Interventionists are seeing increasingly complex iliac disease as patients age, diabetes becomes more prevalent, and smoking continues. As endovascular techniques continue to improve, patients can now be offered minimally invasive solutions for problems that were traditionally addressed with open bypass surgery. These interventions allow for inclusion of patients who were previously believed to be unfit for surgery, and excellent results can be accomplished with significantly less morbidity. Much of the severe iliac occlusive disease that is seen today has been seen before; however, we can now approach these challenges when treating older and sicker patients with less invasive but equally effective and durable therapies.

Initially, intravascular stenting in the iliac anatomy was questioned and was believed to be best reserved for “selective use” following balloon angioplasty.1 As stent technology and techniques improved, complex iliac disease began to be successfully addressed with nitinol stents, with outcomes approaching those of open repair.2,3 The gold standard of aortobifemoral bypass and femoral-femoral bypass was slowly challenged by creative endovascular recanalizations. Surgeons continue to pioneer complex reconstructions for TransAtlantic Inter-Society Consensus (TASC) C and D lesions by performing “hybrid” interventions composed of iliac stenting combined with common femoral and profunda open endarterectomy.4,5

BACKGROUND AND EVIDENCE

Initial reports of stent graft use in the aortoiliac anatomy were performed using off-label, homemade devices. These literal “stent grafts” were comprised of balloonexpandable stents coupled with prosthetic bypass grafts. Despite the rudimentary designs of these devices (requiring assembly and delivery systems as large as 14 F), technical success was excellent, with primary patency rates > 80% at 1 year.6-8 Around the same time, Krajcer et al performed one of the earliest comparisons of bare-metal stents to stent grafts in the iliac position, finding good “technical and early success.”9

Seeing the potential for success in complex disease, interventionists devised increasingly creative approaches to treating difficult aortoiliac occlusive disease. Nelson et al demonstrated early effectiveness of hybrid recon structions, employing common femoral endarterectomy and concomitant bare-metal iliac stent placement (both balloon-expandable and self-expanding).4 Despite the novelty of this technique, and less-refined endovascular devices, this study achieved 1-year patency and a primary assisted patency of 84% and 97%, respectively.

The same group then reported improved success using stent grafts compared to bare-metal stents for challenging iliac disease, namely TASC C and D lesions.5 Selfexpanding stent grafts were employed using both the Wallgraft endoprosthesis (Boston Scientific Corporation, Natick, MA) and the GORE® VIABAHN® Endoprosthesis (W. L. Gore & Associates, Flagstaff, AZ). Specific attention was noted in this study regarding the importance of addressing distal external iliac and common femoral/ profunda occlusive disease via endarterectomy or another outflow procedure. This point has been referenced in several studies and appears to be critical in achieving long-term patency.4-6

The Dutch Iliac Stent trial, although less than a decade old, was one of the first randomized trials to critically examine the effectiveness of stent placement in the iliac anatomy.1 The controversial conclusion asserted that angioplasty with selective stent placement resulted in a “better outcome for symptomatic success compared with patients treated with primary stent placement.”1 The major problem with extrapolating the results of this study concerns the lesions included (ie, stenoses < 10 cm or occlusions < 5 cm), as well as the device employed (a hand-mounted, balloon-expandable, bare-metal Palmaz stent [Cordis Corporation, Bridgewater, NJ]). Today, these lesions would be classified as TASC II A and B lesions.10 The following year, AbuRahma et al published their experience for primary versus selective stenting, noting improved clinical success rates for primary stenting when specifically applied to TASC C and D lesions.3 They concluded that “primary stenting should be offered to all TASC C and D lesions.”3

In the last 5 years, the data have continued to accumulate to support the use of stent grafts in the iliac anatomy (especially for TASC II C and D lesions). Chang et al published their long-term results, which demonstrated that hybrid reconstructions of the common femoral and iliac system have 5-year primary, primary-assisted, and secondary patencies of 60%, 97%, and 98%, respectively.11 This study called specific attention to the improved primary patency rates seen with stent grafts versus baremetal stents (87% ± 5% vs 53% ± 7%; P < .01).

Sabri et al compared bilateral covered stent use to bare-metal stent placement in a “kissing” fashion at the aortic bifurcation, finding superior patency for covered stents at 2 years (92% vs 62%; P = .023).12 In 2011, COBEST (Covered Versus Balloon Expandable Stent Trial), a prospective, randomized, multicenter trial, provided strong data in support of covered stent placement for TASC II C and D lesions, with improved freedom from occlusion and restenosis with covered stent placement when compared to bare-metal stenting at 12 and 18 months (hazard ratio, 0.136; 95% confidence interval, 0.042–0.442).13

