A Fully Magnetically Levitated Circulatory Pump for Advanced Heart Failure
Mandeep R. Mehra,Yoshifumi Naka,Nir Uriel,Daniel J. Goldstein,Joseph C. Cleveland,Paolo C. Colombo,Mary Norine Walsh,Carmelo A. Milano,Chetan B. Patel,Ulrich P. Jorde,Francis D. Pagani,Keith D. Aaronson,David A. Dean,Kelly McCants,Akinobu Itoh,Gregory A. Ewald,Douglas A. Horstmanshof,James W. Long,Christopher T. Salerno +18 more
TLDR
Among patients with advanced heart failure, implantation of a fully magnetically levitated centrifugal‐flow pump was associated with better outcomes at 6 months than was implanted of an axial‐ flow pump, primarily because of the lower rate of reoperation for pump malfunction.Abstract:
BackgroundContinuous-flow left ventricular assist systems increase the rate of survival among patients with advanced heart failure but are associated with the development of pump thrombosis. We investigated the effects of a new magnetically levitated centrifugal continuous-flow pump that was engineered to avert thrombosis. MethodsWe randomly assigned patients with advanced heart failure to receive either the new centrifugal continuous-flow pump or a commercially available axial continuous-flow pump. Patients could be enrolled irrespective of the intended goal of pump support (bridge to transplantation or destination therapy). The primary end point was a composite of survival free of disabling stroke (with disabling stroke indicated by a modified Rankin score >3; scores range from 0 to 6, with higher scores indicating more severe disability) or survival free of reoperation to replace or remove the device at 6 months after implantation. The trial was powered for noninferiority testing of the primary end poi...read more
Citations
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Journal ArticleDOI
A fully magnetically levitated left ventricular assist device - Final report
Mandeep R. Mehra,Nir Uriel,Yoshifumi Naka,Joseph C. Cleveland,Melana Yuzefpolskaya,Christopher T. Salerno,Mary Norine Walsh,Carmelo A. Milano,Chetan B. Patel,Steven W. Hutchins,John Ransom,Gregory A. Ewald,Akinobu Itoh,Nirav Raval,Scott C. Silvestry,Rebecca Cogswell,Ranjit John,Arvind Bhimaraj,Brian A. Bruckner,Brian D. Lowes,John Y. Um,Valluvan Jeevanandam,Gabriel Sayer,Abeel A. Mangi,Ezequiel J. Molina,Farooq H. Sheikh,Keith D. Aaronson,Francis D. Pagani,William Cotts,Antone Tatooles,Ashok N. Babu,Don Chomsky,Jason N. Katz,Paul B. Tessmann,David A. Dean,Arun Krishnamoorthy,Joyce Chuang,Ia Topuria,Poornima Sood,Daniel J. Goldstein +39 more
TL;DR: Among patients with advanced heart failure, a fully magnetically levitated centrifugal‐flow left ventricular assist device was associated with less frequent need for pump replacement than an axial‐flow device and was superior with respect to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.
Journal ArticleDOI
Two-Year Outcomes with a Magnetically Levitated Cardiac Pump in Heart Failure
Mandeep R. Mehra,Daniel J. Goldstein,Nir Uriel,Joseph C. Cleveland,Melana Yuzefpolskaya,Christopher T. Salerno,Mary Norine Walsh,Carmelo A. Milano,Chetan B. Patel,Gregory A. Ewald,Akinobu Itoh,David A. Dean,Arun Krishnamoorthy,William Cotts,Antone Tatooles,Ulrich P. Jorde,Brian A. Bruckner,Jerry D. Estep,Valluvan Jeevanandam,Gabriel Sayer,Douglas A. Horstmanshof,Douglas A. Horstmanshof,James W. Long,Sanjeev K. Gulati,Eric Skipper,John B. O'Connell,Gerald Heatley,Poornima Sood,Yoshifumi Naka +28 more
TL;DR: In patients with advanced heart failure, a fully magnetically levitated centrifugal‐flow pump was superior to a mechanical‐bearing axial‐ flow pump with regard to survival free of disabling stroke or reoperation to replace or remove a malfunctioning device.
Journal ArticleDOI
Advanced heart failure : a position statement of the Heart Failure Association of the European Society of Cardiology
María G. Crespo-Leiro,Marco Metra,Lars H. Lund,Davor Milicic,Maria Rosa Costanzo,Gerasimos Filippatos,Finn Gustafsson,Steven Tsui,Eduardo Barge-Caballero,Nicolaas de Jonge,Maria Frigerio,Righab Hamdan,Tal Hasin,Martin Hülsmann,Sanem Nalbantgil,Luciano Potena,Johann Bauersachs,A. Gkouziouta,Arjang Ruhparwar,Arsen D. Ristić,Ewa Straburzyńska-Migaj,Theresa McDonagh,Petar M. Seferović,Frank Ruschitzka +23 more
TL;DR: There is an urgent need to develop evidence‐based treatment algorithms to prolong life when possible and in accordance with patient preferences, increase life quality, and reduce the burden of hospitalization in this vulnerable patient population.
