Heart failure remains a major cause of death and economic loss in the USA. Newer therapeutic methods have improved the outlook for many but are ineffective for others. While the recent use of implanted blood pumps has shown encouraging results for support of left heart failure, little progress has been made for complete replacement of both sides of the heart. For patients with severe biventricular failure unresponsive to maximal therapeutic measures, cardiac transplantation or replacement with a total artificial heart (TAH) are the remaining options. Existing TAH devices (Abiocor, Syncardia) are too large for many smaller males and most female patients and are either noisy and require large pneumatic tethered lines, or they are subject to clot formation and strokes, and have proven to be unreliable in clinical practice. The goal of this project is to finalize the development of a new, unique, simplified continuous flow TAH (CFTAH) design, which is comprised of a single pump assembly with two impellers and one motor. This double pump concept includes a single continuously rotating brushless DC motor and pump assembly with a centrifugal pump on both ends of the same shaft, rotating at the same speed.
The Specific Aims of the proposed research are: 1) Conduct engineering analysis integrating motor, bearing and pump design to guide refinement of the implantable system for dynamic stability, biocompatibility and hemocompatibility, 2) Develop external electronics to implement and refine our control algorithm, and to demonstrate both its fixed speed and its fail-safe automatic modes of providing adequate and balanced ventricular outputs, while avoiding suction of tissues and atrial pressure imbalance, 3) Perform in vitro system characterization, human blood hemolysis, and endurance testing to verify the CFTAH meets requirements for system performance, resistance to intravascular hemolysis and reliability, and 4) Perform in vivo animal experiments to validate hemodynamic response, biocompatibility, the self regulating mechanical design and automatic speed control mode of operation. This design dramatically reduces the size and complexity of the TAH compared to the devices currently implanted clinically. This design is extremely innovative, exploring radical new concepts in TAH design. The availability of a small, simplified alternative which has a single moving component would address many of the problems seen with existing technologies and provide better management for many patients who presently have no treatment options except transplantation. The overall result would be a TAH that could be implanted into smaller patients with a substantially reduced risk for device failure and morbidity.

Public Health Relevance

Successful completion of this research program will result in development of a unique continuous flow total artificial heart that can be used in all adults and many adolescents. The flows are self adjusting to the varying needs of the patient without sensors or active controls. The single moving component pump is a dramatic advance in the design of total artificial heart when compared to the pulsatile devices currently available for the treatment of end stage biventricular heart failure.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL096619-04
Application #
8449612
Study Section
Special Emphasis Panel (ZRG1-SBIB-V (50))
Program Officer
Baldwin, Tim
Project Start
2010-04-01
Project End
2014-03-31
Budget Start
2013-04-01
Budget End
2014-03-31
Support Year
4
Fiscal Year
2013
Total Cost
$1,303,828
Indirect Cost
$421,584
Name
Cleveland Clinic Lerner
Department
Other Basic Sciences
Type
Schools of Medicine
DUNS #
135781701
City
Cleveland
State
OH
Country
United States
Zip Code
44195
Miyamoto, Takuma; Horvath, David J; Horvath, Dennis W et al. (2018) Simulated Performance of the Cleveland Clinic Continuous-Flow Total Artificial Heart Using the Virtual Mock Loop. ASAIO J :
Karimov, Jamshid H; Grady, Patrick; Sinkewich, Martin et al. (2017) Moderate hypothermia technique for chronic implantation of a total artificial heart in calves. J Artif Organs 20:182-185
Fukamachi, Kiyotaka; Karimov, Jamshid H; Sunagawa, Gengo et al. (2017) Generating pulsatility by pump speed modulation with continuous-flow total artificial heart in awake calves. J Artif Organs 20:381-385
Sunagawa, Gengo; Horvath, David J; Karimov, Jamshid H et al. (2016) Future Prospects for the Total Artificial Heart. Expert Rev Med Devices 13:191-201
Karimov, Jamshid H; Sunagawa, Gengo; Such, Kimberly A et al. (2015) Anatomy of the bovine ascending aorta and brachiocephalic artery found unfavorable for total artificial heart implant. J Artif Organs 18:358-60
Karimov, Jamshid H; Steffen, Robert J; Byram, Nicole et al. (2015) Human Fitting Studies of Cleveland Clinic Continuous-Flow Total Artificial Heart. ASAIO J 61:424-8
Karimov, Jamshid H; Horvath, David; Sunagawa, Gengo et al. (2015) Post-explant visualization of thrombi in outflow grafts and their junction to a continuous-flow total artificial heart using a high-definition miniaturized camera. J Artif Organs 18:354-7
Horvath, David; Karimov, Jamshid H; Byram, Nicole et al. (2015) Sensorless Suction Recognition in the Self-Regulating Cleveland Clinic Continuous-Flow Total Artificial Heart. ASAIO J 61:726-8
Karimov, Jamshid H; Sunagawa, Gengo; Golding, Leonard A R et al. (2015) Double-wire sternal closure technique in bovine animal models for total artificial heart implant. Int J Artif Organs 38:465-7
Karimov, Jamshid H; Moazami, Nader; Kobayashi, Mariko et al. (2015) First report of 90-day support of 2 calves with a continuous-flow total artificial heart. J Thorac Cardiovasc Surg 150:687-93.e1

Showing the most recent 10 out of 15 publications