An analysis of a randomized trial found that cardiac resynchronization therapy (CRT) was cost effective compared with optimal medical therapy in patients with mild heart failure.
CRT devices with defibrillation (CRT-D) were also cost effective compared with CRT devices with biventricular pacemakers (CRT-P).
Lead researcher Michael R. Gold, MD, PhD, of the Medical University of South Carolina, and colleagues published their results online in the Journal of the American College of Cardiology: Heart Failure on Feb. 27.
More than 650,000 people each year are diagnosed each year with heart failure, and heart failure patients account for more than a million hospitalizations each year, according to the researchers. They added that the annual economic burden of heart failure was more than $30 billion.
For this analysis, the researchers evaluated 610 patients with mild heart failure who enrolled in the REVERSE trial, funded by Medtronic.
The patients received CRT devices and were randomized in a 2-to-1 ratio to CRT-ON or CRT-OFF groups. The devices were programmed on or off at pre-specified post-implantation timings.
Medtronic noted that previously published results showed that CRT-ON increased survival by nearly 23 percent for an expected survival rate of 9.76 years for CRT-ON and 7.5 years for CRT-OFF.
The researchers developed a model to examine lifetime costs and benefits. Their primary outcome measure was incremental cost effectiveness ratio (ICER), which they defined as the cost to offer an additional quality-adjusted life year (QALY).
The probabilistic results, which were based on a mean of 1,000 simulations, found that CRT-ON offered a mean benefit of 1.39 QALYs per patient compared with CRT-OFF. On average, CRT-ON cost an additional $12,250, which resulted in $8,840 per QALY gained. The researchers mentioned none of the simulations exceeded the U.S. acceptability threshold of $50,000 per QALY gained.
Meanwhile, CRT-D had a mean benefit of 1.47 QALYs compared with CRT-P at an additional cost of $63,454. The ICER was $43,678 per QALY gained, and 90.9 percent of the simulations were below the $50,000 per QALY gained threshold. The results were similar in all subgroups, according to the researchers.
An exploratory analysis found that CRT-P versus optimal medical therapy generated an ICER of $17,413 per QALY gained, while CRT-D versus an implantable cardioverter defibrillator yielded an ICER of $7,557 per QALY gained.
The researchers acknowledged the study had a few limitations, including that the optimal medical therapy comparator was based on patients randomized to CRT-OFF. Most of the patients had back-up defibrillation and pacing, which the researchers said would not be the case in real-word settings for patients with an inactivated CRT device. They also mentioned that CRT-OFF patients were treated as medication-only and incurred no device-related costs but accumulated ICD benefits, which could have improved performance in the control group.
In addition, 15 percent of patients in the CRT-OFF group were programmed to backup pacing without a pacing indication, which could have led to them having worse outcomes. Further, the researchers mentioned they erred on the side of caution when calculating costs.
“These data can be used to inform optimal decision making in patients with a guideline- based indication for device implantation,” the researchers wrote. “They can also be used as important inputs in environments where economic value plays a role, especially alternative payment models gradually being introduced.”