In older, frailer patients, limb revascularization appeared to preserve both limbs and ambulation longer – and cost less – than either amputation or a program of local wound care.
Although these patients had worse clinical outcomes than did healthy patients who had revascularization, the benefits were still evident, Dr. Neal R. Barshes and his colleagues wrote in the January issue of Annals of Vascular Surgery (Ann. Vasc. Surg. 2014;28:10-17).
"We believe that 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," wrote Dr. Barshes of the Michael E. DeBakey Veterans Affairs Medical Center, Houston, and his coauthors.
The team conducted a clinical outcomes and cost model that ran 1,000 simulated trials of 1,000 patients each. The clinical parameters were drawn from the landmark MOVIE (Model to Optimize Healthcare Value in Ischemic Extremities) study. The study was modified to simulate a patient population older than 80 years, or who had undergone a prior major amputation of the contralateral lower limb, as these two groups have poorer postoperative outcomes than the usual population undergoing revascularization for lower limb ischemia.
The analysis examined outcomes associated with six procedures:
• Primary amputation.
• Local wound care.
• Surgical revascularization followed if needed by surgical revision.
• Surgical revascularization followed if needed by endovascular revision.
• Initial endovascular revascularization followed if needed by surgical revision.
• Endovascular revascularization followed if needed by endovascular revision.
Dr. Neal Barshes
Analysis revealed that primary amputation was the least clinically beneficial and the most expensive procedure, with no limb salvage, a median ambulatory period of 1.5 years, and a total 10-year cost of $185,955. Much of the cost was for nursing and long-term care due to loss of functional independence.
Wound care also produced less desirable outcomes. The median 5-year limb salvage rate was 28%, with a median limb salvage period of about 1.5 years. The median ambulatory period was less than 1 year, and the median total cost, $129,651.
Surgical bypass with either surgical or endovascular revision produced a limb salvage rate of 80%, with a median salvage time of 3 years and a median ambulatory period of 2.4 years. With surgical revision, the median total cost was $113,944; with endovascular revision, it was $110,910.
Endovascular revascularization followed by surgical revision produced a 5-year limb salvage rate of 80%, with a median limb salvage period of about 3 years and a median of 2.4 ambulatory years. The median total cost was $108,794.
Endovascular revascularization with endovascular revision produced a 5-year limb salvage rate of 80.5%, with a median salvage period of 3 years and a median ambulatory period of 2.5 years. This was the least expensive strategy, with a median total cost of $104,118.
These outcomes were much worse than those seen in the population of younger, healthier patients, the researchers said. The median 10-year cost for revascularization was up to $35,000 more. The clinical outcomes of the older population were also worse, with a 3-year period of limb preservation compared with more than 4 years in a healthier population, and about 2.5 ambulatory years compared with 4.6 years.
"In spite of these findings, revascularization still appears to be the most cost-effective alternative to wound care and primary amputation," the team noted. In fact, the less-healthy population actually stands to gain relatively more than the healthier one.
"In other words, the difference in outcomes between revascularization and either local wound care or primary amputation is much larger in this marginal population and therefore more likely to produce cost savings. The situation is akin to performing carotid endarterectomy early after a completed stroke – although the absolute risk of perioperative stroke is higher than when delayed for 6 weeks, the risk reduction of early carotid endarterectomy is significant compared with late carotid endarterectomy."
The research was initially presented at the annual winter meeting of the Peripheral Vascular Surgery Society. The paper did not note any potential financial conflicts of interest or the study’s sponsor.