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E. S. Debus et al., Volume 38, Issue 4, November 2009 DOI 10.1024/0301–1526.38.4.317

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Surgical reconstructions in peripheral arterial occlusive disease E. S. Debus, C. Lohrenz, H. Diener, M. S. Winkler and A. Larena-Avellaneda Klinik und Poliklinik für Gefässmedizin, Universitäres Herzzentrum Hamburg, Universitätsklinikum HamburgEppendorf, Germany Summary

Zusammenfassung

The prognosis of patients suffering from peripheral arterial occlusive disease (PAD) is directly correlated with the severity of the disease. In critically ischemic legs, after one year only 50 % will be alive with a preserved leg. The other 50 % will die or undergo an amputation during this time. Reconstructive surgery is highly effective in PAD caused by extensive arterial lesions. Depending on the localization of the occlusion, operative procedures range from local desobliteration to profundoplasty and from aortofemoral to femorodistal bypass procedures. Especially in critical ischemia, time is of the essence for limb salvage. Evidence-based data for diagnosis and operative treatment are described in detail. Only the consequent use of these critical techniques can improve the prognosis of these patients.

Chirurgische Rekonstruktionen bei peripherer arterieller Verschlusskrankheit Patienten mit peripherer arterieller Verschlusserkrankung (pAVK) haben direkt proportional zum Schweregrad eine schlechte Prognose: trotz adäquater Therapie kann die betroffene Extremität im kritisch ischämischen Zustand lediglich in 50 % innerhalb eines Jahres erhalten bleiben. Die andere Hälfte der Patienten ist nach diesem Zeitraum entweder major-amputiert oder verstorben. In Abhängigkeit von der Verschlusslokalisation reicht das Spektrum der operativen Therapieverfahren von der iliako-femoralen Desobliteration über die Profundaplastik bis hin zu aorto-iliakalen und femoro-poplitealen, femoro-kruralen und femoro-pedalen Bypassverfahren inklusive distal origin Bypässen. Cruro-pedale Rekonstruktionen stellen in der Therapie der kritischen Ischämie in der Regel die effektivste Therapie bei vorgeschalteten langstreckigen Verschlussprozessen dar. Ein stringentes Management ohne Zeitverzug ist für den Erhalt der Extremität wichtig. Evidenzbasierte Daten zur Diagnostik und zur operativen Therapie peripherer Verschlussprozesse werden detailliert dargestellt. Nur bei konsequenter Befolgung der dargestellten Grundsätze kann die schlechte Gesamtprognose des betroffenen Patientengutes gebessert werden.

Key words: Peripheral arterial occlusive disease (PAD), techniques of operative access, limb salvage, patency

Introduction Surgical intervention in the therapy for peripheral arterial occlusive disease (PAD) depends mainly upon the extent and location of the arterial lesion. The use of invasive therapeutic measures in advanced symptomatic stages of PAD is agreed upon, while surgical intervention in early stages (such as IIb in the Fontaine classification) should be used restrictively, depending on the extent of the individual strain. A reduction of pain-

free walking distance to less than 100 meters is considered such an arduous limitation of mobility that most of these patients prefer invasive treatment when possible. The critically ischemic extremity (stage III–IV in the Fontaine classification) is defined as a vascular perfusion diminished to the extent of impending amputation. The danger to tissue vitality in these cases is principally reversible but nonetheless critical and on the verge of irreversible damage. Skeletal muscles

tolerate ischemia for about 6 hours and are therefore the tissue most sensitive to decreased blood supply. Hence, the time period to irreversible tissue damage is determined by this 6-hour interval [6]. With regard to the acuteness of ischemia development, we can differentiate between acute and chronic critical ischemia of extremities [76]. Acute ischemia is defined by a rapid progress or the sudden onset of diminished vascular perfusion with either a relevant aggravation of pre-existing symptoms

