Impella

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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 and is placed through a peripheral artery.[2] From the peripheral artery it pumps blood to the left or right heart via the ascending aorta or pulmonary artery.

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

Medical uses

The Impella device is an alternative for percutaneous mechanical circulatory support that has been utilized as a bridge to recovery. Used alone or in tandem sets, it utilizes the concept of magnetic levitation[clarification needed] to reduce moving parts to an absolute minimum, thus reducing anticoagulation requirements. Cardiogenic shock has been addressed by many devices, most notably the intraaortic 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 for 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.[citation needed] However, recent studies point to significantly greater in-hospital risks of major bleeding, death, and other adverse events for patients supported by Impella devices, compared with those managed with an IABP.[7] A propensity-matched comparison of patients receiving mechanical circulatory support (MCS) for myocardial infarction–related shock saw a nearly one-third excess in mortality and almost a doubling in risk of major bleeding, both in-hospital endpoints, with use of Impella compared to IABP. Impella may provide some of the results similar to venoarterial extracorporeal life support and TandemHeart.[8]

In patients with acute myocardial infarction complicated by cardiogenic shock, haemodynamic support with the Impella device had no significant effect on thirty-day mortality as compared with IABP.[9]

Overall outcomes in the population, regardless of MCS device, were significantly worse for patients after the 2008 approval of Impella.[clarification needed] Among hospitals using Impella, those using it the most had significantly worse outcomes with Impella than those using it the least.[citation needed]

Potential complications related to the use of Impella are device related,[clarification needed] peripheral vascular and distal thrombus formation with subsequent strokes. The most common complications reported were bleeding requiring transfusion, vascular access complications, infection, haemolysis, vascular complications requiring surgical repair, limb ischaemia, and bleeding requiring surgical intervention (2.6%). Valvular complications included aortic and mitral valve injury or mitral valve regurgitation.[10]

Technology

Impella heart pumps are percutaneous microaxial pumps that act as mechanical circulatory support devices in patients in need of hemodynamic support.[11] The pumps are mounted on support catheters and typically inserted through the femoral artery, although axillary and subclavian artery approaches are not uncommon.[12]

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.[13] 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.[14][15][16][17] Second, it increases mean arterial pressure, diastolic pressure, and cardiac output, improving cardiac power output and cardiac index.[15] The combined effects on wall stress and perfusion pressure (especially diastolic pressure) augment coronary perfusion.[14][18] Lastly, augmented cardiac output and forward flow from the left ventricle decreases pulmonary capillary wedge pressure and reduces right ventricular afterload.[19][20][21]

Approval

Impella was approved for mechanical circulatory support in 2008, but large-scale, real-world data on its use are lacking. In June 2008, the Impella 2.5 heart pump received FDA 510(k) clearance[22] 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.[23] In December 2016, the premarket approval was expanded to include the Impella CP heart pump.[24]

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.[25] In July 2010, the automated Impella controller received FDA 510(k) clearance for use by trained healthcare professionals in healthcare facilities and medical transport.[26]

In January 2015, the Impella RP was granted a humanitarian device exemption to provide circulatory assistance for patients with right heart failure.[27]

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

Deaths and strokes in the data base overall increased after the Impella gained regulatory approval in 2008, compared to

earlier years; mortality went up 17% and strokes more than tripled.[28]

In July 2023, the FDA issued a Class I recall for all Impella left-sided blood pumps due to risk of motor damage after contact with a transcatheter aortic valve replacement stent.[29][30]

In March 2024, the FDA issued a warning about Impella left-sided blood pumps being linked to 49 deaths due to left ventricular perforation or wall rupture.[31][32]

