A Totally Implantable Heart Assist System: The Novacor Program

A totally implantable left ventricular assist system (LVAS) has been developed for chronic application in patients with terminal heart failure. Utilizing a unique solenoid-actuated dual pusher-plate blood pump, the system is very responsive and is capable of assuming the total circulation. A belt skin transformer allows inductive power transmission, across the intact skin, from a wearable battery pack to the implanted electronic controller. Multi-year system life testing has been accomplished, with no failures, in a National Institutes of Health (NIH) refereed preclinical readiness testing program. Chronic evaluation in experimental animals has exceeded 17 years of cumulative pump testing, including 28 implants longer than 3 months. An interim configuration of the system, with extracorporeal console-based electronics, has been evaluated clinically in an international multi-center bridge to cardiac transplant study. One hundred and twenty-nine patients received implants for durations to 370 days. Of these, 6 patients are currently supported, 74 (60%) have been transplanted, and 66 (89%) have been discharged. Hemodynamics were rapidly restored to normal. Most patients were mobilized and ambulatory within 2 weeks, and full rehabilitation was achieved in previously severely compromised patients with multi-organ dysfunction. Post-transplant recovery and survival were improved compared to routine transplantation. A wearable left ventricular assist system (LVAS) configuration, representing a hybrid of the totally implantable and console-based systems, has recently been introduced, initially as a bridge to transplant. This system, with its much improved mobility, and the totally implantable system will enable hospital discharge, long-term support, and a greatly improved quality of life.

[1]  L. Garrison,et al.  Donor availability as the primary determinant of the future of heart transplantation. , 1986, JAMA.

[2]  J. Copeland,et al.  The role of mechanical support and transplantation in treatment of patients with end-stage cardiomyopathy. , 1985, Circulation.

[3]  A. Snyder,et al.  Current status of permanent total artificial hearts. , 1989, The Annals of thoracic surgery.

[4]  G L Hallman,et al.  Orthotopic cardiac prosthesis for two-staged cardiac replacement. , 1969, The American journal of cardiology.

[5]  P M Portner,et al.  Clinical experience with the Novacor ventricular assist system. Bridge to transplantation and the transition to permanent application. , 1991, The Journal of thoracic and cardiovascular surgery.

[6]  B. Griffith,et al.  Experience with univentricular support in mortally ill cardiac transplant candidates. , 1990, The Annals of thoracic surgery.

[7]  J. Copeland,et al.  The Total Artificial Heart as a Bridge to Transplantation: A Report of Two Cases , 1986 .

[8]  Malin VanAntwerp,et al.  The Artificial Heart: Prototypes, Policies, and Patients , 1992, Annals of Internal Medicine.

[9]  F D Altieri.  Status of implantable energy systems to actuate and control ventricular assist devices. , 1983, Artificial organs.

[10]  P M Portner,et al.  Implantable electrical left ventricular assist system: bridge to transplantation and the future. , 1989, The Annals of thoracic surgery.

[11]  I. Chalmers.  Letter: Obstetric Delivery Today. , 1976, Lancet.

[12]  P M Portner,et al.  In vitro and in vivo testing of a totally implantable left ventricular assist system. , 1988, ASAIO transactions.

[13]  A R Jonsen,et al.  Artificial heart and assist devices: directions, needs, costs, societal and ethical issues. , 1985, Artificial organs.

[14]  J. C. Norman,et al.  TOTAL SUPPORT OF THE CIRCULATION OF A PATIENT WITH POST-CARDIOTOMY STONE-HEART SYNDROME BY A PARTIAL ARTIFICIAL HEART (ALVAD) FOR 5 DAYS FOLLOWED BY HEART AND KIDNEY TRANSPLANTATION , 1978, The Lancet.

[15]  Yukihiko Nosé,et al.  Progress in artificial organs, 1985 , 1986 .