Background: It is uncertain how intracranial stenting (ICS) has been adopted nationally during a period characterized by a restrictive payment policy by the Centers for Medicare & Medicaid Services, humanitarian device exemption approval by the Food and Drug Administration, and insufficient evidence of effectiveness. We sought to determine the trends in rates of ICS use and associated outcomes in the United States.
Methods and results: From 65 211 328 Medicare Fee-for-Service beneficiaries hospitalized between 2006 and 2010 in acute care hospitals in the United States, we included patients with ICD-9-CM procedure codes for intracranial angioplasty and stenting, excluding those with a principal discharge diagnosis code of cerebral aneurysm or subarachnoid hemorrhage. We report operative rates per 1 000 000 person-years and outcomes including 30-day and 1-year mortality rates. There were 838 ICS procedures performed among Fee-for-Service beneficiaries. The overall hospitalization rate for ICS increased significantly from ≈1 per 1 000 000 person-years (n=35 procedures) in 2006 to 9 per 1 000 000 person-years (n=258 procedures) in 2010 (P=0.0090 for trend). Procedure rates were higher in men than in women, and were highest among patients aged 75 to 84 years and lowest among those ≥85 years. The 30-day mortality rate increased from 2.9% (95% CI, 0.1 to 15.3) to 12.9% (95% CI, 9.0 to 17.6), P=0.1294 for trend, and the 1-year mortality rate increased from 14.7% (95% CI, 5.0 to 31.1) to 19.5% (95% CI, 14.9 to 24.9), P=0.0101; however, the annual changes were not significant after adjustment.
Conclusions: ICS utilization in the United States has modestly increased during a period of inadequate supportive evidence. Humanitarian device exemption and a restrictive payment policy appear to have caused slow adoption of the technology.