Journal ArticleDOI
The Society of Thoracic Surgeons Intermacs 2019 Annual Report: The Changing Landscape of Devices and Indications.
Jeffrey J. Teuteberg,Joseph C. Cleveland,Jennifer A Cowger,Robert S.D. Higgins,Daniel J. Goldstein,Mary E. Keebler,James K. Kirklin,Susan L. Myers,Christopher T. Salerno,Josef Stehlik,Felix G. Fernandez,Vinay Badhwar,Francis D. Pagani,Pavan Atluri +13 more
TL;DR: Over the past 5 years, centrifugal-flow LVADs have become the dominant technology and DT the most common implant strategy and comparisons with other devices from nonrandomized registry studies should be made with caution.
Journal ArticleDOI
National Heart Foundation of Australia and Cardiac Society of Australia and New Zealand: Guidelines for the Prevention, Detection, and Management of Heart Failure in Australia 2018
John Atherton,Andrew Sindone,Carmine G. De Pasquale,Andrea Driscoll,Peter S. Macdonald,Ingrid Hopper,Peter M. Kistler,Tom Briffa,James Wong,Walter P. Abhayaratna,Liza Thomas,Ralph Audehm,Phillip J. Newton,Joan O'Loughlin,Marie Branagan,Cia Connell +15 more
TL;DR: This is an Open Access article, distributed under the terms of the Creative Commons Attribution licence (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted re-use, distribution, and reproduction in any medium, provided the original work is properly cited.
References
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Journal ArticleDOI
Advanced Heart Failure Treated with Continuous-Flow Left Ventricular Assist Device
Mark S. Slaughter,Joseph G. Rogers,Carmelo A. Milano,Stuart D. Russell,John V. Conte,David S. Feldman,Benjamin Sun,Antone Tatooles,Reynolds M. Delgado,James W. Long,Thomas C. Wozniak,Waqas Ghumman,David J. Farrar,O. Howard Frazier +13 more
TL;DR: Treatment with a continuous-flow left ventricular assist device in patients with advanced heart failure significantly improved the probability of survival free from stroke and device failure at 2 years as compared with a pulsatile device.
Journal ArticleDOI
Seventh INTERMACS annual report: 15,000 patients and counting
James K. Kirklin,David C. Naftel,Francis D. Pagani,Robert L. Kormos,Lynne W. Stevenson,Elizabeth D. Blume,Susan L. Myers,Marissa A. Miller,J. Timothy Baldwin,James B. Young +9 more
TL;DR: The seventh annual report of the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) summarizes the first 9 years of patient enrollment and a detailed analysis of outcomes after mechanical circulatory support for ambulatory heart failure is presented.
Journal ArticleDOI
Unexpected Abrupt Increase in Left Ventricular Assist Device Thrombosis
Randall C. Starling,Nader Moazami,Scott C. Silvestry,Gregory A. Ewald,Joseph G. Rogers,Carmelo A. Milano,J. Eduardo Rame,Michael A. Acker,Eugene H. Blackstone,John Ehrlinger,Lucy Thuita,Maria Mountis,Edward G. Soltesz,Bruce W. Lytle,Nicholas G. Smedira +14 more
TL;DR: The rate of pump thrombosis related to the use of the HeartMate II has been increasing at centers and is associated with substantial morbidity and mortality.
Journal ArticleDOI
An analysis of pump thrombus events in patients in the HeartWare ADVANCE bridge to transplant and continued access protocol trial.
Samer S. Najjar,Mark S. Slaughter,Francis D. Pagani,Randall C. Starling,Edwin C. McGee,Peter Eckman,Antone Tatooles,Nader Moazami,Robert L. Kormos,David R. Hathaway,Kevin B. Najarian,Geetha Bhat,Keith D. Aaronson,Steven W. Boyce +13 more
TL;DR: Pump thrombus is a clinically important adverse event in patients receiving an HVAD, occurring at a rate of 0.08 events per patient-year, and this suggests that pump thrombosis event rates could be reduced through careful adherence to patient management guidelines.
Journal ArticleDOI
Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) analysis of pump thrombosis in the HeartMate II left ventricular assist device
James K. Kirklin,David C. Naftel,Robert L. Kormos,Francis D. Pagani,Susan L. Myers,Lynne W. Stevenson,Michael A. Acker,Daniel L. Goldstein,Scott C. Silvestry,Carmelo A. Milano,J.T. Baldwin,Sean Pinney,J. Eduardo Rame,Marissa A. Miller +13 more
TL;DR: Risk factor analysis suggests that a number of patient-related factors contribute to the risk of thrombosis, and that survival remains high (80% at 1 year) with the HMII LVAD.
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