Significant variation in the performance of peripheral vascular interventions (PVI) to treat peripheral vascular disease (PAD) is occurring in outpatient and office-based clinics, a study reports, and the research indicates index revascularization procedures, in particular those performed in office-based labs, are associated with a higher risk of repeat revascularizations.
The findings were published in JACC: Cardiovascular Interventions by Duke cardiologists and researchers who emphasized the need for further study to ensure that PVI procedures are performed consistently and appropriately in all settings.
The study reviewed the results of 218,858 Medicare beneficiaries who underwent an index PVI between 2010 and 2012. Researchers examined 30-day and 1-year rates of all-cause mortality, major lower-extremity amputation, repeat revascularization, and all-cause hospitalization by clinical care location for index PVI.
The analysis was designed to focus on the results of PVI procedures after 2008, when the Centers for Medicare & Medicaid Services (CMS) modified intervention reimbursement rates. A significant percentage of PVIs shifted to ambulatory settings after the policy change.
“What we saw was a gradual shifting of PVI procedures to office-based care clinics,” says W. Schuyler Jones, MD, a Duke cardiologist, study author, and PAD specialist. “Our analyses suggest that more expensive procedures (specifically atherectomy procedures) were being completed in outpatient settings and office-based labs.”
The research team was concerned that this increase was driven by the shift in reimbursement, Jones says, noting that there was no “big sea change” in the clinical approach. “This poses important questions, and it is potentially going to raise red flags,” he says. “Should more complex procedures be done in those settings? Were the right patients being selected?”
Jones cautions that the study was not intended to “throw barbs and shoot arrows.” The Medicare data, he notes, lack granularity about the specific condition of the patients, the severity of the disease, and the characteristics of the clinical care locations. Further study is needed.
“The message to physicians is that we (and others) are going to look at these procedures in these settings and review the types of patients involved to ensure this population is being cared for appropriately,” Jones says.
The PVI research analysis was the third and final project supported by an American Heart Association grant, but Jones says the next research initiative will be an examination of outcomes associated with devices (such as atherectomy) as well as specific patient symptoms such as intermittent claudication.
Ryan S. Turley, MD, a Duke vascular surgeon, was lead author. In addition to Jones, other Duke contributors were Xiaojuan Mi, PhD, Laura G. Qualls, MS, Sreekanth Vemulapalli, MD, Eric D. Peterson, MD, MPH, Manesh R. Patel, MD, and Lesley H. Curtis, PhD. Patel is cardiology chief and co-director of the Duke Heart Center. Peterson is the executive director of the Duke Clinical Research Institute.