Treatment of Acute Myocardial Infarction and Cardiogenic Shock: Outcomes of the RECOVER III Post-Approval Study by SCAI Shock Stage

Background The Society for Cardiovascular Angiography and Interventions (SCAI) proposed a staging system (A-E) to predict prognosis in cardiogenic shock. Herein, we report clinical outcomes of the RECOVER III study for the first time, according to SCAI shock classification. Methods RECOVER III is an observational, prospective, multicenter, single-arm, post-approval study of patients with acute myocardial infarction complicated by cardiogenic shock (AMICS) undergoing percutaneous coronary intervention (PCI) with Impella support. Patients enrolled in RECOVER III were assigned a baseline SCAI shock stage. Staging was then repeated within 24 hours after initiation of Impella. Kaplan-Meier survival curve analyses were conducted to assess survival across SCAI shock stages at both timepoints. Results At baseline assessment, 16.5%, 11.4%, and 72.2% were classified as Stage C, D, and E, respectively. At ≤24 hour assessment, 26.4%, 33.2%, and 40.0% were Stage C, D, and E respectively. Thirty-day survival amongst patients with Stage C, D and E shock at baseline was 59.7%, 56.5% and 42.9%, respectively (p=0.003). Survival amongst patients with Stage C, D and E shock at ≤24 hours was 65.7%, 52.1% and 29.5%, respectively (p<0.001). After multivariate analysis of impact of shock stage classifications at baseline and ≤ 24 hours, only Stage E classification at ≤24 hours was a significant predictor of mortality (OR 4.8, p<0.001). Conclusions In a real-world cohort of patients with AMICS undergoing PCI with Impella support, only Stage E classification at ≤ 24 hours was significantly predictive of mortality, suggesting that response to therapy may be more important than clinical severity of shock at presentation. Clinical Perspective ### Competing Interest Statement Omar Ali, Adam Tawney, Timothy Pow, Simon Dixon, Andres Palomo, Srihari Naidu, Perwaiz Meraj, Michael Johnson, and Akash Rusia have no disclosures. Daniel Burkhoff is on the Steering Committee for RECOVER IV sponsored by Abiomed (institutional compensation). David Wohns discloses institutional research funding and support for educational programs from Abiomed. Mir Basir is a consultant for Abiomed, Boston Scientific, Chiesi, Saranas, and Zoll. Navin Kapur discloses institutional research support from Abbott, Abiomed, Boston Scientific, Getinge, LivaNova, and Teleflex; consulting/speaking honoraria from Abbott, Abiomed, Boston Scientific, Getinge, LivaNova, Teleflex, Edwards, and Zoll. Alexandra Lansky is a consultant to Abiomed. Cindy Grines is on the cVAD advisory board. Mark Anderson receives speaking honoraria from Abiomed. William ONeill is a consultant to Abiomed, Zoll, and Edwards Lifesciences. Ivan Hanson reports proctorships with Edwards Lifesciences and Medtronic. ### Funding Statement This study was funded by Abiomed (Danvers, MA). ### Author Declarations I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained. Yes The details of the IRB/oversight body that provided approval or exemption for the research described are given below: Site No.Site NameIRB Name 104Detroit Medical CenterWayne State University - Medical IRB (M1) 106Massachusetts General HospitalMass General Brigham IRB 109Pinnacle Health Cardiovascular Institute Inc.Pinnacle Health Hospitals Institutional Review Board 114Spectrum HealthSpectrum Health IRB 124Beaumont Health CenterWestern Institutional Review Board (WIRB) 125Winthrop University HospitalNYU Winthrop Hospital Institutional Review Board 129Texas Heart Institute/Baylor College of MedicineIRB for Baylor College of Medicine and Affiliated Hospitals 130University of Michigan Cardiovascular CenterMedical School Institutional Review Board (IRBMED) 134University of Southern CaliforniaUniversity of Southern California IRB 139Baylor Heart and Vascular HospitalBaylor Research Institute Institutional Review Board 140Virginia Commonwealth University Health SystemWestern Institutional Review Board (WIRB) 145Munson Medical CenterMunson Medical Center Institutional Review Board 149St. Vincent HospitalMetroWest Medical Center Institutional Review Board 151University of Alabama at Birmingham (UAB)Western Institutional Review Board (WIRB) 153Mercy MiamiWestern Institutional Review Board (WIRB) 154University of MiamiHuman Subject Research Center at Miller School of Medicine 155Ochsner Clinic FoundationOchsner Clinic Foundation IRB 156Cedars Sinai Medical CenterCedars-Sinai Office of Research Compliance and Quality Improvement IRB 157Integris Cardiovascular PhysiciansINTEGRIS Health Institutional Review Board 158Columbia University Medical CenterColumbia Research Human Research Protection Office IRB 160West Virginia University HospitalWVU Human Research Protection Program IRB 161Orlando HealthOrlando Health Institutional Review Board 162Northwell HealthNorthwell Health Office of the Human Research Protection Program IRB 163University of Louisville School of MedicineUniversity of Louisville, Human Subjects Protection Program Office 164Jackson General HospitalJackson-Madison County General Hospital IRB 166University Hospitals ClevelandAdvarra IRB 168Tulane University Medical CenterTulane University Human Research Protection Program 169Charleston Area Medical CenterCAMC/WVU-Charleston Division Institutional Review Board 170Banner Health Research Institute2The University of Arizona Human Subjects Protection Program IRB 172Tufts Medical CenterTufts Health Sciences IRB 173Vanderbilt University Medical CenterVanderbilt University Human Research Protection Program 174Plaza Medical Center of Fort WorthWestern Institutional Review Board (WIRB) 176Einstein Medical CenterEinstein Healthcare Network IRB 178Memorial Hospital JacksonvilleAscension St. Vincent's IRB 179Henry Ford HospitalHenry Ford Health System IRB 182St. Lukes Health SystemAdvarra 183Carilion Medical CenterWestern Institutional Review Board (WIRB) 184University of Kansas HospitalThe University of Kansas Medical Center Human Research Protection Program 185University of WashingtonWestern Institutional Review Board (WIRB) 187Banner University Medical Center TucsonThe University of Arizona Human Subjects Protection Program IRB 188University Cardiology AssociatesUniversity Hospital IRB/PB 189Delray Medical CenterWestern Institutional Review Board (WIRB) 192Hackensack University Medical CenterWestern Institutional Review Board (WIRB) 198Icahn School of Medicine at Mount SinaiMount Sinai Health System Program for the Protection of Human Subjects IRBs 202Kennestone WellstarWestern Institutional Review Board (WIRB) 203Ascension St. John HospitalWestern Institutional Review Board (WIRB) I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals. Yes I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as [ClinicalTrials.gov][1]. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance). Yes I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable. Yes All data produced in the present study are available upon reasonable request to the authors. [1]: http://ClinicalTrials.gov