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Circulation:
Heart Failure

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  • All Issues
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    • All Subjects
    • Arrhythmia and Electrophysiology
    • Basic, Translational, and Clinical Research
    • Critical Care and Resuscitation
    • Epidemiology, Lifestyle, and Prevention
    • Genetics
    • Heart Failure and Cardiac Disease
    • Hypertension
    • Imaging and Diagnostic Testing
    • Intervention, Surgery, Transplantation
    • Quality and Outcomes
    • Stroke
    • Vascular Disease
  • Browse Features
    • AHA Guidelines and Statements
    • Emerging Investigators
    • Advances in Heart Failure
    • On My Mind
    • Images and Case Reports in Heart Failure
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    • Instructions for Authors
    • → Article Types
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    • Arteriosclerosis, Thrombosis, and Vascular Biology (ATVB)
    • Circulation
    • → Circ: Arrhythmia and Electrophysiology
    • → Circ: Genomic and Precision Medicine
    • → Circ: Cardiovascular Imaging
    • → Circ: Cardiovascular Interventions
    • → Circ: Cardiovascular Quality & Outcomes
    • → Circ: Heart Failure
    • Circulation Research
    • Hypertension
    • Stroke
    • Journal of the American Heart Association
Special Report

Statement Regarding the Pre and Post Market Assessment of Durable, Implantable Ventricular Assist Devices in the United States: Executive Summary

Endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and the Interagency Registry of Mechanically Assisted Circulatory Support.

Michael A. Acker, Francis D. Pagani, Wendy Gattis Stough, Douglas L. Mann, Mariell Jessup, Robert Kormos, Mark S. Slaughter, Timothy Baldwin, Lynne Stevenson, Keith D. Aaronson, Leslie Miller, David Naftel, Clyde Yancy, Joseph Rogers, Jeffrey Teuteberg, Randall C. Starling, Bartley Griffith, Steven Boyce, Stephen Westaby, Elizabeth Blume, Peter Wearden, Robert Higgins, Michael Mack
Download PDF
https://doi.org/10.1161/HHF.0b013e318279f55d
Circulation: Heart Failure. 2012;HHF.0b013e318279f55d
Originally published November 12, 2012
Michael A. Acker
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Francis D. Pagani
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Wendy Gattis Stough
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Douglas L. Mann
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Mariell Jessup
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Robert Kormos
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Mark S. Slaughter
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Timothy Baldwin
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Lynne Stevenson
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Keith D. Aaronson
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Leslie Miller
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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David Naftel
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Clyde Yancy
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Joseph Rogers
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Jeffrey Teuteberg
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Randall C. Starling
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Bartley Griffith
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Steven Boyce
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Stephen Westaby
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Elizabeth Blume
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Peter Wearden
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Robert Higgins
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Michael Mack
From the Division of Cardiothoracic Surgery, University of Pennsylvania, Philadelphia, Pennsylvania (MAA); Department of Cardiac Surgery, University of Michigan, Ann Arbor, Michigan (FDP); Campbell University College of Pharmacy and Health Science, Buies Creek, North Carolina (WGS); Cardiovascular Division, Washington University, St. Louis, Missouri (DLM); Division of Cardiovascular Medicine, University of Pennsylvania, Philadelphia, Pennsylvania (MJ); Department of Cardiothoracic Surgery, University of Pittsburgh, Pittsburgh, Pennsylvania (RK); Division of Cardiothoracic Surgery, University of Louisville, Louisville, Kentucky (MSS); National Heart, Lung, and Blood Institute, Bethesda, Maryland (TB); Cardiovascular Division, Brigham and Women’s Hospital, Boston, Massachusetts (LS); Division of Cardiovascular Medicine, University of Michigan, Ann Arbor, Michigan (KDA); Department of Cardiovascular Sciences, University of South Florida, Tampa, Florida (LM); Department of Cardiothoracic Surgery, University of Alabama, Birmingham, Birmingham, Alabama (DN); Division of Cardiology, Northwestern University, Chicago, Illinois (CY); Division of Cardiology, Duke University, Durham, North Carolina (JR); Heart and Vascular Institute, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania (JT); Cardiovascular Medicine, Cleveland Clinic, Cleveland, Ohio (RCS); Division of Cardiac Surgery, University of Maryland, Baltimore, Maryland (BG); Department of Cardiac Surgery, MedStar Heart Institute, Washington Hospital Center, Washington, DC (SB); Oxford Heart Centre, John Radcliffe Hospital, Oxford, United Kingdom (SW); Department of Cardiology, Boston’s Childrens Hospital, Boston, Massachusetts (EB); Department of Cardiothoracic Surgery, Children’s Hospital of Pittsburgh, Pittsburgh, Pennsylvania (PW); Division of Cardiac Surgery, Ohio State University; Columbus, Ohio (RH); and Cardiothoracic Surgery, Medical City Dallas Hospital, Dallas, Texas (MM).
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Abstract

