British Journal of Radiology (2004) 77, 1007-1015
© 2004 British Institute of Radiology
doi: 10.1259/bjr/97382129
The role of infrapopliteal angioplasty
D Tsetis, MD and
A-M Belli, FRCR
Department of Radiology, St George's Hospital, Blackshaw Road, London SW17 0QT, UK
Correspondence: Dr Anna-Maria Belli
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Abstract
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Infrapopliteal percutaneous transluminal angioplasty (PTA) is currently indicated in patients with critical limb ischaemia (CLI). It may be performed after femoral angioplasty or bypass surgery, to improve outflow and hence patency of the proximally treated segment. Patients with CLI are typically elderly with multiple co-morbidities and limited life expectancy and therefore, a procedure, which is minimally invasive with reduced morbidity and mortality but lesser long-term patency, may be more appropriate than a more invasive procedure with better long-term patency. Clinical success is superior to angiographic patency, because once healing has occurred, should the artery restenose or occlude, collateral flow can be sufficient to preserve tissue integrity if there is no further injury. Although no prospective randomized trials have been performed, the reported limb-salvage rates of PTA are comparable with surgery. As PTA carries a lower morbidity and mortality, shorter hospital stay and does not preclude surgery, it is ideal for this group of patients who are high-risk surgical candidates. Improvements in guide-wire and catheter technology and recanalization techniques mean that very long stenoses or occlusions, and multiple lesions can be treated successfully. At the current time, PTA is the treatment of choice for infrapopliteal occlusive disease; experience with the use of stents in this territory is increasing but currently insufficient to justify their primary use.
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Introduction
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Percutaneous transluminal angioplasty (PTA) of tibioperoneal arteries dates back to the time of Dotter and Judkins original work [1] but until recently has been far less widely reported in the literature compared with PTA of aortoiliac and femoropopliteal segments. This was partly due to the poor results initially experienced with the original guide wires and catheters. With the advent of fine wires, small gauge catheters and greater operator experience in other vascular territories, infrapopliteal PTA has been increasingly applied to patients with critical limb ischaemia (CLI). Patients with atherosclerotic disease confined to the infrapopliteal arteries may be asymptomatic due to the excellent collateral network which develops between tibial arteries; one patent tibial artery is often sufficient to keep a patient free from ischaemic symptoms [2]. When these patients present with CLI they often have severe, extensive three-vessel disease and only 20–30% have a simple, focal lesion with good distal run-off [3, 4]. Patients are usually elderly with several co-morbidities, such as diabetes and coronary artery disease, which increases the surgical risk. Femorodistal and pedal bypass surgery is technically demanding and associated with a 1.8–6% perioperative mortality [5, 6].
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Morphological lesion classification and treatment options
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Complexity and length of the lesion should be taken into consideration when deciding whether endovascular therapy or surgery is indicated, as these parameters are important determinants of short and long term clinical outcome of the treatment offered.
According to the Transatlantic Intersociety Consensus (TASC) Document on Management of Peripheral Arterial Disease (PAD) tibial arterial lesions are classified into four groups:
- Group A consists of single stenoses shorter than 1 cm. Endovascular treatment is recommended for this group as long-term results can be expected to be good.
- Group B consists of multiple focal (<1 cm) stenoses of the tibial or peroneal arteries (including up to two focal stenoses at the tibial trifurcation) and short tibial or peroneal stenoses in conjunction with femoropopliteal disease. These are most commonly treated by endovascular means.
- Group C consists of longer stenoses 1–4 cm and occlusions 1–2 cm as well as extensive stenoses at the tibial trifurcation. Traditionally, these were most commonly treated surgically.
- Group D consists of occlusions longer than 2 cm and diffusely diseased tibial vessels, traditionally considered too extensive for endovascular treatment.
However, due to the improvements in equipment and technique, endovascular therapy is now considered a feasible option in groups C–D. In addition the presence of co-morbid conditions and operator skills should be considered when making the final decision.
