Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock

Marc Samsky¹, Mitchell Krucoff², Andrew D Althouse³, William T Abraham⁴, Philip Adamson⁵, Fernando Aguel⁶, Seth Bilazarian⁷, George D Dangas⁸, Ian C Gilchrist⁹, Timothy D Henry¹⁰, Judith S Hochman¹¹, Navin K Kapur¹², John Laschinger¹³, Roy G Masters¹⁴, Eric Michelson¹⁵, David A Morrow¹⁶, Valarie Morrow¹⁷, E Magnus Ohman¹⁸, Ileana Pina¹⁹, Alastair G Proudfoot²⁰, Joseph Rogers²¹, John Sapirstein²², Fred Senatore²³, Norman Stockbridge²⁴, Holger Thiele²⁵, Alexander G Truesdell²⁶, Ron Waksman²⁷, Sunil Rao²⁸

Affiliations

¹ Duke University Medical Center, Duke Clinical Research Institute, Durham Veterans Administration, Durham, NC. Electronic address: marc.samsky@duke.edu.
² Duke University Medical Center, Cardiovascular Devices Unit, eECG Core Laboratories, Duke Clinical Research Institute, Durham, NC. Electronic address: mitchell.krucoff@duke.edu.
³ Center for Research on Healthcare Data Center (CRHC-DC), Center for Clinical Trials & Data Coordination (CCDC), Division of General Internal Medicine, University of Pittsburgh School of Medicine, Circulation: Cardiovascular Interventions, Pittsburgh, PA. Electronic address: althousead@upmc.edu.
⁴ Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH. Electronic address: william.abraham@osumc.edu.
⁵ Abbott, Austin, TX. Electronic address: Philip.adamson@abbott.com.
⁶ Office of Product Evaluation and Quality, CDRH | Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD. Electronic address: Fernando.Aguel@fda.hhs.gov.
⁷ Abiomed, Danvers, MA. Electronic address: sbilazarian@abiomed.com.
⁸ Mount Sinai Medical Center, New York, NY. Electronic address: George.Dangas@mountsinai.org.
⁹ Pennsylvania State University, Heart and Vascular Institute, Hershey, PA. Electronic address: icg1@psu.edu.
¹⁰ The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, The Carl and Edyth Lindner Family Distinguished Chair in Clinical Research, The Christ Hospital Health Network, Cincinnati, OH. Electronic address: Tim.Henry@thechristhospital.com.
¹¹ NYU-HHC Clinical and Translational Science Institute, New York University School of Medicine, NYU Langone Health, New York, NY. Electronic address: Judith.Hochman@nyulangone.org.
¹² The CardioVascular Center, Tufts Medical Center Boston, MA. Electronic address: nkapur@tuftsmedicalcenter.org.
¹³ U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis (OCEA), 10903 New Hampshire Ave, Silver Spring, MD. Electronic address: john.laschinger@fda.hhs.gov.
¹⁴ University of Ottawa Heart Institute, Medical Adviser Health Canada, Ottawa, Ontario. Electronic address: roy.masters@canada.ca.
¹⁵ Thomas Jefferson University, Philadelphia, PA. Electronic address: eric.michelsonmd@gmail.com.
¹⁶ Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Electronic address: DMORROW@BWH.HARVARD.EDU.
¹⁷ Duke Clinical Research Institute, Durham, NC. Electronic address: Valarie.morrow@duke.edu.
¹⁸ Duke Program for Advanced Coronary Disease, Department of Medicine, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC. Electronic address: erik.ohman@duke.edu.
¹⁹ Wayne State University, Detroit, MI. Electronic address: Ileana.Pina@fda.hhs.gov.
²⁰ Department of Perioperative Medicine, St. Bartholomew's Hospital, London. Electronic address: Alastair.Proudfoot@bartshealth.nhs.uk.
²¹ Duke University Health System, Durham, NC. Electronic address: joseph.rogers@duke.edu.
²² Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Washington, DC.
²³ Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Washington, DC. Electronic address: Fortunato.Senatore@fda.hhs.gov.
²⁴ U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave, Silver Spring, MD. Electronic address: norman.stockbridge@fda.hhs.gov.
²⁵ Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology Leipzig, Germany, Leipzig Heart Institute, Leipzig, Germany. Electronic address: Holger.Thiele@medizin.uni-leipzig.de.
²⁶ Virginia Heart, INOVA Heart and Vascular Institute, Alexandria, VA. Electronic address: atruesdell@tcg.md.
²⁷ Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: Ron.waksman@medstar.net.
²⁸ Duke University Health System Section Chief, Cardiology, Durham VA Health System, Durham, NC. Electronic address: sunil.rao@duke.edu.

PMID: 31707323
PMCID: PMC7604661
DOI: 10.1016/j.ahj.2019.10.006

Review

Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock

Marc Samsky et al. Am Heart J. 2020 Jan.

. 2020 Jan:219:1-8.

doi: 10.1016/j.ahj.2019.10.006. Epub 2019 Nov 7.

