Journal of Vascular Surgery
Volume 47, Issue 3 , Pages 562-565, March 2008

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

Presented at the Society for Vascular Surgery Meeting, Baltimore, Md, Jun 7-10, 2007.

Academic Department of Surgery, Greenville Hospital System University Medical Center, Greenville, SC.

Received 23 July 2007; accepted 12 November 2007.

Article Outline

Background

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.

Methods

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 (≤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 κ 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).

Results

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.

Conclusions

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.

 

Many surgeons are hesitant to operate on claudication because of its relatively benign clinical course and the concern that bypass failure can result in a clinical problem more severe than the initial presentation. Endovascular therapy for lower extremity ischemia has experienced increased popularity within the past two decades owing to its favorable risk/benefit ratio and the appreciation that patients without autogenous conduit can be revascularized and avoid the infection risks of synthetic grafts.1, 2, 3, 4, 5

The benefits of endovascular intervention include a minimally invasive, percutaneous approach, shorter patient hospital stay, and earlier patient return to normal activities.2, 6, 7, 8, 9 Long-term patency of angioplasty is inferior to bypass, however, and the subsequent consequences of failed angioplasty are unclear. The few studies that have examined treatment options and outcomes after endovascular failure provide conflicting evidence. Some studies suggest that future revascularization options are altered and subsequent bypass results are worse than expected after failed endovascular therapy; others report no detrimental anatomic effects on future revascularization.10, 11, 12, 13, 14

The purpose of this study is to evaluate the anatomic effects of early failure after isolated endovascular intervention of the superficial femoral artery and to examine the need for, and outcome of, subsequent revascularization.

Back to Article Outline

Methods 

The prospective vascular database of the Greenville Hospital System University Medical Center showed that between July 1, 1998, and June 30, 2006, 276 patients underwent isolated endovascular intervention of the superficial femoral artery; 154 were for claudication, and 122 were for critical limb ischemia (CLI). Technical or clinical failure ≤200 days of intervention was identified in 23 limbs in 23 patients and defined as an early failure. Of these, 21 limbs in 20 patients were evaluated with arteriography and were available for follow-up. Limbs presented with either symptoms of ischemia requiring reintervention (n = 19), a clinical suspicion and arteriographic confirmation of superficial femoral artery restenosis (n = 1), or severe ischemia requiring major limb amputation (n = 1). The mean follow-up for the early-failure patients was 475 days (range, 137-2171 days); no patients in this group were lost to follow-up.

In the early-failure patients, all but one endovascular procedure was performed in a fixed interventional suite within the operating room or radiology department. Access was obtained through the contralateral common femoral artery in a retrograde fashion when possible. Stenosis and occlusion were traversed intraluminally in most cases. Two of the initial revascularizations were performed with subintimal techniques. Laser-assisted angioplasty (n = 3) and cryotherapy (n = 1) were used sparingly. Two patients underwent thrombolysis before the initial revascularization. The follow-up interval and modality was at the discretion of the primary vascular attending, with typical practice being every 3 months with arterial duplex ultrasound imaging and ankle-brachial indices.

A prospective study was performed to examine the impact of angioplasty failure on the distal run off beds of the affected limbs. The preintervention and postfailure arteriograms were analyzed by three attending vascular surgeons in a blinded fashion to determine the distal bypass targets most suitable for distal anastomosis if bypass were to be performed. The distal anastomotic sites were classified as above knee (AK) popliteal, below knee (BK) popliteal, or tibial. If the chosen target was not unanimous, the consensus choice (2 of 3) was used. Inter-rater reliability of the angiogram scores was assessed using the Fleiss generalized κ for multiple raters.

Clinical outcome for patients who underwent reintervention was examined using the vascular registry database. Life-table analysis was used to estimate survival functions for the time dependent outcomes of secondary patency, limb loss, death, and amputation-free survival. The differences in the curves were assessed using the log-rank test. All statistical measures were performed using SAS 9.1.3 software (SAS Institute, Cary, NC).

Back to Article Outline

Results 

Early failure occurred in only 23 of the 276 patients (8.3%) receiving isolated endovascular intervention of the superficial femoral artery. Of the 21 limbs in 20 patients available for follow-up, 19 limbs received reintervention. The mean time to reintervention was 134 days (range, 98-197 days). Demographics for the patients with failed angioplasty are listed in the Table. The clinical indication for repeat angiography was claudication for nine limbs and CLI for the other 12. Two limbs presented with indications that differed from the original presentation. In one claudicant patient, stent occlusion resulted in rest pain and the patient underwent successful bypass to the BK popliteal artery. A single patient with CLI (rest pain) with an initial occlusion of the superficial femoral artery returned with claudication after development of in-stent restenosis and was treated with repeat percutaneous transluminal angioplasty (PTA) and a stent.