Patients with infrapopliteal lesions alone or in conjunction with femoropopliteal disease are amongst those with the highest likelihood of coronary heart disease [7–10]. PTA is a low-risk and minimally invasive procedure, which rarely compromises a later surgical procedure, and at the same time preserves the saphenous vein for future coronary or lower extremity distal bypass surgery [11]. The total intervention time of infrapopliteal PTA is typically less than 2 h, whilst surgical techniques have a reported mean operation time of 4 h [12]. It also avoids general anaesthesia and the hospital stay is shorter compared with surgical treatment [13]. Repeat PTA, unlike repeat surgical bypass operations, can be easily performed in case of restenosis [14]. For all these reasons, many vascular units now consider endovascular treatment as the first treatment option in critical limb ischaemia (Figure 1
), and reserve surgical revascularization for those where endovascular treatment has failed.
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Figure 1. (a) A 14 cm long occlusion of below-knee popliteal artery, common peroneal trunk and proximal peroneal artery in a patient with critical limb ischaemia. (b) After successful recanalization and balloon dilatation.
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Clinical indications for infrapopliteal angioplasty
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Critical limb ischaemia
This is an increasingly common condition with an estimated incidence of 400–1000 per million population per year [15, 16]. Arterial insufficiency in this group of patients results in skin breakdown, tissue loss (ulcer or gangrene) or foot pain at rest and requires active intervention. These patients are classified to Fontaine stages 3, 4 and categories 4, 5, 6 according to the new Society for Vascular Surgery–International Society for Cardiovascular Surgery (SVS-ISCVS) reporting standards [17], respectively.
This group of patients is characterized by a high mortality rate from cardiovascular disease (46% at 5 years) [18] and a 25% amputation rate despite attempts at revascularization [19].
The typical pattern of disease in CLI includes multiple stenoses and occlusions in the arterial tree from the superficial femoral artery (SFA) to the pedal arch [20]. However, in 25% of patients with CLI, the lesions are confined to the infrapopliteal arterial territory [21]; these patients are predominantly diabetics and are characterized by more extensive disease with calcified and less compliant crural vessels [21, 22].
The traditional surgical treatment for these patients is bypass or primary amputation. Patients with CLI undergoing successful revascularization survive longer and have an increased quality of life compared with patients who have an amputation [23, 24]. Therefore restoration of adequate blood supply to the foot should be attempted whenever possible in all these patients. In those with significant medical co-morbidities, absence of suitable veins to act as conduits for bypass, or inadequate sites for distal anastamosis (no angiographically visible tibial vessels, vessels
1 mm in diameter, or diffusely diseased vessels), PTA may be the only realistic therapeutic option [25].
Even if amputation cannot be avoided, infrapopliteal PTA may allow a lesser amputation in patients who would otherwise have needed a major amputation [26].
Severe claudication
Infrapopliteal PTA is usually reserved for patients with limb-threatening ischaemia as inadvertent occlusion of tibial vessels may occur as a complication of the technique and may threaten an otherwise viable limb. However, because the complication rate is low, some authors recommend infrapopliteal PTA in relatively simple lesions in patients with disabling claudication (walking distance of less than 200 m – Fontaine stage IIb) [2, 27–29] (Figure 2).
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Figure 2. (a) A 1 cm long stenosis of the tibio-peroneal trunk in a patient with disabling claudication. (b) After successful balloon dilatation.
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Prevention of proximal PTA or bypass failure
The saphenous vein is the most suitable graft material for femorodistal bypass. However in the first year after surgery there is a risk of developing graft stenoses, which may threaten patency of the graft [30, 31]. Endovascular interventions may be effective in managing these stenoses, saving the patient a repeat surgical procedure, and obviating the need to use additional native veins or prosthetic materials for distal reconstruction [11]. Endovascular techniques can be used to treat short proximal or distal anastomotic stenoses, in-graft stenoses, or stenoses of the inflow or outflow arteries.
Distal run-off influences long-term patency rates after femoropopliteal PTA or bypass surgery [32–39]; patients with 2–3 patent vessels have significantly better long-term patency rates after femoropopliteal PTA than patients with 0–1 patent calf arteries. In this context PTA could be justified even in claudicants to improve durability of more proximal (PTA and bypass) procedures.
