Holger Thiele1,2, Uwe Zeymer3, Nathalie Thelemann4, Franz-Josef Neumann5, Jörg Hausleiter6, Mohamed Abdel-Wahab1,2,7, Roza Meyer-Saraei4, Georg Fuernau4,8, Ingo Eitel4,8, Rainer Hambrecht9, Michael Böhm10, Karl Werdan11, Stephan B Felix12, Marcus Hennersdorf13, Steffen Schneider3, Taoufik Ouarrak3, Steffen Desch1,2,8, Suzanne de Waha-Thiele4,8. 1. Heart Center Leipzig, University of Leipzig, Germany (H.T., M.A.-W., S.D.). 2. Leipzig Heart Institute, Germany (H.T., M.A.-W., S.D.). 3. Klinikum Ludwigshafen and Institut für Herzinfarktforschung, Germany (U.Z., S.S., T.O.). 4. University Heart Center, Luebeck, Germany (N.T., R.M.-S., G.F., I.E., S.d.W.-T.). 5. Heart Center Bad Krozingen, University of Freiburg, Germany (F.-J.N.). 6. Klinikum der Ludwig-Maximilians, Universität München, Germany (J.H.). 7. Heart Center, Segeberger Kliniken, Bad Segeberg, Germany (M.A.-W.). 8. German Center for Cardiovascular Research, Partner Site Hamburg/Kiel/Luebeck, Luebeck (G.F., I.E., S.D., S.d.W.-T.). 9. Klinikum Links der Weser, Bremen, Germany (R.H.). 10. University Clinic of Saarland, Homburg/Saar, Germany (M.B.). 11. Department of Internal Medicine/Cardiology, Martin-Luther University Halle-Wittenberg, Germany (K.W.). 12. University Medicine Greifswald, Germany (S.B.F.). 13. Department of Internal Medicine/Cardiology, SLK Kliniken Heilbronn, Germany (M.H.).
Abstract
BACKGROUND: The role of intraaortic balloon counterpulsation (IABP) in cardiogenic shock is still a subject of intense debate despite the neutral results of the IABP-SHOCK II trial (Intraaortic Balloon Pump in Cardiogenic Shock II) with subsequent downgrading in international guidelines. So far, randomized data on the impact of IABP on long-term clinical outcomes in patients with cardiogenic shock complicating acute myocardial infarction are lacking. Furthermore, only limited evidence is available on general long-term outcomes of patients with cardiogenic shock treated by contemporary practice. METHODS: The IABP-SHOCK II trial is a multicenter, randomized, open-label trial. Between 2009 and 2012, 600 patients with cardiogenic shock complicating acute myocardial infarction undergoing early revascularization were randomized to IABP versus control. RESULTS: Long-term follow-up was performed 6.2 years (interquartile range 5.6-6.7) after initial randomization. Follow-up was completed for 591 of 600 patients (98.5%). Mortality was not different between the IABP and the control group (66.3% versus 67.0%; relative risk, 0.99; 95% CI, 0.88-1.11; P=0.98). There were also no differences in recurrent myocardial infarction, stroke, repeat revascularization, or rehospitalization for cardiac reasons (all P>0.05). Survivors' quality of life as assessed by the EuroQol 5D questionnaire and the New York Heart Association class did not differ between groups. CONCLUSIONS: IABP has no effect on all-cause mortality at 6-year long-term follow-up. Mortality is still very high, with two thirds of patients with cardiogenic shock dying despite contemporary treatment with revascularization therapy. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov/. Unique identifier: NCT00491036.
BACKGROUND: The role of intraaortic balloon counterpulsation (IABP) in cardiogenic shock is still a subject of intense debate despite the neutral results of the IABP-SHOCK II trial (Intraaortic Balloon Pump in Cardiogenic Shock II) with subsequent downgrading in international guidelines. So far, randomized data on the impact of IABP on long-term clinical outcomes in patients with cardiogenic shock complicating acute myocardial infarction are lacking. Furthermore, only limited evidence is available on general long-term outcomes of patients with cardiogenic shock treated by contemporary practice. METHODS: The IABP-SHOCK II trial is a multicenter, randomized, open-label trial. Between 2009 and 2012, 600 patients with cardiogenic shock complicating acute myocardial infarction undergoing early revascularization were randomized to IABP versus control. RESULTS: Long-term follow-up was performed 6.2 years (interquartile range 5.6-6.7) after initial randomization. Follow-up was completed for 591 of 600 patients (98.5%). Mortality was not different between the IABP and the control group (66.3% versus 67.0%; relative risk, 0.99; 95% CI, 0.88-1.11; P=0.98). There were also no differences in recurrent myocardial infarction, stroke, repeat revascularization, or rehospitalization for cardiac reasons (all P>0.05). Survivors' quality of life as assessed by the EuroQol 5D questionnaire and the New York Heart Association class did not differ between groups. CONCLUSIONS: IABP has no effect on all-cause mortality at 6-year long-term follow-up. Mortality is still very high, with two thirds of patients with cardiogenic shock dying despite contemporary treatment with revascularization therapy. CLINICAL TRIAL REGISTRATION: URL: https://www. CLINICALTRIALS: gov/. Unique identifier: NCT00491036.
Authors: Shannon M Fernando; Danial Qureshi; Peter Tanuseputro; Robert Talarico; Benjamin Hibbert; Rebecca Mathew; Bram Rochwerg; Emilie P Belley-Côté; Eddy Fan; Alain Combes; Daniel Brodie; Matthieu Schmidt; Trevor Simard; Pietro Di Santo; Kwadwo Kyeremanteng Journal: Can J Anaesth Date: 2020-07-15 Impact factor: 5.063
Authors: Karl Werdan; Michael Buerke; Alexander Geppert; Holger Thiele; Bernd Zwissler; Martin Ruß Journal: Dtsch Arztebl Int Date: 2021-02-12 Impact factor: 5.594