In a recently published retrospective review of nearly 700 patients who had non-traumatic amputations at a rural community hospital in Texas, researchers found that 41 percent of major amputations and 51 percent of minor amputations were not preceded by vascular testing in the year prior to amputation.1
The study, published in Vascular and Endovascular Surgery, included 698 patients with 248 patients having major amputations and 450 patients having minor amputations. Varghese and colleagues also found that therapeutic revascularization procedures were not performed in 66 percent of the major amputation cases and 72 percent of those who had minor amputations.1 For the patients who had major amputations, post-op pathology revealed severe atherosclerotic vascular disease (ASVD) in 57 percent of the patients and mild to moderate ASVD in 27 percent of the cohort, according to the study. Researchers also noted there was a significantly higher percentage of tissue viability in the major amputation group (90 percent) in comparison to the minor amputation group (30 percent).
“We believe that a lack of knowledge and understanding of the merits of baseline vascular testing to prevent amputation in high-risk patients is still a major deficit in 2021,” note Fadi Saab, MD, FACC, FSCAI, FASE, and Joji Varghese, MD, FACC, FSCAI, who were co-authors of the study. “More work is needed to raise awareness, not only among the community but also among health-care professionals, particularly primary care, emergency department doctors, hospitalists, and endocrinology providers.
“In addition, there is a great deal of misconception about patients presenting with ischemic wounds. Health-care providers tend to overestimate the risk of evaluation and treatment, but more importantly underestimate the risk of a major amputation.”
The study authors note that late clinical presentation of critical limb-threatening ischemia (CLTI), a lack of dedicated vascular specialty care near the hospital and the lack of a multidisciplinary team at the hospital in question may have contributed to the reduced vascular assessment and treatment.1 However, the prevailing lack of pre-op vascular screening is particularly troubling, according to Dr. Saab, the Chief Operating Officer of Advanced Cardiac and Vascular Centers for Amputation Prevention in Grand Rapids, Mich.
“In my opinion, any center that has the technology to perform an amputation should have the technology, such as ankle-brachial index and arterial duplex ultrasound, to assess for basic vascular status,” emphasizes Dr. Saab, an Associate Professor of Medicine at the Michigan State University College of Human Medicine. “Primary amputation should never be the first line of treatment for critical limb ischemia (CLI) unless life-threatening sepsis, intractable infection, extensive gas gangrene or tissue loss beyond salvage are present.”
Dr. Saab says the increased development of multidisciplinary teams and more standardized protocols for vascular testing are critical to prevent amputations in underserved populations.
“Establishing a multidisciplinary team and CLI protocols are necessary to reduce primary and secondary amputation rates, improve morbidity and mortality and decrease health-care costs related to CLI in rural communities,” notes Dr. Saab.
In order to help facilitate a more standardized approach to vascular assessment in high-risk patients, Drs. Saab and Varghese say the Association of Black Cardiologists, the CardioVascular Coalition, the CLI Global Society, the Preventive Cardiovascular Nurse Association, the Society for Cardiovascular Angiography and Interventions, and the Society of Interventional Radiology have come together to form the PAD Task Force. The physicians note that the PAD Task Force has asked the United States government to convene an intragovernmental workgroup to develop a standardized model for amputation reduction and raise awareness on the issue. Most recently, the PAD Task Force praised reintroduction of the Amputation Reduction and Compassion (ARC) Act in the U.S House of Representatives, according to Drs. Saab and Varghese.2,3 They note that the bill would provide coverage of PAD screening for high-risk patients enrolled in Medicare or Medicaid programs.
“Implementation of this act would encourage appropriate screening and early detection,” points out Dr. Varghese, a structural and peripheral interventional cardiologist at Hendrick Medical Center in Abilene, Texas. “The ARC Act would further disallow payment for non-emergent amputations unless anatomic testing had been done in the three months prior to amputation.”
Drs. Saab and Varghese add that the proposed legislation would also support educational initiatives that would target health care professionals and the public to raise awareness of PAD as well as interventions to reduce amputations, particularly with respect to at-risk populations.
The study authors maintain that aggressive revascularization strategies could have reduced the 54 percent primary amputation rate in patients who had severe ASVD.1 When it comes to vascular assessment in high-risk patients, Drs. Saab and Varghese say revascularization specialists should be aware of the pitfalls of doppler ultrasound and CT angiography, especially in identifying infrapopliteal disease in patients with diabetes. Invasive angiography “should be mandatory for every patient being evaluated for amputations,” maintains Dr. Varghese.
Drs. Saab and Varghese say extravascular ultrasound (EVUS), intravascular ultrasound (IVUS) and digital subtraction angiography can be beneficial in guiding proper treatment planning. They note that currently available low-profile technology, including atherectomy and drug-eluting technology, may provide the tools necessary to treat complex, multi-vessel, multilevel calcified lesions that are common in patients with CLI.
“We also believe it is important to identify specialists who are technically skilled and interested to perform complex peripheral interventions as patients with CLI often have multilevel chronic total occlusions,” emphasizes Dr. Varghese. “CLI revascularization specialists can make this impact and decrease unnecessary amputations.”
Citing a recent study that he co-authored, Dr. Saab says any form of revascularization is better than no attempt at revascularization for patients with CLI.
“Primary major amputation results in shorter survival, higher risk of subsequent major amputation, and higher health-care costs versus any form of revascularization,” notes Dr. Saab.4
Further studies are necessary to compare revascularization strategies for the treatment of CLI, according to Drs. Saab and Varghese. They note that one recent study showed minor differences in mortality and major amputation rates at four years when comparing transluminal angioplasty, stent, atherectomy or surgical bypass.5
- Varghese JJ, Estes BA, Martinsen BJ, et al. Utilization rates of diagnostic and therapeutic vascular procedures among patients undergoing lower extremity amputations in a rural community hospital: a clinicopathological correlation. Vasc Endovascular Surg. 2021;55(4):325-331.
- R.2631 – 117th Congress (2021-2022). Available at: https://www.congress.gov/bill/117th-congress/house-bill/2631?r=1&s=3 . Published April 16, 2021. Accessed June 1, 2021.
- CardioVascular Coalition. PAD Task Force commends reintroduction of ARC Act in the U.S. in recognition of National Minority Health Month. Available at: https://cardiovascularcoalition.com/pad-task-force-commends-reintroduction-of-arc-act/ . Published April 20, 2021. Accessed June 1, 2021.
- Mustapha JA, Katzen BT, Neville BT, et al. Determinants of long-term outcomes and costs in the management of critical limb ischemia: a population-based cohort study. J Am Heart Assoc. 2018;7(16):e009724. doi: 10.1161/JAHA.118.009724.
- Mustapha JA, Katzen BT, Neville RF, et al. Propensity score-adjusted comparison of long-term outcomes among revascularization strategies for critical limb ischemia. Circ Cardiovasc Interv. 2019 Sep;12(9):e008097. doi: 10.1161/CIRCINTERVENTIONS.119.008097.