The evolution history of percutaneous ventricular assist device_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

SHANG Xiaoke ¹ , YANG Yuncong ² , YOU Huihui ² , YANG Xiayan ² , SUN Ming ² , WU Chunlin ² , ZHANG Xiong ² , WANG Meiying ² , WANG Xueli ² , CHEN Song ² , ZHANG Changdong ¹ , LIU Mei ² ,  DONG Nianguo ¹

1. Department of Cardiovascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, P. R. China;
2. Laboratory of Department of Cardiovascular Surgery, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, P. R. China;

Corresponding author：

DONG Nianguo, Email: sxs_dng@163.com

Keywords：

Percutaneous ventricular assist device; axial flow pump; Hemopump; Impella; heart failure

DOI：

10.7507/1007-4848.202307042

Video：

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Percutaneous ventricular assist device (PVAD) is a minimally invasive treatment which can replace the function of the failing heart. It provides circulatory support for patients with severe emergent cardiovascular diseases such as complex coronary artery disease, acute myocardial infarction complicated by cardiogenic shock, and acute decompensated chronic heart failure. PVAD has been developed since the rise of the Hemopump, to the prosperity of the Impella, and increasingly been used as a haemodynamic support to improve prognosis. This article will review the evolution and clinical application of PVAD.

Citation： SHANG Xiaoke, YANG Yuncong, YOU Huihui, YANG Xiayan, SUN Ming, WU Chunlin, ZHANG Xiong, WANG Meiying, WANG Xueli, CHEN Song, ZHANG Changdong, LIU Mei, DONG Nianguo. The evolution history of percutaneous ventricular assist device. Chinese Journal of Clinical Thoracic and Cardiovascular Surgery, 2023, 30(12): 1683-1691. doi: 10.7507/1007-4848.202307042 Copy