The increasing data in support of covered stenting in the iliac anatomy was strengthened by direct comparisons to open repair, demonstrating equivalent patency. Kashyap et al suggested that endovascular techniques “rivaled” open reconstruction, whereas Piazza et al found that extensive iliac and common femoral disease can be effectively treated with hybrid repair (femoral endarterectomy with iliac stenting) with “similar early and longterm efficacy” to open repair.14,15 Piazza et al demonstrated particular effectiveness in intensive care unit and hospital stay lengths in TASC II C and D patients.15

TECHNIQUE OF HYBRID ILIAC REPAIR WITH ENDOPROSTHESES

We have routinely been offering hybrid repair to our patients with diffuse unilateral iliac disease and common femoral involvement. As a rule, we employ general anesthesia but have utilized locoregional anesthesia in selected patients. We begin with open common femoral artery exposure via a vertical groin incision. Diffuse exposure of the distal external iliac artery, proximal superficial femoral artery (SFA), and proximal profunda is essential. Our practice, based on experience, has been to then access the occluded femoral artery with an 18-gauge introducer needle and attempt passage of a stiff Glidewire (Terumo Interventional Systems, Inc., Somerset, NJ) up into the aorta (Figure 1). Contralateral access and brachial access can be especially useful for imaging the aortic bifurcation and gaining wire access across challenging lesions. Retrograde subintimal recanalization can be accomplished using reentry devices should you get stuck in an aortic subintimal plane. Antegrade subintimal recanalization from a brachial or contralateral femoral approach is more easily handled with common femoral arteriotomy and direct exposure of the wire in the subintimal space during endarterectomy.

Standard surgical endarterectomy is then performed from the distal external iliac artery to the profunda. We have found that direct extension of the arteriotomy onto the proximal profunda is more effective in achieving good profunda outflow than proceeding to the proximal SFA. Robust profunda outflow is critical to success, especially if this is the only outflow vessel. If the profunda is severely diseased or diminutive in size, consideration should be given to concomitant distal outflow procedures (eg, femoropopliteal or femorotibial bypass). Preparation of the proximal SFA can aid in future endovascular interventions should they be required. Patch angioplasty is then performed using the preferred patch. Prior to implanting the patch, we utilize an 18-gauge needle to puncture the patch, bringing the wire out of the femoral arteriotomy and through the patch (Figure 2). Once the patch is implanted, we have wire access already through the lesion and exiting the patch.

Finally, we establish definitive inflow via stenting of the iliac system. Readers are cautioned against performing stenting prior to the endarterectomy, as stagnant blood within the freshly placed stents during the endarterectomy can result in stent thrombosis. A long (23-cm) introducer sheath is inserted over the indwelling wire, which is sized for the anticipated stent placement (Figures 3 and 4). Our standard approach is to insert 8-mm endoprostheses, exclusively employing covered stents for these complex lesions, and postdilating with an 8-mm balloon. A metallic marker is placed at the top of the patch angioplasty (or most proximal area of endarterectomy) on the distal external iliac artery (Figure 4, arrow). This greatly aids in the positioning of the stent graft. Completion angiography is routinely performed to document adequacy of the repair and the outflow (Figure 5). Sheaths and wires are removed, and the patch is suture-repaired.

We have often implanted balloon-expandable covered stents for orificial lesions at the aortic bifurcation but find them to be limited in their lengths and flexibility. More commonly, we utilize the GORE® VIABAHN® Device, as it is the only covered stent graft that is approved for use in the iliac anatomy and affords several advantages over other products. When treating TASC II C and D lesions, especially chronic total occlusions of the entire common and external iliac segments, the GORE® VIABAHN® Device simplifies treatment, offering long-length (up to 15 cm) endoprostheses. We have also found the device to display excellent flexibility as one approaches the inguinal ligament in the distal external iliac artery (essential for hybrid reconstructions). Finally, the newest-generation GORE® VIABAHN® Device offers lower-profile delivery and a covalently bonded heparin surface to improve patency.

CONCLUSION

Covered stent use in TASC C and D iliac lesions has a growing body of literature demonstrating its superiority to angioplasty with selective covered or bare-metal stent placement. Additionally, repair of complex lesions with hybrid approaches has long-term data demonstrating results that are equivalent to open surgery, with significantly less morbidity. These data point toward covered stent treatment of complex iliac occlusive lesions as a new standard of care. The GORE® VIABAHN® Device has the advantages of longer device lengths, flexibility when employed in the distal external iliac, low-profile delivery, and heparin-bonded surfaces. As our comfort level increases and future devices emerge, interventionists and surgeons will likely continue to innovate with complex, minimally invasive techniques, combining endovascular and surgical approaches to address challenging iliac occlusive disease in older and sicker patients.

Lee J. Goldstein, MD, FACS, CWS, is Assistant Professor of Vascular Surgery at DeWitt Daughtry Family Department of Surgery, University of Miami, Miller School of Medicine in Miami, Florida. He has disclosed that he has no financial interests related to this article. Dr. Goldstein may be reached at (305) 585-5284; lgoldstein@med.miami.edu.

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