Cardiac safety research consortium "shock II" think tank report: Advancing practical approaches to generating evidence for the treatment of cardiogenic shock

Marc D Samsky¹, Mitchell W Krucoff², David A Morrow³, William T Abraham⁴, Fernando Aguel⁵, Andrew D Althouse⁶, Eric Chen⁷, Joaquin E Cigarroa⁸, Adam D DeVore⁹, Andrew Farb¹⁰, Ian C Gilchrist¹¹, Timothy D Henry¹², Judith S Hochman¹³, Navin K Kapur¹⁴, Valarie Morrow¹⁵, E Magnus Ohman¹⁶, William W O'Neill¹⁷, Ileana L Piña¹⁸, Alastair G Proudfoot¹⁹, John S Sapirstein²⁰, Jonathan H Seltzer²¹, Fred Senatore²², Meir Shinnar²³, Charles A Simonton²⁴, Behnam N Tehrani²⁵, Holger Thiele²⁶, Alexander G Truesdell²⁷, Ron Waksman²⁸, Sunil V Rao²⁹

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 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Electronic address: DMORROW@BWH.HARVARD.EDU.
⁴ Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH. Electronic address: william.abraham@osumc.edu.
⁵ U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis, Silver Spring, MD. Electronic address: fernando.aguel@fda.hhs.gov.
⁶ 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.
⁷ Abbott, Chicago, IL. Electronic address: eric.chen1@abbott.com.
⁸ Division of Cardiology, Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR. Electronic address: cigarroa@ohsu.edu.
⁹ Duke University Medical Center, Duke Clinical Research Institute, Durham Veterans Administration, Durham, NC. Electronic address: adam.devore@duke.edu.
¹⁰ U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis, Silver Spring, MD.
¹¹ Pennsylvania State University, Heart and Vascular Institute, Hershey, PA. Electronic address: icg1@psu.edu.
¹² 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.
¹³ 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.
¹⁴ The CardioVascular Center, Tufts Medical Center Boston, MA. Electronic address: nkapur@tuftsmedicalcenter.org.
¹⁵ Duke Clinical Research Institute, Durham, NC. Electronic address: valarie.morrow@duke.edu.
¹⁶ 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.
¹⁷ Center for Structural Heart Disease, Division of Cardiology, Henry Ford Health System, Detroit, MI. Electronic address: WONEILL1@hfhs.org.
¹⁸ U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis, Silver Spring, MD. Electronic address: ileana.pina@fda.hhs.gov.
¹⁹ Department of Perioperative Medicine, St. Bartholomew's Hospital, London, United Kingdom. Electronic address: Alastair.Proudfoot@bartshealth.nhs.uk.
²⁰ U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis, Silver Spring, MD. Electronic address: John.Sapirstein@fda.hhs.gov.
²¹ WCG-ACI Clinical, Bala Cynwyd, PA. Electronic address: jseltzer@aciclinical.com.
²² U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis, Silver Spring, MD. Electronic address: fortunato.senatore@fda.hhs.gov.
²³ U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis, Silver Spring, MD. Electronic address: Meir.Shinnar@fda.hhs.gov.
²⁴ Abiomed, Danvers, MA. Electronic address: csimonton@abiomed.com.
²⁵ Virginia Heart, INOVA Heart and Vascular Institute, Alexandria, VA. Electronic address: behnamtehrani3@gmail.com.
²⁶ 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.
²⁷ Virginia Heart, INOVA Heart and Vascular Institute, Alexandria, VA. Electronic address: agtruesdell@gmail.com.
²⁸ Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: ronwaksman@gmail.com.
²⁹ Duke University Medical Center, Duke Clinical Research Institute, Durham Veterans Administration, Durham, NC. Electronic address: sunil.rao@duke.edu.

PMID: 33011148
PMCID: PMC7704747
DOI: 10.1016/j.ahj.2020.09.015

Cardiac safety research consortium "shock II" think tank report: Advancing practical approaches to generating evidence for the treatment of cardiogenic shock

Marc D Samsky et al. Am Heart J. 2020 Dec.