Authors

Affiliations

¹ Duke University Medical Center, Duke Clinical Research Institute, Durham Veterans Administration, Durham, NC. Electronic address: marc.samsky@duke.edu.
² Duke University Medical Center, Cardiovascular Devices Unit, eECG Core Laboratories, Duke Clinical Research Institute, Durham, NC. Electronic address: mitchell.krucoff@duke.edu.
³ Center for Research on Healthcare Data Center (CRHC-DC), Center for Clinical Trials & Data Coordination (CCDC), Division of General Internal Medicine, University of Pittsburgh School of Medicine, Circulation: Cardiovascular Interventions, Pittsburgh, PA. Electronic address: althousead@upmc.edu.
⁴ Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH. Electronic address: william.abraham@osumc.edu.
⁵ Abbott, Austin, TX. Electronic address: Philip.adamson@abbott.com.
⁶ Office of Product Evaluation and Quality, CDRH | Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD. Electronic address: Fernando.Aguel@fda.hhs.gov.
⁷ Abiomed, Danvers, MA. Electronic address: sbilazarian@abiomed.com.
⁸ Mount Sinai Medical Center, New York, NY. Electronic address: George.Dangas@mountsinai.org.
⁹ Pennsylvania State University, Heart and Vascular Institute, Hershey, PA. Electronic address: icg1@psu.edu.
¹⁰ The Carl and Edyth Lindner Center for Research and Education at The Christ Hospital, The Carl and Edyth Lindner Family Distinguished Chair in Clinical Research, The Christ Hospital Health Network, Cincinnati, OH. Electronic address: Tim.Henry@thechristhospital.com.
¹¹ NYU-HHC Clinical and Translational Science Institute, New York University School of Medicine, NYU Langone Health, New York, NY. Electronic address: Judith.Hochman@nyulangone.org.
¹² The CardioVascular Center, Tufts Medical Center Boston, MA. Electronic address: nkapur@tuftsmedicalcenter.org.
¹³ U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis (OCEA), 10903 New Hampshire Ave, Silver Spring, MD. Electronic address: john.laschinger@fda.hhs.gov.
¹⁴ University of Ottawa Heart Institute, Medical Adviser Health Canada, Ottawa, Ontario. Electronic address: roy.masters@canada.ca.
¹⁵ Thomas Jefferson University, Philadelphia, PA. Electronic address: eric.michelsonmd@gmail.com.
¹⁶ Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Electronic address: DMORROW@BWH.HARVARD.EDU.
¹⁷ Duke Clinical Research Institute, Durham, NC. Electronic address: Valarie.morrow@duke.edu.
¹⁸ Duke Program for Advanced Coronary Disease, Department of Medicine, Duke Clinical Research Institute, Duke University Medical Center, Durham, NC. Electronic address: erik.ohman@duke.edu.
¹⁹ Wayne State University, Detroit, MI. Electronic address: Ileana.Pina@fda.hhs.gov.
²⁰ Department of Perioperative Medicine, St. Bartholomew's Hospital, London. Electronic address: Alastair.Proudfoot@bartshealth.nhs.uk.
²¹ Duke University Health System, Durham, NC. Electronic address: joseph.rogers@duke.edu.
²² Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Washington, DC.
²³ Division of Cardiovascular and Renal Products, Center for Drug Evaluation and Research, US Food and Drug Administration, Washington, DC. Electronic address: Fortunato.Senatore@fda.hhs.gov.
²⁴ U.S. Food and Drug Administration, Center for Drug Evaluation and Research, 10903 New Hampshire Ave, Silver Spring, MD. Electronic address: norman.stockbridge@fda.hhs.gov.
²⁵ Heart Center Leipzig at University of Leipzig, Department of Internal Medicine/Cardiology Leipzig, Germany, Leipzig Heart Institute, Leipzig, Germany. Electronic address: Holger.Thiele@medizin.uni-leipzig.de.
²⁶ Virginia Heart, INOVA Heart and Vascular Institute, Alexandria, VA. Electronic address: atruesdell@tcg.md.
²⁷ Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: Ron.waksman@medstar.net.
²⁸ Duke University Health System Section Chief, Cardiology, Durham VA Health System, Durham, NC. Electronic address: sunil.rao@duke.edu.

PMID: 31707323
PMCID: PMC7604661
DOI: 10.1016/j.ahj.2019.10.006

No abstract available

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References

1. Leor J, Goldbourt U, Reicher-Reiss H, et al. Cardiogenic shock complicating acute myocardial infarction in patients without heart failure on admission: incidence, risk factors, and outcome. SPRINT Study Group The American journal of medicine 1993;94:265–73. - PubMed
1. Carnendran L, Abboud R, Sleeper LA, et al. Trends in cardiogenic shock: report from the SHOCK Study. The SHould we emergently revascularize Occluded Coronaries for cardiogenic shocK? European heart journal 2001;22:472–8. - PubMed
1. Goldberg RJ, Spencer FA, Gore JM, et al. Thirty-year trends (1975 to 2005) in the magnitude of, management of, and hospital death rates associated with cardiogenic shock in patients with acute myocardial infarction: a population-based perspective. Circulation 2009;119: 1211–9. - PMC - PubMed
1. Aissaoui N, Puymirat E, Tabone X, et al. Improved outcome of cardiogenic shock at the acute stage of myocardial infarction: a report from the USIK 1995, USIC 2000, and FAST-MI French nationwide registries. European heart journal 2012;33:2535–43. - PubMed
1. Kolte 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. Journal of the American Heart Association 2014;3, e000590. - PMC - PubMed

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Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock

Affiliations

Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock

Authors

Affiliations

References

Publication types

MeSH terms

Grants and funding

LinkOut - more resources

Full Text Sources

Medical