Medicare beneficiaries with heart failure who were implanted with left ventricular assist devices (LVADs) had a significant increase in lifetime costs compared with those treated with medical management, according to a cost-effectiveness model.

The Markov model estimated that LVADs had an incremental cost-effectiveness ratio (ICER) of $209,400 per quality-adjusted life-year (QALY) gained in low-risk patients and $171,000 per QALY gained in high-risk patients.

Lead researcher Jacqueline Baras Shreibati, MD, MS, of Stanford University, and colleagues published their results online in the Journal of the American College of Cardiology: Heart Failure on Jan. 11.

“The use of LVADs in patients with advanced [heart failure] who do not require inotropes at the time of implantation is not cost effective by conventional criteria,” the researchers wrote. “LVADs may provide good value in patients with less severe [heart failure] if the cost of follow-up care and the frequency of adverse events can be reduced.”

The researchers identified 220 Medicare beneficiaries who were implanted with LVADs in 2009 or 2010. All of the adults had non–inotrope-dependent heart failure, which previous studies showed was associated with shorter length of stays for LVAD implantation and improved survival compared with inotrope-dependent heart failure.

The Markov model assumed that patients entered at age 61, had heart failure and were at risk for death and for readmissions. It also assumed patients receiving medical management were eligible to receive an LVAD.

The mean age of the Medicare beneficiaries was 61 years old, while 78 percent were male and 80 percent were white. The mean cost of LVAD implantation was $175,420, while the mean pump replacement cost was $90,147.

Patients had a combined 529 admissions in the year before LVAD and 589 admissions in the year following LVAD. Patients who were readmitted to the hospital for any reason following implantation had $7,088 higher costs and stayed 3.5 days longer than before their implantations.

The researchers noted that most of the readmissions were for cardiovascular disease and were longer and more costly after LVAD compared with before implantation, although the mean monthly outpatients costs were approximately $3,000 before and after implantation.

Based on the model, the projected discounted life expectancy after LVAD was 6.28 years, while the one-year survival rate was 83 percent and the two-year survival rate was 75 percent. The discounted life expectancy for low-risk patients receiving medical management was 5.67 years, while the one-year survival rate was 84 percent and the two-year survival rate was 69 percent. For high-risk patients receiving medical management, the discounted life expectancy was 3.44 years, while the survival rates were 73 percent at one year and 53 percent at two years.

The model projected that LVADs cost $726,200 over a six-year period. The readmissions costs after LVAD implantation were $268,700, the cost of outpatient care was $219,500, the cost of device implantation was $175,400 and the cost of heart transplantation was $62,600.

For low-risk patients, LVADs increased survival by 0.61 life-years and 1.74 QALYs at an additional cost of $364,400.

For high-risk patients, LVADs increased survival by 2.84 life-years and 2.78 QALYs at an additional cost of $475,500.

The researchers cited a few limitations of the analysis, including that they only evaluated LVAD implantations in Medicare-eligible patients, a group that comprises 45 percent of implantations. They also noted there have been no randomized trials assessing LVADs in ambulatory patients with advanced heart failure, so they estimated model inputs from registries and administrative claims. In addition, the model included mostly white male participants, so the results might not be applicable to women and minorities.

“The value provided by LVADs in ambulatory patients with advanced [heart failure] does not appear to be favorable by conventional standards but may be acceptable in patient subgroups that have lower adverse event rates or in settings where LVADs can be managed at a lower cost,” the researchers wrote. “Further research of how to care for LVAD patients longitudinally and reduce device complications will be important for policymakers and payers alike as the indications for implantation continue to broaden.”