LAAO Registry Launched to Track ‘Real-World’ Outcomes With Left Atrial Appendage Closure Procedures

Amid ongoing talk over how left atrial appendage occlusion (LAAO) will be reimbursed and disseminate into wider use in the United States, today the American College of Cardiology (ACC) announced the launch of its new LAAO Registry.

Nested within the National Cardiovascular Data Registry, the LAAO Registry will be headed by Paul D. Varosy, MD, of the VA Eastern Colorado Health Care System (Denver, CO). It will serve both as the FDA-mandated post-approval study for the percutaneously implanted Watchman device (Boston Scientific) and as the central repository for long-term registry data on all patients undergoing LAA closure—regardless of the specific device used—in the United States.

“It is exciting that we are launching this registry at the beginning of implementation of this transformative therapy,” Varosy said in an ACC press release. “Clinicians, hospitals, and especially payers will benefit from a clear understanding of how these devices are being used in real-world practice.” The LAAO Registry could provide tools to ensure patients receive the highest possible quality of care, he added.

Reimbursement, Benchmarks Proposed

As reported by TCTMD, last month the Centers for Medicare & Medicaid Services (CMS) released its proposed decision memo outlining the criteria needed to be met for coverage to be considered. That included the requirement that the patient be enrolled in—and that the treating physicians be participating in—a prospective national registry that will follow patients for a least 5 years.

Three professional societies—the ACC as well as the Heart Rhythm Society and the Society for Cardiovascular Angiography and Interventions—teamed up to produce an expert consensus paper also supporting the need for a registry.

Source: 
American College of Cardiology. American College of Cardiology launches LAAO Registry: registry will track use, results of new stroke prevention technology in atrial fibrillation patients. http://www.acc.org/about-acc/press-releases/2015/12/16/11/51/american-college-of-cardiology-launches-laao-registry. Published on: December 16, 2015. Accessed on: December 16, 2015.

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