Left Ventricular Support
2018; Lippincott Williams & Wilkins; Volume: 11; Issue: 9 Linguagem: Francês
10.1161/circinterventions.118.007214
ISSN1941-7632
AutoresGuillaume Marquis‐Gravel, E. Magnus Ohman,
Tópico(s)Cardiac Valve Diseases and Treatments
ResumoHomeCirculation: Cardiovascular InterventionsVol. 11, No. 9Left Ventricular Support Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBLeft Ventricular SupportAre 2 Devices Better Than 1? Guillaume Marquis-Gravel, MD, MSc and E. Magnus Ohman, MD Guillaume Marquis-GravelGuillaume Marquis-Gravel Duke Clinical Research Institute, Durham, NC (G.M.-G., E.M.O.). and E. Magnus OhmanE. Magnus Ohman E. Magnus Ohman, MD, Duke University Medical Center, Box 3126 DUMC, Durham, NC 27710. Email E-mail Address: [email protected] Duke Clinical Research Institute, Durham, NC (G.M.-G., E.M.O.). Duke University Medical Center and Duke Program for Advanced Coronary Disease, Durham, NC (E.M.O.). Originally published17 Sep 2018https://doi.org/10.1161/CIRCINTERVENTIONS.118.007214Circulation: Cardiovascular Interventions. 2018;11:e007214This article is a commentary on the followingConcomitant Intra-Aortic Balloon Pump Use in Cardiogenic Shock Requiring Veno-Arterial Extracorporeal Membrane OxygenationSee Article by Vallabhajosyula et alDespite the exponential progress achieved in the treatment of cardiovascular diseases during the past decades, the prognosis of cardiogenic shock (CS), regardless of its cause, remains poor.1–3 The hemodynamic hallmarks of CS are sustained hypotension and decreased cardiac output in the context of elevated left ventricular (LV) filling pressure.4,5 Systemic hypoperfusion leads to a self-perpetuating lethal spiral characterized by metabolic lactic acidosis and organ dysfunction. Eventually, intrinsic hemodynamic-regulating mechanisms are overwhelmed and cause an irreversible metabolic tipping point where death becomes inevitable despite appropriate restoration of vital organs perfusion. To halt the lethal hemodynamic and metabolic deterioration during CS, some authors have advocated to prioritize restoring peripheral perfusion of organs, such as the brain and the kidneys with mechanical support. Once stabilized, coronary reperfusion with percutaneous coronary intervention or coronary artery bypass graft can be performed to improve outcomes in acute myocardial infarction complicated by CS (AMICS).6 Such an approach has been evaluated by the Detroit Cardiogenic Shock Initiative, where insertion of an axial flow Impella pump (Abiomed, Danvers, MA) before percutaneous coronary intervention seems to be associated with improved survival.7,8 Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) for CS has been in use for several decades9 and has been recommended in patients with severe CS or cardiac arrest.4 In emergency situations, it can be implanted by dedicated teams at the bedside through the femoral vasculature, has the potential to provide up to 7 L of cardiac output depending on the size of the canulae, and can also restore proper oxygenation, which is often compromised as a consequence of pulmonary edema and low cardiac output.4,10However, the advantages of VA-ECMO for restoring peripheral perfusion come at a cost on cardiac hemodynamics and coronary perfusion as shown in the Table.11,12 The predominant hemodynamic consequences of VA-ECMO are related to an increase in the cardiac afterload, manifested by the elevation of the mean and peak systolic LV pressures on the pressure-volume curve of the cardiac cycle, particularly if the heart is unable to eject blood.13 The net effect of VA-ECMO on a failing heart, thus, includes a combination of LV distension and increased afterload,13 on top of the already elevated high volume and filling pressures present in CS. These hemodynamic effects have the potential to progress into accelerated myocardial ischemia and myonecrosis. VA-ECMO is therefore salutary for the perfusion of peripheral vital organs but is at best neutral or at worst detrimental to the failing heart. Strategies to remedy this situation have included LV unloading (venting) to reduce myocardial distension from the increased end-systolic volume, and include intra-aortic balloon pump (IABP) to percutaneous mechanical