A pooled analysis of common femoral and profunda femoris endovascular interventions

Abstract

Background

Atherosclerotic disease of common femoral and profunda femoris arteries has been historically treated with surgical endarterectomy. Endovascular treatment of common femoral artery and profunda femoris artery disease is increasingly reported in the recent literature. This review summarizes short- and mid-term outcomes of endovascular interventions to the common femoral artery and common femoral artery.

Methods

All published series in the English language were identified through a systematic PubMed search. Standard descriptive statistics, reported as mean ± SD, were applied to perform the pooled analysis and calculate the overall outcome measures. Combined overall effect sizes were calculated using fixed-effect meta-analysis.

Results

The analysis included 20 studies with a total of 836 patients (897 limbs, mean age of 70.5 ± 4.3 years, critical limb ischemia 39.6%). Technical success was 95%. Angioplasty alone was undertaken in 68.8% of cases and stenting in 22.3%. Access complications occurred in 2.4% of cases. Post-operative major adverse limb events occurred in 2% and major adverse cardiovascular events in 1% of cases. Primary patency at 6, 12 and 24 months was 87%, 77% and 73%, respectively. Subgroup analysis revealed a significantly higher mean primary patency at 12 months for routine stenting compared to a selective stenting strategy (91.4% versus 75%; p < 0.05).

Conclusions

Endovascular interventions to the common femoral artery and common femoral artery can be performed safely with high technical success. Endovascular therapy may be a favored approach over endarterectomy for highly selected patients of poor surgical risk, with limited life expectancy and those with wound-healing considerations such as re-operative fields or prone to infection.

Keywords

Endovascular profunda femoris common femoral artery profunda stenting common femoral stenting

Introduction

Atherosclerotic disease in the common femoral artery (CFA) and profunda femoris artery (PFA) has been treated by open surgical methods such as endarterectomy or in conjunction with peripheral bypass and has been well established as the current standard of care. The nature of the disease, the ease of access to the femoral bifurcation, the excellent immediate results and durability of femoral endarterectomy and/or profundaplasty, along with the low associated morbidity and mortality, have established this vascular bed as an exclusively surgical domain.^1–3

In most patients, the superficial femoral artery (SFA) carries the burden of atherosclerotic disease and when isolated occlusion or critical stenosis occurs, it does not usually result in limb-threatening ischemia. The profunda-popliteal collateral pathway provides an alternative route of blood flow to the lower extremity that, when disrupted with profunda femoral atherosclerosis, can lead to critical limb ischemia (CLI) in the setting of SFA occlusion or stenosis.^4,5

Femoral bifurcation surgical reconstruction is usually safe, yet, a subset of patients is at higher risk for open surgery. These patients have medical co-morbidities that present an anesthetic risk, wound-healing risk or may involve a more complex dissection and reconstruction due to previous groin procedures (such as femoral endarterectomy or bypass). As experience with endovascular aortoiliac and femoro-popliteal interventions matures, the trend shifted to treating more complex disease in poor risk surgical patients with endovascular rather than surgical modalities.^6–8

Endovascular treatment of CFA and PFA lesions has been viewed with skepticism in terms of long-term patency and clinical outcomes.^9–11 Given the expanding experience and advances with endovascular techniques in this vascular bed, this study aims to provide an assessment of the safety, durability and efficacy of this technique by providing a systematic literature review of published studies on endovascular CFA and PFA interventions.

Methods

Study design

All published series in the English language were identified through a systematic PubMed search. Identifying keywords were, “common femoral artery stenting”, “femoral artery stenting”, “common femoral artery angioplasty”, “profunda femoris stenting”, “profunda femoris angioplasty”, “endovascular common femoral” and “profunda femoris endovascular”. After retrieving the relevant articles, they were searched for any further relevant reports. Any case reports or those containing fewer than five patients were excluded from review.

