Treatment Of Superficial Femoral Artery Research Articles

Failed superficial femoral artery intervention for advanced infrainguinal occlusive disease has a significant negative impact on limb salvage

Endovascular treatment of superficial femoral artery (SFA) lesions is a well-established practice. The repercussions of failed SFA interventions are unclear. Our goal was to review the efficacy of SFA stenting and define negative effects of its failure. A retrospective chart review was conducted from January 2007 to January 2010 that identified 42 limbs in 39 patients that underwent SFA stenting. Follow-up ankle-brachial index and a duplex ultrasound scan was performed at routine intervals. Mean patient age was 68 years (range, 43-88 years); there were 22 men (56%) and 17 women (44%). Intervention indication was claudication in 15 patients (36%), rest pain in seven patients (17%), and tissue loss in 19 patients (45%). There were 15 patients (36%) with TransAtlantic Inter-Society Consensus (TASC) A, nine patients (21%) with TASC B, five patients (12%) with TASC C, and 13 patients (31%) with TASC D lesions. The majority of lesions intervened on were the first attempt at revascularization. Three stents (7.7%) occluded within 30 days. One-year primary, primary-assisted, and secondary patency rates were 24%, 44%, and 51%, respectively. Limb salvage was 93% during follow-up. Seventeen interventions failed (40%) at 1 year. Of these, seven patients (41%) developed claudication, seven patients (41%) developed ischemic rest pain, and three patients (18%) were asymptomatic. During follow-up, three patients (7.7%) required bypass and three patients (7.7%) major amputation, one after failed bypass. All limbs requiring bypass or amputation had TASC C/D lesions. Thirty-day and 1-year mortality was 2.6% and 10.3%, respectively. Interventions performed for TASC C/D lesions are more likely to fail and more likely to lead to bypass or amputation. Interventions performed for TASC C/D lesions that fail have a negative impact on limb salvage. This should be considered when performing stenting of advanced SFA lesions.

COMMENTARY: Miniaturized Retrograde Popliteal Approach in a Supine Patient

With the increasing sophistication of endovascular technology and techniques, the management of peripheral artery disease has undergone tremendous change since Dotter and Judkins first reported the use of endovascular therapy for critical limb ischemia in 1964. As enthusiastic pioneers have demonstrated, an innovative spirit is vital for the advancement of endovascular therapy. An example of this forward-looking attitude can be found in the article on retrograde popliteal access in this issue of JEVT; Fanelli and colleagues deserve high praise for their farsightedness, as well as their tenacity and innovation, despite some criticism of this approach. The treatment of superficial femoral artery (SFA) disease with nitinol stents has expanded the indications for catheter-based revascularization, achieving higher technical success and patency rates than with balloon angioplasty alone. In particular, endovascular therapy for chronic total occlusion (CTO) of the SFA can offer advantages over bypass surgery; it is less invasive, requires shorter hospitalization, entails lower risk of infection and complications of anesthesia, and is repeatable, while preserving vessels for possible future graft surgery. Failed CTO recanalization can be converted to bypass surgery. An endovascular solution for CTO of the SFA is one of the final frontiers of endovascular therapy. Thus, the establishment of a standard recanalization technique for SFA occlusions remains a key goal. During the last decade, antegrade intraluminal and/or subintimal angioplasty techniques for SFA occlusions have gained popularity thanks to the development of nitinol stent technologies. The retrograde popliteal approach has traditionally served as a backup option in case of failed antegrade crossing in the SFA lesion. Against this, the inherent drawbacks of repositioning the patient during the procedure and popliteal puncture site complications require further technical refinement to encourage the widespread application of the retrograde popliteal approach. Focusing on the unique anatomical characteristics of the SFA, I described in 2010 the novel technique of retrograde 3-F popliteal access accomplished in a supine patient by lifting the patient’s heel. In this issue of JEVT, Fanelli et al. retrospectively review their experience with retrograde popliteal access in 26 supine patients after failed antegrade crossing. Despite challenging cases, the technical outcomes were quite satisfactory, with all recanalizations successful and no significant popliteal puncture site complications. However, as shown in the Table, there are some differences between the procedure I reported and the one used by Fanelli et al., although stent delivery is similarly implemented in an antegrade fashion following retrograde guidewire crossing. I felt that their 4-F popliteal approach posed a small risk of puncture site complications and might be uncomfortable for the patient during hemostasis. Considering that catheter-based treatment of lower limb arterial disease has progressed with the downsizing of endovascular equipment, I recommend the application of a 3-F popliteal approach. Given the currently available devices, a 3-F sheath can

Final Results of the Protected Superficial Femoral Artery Trial Using the Filter Wire EZ System

