Author + information
- Received June 22, 2010
- Revision received December 27, 2010
- Accepted January 3, 2011
- Published online August 16, 2011.
- Robert F. Bonvini, MD⁎,†,⁎ (, )
- Aljoscha Rastan, MD⁎,
- Sebastian Sixt, MD⁎,
- Elias Noory, MD⁎,
- Thomas Schwarz, MD⁎,
- Ulrich Frank, MD‡,
- Marco Roffi, MD†,
- Pierre André Dorsaz, PhD†,
- Uwe Schwarzwälder, MD⁎,
- Karlheinz Bürgelin, MD⁎,
- Roland Macharzina, MD⁎ and
- Thomas Zeller, MD⁎
- ↵⁎Reprint requests and correspondence
: Dr. Robert F. Bonvini, Division of Cardiology, University Hospital of Geneva, 4, rue Gabrielle-Perret-Gentil, 1211 Geneva 14, Switzerland
Objectives The purpose of this study was to evaluate the technical feasability, safety, and 1-year efficacy of the endovascular treatment of atherosclerotic common femoral artery (CFA) obstructions.
Background Atherosclerotic CFA obstruction is a known cause of symptomatic peripheral arterial disease. Although surgical endarterectomy is considered the therapy of choice for this condition, little is known about the percutaneous options.
Methods Using a prospectively maintained single-center database, we retrospectively analyzed the outcomes of 360 consecutive percutaneous interventions of the CFA for atherosclerotic disease and assessed procedural success, in-hospital complications, and 1-year patency and target lesion revascularization rates.
Results Ninety-seven procedures (26.9%) were isolated CFA interventions, whereas 157 (43.6%) and 152 (42.2%) also involved inflow and outflow vessels, respectively. Bifurcation lesions were present in 140 cases (38.9%), and concomitant treatment of the profunda femoral artery was performed on 93 occasions (25.8%). Chronic total CFA occlusions were recanalized in 60 cases (16.7%). Balloon angioplasty was performed as the primary intervention in virtually all cases (98.6%), whereas stenting was needed for suboptimal angioplasty results in 133 procedures (36.9%). Failures—defined as a final angiographic result with a >30% residual stenosis—were observed on 26 occasions (7.2%). In-hospital major (i.e., requiring surgery) and minor (i.e., treated percutaneously or conservatively) complications occurred in 5 (1.4%) and 18 (5.0%) procedures, respectively. One-year follow-up data were available for 281 patients (87.5%). Restenosis >50% by duplex scanning and target lesion revascularization were observed in 74 of 268 (27.6%) and 64 of 322 (19.9%) procedures, respectively.
Conclusions This large series suggests that the percutaneous approach may be a valid alternative to surgery for CFA atherosclerotic obstructions.
- common femoral artery
- percutaneous peripheral intervention
- peripheral arterial disease
Common femoral artery (CFA) disease may cause claudication and critical limb ischemia and is usually part of a broader atherosclerotic involvement including the aortoiliac or femoropopliteal territories (1). Although percutaneous treatment has been accepted as the preferred initial revascularization strategy for the majority of atherosclerotic obstructions in the lower limb, CFA disease remains a mainly surgical domain because it is easily accessible and endarterectomy is associated with favorable long-term outcomes (2,3). In the last few years, the improvements in endovascular equipment and the technical skills of operators have led to an increasing number of percutaneous CFA interventions. Herewith, we report a single tertiary center experience of consecutive percutaneous CFA interventions over an 11-year period.
From a prospectively maintained database, we retrospectively selected all consecutive patients who underwent a percutaneous CFA intervention between September 1996 and December 2007 at the Angiology Division of the Heart Center in Bad Krozingen, Germany. Patients with diseases of nonatherosclerotic nature or complicating another endovascular procedure were excluded from the analysis (Fig. 1). Concomitant inflow and outflow lesions requiring revascularization were described as suprainguinal (i.e., iliac) or infrainguinal (i.e., femoropopliteal, below the knee or affecting a bypass) territories. Bifurcation lesions of the CFA were classified according to the Medina classification. This classification was developed for the coronary arteries, and it is now applied for the first time also in the femoral bifurcation (4) (Fig. 2).
The aim of this analysis was to establish the feasibility (defined as number of successful procedures/number of attempts), technical success rate (defined as a final angiographic residual stenosis ≤30%), safety (i.e., in-hospital major and minor complications), and medium-term outcomes of the endovascular CFA approach.
Clinical follow-up, as well as duplex ultrasound (US), were performed between 6 and 18 months following the procedure. Binary restenosis (>50%) was defined as a stenotic peak velocity ratio (PVR) >2.4 (PVR = stenotic peak systolic velocity [PSV]/pre-stenotic PSV). Restenoses >50% observed beyond 18 months were considered disease progression not related to the procedure and were excluded from the outcome analysis.
Percutaneous CFA treatment was considered efficacious in the absence of restenosis (>50%) and target lesion revascularization (TLR)—either percutaneous or surgical—at follow-up. Because the majority of the CFA procedures were associated with an additional iliac or femoropopliteal procedure, the ankle-brachial index (ABI) and claudication class were not considered valuable parameters to appreciate the hemodynamic impact of CFA revascularization and thus were not reported in the detailed patients' analysis.
