Vascular Care Falls Short Before Amputation for CLI: Medicare Analysis

A look back at the care patients with critical limb ischemia (CLI) received in the year prior to amputation suggests that most received minimal vascular care, with 69% not undergoing a revascularization attempt that might have saved the limb or improved overall survival.

Earlier this year, the American Heart Association noted in a policy statement that after a period of decline in the 1990s and early 2000s, major and minor amputations have been on the rise. National surveys, too, reflect a dramatic undertreatment problem in the outpatient setting among patients with PAD. 

Eric Secemsky, MD, MSc (Beth Israel Deaconess Medical Center, Boston, MA), who presented the study at a late-breaking trial session at VIVA 2021, said the data highlight “many of the disparities that we've talked about, we've thought about, we've discussed at these conferences, yet still persist in how we are performing vascular care prior to amputation.”

After multivariable adjustment, male gender, low income, and receiving care at safety-net hospitals—centers that provide healthcare regardless of insurance status—were predictors of low-intensity vascular care for CLI. Among those who were not revascularized in the 1 year prior to amputation, 92% did not undergo angiography. Only about one-quarter of patients received wound care, minor amputation, or debridement prior to their major lower-limb amputation.

“We've seen data like these published before, many years ago in fact, and it's remarkable that we're no better. Even though we’ve known about these issues with how we treat patients before amputation, we haven't really made any progress in terms of treatment strategies, reducing disparities, and improving consistency in care,” Secemsky told TCTMD.

“The sobering fact is the numbers of patients who do not receive an angiogram prior to an amputation has not changed since the last Medicare data that I saw,” noted panelist Subhash Banerjee, MD (UT Southwestern and VA North Texas Health Care System, Dallas), following the presentation. At the same time, he said, the data do not allow for inference as to whether the disparities being seen are caused by problems related to access, clinical skill, timing, or something else.

“It’s hard to really pinpoint the issue,” Secemsky agreed. While ambulatory surgical centers and office-based labs provide some needed access to patients in underserved areas, much more must be done to move the numbers in the right direction, he added. A persistent problem seems to be patients who don’t present to a vascular expert until late in their disease course when even an attempt at an angiogram is often futile.

“So, until we start getting into the community and getting to patients earlier [and] really making a dent in how we screen and treat patients before they go on to develop end-stage limb disease, we're going to probably keep seeing [the same data],” he commented.

Intensity as a Marker of Care and Resources

For the study, Secemsky and colleagues reviewed data on 7,904 Medicare patients with CLI who underwent a major lower-limb amputation in 2017 and had available clinical data for the year prior to the amputation and the 2 years following it. The mean age of patients was 76.5 years, more than 60% were white and male, and one third were low income.

By intensity of vascular care, 31% were classified as receiving high intensity (revascularization), 6% medium intensity (peripheral angiography with no revascularization), and 63% low intensity (neither angiography nor revascularization).

To further illustrate the point that care given prior to an amputation makes a difference in long-term events, Secemsky showed that frequency of death at 2 years after amputation was 23% for those who received low-intensity vascular care, 20% with medium intensity, and 19% with high intensity. Care intensity prior to amputation also was associated with postamputation readmission rates. At 1 year, 40% of high-intensity patients were readmitted compared with 48% of low-intensity patients.

To TCTMD, Secemsky said aside from the importance of offering angiography and revascularization, high-intensity vascular care reflects comprehensive CLI management at centers where patients are “plugged in with providers who are of higher training, more multidisciplinary, and where there are more resources, potentially, as well as other benefits that can improve outcomes.” He added that while the study doesn’t pinpoint safety-net hospitals as a problem in and of themselves, they are likely a marker of poorer access to primary care and screening, as well as to specialty care.

Misti Malone, PhD (US Food and Drug Administration, Silver Spring, MD), who served as a panelist, noted that Secemsky’s data show that patients with CLI who also were being treated for hypertension had a trend toward a lower risk of death, adding to the suggestion that those with comorbidities have a greater frequency of connection with a healthcare provider.

“We've seen this a lot where cardiovascular comorbidities are protective,” Secemsky responded. “I do think that speaks to some type of access and multiple multidisciplinary care.”

A lingering question that the data don’t answer, noted co-moderator Gary Ansel, MD (OhioHealth, Columbus), is how to tease out patients with severe infection who need amputation—and who typically don’t undergo vascular studies—from those with CLI due to blood flow problems. Doing so would allow for more accuracy as to the number of CLI patients “who are not being served because they are not getting noninvasive tests or angiograms,” he explained.

Secemsky agreed, adding that while studies such as his are “great for raising awareness,” much more research is needed to understand how to optimize care for underserved populations at the community level.