Conclusion: A distal protection device during femoral popliteal interventions reduces distal migration of debris. Summary: The study evaluated the safety and efficacy of a single distal protection device (Filter Wire EZ Embolic Protection System, Boston Scientific, Mountain View, Calif) for capturing debris during superficial femoral artery (SFA) percutaneous interventions. An additional aim was to define the incidence of distal embolization during SFA interventions. This was a prospective, single-center registry. The study included 30 patients suitable for percutaneous transluminal angioplasty (PTA). Primary end points were occurrence of distal embolization, decreased runoff, improvement in ankle-brachial index (ABI), and number of filters containing emboli. Secondary end points included procedural or device-related death and/or clinical target lesion revascularization, device delivery, deployment success, and incidence of embolic recovery. Procedural success was defined as <30% residual stenosis, with no worsening of distal runoff as determined by angiography. The study enrolled 29 patients with 30 treated limbs, suitable for PTA, between February 2007 and March 2008. Claudication was the indication for intervention in 26 patients and critical limb ischemia in 3. One patient underwent treatment in both legs. The average degree of stenosis was 86% ± 7%, and stenosis length ranged from 8 to 88 mm. No procedural or device-related complications occurred. Average degree of residual stenosis was 10 % ± 10%. ABI improved from 0.56 ± 0.16 to 0.92 ± 0.19 (P < .05). At 1 month, there was no ultrasound-detected waist stenoses or dissections. Microscopic debris was found in 27 of the 30 filters used. Particle size was 1200 ± 640 μm (range, 90-2000 μm). Histologic analysis indicated debris consisted of platelets, erythrocytes, inflammatory cells, extracellular matrix, and cholesterol. There was no correlation between lesion morphology and type of debris. Comment: This is a small, single-center, nonrandomized commercially sponsored study with the first author having a consulting arrangement with the study sponsor. The study is obviously good marketing material for the manufacture of the FilterWire EZ System. However, assuming the author's observations are accurate, the study should bring some measure of concern to all who perform catheter-based SFA interventions, because these interventions seem to be nearly uniformly associated with distal embolization. Long-term clinical implications of these distal emboli remain to be defined, but as someone once said, they may not be bad, but they can't be good! The true clinical utility of embolic protection devices in all vascular beds remains an intriguing, and certainly a potentially profitable, avenue of research.

First clinical trial of nitinol self-expanding everolimus-eluting stent implantation for peripheral arterial occlusive disease

A novel self-expanding drug-eluting stent was designed to slowly release everolimus to prevent restenosis following peripheral arterial intervention. The purpose of the first-in-human Superficial Femoral Artery Treatment with Drug-Eluting Stents (STRIDES) trial was to evaluate the safety and efficacy of this device for the treatment of symptomatic superficial femoral and proximal popliteal arterial occlusive disease. One hundred four patients were enrolled at 11 European investigative centers in a prospective, nonrandomized, single-arm trial. The patients had severe symptomatic vascular disease, including a significant proportion of patients with critical limb ischemia (17%), diabetes (39%), and single-vessel outflow (26%). The mean lesion length was 9.0 ± 4.3 cm. Ninety-nine percent of patients were available for 12-month follow-up, including duplex imaging in 90% and arteriography in 83%. Clinical improvement, defined as a sustained decrease in Rutherford-Becker clinical category, was achieved in 80% of patients. Primary patency (freedom from ≥50% in-stent restenosis) was 94 ± 2.3% and 68 ± 4.6% at 6 and 12 months, respectively. Plain radiographic examination of 122 implanted devices at 12 months revealed no evidence for stent fracture. The everolimus-eluting self-expanding nitinol stent can be successfully implanted in patients with severe peripheral arterial disease with favorable outcomes and clinical improvements observed in the majority of patients.

Pushing the limits forward: Transradial superficial femoral artery stenting

Percutaneous revascularization of superficial femoral artery (SFA) is increasingly carried out to treat patients with peripheral vascular disease and either intermittent claudication or critical limb ischemia. Transradial vascular access is increasingly adopted for invasive procedures due to reduced access-site complications and improved patient's comfort, compared with transfemoral. However, compared with coronary interventions, the adoption of transradial access in peripheral procedures is limited. Concerning SFA interventions, transradial access is usually prevented by the distance between the vascular access and the target lesion, which extends over the length of the currently available devices. Thanks to technical improvements, resulting in specifically dedicated low-profile equipment with adequate shaft length availability, transradial access is now feasible for the treatment of selected SFA lesions. We report the first two cases of SFA stenting performed by transradial access with a new specifically developed self-expanding nitinol stent with extended delivery system length. This report suggests that, with proper technique and specifically dedicated equipment, transradial SFA stenting is feasible. Treatment of SFA disease by transradial route, allowing for immediate post-procedure walking and simultaneous bilateral interventions, may represent an alternative for effective treatment of selected patients with SFA lesions.

Final Results of the Protected Superficial Femoral Artery Trial Using the FilterWire EZ System

