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Mechanical circulatory support with Impella versus intra-aortic balloon pump or medical treatment in cardiogenic shock—a critical appraisal of current data

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Abstract

Aims

Patients suffering from cardiogenic shock (CS) have a high mortality and morbidity. The Impella percutaneous left-ventricular assist device (LVAD) decreases LV preload, increases cardiac output, and improves coronary blood flow. We aimed to review and meta-analyze available data comparing Impella versus intra-aortic pump (IABP) counterpulsation or medical treatment in CS due to acute myocardial infarction or post-cardiac arrest.

Methods and results

Study-level data were analyzed. Heterogeneity was assessed using the I2 statistic. Risk rates were calculated and obtained using a random-effects model (DerSimonian and Laird). Four studies were found suitable for the final analysis, including 588 patients. Primary endpoint was short-term mortality (in-hospital or 30-day mortality).

In a meta-analysis of four studies comparing Impella versus control, Impella was not associated with improved short-term mortality (in-hospital or 30-day mortality; RR 0.84; 95% CI 0.57–1.24; p = 0.38; I2 55%). Stroke risk was not increased (RR 1.00; 95% CI 0.36–2.81; p = 1.00; I22 0%), but risk for major bleeding (RR 3.11 95% CI 1.50–6.44; p = 0.002; I2 0%) and peripheral ischemia complications (RR 2.58; 95% CI 1.24–5.34; p = 0.01; I2 0%) were increased in the Impella group.

Conclusion

In patients suffering from severe CS due to AMI, the use of Impella is not associated with improved short-time survival but with higher complications rates compared to IABP and medical treatment. Better patient selection avoiding Impella implantation in futile situations or in possible lower risk CS might be necessary to elucidate possible advantages of Impella in future studies.

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Data availability

All data relevant for this study will be given by the authors upon specific request without restriction.

References

  1. Mebazaa A, Combes A, van Diepen S, Hollinger A, Katz JN, Landoni G, Hajjar LA, Lassus J, Lebreton G, Montalescot G, Park JJ, Price S, Sionis A, Yannopolos D, Harjola VP, Levy B, Thiele H. Management of cardiogenic shock complicating myocardial infarction. Intensive Care Med. 2018

  2. Feistritzer HJ, Desch S, de Waha S, Jobs A, Zeymer U, Thiele H (2018) German contribution to development and innovations in the management of acute myocardial infarction and cardiogenic shock. Clin Res Cardiol 107:74–80

    Article  PubMed  Google Scholar 

  3. Mebazaa A, Tolppanen H, Mueller C, Lassus J, DiSomma S, Baksyte G, Cecconi M, Choi DJ, Cohen Solal A, Christ M, Masip J, Arrigo M, Nouira S, Ojji D, Peacock F, Richards M, Sato N, Sliwa K, Spinar J, Thiele H, Yilmaz MB, Januzzi J (2016) Acute heart failure and cardiogenic shock: a multidisciplinary practical guidance. Intensive Care Med 42:147–163

    Article  CAS  PubMed  Google Scholar 

  4. van Diepen S, Katz JN, Albert NM, Henry TD, Jacobs AK, Kapur NK, Kilic A, Menon V, Ohman EM, Sweitzer NK, Thiele H, Washam JB, Cohen MG, American Heart Association Council on Clinical C, Council on C, Stroke N (2017) Council on quality of C, outcomes R and mission L. Contemporary management of cardiogenic shock: a scientific statement from the American heart association. Circulation 136:e232–e268

    Article  PubMed  Google Scholar 

  5. Werdan K, Gielen S, Ebelt H, Hochman JS (2014) Mechanical circulatory support in cardiogenic shock. Euro Heart J 35:156–167

    Article  CAS  Google Scholar 

  6. Sayer GT, Baker JN, Parks KA (2012) Heart rescue: the role of mechanical circulatory support in the management of severe refractory cardiogenic shock. Curr Opin Crit Care 18:409–416

    Article  PubMed  Google Scholar 

  7. Ouweneel DM, Schotborgh JV, Limpens J, Sjauw KD, Engstrom AE, Lagrand WK, Cherpanath TGV, Driessen AHG, de Mol B, Henriques JPS (2016) Extracorporeal life support during cardiac arrest and cardiogenic shock: a systematic review and meta-analysis. Intensive Care Med 42:1922–1934