Demographic and clinical information for 20 patients with early failure after superficial femoral artery angioplasty
DemographicValue
Age, mean ± SD years65.3 ± 11.3
Male, No. (%)12(60)
Critical limb ischemia, No. (%)12(60)
Claudication, No. (%)8(40)
Tobacco Use, No. (%)14(70)
Diabetes, No. (%)13(65)
End-stage renal disease, No. (%)3(15)
Time to failure, mean (range) days134(77-194)

Preintervention angiographic findings included 14 occlusions and seven stenoses. Postfailure arteriographic findings showed 11 occlusions and 10 stenotic lesions. Blinded angiographic analysis of distal anastomotic target sites by the three vascular surgeon judges resulted in unanimous agreement in 12 cases and majority agreement in nine for a κ of 0.54 for inter-rater reliability, considered moderate/good agreement. After analysis, the optimal distal anastomotic site was altered in six limbs (28.6%). The preintervention and postfailure Trans-Atlantic Inter-Society Consensus (TASC) classification for the superficial femoral artery lesions are shown in Fig 1.15 There were no TASC D lesions. The area of intervention was limited to the superficial femoral artery and if necessary extended into the AK popliteal artery. No initial interventions crossed the knee joint.

The preintervention and postfailure distal bypass targets are shown graphically in Fig 2. The TASC classification after failure was unchanged in 14 limbs, worsened in three limbs, and improved in four compared with the initial lesions. Only one patient with an altered distal target presented with a more extensive TASC lesion (TASC A to TASC B). The optimal distal bypass target changed from the AK popliteal artery to the tibial artery in two limbs, from the BK popliteal artery to the tibial artery in two limbs, and from the AK popliteal artery to the BK popliteal artery in two limbs. Half of the limbs with distal anastomotic site alteration (3 of 6) developed occlusion in one runoff vessel. This occurred in only one limb (6.7%) without target alteration.

When clinical factors associated with alteration of the distal target site were examined, including age, sex, race, diabetes, indication for intervention, occlusive vs stenotic atherosclerotic lesion, and the use of a stent with the initial intervention, no factor was predictive of distal target site alteration. Although not statistically significant, patients who presented initially with CLI at the time of their superficial femoral artery angioplasty were more likely to have a change in the optimal distal anastomotic bypass site to a more distal location after failure than patients who presented with claudication (41.7% vs 11.1%, P = .18). Likewise, 36.4% of patients who presented with occlusions experienced distal anastomotic site alteration compared with 20% of patients with stenotic lesions, a difference that did not reach statistical significance.

Despite early interventional failure, salvage with repeat endovascular intervention (PTA in 2, PTA/stent in 12) was possible in 14 limbs (67%). An additional five limbs (23.8%) underwent infrainguinal bypass, one limb did not require repeat intervention, and one limb required major limb amputation secondary to severe infection after repeat PTA/stent. All five secondary bypasses were performed for CLI and included femoral to AK popliteal (n = 1), femoral to BK popliteal (n = 3), and femoral to tibial (n = 1) bypass.

In general, patients receiving secondary intervention after initial superficial femoral artery angioplasty failure fared well. Secondary patency was 58% at 60 months for patients with CLI and 89% for claudicant patients. Secondary patency (80% vs 50%) and limb salvage (86% vs 40%) were better at 60 months for patients without alteration in the distal anastomotic site; however, this too was not statistically significant.

Back to Article Outline

Discussion 

Endovascular techniques have become an accepted option for the treatment of lower extremity ischemia in many centers. Patients with and without bypass options often undergo initial attempts at endovascular revascularization before surgical therapy. Results for intervention vary by site. Distal lesions have less durable results but are being performed with increasing frequency, thus making the need for future reintervention more likely.13, 16, 17, 18, 19 Recognizing the implications of selecting an endovascular procedure for revascularization is important, particularly if the procedure could adversely effect future treatment options.

