Improving Survival in Cardiogenic Shock: Is Impella the Answer?
2018; Elsevier BV; Volume: 131; Issue: 10 Linguagem: Inglês
10.1016/j.amjmed.2018.04.045
ISSN1555-7162
Autores Tópico(s)Cardiac Arrest and Resuscitation
ResumoCardiogenic shock complicates approximately 8% of all ST-segment elevation myocardial infarctions and has a dismal prognosis.1Kolte D Khera S Aronow WS et al.Trends in incidence, management, and outcomes of cardiogenic shock complicating ST-elevation myocardial infarction in the United States.J Am Heart Assoc. 2014; 3e000590 https://doi.org/10.1161/jaha.113.000590Crossref PubMed Scopus (0) Google Scholar Even in patients with cardiogenic shock treated with an invasive approach (cardiac catheterization, angioplasty, and coronary bypass surgery), in-hospital mortality approaches 40%.2Bangalore S Gupta N Guo Y et al.Outcomes with invasive vs conservative management of cardiogenic shock complicating acute myocardial infarction.Am J Med. 2015; 128: 601-608https://doi.org/10.1016/j.amjmed.2014.12.009Abstract Full Text Full Text PDF PubMed Scopus (36) Google Scholar For many years, the intra-aortic balloon pump was thought to be helpful in improving outcomes in cardiogenic shock. However, the landmark randomized, controlled IABP-SHOCK II trial, published in 2012, 3Thiele H Zeymer U Neumann FJ et al.Intraaortic balloon support for myocardial infarction with cardiogenic shock.N Engl J Med. 2012; 367: 1287-1296https://doi.org/10.1056/NEJMoa1208410Crossref PubMed Scopus (1587) Google Scholar concluded that the use of intra-aortic balloon counterpulsation did not significantly reduce mortality in patients with cardiogenic shock complicating acute myocardial infarction. This led investigators to search for alternate mechanical circulatory support systems that might prove effective in reducing mortality in cardiogenic shock. One such system is the Impella device (Abiomed, Danvers, Mass). Impella is a catheter-based miniaturized ventricular assist device. Using a retrograde femoral artery access, it is placed in the left ventricle across the aortic valve. The device pumps blood from the left ventricle into the ascending aorta and systemic circulation at an upper rate between 2.5 and 5.0 L/ min. (In contrast, the ability of the intra-aortic balloon pump to augment cardiac output is very modest; no more than 0.5 L/ min.4Burzotta F Trani C Doshi SN et al.Impella ventricular support in clinical practice: collaborative viewpoint from a European expert user group.Int J Cardiol. 2015; 201: 684-691https://doi.org/10.1016/j.ijcard.2015.07.065Abstract Full Text Full Text PDF PubMed Scopus (130) Google Scholar) The hemodynamic effects provided by Impella result in almost immediate and sustained unloading of the left ventricle while increasing overall systemic cardiac output. These superior hemodynamic effects of the Impella system, when compared with the intra-aortic balloon pump,4Burzotta F Trani C Doshi SN et al.Impella ventricular support in clinical practice: collaborative viewpoint from a European expert user group.Int J Cardiol. 2015; 201: 684-691https://doi.org/10.1016/j.ijcard.2015.07.065Abstract Full Text Full Text PDF PubMed Scopus (130) Google Scholar have resulted in increasing focus on the Impella system as a possible way of making a dent in the devastating mortality rate associated with cardiogenic shock.4Burzotta F Trani C Doshi SN et al.Impella ventricular support in clinical practice: collaborative viewpoint from a European expert user group.Int J Cardiol. 2015; 201: 684-691https://doi.org/10.1016/j.ijcard.2015.07.065Abstract Full Text Full Text PDF PubMed Scopus (130) Google Scholar There have been 3 randomized controlled clinical trials comparing the mortality rates of Impella and the intra-aortic balloon pump in cardiogenic shock.5Ouweneel DM Engstrom AE Sjauw KD et al.Experience from a randomized controlled trial with Impella 2.5 versus IABP in STEMI patients with cardiogenic pre-shock.Int J Cardiol. 2016; 202: 894-896https://doi.org/10.1016/j.ijcard.2015.10.063Abstract Full Text Full Text PDF PubMed Scopus (54) Google Scholar, 6Seyfarth 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: 1584-1588https://doi.org/10.1016/j.jacc.2008.05.065Crossref PubMed Scopus (726) Google Scholar, 7Ouweneel DM Eriksen E Seyfarth M et al.Percutaneous mechanical circulatory support versus intra-aortic balloon pump in cardiogenic shock after acute myocardial infarction.J Am Coll Cardiol. 