The cost-effectiveness of continuous flow left ventricular assist devices (LVADs) has improved significantly compared with pulsatile flow devices, according to a study published online Nov. 3 in Circulation: Heart Failure, but it still fails to meet the standard threshold for being a cost-effective therapy. Nonetheless, the cost reductions obtained in a short window of time suggest these devices may reach that economic benchmark, the authors wrote.
Joseph G. Rogers, MD, of the Duke Clinical Research Institute in Durham, N.C., and colleagues noted that LVADs have filled a need as a destination therapy for advanced heart failure patients who do not qualify for a heart transplant. LVADs using pulsatile pumps have proven to be hemodynamically successful, the authors wrote, but their size, durability and significant adverse events were a drawback. A new generation technology, continuous flow LVADs, are simpler, smaller, more durable and are shown have better outcomes than pulsatile pump devices, including one- and two-year survival rates and fewer replacements due to mechanical failure.
Based on those improvements, Rogers and colleagues hypothesized that the cost-effectiveness of continuous flow devices should also improve. To test that theory, they designed a cost-effectiveness study of continuous flow LVADs compared with optimal medical management (OMM) to calculate an incremental cost-effectiveness ratio (ICER). They then compared those results with the ICER for pulsatile pump devices, which was published in follow-up cost-effectiveness analysis of the REMATCH (Randomized Evaluation of Mechanical Assistance for Treatment of Congestive Heart Failure) trial.
They obtained clinical outcomes and cost date from the REMATCH trial and from Heartmate II Destination Therapy Trial, which randomized advanced heart failure patients to a pulsatile pump device group or a continuous flow device group. Patient factors included predominantly a NYHA Class IV functional status; left ventricular ejection fraction of less than or equal to 25 percent; and ineligibility for a heart transplant. Cost data came from hospital billing data, Medicare payments for implantations and Medicare prospective payments for rehospitalizations.
Analyses were based on a decision analytic model adapted from the Blue Cross Blue Shield Technology Evaluation Center and a Markov model to assess cost-effectiveness. All calculations were in 2009 dollars.
They found that continuous flow LVAD patients had higher five-year costs, quality-adjusted life years and life years compared with OMM patients ($360,407 vs. $62,856; 1.87 vs. 0.37 and 2.42 vs. 0.64, respectively). The continuous flow LVAD ICER was $198,184 per quality-adjusted life year (QALY) and $167,208 per life year. The pulsatile pump device ICER was $802,700 per quality-adjusted life year.
Sensitivity analyses showed findings were most sensitive to the cost of device implantation, long-term survival, cost per rehospitalization and utility associated with patients' functional status.
Their analysis showed that the continuous flow device had a 75 percent reduction in ICER compared to the pulsatile-flow device, Rogers and colleagues wrote. They added that improvements in survival, functional status and lower implantation costs contributed to the reduction.
“The ICER/QALY is still significantly higher than the traditionally-used threshold of $50,000 when considering therapies to be cost-effective, but the incremental cost reduction in a relatively short time period is encouraging,” they proposed.
They acknowledged several potential limitations to the study. The trials data covered various time periods, and some data were more current than other data. The potential that continuous flow LVADs may be implanted in older patients could change results, as could advancements in technology and clinical practice.
They suggested that improvements in continuous flow LVAD and other refinements will help push costs even lower. “Ongoing improvements in patient survival, reduction in long-term complications and readmission rates, and a focus on inpatient and outpatient processes of care would be expected to result in declines in the ICER with the goal of ultimately achieving the current ‘standard’ for cost- effectiveness,” they wrote.