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pends upon a multitude of indicators. The evaluation of spontaneous progress is difficult because these patients are most often in need of comprehensive therapy that cannot be denied simply for study purposes. There is, however, a considerable difference between patients with CLI and claudication: The fate of claudicants is determined mainly by cardio- and cerebrovascular events, whereas the risk of critical leg ischemia remains low, with a risk of amputation of 2 % over the course of 10 years [56]. Patients with surgical therapy differ from patients on drug therapy alone because the latter usually have end-stage vascular disease precluding surgical options. In spite of adequate therapy, as early as one year after diagnosis, 40 % of patients with CLI will lose their leg within 6 months and, approximately up to 20 % will die. Studies on the prevalence of cardiovascular disease in patients with PAD show, based on patient history, clinical examination and electrocardiogram, a prevalence of coronary artery and cerebral artery disease of 40 % to 60 %. In the PARTNERS study, 13% of subjects screened had an ABI of ≤ 0.90 and no symptomatic coronary artery disease (CAD) or cerebral artery disease, 16 % had both peripheral arterial occlusive disease and symptomatic coronary artery or cerebral artery disease, and 24 % had symptomatic coronary artery and cerebral artery disease and a normal ABI [42]. The link between PAD and cerebral artery disease seems to be weaker than that with CAD. On duplex examination, carotid artery disease occurs in 26 % to 50 % of patients with symptomatic PAD, but only about 5 % of patients with PAD will have a history of cerebrovascular event. There is a range of overlap of disease in the cerebral, coronary and peripheral circulations reported in the REACH survey [14]. Of

those patients identified with severe symptomatic PAD, 4.7 % had concomitant CAD, 1.2 % had concomitant cerebral artery disease and 1.6 % had both. Thus, in this survey, about 65 % of patients with PAD had clinical evidence of disease in other vascular territories.as well. However, in one prospective study of 1886 patients aged 62 or over only 37 % of subjects had no evidence of disease in any of the three territories [10]. The prevalence of renal artery stenosis of 50 % or greater ranges from 23 % to 42 %. Although it has not been studied specifically it is highly likely that renal artery stenosis is also a partly independent risk factor for mortality in patients with PAD, since renal artery stenosis of 50 % or greater is associated with a 3.3-fold higher mortality rate than in the general population. The short-term mortality of patients presenting with acute ischemia is 15 % to 20 %. Once they have survived the acute episode, their pattern of mortality will follow that of the claudicant or patient with chronic CLI, depending on the outcome of the acute episode. There is a strong correlation between ABI, as a measure of the severity of the PAD, and mortality. A number of studies, using different ABI ‘cut-off ’ points have demonstrated this relationship. For instance, in a study of nearly 2000 claudicants, patients with an ABI < 0.50 had twice the mortality of claudicants with an initial ABI of > 0.50 [28]. The Edinburgh Artery Study [32] has also shown that the ABI is a good predictor of non-fatal and fatal cardiovascular events as well as of total mortality, in an unselected general population. It has also been suggested that there is an almost linear relationship between ABI and fatal and non-fatal cardiovascular events; each decrease in ABI of 0.10 being associated with a 10 % increase in relative risk for a major vascular event. In a study of patients

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or an abrupt beginning of first-time symptoms. The development from claudication to resting pain and further to tissue loss (ulcus arteriosum) may occur stepwise and most often marks the endpoint of the progressing arterial occlusive process. The acute reduction of pain-free walking distance from 1000 m to 120 m, for example, may be the result of an acute vascular occlusion, but by itself is not considered to portray acute critical ischemia [31, 77]. An overall agreement exists with regard to the expected prognosis of patients who within 6–12 months after onset of symptoms require amputation because of irreversible damage to low perfusion [66, 88]. These patients frequently show a diminished ankle pressure of between 50–70 mmHg as well as lowered tcpO2 levels < 30–50 mmHg [102]. Further, acute critical ischemia is always characterized by the sudden onset of critically diminished peripheral perfusion, consisting of diminished or lost motor and/or sensory functions. Immediate treatment is required without any time loss. Complete loss of function requires therapy within 6 hours of onset, otherwise amputation of the extremity must be feared. To save time, diagnostic angiography may be deferred to the operation theatre – duplex sonography is usually sufficient for preoperative diagnostic work up. Surgical embolectomy is required as early as possible, provided loss of function is not complete. In these cases, intraarterial fibrinolysis or thrombus aspiration may be an option [7]. Intraarterial thrombolysis can be performed safely by ultrasound guidance; after completed thrombolysis the underlying condition (stenosis) can be treated by direct targetted recanalization [62, 99]. The prognosis of patients with chronic critical limb ischemia (CLI) is more difficult to assess and de-

