata.fda.gov/cdrh_docs/pdf8/k083111.pdf|title=US Food and Drug Association. 510(k) Summary – Impella 5.0.|last=|first=|date=|website=|publisher=|access-date=}}
28. ^{{Cite web|url=https://www.accessdata.fda.gov/cdrh_docs/pdf9/K093801.pdf|title=US Food and Drug Association. 510(k) Summary – Impella Controller.|last=|first=|date=|website=|publisher=|access-date=}}
29. ^{{Cite web|url=http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfhde/hde.cfm?id=H140001|title=Humanitarian Device Exemption (HDE). US Food and Drug Administration.|last=|first=|date=|website=|publisher=|access-date=}}
30. ^https://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapprovalsandclearances/recently-approveddevices/ucm598801.htm

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