2017; 69: 278-287https://doi.org/10.1016/j.jacc.2016.10.022Crossref PubMed Scopus (435) Google Scholar However, the numbers of patients enrolled in each of these studies were small. In the largest of these trials (the Impress trial7Ouweneel DM Eriksen E Seyfarth M et al.Percutaneous mechanical circulatory support versus intra-aortic balloon pump in cardiogenic shock after acute myocardial infarction.J Am Coll Cardiol. 2017; 69: 278-287https://doi.org/10.1016/j.jacc.2016.10.022Crossref PubMed Scopus (435) Google Scholar), only 48 patients were studied. No mortality difference was found in any of these trials or, indeed, with meta-analysis of the 3 trials (total of 95 patients),8Ouweneel DM Eriksen E Seyfarth M Henriques JPS Percutaneous mechanical circulatory support versus intra-aortic balloon pump for treating cardiogenic shock.J Am Coll Cardiol. 2017; 69: 358-360https://doi.org/10.1016/j.jacc.2016.10.026Crossref PubMed Scopus (70) Google Scholar which is not surprising, as the trials were underpowered to detect a mortality difference. Moreover, as the investigators of these trials have noted, randomized controlled trials in the emergency setting of cardiogenic shock are exceptionally difficult to conduct,5Ouweneel DM Engstrom AE Sjauw KD et al.Experience from a randomized controlled trial with Impella 2.5 versus IABP in STEMI patients with cardiogenic pre-shock.Int J Cardiol. 2016; 202: 894-896https://doi.org/10.1016/j.ijcard.2015.10.063Abstract Full Text Full Text PDF PubMed Scopus (54) Google Scholar and it is far from certain whether large-scale randomized trials will ever become reality. However, there has been a large body of nonrandomized clinical data suggesting a potentially useful role for the Impella system in the treatment of cardiogenic shock.9O'Neill WW Schreiber T Wohns DHW et al.The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: results from the USpella Registry.J Intervent Cardiol. 2013; 27: 1-11https://doi.org/10.1111/joic.12080Crossref PubMed Scopus (255) Google Scholar, 10Griffith 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: 548-554https://doi.org/10.1016/j.jtcvs.2012.01.067Abstract Full Text Full Text PDF PubMed Scopus (139) Google Scholar, 11Lemaire A Anderson MB Lee LY et al.The Impella device for acute mechanical circulatory support in patients in cardiogenic shock.Ann Thorac Surg. 2014; 97: 133-138https://doi.org/10.1016/j.athoracsur.2013.07.053Abstract Full Text Full Text PDF PubMed Scopus (88) Google Scholar, 12Lauten A Engstrom AE Jung C et al.Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry.Circ Heart Fail. 2012; 6: 23-30https://doi.org/10.1161/circheartfailure.112.967224Crossref PubMed Google Scholar In the USpella Registry of patients with cardiogenic shock treated with Impella devices before undergoing coronary angioplasty, this mechanical support resulted in improved survival to hospital discharge.9O'Neill WW Schreiber T Wohns DHW et al.The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: results from the USpella Registry.J Intervent Cardiol. 2013; 27: 1-11https://doi.org/10.1111/joic.12080Crossref PubMed Scopus (255) Google Scholar In addition, a multicenter, prospective study of the use of the Impella device for the treatment of patients developing cardiogenic shock after cardiac surgery (the RECOVER I trial) reported very favorable results.10Griffith 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: 548-554https://doi.org/10.1016/j.jtcvs.2012.01.067Abstract Full Text Full Text PDF PubMed Scopus (139) Google Scholar The primary end points of this study (death or stroke at 30 days) occurred in only 13% of patients. In 2016, on the basis of analysis of the finding of this study and of the USpella Registry observations, the US Food and Drug Administration granted approval for use of the Impella device for the treatment of cardiogenic shock complicating acute myocardial infarction. A recent meta-analysis of emerging trial and registry data has suggested that in patients with cardiogenic shock undergoing angioplasty, a strategy of implanting the Impella device prior to performing angioplasty is associated with improved survival when compared with a strategy of initiating Impella support only after completion of angioplasty.13Flaherty MP Khan AR O'Neill WW Early initiation of Impella in acute myocardial infarction complicated by cardiogenic shock improves survival: a meta-analysis.JACC Cardiovasc Interv. 