    Article  PubMed  PubMed Central  Google Scholar 

  8. Lauten A, Engstrom AE, Jung C, Empen K, Erne P, Cook S, Windecker S, Bergmann MW, Klingenberg R, Luscher TF, Haude M, Rulands D, Butter C, Ullman B, Hellgren L, Modena MG, Pedrazzini G, Henriques JP (2013) Figulla HR and Ferrari M. Percutaneous left-ventricular support with the Impella-2.5-assist device in acute cardiogenic shock: results of the Impella-EUROSHOCK-registry. Circ Heart Fail 6:23–30

    Article  PubMed  Google Scholar 

  9. Parissis H, Graham V, Lampridis S, Lau M, Hooks G, Mhandu PC (2016) IABP: history-evolution-pathophysiology-indications: what we need to know. J Cardiothorac Surg 11:122

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  10. 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, Bohm M, Ebelt H, Schneider S, Werdan K, Schuler G (2013) Intraaortic balloon pump in cardiogenic shock IIti. 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 382:1638–1645

    Article  PubMed  Google Scholar 

  11. Backhaus T, Fach A, Schmucker J, Fiehn E, Garstka D, Stehmeier J, Hambrecht R, Wienbergen H (2018) Management and predictors of outcome in unselected patients with cardiogenic shock complicating acute ST-segment elevation myocardial infarction: results from the Bremen STEMI Registry. Clin Res Cardiol 107:371–379

    Article  PubMed  Google Scholar 

  12. Shah M, Patnaik S, Patel B, Ram P, Garg L, Agarwal M, Agrawal S, Arora S, Patel N, Wald J, Jorde UP (2018) Trends in mechanical circulatory support use and hospital mortality among patients with acute myocardial infarction and non-infarction related cardiogenic shock in the United States. Clin Res Cardiol 107:287–303

    Article  PubMed  Google Scholar 

  13. Michels G, Wengenmayer T, Hagl C, Dohmen C, Bottiger BW, Bauersachs J, Markewitz A, Bauer A, Grasner JT, Pfister R, Ghanem A, Busch HJ, Kreimeier U, Beckmann A, Fischer M, Kill C, Janssens U, Kluge S, Born F, Hoffmeister HM, Preusch M, Boeken U, Riessen R, Thiele H. Recommendations for extracorporeal cardiopulmonary resuscitation (eCPR): consensus statement of DGIIN, DGK, DGTHG, DGfK, DGNI, DGAI, DIVI and GRC. Clin Res Cardiol. 2018

  14. Chera HH, Nagar M, Chang NL, Morales-Mangual C, Dous G, Marmur JD, Ihsan M, Madaj P, Rosen Y (2018) Overview of Impella and mechanical devices in cardiogenic shock. Expert Rev Med Devices 15:293–299

    Article  CAS  PubMed  Google Scholar 

  15. Remmelink M, Sjauw KD, Henriques JP, de Winter RJ, Koch KT, van der Schaaf RJ, Vis MM, Tijssen JG, Piek JJ, Baan J (2007) Jr. Effects of left ventricular unloading by Impella recover LP2.5 on coronary hemodynamics. Catheterization Cardiovasc Interv 70:532–537

    Article  Google Scholar 

  16. Schrage B, Ibrahim K, Loehn T, Werner N, Sinning JM, Pappalardo F, Pieri M, Skurk C, Lauten A, Landmesser U, Westenfeld R, Horn P, Pauschinger M, Eckner D, Twerenbold R, Nordbeck P, Salinger T, Abel P, Empen K, Busch MC, Felix SB, Sieweke JT, Moller JE, Pareek N, Hill J, MacCarthy P, Bergmann MW, Henriques JPS, Mobius-Winkler S, Schulze PC, Ouarrak T, Zeymer U, Schneider S, Blankenberg S, Thiele H, Schafer A and Westermann D. Impella support for acute myocardial infarction complicated by cardiogenic shock: a matched-pair IABP-SHOCK II trial 30-day mortality analysis. Circulation. 2018