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with type 2 diabetes, the lower the ABI the higher the 5-year risk of a cardiovascular event [61]. The development of an interdisciplinary approach to diagnosis and therapy is desirable in order to adequately handle the different forms of manifestation of the underlying arteriosclerotic occlusive disease. By this means, an increase in sensibility for concomitant disorders may be achieved and due to a more global view of the patient, a comprehensive therapy may be accomplished. In order to serve the patients’ best interests, careful evaluation of competing interests should be confined to a minimum. This can be achieved by demonstrating an understanding of other specialty fields and establishing clear treatment strategies [38].

Basic principles of surgery Suture material For aseptic vascular suture, it is recommended to use non-absorbable suture material with minimal foreign-body reaction. In order to endure the constant strain exercised by the pulse wave, the suture should not display any tendency of plasticity. Polypropylene is a suture material that meets these demands. On the other hand, a reversible elongation might be desirable. Some vascular surgeons prefer polybutester (Novafil®, Vascufil®) under the understanding of a pulse synchronized elastic elongation of the suture. Monofilament suture poses the best option for vascular suture because of minimal tissue trauma. Braided suture material should be avoided since it presents a rough tissue drag and therefore may lead to increased intimal hyperplasia. In case of infection, absorbable synthetic monofilament suture may be used, but insufficiency of the suture due to early bacterial resorption re-

mains a risk. To minimize this risk, the use of long-term absorbable suture like Polydioxanon is recommended in these cases. It is believed that the use of non-absorbable suture in the presence of infection may cause a persistent foreign-body reaction with a permanent host for bacteria and therefore fuel the infection. This hypothesis is not yet proven for monofilament Polypropylene suture material. The vascular suture is accomplished by the use of atraumatic needle-suture combinations. Suture techniques The goal of every vascular suture is to achieve complete haemostasis by an exact adaptation of vessel edges. At the same time, the integrity of the vessel wall must be restored. This can be achieved by using an everting suture technique in which the vessel intima lies exactly upon the other. For this purpose, the following techniques may be applied: 1. Interrupted suture: this type is obligatory in sutures of infantile and juvenile vessels. Because of the expected growth of the young patient, the vessel growth also needs to be taken into account. The interrupted suture allows for an adequate adaption of the anastomotic suture to a certain degree. 2. Running suture: this is a standard technique and can always be used except in the case of infantile/juvenile vessels. 3. Running mattress suture: the advantage of this technique lies in the secure and exact haemostasis due to a broad adaptation of intima. A disadvantage may be the possibility of constriction of the vessel lumen and should therefore be reserved for vessels with a large diameter. 4. Non-eversion-transluminal suture (parachute-suture): this

technique may be used in case of difficult access to the posterior wall (like the internal iliac or common carotid artery). All running sutures carry the risk of collecting an unintentional heap of tissue, which is intended when using the tobacco pouch suture technique, but which can also lead to constriction of the anastomosis. This problem might be avoided by the use of the opposing four-point technique in which double-armed sutures are used for a running opposite suture. Both threads are tied with themselves at the corners of the patch. Then each needle is used to run the suture line in a simple over and over fashion to the middle of the anastomosis and then tied together. Therefore the patch will be suspended at four points, reducing the possibility of tissue collection to a maximum of one-fourth of the total suture line. Bypass material Various materials are used in reconstructive vascular surgery. We differentiate between autologous material (veins, arteries), xenogenous grafts (bovine) and alloplastic prostheses. The alloplastic materials (polyethylenterephtalate, PET, formerly Dacron and polytetrafluorethylene, PTFE) are derived from polymers used in the textile industry. The polyester material is woven or knitted (Figure 1), and the different manufacturing techniques have various advantages and disadvantages. The woven structures are altogether denser, but when remodeling and cutting of bypass ends is needed, the material shows a tendency to fray and therefore is seldom used in cruropedal reconstructions. Porous knitted prostheses or patches, on the other hand, show better healing and incorporation of material but have a higher tendency to dilate. Because of its porous property, this material

