Peripheral artery disease (PAD) has always been overshadowed by its high-profile cousin, coronary artery disease. Now, as the number of costly endovascular interventions has soared nationally, PAD treatment is being scrutinized. In a field where clinical evidence is sparse, a flurry of questions is being asked: When does endovascular therapy make more sense for patients than surgical bypass? When PAD progresses to its most severe form—critical limb ischemia (CLI)—how do the financial and societal costs of revascularization compare with amputating the limb? Could early detection and treatment of PAD save lives and limbs, and perhaps a bundle of healthcare dollars?
Evidence needed, across the PAD spectrum
A pert 80-year-old woman walked into the office of Darren Schneider, MD, chief of vascular and endovascular surgery at New York-Presbyterian Hospital/Weill Cornell Medical Center. She had been referred by another physician who thought the woman needed surgical bypass on the basis of an ultrasound showing popliteal artery occlusion and an abnormal ankle brachial index (ABI). But Schneider’s observations and the patient’s questions left him puzzled. No visible wounds, no real pain emanating from the leg or foot, no ill effects from having walked 20 city blocks to Schneider’s office. In short, nothing to indicate an advanced case of CLI requiring intervention. “Because this woman hadn’t seen her doctor in five years, she decided to go back for a visit, and was told after an ultrasound that she was lucky she did, because she might lose her leg,” recounts Schneider. “That wasn’t true at all. She just needed a doctor who would follow her medically and be there to help if she ever got into trouble.”
The incident is emblematic of the lack of information and the misinformation that impacts the decisions of physicians and hospitals when it comes to treating PAD, which may affect as many as 10 million individuals in the United States alone. Experts worry that patients with the milder forms of PAD are being treated with unnecessary interventions even as patients with CLI are undergoing preventable amputations. In the absence of high-level clinical evidence and universal practice guidelines, decisions tend to be individualized and at times suspect, as evidenced by significant disparities in amputation and revascularization rates by race, socioeconomic status and geographic region.
“It’s the luck of the draw for patients,” says Kenneth Rosenfield, MD, MHCDS, section head for vascular medicine and intervention at Massachusetts General Hospital in Boston and 2016-17 president of the Society for Cardiovascular Angiography and Interventions (SCAI). “They may end up in the hands of a doctor who is talented and aware of CLI and its implications and get aggressive treatment. But they could just as easily find themselves with someone who is not particularly knowledgeable or aggressive. I’m appalled at the number of patients in this country who end up with an amputation for CLI without revascularization even being considered.”
Cost and reimbursement often weigh heavily in the decision. A hospital might get a DRG of more than $11,000 for an above-the-knee amputation, making it more financially attractive than a lengthy and complex endovascular intervention for a CLI patient where the cost of equipment alone could be $10,000, points out Mark W. Burket, MD, chief of the cardiovascular division and director of vascular medicine at the University of Toledo Medical Center in Ohio. “Amputation is seen as the solution because it takes care of the immediate problem with the limb,” he says, “but it’s extremely short-sighted both in terms of patient outcome and finances. After an amputation, the majority of patients do not regain ambulatory status, and there will frequently be a need for revision of the stump. Rehab costs also are considerable, and complications related to both the limb and cardiovascular system are commonplace, driving costs up even more.”
Indeed, a cost–utility analysis of limb preservation in patients with end-stage renal disease (J Vasc Surg 2014;60:369-374) found that a primary amputation strategy for a non-healing foot wound pursued over five years generated total costs of $152,426, while the initial endovascular cost (with repeated interventions as needed) was $121,478, and $124,696 for surgical bypass. Over the patient’s lifetime, the healthcare