support devices.13,14 An ideal unloading device would normalize LV diastolic filling pressures, alleviate ventricular over distension, and enhance coronary perfusion. The IABP is the simplest approach and does provide modest LV support, while not directly off-loading (venting) the ventricle as shown in the Table.Table. Hemodynamic Effects and Observed Outcomes of VA-ECMO and IABP in Acute Myocardial Infarction Complicated by Cardiogenic ShockHemodynamic EffectsVA-ECMOIABP Cardiac output↓↑ End-diastolic volume↓↔ End-systolic volume↑↓ Afterload↑↑↑↓ LV-preload↑↓ Coronary flowinconsistent effect↑ Mean BP↑↑↑↑ Vascular complications and bleeding↑↑↑↑Randomized controlled trialsNone availableNeutral effect on mortalityBP indicates blood pressure; IABP, intra-aortic balloon pump; LV, left ventricular; and VA-ECMO, veno-arterial extracorporeal membrane oxygenation.Despite these appealing theoretical features of venting strategies in patients with CS on VA-ECMO, there is limited clinical data on the value of this 2-device approach in CS, mostly from small nonrandomized studies. The meta-analysis by Vallabhajosyula et al15 published in this issue provides important information about the clinical value of a combined VA-ECMO and IABP approach in CS. They pooled 22 observational studies with a total of 4653 patients. Their findings suggest that the addition of an IABP does not affect significantly short-term mortality in patients with CS requiring VA-ECMO (risk ratio, 0.80; 95% CI, 0.52–1.22). However, in the subgroup of studies with AMICS, IABP implantation seemed to be beneficial with a surprisingly large effect (risk ratio, 0.56; 95% CI, 0.46–0.67). The meta-analysis also lacks important clinical variables, such as vascular complications and bleeding events for most of the included studies. Most importantly, the timing of the insertion of the 2 devices are not provided for the majority of the studies, so it is not clear which device was used first.Given the uniqueness of this combined series, the most important question is whether observations made in the AMICS subgroup should change practice. Meta-analyses can be instrumental in generating hypotheses and inform the design of future trials, but their role in providing guidance on how we should treat patients is limited.16,17 Often, 1 good-quality large-scale randomized trial is more informative than a meta-analysis comprising many studies of limited quality.17,18 The impact on clinical practice of the findings in the AMICS subgroup should be toned down, as a significant publication bias in favor of IABP is observed in the funnel plot, with high overall statistical heterogeneity (I2=81%). The major confounding caused by the lack of randomization of the included studies reduces ability to isolate the effect of IABP from background noise of confounding. A meta-regression analysis would have been welcomed to partly mitigate this concern.17 This meta-analysis does suggest that a possible effect on mortality of IABP+VA-ECMO in patients with AMICS may be present and relatively large, which could affect how future investigation in this field should be developed.Regardless of the methodological limitations of this meta-analysis, the question remains what value VA-ECMO has in AMICS. There has been no randomized trial of this approach in AMICS to date.9 Two prospective randomized trials addressing this important question are being launched in Europe; the EURO SHOCK Heart Attack Study (Dr Anthony Gershlick, University of Leicester; personal communication) and the ECLS-SHOCK trial (Extra-Corporal Life Support in Cardiogenic Shock Complicating Acute Myocardial Infarction; Dr Holger Thiele, University of Leipzig; personal communication). One of the challenges that these trials will face is what therapy should be available in the control arm. It is established that IABP has no significant effect on either 30-day or 1-year mortality.5,19 However, many physicians may feel uncomfortable withholding any therapy that can sustain blood pressure among patients with AMICS, even in a carefully performed randomized trial. Thus, if IABP is used in the control arm and patients cross over to VA-ECMO because of worsening hemodynamics (thus having IABP+VA-ECMO), it may