Indications For Treatment

Clearly, claudication is a problem that interferes with lifestyle and is not a life- or limb-threatening condition. In fact, less than 5 percent of claudicants will progress to limb-threatening ischemia.1,2

The Society for Vascular Surgery practice guidelines recommend claudication be treated conservatively at first with lifestyle modification and exercise therapy, reserving treatment for those with "significant functional or lifestyle-limiting disability when there is a reasonable likelihood of symptomatic improvement with treatment, when pharmacologic or exercise therapy, or both, have failed, and when the benefits of treatments outweigh the potential risks."3

Recent reports suggest that intervening on claudication only hastens amputation by a factor of four to five times.4 We therefore recommend a methodical and cautious approach in this group of patients.

Anatomic Concerns

While there are clear anatomic concerns regarding percutaneous intervention in such a short vessel, particularly the behavior of stents, the treatment of the profunda femoris artery (PFA) is a very critical consideration that requires discussion. The PFA should not be treated as a "side branch" and therefore the sentiment that "jailing" it is acceptable does not consider the downstream effects of excluding such a critical vessel.

The PFA is a crucial vessel that receives collaterals suprainguinally and feeds collaterals infrainguinally. Without the PFA, the leg is clearly in jeopardy, particularly when the superficial femoral artery (SFA) reconstruction reoccludes, as is frequently inevitable in this population.

Jailing the PFA has a one-year patency of 20 percent.5 Unfortunately, this has not been extensively studied and we caution against it given the implications for limb salvage and healing potential. It is generally accepted that without a patent PFA with in-line flow, the leg will not only be in jeopardy but amputations are at risk of poor healing.

Additionally, some lesions are not appropriate for percutaneous interventions, such as bulky, coral-reef-like lesions that obstruct the lumen. Plaque characteristics must weigh in the algorithm to treat a lesion endoluminally vs. with open endarterectomy. Accepting a suboptimal result may mean more rapid return of symptoms and return for intervention, which also interrupts a patient's life and subjects them to additional risk.

While atherectomy may be a good option in selected lesions, there are data to suggest that specifically atherectomy for claudication increases re-intervention and amputation rates.6 Additionally, percutaneous intervention, particularly stenting, may impact a patient's future access site options as well as ipsilateral vascular reconstruction options.

Femoral Endarterectomy and Physiologic Concerns

CFA endarterectomy is a well-tolerated procedure that can be performed under local or spinal anesthesia. It is very durable and can be performed simultaneously with retrograde or prograde transluminal interventions.7 It has been well studied with extensive literature. Even with the addition of antiproliferative drugs, percutaneous intervention still has an inferior patency.8

While the randomized TECCO trial cited in the Cardiology: Interventions article certainly describes interesting results, the published report does not describe how many patients had PFA jailing or endovascular management of the profundia ostium (such as kissing stents).9 While isolated CFA intervention may be reasonable and safe, advanced disease may require an alternative approach.

Regarding the study by Mehta, et al,10 cited in the Cardiology: Interventions article, it is important to note that only 1 percent of the total CFA patients underwent percutaneous intervention (data presented at 2014 Vascular Annual Meeting). Only high-risk patients were included and there was a 20 percent re-intervention rate in this highly-selected population.

Overall, the treatment of isolated CFA lesions is clearly evolving. At the risk of appearing prima facie to oppose progress, we would like to caution against casual percutaneous intervention of the CFA, particularly involving covering of the PFA ostium. Undoubtedly, patients at prohibitively high physiologic risk or those who have previously had surgery or infections in this area would benefit from percutaneous treatment.

It is concerning that adopting a nondiscriminatory approach to percutaneous intervention for the CFA may result in younger, healthy, mildly symptomatic patients who may do well with endarterectomy or medical management undergoing endoluminal femoral intervention with profundal jailing or kissing stents and will be worse than when they started.

As with most procedures and diagnoses in medicine, a multidisciplinary approach and good patient selection are the keys to success and good outcomes. We suggest that CFA percutaneous intervention is not ready for blanket application to all patients and therefore not ready for "prime time." And like many things in peripheral vascular disease, just because we technically can doesn't mean we clinically should.

This article was authored by Issam Koleilat, MD, RPVI, FACS, FSVS, assistant professor of surgery and associate program director of Vascular Surgery Residency and Fellowship at Montefiore Medical Center/Albert Einstein College of Medicine in Bronx, NY, and Mark Androes, MD, RPVI, FACS, associate professor of surgery and division chief of the Department of Vascular Surgery at Prisma Health-Upstate in Greenville, SC.

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Most cardiovascular surgeons consider the common femoral artery (CFA) a sacred vessel not to be treated with endovascular techniques as it is the preferred access site for arterial interventions. The traditional gold standard management for symptomatic CFA lesions has been common femoral endarterectomy (CFE) with or without patch angioplasty.