1.	DeBakey ME. Left ventricular bypass pump for cardiac assistance. Clinical experience. Am J Cardiol, 1971, 27(1): 3-11.
2.	Liotta D, Crawford ES, Cooley DA, et al. Prolonged partial left ventricular bypass by means of an intrathoracic pump implanted in the left chest. Trans Am Soc Artif Intern Organs, 1962, 8: 90-99.
3.	Dixon JF, Farris CD. The ABIOMED BVS 5000 system. AACN Clin Issues Crit Care Nurs, 1991, 2(3): 552-561.
4.	Wampler R, Frazier OH. The Hemopump™, the first intravascular ventricular assist device. Asaio J, 2019, 65(3): 297-300.
5.	Aboul-Hosn W, Wampler R. The Hemopump: Clinical Results and Future Applications. In: Unger F (eds). Assisted Circulation 4. Berlin: Springer, 1995. 152-165.
6.	Xie C, Tang F, Zhang R, et al. Numerical calculation of axial-flow pump’s pressure fluctuation and model test analysis. Adv Mech Eng, 2018, 10(4): 1-13.
7.	Thiele H, Smalling RW, Schuler GC. Percutaneous left ventricular assist devices in acute myocardial infarction complicated by cardiogenic shock. Eur Heart J, 2007, 28(17): 2057-2063.
8.	Wampler RK, Riehle RA. Clinical Experience with the Hemopump Left Ventricular Assist Device. In: Shawl FA(eds). Supported Complex and High Risk Coronary Angioplasty. Boston: Springer, 1991. 231-249.
9.	Loisance D, Dubois-Randé JL, Deleuze P, et al. Prophylactic intraventricular pumping in high-risk coronary angioplasty. Lancet, 1990, 335(8687): 438-440.
10.	Sweeney MS. The Hemopump in 1997: A clinical, political, and marketing evolution. Ann Thorac Surg, 1999, 68(2): 761-763.
11.	Siess T, Meyns B, Spielvogel K, et al. Hemodynamic system analysis of intraarterial microaxial pumps in vitro and in vivo. Artif Organs, 1996, 20(6): 650-661.
12.	Meyns B, Siess T, Laycock S, et al. The heart-Hemopump interaction: A study of Hemopump flow as a function of cardiac activity. Artif Organs, 1996, 20(6): 641-649.
13.	Rosarius N, Siess T, Reul H, et al. Concept, realization, and first in vitro testing of an intraarterial microaxial blood pump with an integrated drive unit. Artif Organs, 1994, 18(7): 512-516.
14.	Siess T, Nix C, Menzler F. From a lab type to a product: A retrospective view on Impella's assist technology. Artif Organs, 2001, 25(5): 414-421.
15.	Triep M, Brücker C, Schröder W, et al. Computational fluid dynamics and digital particle image velocimetry study of the flow through an optimized micro-axial blood pump. Artif Organs, 2006, 30(5): 384-391.
16.	Dowling RD, Gray LA Jr , Etoch SW, et al. The AbioCor implantable replacement heart. Ann Thorac Surg, 2003, 75(6 Suppl): S93-S99.
17.	Bogaev RC, Delgado RM, Taegtmeyer H, et al. Chapter 56 - Circulatory Assist Devices in Heart Failure. Mann DL. In: Heart Failure: A Companion to Braunwald's Heart Disease (Second Edition). Philadelphia: W. B. Saunders, 2011. 818-833.
18.	ABIOMED. Abiomed announces record revenue of $261 million, up 13% year over year. (2022). URL: https://www.abiomed.com/about-us/news-and-media/press-releases/abiomed-announces-record-revenue-of-261-million-up-13-percent-year-over-year. Acessed on 2023-08-17.
19.	Zein R, Patel C, Mercado-Alamo A, et al. A review of the impella devices. Interv Cardiol, 2022, 17: e05.
20.	ABIOMED. FDA approves impella ECP pivotal heart pump and first patients enrolled in pivotal clinical trial (2022). URL: https: //www.abiomed.com/about-us/news-and-media/press-releases/fda-approves-impella-ecp-pivotal-heart-pump-and-first-patients-enrolled-in-pivotal-clinical-trial. Accessed on 2023-08-17.
21.	Cevasco M, Shin M, Cohen W, et al. Impella 5.5 as a bridge to heart transplantation: Waitlist outcomes in the United States. Clin Transplant, 2023: e15066.
22.	Zaky M, Nordan T, Kapur NK, et al. Impella 5. 5 support beyond 50 days as bridge to heart transplant in end-stage heart failure patients. ASAIO J, 2023, 69(4): e158-e162.
23.	ABIOMED. World's first patient implanted with Impella BTR^TM minimally invasive heart pump (2022). URL: https://www.abiomed.com/about-us-/news-and-media/press-releases/worlds-first-patient-implanted-with-impella-btr-minimally-invasive-heart-pump. Accessed on [2023-08-17.
24.	Sjauw KD, KonorzaT, Erbel R, et al. Supported high-risk percutaneous coronary intervention with the Impella 2. 5 device the Europella registry. J Am Coll Cardiol, 2009, 54(25): 2430-2434.
25.	Dixon SR, Henriques JP, Mauri L, et al. A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT Ⅰ Trial): Initial U. S. experience. JACC Cardiovasc Interv, 2009, 2(2): 91-96.