  17. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB (2000) Meta-analysis of observational studies in epidemiology: a proposal for reporting. Meta-analysis of observational studies in epidemiology (MOOSE) group. JAMA 283:2008–2012

    Article  CAS  PubMed  Google Scholar 

  18. Moher D, Liberati A, Tetzlaff J, Altman DG, Group P (2009) Preferred reporting items for systematic reviews and meta-analyses: the PRISMA statement. Ann Intern Med 151:264–269, W64

    Article  PubMed  Google Scholar 

  19. DerSimonian R, Laird N (1986) Meta-analysis in clinical trials. Control Clin Trials 7:177–188

    Article  CAS  PubMed  Google Scholar 

  20. Seyfarth M, Sibbing D, Bauer I, Frohlich G, Bott-Flugel L, Byrne R, Dirschinger J, Kastrati A, Schomig A (2008) 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 52:1584–1588

    Article  PubMed  Google Scholar 

  21. Manzo-Silberman S, Fichet J, Mathonnet A, Varenne O, Ricome S, Chaib A, Zuber B, Spaulding C, Cariou A (2013) Percutaneous left ventricular assistance in post cardiac arrest shock: comparison of intra aortic blood pump and IMPELLA recover LP2.5. Resuscitation 84:609–615

    Article  PubMed  Google Scholar 

  22. Ouweneel DM, Eriksen E, Sjauw KD, van Dongen IM, Hirsch A, Packer EJ, Vis MM, Wykrzykowska JJ, Koch KT, Baan J, de Winter RJ, Piek JJ, Lagrand WK, de Mol BA, Tijssen JG, Henriques JP (2017) Percutaneous mechanical circulatory support versus intra-aortic balloon pump in cardiogenic shock after acute myocardial infarction. J Am Coll Cardiol 69:278–287

    Article  PubMed  Google Scholar 

  23. Karatolios K, Chatzis G, Markus B, Luesebrink U, Ahrens H, Dersch W, Betz S, Ploeger B, Boesl E, O’Neill W, Kill C, Schieffer B (2018) Impella support compared to medical treatment for post-cardiac arrest shock after out of hospital cardiac arrest. Resuscitation 126:104–110

    Article  PubMed  Google Scholar 

  24. Pieri M, Sorrentino T, Oppizzi M, Melisurgo G, Lembo R, Colombo A, Zangrillo A, Pappalardo F (2018) The role of different mechanical circulatory support devices and their timing of implantation on myocardial damage and mid-term recovery in acute myocardial infarction related cardiogenic shock. J Interv Cardiol 31:717–724

    Article  PubMed  Google Scholar 

  25. Meyns B, Stolinski J, Leunens V, Verbeken E, Flameng W (2003) Left ventricular support by catheter-mounted axial flow pump reduces infarct size. J Am Coll Cardiol 41:1087–1095

    Article  PubMed  Google Scholar 

  26. Moller-Helgestad OK, Hyldebrandt JA, Banke A, Rud CS, Udesen NLJ, Linde L, Okkels-Jensen L, Schmidt H, Ravn HB, Moller JE (2019) Impella CP or VA-ECMO in profound cardiogenic shock: left ventricular unloading and organ perfusion in a large animal model. EuroIntervention 14:e1585–e1592

    Article  PubMed  Google Scholar 

  27. Ise H, Kitahara H, Aubin H, Saeed D, Westenfeld R, Akhyari P, Boeken U, Walz R, Albert A, Lichtenberg A, Kamiya H (2018) Additional unloading of the left ventricle using the Impella LP 2.5 during extracorporeal life support in cases of pulmonary congestion. J Surg Case Rep 2018:rjy302

    PubMed  PubMed Central  Google Scholar 

  28. Colombier S, Quessard A, Mastroianni C, Schmidt M, Amour J, Leprince P, Lebreton G. Benefits of impella and peripheral veno-arterial extra corporeal life support alliance. ASAIO J. https://doi.org/10.1097/MAT.0000000000000922

    Article  Google Scholar 

  29. Schiller P, Hellgren L, Vikholm P. Survival after refractory cardiogenic shock is comparable in patients with Impella and veno-arterial extracorporeal membrane oxygenation when adjusted for SAVE score. Euro Heart J Acute Cardiovasc Care. 2018:2048872618799745

