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64 Interventional radiology and endovascular procedures
Clinical tip Re-entry devices
Re-entering the lumen can be problematic in the presence of heavy calcification, and devices such as the Cordis Corporation Outback® or the Medtronic Pioneer® re-entry catheters, which utilize an angled needle to puncture back into the true lumen, have been developed. Both have been shown to be safe and effective in managing peripheral chronic occlusions with a symptom-free interval of 12 months and no procedural or post-procedural complications [4].
Expert comment
Stenting into the popliteal artery can be problematic because of the repeated external compression of the stent when placed at flexion points of the vessel, leading to stent fracture. The IDEV Supera® interwoven nitinol stent has recently shown promising results in the popliteal segment with no stent fractures at one year in the SUPERB trial or at two years in a recent study [5] with significant improvements in symptom classification.
Clinical tip Antiplatelet
therapy
A recent study has shown that dual antiplatelet therapy was associated with reduced peri-interventional platelet activation and a reduced need for target lesion revascularization [6].
Figure 7.3 DSA demonstrating in-line flow
down the SFA following stent placement.
Figure 7.4 DSA demonstrating in-line flow
down the SFA through to the popliteal artery and tibioperoneal trunk following stent placement.
with contrast injection. The existing sheath was exchanged for a 6Fr sheath and multiple 7mm self-expanding nitinol stents (Covidien EverFlex®) were placed with a satisfactory angiographic result with no complications (Figures 7.3 and 7.4). Manual compression to the puncture site followed.
A 300mg loading dose of clopidogrel was administered in recovery and dual antiplatelet therapy with aspirin 75mg od and clopidogrel 75mg od prescribed after the procedure. Follow-up at three months demonstrated improved symptoms and ulcer healing, with a duplex examination showing stent patency with no in-stent restenosis.
Discussion
The prognosis for patients presenting with critical limb ischaemia (CLI) is poor not only for the limb but also for life. A year after diagnosis 25% of patients will have died and 30% will have required a major amputation [7,8]. Vascular death had
65Case 7 SFA endoluminal bypass: critical limb ischaemia treatment
occurred in about 25% of patients ve years after bypass surgery and in nearly 50% of patients after ten years, with the primary cause of death being vascular death [9].
The optimal treatment for patients presenting with CLI is revascularization, as it is associated with a much greater perioperative mortality and morbidity than amputation [10]. Extent of disease, morphology of the lesion(s), and distal run-off combined with patient comorbidities determine the method and success of revas­cularization. TASC guidelines [3] currently recommend that patients presenting with simple occlusive lesions (TASC A) are treated with endovascular therapy and those presenting with advanced occlusive lesions (TASC D) are treated with surgical bypass as a rst-line treatment. Endovascular procedures are only recommended for patients who have a low healing potential following surgical revascularization with TASC C lesions, and treatment recommendations for type B and type C lesions are based on the patient’s comorbidities, fully informed patient preference, and the local operator’s long-term success rates [3].
Endovascular therapy has shorter recovery times and lower morbidity and mortal­ity rates than surgery. Techniques and technology continue to improve and expand, making the treatment and outcomes for advanced disease more achievable by endo­vascular therapy. There are now many different percutaneous treatment options and methods available for recanalization of long-segment SFA occlusions including re­entry catheters, PTA with or without drug-eluting balloons, or self-expanding PTFE and drug-eluting stents. Re-entry catheters also allow accurate re-entry into the lumen following a subintimal approach with reduced risk of damaging healthy native vessel. Recent developments in stent technology for complex femoropopliteal lesions have been promising, with stenting shown to be superior to balloon angioplasty for long lesions. The latest generation of stents, including stent grafts, are of increased length (up to 20cm), have superior fracture resistance, allow complex long lesions to be treat­ed endovascularly, and have comparable outcomes to articial femoropopliteal bypass surgery. With the ever-increasing evolution of drug-eluting technology to further reduce in-stent restenosis rates and increase stent patency, it may be just a matter of time until TASC C and D lesions are primarily treated with endovascular techniques.
Evidence base Angioplasty
for the SFA
Technical and clinical success
>95% [11].
One-year patency 77% following
angioplasty of the stenosis and 65% following recanalization [3].