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Technique of infrapopliteal angioplasty
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The technique for infrapopliteal PTA is similar to PTA in other territories. The infrapopliteal arteries are sensitive to manipulation and antispasmodics are recommended during the procedure. As finer wires and catheters are adopted from coronary technology, smaller sheaths may be used in the femoral artery. If rapid exchange catheters are used, a guiding catheter may be of value to provide proximal support. The balloon dimensions are chosen according to the size of the artery and the length of the lesion.
Stenoses and short occlusions are usually crossed intraluminally but subintimal recanalization is applicable in longer occlusions of 5 cm or more [40]. In resistant lesions, other techniques may be applied e.g. vibrational angioplasty [41, 42], which is a low-energy mechanical technique [43].
Optimal imaging of the vessels should always include a lateral foot projection, as the status of the pedal arch is very important for the procedural outcome.
Anticoagulation regimens vary with some operators giving a single bolus of 5000 units of heparin at the beginning of the procedure, whilst others continue anticoagulation for 24–48 h (1000–1200 U h–1) with an activated partial thromboplastin time of 60 s to 80 s in cases of extensive disease or in prolonged procedures. Acetylsalicylic acid (aspirin) (100–250 mg day–1) is routinely given to all patients. When long complex lesions have been treated or following stent implantation, a more aggressive antithrombotic regimen supported by the coronary literature could be applied: low-molecular heparin for 2–14 days and a combination of aspirin (50–350 mg daily) and clopidogrel (300 mg starting dose followed by 75 mg daily) [44–47]; however this regimen is associated with more puncture site complications [20].
Stenting
There are few reports of stenting in the infrapopliteal arteries. As most procedures are performed for limb salvage, stenting may be advantageous when a successful recanalization procedure is jeopardized by flow limiting dissection or recoil of the vessel. Most coronary stents are applicable in the tibioperoneal arteries, but suitably sized peripheral stents are now available.
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Results of infrapopliteal angioplasty
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The technical success rates of infrapopliteal angioplasty range between 78% and 100% [3, 14, 27–29, 38, 40, 48–56]. Primary patency rates for PTA in crural vessels vary widely and range between 13% and 81% at 1 year and between 48% and 78% at 2 years [14, 57–59]. Occlusion length >10 cm seems to be an adverse factor both for technical success and patency [60].
However, the limb salvage rate is higher at between 77% and 89% at 1 year [14, 40, 53, 57, 59–61] and one recent study reported a 94% limb salvage rate at 3 years [56]. The discrepancy between arterial patency and clinical success reflects the fact that continued relief of symptoms or avoidance of amputation is poorly correlated with long-term patency of the recanalized arterial segment [53]. This feature is more prominent in patients with tissue loss, especially with ulcers, than in those with rest pain. Ulcer healing reduces the oxygen demand and as a consequence less blood flow is generally required to maintain tissue integrity compared with the amount required for initial ulcer healing [62]. Collaterals may therefore be sufficient to preserve tissue integrity if there is no further injury [25].
Corresponding surgical figures for distal bypass grafting show limb salvage rates of the order of 81–88% at 1 year [5, 63–65], 88% at 2 years [65] and 80% at 3 years [5, 66–68]. However up to one-third of patients require repeated interventions to maintain graft patency and limb salvage [23]. In a recently published multicentre trial with more than 500 patients undergoing distal bypass surgery, less than half were alive without amputation and asymptomatic or with only mild symptoms of ischaemia after 12 months [69]. Nicoloff et al [70] also reported that only 14% of patients in their series who had limb-salvage surgery achieved the ideal target of an uncomplicated operation with long-term symptom relief, preservation of functional status and no recurrence or repeat surgery. Unfortunately there are no randomized trials comparing technical and clinical success and quality of life of infrapopliteal PTA with femorodistal bypass surgery.
Comparison between series of infrapopliteal PTA is difficult because in most of the studies patients with critical limb ischaemia are mixed with claudicants and there is absence of stratification for lesion length and run-off status [4]. Another problem with comparing arterial patency between series is that haemodynamic indices such as ankle: brachial pressure index (ABPI) and duplex studies are often unreliable in diabetic patients with severe calcification and in such cases repeat arteriography is the only reliable method of detecting vessel reocclusion [71].