. 2020 Dec:230:93-97.

doi: 10.1016/j.ahj.2020.09.015. Epub 2020 Oct 2.

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 Cardiovascular Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA. Electronic address: DMORROW@BWH.HARVARD.EDU.
⁴ Division of Cardiovascular Medicine, The Ohio State University, Columbus, OH. Electronic address: william.abraham@osumc.edu.
⁵ U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis, Silver Spring, MD. Electronic address: fernando.aguel@fda.hhs.gov.
⁶ 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.
⁷ Abbott, Chicago, IL. Electronic address: eric.chen1@abbott.com.
⁸ Division of Cardiology, Knight Cardiovascular Institute, Oregon Health & Science University, Portland, OR. Electronic address: cigarroa@ohsu.edu.
⁹ Duke University Medical Center, Duke Clinical Research Institute, Durham Veterans Administration, Durham, NC. Electronic address: adam.devore@duke.edu.
¹⁰ U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis, Silver Spring, MD.
¹¹ Pennsylvania State University, Heart and Vascular Institute, Hershey, PA. Electronic address: icg1@psu.edu.
¹² 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.
¹³ 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.
¹⁴ The CardioVascular Center, Tufts Medical Center Boston, MA. Electronic address: nkapur@tuftsmedicalcenter.org.
¹⁵ Duke Clinical Research Institute, Durham, NC. Electronic address: valarie.morrow@duke.edu.
¹⁶ 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.
¹⁷ Center for Structural Heart Disease, Division of Cardiology, Henry Ford Health System, Detroit, MI. Electronic address: WONEILL1@hfhs.org.
¹⁸ U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis, Silver Spring, MD. Electronic address: ileana.pina@fda.hhs.gov.
¹⁹ Department of Perioperative Medicine, St. Bartholomew's Hospital, London, United Kingdom. Electronic address: Alastair.Proudfoot@bartshealth.nhs.uk.
²⁰ U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis, Silver Spring, MD. Electronic address: John.Sapirstein@fda.hhs.gov.
²¹ WCG-ACI Clinical, Bala Cynwyd, PA. Electronic address: jseltzer@aciclinical.com.
²² U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis, Silver Spring, MD. Electronic address: fortunato.senatore@fda.hhs.gov.
²³ U.S. Food and Drug Administration, CDRH/OPEQ/Office of Clinical Evidence and Analysis, Silver Spring, MD. Electronic address: Meir.Shinnar@fda.hhs.gov.
²⁴ Abiomed, Danvers, MA. Electronic address: csimonton@abiomed.com.
²⁵ Virginia Heart, INOVA Heart and Vascular Institute, Alexandria, VA. Electronic address: behnamtehrani3@gmail.com.
²⁶ 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.
²⁷ Virginia Heart, INOVA Heart and Vascular Institute, Alexandria, VA. Electronic address: agtruesdell@gmail.com.
²⁸ Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC. Electronic address: ronwaksman@gmail.com.
²⁹ Duke University Medical Center, Duke Clinical Research Institute, Durham Veterans Administration, Durham, NC. Electronic address: sunil.rao@duke.edu.

PMID: 33011148
PMCID: PMC7704747
DOI: 10.1016/j.ahj.2020.09.015

No abstract available

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Conflict of interest statement

