Trends in Intracranial Stenting Among Medicare Beneficiaries in the United States, 2006–2010

Abstract

BackgroundIt 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 ResultsFrom 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.ConclusionsICS 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.

Evidence-based de-implementation for contradicted, unproven, and aspiring healthcare practices

“…In 2006, Centers for Medicare & Medicaid Services (CMS) announced that they would pay for the procedure only within the confines of a randomized trial. They adhered to such a position, despite pressure from the manufacturer in 2008 [ 26 ].…”

“…During the years it was approved but trial data was lacking, CMS’s policy dramatically limited off-protocol use of the device and effectively protected the public. Altogether, only a few hundred patients received the device (200+ treated on protocol) in the US [ 26 ] — contrast this against the millions of patients who received PCI for stable angina. CMS’s wise 2006 decision likely averted a catastrophic outcome for thousands of patients who might otherwise have been treated with the device.…”

Comparison of outcomes and utilization of extracranial-intracranial bypass versus intracranial stenting for intracranial stenosis

“…It includes patients treated nonelectively on emergency basis as well as those treated electively, and it is not limited based on patient insurance plan. [ 16 ]…”

“…Consistent with previous studies, our study also found that, regardless of the procedure performed, patients with symptomatic ICAD were older and had more comorbidities than patients with asymptomatic ICAD. [ 16 32 ] Increasing age is associated with anatomical changes, such as narrowing of small vessels and loss of elasticity in vessel walls, and increased tendency for atheroma formation, which both play an important role in the development of ICAD. [ 18 ] Patients with multiple comorbid conditions, especially hypertension, hyperlipidemia, diabetes, and obesity, are at a higher risk of developing ICAD compared with healthier patients with fewer or no comorbidities.…”

“…[ 18 ] Patients with multiple comorbid conditions, especially hypertension, hyperlipidemia, diabetes, and obesity, are at a higher risk of developing ICAD compared with healthier patients with fewer or no comorbidities. [ 16 ]…”