Methodology

Initial database query provided 1694 reports (Figure 1), and of these 29 were judged relevant based on abstract review.^12–40 Twenty of these reports were included after final review by the authors.^{12–16,18,19,21,22,25–28,31,33,35–37,39,40} After reviewing the full paper, data regarding patient numbers and demographics, indications, pre- and post-intervention ankle-brachial index (ABI), site of intervention, and patency of SFA, technical success, type of endovascular approach, complications, patency and mortality rates were extracted and analyzed (Table 1).

Figure 1.

Flow diagram for inclusion and exclusion of relevant clinical reports.

Table 1.

Demographic information of pooled series.

Patients/limbs	836/897
Technical success ±SD (%)	95.2 ± 5.0
Mean age (years)	70.5 ± 4.3
Mean length of follow-up (months)	22
Indications for procedure
- Claudication	58.5%
- Critical limb ischemia	39.6%
- Other	1.9%
Route of percutaneous access
- Contralateral femoral artery	65.5%
- Ipsilateral femoral artery	17%
- Brachial artery	7.1%
- Other (e.g. pedal)	10.4%
Overall access complications	2.4%

ABI: ankle-brachial index; P0: primary patency; PA: primary assisted patency; F/U: follow-up.

Definitions

Stenosis is defined as a narrowing of the arterial lumen; in the context of endovascular procedures, this is usually defined as “significant” when the luminal narrowing is greater than 70% and “residual” when luminal narrowing is greater than 30% following endovascular or open intervention. Restenosis is defined as the presence of luminal narrowing that reoccurs following an endovascular or open procedure. Binary restenosis refers to the discrete presence or absence of luminal narrowing following an endovascular or open procedure. Target lesion (or limb) revascularization (TLR) is defined as a re-intervention performed for ≥50% diameter stenosis (confirmed by angiography) within ±5 mm proximal and/or distal to the area of previously treated luminal narrowing following documentation of recurrent clinical symptoms or objective measures of re-stenosis, e.g. duplex or ABI reduction.

Statistical analysis

Data retrieved from each paper were entered into a database using SPSS 17 for Windows (SPSS Inc, Chicago, IL, USA). Standard descriptive statistics, reported as mean ± SD, were applied to perform the pooled analysis and calculate the overall outcome measures. Where possible, comparison of similar effects and outcomes was attempted, given the heterogeneity of the data. In order to increase the consistency of data interpretation, the weighted average of the percent experiencing outcome, after arcsine transformation, was computed. Weights were based on the variance of the effect size – i.e. the transformed proportion – in each study. Average effect size and confidence intervals were derived by applying the fixed-effect meta-analysis algorithm presented by Borenstein et al.⁴¹ The I-squared statistic was computed to assess study heterogeneity.

Results

Patient population

The analysis included 20 retrospective studies with a total of 836 patients and 897 limbs treated (Table 2). The mean age of patients intervened upon was 70.5 ± 4.3 years (range 62.8–82.1). The mean length of follow-up was 22 months (range 5.5–60). Indications for performing endovascular intervention were CLI in 39.6%, claudication in 58.5% and other in 1.9%.

Table 2.

Mid-term outcomes – Major Adverse Limb Events.

Limbs	897
Mean follow-up (months)	21.6
MALE overall	13.4%
Amputation	1.9%
Endovascular re-interventions	4.6%
Open re-interventions	6.9%

SD: standard deviation; MALE: Major Adverse Limb Events.

The CFA was the target lesion in the majority of limbs (541, 60.3%), while the PFA was included in the remaining ones (356, 39.7%). Contralateral femoral access was the most commonly used access for interventions (65.5%) with ipsilateral femoral access in 17%, brachial access in 7.1% and other (e.g. pedal or SFA access) in 10.4%. Concomitant interventions on the aortoiliac segment or the SFA were undertaken in 60% of patients.^{13–15,18,26–28,31,33,35,39,40} Angioplasty alone was undertaken in 68.8% of treated patients. Angioplasty followed by selective or routine (three studies stenting was performed in 22.3% of patients. Urokinase thrombolysis was performed in 0.3% of all patients. Atherectomy was performed in 3.5% of interventions. Inability to cross the lesion and/or aborted intervention due to technical reasons, such as vessel perforation, occurred in 46 patients (5.1%) of the dataset.