Conflicts of interest Alexander G. Truesdell is a consultant and member of the Speakers Bureau of Abiomed Inc. David A. Morrow reports no conflicts relevant to this work and reports grants from Anthos Therapeutics, grants and personal fees from AstraZeneca, personal fees from Bayer Pharma, grants from Daiichi Sankyo, grants from Eisai,grants from GlaxoSmithKline, personal fees from InCarda, grants from Medicines Company, grants and personal fees from Merck & Co, grants and personal fees from Novartis, grants from Pfizer, grants from Quark, grants from Regeneron, grants and personal fees from Roche Diagnostics, grants from Siemens, grants from Takeda, and grants from Zora Biosciences outside the submitted work; Dr. Morrow is also a member of the TIMI Study Group which has received institutional research grant support through Brigham and Women's Hospital from Abbott; Amgen; Aralez; AstraZeneca; Bayer HealthCare Pharmaceuticals, Inc.; BRAHMS, Daiichi-Sankyo; Eisai; GlaxoSmithKline; Intarcia; Janssen; MedImmune; Merck; Novartis; Pfizer; Poxel; Quark Pharmaceuticals; Regeneron; Roche; Siemens; Takeda; The Medicines Company; and Zora Biosciences. E. Magnus Ohman mentions Chiesi (USA), Jansen Pharmaceutical, Xylocor, Cardinal Health, Milestone Pharmaceutical, Abiomed, and Cara Therapeutics. Ian C. Gilchrist reports no conflicts relevant to this work and is a consultant for Terumo Medical, Inc. Judith S. Hochman reports no conflicts relevant to this work; Dr. Hochman is PI for the ISCHEMIA trial for which, in addition to support by National Heart, Lung, and Blood Institute grant, there were in-kind donations for participating sites from Abbott Vascular; Medtronic, Inc.; St. Jude Medical, Inc.; Volcano Corporation; Arbor Pharmaceuticals, LLC; AstraZeneca Pharmaceuticals, LP; Merck Sharp & Dohme Corp.; Omron Healthcare, Inc.; and Amgen Inc.; and financial donations from Arbor Pharmaceuticals LLC and AstraZeneca Pharmaceuticals LP. Navin K. Kapur is a consultant/receives speaker honoraria from Abbott, Abiomed, Boston Scientific, Medtronic, LivaNova, Getinge, MD Start, and Precardia as well as institutional research grants from Abiomed, Boston Scientific, and MD Start. Ron Waksman is an advisory board/board member and consultant for Abbott Vascular, Amgen, Pi-Cardia LTD, Cardioset, Medtronic, Philips (Volcano), and Boston Scientific Corp; consultant for Biosensors, Biotronik; received grant support from Abbott Vascular, AstraZeneca, Biosensors, Biotronik, Chiesi, and Boston Scientific Corp; is on the Speaker Bureau of AstraZeneca and Chiesi; and is an investor in MedAlliance. Eric Chen is an employee of Abbott. Adam DeVore reports research funding through his institution from the American Heart Association; Amgen; AstraZeneca; Bayer; Intra-Cellular Therapies; American Regent, Inc; the NHLBI; Novartis; and PCORI. He also provides consulting services for Amgen, AstraZeneca, Bayer, CareDx, InnaMed, LivaNova, Mardil Medical, Novartis, Procyrion, scPharmaceuticals, Story Health and Zoll and has also received non-financial support from Abbott for educational activities. William O’Neill is a consultant for Abiomed and Abbott and receives consulting fees for his services. Charles A. Simonton is an employee of Abiomed. Behram N. Tehrani is a consultant for Medtronic. Alastair G. Proudfoot, Andrew D. Althouse, Fernando Aguel, Fred Senatore, Holger Thiele , Ileana Pina, John Sapirstein, Marc Samsky, Mitchell Krucoff, Sunil Rao, Timothy D. Henry, Valarie Morrow, William T. Abraham, Joaquin E. Cigarroa, Jonathan Seltzer, and Meir Shinnar all report no conflicts relevant to this work.

References

1. Samsky M, Krucoff M, Althouse AD, et al. Clinical and regulatory landscape for cardiogenic shock: A report from the Cardiac Safety Research Consortium ThinkTank on cardiogenic shock. Am Heart J 2019;219:1–8. - PMC - PubMed
1. Sollano JA, Gelijns AC, Moskowitz AJ, et al. Volume-outcome relationships in cardiovascular operations: New York State, 1990-1995. J Thorac Cardiovasc Surg 1999;117:419–28. discussion 428–30. - PubMed
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Cardiac safety research consortium "shock II" think tank report: Advancing practical approaches to generating evidence for the treatment of cardiogenic shock

Affiliations

Cardiac safety research consortium "shock II" think tank report: Advancing practical approaches to generating evidence for the treatment of cardiogenic shock

Authors

Affiliations

Conflict of interest statement

References

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MeSH terms

Grants and funding

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