Our results differ dramatically from the results of Böckler et al,10 who studied 25 consecutive patients presenting with failed infrainguinal angioplasty with primary stenting for claudication in 19 or CLI in six. All but one patient in their study presented with CLI after endovascular failure, and 88% presented with stent occlusions. Repeat interventions for the patients in the Böckler et al series included 16 bypass grafts, 4 endarterectomies, 3 amputations, and 1 sympathectomy. The 12-month patency for bypass after endovascular failure was dramatically worse than for a cohort of patients undergoing primary bypass (33% vs 88%).10

Ryer et al11 and Galaria et al13 describe results similar to those found in our study, although they did not provide anatomic details about the distal vasculature. Postfailure bypass level and distal anastomotic site were not altered in either study. In the study by Ryer et al, however, repeat endovascular intervention was performed in 83% of endovascular failures, and postfailure bypass was more common in the study by Galaria et al. An interesting study by Lipsitz et al14 addressed the regional anatomic effects of endovascular intervention. They noted that most collateral vessels in the region of intervention are preserved after subintimal angioplasty.14 The preservation of collaterals suggests a limit to the ischemic repercussions if occlusion recurs, although this was not directly examined in their study.

Early failure after isolated intervention of the superficial femoral artery is uncommon in our experience, occurring in less than 9% of patients. Most patients return with clinical findings similar to their first presentation. Two-thirds of the patients in this study with early failure were treated with endovascular techniques, with an overall secondary patency rate of 79% at 1 year. When failure occurs, it alters the distal bypass target in 28% of cases. Restenosis typically occurs within the area of the superficial femoral artery that has been previously treated, leaving the distal anatomy preserved. Significant embolization to the distal runoff or long, progressive occlusions were not identified as the source of failure; however, the runoff vessels were altered in half of the limbs with distal anastomotic site alteration, which is much higher than in the nonaltered patients. Before intervention, significant efforts are made to identify intraluminal thrombus. In patients with occlusion, our standard technique is a “wire traversal test” to observe the passage characteristics of the wire. Easy passage with minimal resistance suggests thrombotic occlusion, and these patients undergo mechanical thrombectomy or thrombolysis, or both, before angioplasty.

The indication for intervention and the initial lesion appear to affect the repercussions of early endovascular failure, but the use of stents does not. Only one patient had stent placement into the AK popliteal artery, directly eliminating that site as a bypass site. Although small numbers prevent statistical confirmation, patients with CLI were more likely to have migration of the distal bypass site than those with claudication (41.7% vs 11.1%). The incidence of distal target site alteration was equivalent in patients with initial PTA or PTA/stent (28.6%). The distal anastomotic site was altered in 36.4% of patients presenting with occlusions and only 20% of patients with stenotic lesions. Because most of the patients in the study by Böckler et al recurred with occlusion, this may be the reason their patients appear to have worse outcomes.

The small patient sample size does place limitations on this study, and makes a type II error likely, especially when comparing patients according to indications for intervention. However, this is also a sign of the durability of superficial femoral artery intervention, given the early failure rate of only 8.3% in this study.

Back to Article Outline

Conclusion 

Early failure after endovascular intervention of the superficial femoral artery alters future bypass options in 30% of patients. Most early recurrent lesions are similar to or less extensive than the initial lesion when comparing the TASC classification and the degree of stenosis. Repeat endovascular intervention can be considered before using open surgical techniques for these early-failure patients, resulting in acceptable limb salvage. However, endovascular intervention should be considered with more caution in CLI patients with limited conduit because distal target alteration seems to be more likely in these patients and could result in a less than optimal bypass if early failure occurs. In contrast, the findings in this study support a liberal application of endovascular intervention to the superficial femoral artery in patients with claudication in regards to early failure. Additional studies are needed to assess the repercussions of delayed endovascular failure in terms of symptoms, anatomy, and future revascularization options.