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. ^ "How Abiomed became a major medical device company". 10 October 2017.
  4. ^ "Explore Impella® Technology for Heart Recovery".
  5. ^ a b "Impella Ventricular Support Systems - P140003/S018". www.fda.gov. Archived from the original on 2018-04-24.
  6. ^ "Stocks". Bloomberg News.
  7. ^ Amin, AP; Spertus, JA; Curtis, JP; Desai, N; Masoudi, FA; Bach, RG; McNeely, C; Al-Badarin, F; House, JA; Kulkarni, H; Rao, SV (28 January 2020). "The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support". Circulation. 141 (4): 273–284. doi:10.1161/CIRCULATIONAHA.119.044007. PMID 31735078. S2CID 208143531.
  8. ^ 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.
  9. ^ Alushi, B; Douedari, A; Froehlig, G; Knie, W; Wurster, TH; Leistner, DM; Stahli, BE; Mochmann, HC; Pieske, B; Landmesser, U; Krackhardt, F; Skurk, C (2019). "Impella versus IABP in acute myocardial infarction complicated by cardiogenic shock". Open Heart. 6 (1): e000987. doi:10.1136/openhrt-2018-000987. PMC 6546200. PMID 31218000.
  10. ^ Sef, Davorin; Kabir, Tito; Lees, Nicholas James; Stock, Ulrich (March 2021). "Valvular complications following the Impella device implantation". Journal of Cardiac Surgery. 36 (3): 1062–1066. doi:10.1111/jocs.15303. ISSN 0886-0440. PMID 33410194. S2CID 230818477.
  11. ^ Bossi, Eleonora; Marini, Claudia; Gaetti, Giovanni; Diamanti, Luca; Alessio, Davide; Bertoldi, Letizia Fausta; Pappalardo, Federico; Odone, Anna (2021-10-29). "Efficacy and safety of Impella 5.0 in cardiogenic shock: an updated systematic review". Future Cardiology. 18 (3): 253–264. doi:10.2217/fca-2021-0046. ISSN 1744-8298. PMID 34713720. S2CID 240153209.
  12. ^ 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.
  13. ^ "Impella".
  14. ^ a b 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.
  15. ^ a b 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.
  16. ^ 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. S2CID 20486030.
  17. ^ 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.
  18. ^ 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. S2CID 36884928.
  19. ^ 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. S2CID 41290964.
  20. ^ 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.
  21. ^ 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.
  22. ^ "FDA 510(k) clearance". Food and Drug Administration. 31 August 2021.
  23. ^ "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". Food and Drug Administration.
  24. ^ "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". Food and Drug Administration.
  25. ^ "US Food and Drug Association. 510(k) Summary – Impella 5.0" (PDF).
  26. ^ "US Food and Drug Association. 510(k) Summary – Impella Controller" (PDF).
  27. ^ "Humanitarian Device Exemption (HDE). US Food and Drug Administration".
  28. ^ Amin, Amit P.; Spertus, John A.; Curtis, Jeptha P.; Desai, Nihar; Masoudi, Frederick A.; Bach, Richard G.; McNeely, Christian; Al-Badarin, Firas; House, John A.; Kulkarni, Hemant; Rao, Sunil V. (28 January 2020). "The Evolving Landscape of Impella Use in the United States Among Patients Undergoing Percutaneous Coronary Intervention With Mechanical Circulatory Support". Circulation. 141 (4): 273–284. doi:10.1161/CIRCULATIONAHA.119.044007. PMID 31735078. S2CID 208143531.
  29. ^ "FDA Announces Class I Recall of All Left-Sided Impella Pumps". HCP Live. 2023-07-27. Retrieved 2024-03-29.
  30. ^ "Abiomed's latest Impella recall linked to 129 injury, 49 death reports". MedTech Dive. Retrieved 2024-03-29.
  31. ^ "FDA Warns About Impella Left-Sided Blood Pumps, Linked to 49 Deaths". HCP Live. 2024-03-29. Retrieved 2024-03-29.
  32. ^ "Abiomed Impella 'Instruction for Use' Recall Linked to 49 Deaths". www.mddionline.com. Retrieved 2024-03-29.

Notes

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