Procedure Guides
Arterial

Peripheral Artery Disease

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Procedure Guide

  • Claudication refractory to medical therapy (needs documented for reimbursement) with imaging evidence of good targets for endovascular management (TASC classifications)

    • Only ~25% of people with intermittent claudication with deteriorate.

    • Endovascular intervention should be avoided in the CFA given that their are superior surgical options.

    • Fontaine stage I/Rutherford-Becker category 0: Asymptomatic, normal exercise testing

    • Fontaine stage IIa/Rutherford-Becker category 1: Mild claudication, ABI 0.80-0.95, AP post exercise >50mmHg 

    • Fontaine stage IIb/Rutherford-Becker category 2: Moderate claudication, between category 1-3 

    • Fontaine stage IIb/Rutherford-Becker category 3: Severe claudication, ABI 0.40-0.80, cannot complete treadmill exercise, AP post exercise <50 mmHg 

    • Fontaine stage III/Rutherford-Becker category 4: Ischemia rest pain, ABI <0.40, flat or barely pulsatile ankle PVR

    • Fontaine stage IV/Rutherford-Becker category 5: Minor tissue loss, resting AP <50 mmHg, flat or barely pulsatile ankle PVR

    • Fontaine stage IV/Rutherford-Becker category 6: Major tissue loss, with same objective criteria

  • Rutherford Class I or IIA critical limb ischemia (CLI). Some may intervene on carefully selected Class IIB.

    • Class I: decreased arterial doppler with preserved sensory and motor function

    • Class IIA: loss of arterial doppler with minimal to no sensory loss

    • Class IIB: rest pain and mild/moderate motor function loss

    • Class III: severe sensory and motor function loss

    • Japanese CLI registry risk stratification:

      • Worst outcomes if coexisting heart failure, wound infections, or BMI <18.5

      • Low risk = 0 criteria; Intermediate risk = 1 criterion; High risk = 2-3 criteria

  • WIfI classification - SVS classification based on Wound, Ischemia (ABI, TP testing), and foot Infection

  • Medically unstable

  • Life-threatening infected (wet) gangrene or osteomyelitis 

  • Benefit unlikely, e.g., widespread ulceration, gangrene, Rutherford Class 3 CLI

  • High bleeding risk if planning for lysis (below)

    • Absolute:

      • Active internal bleeding

      • Recent ICH or large vessel territory CVA

      • GI bleed within 10-14 days

      • Major surgery or neurosurgery within 3 weeks

    • Relative:

      • Major surgery or neurosurgery within 3 wks - 3 mo

      • Head injury within 3 months

      • Recent puncture of noncompressible vessel

      • Internal bleeding with 2-4 wks

      • CPR within 10-14 days

      • Uncontrolled hypertension

      • Uncorrected coagulopathy (INR >1.7, Plt <75K)

  • Supervised exercise therapy (SET) and medical therapy

    • Some studies have suggested more effective overall than stenting

    • Takes ~6mo to start seeing results but continued improvement with similar effects on QoL

    • Recent studies such as this one suggest similar outcomes to revascularization for intermittent claudication

  • Bypass vs. Endovascular Therapy: general movement towards endovascular first even for TASC C and D due to newer technologies and decreased length of stay, complications, and costs. Consider surgery for lesions that are long, eccentrically calcified, or secondary to radiation.

    • Primary amputation is associated with decreased survival as well as increased costs and risk of future amputations compared to endovascular or surgical revascularization. Even if there is gangrene, it can be helpful to vascularize and do a smaller amputation.

    • BEST-CLI trial: suggested superior outcomes with bypass first strategy if adequate saphenous vein. However, study is controversial with critics suggests it is highly flawed due to poor endovascular technique and bias.

    • Upper extremity: 

      • 90% result from thromboembolism

      • Endovascular: 95-100% limb salvage for acute, 60-100% success for chronic occlusive, 100% for stenosis -> patency 91-100% (1-yr), 85% (3-yrs), 75% (5-yrs)

    • Aortoiliac (“inflow dx”):

      • Endovascular: 80% success for occlusive, 96% for stenosis -> patency 80% (4yr), 75% primary 88-99% secondary (5-yr)

      • Aortoiliac Bypass: 85-90% 5yrs patency; (Iliac Endarterectomy, Iliofemoral Bypass, Aortofemoral Bypass) 85-90% 5yrs patency > Axillofemoral Bypass (50-80% 3yr patency)

    • Femoropopliteal (“outflow dx”):

      • BASIL trial found had equivalent amputation free survival at 6 mo with less costs and complications with endovascular therapy but patients living >2 yrs had superior survival with surgical management. However, endovascular management only included angioplasty alone.