  30. Wilkins CE, Herrera TL, Nagahiro MK, Weathers LB, Girotra SV, Sandhu F (2019) Outcomes of hemodynamic support with impella for acute myocardial infarction complicated by cardiogenic shock at a rural community hospital without on-site surgical back-up. J Invasive Cardiol 31:E23–E29

    PubMed  Google Scholar 

  31. Ouweneel DM, de Brabander J, Karami M, Sjauw KD, Engstrom AE, Vis MM, Wykrzykowska JJ, Beijk MA, Koch KT, Baan J, de Winter RJ, Piek JJ, Lagrand WK, Cherpanath TG, Driessen AH, Cocchieri R, de Mol BA, Tijssen JG, Henriques JP. Real-life use of left ventricular circulatory support with Impella in cardiogenic shock after acute myocardial infarction: 12 years AMC experience. Euro Heart J Acute Cardiovasc Care. 2018:2048872618805486

  32. Turagam MK, Vuddanda V, Koerber S, Garg J, Yarlagadda B, Dar T, Aryana A, Di Biase L, Natale A, Lakkireddy D. Percutaneous ventricular assist device in ventricular tachycardia ablation: a systematic review and meta-analysis. J Interv Card Electrophysiol. 2018

  33. Annamalai SK, Esposito ML, Jorde L, Schreiber T, SA Hall, O’Neill WW, Kapur NK (2018) The impella microaxial flow catheter is safe and effective for treatment of myocarditis complicated by cardiogenic shock: an analysis from the global cVAD registry. J Cardiac Fail 24:706–710

    Article  Google Scholar 

  34. Pesarini G, Gratta A, Dolci G, Lunardi M, Ribichini FL (2018) Impella-protected PCI: the clinical results achieved so far. Minerva Cardioangiol 66:612–618

    Article  PubMed  Google Scholar 

  35. Baumann S, Werner N, Ibrahim K, Westenfeld R, Al-Rashid F, Sinning JM, Westermann D, Schafer A, Karatolios K, Bauer T, Becher T, Akin I (2018) Indication and short-term clinical outcomes of high-risk percutaneous coronary intervention with microaxial impella(R) pump: results from the German impella(R) registry. Clinical Res Cardiol 107:653–657

    Article  Google Scholar 

  36. Thiele H, Jobs A, Ouweneel DM, Henriques JPS, Seyfarth M, Desch S, Eitel I, Poss J, Fuernau G, de Waha S (2017) Percutaneous short-term active mechanical support devices in cardiogenic shock: a systematic review and collaborative meta-analysis of randomized trials. Euro Heart J 38:3523–3531

    Article  Google Scholar 

  37. O’Neill WW, Schreiber T, Wohns DH, Rihal C, Naidu SS, Civitello AB, Dixon SR, Massaro JM, Maini B, Ohman EM (2014) The current use of Impella 2.5 in acute myocardial infarction complicated by cardiogenic shock: results from the USpella registry. J Interv Cardiol 27:1–11

    Article  PubMed  Google Scholar 

  38. Loehn T, O’Neill WW, Lange B, Pfluecke C, Schweigler T, Mierke J, Waessnig N, Mahlmann A, Youssef A, Speiser U, Strasser RH, Ibrahim K. Long term survival after early unloading with Impella CP((R)) in acute myocardial infarction complicated by cardiogenic shock. Euro Heart J Acute Cardiovasc Care. 2018:2048872618815063

  39. Kapur NK, Alkhouli MA, DeMartini TJ, Faraz H, George ZH, Goodwin MJ, Hernandez-Montfort JA, Iyer VS, Josephy N, Kalra S, Kaki A, Karas RH, Kimmelstiel CD, Koenig GC, Lau E, Lotun K, Madder RD, Mannino SF, Meraj PM, Moreland JA, Moses JW, Kim RL, Schreiber TL, Udelson JE, Witzke C (2019) Wohns DHW and O’Neill WW. unloading the left ventricle before reperfusion in patients with anterior ST-segment-elevation myocardial infarction. Circulation 139:337–346

