Six recent updates on LVADs

Results from several studies published or presented this year have indicated the potential benefits of left ventricular assist devices in patients with HF, including improved survival, clinical outcomes and the potential to regenerate heart muscle with prolonged use.

However, along with these encouraging developments, new data indicating the risks associated with this therapy have emerged, along with an FDA warning regarding potential serious adverse events associated with two existing LVADs.

Cardiology Today has compiled six articles from 2015 related to the use of LVADs in patients with HF.

1. LVAD use associated with improved 1-year survival and functional status vs. optimal medical management in patients with advanced HF

Results from the ROADMAP study, presented at the International Society for Heart and Lung Transplantation Annual Meeting and Scientific Sessions, indicated that patients with NYHA class IIIb/IV HF who were assigned to LVAD therapy had better rates of survival and improved 6-minute walk test results at 1 year compared with patients who received optimal medical management. Patients treated with an LVAD were also more likely to experience an improvement to NYHA class I or II. Read more

2. Long-term LVAD use may enable regeneration of heart muscle in adult patients with HF

In this study of 10 patients with HF, researchers reported that prolonged use of LVAD (longer than 6 months) led to muscle cell division, a deactivation of DNA damage response and a possible reversal of cardiomyocyte hypertrophy, as indicated by a significant decrease in cardiomyocyte size. Read more

3. The FDA warns of serious adverse events associated with two LVADs

The FDA recently issued a warning of serious adverse events related to the HeartMate II LV assist system (Thoratec Corp.) and the HeartWare ventricular assist system HVAD (HeartWare Inc).

Both devices were associated with increased risk for bleeding complications. Additionally, the HeartMate II was associated with increased risk for pump thrombosis, while use of the HeartWare HVAD was linked with increased stroke risk. Read more

4. LVADs improved clinical outcomes in patients with restrictive cardiomyopathy

In a study of 28 patients with end-stage restrictive cardiomyopathy treated with a continuous-flow LVAD, surviving patients had no device-related complications in 54% of cases, and 64% of those who did not receive a heart transplant survived at 1 year. Factors associated with improved survival included larger LV end-diastolic and end-systolic dimensions. Read more

5. Patients with LVADs at risk for cognitive decline, poor outcomes

Results from two studies published in Circulation: Cardiovascular Quality and Outcomes indicated that patients with HF treated with LVADs were at risk for cognitive decline and poor global outcomes.

In the cognitive decline study of 1,151 patients, 29% exhibited significant cognitive decline within 1 year of LVAD placement. In a separate study of 164 patients, 35.4% experienced poor outcomes at 1 year, including death, disabling stroke precluding transplant, poor patient-reported health status or recurrent HF. The researchers noted, however, that the risk for death at 1 year was higher among patients who did not receive an LVAD. Read more

6. The FDA approves expansion of HeartMate III clinical trial

In April of 2015, Thoratec Corporation announced that it had received FDA approval to expand its U.S. clinical trial of the HeartMate III device, which is intended to decrease adverse events among patients with HF.

The company was approved for enrollment of up to 1,028 patients across 60 sites in a noninferiority study comparing HeartMate III with the HeartMate II device. Read more