      • Endovascular: 2-yr patency >80% w/ Zilver DCB; Supera stent primary patency 89% @ 1 yr, 84% @ 2 yrs, and 82% @ 3 yrs (SUPERB trial); Generally stent > angioplasty alone and covered = bare metal stents.

      • STRIDE Registry (n=96): Indigo aspiration thrombectomy for CLI, TIMI 0 in 94.5%, 60% popliteal clot 44.7% SFA, 30d limb salvage 98%, major bleeding 4.2%, device-related event 1.0%, TIMI 2/3 achieved in 94.4%

      • Femoropopliteal Bypass: 65 v. 33-50% 5-yr patency for vein vs. synthetic graft

      • Femorotibial Bypass: 75-80% 5-yr vs. 25% 3-yr patency for vein vs. synthetic graft

      • Percutaneous Transmural Arterial Bypass (PTAB) with DETOUR system is on endovascular option for long refractory occlusions. Initial work shows good patency but unclear long term effects on venous system.

    • Infrapopliteal (contemporary review):

      • Endovascular: >90% technical success but restenosis/occlusion >60% in 3mo; 3-yr limb salvage rate is similar to surgery at 82%

        • LIFE-BTK Trial: Everolimus-eluting resorbable scaffold (Esprit BTK scaffold, Abbott) was superior to angioplasty alone in preventing amputation and restenosis/occlusion at 1 year. This was true regardless of lesion length.

        • DES vs. PTA/BMS 1-yr primary patency 75-85% v. 54-57% (ACHILLES, DESTINY, YUKON, PADI trials)

        • Saval stent trial: DES for below the knee, nitinol, self-expanding, didn’t meet safety and efficacy criteria, unclear why particularly with data muddied by substantial dropout from the COVID-19 pandemic

        • Four negative RCT assessing DEBs (IN.PACT DEEP, Lutonix 014 DCB, SINGA-PACLI, BioLux2)

      • Surgical: similar w/ primary patency 61%, limb salvage 88.5% (PREVENT III trial)

    • Popliteal aneurysms: surgical repair superior to endovascular long term despite lower post-op complications and length of stay

    • Bypass graft occlusion: 

      • Early thrombosis often associated with technical defect and needs surgical repair

      • Delay endovascular intervention at least 14d after vein graft and 30d after synthetic graft creation

      • Late thrombosis often associated with poor inflow or outflow stenosis

    • Artherectomy/plaque modification - role unclear due to risks of distal emboli and restenosis. See Disrupt PAD III trial for best real world data.

      • Currently no high quality studies supporting its use though there are smaller and industry sponsored trials. Example below.

      • Rotarex Atherectomy and Thrombectomy System (n=220): technical success 47% with device alone vs 94.1% used with others, freedom from TLR 97% at 1mo sustained at 6 and 12mo

  • History and exam to rule out other etiologies of leg pain (e.g. neurologic, cellulitis, venous insufficiency)

    • Most predictive exam findings: ulcers, asymmetric coolness, absent femoral pulse, limb bruit

    • Other supportive findings: absent distal pulse, venous refill, skin change (pallor,  erythema ab igne, Buerger’s test), capillary refill, atrophic skin, hair loss

  • Combined physiologic and anatomic testing to characterize disease if not CLI

    • Physiologic > anatomic: segmental limb pressures (upper thigh should be 30-40 mmHg > brachial), doppler waveform, pulse volume recordings, exercise testing (drop in ABI, reproduce symptoms)

    • Anatomic > physiologic: MRA, CTA > duplex scanning. 

    • Tissue perfusion: 

      • Skin perfusion pressure (SPP, cheaper and faster, mmHg): >50 (nml), 40-50 (mild ischemia), 30-40 (gray zone), <30 (critical ischemia, poor healing)

      • Transcutaneous oximetry test (TcPO2, longer and more expensive, mmHg):  >70 (nml), 30-40 (impaired wound healing), <30 (critical ischemia, poor healing)

  • Optimize medical management (aka keep the patient alive): 

    • Diet and exercise (superior to stenting and best medical therapy in CLEVER trial, both supervised and home-based shown to be effective), smoking cessation, diabetes control (A1c<7, metformin, SGLT2 inhibitors), BP control (<120/80 per SPIRIT trial), statins/LDL reduction (e.g. atorvastatin) 

    • Antiplatelets: Plavix (75 mg) superior to ASA (325 mg) in CAPRIE trial. DAPT provides no additional benefit with increased bleeding risk.

