Even among patients with poor baseline functional status, advanced age or severe systemic comorbidities, revascularization for attempts at limb preservation provides more health benefits and has lower long-term costs compared with wound care alone or primary amputation, according to study results published in the Annals of Vascular Surgery.
“Revascularization and limb salvage attempts are often offered to patients with foot wounds and chronic limb ischemia who are thought to be good-risk candidates, but some skepticism remains about the utility of these efforts for elderly patients with marginal functional status,” the researchers wrote. “We sought to determine whether limb preservation efforts in this population could be justified from a patient-centered, cost-effective perspective.”
Revascularization for limb preservation
Using a probabilistic Markov model, researchers simulated the clinical outcomes, health utilities and costs over a 10-year period with various management strategies. Researchers obtained clinical parameter estimates from previous clinical trials and large observational series and cost estimates from cost literature, as well as a single-center study that reviewed total cost accumulated, including secondary amputations, wound care, outpatient nursing care and nursing home costs.
The primary measure of cost-effectiveness included cost per year of ambulation with limb preservation or with a prosthesis after amputation.
“In this subset we looked at a patient population that was older or had comorbidities that were generally associated with poor overall long-term survival, as well as patients who had some sort of functional impairment. Either they had a contralateral amputation previously or because of their advanced age they had some problems with ambulation,” Neal R. Barshes, MD, MPH, of the Baylor College of Medicine, told O&P Business News. “These are patients for whom practitioners often have some reluctance to take aggressive measures for revascularization. But it actually seemed that revascularization in this patient subset is actually cost effective and of the scenarios that we looked at there was potential for cost savings.”
Study results showed the total 10-year costs of revascularization — either endovascular or surgical — were lower than the costs of either local wound care alone or primary amputation. Researchers also found revascularization strategies produced more health benefits when measured in terms of years or ambulatory ability, years of limb salvage or quality-adjusted life-years. Primary amputation did not prove to be cost-effective in any of the scenarios modeled in deterministic sensitivity analyses, according to study results.
“These results may remove some of the reluctance that some providers have at offering revascularization to older patients or patients who have undergone previous major (above the ankle) amputation or who have advanced comorbidities,” Barshes said. “Hopefully the results of this study will show that the health benefits that those patients derive from revascularization are pretty significant, so, despite their advanced age and comorbidities, it is still a worthwhile endeavor to do revascularization.”
Tailoring clinical decisions
Although revascularization was beneficial to patients with poor baseline functional status, the researchers concluded it may not be beneficial to each individual’s clinical situation and cannot be generalized to patients with comorbidities that would limit lifespan even more, such as certain cancers. However, based on the study results, the researchers recommend that revascularization or local wound care would be the best treatment options for patients with ischemia-associated limb-threatening wounds, while major amputation should be reserved for patients who “develop life-threatening foot infections that cannot be controlled with foot drainage or minor amputations and subsequent palliative wound care.” Primary amputation is not safer than revascularization and appears to be associated with higher perioperative rates of morbidity and mortality compared with surgical revascularization.
“In terms of further studies that other groups may be looking at, any study that focuses on patient centered outcomes is going to be very important to clinicians in the future,” Barshes said. “We need more data in terms of patient centered outcomes after major amputation and after revascularization, especially general measures that are specifically from the patient perspective.” — by Casey Tingle
Disclosure: Barshes has no relevant financial disclosures.
