Journal of Vascular Surgery
Volume 50, Issue 3 , Pages 505-509, September 2009

Iatrogenic injuries of the common femoral artery (CFA) and external iliac artery (EIA) during endograft placement: An underdiagnosed entity

Presented at the Thirty-third Meeting of the Southern Association for Vascular Surgery, Tucson, Ariz, January 14, 2009.

Division of Vascular Surgery, Maimonides Medical Center, Brooklyn, NY

Received 27 January 2009; accepted 28 March 2009. published online 13 July 2009.

Article Outline

Objective

Early limb occlusions following endovascular treatment of aorto-iliac aneurysmal disease is not uncommon (4%-13%). To assess whether the femoral artery entry site could potentially cause this complication, we prospectively evaluated the ipsilateral common femoral artery (CFA) and distal external iliac artery (EIA) with intraoperative duplex scans (IDS).

Methods

There were 134 patients with infrarenal nonruptured abdominal aorto-iliac aneurysms treated with endografts since 2002 at our institution. Age ranged from 65 to 89 years (mean: 77 ± 7 years). Aneuryx (n = 41), Zenith (n = 50), and Excluder (n = 43) endografts were used for repair. All procedures were performed via open exposure of the CFA. Introducer diameter varied from 12 mm to 22 mm. All patients underwent IDS of the CFA and distal EIA after repair of the arteriotomies.

Results

In 34 patients (25%), we documented intimal dissections causing severe (>70%) stenoses. Of the 271 arteries that were examined, 38 (14%) had abnormal findings that demanded intervention. These were repaired with flap excision, tacking sutures revision, or patch angioplasty (n = 36). Repeat IDS confirmed the adequacy of the repair. No statistical difference was noted if the site of larger introducer sheath and the incidence of flap formation. In addition, 10 small flaps or plaques were visualized but did not create significant stenosis. No differences were noted in the incidence of positive duplex exams between each type graft (P = .4). No early or late iliac limb occlusions were noted. Follow-up of 94% was obtained.

Conclusions

Completion arterial duplex scans are helpful in detecting a substantial number of clinically unsuspected technical defects caused by introducer sheaths. Timely diagnosis and repair of these defects may decrease the incidence of early limb occlusion following endograft placement.

 

Open common femoral artery exposure remains the gold standard for the introduction of large bore sheaths for access to perform endovascular repair treatment of aorto-iliac aneurysmal disease. Early limb occlusions following endograft placement is one of the most common complications of this procedure and reported in 4% to 13% of cases in the literature.1, 2, 3, 4, 5, 6 The etiology of this complication is presumed to be one of the following reasons: limb kinking, graft displacement, limited outflow, unsupported endografts, hypercoagulable state, iliac arteries tortuosity, or small size etc.1, 2, 3, 4, 5, 6 Completion arteriograms routinely performed after device deployment could detect the majority of anatomical defects that could be treated intraoperatively. However, completion arteriograms do not include imaging of the common femoral arteries (CFA). One of the potential reasons to cause an outflow obstruction and subsequent limb thrombosis could be flap or dissection of the access artery due to damage by the endograft delivery system. To assess whether the intraluminal defects of the entry site could potentially cause early limb occlusion, we prospectively evaluated bilateral CFA and distal external iliac artery (EIA) with intraoperative duplex scans (IDS).

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Methods 

Patients 

One hundred thirty-four consecutive patients (82% males) with nonruptured abdominal aorticiliac aneurysms were treated with endografts since 2002 at our institution. Patients' age ranged from 55 to 90 years (mean: 77 ± 8 years). Only two conduits were used in this series. No completion duplex was used in these two accesses.

Surgical technique 

All procedures were performed via open exposure of the CFA. Introducer sheaths diameter varied from 12 Fr to 22 Fr. After puncture of the artery in the softest palpable portion of the vessel with an 18 G stainless steel arterial entry needle, a metal J-wire was placed. Simple dilation was used for placement of the sheath. There were three types of endografts used in this series. Forty-one patients (31%) were treated with AneuRx devices (Medtronic, Minneapolis, Minn), 50 (37%) with Zenith (Cook, Bloomington, Ind), and the remaining 43 (32%) with Excluder (Gore, Flagstaff, Ariz). Primary repair with transverse interrupted 6-0 prolene sutures was used to close the artery, and patch repair with a Dacron patch was used if completion duplex revealed a significant defect.

