4 Efficacy

4 Efficacy

This section describes efficacy outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedure overview.

4.1 In a non-randomised prospective comparative study of patients at risk of imminent death from irreversible biventricular heart failure, total artificial heart (TAH) implantation (n=81) was compared with no TAH implantation (matched historical controls; n=35). The rates of survival to heart transplantation were 79% (95% confidence interval [CI] 68% to 87%) in the TAH group compared with 46% in the control group (p<0.001). The 1‑year survival to heart transplantation rates were 70% (95% CI 63% to 77%) and 31% respectively (p<0.001).

In a non-randomised retrospective comparative study (United Network of Organ Sharing [UNOS] database analysis) comparing TAH support (n=212) with biventricular assisted device (BIVAD) support (n=366) as a bridge to transplantation (BTT) in adult patients, device support survival rates were similar in both groups (p=0.8): 95% compared with 93% at 30 days and 77% compared with 69% at 1 year.

In a non-randomised retrospective comparative study comparing TAH support (n=81) with paracorporeal BIVAD support (n=67) as a BTT in 148 adult patients, device support survival rates were similar between the groups (p=0.87): 76% compared with 72% at 30 days; 63% compared with 61% at 2 months; and 46% compared with 53% at 6 months respectively.

In a case series of 101 patients at risk of imminent death from irreversible biventricular heart failure and eligible for transplant, survival to heart transplantation with TAH implantation as a BTT was 68% (69/101). In a case series of 90 patients with biventricular failure treated by TAH implantation as a BTT, actuarial survival on device was 74±5%, 63±6% and 47±8% at 30, 60 and 180 days after implantation respectively. In a case series of 27 patients with TAH implantation as a BTT, 44% (12/27) of patients were discharged from hospital within a median of 88 days after implantation (range 35 to 152 days). Support time between discharge and transplantation was spent out of hospital in 87% of patients.

4.2 In the non-randomised prospective comparative study comparing patients with TAH implantation (n=81) with matched historical controls (n=35), the survival rates at 1 and 5 years after transplantation in the TAH group were 86% and 64% compared with 69% and 34% in the control group respectively (p values not reported). In the non-randomised retrospective comparative study (UNOS database analysis) comparing TAH support with BIVAD support, survival rates after transplantation were 88% compared with 93% at 30 days, 78% compared with 83% at 1 year, and 67% compared with 73% at 3 years respectively (p=0.06). In the non-randomised comparative study of 148 patients, survival rates after transplantation in the TAH group (n=51) and the paracorporeal BIVAD group (n=39) were similar (p=0.60): 77% compared with 76% at 1year; 72% compared with 70% at 3 years; and 70% compared with 58% at 5 years. In the case series of 101 patients with TAH implantation, survival after transplantation at 1, 5 and 10 years was 77%, 61% and 41% respectively. In the case series of 90 patients with TAH implantation, actuarial survival rates after transplantation were 78±6%, 71±6% and 63±8% at 1, 5 and 8 years respectively. In the case series of 27 patients with TAH implantation, survival after transplantation (n=12) at a median 20‑month follow-up was 91%.

4.3 In the non-randomised prospective comparative study comparing patients who had TAH implantation (n=81) with matched historical controls (n=35), the overall survival rate at 1 year was 70% (95% CI 63% to 77%) and 31% respectively (p<0.001). In the case series of 101 patients with TAH implantation, the overall survival at 1, 5, 10 and 15 years was 55% (n=56), 43% (n=35), 28% (n=18), and 26% (n=3) respectively.

4.4 In the non-randomised prospective comparative study comparing patients with TAH implantation (n=81) with matched historical controls (n=35), quality of life in the TAH group improved significantly: 75% of patients were out of bed 1 week after implantation and mobility (defined as ability to walk more than 100 feet) was seen in 61% of patients (method of measurement not reported). In the case series of 27 patients with TAH implantation, the quality of life results for 12 patients at home (measured using a modified ED‑5D defined by INTERMACS) showed that only 1 young patient was able to return to school. Patients and families reported the console's noise as bothersome.

4.5 The specialist advisers listed the key efficacy outcomes as survival to hospital discharge, survival and successful BTT at 6 and 12 months, and survival after transplantation.

  • National Institute for Health and Care Excellence (NICE)