The purpose of this study was to evaluate the safety and efficacy of debris-capture for distal protection using the FilterWire EZ Embolic Protection System (Boston Scientific, Mountain View, CA) with the additional aim to further define the incidence of distal embolization during superficial femoral artery (SFA) interventions. A prospective, single-centre registry was designed to evaluate the performance of the FilterWire EZ in capturing debris during standard SFA percutaneous intervention. The PRO-RATA study included 30 patients suitable for PTA (Fontaine IIb to III or Rutherford I to II classification). The primary end points were occurrence of distal embolization or decreased runoff, improvement in ankle-brachial index ankle-brachial index (ABI) after the procedure, and number of filters containing emboli. Secondary end points included major adverse events (i.e., procedure- or device-related death and/or clinical target lesion revascularisation), device delivery, deployment success, and incidence of embolic recovery (patients with device success exhibiting embolic protection in the filter). Procedural success was determined as ≤30% residual stenosis with no worsening of distal runoff as determined on angiography. A total of 29 patients (age 66.2 ± 12 years; total no. of limbs = 30; total no. of lesions = 30) suitable for PTA were enrolled in the study between February 2007 and March 2008. There were 26 patients with claudication (Fontaine IIB) and 3 patients with stage IV peripheral vascular disease. In one patient, lesions in both legs were treated. No procedural or device-related complications occurred. The average degree of stenosis was 86 ± 7%. Stenosis length ranged from 8 to 88 mm. The average degree of residual stenosis was 10 ± 10%. ABI improved from 0.56 ± 0.16 to 0.92 ± 0.19 (P < 0.05). No restenosis or dissection was seen at 1-month ultrasound follow-up. Macroscopic debris was found in 27 of 30 filters of all distal protection devices used in all 29 patients. Debris particle size ranged from 90 to 2000 μm (1200 ± 640). Histological debris analysis showed platelets, erythrocytes, inflammatory cells, extracellular matrix, and cholesterol as being the major components of emboli. Additional immunochemistry showed no correlation between lesion morphology and debris components. The FilterWire EZ is easy and safe to handle. The system caused no complications. In all cases, macroscopic debris was captured. Using a distal protection device during femoropopliteal interventions has the potential to prevent migration of debris, which may be important for high-risk patients with limited distal runoff.

Predictors of failure and success of tibial interventions for critical limb ischemia

The efficacy of tibial artery endovascular intervention (TAEI) for critical limb ischemia (CLI) and particularly for wound healing is not fully defined. The purpose of this study is to determine predictors of failure and success for TAEI in the setting of CLI. All TAEI for tissue loss or rest pain (Rutherford classes 4, 5, and 6) from 2004 to 2008 were retrospectively reviewed. Clinical outcomes and patency rates were analyzed by multivariable Cox proportional hazards regression and life table analysis. One hundred twenty-three limbs in 111 patients (62% male, mean age 74) were treated. Sixty-seven percent of patients were diabetics, 55% had renal insufficiency, and 21% required hemodialysis. One hundred two limbs (83%) exhibited tissue loss; all others had ischemic rest pain. All patients underwent tibial angioplasty (PTA). Tibial excimer laser atherectomy was performed in 14% of the patients. Interventions were performed on multiple tibial vessels in 20% of limbs. Isolated tibial procedures were performed on 50 limbs (41%), while 73 patients had concurrent ipsilateral superficial femoral artery or popliteal interventions. The mean distal popliteal and tibial runoff score improved from 11.8 ± 3.6 to 6.7 ± 1.6 (P < .001), and the mean ankle-brachial index increased from 0.61 ± 0.26 to 0.85 ± 0.22 (P < .001). Surgical bypass was required in seven patients (6%). The mean follow up was 6.8 ± 6.6 months, while the 1-year primary, primary-assisted, and secondary patency rates were 33%, 50%, and 56% respectively. Limb salvage rate at 1 year was 75%. Factors found to be associated with impaired limb salvage included renal insufficiency (hazard ratio [HR] = 5.7; P = .03) and the need for pedal intervention (HR = 13.75; P = .04). TAEI in an isolated peroneal artery (odds ratio = 7.80; P = .01) was associated with impaired wound healing, whereas multilevel intervention (HR = 2.1; P = .009) and tibial laser atherectomy (HR = 3.1; P = .01) were predictors of wound healing. In patients with tissue loss, 41% achieved complete closure (mean time to healing, 10.7 ± 7.4 months), and 39% exhibited partial wound healing (mean follow up, 4.4 ± 4.8 months) at last follow up. Diabetes, smoking, statin therapy, and revascularization of > 1 tibial vessel had no impact on limb salvage or wound healing. Re-intervention rate was 50% at 1 year. TAEI is an effective treatment for CLI with acceptable limb salvage and wound healing rates, but requires a high rate of reintervention. Patients with renal failure, pedal disease, or isolated peroneal runoff have poor outcomes with TAEI and should be considered for surgical bypass.

Long-Term Results of Open Versus Endovascular Revascularization of Superficial Femoral Artery Occlusive Disease: A Case-Control Series