26.	O'Neill WW, Kleiman NS, Moses J, et al. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: The PROTECT Ⅱ study. Circulation, 2012, 126(14): 1717-1727.
27.	Cohen MG, Matthews R, Maini B, et al. Percutaneous left ventricular assist device for high-risk percutaneous coronary interventions: Real-world versus clinical trial experience. Am Heart J, 2015, 170(5): 872-879.
28.	Schreiber T, Wah Htun W, Blank N, et al. Real-world supported unprotected left main percutaneous coronary intervention with impella device; data from the USpella registry. Catheter Cardiovasc Interv, 2017, 90(4): 576-581.
29.	O'Neill WW, Anderson M, Burkhoff D, et al. Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices. Am Heart J, 2022, 248: 139-149.
30.	Flaherty MP, Pant S, Patel SV, et al. Hemodynamic support with a microaxial percutaneous left ventricular assist device (Impella) protects against acute kidney injury in patients undergoing high-risk percutaneous coronary intervention. Circ Res, 2017, 120(4): 692-700.
31.	Wollmuth J, Patel MP, Dahle T, et al. Ejection fraction improvement following contemporary high-risk percutaneous coronary intervention: RESTORE EF Study results. J Soc CardiovascAngiog Interv, 2022, 1(5): 100350.
32.	Recovery AH. First patient enrolled in PROTECT Ⅳ randomized controlled trial of Impella® Heart Pumps. URL: https://www.heartrecovery.com/protect-iv. Acessed on 2023-08-18.
33.	Seyfarth M, Sibbing D, Bauer I, et al. 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. J Am Coll Cardiol, 2008, 52(19): 1584-1588.
34.	Griffith BP, Anderson MB, Samuels LE, et al. The RECOVER Ⅰ: A multicenter prospective study of Impella 5. 0/LD for postcardiotomy circulatory support. J Thorac Cardiovasc Surg, 2013, 145(2): 548-554.
35.	O'Neill WW, Schreiber T, Wohns DH, et al. The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: Results from the USpella Registry. J Interv Cardiol, 2014, 27(1): 1-11.
36.	Basir MB, Schreiber TL, Grines CL, et al. Effect of early initiation of mechanical circulatory support on survival in cardiogenic shock. Am J Cardiol, 2017, 119(6): 845-851.
37.	Ouweneel DM, Eriksen E, Sjauw KD, et al. Percutaneous mechanical circulatory support versus intra-aortic balloon pump in cardiogenic shock after acute myocardial infarction. J Am Coll Cardiol, 2017, 69(3): 278-287.
38.	Schrage B, Ibrahim K, Loehn T, et al. Impella support for acute myocardial infarction complicated by cardiogenic shock. Circulation, 2019, 139(10): 1249-1258.
39.	Basir MB, Kapur NK, Patel K, et al. Improved outcomes associated with the use of shock protocols: Updates from the National Cardiogenic Shock Initiative. Catheter Cardiovasc Interv, 2019, 93(7): 1173-1183.
40.	Tehrani BN, Truesdell AG, Sherwood MW, et al. Standardized team-based care for cardiogenic shock. J Am Coll Cardiol, 2019, 73(13): 1659-1669.
41.	Udesen NJ, Møller JE, Lindholm MG, et al. Rationale and design of DanGer shock: Danish-German cardiogenic shock trial. Am Heart J, 2019, 214: 60-68.
42.	Møller JE, Gerke O. Danish-German cardiogenic shock trial-DanGer shock: Trial design update. Am Heart J, 2023, 255: 90-93.
43.	Møller JE, Kjaergaard J, Terkelsen CJ, et al. Impella to treat acute myocardial infarct-related cardiogenic shock. J Clin Med, 2022, 11(9): 2427.
44.	Kapur NK, Kim RJ, Moses JW, et al. Primary left ventricular unloading with delayed reperfusion in patients with anterior ST-elevation myocardial infarction: Rationale and design of the STEMI-DTU randomized pivotal trial. Am Heart J, 2022, 254: 122-132.
45.	Rihal CS, Naidu SS, Givertz MM, et al. 2015 SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of percutaneous mechanical circulatory support devices in cardiovascular care: Endorsed by the American Heart Assocation, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention. J Am Coll Cardiol, 2015, 65(19): e7-e26.
46.	中华医学会心血管病学分会介入心脏病学组, 中国医师协会心血管内科医师分会血栓防治专业委员会, 中华心血管病杂志编辑委员会. 中国经皮冠状动脉介入治疗指南(2016). 中华心血管病杂志, 2016, 44(5): 382-400.
47.	Henry TD, Tomey MI, Tamis-Holland JE, et al. Invasive management of acute myocardial infarction complicated by cardiogenic shock: A scientific statement from the American Heart Association. Circulation, 2021, 143(15): e815-e829.
48.	中华医学会心血管病学分会, 中华心血管病杂志编辑委员会. 经皮机械循环辅助在复杂心血管疾病介入治疗应用中国专家共识. 中华心血管病杂志, 2022, 50(10): 959-972.

