The use of implantable left ventricular assist devices (LVADs) has been increasing to serve the growing population of patients with end-stage congestive heart failure. However, up to 40% of patients have significant right ventricular (RV) failure that limits the utility of implantable LVAD therapy. RV failure leads to two problems: decreased forward flow and high right heart pressures that result in passive congestion of the liver, kidneys, and abdominal organs. Both factors contribute to multiorgan failure, the leading cause of death after LVAD implant. Such patients commonly require prolonged inotropic support or support with a right ventricular assist device (RVAD). Clinically available RVADs are not implantable devices and have several limitations due to poor blood compatibility, high infection rates, poor long-term durability, need for anticoagulation, need for a hospital stay, high mortality, and a less than ideal quality of life. We have reported a poor prognosis in patients with LVAD support who also required external RVAD support or prolonged inotropic support. A safe, effective, implantable RVAD could save the lives of many such patients with RV failure. We have developed the CorAide TM LVD-4000 Assist System, which is based on an implantable, third generation, centrifugal pump. A rotating assembly is fully suspended without mechanical contact or wear during operation. If the CorAide LVAD can be modified and used as an RVAD, the resulting CorAide biventricular ventricular assist device (BVAD) will be an ideal system for permanent support (destination therapy). The main objectives of this proposed program are to design, develop, and clinically evaluate an implantable RVAD that can be used as a component of an implantable BVAD for patients with severe biventricular failure.
The specific aims are (1) Design and develop an implantable RVAD based on the CorAide LVAD, third generation centrifugal blood pump, (2) Design and develop an advanced fail-safe control algorithm capable of fixed speed or automatic mode that balances RVAD and LVAD performance, (3) Undertake in vivo characterization testing of the system both as an isolated RVAD and as a BVAD with the CorAide LVAD, (4) Undertake in vivo and in vitro reliability testing of the complete RVAD system, and (5) Obtain FDA approval for Investigational Device Exemption (IDE) and undertake clinical pilot studies using an institutionally approved program for patient selection and data collection. In this proposal, we will design and develop an RVAD in the first year, perform the characterization study in the second year, perform in vivo and in vitro reliability studies in the second and third years, and perform a clinical trial in the fourth and fifth years. The successful completion of this program will provide clinicians and patients with a safe and effective option for outpatient mechanical support that allows an excellent quality of life.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project (R01)
Project #
5R01HL074896-03
Application #
6931173
Study Section
Special Emphasis Panel (ZRG1-SB (50))
Program Officer
Baldwin, Tim
Project Start
2004-08-03
Project End
2009-05-31
Budget Start
2005-06-01
Budget End
2006-05-31
Support Year
3
Fiscal Year
2005
Total Cost
$1,947,997
Indirect Cost
Name
Cleveland Clinic Lerner
Department
Other Basic Sciences
Type
Schools of Medicine
DUNS #
135781701
City
Cleveland
State
OH
Country
United States
Zip Code
44195
Ootaki, Chiyo; Yamashita, Michifumi; Ootaki, Yoshio et al. (2013) Periarteritis in lung from a continuous-flow right ventricular assist device: role of the local Renin-Angiotensin system. Ann Thorac Surg 96:148-54
Takaseya, Tohru; Fujiki, Masako; Shiose, Akira et al. (2012) Hemodynamic differences between the awake and anesthetized conditions in normal calves. J Artif Organs 15:225-30
Fukamachi, Kiyotaka; Shiose, Akira; Massiello, Alex L et al. (2012) Implantable continuous-flow right ventricular assist device: lessons learned in the development of a cleveland clinic device. Ann Thorac Surg 93:1746-52
Saeed, Diyar; Shalli, Shanaz; Fumoto, Hideyuki et al. (2010) In vivo evaluation of zirconia ceramic in the DexAide right ventricular assist device journal bearing. Artif Organs 34:512-6
Saeed, Diyar; Massiello, Alex L; Shalli, Shanaz et al. (2010) Introduction of fixed-flow mode in the DexAide right ventricular assist device. J Heart Lung Transplant 29:32-6
Takaseya, Tohru; Fumoto, Hideyuki; Shiose, Akira et al. (2010) In vivo biocompatibility evaluation of a new resilient, hard-carbon, thin-film coating for ventricular assist devices. Artif Organs 34:1158-63
Saeed, Diyar; Ootaki, Yoshio; Ootaki, Chiyo et al. (2008) Acute in vivo evaluation of an implantable continuous flow biventricular assist system. ASAIO J 54:20-4
Ootaki, Chiyo; Yamashita, Michifumi; Ootaki, Yoshio et al. (2008) Reduced pulsatility induces periarteritis in kidney: role of the local renin-angiotensin system. J Thorac Cardiovasc Surg 136:150-8
Saeed, Diyar; Zahr, Roula; Shalli, Shanaz et al. (2008) Median sternotomy approach for chronic bovine experiments. ASAIO J 54:585-8
Fukamachi, Kiyotaka; Saeed, Diyar; Massiello, Alex L et al. (2008) Development of DexAide right ventricular assist device: update II. ASAIO J 54:589-93

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