    Article  PubMed  Google Scholar 

  40. Flaherty MP, Khan AR, O’Neill WW (2017) Early Initiation of Impella in acute myocardial infarction complicated by cardiogenic shock improves survival: a meta-analysis. JACC Cardiovasc Interv 10:1805–1806

    Article  PubMed  Google Scholar 

  41. Abdin A, Poss J, Fuernau G, Ouarrak T, Desch S, Eitel I, de Waha S, Zeymer U, Bohm M, Thiele H (2018) Revision: prognostic impact of baseline glucose levels in acute myocardial infarction complicated by cardiogenic shock-a substudy of the IABP-SHOCK II-trial. Clin Res Cardiol 107:517–523

    Article  CAS  PubMed  Google Scholar 

  42. Masyuk M, Wernly B, Lichtenauer M, Franz M, Kabisch B, Muessig JM, Zimmermann G, Lauten A, Schulze PC, Hoppe UC, Kelm M, Bakker J, Jung C (2019) Prognostic relevance of serum lactate kinetics in critically ill patients. Intensive Care Med 45:55–61

    Article  CAS  PubMed  Google Scholar 

  43. de Waha S, Schoene K, Fuernau G, Desch S, Eitel I, Poss J, Meyer-Saraei R, Eitel C, Tilz R, Schuler G, Werdan K, Schneider S, Ouarrak T, Zeymer U, Thiele H (2018) Prognostic impact of atrial fibrillation in cardiogenic shock complicating acute myocardial infarction: a substudy of the IABP-SHOCK II trial. Clin Res Cardiol 107:233–240

    Article  PubMed  Google Scholar 

  44. Jung C, Fuernau G, Eitel I, Desch S, Schuler G, Kelm M, Adams V, Thiele H (2017) Incidence, laboratory detection and prognostic relevance of hypoxic hepatitis in cardiogenic shock. Clinical Res Cardiol 106:341–349

    Article  CAS  Google Scholar 

  45. de Waha S, Graf T, Desch S, Fuernau G, Eitel I, Poss J, Jobs A, Stiermaier T, Ledwoch J, Wiedau A, Lurz P, Schuler G, Thiele H (2017) Outcome of elderly undergoing extracorporeal life support in refractory cardiogenic shock. Clinical Res Cardiol 106:379–385

    Article  Google Scholar 

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Funding

No (industry) sponsorship has been received for this study.

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Authors and Affiliations

  1. Clinic of Internal Medicine II, Department of Cardiology, Paracelsus Medical University of Salzburg, Salzburg, Austria

    Bernhard Wernly, Clemens Seelmaier, Ingrid Pretsch, Michael Lichtenauer & Uta C. Hoppe

  2. Department of Cardiology, Charité—Universitaetsmedizin Berlin, Berlin, Germany

    David Leistner, Ulf Landmesser & Alexander Lauten

  3. Deutsches Zentrum für Herz-Kreislaufforschung (DZHK)—Partner Site Berlin, Berlin, Germany

    David Leistner, Ulf Landmesser & Alexander Lauten

  4. Berlin Institute of Health (BIH), 10117, Berlin, Germany

    David Leistner & Ulf Landmesser

  5. Department of Cardiology, Universitaetsspital Zuerich, Zuerich, Switzerland

    Barbara E. Stähli

  6. Division of Cardiology, Pulmonology, and Vascular Medicine, Medical Faculty, University Duesseldorf, Duesseldorf, Germany

    Christian Jung

  7. Department of Internal Medicine/Cardiology, Heart Center Leipzig at University of Leipzig, Leipzig, Germany

    Holger Thiele

Authors
  1. Bernhard Wernly
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  2. Clemens Seelmaier
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  3. David Leistner
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  4. Barbara E. Stähli
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  7. Christian Jung
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  8. Uta C. Hoppe
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  9. Ulf Landmesser
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  10. Holger Thiele
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  11. Alexander Lauten
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Correspondence to Alexander Lauten.

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Wernly, B., Seelmaier, C., Leistner, D. et al. Mechanical circulatory support with Impella versus intra-aortic balloon pump or medical treatment in cardiogenic shock—a critical appraisal of current data. Clin Res Cardiol 108, 1249–1257 (2019). https://doi.org/10.1007/s00392-019-01458-2

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