Intraoperative duplex scans 

All patients underwent IDS of bilateral CFA and distal EIA after repair of the arteriotomies. Care was taken to include site of the primary repair of the actual entry site, the proximal and distal artery, and any clamp sites. An ATL HDI 5000 scanner with a SonoCT feature (Phillips, Bothell, Wash) operated by a registered vascular technologist was used in all cases. An intraoperative CL10-5 MHz or CL 15-7 MHz “hockey stick” transducer inserted in a sterile latex cover filled with acoustic gel was used by the vascular surgeon to insonate the arterial access site from the distal EIA to CFA bifurcation. Our protocol included B-mode imaging of these arterial segments in sagittal and transverse planes, color flow imaging, power Doppler, and spectral waveform analysis. Peak systolic velocities (PSV) obtained in the visualized arteries were compared to the contralateral site and ratio over 2:1 in the absence of significant local stenosis raised suspicion of proximal obstruction on the side with lower PSV. A biplanar arteriogram was performed in these two cases. Indications for CFA exploration based on B-mode abnormalities were mobile flaps ≥ 3.5 mm causing a localized PSV ratio ≥ 2. IDS (for both groins) duration ranged from 7 to 15 minutes (mean: 11 ± 3 min).

Postoperative follow-up duplex scan 

All patients had follow-up duplex scans performed two to four weeks after surgery and every six months thereafter. Duplex scan protocol included assessment of the endograft as well as ilio-femoral arterial segment. In patients with adjunctive bypasses, scans of the bypasses were also performed. In this series, there were seven femoral-femoral bypasses and three femoral to internal iliac bypasses.

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Results 

In 34 patients (25%), we documented intimal dissections causing severe stenoses (>70%) stenoses (Fig 1, Fig 2, Fig 3, Fig 4, Fig 5). Of the 271 arteries that were examined (268 CFA and EIA and three internal iliac arteries), 38 (14%) had abnormal findings that demanded intervention. These were repaired with flap excision, tacking sutures revision or patch angioplasty (n = 36) at the site of device insertion. After patch angioplasty, repeat completion duplex revealed no significant lesions. Two low peak systolic velocities were corrected with stenting of missed lesions in the iliac arteries (Fig 6). Repeat IDS confirmed the adequacy of the repair. No statistical difference was noted between the site of larger introducer sheath or size of the sheath placed and the incidence of flap formation. No relation could be found with age (P = .5) or gender (P = .87) distribution. No differences were noted in the incidence of positive duplex exams between each type graft (P = .4). In addition, 10 small flaps or plaques were visualized but did not create significant stenosis. No early or late iliac limb occlusions were noted. Ninety-four percent follow-up was obtained. Follow-up ranged from 0 to 72 months (mean: 24 ± 6 months). No further areas of significant restenosis were noted on follow-up duplex in the patched or non-patched arteries.

  • View full-size image.
  • Fig 4. 

    Elevated peak systolic velocities, waveform, and duplex images illustrating hemodynamically significant posterior plaque in common femoral artery of a patient undergoing endovascular aneurysm repair (EVAR).

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Discussion 

Since the introduction of endovascular aneurysm repair (EVAR) in 1991, open femoral artery exposure has remained the preferred method of obtaining access for introduction of large bore sheaths and deployment of endografts.6 While completion angiograms of the aorta and iliac arteries provide information regarding technical defects that can be addressed at the time of the procedure, they do not adequately study the access vessel, the common femoral or distal external iliac artery. Woody and Makaroun, in their review, noted that completion single plane arteriograms have the potential to miss a multitude of technical defects, whereas biplanar arteriogram or intravascular ultrasound (IVUS) give much greater detail of endograft and limb anatomy and may identify unappreciated limb problem.7 Amseur et al utilized IVUS routinely after graft deployment in their series and were able to pre-emptively treated graft infolding with additional stent placement that was not evident on arteriograms.8