At three and five years, patency
rates decrease to 40–50% [3]
Sub-intimal angioplasty (SIA):
technical success reported to be
between 74% and 92% [12,13]
shown to be effective even with
unfavourable anatomy with up to 83% of limb salvage [14]
risk of vessel perforation is higher
for SIA than for conventional PTA with an overall risk of 5–8%, particularly in heavily calcified vessels [15]
Evidence base DEB for the SFA
Drug-eluting balloons (DEBs) coated with paclitaxel are showing promising results, as demonstrated in the following trials.
The Thunder trial (Paccocath–Cotavance technology) demonstrated that the use of paclitaxel-
coated angioplasty balloons during the treatment of femoropopliteal arterial disease was associated
with significant reductions in late lumen loss and target-lesion revascularization (TLR) (TLR at 24
months was 37% in standard balloon angioplasty versus 15% in the drug-coated balloon group)
[16].
The FemPac trial (Paccocath–Cotavance technology) demonstrated reduced restenosis in patients
undergoing angioplasty of femoropopliteal arteries (TLR at 18–24 months was 50% in the standard
balloon angioplasty versus 13% in the drug-coated balloon group) [17].
Levant 1 trial (Lutonix MoxyTM paclitaxel-coated balloon): the six-month average late lumen
loss, the trial’s primary end point, was 0.46mm in patients in the paclitaxel-coated balloon group
compared with 1.09mm for the conventional angioplasty control group (p=0.016). There was also
a non-significant trend in favour of the druft5>g-coated balloon for target lesion revascularization
(13% versus 22%).
The Pacifier trial (Medtronic In.Pact PacifierTM paclitaxel-coated balloon) demonstrated a lower rate
of late lumen loss (0.01mm) associated with the use of the drug-eluting balloon compared with
patients treated with an uncoated balloon (0.65mm). TLR at one year was 7.1% for the DEB versus
34.9% for the uncoated balloon.
66 Interventional radiology and endovascular procedures
Evidence base Surgery for
the SFA
The large UK Bypass versus Angioplasty in Severe Ischaemia of the Leg trial compared bypass surgery with PTA/SIA for patients with femoropopliteal disease and severe limb ischaemia [25].
The primary outcome,
amputation-free survival after 6 months, did not differ between groups.
There was no difference in all-
cause mortality or quality of life at two years between the groups.
Surgical therapy was more
expensive than endovascular treatment.
Re-intervention rates were
significantly higher in the angioplasty group (28% versus 17%).
Evidence base Stents for the SFA
Late restenosis secondary to intimal hyperplasia remains the Achilles heel of stenting.
Four randomized trials (Absolute, Fast, Resilient, Scirocco II) for PTA versus stent have not shown a
convincing advantage in favour of stents for short femoropopliteal stenoses (<10cm).
New generation stents are designed to try and combat the problems of restenosis and stent
fracture.
67% one-year restenosis with angioplasty compared with 37% for nitinol stent deployment [18.]
New PTFE-lined stents have been designed to try and prevent in-stent restenosis through
ingrowth
Studies have demonstrated comparable patency rates over one, two, and 4 years between
PTFE-lined stents (Gore ViabahnTM) and surgical bypass with synthetic material (Dacron or PTFE) [19–21] with significantly reduced hospital stay for the covered stent group (0.9 versus 3.1 days) [19].
Evidence base DES for the SFA
Sirolimus-coated stents
The SIROCCO trials [22,23] compared sirolimus-coated stents with bare metal stents. They failed
to show a demonstrable efficacy of DESs compared with bare metal nitinol stents.
Everolimus-coated stents
The STRIDES trial suggested improved patency of everolimus-coated stents versus bare metal
stents at six months but this was not sustained at 12 months.
Paclitaxel-coated stents
Recent trials evaluating paclitaxel-eluting stents for above knee lesions demonstrated promising
anatomical and clinical results with 86% primary patency rate at 12 months [24]
Recently released but unpublished three-year data from the Zilver PTX (Cook Medical)
randomized controlled trial of paclitaxel-eluting stents for femoropopliteal disease have shown 70.7% primary patency in the SFA at 36 months for patients treated with the Zilver PTX paclitaxel-eluting stent. This compares with 49.1% patency for patients with percutaneous transluminal angioplasty nd provisional bare metal stent placement in the study of 479 patients.