Technical considerations

Technical success was similarly defined across studies as a residual stenosis of <30% following percutaneous transluminal angioplasty and the absence of a flow-limiting dissection.²² The mean technical success rate of endovascular interventions was 95.2 ± 5.0% (range 85–100%), which corresponds to the inferred 5.1% rate of failed/aborted intervention. The small fractional difference is attributed to numerical rounding within the dataset.

Similar techniques for endovascular treatment are described in the referenced studies and include the use of sheaths ranging from 4 to 7 French in diameter with wire and catheter manipulations to cross arterial lesions. Balloon angioplasty was performed in all cases, and for those reporting selective stenting this was performed if the final diameter stenosis after balloon dilation was ≥30% or if a flow-limiting dissection was observed.³¹ Intravenous unfractionated heparin was used at the time of intervention as was antiplatelet therapy. Complex lesions involving the femoral bifurcation were treated individually and utilized a variety of techniques. These can be summarized broadly as one of the following techniques (Figure 2): (1) kissing balloons (2) kissing stents (3) single stent, jailed PFA (4) single stent, jailed SFA.

Figure 2.

Endovascular strategies for complex femoral bifurcation lesions.

Post-procedural outcomes

Mean pre-intervention ABI was 0.44 ± 0.12 (range 0.28–0.71). The mean post-intervention ABI was 0.69 ± 0.14 (range 0.53–0.99) representing an absolute increase of the aggregated mean ABI of 0.25. Access complications were the most frequently observed with a rate of 2.4% and was not significantly associated with the route of access for intervention. Post-operative major adverse limb events (MALE), defined as any form of re-intervention or amputation, occurred in 2% (amputation in 0.6%, endovascular re-intervention in 0.6% and open re-intervention in 0.9%). Major adverse cardiovascular events (MACE) defined as myocardial infarction (MI), stroke or death occurred in 1%.

Mid-term outcomes

MALE occurred in 13.4% of patients at a mean follow-up interval of 21.6 months. During this follow-up period, amputation was performed on 1.9% of limbs (including post-procedural amputations) with endovascular re-interventions occurring in 4.6% and open surgical re-interventions in 6.9% (Table 3). Primary patency at 6, 12 and 24 months was 87%, 77% and 73%, respectively (Figure 3). There was insufficient data to apply the meta-analysis algorithm for primary assisted and secondary patency estimates.

Figure 3.

Mean primary patency of revascularized limb at 6, 12 and 24 months.

Table 3.

Selected data from literature review on common femoral and profunda femoris endovascular intervention.

