May 26, 2015
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Analysis: LAA closure carries less per-patient cost than warfarin, aspirin

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BOSTON — Left atrial appendage closure is associated with lower per-patient costs for patients with atrial fibrillation compared with treatment with warfarin or aspirin, according to an analysis conducted by Boston Scientific and presented at the Heart Rhythm Society Annual Scientific Sessions.

The results were driven by reduction in risk for stroke, according to the researchers.

The researchers aimed to quantify the economic effect to Medicare of treatment of nonvalvular AF with a left atrial appendage (LAA) closure device (Watchman, Boston Scientific) compared with treatment with warfarin or aspirin.

Kenneth Stein, MD, FHRS

Kenneth Stein

“AF is the most common arrhythmia seen in U.S. adults, AF is associated with a fivefold increase in the risk for stroke, the most feared complication of AF is stroke and many patients think of stroke as being worse than death,” Kenneth Stein, MD, FHRS, chief medical officer, rhythm management, Boston Scientific, told Cardiology Today. “And yet, large population studies in the United States show that about half the patients at high risk for stroke choose not to be treated because of some of the disadvantages of the drugs.”

Stein and colleagues developed a budget impact model from a Medicare perspective during a 10-year time horizon. They incorporated clinical event probabilities for LAA closure and warfarin from the 4-year results of the PROTECT AF pivotal trial and for aspirin from the ACTIVE trial. The model included all costs of treatment and related complications, including acute, direct and long-term disability costs related to stroke.

During the 10-year time horizon, the overall risk for stroke was 11.4% (ischemic stroke, 9.9%; hemorrhagic stroke, 1.5%) for the LAA closure group, 17.2% (ischemic stroke, 8.7%; hemorrhagic stroke, 8.5%) for the warfarin group and 22.1% (ischemic stroke, 20.6%; hemorrhagic stroke, 1.5%) for the aspirin group, according to the researchers.

Their model also indicated that the overall risk for major bleeding was 10.6% for the LAA closure group, 16% for the warfarin group and 9.5% for the aspirin group.

Stein and colleagues determined that the modeled 10-year mean costs per patient were $27,863 for the LAA closure group, $37,867 for the warfarin group and $46,631 for the aspirin group.

“We need to be mindful of the value that our therapies bring patients,” Stein said in an interview. “We have to do what we can to get good outcomes, but we also have to be responsible and make sure any of our therapies … do it in a way that provides value. So the importance of this analysis is that the Watchman device, when used in appropriate patients, is actually very attractive from a cost point of view. Not only does it get you good patient outcomes, but for the majority of patients who get it, it’s actually cost-saving over the long run.”

The Watchman device received FDA approval in March. It has been launched at the centers involved in clinical trials and is slowly being adopted at other centers as physicians receive training, Stein said. – by Erik Swain

Reference:

Amorosi S, et al. Abstract PO01-41. Presented at: Heart Rhythm Society Annual Scientific Sessions; May 13-16, 2015; Boston.

Disclosure: The study was funded by Boston Scientific. Stein is an employee of Boston Scientific.