Introduction: We performed a case-control comparison of long-term results of femoral-popliteal bypass and superficial femoral artery (SFA) endovascular interventions to examine characteristics of patients and procedures to optimize results. Methods: Femoral-popliteal bypasses and SFA interventions performed for consecutive patients with symptoms (Rutherford 3 to 6) between 2001 and 2008 were reviewed. Time-dependent outcomes were assessed with Kaplan-Meier survival analyses. Log-rank analyses, univariate, and multivariate analyses were performed. Results: During the study period, 152 limbs in 141 patients (66% male; mean age, 66 ± 22 years) underwent femoral-popliteal bypass; 233 limbs in 204 patients (49% male; mean age, 70 ± 11 years) underwent SFA intervention. Surgery was performed less commonly for claudication (46% vs 56%) and more commonly for critical ischemia (54% vs 44%). Six-year primary, primary assisted, and secondary patency rates were 56%, 64%, and 75%, respectively, for bypass patients and 40%, 67%, and 85%, respectively, for SFA interventions. Six-year limb salvage was 80% for surgery and 92% for SFA interventions. Complications occurred in 21% of the surgery group and in 1.2% of the endovascular group. Reintervention was required in 24% of surgery patients and in 14% of endovascular patients. Failure of SFA intervention led to bypass in 5% of patients; however, prior failed intervention did not change the target artery. Predictors of failure for surgery and SFA interventions were female gender, diabetes, creatinine >1.8 mg/dL, and critical limb ischemia; however, limb salvage was no different for all groups. Conclusions: Although long-term patency and limb salvage were equivalent, reinterventions and complications occurred at a higher rate in the surgery group. Patients with critical limb ischemia, diabetes, or renal failure had decreased patency with both treatments; however, limb salvage was not disadvantaged for any group. SFA stent placement should therefore be the initial therapy for patients with SFA occlusive disease.

Balloon angioplasty versus stenting with nitinol stents in intermediate length superficial femoral artery lesions

Recent randomized trials investigating stent implantation compared with balloon angioplasty for treatment of superficial femoral artery (SFA) disease have given divergent results in short (mean 5 cm) and intermediate (mean 10 cm) lesions. We reinvestigated whether primary nitinol stenting is associated with a morphologic and clinical benefit when compared with percutaneous transluminal angioplasty with optional stenting (PTA) in intermediate-length lesions. We randomly assigned 73 patients with severe claudication or chronic limb ischemia and average 8 cm long (range 3-20 cm) SFA stenosis or occlusion to primary stent implantation (n = 34) or PTA (n = 39). Restenosis >50% and clinical outcome were assessed at 3, 6, and 12 months postintervention. Average length of the treated segments was 98 + or - 54 mm and 71 + or - 43 mm in the stent and PTA groups (P = 0.011), respectively. In the PTA group, secondary stenting was performed in 10 of 39 patients (26%) due to a suboptimal result after balloon dilation. Restenosis rates in the stent and PTA groups were 21.9% versus 55.6% (P = 0.005) at 6 months by CT-angiography, and 2.9% versus 18.9% (P = 0.033), 18.2% versus 50.0% (P = 0.006), and 34.4% versus 61.1% (P = 0.028) at 3, 6, and 12 months by sonography, respectively. Clinically, patients in the stent group reported a significantly higher maximum walking capacity compared with the PTA group at 6 and 12 months. In this randomized multicenter trial, primary stenting with a self-expanding nitinol stent for treatment of intermediate length SFA disease resulted morphologically and clinically superior midterm results compared with balloon angioplasty with optional secondary stenting.

Implications of In Situ Thrombosis and Distal Embolization during Superficial Femoral Artery Endoluminal Intervention

Endoluminal therapy for superficial femoral artery (SFA) occlusive disease is commonplace, but the incidence and outcomes of in situ thrombosis (IST) and distal embolization (DE) have not been well defined. The aim of this study was to examine the impact of IST and DE on long-term outcomes of SFA interventions. A database of patients undergoing endovascular treatment of the SFA was queried. Patients who developed either IST treated by pharmacomechanical lytic therapy or DE were selected and compared to those without either event (control). Kaplan-Meier survival analyses were performed to assess time-dependent outcomes, with 2-year outcomes reported. Factor analyses were performed using a Cox proportional hazard model for time-dependent variables. There were 818 limbs that underwent endovascular treatment for symptomatic SFA disease (59% for claudication and 41% rest pain and tissue loss). In the control group, 69% underwent angioplasty, 16% underwent primary stenting, and 15% underwent laser/directional atherectomy. In the IST group, these numbers were 41%, 28%, and 31%, respectively, while in the DE group they were 35%, 32%, and 33%, respectively. Overall the rates were 7.3% with 3.5% suffering IST (all treated with lytic therapy) and 3.8% suffering DE (68% treated percutaneously and the remainder treated by embolectomy). Females were more likely to experience either event. Compared to the control group, only one-third of the patients who suffered DE had primary angioplasty, while the remainder underwent primary stenting or laser/directional atherectomy. There was no difference in primary, assisted primary, or secondary patency rates between the control and DE groups. DE resulted in significantly lower limb salvage (87 + or - 2% vs. 68 + or - 8%, control vs. DE, p<0.05) and freedom from recurrent symptoms (73 + or - 2% vs. 69 + or - 8%, control vs. DE, p<0.05), while IST treated with lytic therapy was associated with lower patency (67 + or - 2% vs. 37 + or - 6% primary, 77 + or - 2% vs. 41 + or - 9% assisted primary, and 79 + or - 2% vs. 44 + or - 9%, secondary, control vs. IST, p<0.01). There was no difference in outcomes based on whether surgical or percutaneous therapy was used to treat DE. While preoperative tibial runoff did not influence limb loss after DE, it was significantly associated with decreased patency after IST. DE during SFA interventions is associated with limb loss independently of preoperative runoff and subsequent intervention while the use pharmacomechanical lytic therapy for IST is associated with loss of patency but equivalent limb salvage and freedom from recurrent symptoms.