The incorporation of complex medical device technologies into clinical practice is governed by critical oversight of the US Food and Drug Administration. This regulatory process requires a judicious balance between assuring safety and efficacy, while providing efficient review to facilitate access to innovative therapies. Recent contrasting views of the regulatory process have emphasized the difficulties in obtaining an optimal balance. Mechanical circulatory support has evolved to become an important therapy for patients with advanced heart failure with the advent of more durable, implantable ventricular assist devices. The regulatory oversight of these new technologies has been difficult owing to the complexities of these devices, associated adverse event profile, and severity of illness of the intended patient population. Maintaining a regulatory environment to foster efficient introduction of safe and effective technologies is critical to the success of ventricular assist device therapy and the health of patients with advanced heart failure. Physicians representing key surgical and cardiology societies, and representatives from the Food and Drug Administration, National Heart, Lung, and Blood Institute, Centers for Medicare and Medicaid Services, Interagency Registry of Mechanically Assisted Circulatory Support, and industry partners gathered to discuss relevant issues regarding the current regulatory environment assessing ventricular assist devices. The goal of the meeting was to explore innovative ways to foster the introduction of technologically advanced, safe, and effective ventricular assist devices. The following summary reflects opinions and conclusions endorsed by The Society of Thoracic Surgeons, American Association for Thoracic Surgery, American Heart Association, Heart Failure Society of America, International Society for Heart and Lung Transplantation, and the Interagency Registry of Mechanically Assisted Circulatory Support.

  • AHA Scientific Statements
  • heart-assist device
  • heart failure
  • © 2012 American Heart Association, Inc.
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Circulation: Heart Failure
April 2018, Volume 11, Issue 4
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    Statement Regarding the Pre and Post Market Assessment of Durable, Implantable Ventricular Assist Devices in the United States: Executive Summary
    Michael A. Acker, Francis D. Pagani, Wendy Gattis Stough, Douglas L. Mann, Mariell Jessup, Robert Kormos, Mark S. Slaughter, Timothy Baldwin, Lynne Stevenson, Keith D. Aaronson, Leslie Miller, David Naftel, Clyde Yancy, Joseph Rogers, Jeffrey Teuteberg, Randall C. Starling, Bartley Griffith, Steven Boyce, Stephen Westaby, Elizabeth Blume, Peter Wearden, Robert Higgins and Michael Mack
    Circulation: Heart Failure. 2012;HHF.0b013e318279f55d, originally published November 12, 2012
    https://doi.org/10.1161/HHF.0b013e318279f55d

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    Statement Regarding the Pre and Post Market Assessment of Durable, Implantable Ventricular Assist Devices in the United States: Executive Summary
    Michael A. Acker, Francis D. Pagani, Wendy Gattis Stough, Douglas L. Mann, Mariell Jessup, Robert Kormos, Mark S. Slaughter, Timothy Baldwin, Lynne Stevenson, Keith D. Aaronson, Leslie Miller, David Naftel, Clyde Yancy, Joseph Rogers, Jeffrey Teuteberg, Randall C. Starling, Bartley Griffith, Steven Boyce, Stephen Westaby, Elizabeth Blume, Peter Wearden, Robert Higgins and Michael Mack
    Circulation: Heart Failure. 2012;HHF.0b013e318279f55d, originally published November 12, 2012
    https://doi.org/10.1161/HHF.0b013e318279f55d
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