“Left ventricular assist devices” (LVAD) are mechanical heart pumps which are used to support patients who have end stage heart failure. This patient group has high mortality rates. On a worldwide basis, there have been several thousand implantations of LVAD; of these 18 were carried out in Norway (October 2008). LVAD can be used to stabilise patients waiting for heart transplants (bridge to transplantation) or as an alternative to transplants. We have been asked by the Norwegian Council for Quality Improvement and Priority Setting in Health Care to evaluate the evidence for clinical effect, safety and cost of using implantable heart pumps.
- We found two systematic reviews from 2006 and 2007 which summarise the use of heart pumps both as bridge to transplantation and as long-term treatment. A search for updates identified a further 14 cohort studies and one cross-sectional study.
- LVAD as bridge to transplantation:
Five cohort studies showed a significant increase in survival for patients who received LVAD prior to transplant, compared to patients who did not receive LVAD. Four cohort studies showed no difference. It is therefore unclear whether heart pumps increase survival for patients who are waiting for transplants. Some studies suggest that patients who received LVAD implants before transplants had fewer complications after the transplant than patients who did not receive LVAD implants. Two very small cohort studies showed an increase in functional capacity for patients with LVAD. For quality of life, the documentation was unclear.
- LVAD as long-term treatment:
The documentation on survival was limited to one randomised controlled trial (RCT) using an older type of pump. This study showed that patients with LVAD had significantly better survival after both one and two years compared to patients on medical treatment. Complications were normal both for patients with LVAD and for patients on standard medical treatment, but patients with LVAD had double the risk of having a serious complication. Functional status and quality of life were significantly better for patients with LVAD compared to those on standard medical treatment.
- The incremental cost-effectiveness ratio (cost/Quality Adjusted Life Year) for heart pumps as bridge to transplantation varied between NOK 794 000 and 4,783 million (including transplantation costs), depending on the comparator. For long-term treatment, the incremental cost-effectiveness ratio varied from NOK 2,075 to NOK 6,891 million depending on the type of heart pump. Because of a lack of data on the effect of the newest pumps, health economic studies for those pumps are limited. The probability of the heart pumps’ becoming cost-effective is small unless the cost of the pumps and implantation decreases or the benefit of using them increases.
- The documentation for the newest pumps on the market is very limited. Two ongoing RCTs were identified and two cohort studies (VentrAssist and HeartMate II). These studies are expected to be completed in 2009-12, and may be able to add useful documentation about the effect of the newest heart pumps.