Impact of Chronic Kidney Disease on Outcomes of Superficial Femoral Artery Endoluminal Interventions

While aggressive endoluminal therapy for superficial femoral artery (SFA) occlusive disease is commonplace, the implications of chronic kidney disease (CKD) on long-term outcomes in this population are unclear. We examined the consequences of endovascular treatment of the SFA in patients with and without varying stages of CKD. A database of patients undergoing endovascular treatment of the SFA between 1986 and 2007 was queried, and two groups were defined: estimated glomerular filtration rate (eGFR) <or=60 and >60 mL/min/1.73 cm(2). Intention-to-treat analysis was performed. Results were standardized to TransAtlantic Inter-Society Consensus (TASC-II) and Society for Vascular Surgery criteria. Kaplan-Meier analyses were performed to assess time-dependent outcomes. Factor analyses were performed using a Cox proportional hazard model for time-dependent variables. Data are presented as mean +/- standard deviation where appropriate. There were 525 limbs in 535 patients (68% male, average age 66 +/- 14 years) that underwent endovascular treatment for claudication or chronic critical limb ischemia (51%). Patients with eGFR <or=60 were older and had significantly more coronary artery disease, congestive heart failure, diabetes mellitus, and hyperlipidemia. TASC-II lesion distribution was equivalent (37% for TASC-II C and D), but tibial runoff was significantly worse in the eGFR <or=60 group. In addition, there were more inflow and outflow interventions in the eGFR <or=60 group. In patients with claudication, there was no difference in patency or limb salvage between those with eGFR <or=60 and >60. In patients with critical limb ischemia, there was no difference in patency between those with eGFR <or=60 and >60. Limb salvage was worse in patients with eGFR <or=60 compared to eGFR >60. With respect to limb salvage, six factors were significantly associated with a reduction in rates: presence of tissue loss at presentation (relative risk [RR] = 6.45, p = 0.003), 0 or 1 vessel tibial runoff (RR = 2.56, p < 0.01), progression of distal disease noted in follow-up (RR = 4.62, p < 0.01), embolization at the initial intervention (RR = 2.70, p < 0.05), diabetes mellitus (RR = 3.71, p < 0.01), and a history of congestive heart disease (RR = 2.42, p < 0.01). Notable factors that were not significantly associated included lesion calcification (p = 0.64), TASC C or D lesion categorization (p = 0.99), acute occlusion at initial intervention (p = 0.40), and adjuvant stenting (p = 0.67). CKD does not impact the patency of SFA interventions. Limb salvage in patients with critical ischemia is significantly worse when the eGFR is <or=60 mL/min/1.73 cm(2).

Atherosclerotic Peripheral Vascular Disease Symposium II

Percutaneous intervention for peripheral artery disease has evolved from balloon angioplasty for simple focal lesions to multimodality techniques that enable treatment of severe arterial insufficiency. This technological expansion comes without a standard approach or algorithm, which makes the decision-making process more subjective than objective. Nevertheless, clinical tools are available that can have a favorable effect on patient care, and these promote usage. So, when are standard endovascular techniques (such as balloon and stents) good enough, and when are the latest advances (eg, atherectomy, drug-eluting stents) more appropriate? This section will address these questions for acute limb ischemia (ALI) and chronic critical limb ischemia (CLI). It will also delineate the problem of restenosis, particularly of the superficial femoral artery (SFA), and describe treatment alternatives. The discussion will review the role of drug-eluting stents, atherectomy devices, reentry catheters, and brachytherapy, as well as their potential complications and appropriate remedies. Treatment algorithms for aortoiliac and infrainguinal disease are provided in Figures 1 through 3⇓⇓. Figure 1. Treatment algorithm for acute lower-limb ischemia. *Short infusion of thrombolytic therapy proximal to occlusion can be used to facilitate wire traversal. Figure 2. Simplified treatment algorithm for symptomatic aortoiliac disease in patients deemed candidates for revascularization. In patients with multilevel disease, the aortoiliac segment should be addressed first. TASC indicates TransAtlantic Inter-Society Consensus; AI, aortoiliac; PTA, percutaneous transluminal angioplasty; PE, physical examination; ABI, ankle-brachial index; and U/S, ultrasound. Figure 3. Simplified treatment algorithm for symptomatic infrainguinal peripheral arterial disease, assuming concomitant aortoiliac disease has been treated and the patient is an acceptable candidate for revascularization. *Alternative therapies to PTA include cryotherapy, atherectomy (directional, rotational, ablative), and cutting balloon. †Alternative stent options include stent (graft, balloon expanding, and self expanding) and drug-eluting stent. PTA indicates percutaneous transluminal angioplasty; TASC, TransAtlantic Inter-Society Consensus; PE, physical examination; …

Endovascular Superficial Femoral Artery Treatment: Can it Be as Good as Bypass?

Care of the vascular patient has changed drastically during the last decade, with the introduction of endovascular therapies. Medical management and open surgical bypass have been the traditional options for superficial femoral artery (SFA) occlusive disease. Endovascular revascularization of the SFA, however, has been increasingly utilized during the past decade. Results of endovascular interventions for SFA stenoses and/or occlusions have been mixed. In addition, several different techniques have been developed to address similar lesions. This added complexity makes it difficult to compare endovascular therapies to surgical bypass. This review will discuss the difficulties in comparing open and endovascular therapies as well as outcomes of endovascular therapies. Finally, the role of endovascular interventions for SFA lesions in the future will be discussed.