2017; 10: 1805-1806https://doi.org/10.1016/j.jcin.2017.06.027Crossref PubMed Scopus (42) Google Scholar In addition, there has been increasing support for the idea of routine Swan-Ganz monitoring during treatment of cardiogenic shock.4Burzotta F Trani C Doshi SN et al.Impella ventricular support in clinical practice: collaborative viewpoint from a European expert user group.Int J Cardiol. 2015; 201: 684-691https://doi.org/10.1016/j.ijcard.2015.07.065Abstract Full Text Full Text PDF PubMed Scopus (130) Google Scholar To determine the feasibility and clinical utility of routinely incorporating these 2 concepts in the treatment of cardiogenic shock, William O'Neill formed the Detroit Cardiogenic Shock Initiative.14Basir MB Schreiber T Dixon S et al.Feasibility of early mechanical circulatory support in acute myocardial infarction complicated by cardiogenic shock: the Detroit Cardiogenic Shock Initiative.Catheter Cardiovasc Interv. 2017; 91: 454-461https://doi.org/10.1002/ccd.27427Crossref PubMed Scopus (147) Google Scholar Specifically, 4 sites in the metropolitan Detroit area agreed to treat patients with cardiogenic shock complicating acute myocardial infarction using a mutually agreed upon protocol emphasizing invasive hemodynamic monitoring and rapid initiation of Impella support. Survival to discharge in the 41 patients enrolled in this single-arm study was 76%, a significant improvement from institutional historical control rates of 50%.14Basir MB Schreiber T Dixon S et al.Feasibility of early mechanical circulatory support in acute myocardial infarction complicated by cardiogenic shock: the Detroit Cardiogenic Shock Initiative.Catheter Cardiovasc Interv. 2017; 91: 454-461https://doi.org/10.1002/ccd.27427Crossref PubMed Scopus (147) Google Scholar Given these encouraging results, a national, multicenter, quality initiative entitled the National Cardiogenic Shock Initiative has been launched. Among the metrics that will be tracked in this study is whether survival >80% can be achieved with the strategy developed in the Detroit initiative.14Basir MB Schreiber T Dixon S et al.Feasibility of early mechanical circulatory support in acute myocardial infarction complicated by cardiogenic shock: the Detroit Cardiogenic Shock Initiative.Catheter Cardiovasc Interv. 2017; 91: 454-461https://doi.org/10.1002/ccd.27427Crossref PubMed Scopus (147) Google Scholar It is our expectation that there will soon be widespread adoption of this strategy of early Impella placement in the treatment of patients with cardiogenic shock. In turn, it is hoped that this strategy will result in improved survival. Currently in the United States, 42% of patients with cardiogenic shock complicating myocardial infarction are treated with an intra-aortic balloon pump, despite a lack of evidence for this treatment in cardiogenic shock.15Sandhu A McCoy LA Negi SI et al.Use of mechanical circulatory support in patients undergoing percutaneous coronary intervention: insights from the National Cardiovascular Data Registry.Circulation. 2015; 132: 1243-1251https://doi.org/10.1161/circulationaha.114.014451Crossref PubMed Scopus (0) Google Scholar In contrast, only 6% are treated with an Impella device.16O'Neill WW Outcomes for 15,259 U.S. patients with acute myocardial infarction cardiogenic shock (AMICS) supported with the Impella .in: The American College of Cardiology Annual Meeting , Washington, DC2017Google Scholar Although there is an absence of evidence based on randomized clinical trials, a growing body of registry and observational data suggests an important role for the Impella system in the treatment of cardiogenic shock. Accordingly, it would appear reasonable to expect a significant increase over the next few years in the use of the Impella device in the treatment of cardiogenic shock, with a parallel decrease in use of the intra-aortic balloon pump.
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