    • Ticagrelor equivocal to clopidogrel for preventing CV events in patients with PAD. Bleeding events the same. (EUCLID trial)

    • Rivaroxaban 2.5 mg BID + ASA is superior to ASA alone but increased risk of bleeding in pts with atherosclerotic vascular disease (COMPASS trial, 3.1 v 1.9% major bleeding) and PAD after recanalization (VOYAGER PAD trial, HR 1.42 for major bleeding). Likely due to evidence that thrombin levels are systemically elevated in patients with PAD.

    • Cilostazol 100 mg BID: only medication superior to placebo but has FDA black box warning for CHF. Can try reduced dose to 50 mg BID. Both doses effective in multiple RCTs.

  • Hold clopidogrel 5d prior and LMWH 1 dose prior

  • Consider premedication with 325 mg ASA for 3d prior, 10 mg sublingual nifedipine if concern for vasospasm

  • (Optional) Some use a popliteal sciatic nerve block to help with pain.

  • Access(es): Many different approaches and techniques: contralateral vs ipsilateral femoral vs radial vs retrograde pedal (e.g. TAMI)

    • Contralateral CFA is a good general approach but has more limited pushability and wire/catheter control for crossing difficult lesions.

    • Ipsilateral CFA/SFA access improves pushability and control but may require SFA access and sometimes awkward ergonomics if the patient has a large panus.

    • Radial access is good for patient comfort but requires very long tools with limited pushability and control

    • Retrograde pedal access is a good alternative but may be limited by vessel/sheath size for devices. Often a good adjunct with CFA access to cross difficult lesions. Only PT or AT due to risk of compartment syndrome with peroneal access. Requires similar cocktail (“TAMI solution”) to radial access, e.g., heparin 2000U, nitroglycerin 200 mcg, verapamil 2.5 mg.

  • Some start with advancing a 4 Fr Omni flush catheter in to the abdominal aorta and bilateral external iliacs for pelvic and bilateral lower extremity diagnostic angiograms prior to sheath access. If no intervenable lesion, the catheter can be removed and with only a 4 Fr hole in the artery.

    • Advance Omni flush over a working wire (e.g. Bentson, Coons). Can then use an angled glidewire to select the contralateral external iliac and advance the Omni flush.

    • Historically a significant lesion has been defined as >50% stenosis, mean gradient >5 mmHg or systolic gradient >10 mmHg, though measuring pressures is rare.

    • Consider contrast reduction techniques with ESRD, e.g, 1 mL contrast in 9 mL saline still makes decent imaging or CO2 proximal to tibials.

    • Low viscosity contrast such as Visipaque can be used to improve patient comfort over Isovue.

    • Be wary of anatomic variants such tibioperitoneal trifurcation (2.0%), shared origin of peroneal and AT (1.2%), high AT takeoff (3.0%), congenitally hypoplastic tibial vessels (3.8%)

  • Establish stable sheath access. Some recommend 6 Fr for CFA access as nearly all devices will fit while 5 Fr access may limit you. Often 4 Fr is required for pedal access. Longer sheaths are helpful for contralateral CFA access to improve pushability and control.

  • If treating, administer 70-100 U/kg heparin for ACT 250-300 (Angiomax is a heparin alternative).

  • Cross target lesion: Many different approaches and techniques. Key is to recognize when the wire is luminal vs subintimal and confirm reentry (lumen to lumen) before plasty or stenting.

    • CTOP classification can be helpful to predict where wire will tend to course for different occlusions.

    • Many start with a long (e.g. 300 cm) 0.014” wire (e.g. Abbott Command, Asahi Gladius, Luge, Stabilizer PTX, Pilot 50, Glidewire Advantage) or 0.018” wire (e.g. Boston Sci V18, SV5, Terumo GT or Glidewire advantage) plus a curved and/or crossing catheter [e.g. Bern, Cook CXI (avoid if egg allergy), Cordis Frontrunner, Bard Crosser, Boston Sci TruePath] or “screwing” catheters (e.g. Corsair, Turnpike).

      • NOTE Most DES and atherectomy devices require an 0.014” wire.

    • Cheap (<$50) approach is VER catheter + LLT wire, which works for many lesions

    • If unsuccessful, subintimal crossing with reentry can be effective, especially below the knee. Example devices for lumen re-entry: Pioneer Reentry catheter (Volcano), OffRoad Balloon (Boston Scientific), and Outback (Cordis).

    • Other described approaches for refractory lesions include sharp recanalization with a 65 cm chiba needle (Cook), carefully using fluoroscopy in multiple projection and ultrasound to try to stay intravascular.

