First Clinical Trials of a Totally Implantable Destination Therapy Ventricular Assist System

Snyder, Alan J.; Pae, Walter E.; Boehmer, John; Rosenberg, Gerson; Weiss, Jason; Pierce, William S.; Thompson, James A.; Lewis, Jeff; Frank, Daniel J.; Zintak, H; Scholl, Stefan; Körfer, Reiner; El‐Banayosy, Aly; Arusoglu, Latif; Fey, O.; Morshuis, M.

doi:10.1201/b14731-9

Cited by 8 publications

(3 citation statements)

References 3 publications

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“…So the TET system having air‐core coils has stable energy transmission with high reliability. Already, two TET systems having air‐core coils have been clinically applied for a totally implantable artificial heart (9) and for a totally implantable left VAD (10,11). However, the TET system having air‐core coils has lower energy‐transmission efficiency of under 80% because of poor electromagnetic coupling between both coils.…”

Section: Discussionmentioning

confidence: 99%

A New Transcutaneous Energy Transmission System With Hybrid Energy Coils for Driving an Implantable Biventricular Assist Device

Okamoto

Yamamoto²,

Akasaka

et al. 2009

Artificial Organs

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We have developed a new transcutaneous energy transmission (TET) system for a totally implantable biventricular assist device (BVAD) system in the New Energy and Industrial Development Organization (NEDO) artificial heart project. The TET system mainly consists of an energy transmitter, a hybrid energy coil unit, an energy receiver, an internal battery system, and an optical telemetry system. The hybrid energy coil unit consists of an air-core energy transmission coil and an energy-receiving coil having a ferrite core. Internal units of the TET system are encapsulated in a titanium alloy casing, which has a size of 111 mm in width, 73 mm in length, and 25 mm in height. In in vitro experiments, the TET system can transmit a maximum electric energy of 60 Watts, and it has a maximum transmission efficiency of 87.3%. A maximum surface temperature of 46.1 degrees C was measured at the ferrite core of the energy-receiving coil during an energy transmission of 20 Watts in air. The long-term performance test shows that the TET system has been able to operate stably for over 4 years with a decrease of energy-transmission efficiency from 85% to 80%. In conclusion, the TET system with the hybrid energy coil can overcome the drawback of previously reported TET systems, and it promises to be the highest performance TET system in the world.

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Section: Discussionmentioning

confidence: 99%

A New Transcutaneous Energy Transmission System With Hybrid Energy Coils for Driving an Implantable Biventricular Assist Device

Okamoto

Yamamoto²,

Akasaka

et al. 2009

Artificial Organs

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“…To date, over 5000 patients have been implanted with VADs, with approximately 70% of them being transplanted successfully and 80% of them being subsequently discharged home] 4 For patients who cannot undergo heart transplantation because of shortages of donor hearts, age limitations or complications of immunosuppressive therapy, destination therapy with the VAD has been started. 5 The replacement-type device, the CardioWest total artificial heart (TAH), has been implanted in 150 patients, with similar results as those of the VAD. 6' 7 The Benecor and Abiocor totally implantable TAHs are approaching the final development stage and will go into preclinical trials around the year 2004.…”

Section: Introductionmentioning

confidence: 86%

Mechanical circulatory support devices for bridge to heart transplantation, bridge to recovery, or destination therapy

Takatani

Sakamoto

2000

J Artif Organs

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Both the ventricular assist device (VAD) and the total artificial heart (TAH) have been effective in supporting circulation of end-stage cardiac patients and in bridging to heart transplantation. However, because of a shortage of donor hearts and age limitations, destination therapy with the completely implantable VAD has also been started. The totally implantable TAH in the United States is in the final stage of development and will go into preclinical trials in 2004. In Japan, heart transplantation has been re-instituted since last year, but because of shortages of donor hearts the waiting time prior to transplantation is fairly long. To date, six heart transplantations have been carried out, of which four have been bridged transplantations using extracorporeal or implantable VADs. With the extracorporeal VADs, patients cannot be discharged home, which increases the hospital expenses. With the implantable VADs such as Novacor and HeartMate imported from the USA, patients can be discharged home, but major threats with these devices are thromboembolic complications and infection. These devices are also fairly large, being designed for 80-kg patients, and are thus difficult to implant in patients of 50 to 60kg, including women.

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“…Three TCSs have so far been developed and reported. A TCS using electromagnetic coupling has already been used clinically in pacemakers (1) and in implantable artificial hearts (2). A radio wave wireless TCS has also been used clinically for continuous monitoring of a pacemaker at home (3).…”

mentioning

confidence: 99%

A New Transcutaneous Bidirectional Communication for Monitoring Implanted Artificial Heart Using the Human Body as a Conductive Medium

et al. 2012

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A transcutaneous communication system (TCS) is a key technology for monitoring and controlling artificial hearts and other artificial organs in the body. In this study, we developed a new TCS that uses the human body as a conductive medium. Direct data exchange provides a higher level of communication security compared to that of wireless methods without physical constraints such as an external wire. The external and internal units of the new TCS each consist mainly of a data transmitter and a data receiver. The data transmitter has an amplitude shift keying (ASK) modulator (carrier frequencies: 4 and 10 MHz) and an electrode. The ASK-modulated data current is led into the body through the electrode, and it flows back to the energy source through the body, the data receiver, and the earth ground that includes all conductors and dielectrics in the environment that are in close proximity to the patient. Performance of the TCS was evaluated by a communication test on the surface of the human body and in an animal experiment using a goat. The TCS was able to transmit data concurrently for 4 weeks between everywhere on the surface of the body and everywhere inside the body under full-duplex communication at a transmission rate of 115 kbps. The power consumption of each TCS unit was 125 mW with an ASK-modulated current of 7 mA (root-mean-square). While further study is required to secure its safety, the newly developed TCS has promise to be a next-generation transcutaneous communication device.

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First Clinical Trials of a Totally Implantable Destination Therapy Ventricular Assist System

Cited by 8 publications

References 3 publications

A New Transcutaneous Energy Transmission System With Hybrid Energy Coils for Driving an Implantable Biventricular Assist Device

A New Transcutaneous Energy Transmission System With Hybrid Energy Coils for Driving an Implantable Biventricular Assist Device

Mechanical circulatory support devices for bridge to heart transplantation, bridge to recovery, or destination therapy

A New Transcutaneous Bidirectional Communication for Monitoring Implanted Artificial Heart Using the Human Body as a Conductive Medium

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