Part 3/Chapter 16/8-min read

Conduits, Grafts, Stents, Stent-Grafts, and Device Evaluation

Conduits, grafts, stents, and stent-grafts chosen by the clinical problem rather than by catalogue: durability, procedural risk, time to flow restoration, surveillance burden, and tolerance for reintervention. The chapter frames device evaluation for PAD, CLTI, aneurysmal, venous, and access reconstructions.

Edited by Tal M. Hörer MD, PhD · David T. McGreevy MD, PhD·Reviewed ·5 sections · 36 references

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Device evaluation and reporting frameworks

Device evaluation begins with the clinical presentation. For lower-extremity peripheral artery disease, the patient's status as asymptomatic, claudication, chronic limb-threatening ischemia (CLTI), or acute limb ischemia (ALI) dictates the acceptable balance among durability, procedural risk, time to flow restoration, surveillance burden, and tolerance for reintervention . For chronic limb-threatening ischemia, the PLAN approach integrates patient risk, limb severity, and anatomic complexity via the Global Limb Anatomic Staging System to guide the choice between endovascular and surgical options .

Procedural success is judged against the clinical outcome it is meant to improve. Reporting frameworks define technical success, hemodynamic improvement, target-lesion patency, freedom from clinically driven target-lesion revascularization, limb salvage, and survival as the standard metrics for lower-extremity interventions . Objective performance goals provide benchmark endpoints for major adverse limb events and limb loss in studies lacking a surgical control group .

For aneurysm repair, anatomic eligibility dictates device selection. The device must obtain a durable seal and fixation, pass safely through access vessels, and permit reliable surveillance for endoleak, sac change, and migration . Hostile neck anatomy, including adverse neck length and angulation, predicts failure; severe anatomic constraints require consideration of open repair, fenestrated or branched endovascular strategies, or escalated surveillance .

Early procedural success does not guarantee late durability. In EVAR-1 (2016), an initial perioperative survival advantage for endovascular abdominal aortic aneurysm repair over open repair was lost by 3 years, and long-term aneurysm-related mortality and reintervention were higher after endovascular repair . Post-implantation registry analyses show that endoleak, limb occlusion, migration, and sac enlargement generate a steady cumulative need for secondary intervention, while explanted graft analysis reveals structural fatigue, fabric failure, and infection that clinical imaging alone may miss .

Conduits and graft material

Autologous vein is the preferred conduit for surgical lower-extremity bypass when long-term durability is sought, particularly when restoring limb-salvage flow to a compromised distal bed . Contemporary guidelines explicitly advise against using nonautologous conduit for infrainguinal bypass unless there is no suitable endovascular option and no adequate autologous vein .

When autologous vein is unavailable, the choice of prosthetic conduit depends on the target segment. For above-knee femoropopliteal bypass, a meta-analysis showed Dacron yields superior primary patency at 24, 36, and 60 months compared with polytetrafluoroethylene (PTFE), though amputation, morbidity, and mortality rates do not differ significantly . However, autologous vein retains superior 60-month primary patency over any prosthetic in the above-knee position .

For below-knee femoropopliteal or infrapopliteal bypass, prosthetic conduit is a higher-risk durability compromise. Heparin-bonded expanded PTFE provides higher 1-year primary patency than standard expanded PTFE in these positions, but outcomes remain inferior to good-quality great saphenous vein . Great saphenous vein harvest technique directly affects conduit integrity and wound morbidity . Adjunctive vein cuffs or patches modify anastomotic geometry and the prosthetic-to-artery interface when a prosthetic graft is sewn to an infragenicular target .

For common femoral endarterectomy, bovine pericardium provides high primary patency with low infection and pseudoaneurysm rates, serving as a reasonable alternative to autologous vein or polyester patching . Cryopreserved arterial allograft is a viable rescue conduit for infected or contaminated fields, but requires long-term imaging surveillance for progressive degeneration, pseudoaneurysm formation, anastomotic disruption, and thrombosis .

Infrainguinal bypass conduit selection

  • Chronic limb-threatening ischemia requiring infrainguinal bypass

    Preferred conduit
    Autologous vein (Global Vascular Guidelines 2019)
    Alternative conduit
    Nonautologous conduit only if no endovascular option and no adequate vein exist
    Citation

  • Above-knee femoropopliteal bypass, vein unavailable

    Preferred conduit
    Dacron
    Alternative conduit
    Polytetrafluoroethylene
    Citation

  • Below-knee or infrapopliteal bypass, vein unavailable

    Preferred conduit
    Heparin-bonded expanded polytetrafluoroethylene
    Alternative conduit
    Standard expanded polytetrafluoroethylene
    Citation

  • Infected native or prosthetic aortic reconstruction

    Preferred conduit
    Extra-anatomic or autologous in-situ reconstruction
    Alternative conduit
    Cryopreserved arterial allograft, with long-term surveillance for degeneration
    Citation

Stents, stent-grafts, and drug-device evidence

In aortoiliac occlusive disease, COBEST (2011, 2016) demonstrated that covered balloon-expandable stents provide greater freedom from binary in-stent restenosis, sustained primary patency out to 5 years, and fewer revascularisations compared with bare-metal stents. This advantage is largest in TransAtlantic Inter-Society Consensus II C and D lesions, while no significant difference exists in TASC II B lesions . Branch coverage, landing-zone disease, and contralateral access define the anatomic limits of covered-stent deployment .