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Figure 1: Structural formula and appearance of commonly used alloplastic material in vascular surgery

must be immersed in blood prior to implantation (clotting). This step can be neglected in prostheses coated with (bovine) collagen, albumin, or gelatin. The healing and incorporation process of PET-webs may be optimized by using a velour coating. By further impregnation with silver ions, an antibacterial effect is aimed for. In the manufacturing process for polytetrafluorethylene, a knotted fibril structure is generated that can display various densities. The pore size of PTFE materials can range between 1 and 100 µm. Due to this microporous structure, a higher density as well as an improved incorporation process can be achieved. Operative quality control Following the reconstruction process, some sort of technical quality check should be performed. Various techniques are used to accomplish adequate quality control, and among the most commonly used techniques are angiography, operative flow recording, or color-coded duplex sonography. Alternatively, a post-operative color-coded duplex

sonography may be performed. The intra-operative controls are preferred since they allow immediate adjustment, if needed.

Surgical therapy of peripheral arterial occlusive disease Surgical therapy of the aortoiliac segment Surgical intervention in this region shows significantly higher long-term success rates compared to surgical interventions in distal localizations. The method of choice depends on whether the stenosis or occlusion is strictly localized, or diffuse, or both (Table I). Bilateral stenosis or occlusion The gold standard for treatment of extensive bilateral pelvine stenosis or occlusion (TASC C and D lesion, according to the TASC II document [66]) is still represented by the use of an aortobifemoral y-prosthesis. With a 10-year patency rate of 73 %–83 % there is still no other method that can

compete with such success. Various access paths (retroperitoneal, minimal invasive, and laparoscopic) have shown equal performance. There are no significant differences in the outcome when comparing end-toend anastomosis with end-to-side anastomosis techniques. Altogether, the number of this type of intervention has gradually been reduced over the last few years, mostly as a result of a more differentiated diagnostic evaluation in favor of less invasive methods. Aortoiliac endarterectomy is a technically more elaborate procedure often used in surgery on younger patients with localized unilateral or bilateral stenosis or occlusion. Since the introduction of interventional methods such as stent implantation or dilatation, the method of endarterectomy has been replaced. Recent interest in endarterectomy has been revived although it is not as widely practiced as bypass grafting and may be technically more challenging. Reported 5-year primary patency rates range from 60 % to 94 %, reflecting a degree of variability depending upon the operator [9]. Localized endarterectomy has a better outcome compared to desobliteration techniques of the whole aortoiliac segment. The axillofemoral and axillobifemoral bypass has been designed for extra-anatomical bypassing in case of infectious situations [60] such as infection of the prosthesis or aortointestinal fistulas and should primarily be reserved for high-risk patients (Table II). According to recent studies, these prostheses have displayed a patency rate of up to 75 % and more in a 5-year time period [66]. The improved patency is attributed to enhanced bypass material. Management of accompanying infrainguinal occlusion processes About 50 % of all patients needing surgery because of aortoiliac oc-

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Table I: Morphological classification of aortoiliac lesions (according to TASC II; CIA: common iliac artery, EIA: external iliac artery; CFA: common femoral artery) Type of lesion

Morphology

Treatment of choice

Type A lesion

- Solitary CIA stenosis or < 3 cm EIA stenosis (uni- and bilateral)

endovascular

Type B lesion

- < 3 cm stenosis of infrarenal aorta

endovascular

- Unilateral CIA occlusion

The patient’s co-morbidities, fully informed patient preference and the local operator’s long-term success rates must be considered when making treatment recommendations

- Single or multiple stenosess not extending 3–10 cm, not reaching the CFA - EIA occlusion not involving the origins of IIA or CFA

Type C lesion

- Bilateral CIA occlusion

open surgery in good risk patients.

