Percutaneous Hemodynamic Support (Impella) in Patients with Advanced Heart Failure and/or Cardiogenic Shock Not Eligible to PROTECT II Trial

Abstract

PROTECT I and II trials have tested the efficacy of Impella in patents with high-risk percutaneous coronary intervention (PCI). However, patients with severe hemodynamic instability such as cardiac arrest, ST-segment elevated myocardial infarction (STEMI), or cardiogenic shock were excluded. The objective was to investigate the efficacy of Impella in sicker patient population who were not included in PROTECT trials. These patients merit high-risk PCI who had cardiogenic shock and unstable or decompensated heart failure (HF). From December 2010 to March 2012, 10 consecutive patients with extremely high surgical risk and hemodynamic instability underwent urgent PCI with Impella 2.5 support (Abiomed Inc., Danvers, MA). These patients were presented with advance HF and/or cardiogenic shock. Among the 10 included patients, 3 patients were with cardiac arrest and 1 patient was with acute myocardial infarction. All patients had successful Impella implantation and remained hemodynamically stable during high-risk PCI. Among the 10 patients 2 patients (20%) died within 1 month and 1 patient developed limb ischemia. In high-risk population nonrandomizable to PROTECT trials with advance HF/cardiogenic shock, Impella could be an important tool for hemodynamic support to PCI or could be a bridge to left ventricle assist device to achieve good recovery. Larger studies need to be conducted on this high-risk population.

Keywords

left ventricle assisting device - heart failure - percutaneous coronary intervention - cardiogenic shock

• References

• 1 Henriques JP, Remmelink M, Baan Jr J , et al. Safety and feasibility of elective high-risk percutaneous coronary intervention procedures with left ventricular support of the Impella Recover LP 2.5. Am J Cardiol 2006; 97 (7) 990-992
• 2 Burzotta F, Paloscia L, Trani C , et al. Feasibility and long-term safety of elective Impella-assisted high-risk percutaneous coronary intervention: a pilot two-centre study. J Cardiovasc Med (Hagerstown) 2008; 9 (10) 1004-1010
• 3 Iliodromitis KE, Kahlert P, Plicht B , et al. High-risk PCI in acute coronary syndromes with Impella LP 2.5 device support. Int J Cardiol 2011; 153 (1) 59-63
• 4 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
• 5 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
• 6 Alasnag MA, Gardi DO, Elder M , et al. Use of the Impella 2.5 for prophylactic circulatory support during elective high-risk percutaneous coronary intervention. Cardiovasc Revasc Med 2011; 12 (5) 299-303
• 7 Maini B, Naidu SS, Mulukutla S , et al. Real-world use of the Impella 2.5 circulatory support system in complex high-risk percutaneous coronary intervention: the USpella Registry. Catheter Cardiovasc Interv 2012; 80 (5) 717-725
• 8 Meyns B, Dens J, Sergeant P, Herijgers P, Daenen W, Flameng W. Initial experiences with the Impella device in patients with cardiogenic shock - Impella support for cardiogenic shock. Thorac Cardiovasc Surg 2003; 51 (6) 312-317
• 9 Dens J, Meyns B, Hilgers RD , et al. First experience with the Impella Recover(R) LP 2.5 micro axial pump in patients with cardiogenic shock or undergoing high-risk revascularisation. EuroIntervention 2006; 2 (1) 84-90
• 10 Kawashima D, Gojo S, Nishimura T , et al. Left ventricular mechanical support with Impella provides more ventricular unloading in heart failure than extracorporeal membrane oxygenation. ASAIO J 2011; 57 (3) 169-176
• 11 Remmelink M, Sjauw KD, Henriques JP , et al. Effects of left ventricular unloading by Impella recover LP2.5 on coronary hemodynamics. Catheter Cardiovasc Interv 2007; 70 (4) 532-537
• 12 Jolly N. Role of Impella 2.5 heart pump in stabilizing diastolic aortic pressure to avert acute hemodynamic collapse during coronary interventions. J Invasive Cardiol 2009; 21 (7) E134-E136
• 13 Gupta A, Allaqaband S, Bajwa T. Combined use of Impella device and intra-aortic balloon pump to improve survival in a patient in profound cardiogenic shock post cardiac arrest. Catheter Cardiovasc Interv 2009; 74 (6) 975-976
• 14 Kovacic JC, Nguyen HT, Karajgikar R, Sharma SK, Kini AS. The impella recover 2.5 and TandemHeart ventricular assist devices are safe and associated with equivalent clinical outcomes in patients undergoing high-risk percutaneous coronary intervention. Catheter Cardiovasc Interv 2011; (Jan) 13
• 15 Lamarche Y, Cheung A, Ignaszewski A , et al. Comparative outcomes in cardiogenic shock patients managed with Impella microaxial pump or extracorporeal life support. J Thorac Cardiovasc Surg 2011; 142 (1) 60-65
• 16 Engström AE, Cocchieri R, Driessen AH , et al. The Impella 2.5 and 5.0 devices for ST-elevation myocardial infarction patients presenting with severe and profound cardiogenic shock: the Academic Medical Center intensive care unit experience. Crit Care Med 2011; 39 (9) 2072-2079
• 17 Lam K, Sjauw KD, Henriques JP, Ince C, de Mol BA. Improved microcirculation in patients with an acute ST-elevation myocardial infarction treated with the Impella LP2.5 percutaneous left ventricular assist device. Clin Res Cardiol 2009; 98 (5) 311-318
• 18 Harmon L, Boccalandro F. Cardiogenic shock secondary to severe acute ischemic mitral regurgitation managed with an Impella 2.5 percutaneous left ventricular assist device. Catheter Cardiovasc Interv 2012; 79 (7) 1129-1134
• 19 Patanè F, Zingarelli E, Sansone F, Rinaldi M. Acute ventricular septal defect treated with an Impella recovery as a 'bridge therapy' to heart transplantation. Interact Cardiovasc Thorac Surg 2007; 6 (6) 818-819
• 20 Samoukovic G, Rosu C, Giannetti N, Cecere R. The Impella LP 5.0 as a bridge to long-term circulatory support. Interact Cardiovasc Thorac Surg 2009; 8 (6) 682-683