Author/date	Limbs (n)	Age	CLI (n)	Claudic (n)	Angioplasty only (n)	Stenting (n)	Pre ABI	Post ABI	P0/PA patency overall	Mean F/U (m)	Open re-intervention (n)	Major limb loss	Technical success (%)
Motarjeme et al.¹²	12		1	11	12	0							100.0
Dacie and Daniell¹³	26	69.5	15	14	24	0	0.46	0.59		17.5	10	3	89.7
Hoffman et al.¹⁴	43	67.4	28	15	41	0			61%	18	9	0	95.0
Bulvas et al.¹⁵	21	66.0	9	12	19	0	0.35	0.64			1	1	90.0
Varty et al.¹⁶	28	67.0	6	21	27	0					3	0	96.0
Silva¹⁸	32	69.0	19	13	27	1	0.5	0.7	88%	34	3	3	91.0
Stricker and Jacomella²¹	33	70.0	6	27	0	33	0.71	0.99	86%	30	2	1	100.0
Diehm et al.¹⁹	14	77.0	14	0	11	3					2	1	100.0
Dick et al.²²	55	72.0	17	38	47	0	0.48	0.53	71%	13	12	0	85.0
Donas et al.²⁵	15	75.6	15	0	12	3	0.3	0.6	80%	24	0	1	100.0
Cotroneo and Iezzi²⁶	27	82.1	15	12	27	0	0.31	0.78	57.90%	9.4	3	0	100.0
Baumann et al.²⁷	104	72.0	20	84	74	28	0.28	0.54	54%	16	2	1	98.0
Azéma et al.²⁸	40	67.3	12	28	0	40			90%	12	6		100.0
Paris et al.³¹	26	68.9	10	16	0	26	0.47	0.77	88%	31		1	100.0
Dattilo et al.³³	31	62.8	5	18	3	1			83%	24		2	90.0
Calligaro et al.³⁵	17	69.5	3	5	0	17			100%	12.3	0	0	100
Soga et al.³⁶	111	72	36	75	98	10	0.55	0.86	47%	60	1	0	97
Davies et al.³⁹ 2013	44	72	32	12	42	0			72%	12	4	3	90
Davies et al.³⁹	121	71	74	47	107	1			77%	12			90
Bonvini et al.³⁷	97	68.7	19	78	46	37	0.46	0.69	80%	12	4	0	92

CLI: critical limb ischemia; ABI: ankle-brachial index; P0: primary patency; PA: primary assisted patency; F/U: follow-up.

Routine stenting outcomes

There were three studies that routinely placed stents in the femoral location.^21,28,35 Collectively, 79 patients and 90 limbs were treated in this subgroup with a mean age of 68.9 years. The indication for the procedure was claudication in 66.7%, CLI in 23.3% of patients and other in 10% of patients. The technical success rate for all of these selected studies was 100%. One study used polytetrafluoroethylene (PTFE) covered self-expanding stents between 6 and 10 mm depending on the reference vessel diameter to be treated (Viabahn stent grafts. W.L. Gore and Associates Inc, Flagstaff, Ariz) exclusively,³⁵ while the remaining two studies utilized a variety of non-covered self-expanding and balloon-expandable stents (Wallstent, Boston Scientific, Natick, MA; Jostent and WaveMax, Jomed AB, Helsingborg, Sweden; Everflex, eV3, Paris; E. Luminexx and Flexstar, Bard, Voisins le Bretonneux; Amiia and OptaPro, Cordis, Issy Les Moulineaux).^28,35 Stents used in the selective stenting studies included Wallstent, Boston Scientific, Natick, MA; Jostent and WaveMax, Life Stent, Edwards Lifesciences, Irvine, CA; Xpert, Abbott Vascular, Redwood City, CA; SMART, Cordis Endovascular Systems, Miami Lakes, Fl; Misago, Terumo Corporation, Tokyo, Japan). Selective stenting sizes ranged from 4 to 8 mm with the majority being 7–8 mm stents. Subgroup analysis revealed a significantly higher mean primary patency at 12 months for routine stenting compared to a selective stenting strategy (91.4% versus 75%; p < 0.05), a difference that persisted at 24 months (89% versus 70.3%; p < 0.05) (Figures 4 and 5).

Figure 4.

Mean primary patency of revascularized limb for routine versus selective stenting.

Figure 5.

Primary patency at 12 months.

Discussion

Surgical revascularization of the femoral bifurcation, in the form of femoral endarterectomy and profundaplasty, dominates the literature and remains the standard of care.^1–5 This current review of contemporary series of endovascular interventions on common femoral and profunda femoris disease challenges the traditional notion that atherosclerotic disease in this location should be treated exclusively with surgery, indicating that a carefully selected subgroup of patients may be suitable for endovascular treatment. Endovascular treatment of femoral disease has been previously criticized for a lack of durability. However, this review provides data on procedural morbidity and mortality and mid-term outcomes that challenges these criticisms.