The effect of different risk factors on PTA outcome has not been fully established. In the majority of the studies diabetics have a lower limb salvage rate [48, 72–75]. Reduced rates of ulcer healing in diabetics is thought to be due to persistent haemodynamic impairment in the distal crural arteries despite successful restoration of blood-flow in the proximal crural segments [75]. However some reports dispute that diabetes is a predictor of poor clinical success [14, 51]. Other adverse factors include renal insufficiency [4, 14] elevated lipoprotein (a) levels > 30 mg dl–1 [75], presence of ulceration or gangrene [48, 71] and lack of angiographic improvement achieved by PTA at the site of the most severe ischaemia [14]. According to some reports, extensive atherosclerotic disease has a negative effect on the outcome of the procedure [4, 29, 76]. Conversely, there are some reports stating that degree of occlusion, length of stenosis, or quality of distal run-off are not predictors of poor outcome [77, 78]. From a technical point of view restoration of straight-line flow to the pedal arch by PTA in one or more tibial arteries is necessary for clinical success according to the majority of investigators; dilatation of a proximal lesion is not sufficient in salvaging the critically ischaemic limb when the distal artery is severely diseased [29, 49, 79]. Soder et al found in their prospective study that angiographic improvement with arterial filling at the most ischaemic site after PTA is more important than reconstitution of one continuous artery down to the level of the malleolus. In fact they found that recanalization of lesions in the upper or middle third of crural arteries is often sufficient, especially when two or three arteries are treated [14]. In addition, the status of the pedal arch is extremely important in determining the outcome of distal PTA and should be imaged as part of the procedure. Approximately 20% of patients requiring limb salvage have heavily diseased pedal arches, in which case any revascularization procedures will have limited success [14, 80].
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Complications of infrapopliteal angioplasty
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Major complications range between 2% and 6% of cases and are mostly due to puncture site haematomas and acute arterial occlusions [20]. Puncture site haematomas can be life threatening particularly in this older group of patients [81]. These patients usually have multiple co-morbidities. They should be strictly monitored to detect any signs of haemorrhage. Arterial closure devices may be helpful in reducing puncture site complications [82, 83]. Iatrogenic arterial occlusions may occur due to spasm or dissection and may require thrombolysis or stenting. Liberal use of antispasmodic agents reduces the risk of severe spasm leading to thrombosis. Embolic occlusions usually respond to thrombolysis and/or aspiration thrombectomy. Arterial perforation can occur in up to 3.7% of cases and is more common in the elderly and in diabetics [84] but rarely causes problems requiring active intervention; however balloon tamponade or coil embolisation may occasionally be necessary. The risk of infection is very low, however administration of antibiotics may be prudent if the procedure is prolonged or there is infection at the site of distal tissue loss.
The 30-day mortality after PTA is less than 1.7% [14, 38, 85], which compares favourably with distal bypass surgery, which has a perioperative mortality rate of 1.8–6% [5, 6, 86].
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New approaches to infrapopliteal angioplasty
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Several new methods are currently being explored to recanalize extensive complex lesions or inhibit neointimal proliferation and reocclusion. These approaches are currently under clinical investigation and may have the potential to become established adjunctive interventional methods in the infrapopliteal territory.
Lasers
Recent improvements in laser angioplasty, including optimally spaced laser fibres athermic catheters and saline infusion techniques can produce larger laser channels, minimize thermal injury and significantly reduce arterial dissection [87]. Excimer laser is a pulsed laser system working at a wavelength of 308 nm, which ablates or vaporizes the lesion material [88–90]. In the recently completed Laser Angioplasty for the Critical Limb Ischaemia Phase 2 Trial (LACI 2) 41% of the 432 lesions treated were located in the infrapopliteal territory [91]. The majority of these lesions were complex ones combining stenoses and occlusions in a cohort of patients considered poor surgical candidates for bypass surgery. Limb salvage was achieved in 93% of survivors at 6 months and only 2% of the patients required surgical intervention during follow-up. The results of this trial are at least as good as the best published case series of PTA in CLI.