A final word from the expert
This case study highlights the increasing practice of treating TASC C and D lesions with endovascular techniques. Unfortunately, traditionally many centres have poorly monitored theses patients post procedure. Medium to long term patency of an ‘endoluminal bypass’ can be improved if a more robust regime of follow up is pursued with regular duplex imaging and secondary interventions performed where required in the manner that most vascular surgeons follow up and maintain patency of bypass grafts. If such an approach is more widely adopted it is only a matter of time before endovascular therapy is considered the primary treatment of choice.
References
1. Rutherford RB, Baker JD, Ernst C, et al. Recommended standards for reports dealing with lower ext remity ischemia: revised version. J Vasc Surg 1997; 26(3): 517–38. Erratum. J Vasc Su rg 2001; 33(4): 805.
2. Fontaine R, Kim M, Kieny R. [Surgical treatment of peripheral circulation disorders.] Helv Chir Acta 1954; 21(5-6): 499–533 (in German).
3. Norgren L, Hiatt W, Dormandy J, et al. Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Eur J Vasc Endovasc Surgery 2007; 33(Suppl 1): S1–S75.
4. Smith M, Pappy R, Hennebry T. Re-entry devices in the treatment of peripheral chronic occlusions. Tex Heart Inst J 2011; 38(4): 392–7.
5. Scheinert D, Grummt L, Piorkowski M, et al. A novel self-expanding interwoven nitinol stent for complex femoropopliteal lesions: 24-month results of the SUPERA SFA registry. J Endovasc Ther 2011; 18(6): 745–52.
6. Tepe G, Bantleon R, Brechtel K, et al. Management of peripheral arterial interventions with mono or dual antiplatelet therapy—the MIRROR study: a randomized and double­blinded clinical trial. Eur Radiol 2012; 22(9):1998–20 06.
7. Norgren L, Hiatt WR, Dormandy JA, et al., Inter-Society Consensus for the Management of Peripheral Arterial Disease (TASC II). Available at: <www.tasc-2-pad.org> (accessed October 2007).
8. Gottsater A. Managing risk factors for atherosclerosis in critical limb ischaemia. Eur J Vasc Endovasc Surg 2006; 32(5): 478–83.
9. Van Hattum ES, Tangelder MJ, Lawson JA, et al. Long-term risk of vascular events after peripheral bypass surgery. A cohort study. Thromb Haemost 2012; 108(3): 543–53.
10. Santilli JD, Santilli SM. Chronic critical limb ischemia: diagnosis, treatment and progno­sis. Am Fam Physician 1999; 59(7): 1899–1908.
11. Muradin GS, Bosch JL, StijnenT, Hununk MG. Balloon dilation and stent implantation for treatment of femoropopliteal arterial disease: meta-analysis. Radiology 2001; 221:137– 45.
12. Yilmaz S, Sindel T, Yegin A, et al. Subintimal angioplasty of long supercial femoral artery occlusions. J Vasc Interv Radiol 2003; 14: 997–1010.
13. Flørenes T, Bay D, Sandbaek G, et al. Subintimal angioplasty in the treatment of patients with intermittent claudication: long term results. Eur J Vasc Endovasc Surg 2004; 28: 645–50.
14. Kim JS, Kang TS, Ahn CM, et al. Efcacy of subintimal angioplasty/stent implantation for long, multisegmental lower limb occlusive lesions in patients unsuitable for surgery. J Endovasc Ther 2006; 13: 514–21.
15. Hayes PD, Chokkalingam A, Jones R, et al. Arterial perforation during infrainguinal lower limb angioplasty does not worsen outcome: results from 1409 patients. J Endovasc Ther 2002; 9: 422–7.
16. Tepe G, Zeller T, Albrecht T, et al. Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg. N Engl J Med 2008; 358(7): 689–99.
17. Werk M, Langner S, Reinkensmeier B, et al. Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial. Circulation 2008 23; 118(13): 1358–65.