Traditionally, open vascular surgery for disease of the common femoral, profunda femoris and femoral bifurcation has significant advantages over endovascular modalities, including long-term durability, low rates of significant complications and excellent clinical outcome data with respect to limb salvage, relief of symptoms and wound healing.^2,42,43 In addition, the vital role for maintaining profunda femoris patency as a contributor to collateral flow to the distal extremity, and henceforth limb salvage has led to great hesitation in adopting endovascular treatment for this vessel.⁹ This is due to the femoral bifurcation being an area of flexibility and therefore considered a point of stress for endovascular stents that may lead to fracture.^44–46 Femoral endarterectomy, however, does require careful attention to the anesthetic management of poor surgical risk patients and can require complex and lengthy reconstructions in patients who have undergone previous femoral operations. This exposes such patients to perioperative morbidity such as infection, a higher bleeding risk, longer hospitalization and recovery time. In such cases, an endovascular approach may have a role, provided that the perioperative and mid-term outcomes are reasonably comparable to surgery.

Siracuse et al.⁹ describe the perioperative safety of common femoral endarterectomy in the endovascular era in a study of 1513 patients. The authors report a 1.5% 30-day mortality rate with a total complication rate of 16.9%. These results compare with a study examining long-term outcomes following isolated endarterectomy of the femoral bifurcation, demonstrating a 1.8% in-hospital mortality rate with survival at 5.9 years of 60.5% and post-operative complications occurring in up to 36.9% of patients.⁴³ These data from single-institution experiences and large national database review suggest that surgical endarterectomy is a safe and durable operation with a low 30-day post-operative mortality and complication rate, of which the majority were minor complications such as superficial surgical site infection.^9,43

The safety of the endovascular approach is reinforced by the very low 30-day post-operative mortality rate from the pooled series and highlights the safety of this approach. The pooled mean estimates of perioperative complications with endovascular therapy reveal a 2.4% rate of access complications, the majority of which were managed conservatively without surgical intervention. The dataset did not allow for an evaluation of longer term mortality and morbidity.

The mean primary patency rates for endovascular interventions were 73% at 24 months for selectively stented limbs and 89% at 24 months for routinely stented limbs, a difference that was statistically significant. A recent review of endovascular common femoral interventions describes excellent medium-term results from a single-center prospective study of 53 patients. Stents were used in 95% of cases to the CFA with patency rates of 92.5% at a mean follow-up of 24 months.⁴⁷ The patency data more accurately reflect the total limb patency as aortoiliac and femoro-popliteal interventions were performed concomitantly with common femoral and profunda femoris interventions in the majority of reported series. In the endovascular era, it is rare for isolated arterial segments to be treated if other lesions are noted during angiography and are treatable by endovascular means. These data should be interpreted, however, in the more important overall clinical context of patient outcome and limb salvage. When looking at the overall effectiveness of a “total endovascular” solution for limb salvage, this translates to a very low amputation rate in the follow-up period of less than 2%. Re-interventions on a particular limb, either endovascular or surgically, also occurred infrequently in less than 12% of patients during the follow-up period.

Analysis of the pooled data reveals a majority of interventions performed for claudication, rather than CLI. This stance reflects a somewhat aggressive posture to femoral bifurcation lesions with respect to selecting candidates for endovascular rather than surgical treatment, given the proven durability and low morbidity of surgery. This difference may be due to an endovascular bias of the authors in this series; however, when compared to contemporary open surgical series is similar in terms of the proportion of patients with claudication and CLI.

Data from superficial femoral and popliteal artery intervention suggest a role for routine stenting with respect to increased patency rates when compared to angioplasty alone or in conjunction with selective stenting.^48–50 Significant differences in patency between routine and selectively stented CFA and PFA were seen at 12 and 24 months. Re-intervention in the setting of previous common femoral stenting was reported in one series of routine femoral stenting with successful performance of access to the stented femoral artery.²¹ The authors describe re-interventions in four patients in total with fluoroscopic or duplex guidance to access the femoral artery above or below the stent struts. These four patients underwent contralateral endovascular treatment to the femoral bifurcation without complication. Stent fracture, kinking and crushing have all been described in the endovascular experience with stenting across areas of flexion such as joints and has been linked to pseudoaneurysm, recurrent stenosis and thrombosis of the stented vessel.^{44–46,50–55} The clinical effect of stent fracture in femoro–popliteal interventions, however, has not been conclusively elucidated.^54,55 In the pooled data from routine stenting studies described above, there were only two stent fractures seen with no clinical consequence identified in either patient during the period of study follow-up.^21,28