Cutting balloons
Cutting balloons (Barath, San Diego, CA) were designed for the endovascular treatment of coronary in-stent restenosis [92, 93]. The catheters have 3–4 microsurgical blades mounted longitudinally on the balloon that disrupt the fibroelastic continuity of the ring of neointima hyperplasia during balloon inflation. These devices cause less intimal trauma compared with conventional PTA due to the reduced wall-tension induced by the microincisions into the neointimal hyperplastic tissue [93, 94]. They are advantageous compared with atherectomy due to their low-profile (4 F) and high flexibility. Although application of this technique in peripheral arteries is still limited, it appears that it is effective in the treatment of resistant femorodistal bypass stenoses and complex infrapopliteal obstructions such as ostial and bifurcational lesions [94, 95].
Intravascular sonotherapy
Intravascular sonotherapy represents a non-ablative, non-thermal form of therapeutic ultrasound, which causes change in cell shape due to disassembly of microtubules and microfilaments. On a later phase, however healing effects lead to reassembly of these structures with recovery to a normal cell shape. Intravascular sonotherapy has proven its efficacy in animal studies with respect to reduction of neointimal ingrowth after stent placement, while a multicentre observational study in humans has documented its safety and beneficial effect after coronary stenting, even in complex cases [96–98]. Intravascular sonotherapy is applied with a 4 F or 5 F monorail catheter with multiple ultrasound transducers.
Coated stents
Surface characteristics of stents are relevant to in-stent restenosis. Different strategies to optimize these characteristics include (electomechanical) polishing, ion implantation or coating. More recently stents coated with a thin and highly adherent film of turbostratic pyrolic carbon (Carbofilm), a material which shows excellent thrombo-resistance (high haemocompatibility) and mitigation of inflammatory response (high biocompatibility), have been compared with PTA alone in a prospective randomized multicentre trial in 32 patients with high grade infrapopliteal artery stenoses up to 3 cm in length [99]. The 6 month patency rate for PTA group was 51.2% versus 81.2% for the Carbostent group. The 12 month patency rate for the stented group was 81.2%. These results are statistically significant.
Drug-eluting stents
Stents may be used as a vehicle for delivering antiproliferative drugs locally and achieving high local drug concentrations over a longer period of time without systemic toxicity. Suitable drugs are those which preferentially target smooth muscle cell proliferation and maintain this antiproliferative effect during the first 4 weeks after the procedure [100]. Sirolimus-eluting stents are the only ones which have been studied in the peripheral (femoropopliteal) arteries. Preliminary reports in the femoral artery suggested improved patency of the slow Sirolimus (rapamycin) eluting stent (SES) group at 18 months [101], however this advantage disappeared at 24 month follow-up and there was no difference in restenosis rate in the two types of drug-eluting stents and bare stent groups. Similar systems are currently under investigation in the infrapopliteal region including a balloon-expandable coronary stent design coated by a nanoporous ceramic coating containing tacrolimus.
Absorbable stents
Recently a magnesium alloy absorbable stent has been used in focal infrapopliteal stenoses in patients with CLI. Animal tests of this stent showed an absorption time of approximately 2 months with no evidence of toxicity [102]. However, the clinical results are preliminary. Such stents may be used alone or act as a platform to drug loading [103].
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Conclusions
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PTA is the treatment of choice in patients with infrapopliteal occlusive disease who typically present with CLI. With recent advances in technology, long and multiple stenotic and occlusive lesions can be treated successfully. This minimally invasive procedure carries a lower morbidity and mortality and shorter hospital stay compared with surgery and should be the first treatment option in all patients with CLI who would otherwise be offered distal bypass surgery or amputation, as failure rarely precludes surgery. Clinical success is superior to angiographic patency and in the majority of cases repeat angioplasty can be performed if there is recurrence of ischaemic symptoms and signs. Infrapopliteal PTA can also be performed after femoral angioplasty or bypass surgery, to improve outflow and hence patency of the proximally treated segment.
Received for publication March 3, 2004.
Revision received July 7, 2004.
Accepted for publication August 9, 2004.
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Abstract
Introduction