- Bilateral EIA stenoses 3–10 cm stenosis, not reaching the CFA

The patient’s co-morbidities, fully informed patient preference and the local operator’s long-term success rates must be considered when making treatment recommendations

- Unilateral EIA stenosis, extending into the CFA - Unilateral EIA occlusion, extending to the CFA and / or IIA - Heavily calcified unilateral EIA occlusion, with or without involving the origins ot the CFA and / or IIA

Type D lesion

- Infrarenal aortoiliac occlusion

open surgery

- Diffuse disease involving the aorta and both iliac arteries, requiring treatment - Diffuse unilateral multiple stenoses involving CIA, EIA and CFA - Unilateral occlusion of CIA and EIA - Bilateral EIA occlusion - Iliac stenosis with coexisting aneurysm of aorta not amenable to endograft placement or other lesions needing open aortic or iliac surgery

Table II: Long term patency following various surgical techniques for aortoiliacal reconstruction 5-year patency % (range)

Procedure Aortobifemoral Axillo uni femoral bypass Axillo bi femoral bypass Femoral femoral bypass

clusion processes display relevant accompanying stenosis of the infrainguinal region. The need for subsequent femorodistal vascular reconstruction is estimated at 20 %–

10-year patency % (range)

Claudication

CLI

Claudication

CLI

91 (90–94)

87 (80–88)

86 (85–92)

81 (78–83)

51 (44–79) 71 (50–76) 75 (55–92)

25 %, according to our own practice. In most cases, revascularizing interventions at the proximal end sufficiently improve blood influx. In the following situations, however, a

simultaneous distal reconstruction will be necessary: • whenever the proximal lesion shows no relevant hemodynamic disturbance

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ties, making a transabdominal approach less desirable. Patency rates depend upon the indication for the reconstruction and the justification for the unilateral bypass (normal inflow artery versus high surgical risk) [25]. In some cases, patency of unilateral bypass can be supplemented by endovascular means. The thoracic aorta has also been used as an inflow artery. Extra-anatomic bypass, however, rarely performs as well as aortobifemoral bypass in diffuse disease and, therefore, is seldom recommended for claudication [66]. Evidence is lacking for recommending the preferred material for anatomic or extra-anatomic prosthetic bypass procedures.

1946. With this method, the stenotic plaque is peeled directly out of the opened vessel lumina. For this technique, the vessel is usually opened in a longitudinal fashion. It is important to extend the arteriotomy about 1–2 cm distal and proximal to the lesion in order to guarantee sufficient management of the landing point. Subsequently, an adequate dissection layer is chosen in the media layer in order to ensure a safe and easy extraction of the subintimal plaque. In case of a subtle plaque tail, luminal vascular reconstruction is finished at this point. Most of the time, the plaque seems to carry on to the periphery and to central regions, making a transverse cut in the media region necessary. In this case, a fixating suture of the plaque tail in the direction of blood flow is recommended to prevent distal dissection. This can be accomplished by using running sutures. Before closure of the arteriotomy, it is of utmost importance to check for a clean, detritus-free desobliteration layer to prevent local thrombus formation with further embolization and early occlusion of the vessel. In very few cases, the eversion desobliteration technique might be of use. In this technique, the artery is opened by a transverse or diagonal incision, and a circular dissection of the layer between media and serosa is performed. The vascular serosa is now everted over the calcified plaque until the plaque is completely everted. An advantage of this technique is definitely the avoidance of stenosis as compared to a longitudinal arteriotomy. However, a disadvantage is the lack of adequate handling of the distal plaque tail associated with the risk of dissection.

