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Endovascular revascularization for peripheral artery disease (PAD) is now done outpatient more than inpatient among Medicare beneficiaries but with high mortality and rehospitalizations risks that highlight the need for better evidence-based medicine, researchers suggested.

A was observed at 1 year across Medicare patients getting these treatments, according to a report in the June 12 issue of JACC: Cardiovascular Interventions by W. Schuyler Jones, MD, of the Duke Clinical Research Institute in Durham, N.C., and colleagues.

Among all 218,858 Medicare beneficiaries who got an index PAD intervention on a lower extremity (angioplasty and/or atherectomy/stenting) from 2010 to 2012, procedures were performed inpatient 38.7% of the time, 53.3% in outpatient hospitals, and 8.0% in office-based clinic settings.

Inpatient PAD treatment was tied to fewer repeat revascularizations in the first year than were outpatient procedures, with rates of 25.1% versus 26.9% for outpatient hospitals and 38.6% for office-based clinics (both P<0.001). But inpatient treatment was associated with greater risks of:

• All-cause mortality (23.6% versus 10.4% versus 11.7%, P<0.001)
• Major lower extremity amputation (10.1% versus 3.7% versus 3.5%, P<0.001)
• All-cause repeat hospitalizations (63.3% versus 48.5% versus 48.0%, P<0.001)
• MI or stroke (9.7% versus 8.5% versus 8.0%, P<0.001)

"The rates of all-cause mortality, major lower extremity amputation, and all-cause hospitalization observed in this study highlight a pressing need for improved clinical care for Medicare beneficiaries with PAD," Jones' group emphasized.

"These results serve as a call to action for the vascular community (including the major professional societies for cardiology, vascular surgery, and radiology) to develop systems to more closely examine current practices, develop a firm evidence base, and ultimately improve clinical outcomes."

Jones and colleagues also called for quality improvement programs that can make use of newer electronic health records systems for real-time outcome measurements.

Meanwhile, "we do not argue that the shift to outpatient and office-based laboratories is a mistake. Indeed, we recognize that these settings provide greater convenience for patients, greater access in rural and hospital-poor regions, and an efficient and less costly setting for care, all with similar safety," according to Joshua Beckman, MD, and Esther Kim, MD, both of Vanderbilt Heart and Vascular Institute in Nashville, Tenn.

"However, it is unlikely that the changes in reimbursement rates for peripheral interventions made in 2008 by the Centers for Medicare and Medicaid Services were intended to result in this variability in practice. Specifically, although the reduction in inpatient procedures was likely planned, the twofold increase in the use of atherectomy in the outpatient setting and a 50-fold increase in use in the office-based clinic setting from 2006 to 2011 likely were not," the duo commented in an .

Major baseline differences existed between treatment setting groups in Jones' study, not least with the inpatient cohort presenting with more critical limb ischemia and having more comorbidities.

Other limitations included no data on PAD severity and lesion characteristics in the Medicare administrative database and inability to identify staged revascularizations.

Independent predictors of survival at 1 year included outpatient hospital and office-based settings (P<0.001 across surgeons, radiologists, and cardiologists). Even so, the office-based setting -- where atherectomy was most popular -- painted a less-than-favorable picture.

"Despite a lower comorbidity burden, patients receiving care in the office-based setting had a significantly higher rate of repeat revascularization compared with the other 2 locations. Compared with the use of other technologies, atherectomy has the most limited evidence base, so other factors are likely driving its use in the office-based setting," according to the editorialists.

"One factor may be the generous reimbursement for atherectomy in the office-based setting," Beckman and Kim suggested. "These investigators have previously reported increases in the rates of atherectomy after changes in Medicare reimbursement, and it is notable that the trend continues unabated."