Nine-month results of the REFORM study: a prospective, single-arm, multicenter clinical study of the safety and effectiveness of the Formula™ balloon-expandable stent for treatment of renal artery stenosis.

OBJECTIVES: To evaluate the 9-month safety and effectiveness outcomes of the Formula™ balloon-expandable renal stent (Cook Medical, Bloomington, IN) for the treatment of atherosclerotic renal artery stenosis (RAS) following suboptimal angioplasty. BACKGROUND: Atherosclerotic RAS can cause hypertension and ischemic nephropathy. When clinically indicated, an interventional approach with renal angioplasty and stent implantation is the preferred method for revascularization of atherosclerotic renal artery stenoses. METHODS: The REFORM study is a prospective, multicenter, single-arm study of stent implantation following suboptimal PTRA using the Formula stent. One hundred patients with atherosclerotic ostial renal artery lesions =18 mm in length with a >50% residual stenosis following PTA were enrolled. The primary endpoint was 9-month primary patency. RESULTS: The 9-month primary patency rate was 91.7%. The 9-month major adverse event rate was 2.2%. Mean systolic blood pressure was significantly decreased at follow-up (from 150 ± 21 mm Hg at baseline to 141 ± 21 mm Hg at 9 months; P = 0.003). Mean serum creatinine (SCr) level and mean estimated glomerular filtration rate (eGFR) were not significantly different at 9 months. A clinically meaningful improvement in renal function (i.e., =25% increase in eGFR or =0.5 mg/dl decrease in SCr) was observed in 9% of patients at 1 month and 12% of patients at 9 months. A clinically meaningful decline in renal function (i.e., =25% decrease in eGFR or =0.5 mg/dl increase in SCr) was observed in only 3% of patients at 1 month and 7% of patients at 9 months. CONCLUSIONS: The Formula stent was safe and effective in treating atherosclerotic RAS following suboptimal angioplasty.

The Basics of Interventional Radiology Management in a Large Radiology Group: A Bird's-Eye View.

Through nearly 6 decades of growth we have enjoyed and suffered under many different types of management structures. From these experiences we have become believers in a central committee structure that advances our agenda with hospital administrators and third-party payers. The best way to illustrate what we think is a winning solution is by describing our present management system. Herein we describe what we do and what works for our large radiology group as well as our interventional practice. Although this structure works well for our large medical group, it will likely work equally well for a smaller medical group.

Coding issues for interventional radiology: get paid for what you do!

As interventional radiology continues to evolve into a true clinical practice, more time will be spent on the clinical decision process; this time is reimbursable in the form of evaluation and management (E&M) services. Once assumed to be an inherent part of the procedure itself, we know many procedures now do not include follow-up E&M components. Unfortunately, E&M coding is somewhat complex and requires rigorous documentation. Below is a discussion of the fundamentals of E&M services, general principles of documentation, and the mechanics of coverage and reimbursement.