A newly released study finds that patients who underwent a less-invasive procedure to open clogged leg arteries were just as like to survive with their legs intact and avoid amputation as patients who had more invasive surgery, according to an article published in circulation: Cardiovascular Quality and Outcomes, an American Heart Association (AHA) journal.
According to UC Davis Health researchers, critical limb ischemia, considered to be the most severe form of clogged leg arteries, may result in slow healing leg wounds, gangrene, or the need for amputation. Their study notes that the incidence of critical limb ischemia continues to increase as the nation’s population ages. By the year 2050 it is estimated that the number of patients who undergo amputation will more than double from 1.6 million, to 3.6 million, say the researchers.
“The question has been whether to first offer an open surgery or an endovascular procedure to patients with critical limb ischemia. Each strategy has its benefits, but it is unclear which one first is optimal and we wanted to gain a better understanding of what the current outcomes were,” said Jonathan Lin, M.D., a surgery resident in the department of surgery at UC Davis Health, in a July 30 statement announcing the study’s findings.
Considering Open Surgery vs. Endovascular Procedures
During an open surgery, requiring a hospital stay and usually about a month to recover, a section of vein from the patient (or a synthetic material if there is no appropriate vein available) is used to bypass the blockage and provide an alternative route for the blood to reach the lower leg and foot. In a less invasive endovascular procedure, performed on an out-patient basis and may be performed on patients not healthy enough for open surgery, the physician gains access to the inside of the artery with a thin, flexible tube and wire that is inserted through a small incision in the groin and guided to the blocked area. After the clogged area is opened, it can be supported and propped open by inserting a medicine-coated wire mesh tube.
The UC Davis Health researchers examined records of more than 16,000 patients (59 percent male, average age 71 years). Patients had undergone either open bypass first (36 percent) or an endovascular procedure first (64 percent) for critical limb ischemia at non-government hospitals in California between 2005 and 2013.
During the study period when comparing patients who received open surgery first to those who were first treated with an endovascular procedure, the US Davis researchers found those receiving the endovascular procedure had a longer period of amputation-free survey. These patients were less likely to require a major amputation – below or above the knee, during the study. But these patients were slightly more likely to require another procedure or surgery to restore blood flow. Finally, they were no more likely to die, although at the time of their procedures many had serious medical conditions such as kidney failure, congestive heart failure, and diabetes.
“The data here suggest that, in the grand scheme of things, an endovascular-first approach is at least not producing a worse result,” says Lin. “Regardless, the type of therapy a patient will receive needs to be a decision that patients and their physicians arrive at together. Critical limb ischemia is usually not an emergency and there is time to determine the most appropriate course of therapy, “he adds.
Taking a Look at Limitations of the Study
The UC Davis Health researchers say that their study was limited by not having information on medical factors (such as the severity of their wounds and whether they had a long and wide enough vein to perform a bypass) that might have influenced whether patients were treated with open surgery or an endovascular procedure. The patient population was also limited to specific hospitals in California, they said.
Co-authors are Ann Brunson, M.S.; Patrick S. Romano, M.D., M.P.H.; Matthew W. Mell, M.D., M.S.; and Misty Humphries, M.D., M.A.S.
The National Center for Advancing Translational Sciences, National Institutes of Health, funded the study.