Transradial Intervention of Iliac and Superficial Femoral Artery Disease is Feasible

Percutaneous intervention of iliac artery (IA) and superficial femoral artery (SFA) disease is often performed via ipsilateral or contralateral femoral access. However, this approach may be difficult in patients with severe iliac or common femoral artery atherosclerosis, morbid obesity, or conditions prohibiting prolonged bed rest. Percutaneous transradial coronary intervention has gained popularity due to the low frequency of access site complications, early ambulation, and perhaps cost savings with early discharge. Transradial intervention (TRI) of IA and SFA disease has been previously described only in anecdotal case reports. Out of 159 patients who underwent IA and SFA intervention, 15 had their intervention attempted via the radial artery. TRI was attempted at the operator's discretion for one of the following reasons: absent femoral pulses, severe bilateral IA disease, obesity, or conditions prohibiting prolonged supine rest. Clinical and procedural characteristics were collected retrospectively. Fourteen patients (93%) had successful intervention completed through the transradial approach. One patient needing an intervention of the distal SFA was converted to contralateral femoral approach because of the inadequate stent shaft length. Eighteen IA lesions and six SFA lesions were treated successfully with a good final angiographic result via a 6 FR radial access system. The ankle brachial index improved from a mean of 0.66 to 0.93. None of the patients had any procedural or access site-related complications. TRI is a feasible and safe alternative for percutaneous treatment of IA and SFA disease in carefully selected patients.

Impact of runoff on superficial femoral artery endoluminal interventions for rest pain and tissue loss

While aggressive endoluminal therapy for superficial femoral artery (SFA) occlusive disease is commonplace, the implications of runoff on long-term outcomes of these interventions in patients with rest pain and tissue loss is unclear. Runoff is known to negatively effect graft patency. The aim of this study is to examine the impact of distal runoff on long-term outcomes of SFA interventions for critical ischemia. A prospective database of patients undergoing endovascular treatment of the SFA between 1986 and 2007 was queried. Patients with Rutherford symptom classification 4, 5, and 6 were selected. Patients with concomitant tibial interventions were excluded. Pre-operative angiograms were reviewed in all cases to assess distal popliteal and tibial runoff and were scored according to modified Society of Vascular Surgery criteria for both vessels such that a higher score implies worse runoff (minimum 1 and maximum 19). Three runoff score groups were identified: <5 (good), 5-10 (compromised), and >10 (poor). Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Multivariate and factor analyses were performed. Three hundred six limbs in 241 patients (57% male, mean age 68 years) underwent endovascular treatment for critical ischemia (44% rest pain and 56% tissue loss.) Technical success was 96% with 61% SFA undergoing angioplasty, 37% SFA primary stenting and 2% SFA an atherectomy. Overall mortality was 1% and overall morbidity was 16% at 90 days after the procedure. At 5 years, vessels with compromised and poor runoff had significantly worse cumulative patency (82 +/- 9%, 56 +/- 4%, and 52 +/- 7% for good, compromised, and poor runoffs, respectively, mean +/- standard error of the mean [SEM]). Freedom from recurrent symptoms (65 +/- 8%, 39 +/- 9%, and 18 +/- 9% for good, compromised, and poor runoffs, respectively) and limb salvage (65 +/- 5%, 41 +/- 4%, and 20 +/- 6% for Good, Compromised, and Poor runoffs, respectively) were incrementally curtailed by worsening runoff with significant decreases as runoff category deteriorated. In patients presenting with rest pain and tissue loss who are treated with SFA percutaneous interventions, patency is negatively affected by compromised and poor runoffs in keeping with the bypass literature. More importantly, freedom from recurrent symptoms and limb salvage are incrementally curtailed as runoff scores worsen. These findings are consistent with the bypass literature.

Percutaneous Superficial Femoral Artery Interventions for Claudication—Does Runoff Matter?