1. DeBakey ME. Left ventricular bypass pump for cardiac assistance. Clinical experience. Am J Cardiol, 1971, 27(1): 3-11.
2. Liotta D, Crawford ES, Cooley DA, et al. Prolonged partial left ventricular bypass by means of an intrathoracic pump implanted in the left chest. Trans Am Soc Artif Intern Organs, 1962, 8: 90-99.
3. Dixon JF, Farris CD. The ABIOMED BVS 5000 system. AACN Clin Issues Crit Care Nurs, 1991, 2(3): 552-561.
4. Wampler R, Frazier OH. The Hemopump™, the first intravascular ventricular assist device. Asaio J, 2019, 65(3): 297-300.
5. Aboul-Hosn W, Wampler R. The Hemopump: Clinical Results and Future Applications. In: Unger F (eds). Assisted Circulation 4. Berlin: Springer, 1995. 152-165.
6. Xie C, Tang F, Zhang R, et al. Numerical calculation of axial-flow pump’s pressure fluctuation and model test analysis. Adv Mech Eng, 2018, 10(4): 1-13.
7. Thiele H, Smalling RW, Schuler GC. Percutaneous left ventricular assist devices in acute myocardial infarction complicated by cardiogenic shock. Eur Heart J, 2007, 28(17): 2057-2063.
8. Wampler RK, Riehle RA. Clinical Experience with the Hemopump Left Ventricular Assist Device. In: Shawl FA(eds). Supported Complex and High Risk Coronary Angioplasty. Boston: Springer, 1991. 231-249.
9. Loisance D, Dubois-Randé JL, Deleuze P, et al. Prophylactic intraventricular pumping in high-risk coronary angioplasty. Lancet, 1990, 335(8687): 438-440.
10. Sweeney MS. The Hemopump in 1997: A clinical, political, and marketing evolution. Ann Thorac Surg, 1999, 68(2): 761-763.
11. Siess T, Meyns B, Spielvogel K, et al. Hemodynamic system analysis of intraarterial microaxial pumps in vitro and in vivo. Artif Organs, 1996, 20(6): 650-661.
12. Meyns B, Siess T, Laycock S, et al. The heart-Hemopump interaction: A study of Hemopump flow as a function of cardiac activity. Artif Organs, 1996, 20(6): 641-649.
13. Rosarius N, Siess T, Reul H, et al. Concept, realization, and first in vitro testing of an intraarterial microaxial blood pump with an integrated drive unit. Artif Organs, 1994, 18(7): 512-516.
14. Siess T, Nix C, Menzler F. From a lab type to a product: A retrospective view on Impella's assist technology. Artif Organs, 2001, 25(5): 414-421.
15. Triep M, Brücker C, Schröder W, et al. Computational fluid dynamics and digital particle image velocimetry study of the flow through an optimized micro-axial blood pump. Artif Organs, 2006, 30(5): 384-391.
16. Dowling RD, Gray LA Jr , Etoch SW, et al. The AbioCor implantable replacement heart. Ann Thorac Surg, 2003, 75(6 Suppl): S93-S99.
17. Bogaev RC, Delgado RM, Taegtmeyer H, et al. Chapter 56 - Circulatory Assist Devices in Heart Failure. Mann DL. In: Heart Failure: A Companion to Braunwald's Heart Disease (Second Edition). Philadelphia: W. B. Saunders, 2011. 818-833.
18. ABIOMED. Abiomed announces record revenue of $261 million, up 13% year over year. (2022). URL: https://www.abiomed.com/about-us/news-and-media/press-releases/abiomed-announces-record-revenue-of-261-million-up-13-percent-year-over-year. Acessed on 2023-08-17.
19. Zein R, Patel C, Mercado-Alamo A, et al. A review of the impella devices. Interv Cardiol, 2022, 17: e05.
20. ABIOMED. FDA approves impella ECP pivotal heart pump and first patients enrolled in pivotal clinical trial (2022). URL: https: //www.abiomed.com/about-us/news-and-media/press-releases/fda-approves-impella-ecp-pivotal-heart-pump-and-first-patients-enrolled-in-pivotal-clinical-trial. Accessed on 2023-08-17.
21. Cevasco M, Shin M, Cohen W, et al. Impella 5.5 as a bridge to heart transplantation: Waitlist outcomes in the United States. Clin Transplant, 2023: e15066.
22. Zaky M, Nordan T, Kapur NK, et al. Impella 5. 5 support beyond 50 days as bridge to heart transplant in end-stage heart failure patients. ASAIO J, 2023, 69(4): e158-e162.
23. ABIOMED. World's first patient implanted with Impella BTR^TM minimally invasive heart pump (2022). URL: https://www.abiomed.com/about-us-/news-and-media/press-releases/worlds-first-patient-implanted-with-impella-btr-minimally-invasive-heart-pump. Accessed on [2023-08-17.
24. Sjauw KD, KonorzaT, Erbel R, et al. Supported high-risk percutaneous coronary intervention with the Impella 2. 5 device the Europella registry. J Am Coll Cardiol, 2009, 54(25): 2430-2434.
25. Dixon SR, Henriques JP, Mauri L, et al. A prospective feasibility trial investigating the use of the Impella 2.5 system in patients undergoing high-risk percutaneous coronary intervention (The PROTECT Ⅰ Trial): Initial U. S. experience. JACC Cardiovasc Interv, 2009, 2(2): 91-96.
