Part 3/Chapter 16/11-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.

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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, , chronic limb-threatening ischemia (), or acute limb ischemia () dictates the acceptable balance among durability, procedural risk, time to flow restoration, surveillance burden, and tolerance for reintervention . For chronic limb-threatening ischemia, the 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 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 -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 . The 2010 systematic review by Nordon and colleagues documents an ongoing need for secondary intervention after EVAR, supporting long-term attention to device failure rather than an assumption that early technical success ensures durability . Explanted-graft analysis provides complementary historical device-failure context . Contemporary planning should also use ESVS 2024 guidance on anatomy, device instructions for use and risk-stratified long-term surveillance .

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 . The 2019 Global Vascular Guidelines restrict nonautologous infrainguinal bypass when an adequate vein or suitable endovascular option is available . The 2024 guideline recommends autogenous vein for popliteal/infrapopliteal CLTI bypass when available (I A), but recognizes prosthetic or cadaveric alternatives when a surgical strategy is selected and suitable vein is unavailable (IIa B-NR). Vein preference is therefore not an instruction to use an unsuitable vein, nor a statement that bypass is always preferable to endovascular treatment.

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 (), 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 , 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 .

Animal-derived and biosynthetic conduits

Cryopreserved human allograft, bovine pericardial patch, bovine carotid graft and biosynthetic graft are distinct materials; evidence for one is not automatically evidence for another.

Artegraft
Comparison A

Artegraft

Trade-offs
  • Not a human allograft or bovine pericardial patch. Assess bovine hypersensitivity
  • runoff and graft sizing. The IFU advises at least 12 days before first dialysis cannulation.
Comparison B

Omniflow II

Trade-offs
  • Not infection-proof: active infection is a do-not-use circumstance unless no alternative can prevent amputation or death. The IFU also warns against balloon angioplasty/stenting of the graft and requires attention to late degeneration.

These labels establish material and intended use, not superiority over good-quality autologous vein or interchangeable infection outcomes. Select a conduit by indication, available vein, anatomy and infection/source-control requirements.

Infrainguinal bypass conduit selection
  • Chronic limb-threatening ischemia requiring infrainguinal bypass

    Preferred conduit
    Suitable autologous vein, when available
    Alternative conduit
    If suitable vein is unavailable and surgery is selected, consider an alternative conduit after weighing the endovascular option; the 2019 and 2024 recommendations differ in wording and strength.
    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

TransAtlantic Inter-Society Consensus (TASC) II is a historical anatomic classification, with separate aortoiliac and femoropopliteal schemes. It should not be confused with clinical limb-threat staging. In aortoiliac disease, representative examples are:

ClassificationTASC II Class and Example, not the complete class definition
A
Example, not the complete class definition
Unilateral or bilateral common iliac artery .
B
Example, not the complete class definition
Unilateral common iliac artery occlusion.
C
Example, not the complete class definition
Bilateral common iliac artery occlusion.
D
Example, not the complete class definition
Infrarenal aortoiliac occlusion.

Use the complete segment-specific definition when reporting a case; a class letter alone does not determine contemporary treatment. The original classification remains useful for interpreting older device trials .

In aortoiliac occlusive disease, COBEST (2011, 2016) demonstrated a covered-stent patency advantage over bare-metal stents, although the 5-year analysis was post hoc and only 77 of 125 original participants were assessed. 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 . The 2018 aggregate-data mortality signal prompted a regulatory investigation; subsequent evidence changed the regulatory assessment . In July 2023, the FDA concluded that updated evidence did not support excess mortality from paclitaxel-coated PAD devices. This does not establish superior outcomes for every drug-device strategy or every population; selection still requires discussion of expected benefit, alternatives and routine follow-up .

Later evidence and recommendations require separate interpretation. A 2026 pooled analysis found no significant mortality increase at one, two or five years . In SWEDEPAD-2, patients with intermittent claudication had no disease-specific quality-of-life benefit at one year; mortality was not significantly different over the full follow-up but was higher in the paclitaxel group over five years . The ESVS 2026 focused update therefore limits consideration of paclitaxel-coated devices in claudication to selected restenosis cases, with discussion of uncertain long-term safety and modest symptomatic benefit. This population-specific guidance must not be erased by the earlier FDA assessment or extrapolated automatically to CLTI .

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 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 .

GuidelinesStent and stent-graft selection: the clinical decision
  • Complex aortoiliac occlusive disease
    Choice being made
    Covered balloon-expandable versus bare-metal stent.
    Practical constraint and evidence boundary
    COBEST supports a covered-stent patency advantage, especially in C/D disease, but branch coverage, access caliber and adequate landing zones may prevent safe use. It does not establish a universal advantage for focal B lesions.
  • Femoropopliteal CLTI selected for endovascular treatment
    Choice being made
    Plain balloon with optional bare-metal stent, drug-coated balloon with optional stent, or primary drug-eluting stent.
    Practical constraint and evidence boundary
    BASIL-3 did not demonstrate improved amputation-free survival with the drug-device strategies. Distinguish patency/reintervention endpoints from survival and limb salvage; treat flow-limiting residual disease according to the angiographic result.
  • Carotid stenting already selected on clinical grounds
    Choice being made
    Stent design and cerebral protection strategy, not a choice between interchangeable devices.
    Practical constraint and evidence boundary
    The MicroNet trial studied filter-protected stenting and imaging-defined . A mesh-covered stent is not itself a flow-reversal system, and fewer MRI lesions do not by themselves establish superiority over carotid endarterectomy.
  • Complicated acute type B dissection
    Choice being made
    Proximal thoracic stent-graft treatment with or without a distal reconstruction adjunct.
    Practical constraint and evidence boundary
    PETTICOAT adds distal bare-metal support; STABILISE additionally disrupts the septum. They are distinct selected strategies, not routine components of every , and high technical success does not establish long-term comparative benefit.

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

Paclitaxel device safety should be discussed with its chronology intact: the 2018 signal prompted further investigation, while the FDA’s 2023 update did not support excess mortality on the updated evidence. The 2026 ESVS claudication update is more restrictive, allowing consideration only in selected restenosis cases; SWEDEPAD-2 found no one-year quality-of-life benefit and a five-year mortality signal despite a nonsignificant full-follow-up comparison. Decisions therefore require population- and time-specific interpretation, alternatives and patient preferences , rather than treating FDA2023 as the final evidence assessment .

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 .

Further reading

  • A Systematic Review and Meta-Analysis of Heparin-Bonded Expanded Polytetrafluoroethylene Grafts for Below-The-Knee Femoral Bypass Surgery. (2024). Heparin-bonded ePTFE conduit outcomes below the knee.
  • Safety of paclitaxel-coated devices in patients with peripheral artery disease: an updated systematic review and meta-analysis of randomized controlled trials. (2026). Paclitaxel-device safety synthesis; interpret alongside the distinct 2026 ESVS focused guidance and SWEDEPAD findings.

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