  • The subsequent intervention varies between and with combinations of thrombolysis, thrombectomy, angioplasty, stenting, and deep vein arterialization (DVA)

    • Thrombectomy:

    • Thrombolysis:

      • Good optional for more extensive acute to subacute thrombus that may facilitate additional interventions the next day.

      • May need smaller profile catheters below the popliteal or the catheter will be occlusive and won’t work, e.g., 4 Fr Cragg-McNamara/Unifuse or 2.9 Fr MicroMewi

      • Agents: recombinant tPA (r-tPA, 0.25-0.5 mg/hr), reteplase (rTA, 0.25-0.5 U/hr), tenecteplase (TNK, 0.25-0.5 mg/hr)

      • Often people run 200-700 U/hr heparin via sheath during lysis, though some studies show no benefit

      • Some use combination of reteplase and abciximab (ReoPro)

    • Angioplasty:

      • Iliacs - only enough to pass the stent if stenting, particularly in EIA > CIA where rupture is more common and catastrophic, e.g., 4 mm balloon prior to stenting in common iliac and 8 atm rather than >10 atm. Careful for plasty of EIA, which is very prone to dissection.

      • General sizing 4-5 mm popliteal, 2-3 mm tibial, 2 mm pedal.

      • Previously suggested DCB mortality association likely untrue. DCB clearly superior to bland angioplasty in fem-pop for primary patency (LEVANT II, IN.PACT SFA, ILLUMENATE EU RCTs and global registries) but not below the knee.

    • Stenting: generally oversize ~1 mm

      • General indications include lesions refractory to plasty, flow limiting dissection, and after recanalization of total occlusion

      • Self expanding covered stents are ideal in the iliacs in terms of patency (COBEST trial, ICE trial) but uncovered stents may be helpful in the external iliac to avoid jailing off the internal iliac (need at least one side patent).

      • Balloon-expandable stents have better flexibility, radial force, and deployment precision so less risk of migration; BUT more rigid so less tolerable of external compression

      • ONLY current option below the knee is coronary balloon expandable stents off label.

      • Drug-eluting stent (e.g. Zilver PTX) superior to BMS in terms of 5yr primary patency (72.4 v 53.0%) and clinical benefit index (81.8 v 63.8%)

      • Avoid “raising the aortic bifurcation” when possible but can place short distal aortic stent graft (“aortic cuff”) with kissing iliac stents inside as necessary. This requires larger sheath access though.

      • Avoid crossing the inguinal ligament or treatment the CFA endovascularly as there are superior surgical options.

      • Respect the profunda and avoid damaging/jailing it at all costs

    • Intravascular Lithotripsy (IVL): generally oversize 0-10%

      • No prospective control trial to date but multiple studies suggesting better luminal gain and patency for heavily calcified atherosclerotic disease.

      • Delivers high effective pressure to disrupt calcium with low pressure insufflation (<10 atm). Minimal issues with distal embolization or dissection.

    • DVA: last resort, causes venous HTN so distal DVA ideal

      • LimFlow device (now FDA approved): technical success 99%, avoidance of death or amputation 66% at 6mo, 25% had complete wound healing

  • IVUS is likely helpful for guiding treatment per multidisciplinary international consensus. However, other note no clear evidence it helps.

  • Restoration of pulses can also help guide your end point

  • Ensure ACT <150-160 prior to removing sheath. Can use protamine to reverse heparin if necessary.

  • Closure devices primarily made for groin access. For pedal access, can inflate balloon via groin access, remove sheath, and place hemostasis device prior to deflating the balloon.

  • Check distal pulses via palpation and doppler

Higher for Rutherford 6 vs 4 or 5 disease, e.g., severe angiographic complications of 11.7% vs 14.7%

  • Hematoma (5-9%)

  • Dissection (3-6%)

  • Pseudoaneurysm (0.2-2%)

  • Thromboembolism (1-8%)

  • Perforation (2.0-2.5%)

  • Abrupt closure (2.3-3.1%)

  • Sepsis/MI/stent infection (0.2%)

  • Amputation (0.2%)

  • If lysis, people often monitor fibrinogen levels though there is little to no data supporting this practice so some have stopped checking it.

  • Optimize medical therapy as described above.

  • Some do DAPT for a few months followed by ASA for life (no clear evidence that clopidogrel, ticagrelor, or vorapaxar offer superior benefit given bleeding risks) 

  • Follow up clinic visit with ABI (or TBI if ABI >1.40) in 2-4 weeks then 3-6 months