There are many challenges related to endovascular interventions in this location, which include but are not limited to short length to bifurcation, plaque shift, distal embolism, bending with stent fracture and the risk of dissection or disease extension into the origin of the profunda femoris artery (PFA).

The PFA is often referred to as the "lifeline" of the lower extremity as it maintains limb viability when superficial femoral artery (SFA) interventions fail as is frequently described. Yet, there is a growing body of evidence supporting endovascular interventions for CFA occlusive disease with short-term patency approaching that of CFE.1-4

The reported primary patency of CFE is 93 percent at one year, and ranges between 74 to 91 percent at five years and as high as 94 percent at 10 years.5-7 Despite these patency reports, a significant combined morbidity/mortality rate of 15 percent has been described in a large national cohort study.8

Nguyen, et al, reported on 1,843 patients undergoing CFE and noted a morbidity of 15 percent and a mortality of 3.4 percent, raising concerns over its safety in higher risk groups.8 This report suffers from many of the same limitations as most administrative database reports that include interventions by a broad array of surgeons. Several single center retrospective studies of board certified vascular surgeons have yielded markedly improved results.5-7,9

Historically, balloon angioplasty reports for CFA intervention have reported poor outcomes.2,10,11 However, with advances in endovascular technology, improved short- and medium-term results have been reported in recent studies.

Short-term primary patency of 90 percent at one year has been described with directional atherectomy (DA) associated with adjunctive use of drug-coated balloon (DCB) angioplasty3 and 88 percent primary patency at two years has been described with DA alone.2

Additionally, Thiney, et al, reported a 92.3 percent primary patency1 and Nasr, et al, reported a five-year primary patency of 72 percent.4 Unfortunately, overall there exists a paucity of long-term data regarding the use of endoluminal technologies in the CFA.

Two randomized controlled clinical trials have compared endovascular and open repair of CFA. Linni, et al, compared bioabsorbable stent implantation (BASI) with CFE. BASI had poor results with one-year primary patency of 80 percent compared with 100 percent for CFE.12

Additionally, the TECCO trial compared CFA stents with CFE and included bifurcation lesions with use of self-expanding stents in CFA and balloon expandable stents for SFA and profunda ostial stenosis.13

In this study, CFE had a 26 percent morbidity compared with 12.5 percent in the stent group with no significant difference in two-year primary patency and target lesion revascularization. However, the two-year primary patency in the surgery group was 82.3 percent, notably much lower than historically reported.

Currently, the PESTO-AFC trial (NCT02517827) comparing DA/DCB vs. CFE and the VMI-CFA trial (NCT02804113) evaluating the efficacy of the Supera stent in CFA lesions are enrolling. The results of these studies are awaited and the hope is for longer-term results.

In summary, CFE has a higher rate of immediate postoperative complications and longer hospital stay compared with endovascular interventions. Anesthesia risks can be reduced by appropriate patient selection and medical optimization. Wound complications when adequately monitored can be managed by timely use of antibiotics with or without surgical debridement and sartorius myoplasty.

Overall outcomes may be superior when managed by board certified vascular providers. Periprocedural morbidity and mortality of endovascular interventions is significantly lower than endarterectomy, however long-term results are not known and the complications can be more consequential and difficult to salvage.

Embolism, such as during angioplasty or atherectomy, may involve tibial vessels resulting in tissue loss and compromised outflow effecting the long-term patency of the intervention. Dissection may require bail out stenting, which has been described as high as 37 percent2,10,11,14 with angioplasty alone and presence of a stent in CFA may limit its use for future access due to the risk of fracture and infection.

Finally, shifting plaque or creating a dissection involving the origin of the PFA can place the extremity at a significant risk of a major amputation in the event of failed SFA interventions. Salvage of these complications with surgery is feasible but does increase the complexity of intervention and its associated morbidity. More data are needed to assess long-term patency of endovascular interventions and it is likely that it will be lower than that with surgery with associated increased need for re-intervention with risk of limb loss and increased costs.

Most vascular surgeons in the U.S. do not advocate CFA endovascular interventions due to these concerns. However, with the advent of compelling recent short- and medium-term data, it may be acceptable to use an endovascular technique for a symptomatic CFA lesion in a high-surgical risk patient with limited long-term survival.

References are available with the online version of this article at ACC.org/Cardiology.

This article was authored by Sashi K. Inkollu, MD, assistant professor, Division of Vascular Surgery; Luke K. Marone, MD, professor and chief, Division of Vascular Surgery; and Vinay Badhwar MD, FACS, FACC, professor and chair, Cardiovascular and Thoracic Surgery; West Virginia University, Morgantown, WV.

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