Endoluminal therapy for superficial femoral artery (SFA) occlusive disease for claudication is commonplace, but the implications of tibial vessel runoff on long-term outcomes of these interventions in patients with claudication are unclear. Runoff is known to negatively affect graft patency, but no data are available on the impact of runoff on percutaneous SFA interventions and their implications during follow-up. We examined the impact of distal popliteal and tibial runoff on long-term outcomes of SFA interventions for claudication. A prospective database of patients undergoing endovascular treatment of the SFA between 1986 and 2007 was queried. Patients with Rutherford symptom classifications 1, 2, and 3 were selected; those with concomitant tibial interventions were excluded. Angiograms were reviewed preoperatively in all cases to assess distal popliteal and tibial runoff and scored according to modified Society for Vascular Surgery criteria for both vessels such that a higher score implies worse runoff (minimum 1, maximum 19). Three run-off score groups were identified: <5 (good), 5-10 (compromised), and >10 (poor). Kaplan-Meier survival analyses were performed to assess time-dependent outcomes. Multivariate and factor analyses were performed. There were 481 limbs in 347 patients (70% male, average age 66 years) that underwent endovascular SFA treatment for claudication: 87% had hypertension, 51% had diabetes mellitus, 67% had hyperlipidemia, and 16% had chronic renal insufficiency (1% on hemodialysis). Technical success was 92%, with 63% SFA undergoing angioplasty, 26% SFA undergoing primary stenting, and 3% SFA undergoing atherectomy. Overall mortality was 1.1% and overall morbidity was 17% at 90 days after the procedure. At 5 years, vessels with compromised and poor runoff had significantly lower freedom from recurrent symptoms and lower freedom from restenosis. Primary and assisted primary patency rates were significantly worse in patients with poor runoff. However, secondary patency was equivalent between the groups. Compromised or poor runoff was associated with incremental lower limb salvage. Following SFA percutaneous interventions for claudication, runoff can identify patients more likely to develop restenosis and recurrent symptoms and, more importantly, those at higher risk of limb loss. Defining such subgroups allows a clear risk stratification of patients with claudication and can guide the intensity of surveillance in the outpatient setting.

Contemporary outcomes after superficial femoral artery angioplasty and stenting: The influence of TASC classification and runoff score

A recent randomized trial suggested nitinol self-expanding stents (SES) were associated with reduced restenosis rates compared with simple percutaneous transluminal angioplasty (PTA). We evaluated our results with superficial femoral artery (SFA) SES to determine whether TransAtlantic InterSociety Consensus (TASC) classification, indication for intervention, patient risk factors, or Society of Vascular Surgery (SVS) runoff score correlated with patency and clinical outcome, and to evaluate if bare nitinol stents or expanded polytetrafluoroethylene (ePTFE) covered stent placement adversely impacts the tibial artery runoff. A total of 109 consecutive SFA stenting procedures (95 patients) at two university-affiliated hospitals from 2003 to 2006 were identified. Medical records, angiographic, and noninvasive studies were reviewed in detail. Patient demographics and risk factors were recorded. Procedural angiograms were classified according to TASC Criteria (I-2000 and II-2007 versions) and SVS runoff scores were determined in every patient; primary, primary-assisted, secondary patency, and limb salvage rates were calculated. Cox proportional hazard model was used to determine if indication, TASC classification, runoff score, and comorbidities affected outcome. Seventy-one patients (65%) underwent SES for claudication and 38 patients (35%) for critical limb ischemia (CLI). Average treatment length was 15.7 cm, average runoff score was 4.6. Overall 36-month primary, primary-assisted, and secondary rates were 52%, 64%, and 59%, respectively. Limb salvage was 75% in CLI patients. No limbs were lost following interventions in claudicants (mean follow-up 16 months). In 24 patients with stent occlusion, 15 underwent endovascular revision, only five (33%) ultimately remained patent (15.8 months after reintervention). In contrast, all nine reinterventions for in-stent stenosis remained patent (17.8 months). Of 24 patients who underwent 37 endovascular revisions for either occlusion or stenosis, eight (35%) had worsening of their runoff score (4.1 to 6.4). By Cox proportional hazards analysis, hypertension (hazard ratio [HR] 0.35), TASC D lesions (HR 5.5), and runoff score > 5 (HR 2.6) significantly affected primary patency. Self-expanding stents produce acceptable outcomes for treatment of SFA disease. Poorer patency rates are associated with TASC D lesions and poor initial runoff score; HTN was associated with improved patency rates. Stent occlusion and in-stent stenosis were not entirely benign; one-third of patients had deterioration of their tibial artery runoff. Future studies of SFA interventions need to stratify TASC classification and runoff score. Further evaluation of the long-term effects of SFA stenting on tibial runoff is needed.

Surgical implications of early failed endovascular intervention of the superficial femoral artery

It is generally accepted that failed infrainguinal bypass with prosthetic material significantly compromises arterial run off, which may limit future revascularization. It is well known that the negative consequences of early vein graft thrombosis are limited, but the effect of failed peripheral angioplasty on the distal vasculature is poorly studied. The purpose of this study was to determine whether early failure after superficial femoral artery intervention influences subsequent revascularization options. Between July 1, 1998, and June 30, 2006, 276 patients underwent endovascular intervention of the superficial femoral artery. A prospective analysis of angiograms done before the intervention and after early failure (<or=200 days) was performed in a blinded fashion by three attending vascular surgeons to determine the optimal distal bypass site if an operation were to be performed. Inter-rater reliability of the angiogram scores was assessed using the Fleiss generalized kappa for multiple raters. Potential distal anastomotic sites were classified as above knee popliteal, below knee popliteal, tibial, or no adequate site. A consensus classification was determined for each patient (2 of 3 raters). Of the 276 patients who underwent endovascular intervention of the superficial femoral artery, early failure was noted in 24 limbs in 23 patients. Angiographic records were available for 21 limbs in 20 patients (60% men; mean age, 65.3 +/- 11.3 years), of which 60% had critical limb ischemia, 40% had claudication, and 65% had diabetes. The distal bypass site was altered in six limbs (28.6%); four from popliteal to tibial and two from above knee to below knee popliteal. Inter-rater reliability was 0.54 (moderate/good). The procedures performed on these early failures were percutaneous transluminal angioplasty +/- stent (n = 14), infrainguinal bypass (n = 5), and no treatment (n = 1). Only 0.4% (1 of 276) of patients required major limb amputation due to early failure of a superficial femoral artery intervention. Early failure after isolated endovascular intervention of the superficial femoral artery is infrequent and alters the distal target in 30% of early-failure patients if open bypass is planned. Salvage with repeat angioplasty, if necessary, can be accomplished in most patients, and the need for limb amputation is exceedingly rare. The early failure results in this study support a more liberal application of endovascular intervention to the superficial femoral artery in patients with lower extremity ischemia, especially claudication. The repercussions of late endovascular failure as well as the effects of disease progression need further study.

