Safety and Feasibility of the Impella® Device in High-Risk Percutaneous Coronary Intervention
- Hemodynamic support with the Impella® device is associated with low mortality and low adverse events in patients undergoing high-risk percutaneous coronary intervention (HRPCI), according to a systematic review.
According to findings from a systematic review by Ichou et al, the Impella® device is safe and feasible for patients undergoing high-risk percutaneous coronary intervention (HRPCI).1
Systematic Review of Impella Device Use in HRPCI
Support with the Impella device is associated with increased cardiac output, improvement in left ventricular ejection fraction (LVEF), and reduction in infarct size.2,3,4,5 Additionally, the Impella device unloads the LV, ultimately decreasing end-diastolic wall stress and pulmonary capillary wedge pressure.6
The investigators of this systematic review identified 20 studies which evaluated the outcomes of Impella device support in HRPCI. These studies included a total of 1287 patients from 4 randomized controlled trials and 16 observational studies. The average left ventricular ejection fraction (LVEF) ranged from 23% to 37%.
Success rate for intervention was high across studies, ranging from an average of 90% to 100%. Mean Impella device output was approximately 2.1 L/min during support, and the number of treated lesions ranged from 1.8 to 3.0.
Among the controlled studies included in this analysis, the investigators observed low rates of all-cause mortality following Impella device support.
In addition, O'Neill et al demonstrated a significantly lower rate of stroke associated with Impella device support vs IABP at 30 days (0% vs 1.8%, respectively; P = 0.04).10 Investigators also observed a trend toward lower rates of repeat revascularization (3.6% vs 7.8%; P = 0.06) and major adverse cardiac events (40.6% vs 49.3%; P = 0.07) among patients receiving the Impella device vs IABP.
The Take Home
This systematic review which includes 1287 patients demonstrates the favorable outcomes associated with the Impella device compared with IABP, particularly in regard to hemodynamic improvement and safety.
- Ait Ichou J, Larivée N, Eisenberg MJ, Suissa K, Filion KB. The effectiveness and safety of the Impella ventricular assist device for high-risk percutaneous coronary interventions: A systematic review. Catheter Cardiovasc Interv [published online September 20, 2017]. doi: 10.1002/ccd.27316.
- Valgimigli M, Steendijk P, Sianos G, Onderwater E, Serruys PW. Left ventricular unloading and concomitant total cardiac output increase by the use of percutaneous Impella Recover LP 2.5 assist device during high-risk coronary intervention. Catheter Cardiovasc Interv. 2005;65(2):263-267.
- Meyns B, Dens J, Sergeant P, et al. Initial experiences with the Impella device in patients with cardiogenic shock - Impella support for cardiogenic shock. Thorac Cardiovasc Surg. 2003;51(6):312-317.
- Gaudard P, Mourad M, Eliet J, et al. Management and outcome of patients supported with Impella 5.0 for refractory cardiogenic shock. Crit Care. 2015;19:363.
- Meyns B, Stolinski J, Leunens V, Verbeken E, Flameng W. Left ventricular support by catheter-mounted axial flow pump reduces infarct size. J Am Coll Cardiol. 2003;41(7):1087-1095.
- Henriques José PS, Remmelink M, Baan J, van der Schaaf, René J, Vis MM, Koch KT, Scholten EW, de Mol, Bas AJM, Tijssen Jan GP, Piek JJ, de Winter, Robbert J. 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;97:990-992.
- 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.
- 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;52:1584–1588. J Am Coll Cardiol. 2008;52(19):1584-1588.
- 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.
- 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.
To learn more about the Impella® platform of heart pumps, including important risk and safety information associated with the use of the devices, please visit: www.protectedpci.com/indications-use-safety-information/