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J Thorac Cardiovasc Surg 2002;124:1063-1067
© 2002 The American Association for Thoracic Surgery


Editorials

Adverse events in the use of HeartMate vented electric and Novacor left ventricular assist devices: Comparing apples and oranges

Michael K. Pasque, MD, Joseph G. Rogers, MD

From the Department of Surgery, Division of Cardiothoracic Surgery, and the Department of Medicine, Division of Cardiology, Washington University School of Medicine, St Louis, Mo.

Received for publication Jan 9, 2002. Accepted for publication Feb 3, 2002. Address for reprints: Michael K. Pasque, MD, Division of Cardiothoracic Surgery, Suite 3108 Queeny Tower, Barnes-Jewish Hospital, One Barnes-Jewish Hospital Plaza, St Louis, MO 63110 (E-mail: pasquem@msnotes.wustl.edu).

The first 300 words of the full text of this article appear below.


    Introduction
 
There are two Food and Drug Administration-approved, implantable, electrical left ventricular assist devices (LVADs) currently available to cardiothoracic surgeons for use in patients with end-stage heart failure. These are the HeartMate vented electric (VE) and Novacor devices, marketed by Thoratec Corporation (Pleasanton, Calif) and WorldHeart Corporation (Ottawa, Ontario, Canada), respectively. Until recently, objective data concerning device-use end points for these two LVADs was limited. Device choice, therefore, has been influenced primarily by single center reports, anecdotal communications, or marketing rhetoric. For the first time, however, we now have important objective information characterizing anticipated adverse event rates based on clinical outcomes in large multicenter trials and objective reports of in vitro durability testing. Clinicians who accept the responsibility of using this complex therapy in patients with end-stage heart failure must be expected to objectively analyze this available information.

First things first. We are the surgical and medical directors of the heart failure service at Washington University Medical School at Barnes-Jewish Hospital in St Louis, Missouri. In this capacity, we have served as the institutional principal investigators of the Novacor bridge-to-transplant and INTrEPID trials at Barnes-Jewish Hospital. We have no financial interest in, and do not serve on the medical advisory boards of, either of the companies that market these two devices. We currently have both devices available at our institution for the treatment of end-stage heart failure.


    Thromboembolism
 
Both of the currently available LVADs require that nonphysiologic surfaces be placed in contact with the recipient blood pool, therefore rendering a finite incidence of thromboembolism as a recognized complication of their use. Much has been made of the novel textured "biologic" blood-contacting surface of the HeartMate VE device, which has allowed use of this device without routine systemic anticoagulation, other than platelet-inhibiting drugs. Much has also been made of the history of thromboembolism . . . [Full Text of this Article]




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