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CardioWest total artificial heart: a retrospective controlled study
F A Arabia1, J G Copeland, R G Smith
1Health Sciences Center, University of Arizona, Tucson 85724-5071, USA. arabia@u.arizona.edu
Insights
The CardioWest total artificial heart (TAH) significantly improves survival rates for heart transplant candidates awaiting a donor heart. This pneumatic device offers a successful bridge to transplantation, replacing failing ventricles with a reasonable risk profile.
Area of Science:
- Cardiology
- Medical Devices
- Transplantation Surgery
Background:
- The CardioWest total artificial heart (TAH) is a pneumatic device designed to replace failing ventricles.
- It serves as a crucial bridge to heart transplantation for critically ill patients.
- The TAH is approved by the Food and Drug Administration (FDA) and used in select U.S. centers.
Purpose of the Study:
- To evaluate the efficacy and survival rates of the CardioWest TAH as a bridge to heart transplantation.
- To compare outcomes of patients bridged with the TAH versus those on the waiting list.
Main Methods:
- A retrospective study comparing two groups of heart transplant candidates (Group A: received TAH, Group B: control).
- Patients in Group A (n=24) received the CardioWest TAH between January 1993 and July 1996.
- Group B (n=18) met TAH criteria but did not receive the device; preimplantation data including pulmonary vascular resistance, creatinine, and bilirubin were analyzed.
Main Results:
- The TAH group (Group A) achieved a 91.7% survival rate, with 22 of 24 patients transplanted and discharged.
- The control group (Group B) had a survival rate of 38.9%, with 7 of 18 transplanted patients surviving.
- A statistically significant difference (p = 0.0003) in survival was observed between the groups.
Conclusions:
- The CardioWest TAH is an effective and successful method for bridging patients to heart transplantation.
- It offers a viable option for patients with end-stage ventricular failure awaiting transplant.
- The study demonstrates a significant survival benefit for patients receiving the TAH compared to the control group.
Abstract:
The CardioWest total artificial heart (TAH) is a pneumatic device that is used as a bridge to heart transplantation and the only TAH available that totally replaces the failing ventricles. It has been utilized in selected centers in the U.S.A. with approval from the Food and Drug Administration. Strict criteria have been developed to select candidates to be bridged with the TAH. The patient must be a heart transplant candidate of age >18 and <59 years with a body surface area (BSA) > or = 1.7 m2, cardiac index (CI) <2.0 L/min/m2, and 2 inotropic agents or 1 plus an intraaortic balloon pump (IABP). A total of 24 heat transplant candidates (Group A) met the entry criteria and underwent placement of the TAH between January 1993 and July 1996. Group A consisted of 23 males; 16 patients had an IABP. The control group (Group B) consisted of 18 heart transplant candidates who met the TAH entry criteria but never received a TAH. Group B consisted of 15 males; 14 patients had an IABP. Preimplantation pulmonary vascular resistance (PVR) (Wood units), serum creatinine (mg/dl), and total bilirubin (mg/dl) were determined in both groups. The mean values for Groups A and B were, respectively, age: 47 and 47 years, BSA: 2.01 and 1.93 m2, CI: 1.5 and 1.8 L/min/m2, PVR: 2.88 and 2.47 Wood units, creatinine: 1.5 and 1.6 mg/dl, and bilirubin: 1.8 and 1.4 mg/dl. In Group A, 1 patient died on the TAH, 1 patient died after transplant, and 22 patients reached transplant and were discharged home for a survival rate of 91.7%. In Group B, 10 patients died while waiting for a heart transplant. Of the 8 patients transplanted, 7 survived and were discharged home for a survival rate of 38.9% (p = 0.0003). In summary the CardioWest TAH provided an excellent and successful method of bridging patients to heart transplantation with a reasonable risk.