Incidence and clinical significance of distal embolization during percutaneous interventions involving the superficial femoral artery

Distal embolization of plaque or thrombus may cause organ ischemia following percutaneous peripheral interventions. The purpose of this study was to evaluate the incidence and clinical significance of particulate embolization during percutaneous superficial femoral artery (SFA) intervention by monitoring with continuous Doppler ultrasound. The rate and timing of embolization at various phases of intervention such as guidewire crossing, balloon angioplasty, stent deployment, and directional atherectomy were analyzed and compared. Sixty patients underwent SFA intervention. Of these 60 patients, 10 patients underwent percutaneous transluminal angioplasty (PTA) alone, 40 patients underwent PTA with stenting, and 10 patients underwent plaque excision with the SilverHawk atherectomy device (8) or Spectranetics excimer laser (2) with or without additional PTA or stent placement. A 4-MHz Doppler probe was used for continuous monitoring in the ipsilateral popliteal artery. Distal embolization was registered as embolic signals (ES). ES were quantitatively assessed during critical portions of the procedure including guidewire crossing, balloon angioplasty, stent deployment and/or atherectomy. ES during different phases of intervention were compared using analysis of variance (ANOVA). ES was noted in every patient during wire crossing, angioplasty, stent deployment and atherectomy. The average number of ES noted during guidewire crossing was 8, PTA was 12, stent deployment was 28, SiverHawk atherectomy was 49, and Spectranetics excimer laser was 51. The frequency of ES was statistically higher during stent deployment vs wire crossing or balloon angioplasty but equivalent to that generated by plaque excision. ES was observed more frequent during balloon angioplasty than during wire crossing. In one patient who was treated with the excimer laser, a single runoff vessel was occluded with embolic debris but patency was restored angiographically after thrombolysis. The patient went on to require below knee amputation. During follow-up, all patients with claudication reported improved symptoms and those with ulcers or gangrene demonstrated healing. The average increase in ankle-brachial index following intervention was 0.31. While ES were recorded at each step of SFA intervention, the frequency was greatest during stent deployment. Despite the frequency of these events, only one patient developed angiographically and clinically significant embolization. Thus, our findings do not support the routine use of protection devices during percutaneous SFA intervention.

Sustained benefit at two years of primary femoral-popliteal stenting compared with balloon angioplasty with optional stenting

Conclusions: At 2 years, there is a sustained morphologic benefit for treatment of superficial femoral artery (SFA) obstructions using self-expanding nitinol stents inserted primarily vs balloon angioplasty with optional stenting. There was no statistically significant clinical benefit in primary stenting vs optional stenting at 2 years. Summary: The authors previously published data from the angioplasty vs stenting with nitinol stents in the superficial femoral artery (ABSOLUTE) trial. At 1 year, there was benefit from primary stenting vs optional stenting (N Engl J Med 2006;354:1879-88). The authors now report 2-year data on restenosis and clinical outcomes of the original patient group. There were 104 patients with clinical limb ischemia and SFA occlusions originally entered into the study. At 2 years, 98 patients (94%) were available for assessment of restenosis (>50% by duplex ultrasound imaging) and for assessment of clinical and hemodynamic outcome using ankle-brachial index and treadmill walking distance. At 2 years, by an intention to treat analysis, restenosis rates were 45.7% (21 of 46) in the primary stenting group vs 69.9% (36 of 52) in the optional stenting group (P = .031). Primary and secondary (n = 63) stenting were both superior to plain balloon angioplasty (n = 35) with respect to the occurrence of restenosis (49% vs 74.3%; P = .028) using a treatment-received analysis. There was no statistical benefit in the primary stent group towards better treadmill walking (average 302 vs 196 m; P = .12) or any significant improvement in ankle-brachial index values in the primary stented vs optional stented group (average, 0.88 vs 0.78; P < .09). There was no difference in intervention rate in the primary stenting (17 of 46 [37.0%]) vs optional stenting group (28 of 52 [53.8%]; P = .14). Comment: The authors put a favorable spin on their data by emphasizing a “trend” towards improved clinical benefit with primary vs optional stenting. Nevertheless, statistically insignificant is still statistically insignificant. Although larger numbers may have shown improvement in clinical benefit with primary stenting vs optional stenting, a 45% restenosis rate in stented patients at 2 years without clear clinical benefit indicates percutaneous treatment of SFA occlusive lesions is still not very good treatment of SFA occlusive lesions.