In the femoropopliteal segment, drug-eluting balloons reduce binary restenosis, target-lesion revascularization, and late lumen loss compared with uncoated balloons . Primary drug-coated balloon angioplasty and primary drug-eluting stent placement yield broadly similar mid-term primary patency, though bail-out stenting is required after balloon use for long lesions or flow-limiting dissections . The Zilver PTX trial (2016) confirmed sustained event-free survival and patency superiority over plain balloon angioplasty for paclitaxel-eluting stents . Device evaluation in this segment must account for systemic safety, as meta-analyses identify a signal of increased all-cause mortality at 2 and 5 years following use of paclitaxel-coated balloons and stents . In that meta-analysis all-cause mortality was 7.2% with paclitaxel-coated devices versus 3.8% with control at 2 years (risk ratio 1.68), rising to 14.7% versus 8.1% at 5 years, a dose-related signal that prompted the FDA safety advisory and was only partially attenuated by later patient-level pooled analyses.

For carotid revascularization, embolic protection is an integral design feature. MicroNet-covered carotid stents produce fewer new ipsilateral ischemic lesions on diffusion-weighted magnetic resonance imaging than conventional open-cell stents . Transcarotid artery revascularization using dynamic flow reversal offers comparable 30-day stroke and death profiles to carotid endarterectomy, with potentially lower rates of cranial nerve injury .

For thoracic and complex aortic disease, PETTICOAT and STABILISE techniques for complicated acute type B aortic dissection use distal bare-metal stent extension or intentional septal disruption to achieve 97% to 100% technical success and variable aortic remodeling . Physician-modified endografts and off-the-shelf branched arch devices expand options for juxtarenal and arch pathology, evaluated by sealing-zone durability and endoleak rate .

Dedicated venous self-expanding stents for iliofemoral venous outflow obstruction are evaluated on prospective durability and patency. Procedural success relies heavily on obstruction anatomy, expected venous inflow and outflow, symptom targeting, and rigorous follow-up to prevent occlusion .

Stent and stent-graft selection criteria
Comparison A

Aortoiliac occlusive disease (TASC II C and D)

Notes
  • Requires suitable landing zones without covering essential branches
Comparison B

Femoropopliteal occlusive disease

Notes
  • Bail-out stenting often required after balloon use for long lesions or flow-limiting dissection
Comparison C

Carotid artery stenosis

Notes
  • Outcomes rely on anatomic suitability for the access and protection mechanism
Comparison D

Complicated acute type B aortic dissection

Notes
  • Remodeling outcomes differ
  • technical success does not guarantee late stabilization

Clinical integration and surveillance strategy

Imaging surveillance must be designed around the known failure modes of the implanted device. A device requiring lifelong follow-up is avoided when the patient is unlikely to complete surveillance and a durable alternative exists . Routine device surveillance targets specific endpoints based on the intervention:

  • Endovascular aneurysm repair: evaluation for endoleak, migration, sac enlargement, and limb compromise .
  • Infrainguinal bypass: assessment of inflow, conduit patency, anastomotic integrity, and runoff failure.
  • Cryopreserved allograft: monitoring for progressive degeneration, pseudoaneurysm, anastomotic disruption, and thrombosis .

Aortic graft and endograft infections alter the device hierarchy. Selected stable patients without fistula can initially be managed conservatively with prolonged targeted antimicrobial therapy and imaging surveillance. However, persistent sepsis, aortoenteric fistula, or anastomotic bleeding demands definitive surgical excision and extra-anatomic or in-situ reconstruction .

Areas of controversy

The magnitude and causation of the long-term mortality signal associated with paclitaxel-coated balloons and stents in the femoropopliteal segment remain debated. Patient-level analyses have only partially resolved these regulatory advisories, requiring individualized decisions regarding mortality risk versus revascularization benefit .

The boundary between conservative-first management and prompt definitive excision in aortic graft infection is not absolute, with treatment effects heavily influenced by selection bias and infection virulence .

While covered stents possess a clear primary patency advantage in complex TASC II C and D aortoiliac disease, their superiority in shorter focal TASC II B lesions is not established and must be weighed against access caliber and branch coverage risks .

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