Treat Critical Limb Ischemia Early
PTA other technologies effective in achieving limb salvage.
As the population of people with diabetes grows in the United States, so will the number of patients with critical limb ischemia (CLI), according to a speaker at TCT yesterday.
The incidence of CLI is currently about 500 to 1,000 per million people, according to Gary M. Ansel, MD, of Riverside Methodist Hospital in
Columbus, Ohio.
Ansel said that early evaluation and treatment could be key to saving limbs, and in some circumstances, saving lives.
The markers of CLI include pain, ulceration and gangrene. Between 40% and 45% of CLI-related amputations occur in diabetics. Prognosis is poor (Figure).
Diagnoses to consider when treating these patients include atherosclerotic occlusive disease, Buerger’s disease, vasculitis, neuropathy, coagulopathies and embolic disease.
Factors that influence healing in CLI patients include: plantar arch patency, amount of tissue destruction, presence of infection, need for debridement or skin graft, available conduit for bypass, comorbidities, and nutritional status, Ansel said.
Treatment success
Ansel cited data showing that percutaneous transluminal balloon angioplasty (PTA) in 993 patients from 1999 to 2003 achieved a technical success rate of 95%, a five-year salvage rate of 88%, and a minimal need for repeat procedures (about 13%).
He cited other smaller studies that found similar success and limb salvage rates at two years, ranging between 25% and 85%.
As research evolves to find technologies that may surpass PTA, it will be important to establish primary endpoints for trials and minimum numbers of patients, and to iron out cost issues.
Ansel cited data from a cohort of 73 patients examining intrafemoral cutting balloon angioplasty. Results showed that stents were needed in 20% of those cases; limb salvage was achieved in 89.5% of cases.
The phase-2 results of the LACI trial, which looked at laser angioplasty for critical limb ischemia in 155 limbs, showed a 93% rate of limb salvage at six months.
Stenting
Ansel cited Cypher (Cordis/Johnson & Johnson) data that noted no cases of stent occlusion or restenosis in patients, compared with four and nine cases, respectively, in the control arms.
He also cited data from Feiring et al that looked at tibial stents used in 92 limbs that yielded a 94% technical success rate and clinical success with healing in 96% after one-year follow up.
Ansel said these procedures are all worth considering in patients who are at high surgical risk.