Results with the Novacor assist system and evaluation of long-term assistance✩

Abstract

LVAD Novacor has provided reliable mechanical performance and good hemodynamic improvement. Most complications seem to occur in the first 90 days, therefore long-term assistance could be considered. A reduction of the high rate of thromboembolic complications remains mandatory to improve the clinical results.

Cardiac Replacement with a Total Artificial Heart as a Bridge to Transplantation

“…With the use of these devices, the rate of survival from the time of implantation to the time of transplantation has ranged from 51 to 71 percent. [5][6][7][8][9] Worldwide, more than 5000 patients have received these devices.…”

“…Among the patients who received the device on a per-protocol basis, the rate of survival to transplantation was 79 percent. Previous studies of approved devices [5][6][7][8][9] have reported rates of survival to transplantation of 51 to 71 percent with left ventricular assist devices and 58 to 61 percent with biventricular assist devices.…”

“…8 In this study, bleeding caused death in 2 patients and necessitated repeated surgery in 21, for a combined frequency of 28 percent. Published studies [5][6][7][8][9] have documented rates of similarly defined end points (death or repeated surgery) of 35 to 48 percent (for the HeartMate left ventricular assist device), 22 to 40 percent (for the Novacor device), and 23 to 33 percent (for the Thoratec biventricular assist device). Among the patients in the protocol group in this study, infection caused one death and contributed to seven others, but most infections neither delayed transplantation (84 percent, no delay) nor had a major clinical effect (81 percent, no clinical effect).…”

Ventricular Assist Devices: Is Destination Therapy a Viable Alternative in the Non-Transplant Candidate?

“…Even with these very early devices, it was clear they could improve hemodynamics, reverse end-organ damage and reduce symptoms, [5] however; this came at a price of long hospital stays. By 1998, electric powered devices which were intra-corporeal and freed patients from tethering to a console were being used as a bridge to transplantation, most notably the Heartmate VE (Thermocardiosystems) [6] and Novacor (Baxter) [7]. The ability to discharge a patient home was a critical step forward which led to the field taking a great leap - testing devices in end stage patients who were not transplant candidates [8].…”

Past, Present, and Future Regulatory Aspects of Ventricular Assist Devices

“…In 2002, the FDA believed that it might be more appropriate to rely on a performance goal using prospectively identified criteria to define success for bridging patients to cardiac transplantation in order to facilitate single-arm clinical trials. After an extensive literature review, six publications were used as the basis for this performance goal [2][3][4][5][6][7]. These papers supported a 65-70% survival to cardiac transplantation rate as the performance goal for approved BTT devices.…”