Continuous variables were expressed as mean ± SD. Categorical data were presented as numbers and percentages, and comparisons among the groups were made with the chi-square test. p < 0.05 was considered statistically significant. Univariate analysis of clinical and procedural predictors of adverse events (i.e., procedural failure, periprocedural and in-hospital complications, restenosis, and 1-year TLR) was performed for approximately 20 parameters. Factors showing p < 0.1 were then included in a logistic regression model, and the odds ratios (ORs) and 95% confidence intervals (CIs) were computed.
During 11 years, 466 consecutive patients underwent 516 percutaneous CFA interventions. A total of 145 patients (156 lesions) were excluded from the analysis because the procedure was performed for nonatherosclerotic disease or to treat an endovascular access complication (Fig. 1). Of the remaining 321 patients with a significant (≥70%) CFA lesion, 39 (12.1%) presented with a bilateral CFA stenosis, for a total of 360 procedures. The baseline patient characteristics, as well as the lesion and procedural parameters and techniques, are reported in Tables 1 and 2.⇓ Balloon angioplasty was performed as the primary intervention in virtually all patients (98.6%), and stenting was used as bailout indication, at the operators' discretion, for flow-limiting dissections or suboptimal results (i.e., >50% residual stenosis).
Table 3 reports clinical and procedural outcomes as well as restenosis and TLR rates at follow-up. Duplex US or clinical follow-up controls were available for 281 of 321 patients (87.5%) and 316 of 360 procedures (87.8%) for a mean of 10.3 ± 5.4 months. The restenosis rate was 27.6% (74 of 268 analyzable lesions), whereas the clinically driven TLR rate was 19.9% (64 of 322 analyzable interventions). Patients presenting with restenosis and those presenting with TLR were matched. Procedural-related complications were observed on 23 of 360 occasions (6.4%): 5 (1.4%) required surgery and the remaining 18 (5.0%) were treated percutaneously or conservatively.
The results of multivariate analyses addressing the predictors of adverse events are reported in Table 4. Probably related to the operators' experience and the improvement of the equipment, the performance of CFA interventions in the second period of the study (i.e., 2002 to 2007) was independently associated with a decreased risk of procedural failure (OR: 0.35; 95% CI: 0.15 to 0.83; p = 0.013). The combination of a CFA intervention with another infrainguinal procedure was associated with an increased risk of 1-year TLR (OR: 1.97; 95% CI: 1.12 to 3.44; p = 0.015), whereas no significant outcome differences were observed for de novo lesions compared with post-endarterectomy lesions (Table 5). Procedures involving the CFA bifurcation were further associated with an increase of risk of procedural failure (OR: 2.71; 95% CI: 1.19 to 6.15; p = 0.013) and a trend toward more restenosis and TLR at 1 year. The use of stents was identified as the only independent protective factor against procedural failure (OR: 0.20; 95% CI: 0.06 to 0.69; p = 0.005), 1-year restenosis (OR: 0.53; 95% CI 0.29 to 0.97; p = 0.046), and TLR (OR: 0.49; 95% CI: 0.26 to 0.91; p = 0.021), whereas the use of atherectomy devices was associated with only a trend toward significant TLR reduction (Table 5).
This series of consecutive endovascular procedures involving severe atherosclerotic stenosis of the CFA—to our knowledge the largest published so far—shows that CFA percutaneous interventions are associated with high success (92.8%) and low complication rates (1.4% of major and 5.0% of minor complications). The 1-year binary restenosis rate of 27.6% and clinically driven TLR rate of 19.9% are lower than the ones commonly encountered in the superficial femoral artery (5).
Technical aspects for CFA interventions: angioplasty versus stenting
Stenting in the iliac and femoropopliteal regions (especially for long lesions) is associated with a better patency rate compared with that of balloon angioplasty alone (1,5); however, stent fracture or crushing remains independent predictors of poor outcomes (6). In our series, stenting in the CFA location was used only in the case of flow-limiting dissection or unsatisfactory results. Interestingly, our analysis showed that stenting, even in the groin region, still remained a favorable independent predictor for less restenosis and TLR at 1 year, without an increased incidence of fracture on duplex US examination. The technical procedural success with angioplasty alone, using balloons well matched to the original CFA vessel diameter, was achieved in 63.1% of the procedures. In the remaining cases where stenting was necessary, our strategy was always to favor a 1-stent technique, in order to avoid too much stents and struts overlap in the CFA bifurcation. Indeed, by treating bifurcation lesions, adopting a 1-stent technique can be recommended as the preferred bifurcation stenting approach, because it is easier to perform and is associated with better outcomes (7–9).
Despite the good results shown in the stent subgroup analysis, several caveats should be considered before broadly applying stenting for the treatment of CFA lesions. Whenever possible, preservation of the CFA access should be targeted to allow subsequent percutaneous coronary and peripheral interventions, as well as surgical procedures. Therefore, if stenting is needed, a self-expanding stent as short as possible (e.g., 20 to 30 mm) should be chosen to allow the placement of the femoral bypass anastomosis or the CFA puncture—under fluoroscopic guidance—just above or below the implanted stent. Finally, in rare cases when no other vascular access is available, direct puncture through the CFA stent may be carefully performed (10).