26. O'Neill WW, Kleiman NS, Moses J, et al. A prospective, randomized clinical trial of hemodynamic support with Impella 2.5 versus intra-aortic balloon pump in patients undergoing high-risk percutaneous coronary intervention: The PROTECT Ⅱ study. Circulation, 2012, 126(14): 1717-1727.
27. Cohen MG, Matthews R, Maini B, et al. Percutaneous left ventricular assist device for high-risk percutaneous coronary interventions: Real-world versus clinical trial experience. Am Heart J, 2015, 170(5): 872-879.
28. Schreiber T, Wah Htun W, Blank N, et al. Real-world supported unprotected left main percutaneous coronary intervention with impella device; data from the USpella registry. Catheter Cardiovasc Interv, 2017, 90(4): 576-581.
29. O'Neill WW, Anderson M, Burkhoff D, et al. Improved outcomes in patients with severely depressed LVEF undergoing percutaneous coronary intervention with contemporary practices. Am Heart J, 2022, 248: 139-149.
30. Flaherty MP, Pant S, Patel SV, et al. Hemodynamic support with a microaxial percutaneous left ventricular assist device (Impella) protects against acute kidney injury in patients undergoing high-risk percutaneous coronary intervention. Circ Res, 2017, 120(4): 692-700.
31. Wollmuth J, Patel MP, Dahle T, et al. Ejection fraction improvement following contemporary high-risk percutaneous coronary intervention: RESTORE EF Study results. J Soc CardiovascAngiog Interv, 2022, 1(5): 100350.
32. Recovery AH. First patient enrolled in PROTECT Ⅳ randomized controlled trial of Impella® Heart Pumps. URL: https://www.heartrecovery.com/protect-iv. Acessed on 2023-08-18.
33. Seyfarth M, Sibbing D, Bauer I, et al. 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. J Am Coll Cardiol, 2008, 52(19): 1584-1588.
34. Griffith BP, Anderson MB, Samuels LE, et al. The RECOVER Ⅰ: A multicenter prospective study of Impella 5. 0/LD for postcardiotomy circulatory support. J Thorac Cardiovasc Surg, 2013, 145(2): 548-554.
35. O'Neill WW, Schreiber T, Wohns DH, et al. The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: Results from the USpella Registry. J Interv Cardiol, 2014, 27(1): 1-11.
36. Basir MB, Schreiber TL, Grines CL, et al. Effect of early initiation of mechanical circulatory support on survival in cardiogenic shock. Am J Cardiol, 2017, 119(6): 845-851.
37. Ouweneel DM, Eriksen E, Sjauw KD, et al. Percutaneous mechanical circulatory support versus intra-aortic balloon pump in cardiogenic shock after acute myocardial infarction. J Am Coll Cardiol, 2017, 69(3): 278-287.
38. Schrage B, Ibrahim K, Loehn T, et al. Impella support for acute myocardial infarction complicated by cardiogenic shock. Circulation, 2019, 139(10): 1249-1258.
39. Basir MB, Kapur NK, Patel K, et al. Improved outcomes associated with the use of shock protocols: Updates from the National Cardiogenic Shock Initiative. Catheter Cardiovasc Interv, 2019, 93(7): 1173-1183.
40. Tehrani BN, Truesdell AG, Sherwood MW, et al. Standardized team-based care for cardiogenic shock. J Am Coll Cardiol, 2019, 73(13): 1659-1669.
41. Udesen NJ, Møller JE, Lindholm MG, et al. Rationale and design of DanGer shock: Danish-German cardiogenic shock trial. Am Heart J, 2019, 214: 60-68.
42. Møller JE, Gerke O. Danish-German cardiogenic shock trial-DanGer shock: Trial design update. Am Heart J, 2023, 255: 90-93.
43. Møller JE, Kjaergaard J, Terkelsen CJ, et al. Impella to treat acute myocardial infarct-related cardiogenic shock. J Clin Med, 2022, 11(9): 2427.
44. Kapur NK, Kim RJ, Moses JW, et al. Primary left ventricular unloading with delayed reperfusion in patients with anterior ST-elevation myocardial infarction: Rationale and design of the STEMI-DTU randomized pivotal trial. Am Heart J, 2022, 254: 122-132.
45. Rihal CS, Naidu SS, Givertz MM, et al. 2015 SCAI/ACC/HFSA/STS clinical expert consensus statement on the use of percutaneous mechanical circulatory support devices in cardiovascular care: Endorsed by the American Heart Assocation, the Cardiological Society of India, and Sociedad Latino Americana de Cardiologia Intervencion; Affirmation of Value by the Canadian Association of Interventional Cardiology-Association Canadienne de Cardiologie d'intervention. J Am Coll Cardiol, 2015, 65(19): e7-e26.
46. 中华医学会心血管病学分会介入心脏病学组, 中国医师协会心血管内科医师分会血栓防治专业委员会, 中华心血管病杂志编辑委员会. 中国经皮冠状动脉介入治疗指南(2016). 中华心血管病杂志, 2016, 44(5): 382-400.
47. Henry TD, Tomey MI, Tamis-Holland JE, et al. Invasive management of acute myocardial infarction complicated by cardiogenic shock: A scientific statement from the American Heart Association. Circulation, 2021, 143(15): e815-e829.
48. 中华医学会心血管病学分会, 中华心血管病杂志编辑委员会. 经皮机械循环辅助在复杂心血管疾病介入治疗应用中国专家共识. 中华心血管病杂志, 2022, 50(10): 959-972.

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