Similarly, when the access artery is closed, there could be potential vessel injury that has not been addressed that could potentially lead to early limb occlusion after the endograft depoloyment. While some of these defects may have remodeled well, some may have resulted in a limb occlusion. Indeed in our experience, we found a surprisingly high incidence (14%) of clinically undetectable intraluminal flaps that were revealed when performing an intraoperative completion arterial duplex scan of the access vessels after what was felt to be a straightforward closure of the access vessel after EVAR. Intraoperative completion arterial duplex after various procedures such as carotid endarterectomy, infrainguinal bypass, or balloon angioplasty has been used to identify and repair technical defects and/or residual disease to improve clinical outcome and patency of these procedures.9, 10, 11 In the present study, we found undetectable intraluminal flaps, with many of them being hemodynamically significant and creating obstruction to the outflow from the isiplateral graft limb. All these defects were created by the plaque dissection with introducer sheaths. Although all of these patients had contrast arteriograms routinely performed after endograft deployment, none of these flaps were detected since they were covered by the introducer sheaths at the time of this standard completion study. Another advantage of IDS is the ability for hemodynamic data collection. Significant difference in PSV (ratio of ≥ 2) and spectral waveform (biphasic or monophasic) as compared with the contralateral site raises high suspicion of significant proximal obstruction such as limb kinking or stenosis. This was the case in two of our patients who had a severe limb stenosis missed on uniplanar completion arteriogram.

Cochennec et al, in a recent retrospective review, studied the clinical patterns, outcomes, and predictive factors of graft limb occlusion.6 Over a 10 year period, 33 patients had 36 occluded limbs after 460 patients with abdominal aortic aneurysm were treated with EVAR with a variety of stent grafts. The data showed that graft kinking was the predominant risk factor for graft limb occlusion. Poor outflow, defined as >70% stenosis of the iliac or common femoral artery, was also found to be a predictive factor for graft limb occlusion. Of seven patients found to have poor outflow, five patients (71.4%) had limb thrombosis as compared with 31 of 822 limbs (3.8%) without poor outflow.6 Arterial dissection and compromised runoff that is pre-existing or created at the time of graft implantation are known causes of graft occlusion.7 Given the data presented here, it is possible that the seven limbs with poor outflow may have had undetected intimal flaps from the introducer sheath that progressed to limb occlusion.

Limb occlusions after EVAR can present from symptoms ranging from no symptoms to acute limb ischemia. These limbs are treated with endovascular thrombolysis and stent placement, open surgical thromboembolectomies, extra-anatomic bypasses (femoral-femoral bypass, axillary-femoral bypass) or simple observation based on their clinical presentation.1, 4, 6, 7, 12, 13, 14 Various series have reported 27% to 33% of patients requiring secondary interventions after EVAR followed over an 18 months to three year period.7, 14. The need for high rate of secondary intervention would seem to detract from a procedure whose advantages are lower morbidity and mortality, shorter hospital stay and recovery time, less pain, and decreased blood loss.6, 7 This rate is probably lower now with the use of newer generation of endografts and greater skill level among practitioners in deployment accuracy and earlier identification of technical problems.15 Thus, this would make undetected access vessel injuries a more significant reason for post-implantation graft limb occlusion. Detailed studies and aggressive approach to identifying graft limb compromise is of paramount importance for prevention.

While during this series, we had a registered vascular technologist perform this exam. We actually no longer use the registered vascular technologist. We perform the scan ourselves as we have become comfortable with performing the scan.

The use of suture mediated closure devices has allowed for a totally percutaneous aneurysm repair.16 The early results suggest this technique allows for significantly less groin complication rates with rare incidence of femoral thrombosis, although the majority of data on this technique are single institution series.17, 18, 19, 20, 21 Some authors have found that the addition of using intraoperative duplex to gain access for this technique significantly reduces access site related complications as compared with standard percutaneous access.17 As experience increases with this technique, undetected intimal flaps and hemodynamically significant lesions may become an increasingly significant cause of graft limb occlusion. The knowledge and availability of duplex machines intraoperatively gives vascular specialists another imaging modality to aggressively detect and reduce potential complications of endograft repair of aorto-iliac aneurysmal disease with minimal increase in operative time (mean: 11 minutes). The authors were pleased to note that none of the endografts in this series underwent early limb occlusion. The authors recommend intraoperative diagnosis and repair of the entry site defects may increase early and potentially late limbs patency following endograft placement.

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Author contributions 


Conception and design: AH, EA, AS, NP, KG, NM

Analysis and interpretation: AH, EA, AS, NP, KG, NM

Data collection: AH, EA, AS, NP, KG, NM

Writing the article: AH, KG

Critical revision of the article: AH

Final approval of the article: AH

Statistical analysis: AH

Obtained funding: N/A

Overall responsibility: AH

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References 

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 Competition of interest: none.

PII: S0741-5214(09)00793-9

doi:10.1016/j.jvs.2009.03.050

Journal of Vascular Surgery
Volume 50, Issue 3 , Pages 505-509, September 2009

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