18. Schillinger M, Sabeti S, Loewe C, et al. Balloon angioplasty versus implantation of nitinol stents in the supercial femoral artery. N Engl J Med 2006; 354: 1879–88.
19. Kedora J, Hohmann S, Garrett W, et al. Randomized comparison of percutaneous Viabahn stent grafts vs prosthetic femoral-popliteal bypass in the treatment of supercial femoral arterial occlusive disease. J Vasc Surg 2007; 45: 10–16.
20. McQuade K, Gable D, Hohman S, et al. Randomized comparison of ePTFE/nitinol self­expanding stent graft vs prosthetic femoral-popliteal bypass in the treatment of super­cial femoral artery occlusive disease. J Vasc Surg 2009; 49(1): 109–16.
21. McQuade K, Gable D, et al. Four-year randomized prospective comparison of percutane­ous ePTFE/nitinol self-expanding stent graft versus prosthetic femoral-popliteal bypass in the treatment of supercial femoral artery occlusive disease. J Vasc Surg 2010; 52(3): 584–91.
67Case 7 SFA endoluminal bypass: critical limb ischaemia treatment
68 Interventional radiology and endovascular procedures
22. Duda SH, Bosiers M, Lammer J, et al. Drug-eluting and bare nitinol stents for the treat­ment of atherosclerotic lesions in the supercial femoral artery: long-term results from the SIROCCO trial. J Endovasc Ther 2006; 13: 701–10.
23. Duda SH, Bosiers M, Lammer J, et al. Sirolimus-eluting versus bare nitinol stent for obstr uctive supercial femoral ar tery disease: the SIROCCO II trial. J Vasc Interv Radiol 2005; 16: 331–8.
24. Dake MD, Scheinert D, Tepe G, et al; Zilver PTX Single-Arm Study Investigators. Nitinol stents with polymer-free paclitaxel coating for lesions in the supercial femoral and popliteal arteries above the knee: twelve-month safety and effectiveness results from the Zilver PTX single-arm clinical study. J Endovasc Ther 2011; 18(5): 613–23.
25. Adam DJ, Beard JD, Cleveland T, et al. Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL): multicentre randomised controlled trial. Lancet 2005; 366: 1925–34.
CASE
8
Below the knee angioplasty: bare versus drug-eluting stents
Stavros Spiliopoulos
Expert commentary Dimitrios Siablis
Case history
A 74-year old patient suffering from critical limb ischaemia (CLI) of the left lower limb was scheduled to undergo angiographic evaluation of the peripheral arterial bed and subsequent percutaneous endovascular revascularization attempt in the interventional radiology department. The patient’s baseline symptomatology was severe rest pain that was not responding to common analgesics, while physical examination revealed dry gangrene of the left toe and stage 5 CLI according to the Rutherford–Becket classication of peripheral arterial occlusive disease (PAOD). The ankle–brachial index (ABI) at presentation was 0.60.
Learning point
CLI is a manifestation of PAOD that describes patients with typical chronic ischaemic rest pain or with ischaemic skin lesions, either ulcers or gangrene (Fontaine III–IV and Rutherford–Becker 4–6 classifications). The diagnosis of CLI should be confirmed by the ABI and toe systolic pressure. Ischaemic rest pain most commonly occurs with an ABI ≤50mmHg or toe pressure ≤30mmHg. In the presence of ulcers or gangrene, CLI is suggested by an ABI <70mmHg or a toe systolic pressure <50mmHg. However, currently there is no consensus regarding the vascular haemodynamic parameters required to make the diagnosis of CLI. Moreover, ABI measurement can produce false­positive outcomes in diabetic patients because the reduced vessel wall elasticity results in increased ABI values. Finally, it should be noted that, by definition, the term CLI refers to patients with chronic ischaemia (presence of symptoms for more than two weeks) [1].
The patient suffered from multiple comorbidities including ischaemic coronary disease, chronic kidney failure under dialysis, and insulin-dependent diabetes mel­litus and was judged unt for surgery by the vascular surgery department. The decision to attempt a percutaneous endovascular approach was taken in a multi­disciplinary meeting between interventional radiologists, vascular surgeons, and nephrologists. No history of allergies, coagulation disorder, or other contraindica­tion to percutaneous endovascular treatment was present. Baseline demographics are reported in Table 8.1.
