“We’re going to see more and more amputations if we don’t figure out the right post procedure thromboprophylaxis regime ASAP,” Anahita Dua, MD, warned during a lecture on innovative approaches to preventing amputation at the Vascular Society of Great Britain and Ireland’s (VSGBI) annual scientific meeting (Nov. 22–24).
Diabetes is a significant and growing problem for the vascular community, the associate professor of surgery at Harvard Medical School and vascular surgeon at Massachusetts General Hospital in Boston began. She explained to the audience: “Because our diabetic drugs are doing their job and the way we take care of these patients is getting better, they are living longer so we are seeing more of these patients.”
At the Dublin, Ireland, meeting, Dua noted that this rise in prevalence will be accompanied by a parallel increase in the number of associated complications, specifically “complications we, as a society, may not have dealt with before”. She highlighted one that is a particular cause for concern: the microvascular dissemination of the foot. And, to make matters worse, “we have nothing to help these ‘no-option’ patients,” she said.
Dua’s talk—titled ‘Going out on a limb to save a life and a limb’—first focused on deep venous arterialization (DVA)—a new technique that, according to the presenter, “is kind of taking the world by storm”.
She first addressed some misconceptions. “There are going to be a couple of guys in the audience who are going to turn to their friend and say ‘we did this in the 80s’. No, you didn’t—I promise. You did some version of something that was called this in the 80s, but things have changed because technology and medicine have changed,” she said.
So, this is not a new concept, the presenter stressed, noting in fact that there are reports of attempts from 1881. Following a “big breakthrough” in the 1970s, however, she remarked that the technique fell out of favor “because it didn’t really work in the way it was meant to.” There were various reasons for this, according to Dua. “We were plagued by a lack of technology, lack of buy-in and lack of patients.”
The presenter highlighted some data on the new and improved iteration of this technique, first mentioning the PROMISE II trial, for which she was an investigator. While amputation-free survival was the primary endpoint, Dua focused on the limb salvage rate, which was 76% in patients who otherwise may have had no other option but an amputation.
This is where the presenter turned the audience’s attention to another study—CLariTI—designed to illuminate the ‘real-world’ amputation rate in the U.S. The presenter reported that, in this study of 180 patients at 22 sites across the country, up to 73% who underwent an amputation did not have a diagnostic angiogram, while 54% had no revascularization attempts. “We need to make sure that across the country all of these patients are getting the same level of care,” Dua stressed.
The presenter continued that in patients who were told they had no conventional options for salvage and/or had undergone two failed attempts at revascularization, the limb salvage rate was 48% at one year—so, “about a coin toss,” as Dua put it. The pooled results from PROMISE I and PROMISE II, however, which the presenter reiterated focused on DVA, revealed a higher limb salvage rate of 73%.
“I really think that that is the future, or the only thing we have, frankly, right now, for patients that are coming in with microvascular dissemination of the foot and no other options,” Dua opined, based on these data.
Anticoagulation: “One size fits all doesn’t work”
Despite the progress made for these patients technique-wise, Dua told the audience that the issue of postoperative anticoagulation is hindering outcomes. “What do we do immediately after we’ve done this amazing, futuristic surgery?” she asked. “We put them on ‘one-size-fits-all’ thromboprophylaxis because we have little idea what we’re doing.” This result is suboptimal outcomes with up to 20% of patients needing reintervention from stenosis or thrombosis in the first six months post procedure.
Dua advocated moving away from a “one-size-fits-all” approach, talking through some of the work she is currently conducting on this in her lab at Massachusetts General Hospital.
She noted that, based on her research, a patient’s platelets need to be inhibited by 30% to get a reasonable decrease in thrombosis. In order to get to this number, she explained, every patient will take different medications. “What we should be doing is testing the blood, determining whether or not you hit a particular level, and then treating accordingly,” she said.
The presenter mentioned, for example, that men and women require different treatment. “We are undertreating women, even though we think we’re treating them the same. Because of course our studies have not included that many women, so we haven’t seen this.” The answer? “We need to personalize it,” according to Dua.
The presenter noted that her work in this field has been published in the Journal of the American Heart Association (JAHA), but the task now is to translate the data into practice. In this regard, Dua referenced an ongoing trial she is conducting called TEG-MED. Dua and her team have formed an anticoagulation algorithm based on the 30% figure highlighted in their previous research. The aim now is to work out which patient needs what medication to get to that figure, remarking again that “every patient is slightly different”.
“The future for these patients is very bright,” Dua said in her concluding remarks. “We’re figuring out the coagulation story, we’re starting to understand that there are patients that can be helped with deep venous arterialization and we’re accepting this new technology, and I really feel that—over time—we don’t have to even say we’re going out on a limb to save a limb, because it’s just going to become our standard of care.”
