Subintimal Angioplasty Shown Durable, Effective at 3 Years

By Sharon Worcester

RIO GRANDE, P.R. -- Subintimal angioplasty offered good patency and limb salvage rates at up to 3-year follow-up in a study of patients with critical limb ischemia or disabling claudication, and also proved beneficial for high-risk patients facing amputation, Dr. Eric C. Scott reported at the annual meeting of the Southern Association for Vascular Surgery.

A total of 104 patients underwent subintimal angioplasty of 105 occlusive lesions involving the iliac, superficial femoral, popliteal, or tibial arteries. Of these patients, 36 presented with disabling claudication, and 95% of them had immediate relief following subintimal angioplasty. About 85%, 74%, and nearly 70% maintained improvement at 1, 2, and 3 years, respectively.

A total of 55 of the 104 patients presented with critical limb ischemia, and 67% of those achieved resolution of rest pain or ischemic wounds. Limb salvage in this group of patients was 90% at 1 year and 75% at 3 years, said Dr. Scott of Eastern Virginia Medical School, Norfolk. In 15 patients with critical limb ischemia considered at high risk for amputation and contraindicated for operative bypass, limb salvage was 43% at 3 years, he said.

Of 77 patients who were operative candidates but chose subintimal angioplasty, 83% avoided open surgical bypass at 1-year follow-up, and 73% had done so at 3-year follow-up.

Overall, primary patency was 55%, 43%, and 35% at 1, 2, and 3 years, respectively. Primary assisted patency rates were 64%, 54%, and 46% at 1, 2, and 3 years, and secondary patency rates were 71%, 63%, and 51% at 1, 2, and 3 years. A total of 23 endovascular reinterventions were done to maintain patency, for a rate of 0.21 interventions per patient per year. No open surgery was needed to maintain patency.

Patients in the study had a mean age of 68 years, and slightly more than half were men. Most had risk factors for peripheral vascular disease, including coronary artery disease in 74% of patients, tobacco use in 58% of patients, diabetes mellitus in 55% patients, end- stage renal disease in 12% of patients, and prior open bypass procedures in 14% of patients.

The mean follow-up was 23 months, and the technical success rate was 87%, with failures most often due to inability to advance the subintimal guidewire back into the true lumen. Reentry devices were not routinely available during the study period, Dr. Scott noted.

Procedural complications occurred in six patients and included three arterial perforations, one retroperitoneal hematoma, one femoral artery pseudoaneurysm, and one distal embolization. All were managed percutaneously, and 30-day survival was 100%.

The findings suggest that subintimal angioplasty--a procedure with a growing number of indications, but for which enthusiasm has been tempered by a lack of data regarding durability and lasting limb salvage--is indeed a durable procedure, Dr. Scott said.

Subintimal angioplasty is effective as a first-line therapy for claudication and critical limb ischemia, and is a particularly attractive treatment option for patients who are poor surgical candidates, he concluded.

The findings are encouraging for a number of reasons, including the fact that they are from early experience with subintimal angioplasty, and it is likely that with additional experience and the introduction of reentry devices, outcomes will continue to improve, Dr. Scott said.