Pre-procedural Doppler examination revealed haemodynamically signicant multilevel disease of the left supercial femoral artery (SFA) and below the knee (BTK) vessels, but no signicant lesions were detected in the left iliac and common femoral arteries.
70 Interventional radiology and endovascular procedures
Table 8.1 Patient’s baseline demographics and procedural details
Gender Male Age (years) 74 Baseline Rutherford–Becket classification of PAOD 5 Baseline ankle–brachial index (ABI) 0.65 Body mass index (BMI) 22.5 (normal) Comorbidities Coronary disease
Medication Index lesion length 90mm Stented lesion 94mm Pre-procedural minimum vessel diameter 1.0mm Post-procedural minimum vessel diameter 3.0mm Remaining stenosis 0%
Clinical tip
Pre-procedural imaging prior to BTK interventions should provide accurate information about the inflow and the infrapopliteal arterial status and includes multidetector computed tomography angiography (MDCTA), contrast-enhanced magnetic resonance angiography (CEMRA), high-frequency duplex ultrasound (HFDU), and digital subtractive angiography (DSA) [1–3]. Choosing which imaging modality should be performed is case sensitive as each method presents specific advantages and disadvantages. Nonetheless, appropriate procedural planning necessitates detailed pre-procedural evaluation of the iliac arteries, the common femoral arteries, the SFA, the popliteal and infrapopliteal arteries, and the distal foot vasculature.
Insulin-dependent diabetes mellitus Hypercholesterolaemia Chronic renal failure (dialysis) Insulin, β-blockers, statins, clopidogrel
Expert comment
In patients who are not already under antiplatelet therapy, dual antiplatelet therapy with oral clopidogrel (75mg/day) and aspirin (100mg/day) is recommended at least three days prior to infrapopliteal intervention. In cases where this three-day antiplatelet regiment is not applied, a loading dose of clopidogrel 300mg (12 hours before the procedure) or clopidogrel 600mg (2 hours before the procedure) can be administered [4].
Pre-procedural laboratory examinations included baseline complete blood count, platelets, and clotting prole (INR, prothrombin time, partial thromboplastin time). The patient was already under antiplatelet therapy with clopidogrel 75mg 1 × 1 due to coronary disease.
Based on the pre-procedural imaging a decision was taken to perform a direct antegrade common femoral artery access as it allows easier catheter manoeuvres as well as better pushability and trackability of all the endovascular materials, especially when dealing with calcied distal occlusions. In our department local anaesthesia and arterial puncture is obtained under ultrasound guidance as it has been reported to produce a superior analgesic effect [5]. A 4Fr sheath was positioned in order to perform a selective diagnostic DSA, which revealed multiple signicant stenosis (up to 80%) of the left SFA. The sheath was upgraded to 6Fr and the lesions were negotiated using a standard straight hydrophilic guidewire and a 4Fr vertebral catheter which was subsequently used to perform an angio­graphic evaluation of the BTK arteries. Selective DSA revealed occlusions from the origin of the anterior and posterior arteries, signicant tortuous stenosis (50–60%) and one near-occlusion at the rst segment of the peroneal artery, which was the only patent infrapopliteal vessel (Figure 8.1a). The arterial supply of the distal foot was maintained by the distal peroneal collateral network (Figure 8.1e). The peroneal artery demonstrated marked calcications of the vessel wall, typical of
(a) (b) (c)(d) (e)
Figure 8.1 (a) Baseline selective angiogram of the infrapopliteal arteries. Occlusion of the anterior
and posterior tibial arteries is noted. The peroneal artery is the only patent vessel to the distal foot. (b) Magnified picture demonstrating a 50–60% stenosis (arrow) and a near-occlusion (distal arrow) at the proximal segment of the peroneal artery. (c) DSA at an angle of 45° with respect to the previous DSA, demonstrating areas of turbulent flow (double arrows) indicating marked atherosclerosis. (d) No other significant lesions were detected in the mid and distal segments of the peroneal artery; (e) the arterial supply of the distal foot was preserved by collaterals.