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• •

stenosis of the profunda region occlusion of the superficial femoral artery in the popliteal segment • occlusion of 2 or 3 crural arteries • existence of distal tissue necrosis Although this poses a relevant clinical problem, the available literature is sparse. Unilateral aortoiliac occlusion Compared to the extra anatomical reconstruction (cross-over bypass), the anatomical aortofemoral bypass represents a safe method for longterm vascular reconstruction in unilateral lesions. The patency rates are almost equal to those of bifemoral prostheses, but because of the tendency of progression of the underlying disease, there is always the risk of subsequent contralateral occlusion. Due to this progression and the possible necessity of another reconstruction, some researchers prefer primary prophylactic implantation of aortobifemoral prostheses [93]. Early occlusion of the donor vessel caused by progression of the underlying disease with decreasing influx may be one cause for the poorer performance of femorofemoral crossover bypasses. However, these findings are not based upon randomized study data. Admittedly, the patency rate of stent-supported balloon angioplasty of the iliac artery shows excellent results even when the stenosis is up to 5 cm long (TASC A and B lesions) [52, 81, 91]. In some situations, when an abdominal approach is to be avoided due to anatomic considerations (‘hostile abdomen’) or cardiac and/or pulmonary risks, a modified retroperitoneal approach or a unilateral bypass with a femoro-femoral crossover may be used. Consideration should be given to using an axillo (bi) femoral or cross-over femoral bypass in patients with increased comorbidi-

Surgical reconstruction of the femoral region Basic principles The following guiding principle holds true for infrainguinal reconstruction: • distal anastomosis should be placed upon the largest and least calcified recipient artery. • autologous material should be used for infrainguinal bypasses. • the bypass length should be kept as short as possible (the donor artery does not always have to be the common femoral artery). The bypass length does not seem to be as important as the quality of the distal recipient artery is in terms of patency rate. A longer bypass may be tolerated to reach a better artery located in a more distal area. The choice of surgical procedure is dependent on location and extent of the lesions (Table III). Open desobliteration and eversion Open desobliteration (DO, or endarterectomy) presents a classical surgical method in the treatment of PAD. This technique was established by Jean Cid Dos Santos in

Patch plasty This technique is a common reconstructive method. It can be used alone or in combination with

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Table 3: Morphological classification of lesions in the femoropopliteal region (according to TASC II; CFA: common femoral artery, SFA: Superficial femoral artery) Type of lesion

Morphology

Treatment of choice

Type A lesion

- Single stenosis ≤ 10 cm in length

endovascular

- Single occlusion ≤ 5 cm in length

Type B lesion

Type C lesion

Type D lesion

- Multiple lesions (stenoses or occlusions), each ≤ 5 cm - Single stenosis or occlusion ≤ 15 cm not involving the infra geniculate popliteal artery - Single or multiple lesions in the absence of continuous tibial vessels to improve inflow for a distal bypass - Heavily calcified occlusion ≤ 5 cm in length - Single popliteal stenosis

endovascular

- Multiple stenoses or occlusions totaling > 15 cm with or without heavy calcification - Recurrent stenoses or occlusions that need treatment after two endovascular interventions

open surgery in good risk patients

- Chronic total occlusions of CFA or SFA (> 20 cm, involving the popliteal artery) - Chronic total occlusion of popliteal artery and proximal trifurcation vessels

open surgery

desobliterating procedures. The idea behind this method is to avoid a constricting longitudinal suture after arteriotomy in areas of vulnerable vascular status. The suture of patch segments follows common principles in vascular surgery. Most often, the four-point suture technique is used in combination with non-absorbable monofilament thread. The most frequently used patches are autologous venous patches (greater or lesser saphenous vein), alloplastic (PET / PTFE), as well as xenogenous patches made from denaturized bovine pericardium (Vascuguard®). Advantages of autologous material are superior healing and incorporation, excellent patency rates, and little susceptibility to infection. Unfortunately, these resources are limited, and sacrificing epifascial veins should be avoided since often these veins are also needed for coronary

interventions in patients with arteriosclerosis. Alloplastic materials display a good standard method with excellent long-term results. Still, they are prone to infection and therefore should not be used in the groin area where lymphatic vessels are often injured. Xenogenous material combines the advantages of biomaterial (infection resistance, compliance match, excellent patency rates) with those of alloplastic materials (unlimited availability). Biomaterial also allows future puncturing for invasive diagnostic measures or even interventional therapy. Half-opened or closed-ring desobliteration (remote endarterectomy) This technique is used in long segment lesions, that do not allow for complete exposure of the vessel. In this case, it is possible to perform a