A comparison between femoral endarterectomy and common femoral and profunda femoris endovascular interventions raises questions as to the role of endovascular interventions on selected subgroups of patients not favored for surgery. The decision to operate or intervene endovascularly on a particular patient depends on many factors, most prominently the anatomic characteristics of the atherosclerotic disease but additionally the general health of the patient and technical complexity of the proposed solution. Surgical endarterectomy is a well-established, successful treatment for common femoral and profunda femoris disease. This review of contemporary outcomes following endovascular interventions on the CFA and PFA suggests that endovascular interventions may be a justifiable option for patients with a very high surgical risk or patients with limited life expectancy. Situations where incisional wound-healing issues are a definite concern, such as multiple re-operative fields and those patients whose recovery from an operation may be compromised, such as nutritionally deplete patients or those at high risk of infection, may also be more reasonable candidates for endovascular therapy.

Limitations

This review of the literature is limited by heterogeneity of the interventions performed. In most of the series, another arterial segment was treated in addition to the femoral intervention and this makes the interpretability of the contribution of the CFA intervention to clinical improvement less clearly defined. The TECCO trial (Endovascular Versus Open Repair of the CFA; Clinicaltrials.gov identifier NCT01353651) aims to randomize 120 patients between surgery and endovascular therapy for isolated CFA lesions. In addition to a direct comparison of outcomes between surgery and endovascular therapy, this trial may shed light on the true outcomes from isolated CFA endovascular intervention without concomitant arterial segment treatment.

The endovascular interventions performed varied between studies with angioplasty being used primarily and stenting added selectively or routinely following initial angioplasty. In addition, the type of stent used (self-expanding, balloon-expandable, covered versus bare-metal) was not the same in all studies. The indication to perform endovascular common femoral and profunda femoral interventions comprised both patients with claudication and CLI (including ischemic rest pain and tissue loss), which is known to influence the long-term outcome; however, the proportion of claudicants to CLI patients exhibits a similar pattern to reported series of endarterectomy.

A weakness of any review of published studies is the inconsistency of the data across the studies. Resultantly, there are some studies with more complete data than others and the impact of the non-reported data with respect to the overall outcomes is unknown. The effect of missing data is mitigated somewhat by the large numbers of studies and interventions performed, however, and may still be more representative of true population results than a single-institution report.

Conclusions

Common femoral endarterectomy is a durable and safe operation and is the standard of care for atherosclerotic disease affecting the femoral bifurcation. Endovascular interventions on the CFA and PFA can be performed safely, however, and with a high degree of technical success. Mid-term patency is good and may be further improved by routine stenting at the femoral bifurcation, although stenting at this location may present challenges if further endovascular or surgical intervention is planned.

The rate of any re-intervention on the treated extremity, either endovascularly or surgically, is similar at one year between endarterectomy and primary endovascular therapy. The reason for this surprising result is likely because the re-intervention is most often for additional inflow or outflow procedures as atherosclerotic disease is rarely limited to just the femoral bifurcation. Primary endovascular therapy may be a more favorable approach than surgery for a carefully selected subset of patients at higher surgical risk or those with short life expectancies or with wound-healing considerations.

Footnotes

Acknowledgement

This study was presented at the VESS Winter Meeting 2015.

Declaration of conflicting interests

The author(s) declared no potential conflicts of interest with respect to the research, authorship, and/or publication of this article.

Funding

The author(s) received no financial support for the research, authorship, and/or publication of this article.

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