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Title: Flow Measurement with DuraHeart™ Left Ventricular Assist System (LVAS)

Author: Michiel Morshuis, M.D.

Creation Date: May 31 2010

Enhancing blood flow in congestive heart failure patients may entail the use of a left ventricular assist system (LVAS) as either bridge-to-transplant or destination therapy. An axial or centrifugal pump is the central component of the LVAS. Axial flow blood pumps employ a rotor with helical blades along the axis situated in line with the inlet conduit and outlet graft. Centrifugal pumps move blood by means of an impeller housed in a chamber into which an inflow conduit feeds left ventricular blood. The impeller then moves blood through an outflow graft into the aorta. Conventional centrifugal pumps rely on an impeller that is mounted on an axle or is hydromechanically supported. Centrifugal magnetically levitated pumps, such as the DuraHeart™ System (Terumo Heart, Ann Arbor, MI), represent a significant innovation in LVAS design, using magnetic force to suspend and drive the impeller within the device housing. In the DuraHeart device, a 250-micron gap on either side of the impeller and between the chamber walls and the impeller body allows blood to flow more evenly through the pump and reduces injury to blood cells. The DuraHeart centrifugal magnetically levitated pump also provides reliably consistent and accurate flow measurements without the need for flow sensors.

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Title: DuraHeart™ magnetically levitated centrifugal left ventricular assist system for advanced heart failure patients

Author: Michiel Morshuis, Michael Schoenbrodt, Chisato Nojiri, Daniela Roefe, Sebastian Schulte-Eistrup, Jochen Boergermann, Jan F Gummert and Latif Arusoglu

Creation Date: January 01 2010

The implantable left ventricular assist system (LVAS) using pulsatile pump technology has become an established therapeutic option for advanced heart failure patients. However, there have been technological limitations in some older designs, including a high incidence of infection and mechanical failures associated with moving parts, and the large size of both implantable pump and percutaneous cable. A smaller rotary blood pump emerged as a possible alternative to a large pulsatile pump to overcome some of these limitations. The technological advancement that defines the third-generation LVAS was the elimination of all mechanical contacts between the impeller and the drive mechanism. The DuraHeartTM LVAS is the world’s first third-generation implantable LVAS to obtain market approval (CE-mark), which combines a centrifugal pump and active magnetic levitation. The initial clinical experience with the DuraHeart LVAS in Europe demonstrated that it provided significantly improved survival (85% at 6 months and 79% at 1 year), reduced adverse event rates and long-term device reliability (freedom from device replacement at 2 years: 96 ± 3%) over pulsatile LVAS.

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Title: Implantation technique for the DuraHeart left ventricular assist system

Author: Takeshi Komoda, MD · Yuguo Weng, MD Chisato Nojiri, MD, PhD · Roland Hetzer, MD, PhD

Creation Date: January 23 2007

DuraHeart (Terumo Heart, Ann Arbor, MI, USA) is the world’s fi rst magnetically levitated centrifugal pump. The pump was developed initially in Japan as the Terumo implantable left ventricular assist system (T-ILVAS),1,2 and was further developed in the USA. The DuraHeart was first implanted in clinical trials in Europe in 20 patients between January 2004 and August 2005. The Deutsches Herzzentrum Berlin contributed 5 cases with a maximal support duration of 482 days. As a result of our surgical experience with 266 implantations of various left ventricular assist devices (LVADs) up to the end of August 2005 (Novacor: 116 cases, Incor: 76 cases, DeBakey: 40 cases, TCI HeartMate: 23 cases, LionHeart: 6 cases, DuraHeart 5 cases), we made some modifications to the implantation technique for the DuraHeart. The procedure will be described in detail to facilitate further clinical use of this system in Japan and in other countries.

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Title: European experience of DuraHeartTM magnetically levitated centrifugal left ventricular assist system

Author: Michiel Morshuis,Aly El-Banayosy,Latif Arusoglu,Reiner Koerfer,Roland Hetzer,Georg Wieselthaler,Alain Pavie,Chisato Nojiri

Creation Date: December 16 2008

The DuraHeart (Terumo Heart, Inc., Ann Arbor, Michigan, USA) is the world’s first approved magnetically levitated centrifugal left ventricular assist system designed for long-term circulatory support. We report the clinical outcomes of 68 patients implanted with the DuraHeart as a bridge to cardiac transplantation in Europe.

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