By Jeffrey Carr, MD, FACC, FSCAI
CMS can take steps to raise awareness, including a specific quality measure, to ensure that testing occurs prior to nontraumatic amputation.
EVERY DAY, APPROXIMATELY 500 Americans lose a limb and join millions of others who will struggle with a lifetime of high medical bills, disability, and significant barriers to participating in their communities.1 The greatest risk factor for developing this condition—which is completely preventable if caught early—is diabetes, the prevalence of which is at an all-time high.
Within the Medicare program, African Americans living with diabetes are nearly 3 times as likely to experience limb loss as other beneficiaries; the disparity is even worse in certain regions, such as the rural Southeast.3 Meanwhile, Hispanics are between 50% and 75% more likely than whites to undergo an amputation,4 and studies have shown that Native
Americans—especially those living in rural Western regions—are substantially more likely to receive a diagnosis of diabetes and undergo an amputation than their white counterparts.5
The good news is that we already have the capability to identify and treat vascular diseases before they progress to the point of amputation. And we have the technical know-how to bring the right care to the right people. What’s missing is a comprehensive, national strategy that integrates public awareness, increased screening and arterial testing for those determined to be at risk, and improved multidisciplinary care with new patient safety measures.
With as many as 18 million Americans at risk for limb loss due to peripheral artery disease (PAD)6 and the unprecedented prevalence of diabetes, we clearly need more effective public awareness.2 This applies to patients, who should receive better education about the risks of PAD, as well as providers, who should have better incentives to perform standard arterial testing on at-risk patients. In this regard, CMS should take cues from the previously successful Fistula First Breakthrough Initiative, which significantly increased the percentage of patients with end-stage renal disease receiving fistulas by setting standards for the entire field.7Implementing a similar amputation reduction initiative, with a specific focus on providers in minority communities, could raise the benchmark across the whole spectrum of cardiovascular care providers.
Screening for At-Risk Populations
Based on the US Preventive Services Task Force assigned grade of I, or insufficient evidence, there is great room for improvement in PAD screening the general US population and in identifying disease in asymptomatic, at-risk populations. Despite guidelines issued by the American College of Cardiology and American Heart Association that recommend screening of at-risk patients—those who are over age 65, have a history of diabetes, smoking, and/or PAD, or have received a diagnosis of other vascular disease8—we know that screenings are not taking place among these patient groups, therefore increasing the likelihood for advanced disease and limb loss.
No Amputation Without Arterial Testing
But awareness is not enough if arterial testing remains underutilized. According to a 2014 study, more than 30% of patients who underwent a nontraumatic amputation had no arterial testing the prior year to evaluate whether they would be a potential candidate for revascularization or another intervention.9 Providers should make screening mandatory for all at-risk patients, and no amputation should occur unless a patient receives an invasive angiogram or other arterial vascular evaluation first. A 2011 analysis of more than a million Medicare patients with critical limb ischemia (CLI) found that this practice reduced the odds of amputation among patients with CLI by 90%.10 At some centers—particularly The Surgical
Clinic in Nashville, Tennessee, and Martin Memorial Hospital in Stuart, Florida—an angiogram before an amputation is routine. Both centers saw significant declines in their nontraumatic amputation rates since implementing this requirement.11,12
Improved Quality Measures and Multidisciplinary Care
Many facilities remain out of reach for patients living in underserved communities, which have populations that are disproportionately African American, Hispanic, and Native American. Reaching these communities requires that care be improved in other settings and that CMS promote policies to encourage more providers to coordinate care.
Quality measures for facilities that accept Medicare are also improving. As recently as this year, CMS approved 2 new cardiovascular-related measures as Qualified Clinical Data Registries (QCDRs), which will track the rates of noninvasive vascular testing prior to revascularization for patients with CLI or who have claudication. Because they are applicable
to all specialties that provide revascularization care, these measures are expected to give investigators greater insight into the decision-making process that precedes an amputation.
However, there is room for CMS to go further. The CardioVascular Coalition’s most recent Quality Measures Working Group recommends that CMS implement an additional measure to track use of a patient safety survey prior to undergoing a nontraumatic amputation. Facilities would be required to go through a Safe Surgery Checklist with patients before proceeding with an amputation and report the results as part of Medicare’s QCDR program.
Better measures like these have the potential to improve care quality and save money. Research shows that patients who avoid amputation have a higher quality of life afterward and experience fewer adverse effects associated with limb loss—such as depression and disability.13 And, according to an analysis by Avalere Health, cutting the number of Medicare patients with major amputations in half could save the program $2 billion over 10 years.14 could save the program $2 billion over 10 years.14
When considering all these factors, it is clear that opportunities exist for improving how both PAD and CLI are screened, diagnosed, and treated among the Medicare population, particularly minorities who are at greatest risk. The progress made in the field of vascular care indicates that there is no good reason any amputation should occur when limb preservation is a possibility. This is why the CardioVascular Coalition is calling for a national Sprint to Zero initiative that seeks to eliminate senseless amputations through increased awareness, higher screening rates, and the use of a multidisciplinary approach that will ensure no amputation is performed on a patient without arterial testing.