Back to Article Outline

Author contributions 


Conception and design: CJ, CK, JY, ST, DC, EL

Analysis and interpretation: CJ, JY, ST, DC

Data collection: CJ, CK

Writing the article: CJ, JY, DC, ST

Critical revision of the article: CJ, JY, ST

Final approval of the article: CJ, JY

Statistical analysis: CK

Obtained funding: Not applicable

Overall responsibility: CJ

Back to Article Outline

References 

  1. Sullivan TM, Taylor SM, Blackhurst DW, Langan EM, Cull DL, Carsten CG, et al. Has endovascular surgery reduced the number of open vascular operations performed by an established surgical practice?. J Vasc Surg. 2002;36:514–519
  2. Kudo T, Chandra FA, Kwun WH, Haas BT, Ahn SS. Changing pattern of surgical revascularization for critical limb ischemia over 12 years: endovascular vs. open bypass surgery. J Vasc Surg. 2006;44:304–313
  3. Haider SN, Kavanagh EG, Forlee M, Colgan MP, Madhavan P, Moore DJ, et al. Two-year outcome with preferential use of infrainguinal angioplasty for critical ischemia. J Vasc Surg. 2006;43:504–512
  4. Anderson PL, Gelijns A, Moskowitz A, Arons R, Gupta L, Weinberg A, et al. Understanding trends in inpatient surgical volume: vascular interventions, 1980-2000. J Vasc Surg. 2004;39:1200–1208
  5. Hallett JW, Byrne J, Gayari MM, Ilstrup DM, Jacobsen SJ, Gray DT. Impact of arterial surgery and balloon angioplasty on amputation: a population-based study of 1155 procedures between 1973 and 1992. J Vasc Surg. 1997;25:29–38
  6. Wolf GL, Wilson SE, Cross AP, Deupree RH, Stason WB. Surgery or balloon angioplasty for peripheral vascular disease: a randomized clinical trial (Principal investigators and their Associates of Veterans Administration Cooperative Study Number 199). J Vasc Interv Radiol. 1993;4:639–648
  7. Holm J, Arfvidsson B, Jivegard L, Lundgren F, Lundholm K, Schersten T, et al. Chronic lower limb ischaemia (A prospective randomised controlled study comparing the 1-year results of vascular surgery and percutaneous transluminal angioplasty (PTA)). Eur J Vasc Surg. 1991;5:517–522
  8. Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, et al. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005;366:1925–1934
  9. Dosluoglu HH, O’Brien-Irr MS, Lukan J, Harris LM, Dryjski ML, Cherr GS. Does preferential use of endovascular interventions by vascular surgeons improve limb salvage, control of symptoms, and survival of patients with critical limb ischemia?. Am J Surg. 2006;192:572–576
  10. Bockler D, Blaurock P, Mansmann U, Schwarzbach M, Seelos R, Schumacher H, et al. Early surgical outcome after failed primary stenting for lower limb occlusive disease. J Endovasc Ther. 2005;12:13–21
  11. Ryer EJ, Trocciola SM, DeRubertis B, Lam R, Hynecek RL, Karwowski J, et al. Analysis of outcomes following failed endovascular treatment of chronic limb ischemia. Ann Vasc Surg. 2006;20:440–446
  12. Sandford RM, Bown MJ, Sayers RD, London JN, Naylor AR, McCarthy MJ. Is infrainguinal bypass grafting successful following failed angioplasty?. Eur J Vasc Endovasc Surg. 2007;34:29–34
  13. Galaria II, Davies MG. Percutaneous transluminal revascularization for iliac occlusive disease: long-term outcomes in TransAtlantic Inter-Society Consensus A and B lesions. Ann Vasc Surg. 2005;19:352–360
  14. Lipsitz EC, Ohki T, Veith FJ, Rhee SJ, Kurvers H, Timaran C, et al. Fate of collateral vessels following subintimal angioplasty. J Endovasc Ther. 2004;11:269–273
  15. Norgren L, Hiatt WR, Dormandy JA, Nehler MR, Harris KA, Fowkes FG. Inter-Society Consensus for the management of peripheral arterial disease (TASC II). J Vasc Surg. 2007;45(suppl S):S5–S67
  16. Kudo T, Chandra FA, Ahn SS. Long-term outcomes and predictors of iliac angioplasty with selective stenting. J Vasc Surg. 2005;42:466–475
  17. Duda SH, Bosiers M, Lammer J, Scheinert D, Zeller T, Oliva V, et al. Drug-eluting and bare nitinol stents for the treatment of atherosclerotic lesions in the superficial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther. 2006;13:701–710
  18. Surowiec SM, Davies MG, Eberly SW, Rhodes JM, Illig KA, Shortell CK, et al. Percutaneous angioplasty and stenting of the superficial femoral artery. J Vasc Surg. 2005;41:269–278
  19. Schillinger M, Sabeti S, Loewe C, Dick P, Amighi J, Mlekusch W, et al. Balloon angioplasty versus implantation of nitinol stents in the superficial femoral artery. N Engl J Med. 2006;354:1879–1888

 Competition of interest: none.

PII: S0741-5214(07)01787-9

doi:10.1016/j.jvs.2007.11.044

Journal of Vascular Surgery
Volume 47, Issue 3 , Pages 562-565, March 2008

Article Tools

* Image Usage & Resolution