create a neutral trial of VA-ECMO versus IABP, because of a possible cross-over effect as suggested by this meta-analysis. Therefore, this meta-analysis raises thorny issues that future VA-ECMO trials will need to tackle.We believe that the first order is to establish if VA-ECMO has any utility in AMICS. Unfortunately, randomized trials in CS with any device are slow to complete, limiting our ability to provide best evidence-based care. In the meantime, a team approach and protocol should be developed according to the experience of each institution to better care for patients with AMICS similar to what O'Neill et al7 had done with the Detroit Cardiogenic Shock Initiative.8 Ideally, we should develop a North American repository to collect data on AMICS so that different regional protocols could be evaluated in a national context until the randomized trials can define the optimal approach. The journey may be long, but these high-risk patients deserve that we get the answers right for the best care in CS.DisclosuresDr Marquis-Gravel is supported by a research grant from the Canadian Institute of Health Research. Dr Ohman has research grants with Chiesi, Gilead, Janssen, and Portola, and consulting relationship with Abiomed, Abbott, ACI Clinical, Cordis, Faculty Connection, Gilead, Janssen, Medscape, and Xylocor.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.https://www.ahajournals.org/journal/circinterventionsE. Magnus Ohman, MD, Duke University Medical Center, Box 3126 DUMC, Durham, NC 27710. Email [email protected]duke.eduReferences1. Wayangankar SA, Bangalore S, McCoy LA, Jneid H, Latif F, Karrowni W, Charitakis K, Feldman DN, Dakik HA, Mauri L, Peterson ED, Messenger J, Roe M, Mukherjee D, Klein A. Temporal trends and outcomes of patients undergoing percutaneous coronary interventions for cardiogenic shock in the setting of acute myocardial infarction: a report from the CathPCI Registry.JACC Cardiovasc Interv. 2016; 9:341–351.CrossrefMedlineGoogle Scholar2. Shah M, Patel B, Tripathi B, Agarwal M, Patnaik S, Ram P, Patil S, Shin J, Jorde UP. Hospital mortality and thirty day readmission among patients with non-acute myocardial infarction related cardiogenic shock [published online June 10, 2018].Int J Cardiol. doi: 10.1016/j.ijcard.2018.06.036Google Scholar3. Shah RU, de Lemos JA, Wang TY, Chen AY, Thomas L, Sutton NR, Fang JC, Scirica BM, Henry TD, Granger CB. Post-hospital outcomes of patients with acute myocardial infarction with cardiogenic shock: findings from the NCDR.J Am Coll Cardiol. 2016; 67:739–747. doi: 10.1016/j.jacc.2015.11.048CrossrefMedlineGoogle Scholar4. Atkinson TM, Ohman EM, O'Neill WW, Rab T, Cigarroa JE; Interventional Scientific Council of the American College of Cardiology. A practical approach to mechanical circulatory support in patients undergoing percutaneous coronary intervention: an interventional perspective.JACC Cardiovasc Interv. 2016; 9:871–883. doi: 10.1016/j.jcin.2016.02.046CrossrefMedlineGoogle Scholar5. Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Fuhrmann J, Böhm M, Ebelt H, Schneider S, Schuler G, Werdan K; IABP-SHOCK II Trial Investigators. Intraaortic balloon support for myocardial infarction with cardiogenic shock.N Engl J Med. 2012; 367:1287–1296. doi: 10.1056/NEJMoa1208410CrossrefMedlineGoogle Scholar6. Kalavrouziotis D, Rodés-Cabau J, Mohammadi S. Moving beyond SHOCK: new paradigms in the management of acute myocardial infarction complicated by cardiogenic shock.Can J Cardiol. 2017; 33:36–43. doi: 10.1016/j.cjca.2016.10.018CrossrefMedlineGoogle Scholar7. O'Neill WW, Grines C, Schreiber T, Moses J, Maini B, Dixon SR, Ohman EM. Analysis of outcomes for 15,259 US patients with acute myocardial infarction cardiogenic shock (AMICS) supported with the Impella device.Am Heart J. 2018; 202:33–38. doi: 10.1016/j.ahj.2018.03.024CrossrefMedlineGoogle Scholar8. Basir MB, Schreiber T, Dixon S, Alaswad K, Patel K, Almany S, Khandelwal A, Hanson I, George A, Ashbrook M, Blank N, Abdelsalam M, Sareen N, Timmis SBH, O'Neill Md WW. Feasibility of early mechanical circulatory support in acute myocardial infarction complicated by cardiogenic shock: the Detroit cardiogenic shock initiative.Catheter Cardiovasc Interv. 