71Case 8 Below knee angioplasty: bare vs drug-eluting stents
Expert comment
Decreased contrast media enhancement of a specific infrapopliteal arterial segment combined with decreased arterial flow should be considered as a radiological sign of flow-limiting atherosclerotic disease and treated appropriately.
patients who undergo dialysis, while the whole proximal peroneal segment gave the impression of diffuse atherosclerotic disease in various runs performed at dif­ferent angles (Figures 8.1b, c).
A decision was taken to perform direct overlapping stenting of the entire proxi­mal peroneal segment using balloon-expandable sirolimus-eluting stents (CYPHER Select©, Cordis, NJ, USA). A bolus dose of 5000IU of heparin was administered intra-arterially and balloon angioplasty of the SFA was successfully performed. The BTK lesions were crossed successively using a 0.014 inch guidewire (PT2® Guide Wire, Boston Scientic, MA, USA). The rst stent (3 × 33mm) was deployed in the proximal segment (Figure 8.2a). A check angiogram after the deployment of the rst stent demonstrated elastic recoil of the previously pre-dilated near­occlusion. The remaining segment was treated using two DESs (2.75 × 33mm a nd
2.75 × 28mm), again in an overlapping manner (Figure 8.2b). At the end of the procedure a straight arterial line of high antegrade ow down to the distal foot was achieved (Figure 8.2c).
Quantitative-vessel analysis using integrated semi-automated software (Allura Xper FD20, Philips, Amsterdam, The Netherlands) demonstrated 0% remaining ste­nosis at the end of the procedure, and the minimum diameter of the treated arterial vessel increased from 1.0mm to 3.0mm after stenting. Arterial haemostasis was obtained using an extra-luminal clip-based vascular closure device (StarClose®, Abbott Vascular Devices, CA, USA) and no immediate or short-term complications were noted. Dual antiplatelet therapy with aspirin 100mg 1 × 1 and clopidogrel 75mg 1 × 1 for six months followed by clopidogrel 75mg 1 × 1 for life was prescribed, and
72 Interventional radiology and endovascular procedures
(a) (b) (c)
Figure 8.2 Stenting procedure. (a) DSA image following the deployment of a 3 × 33mm DES in the
proximal segment of the lesion (double arrow). (b) A second 2.75 × 33mm DES was deployed across the distal part of the lesion (double-headed arrow). The arterial segment between the two stents (circled area) was subsequently covered with a 2.75 × 28mm DES. The lesion was post-dilated with a
3.5 × 80mm balloon. (c) Final check angiogram demonstrating a straight arterial flow with no evidence of dissection or remaining stenosis along the treated area. Note the increased contrast enhancement compared with Figure 1c.
the patient was discharged after overnight hospitalization. Post-procedural surgical care was advised with clinical follow-up of regular visits at one and six weeks, six and twelve months, and annually thereafter. Imaging follow-up included Doppler ultrasound at three and six months, as well as annual DSA. After three months follow-up the ABI gradually reached 0.8 which permitted the vascular surgeon to safely perform surgical debridement to induce better wound healing. During the three- and six-month follow-up periods there were no signs of SFA or peroneal restenosis on Doppler ultrasound. The Rutherford–Becker classication at six and twelve months follow-up improved from 5 to 2 (moderate claudication). Complete wound healing was noted after twelve months follow-up (Figure 8.3). Follow-up angiography after two years revealed a patent peroneal artery with no evidence of in-stent restenosis (Figure 8.4). After three years clinical follow-up the patient is alive and has not suffered any major or minor amputation, and there are no signs of clinical relapse.
73Case 8 Below knee angioplasty: bare vs drug-eluting stents
(a) (b) (c)
Figure 8.3 Follow-up. (a) Magnified DSA image after two years follow-up shoeing a completely
patent peroneal artery with no evidence of in-stent restenosis. (b) Magnified single-exposure picture demonstrating the stent’s integrity. Note the heavily calcified arterial wall, typical of dialysis patients. (c) The peroneal artery is patent to the distal foot.
Baseline 6 months 12 months
(a)
Figure 8.4 Photographic documentation of wound status. (a) Pre-procedural gangrene. (b) Photo taken
six months after the procedure, following surgical debridement. (c) Complete wound healing after follow­up for one year.
(b) (c)