Recently, at our institution, the Silverhawk atherectomy device (ev3 Endovascular, Inc., North Plymouth, Minnesota) became one of the preferred revascularization strategies for CFA intervention, with the exception of severe calcific lesions. This is because with the Silverhawk or similar atherectomy devices, it is possible to obtain a good angiographic result, avoiding balloon-induced dissections, thus finally minimizing the need for stent implantation (11). However, this approach was mainly used in the last 2 years of the series, only once operators' experience with the device became sufficient, allowing the safe and efficacious treatment also of complex CFA lesions (i.e., bifurcations). Interestingly, the use of this device was associated with a positive trend toward less TLR at 1 year (OR: 0.18; 95% CI: 0.02 to 1.42; p = 0.090). The lack of statistical significance, despite the impressive OR, is likely due to the limited sample size of patients treated with this technology (n = 25).
Clinical implications: endovascular versus surgical approach for CFA lesions
Surgery is considered the gold standard treatment for CFA lesions. It may be associated with a technical success rate close to 100% and a 1-year primary patency rate approaching 93%. Long-term outcomes after surgical endarterectomy are also favorable, with cumulative patency rates—including primary, primary assisted, and secondary patency—up to 90% at 5 years (2,3). However, the morbidity associated with the surgery is not negligible (3,12). Accordingly, major hematoma, wound infection, nerve damage with persistent sensory disturbances, and the need for surgical revision may occur in up to 5% of cases (12), and the incidence of minor complications such as seromas and hematomas may be as high as 20% (3).
The Transatlantic Inter-Society Consensus (TASC) II guidelines, published in 2007, recommend a surgical approach for CFA stenosis, and no alternative treatment is mentioned in this document, fostering the assumption that surgery is the only available approach for CFA lesions (1). However, it should be stressed that data for surgical CFA endarterectomies are rare. Indeed, the largest series published so far included 101 patients, with a complication rate of 22.6% (1% mortality, 3.6% complications requiring a second operation, and 18% minor complications) (3).
Concerning the percutaneous approaches to atherosclerotic CFA lesions, data are even scarcer, with only a few retrospective series—the largest including 27 patients—published so far (7,8). However, thanks to modern endovascular equipment and techniques, the successful treatment of a growing number of TASC II D lesions is now possible (13), and this trend associated with our favorable results suggests that CFA stenosis may reasonably be treated with an endovascular approach first.
The major limitations of the present study are the retrospective nature of the analysis and the lack of a surgical control group during the same period. Another important issue is that 70.7% of the patients (227 of 321) had a combined revascularization procedure, thus not allowing isolation of the CFA revascularization effect. For this reason, this paper, similar to most of the published CFA series, does not include any clinical efficacy parameters (e.g., ABI, claudication class) and is focused only on the technical feasibility, safety, and 1-year patency and revascularization rates (3,7,8).
Another limitation of the present study is that because of the constant and rapid evolution of the endovascular field in recent years, our results, obtained from an 11-year time period, might be considered relatively out of date, especially in Europe, where modern techniques and equipment are readily available. However, we believe that reporting the satisfactory results with standard techniques serves as a foundation for further testing of newer technology.
Finally, the follow-up CFA imaging (mainly duplex US) was not standardized and was performed at different time points in nearly 75% of the patients, resulting in an analyzable restenosis rate of 268 of 360 CFA lesions. However, our standard practice is to conduct clinical follow-up examinations and determine ABI in the first year after the procedure and only mandate duplex US if symptoms have recurred. With this routine follow-up program, we have obtained sufficient data concerning restenosis and most importantly concerning clinically driven TLR for the majority of the patients (281 of 321 [87.5%]), and this for the most important period concerning restenosis occurrence (i.e., from the sixth to 18th months after the intervention).
This retrospective analysis of 360 consecutive CFA interventions performed in 321 patients showed that the endovascular approach with balloon angioplasty and provisional stenting is associated with a high success rate, low rate of in-hospital complications, and acceptable restenosis rate at medium-term follow-up. Our data suggest that the endovascular approach of CFA, even for complex lesions, may be a valid alternative to surgery. Randomized trials are needed to define the optimal revascularization strategy for patients with CFA atherosclerotic lesions.
The authors have reported that they have no relationships relevant to the contents of this paper to disclose.
- Abbreviations and Acronyms
- ankle-brachial index
- common femoral artery
- confidence interval
- odds ratio
- target lesion revascularization
- Received June 22, 2010.
- Revision received December 27, 2010.
- Accepted January 3, 2011.
- American College of Cardiology Foundation
- Kasapis C.,
- Henke P.K.,
- Chetcuti S.J.,
- et al.
- Scheinert D.,
- Scheinert S.,
- Sax J.,
- et al.
- Stricker H.,
- Jacomella V.
- Zhang F.,
- Doug L.,
- Ge J.
- Sixt S.,
- Alawied A.K.,
- Rastan A.,
- et al.