2018; 91:454–461. doi: 10.1002/ccd.27427CrossrefMedlineGoogle Scholar9. Keebler ME, Haddad EV, Choi CW, McGrane S, Zalawadiya S, Schlendorf KH, Brinkley DM, Danter MR, Wigger M, Menachem JN, Shah A, Lindenfeld J. Venoarterial extracorporeal membrane oxygenation in cardiogenic shock.JACC Heart Fail. 2018; 6:503–516. doi: 10.1016/j.jchf.2017.11.017CrossrefMedlineGoogle Scholar10. Boulate D, Luyt CE, Pozzi M, Niculescu M, Combes A, Leprince P, Kirsch M. Acute lung injury after mechanical circulatory support implantation in patients on extracorporeal life support: an unrecognized problem.Eur J Cardiothorac Surg. 2013; 44:544–549; discussion 549. doi: 10.1093/ejcts/ezt125CrossrefMedlineGoogle Scholar11. Kawashima D, Gojo S, Nishimura T, Itoda Y, Kitahori K, Motomura N, Morota T, Murakami A, Takamoto S, Kyo S, Ono M. Left ventricular mechanical support with Impella provides more ventricular unloading in heart failure than extracorporeal membrane oxygenation.ASAIO J. 2011; 57:169–176. doi: 10.1097/MAT.0b013e31820e121cCrossrefMedlineGoogle Scholar12. Lucas SK, Schaff HV, Flaherty JT, Gott VL, Gardner TJ. The harmful effects of ventricular distention during postischemic reperfusion.Ann Thorac Surg. 1981; 32:486–494.CrossrefMedlineGoogle Scholar13. Rihal CS, Naidu SS, Givertz MM, Szeto WY, Burke JA, Kapur NK, Kern M, Garratt KN, Goldstein JA, Dimas V, Tu T; Society for Cardiovascular Angiography and Interventions (SCAI); Heart Failure Society of America (HFSA); Society for Thoracic Surgeons (STS); American Heart Association (AHA); American College of Cardiology (ACC). 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 Association, 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).Catheter Cardiovasc Interv. 2015; 85:E175–E196. doi: 10.1002/ccd.25720MedlineGoogle Scholar14. Alkhouli M, Narins CR, Lehoux J, Knight PA, Waits B, Ling FS. Percutaneous decompression of the left ventricle in cardiogenic shock patients on venoarterial extracorporeal membrane oxygenation.J Card Surg. 2016; 31:177–182. doi: 10.1111/jocs.12696CrossrefMedlineGoogle Scholar15. Vallabhajosyula S, O'Horo JC, Antharam P, Ananthaneni S, Vallabhajosyula S, Stulak JM, Eleid MF, Dunlay SM, Gersh BJ, Rihal CS, Barsness GW. Concomitant intra-aortic balloon pump use in cardiogenic shock requiring veno-arterial extracorporeal membrane oxygenation use: a systematic review and meta-analysis.Circ Cardiovasc Interv. 2018; 11:e006930. doi: 10.1161/CIRCINTERVENTIONS.118.006930LinkGoogle Scholar16. Ohman EM, Patel MR. Should a meta-analysis guide our practice?JACC Cardiovasc Interv. 2018; 11:844–846.CrossrefMedlineGoogle Scholar17. da Costa BR, Juni P. Systematic reviews and meta-analyses of randomized trials: principles and pitfalls.Eur Heart J. 2014; 35:3336–3345. doi: 10.1093/eurheartj/ehu424CrossrefMedlineGoogle Scholar18. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB. Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis Of Observational Studies in Epidemiology (MOOSE) group.JAMA. 2000; 283:2008–2012.CrossrefMedlineGoogle Scholar19. Thiele H, Zeymer U, Neumann FJ, Ferenc M, Olbrich HG, Hausleiter J, de Waha A, Richardt G, Hennersdorf M, Empen K, Fuernau G, Desch S, Eitel I, Hambrecht R, Lauer B, Böhm M, Ebelt H, Schneider S, Werdan K, Schuler G; Intraaortic Balloon Pump in cardiogenic shock II (IABP-SHOCK II) Trial Investigators. Intra-aortic balloon counterpulsation in acute myocardial infarction complicated by cardiogenic shock (IABP-SHOCK II): final 12 month results of a randomised, open-label trial.Lancet. 2013; 382:1638–1645. doi: 10.1016/S0140-6736(13)61783-3CrossrefMedlineGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsRelated articlesConcomitant Intra-Aortic Balloon Pump Use in Cardiogenic Shock Requiring Veno-Arterial Extracorporeal Membrane OxygenationSaraschandra Vallabhajosyula, et al. Circulation: Cardiovascular Interventions. 2018;11 September 2018Vol 11, Issue 9 Advertisement Article InformationMetrics © 2018 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.118.007214PMID: 30354607 Originally publishedSeptember 17, 2018 Keywordsmyocardial infarctionhypotensionprognosisEditorialspatientsPDF download Advertisement SubjectsAcute Coronary SyndromesCoronary Artery DiseaseMyocardial InfarctionRevascularization
Referência(s)