The patient’s co-morbidities, fully informed patient preference and the local operator’s long-term success rates must be considered when making treatment recommendations

The patient’s co-morbidities, fully informed patient preference and the local operator’s long-term success rates must be considered when making treatment recommendations

local arteriotomy in a well-exposed vascular segment (external iliac artery via retroperitoneal access, common femoral artery via groin access), followed by exposing the correct layer of dissection. Then a ring stripping device can be passed over the plaque or stenosis and with alternating rotational moves shoved in the proximal or distal direction. If the plaque is located in the iliac vascular system, this technique is called retrograde ring desobliteration (DO), which can be performed as a closed DO, meaning that a distal exposure of the DO endpoint is not necessary. If desobliteration takes place starting from the groin in the distal direction, the technique is called antegrade ring DO, which is used as a half-open dissection. This technique requires a distal fixation of the residual dissection flap. Although this technique has almost vanished due

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Table 4: Randomized trials of types of conduits [2, 35, 46, 50] Above-knee femoral popliteal bypass

5-year patency

Vein

74–76%

PTFE

39–52%

to lack of sufficient results, it seems to have been revived together with the improvement of anti-coagulatory drugs and technical advances. Bypass Infrainguinal bypass procedures need to take off from a patent and uncompromised inflow artery although the actual level (common femoral artery versus superficial femoral or popliteal artery) does not correlate with patency. If the infrainguinal bypass is constructed following an inflow procedure, patency is improved by making the proximal anastomosis to a native artery rather than to the inflow graft (usually limb of aortobifemoral bypass) [55]. The quality of the outflow artery is a more important determinant of patency than the actual level where the distal anastomosis is performed. A distal vessel of the best quality should be used for the distal anastomosis. Femoropopliteal bypasses Alloplastic prostheses have become an accepted alternative to autologous vein bypass in the femoropopliteal region; however, the greater saphenous vein (GSV) is increasingly favored for this region. Comparative meta-analysis studies have showed better results for the autologous vein bypass above the knee joint. The 5year patency rate for GSV was reported to be 66 % followed by PTFE with 47 % [19, 84]. Below the knee joint, the difference becomes more evident. Here, the 5-year patency rate was reported to be 77 % for reversed GSV, 68 % for in-situ GSV, 60 % for

human umbilical vein (HUV), and only 40 % for PTFE. Several randomized studies have showed equal patencies for PTFE and Dacron [1]. The HUV initially showed a tendency towards better patency rates, but in the course of the study, it tends to undergo degenerating processes with secondary formation of aneurysms [63]. A recent study however has demonstrated similar long term results of graft patency, when femoropopliteal HUV bypasses are compared to PTFE conduit [85]. Conduit Vein has better long-term patency than prosthetic in the infra inguinal region (Table IV) [2, 35, 46, 50]. Over the short term, PTFE has delivered near equivalent results in the above knee position. A recent metaanalysis compared Dacron favourable with PTFE conduits in the above knee segment [92]. A meta-analysis suggests much less satisfactory results of polytetrafluoroethylenecoated grafts (PTFE) to the infrapopliteal arteries (5-year patency: primary 30.5 %, secondary 39.7 %) [4]. The consequences of a prosthetic graft occlusion may be more severe than a vein graft occlusion [45]. A recent study questioned the wisdom of using a prosthetic graft when acceptable vein was available in order to ‘save the vein’. Using this strategy, up to 33 % of subsequent secondary bypass grafts did not have adequate vein available at that time. The greater saphenous vein, either in a reversed or in situ configuration offers the best match of size and

quality. In its absence, other venous tissue including contralateral long saphenous vein, lesser saphenous vein, femoral vein and arm vein have been used. Venous grafts all have better results than prosthetic materials. Profundoplasty Stenosis at the origin of the profunda femoris artery may lead to decreased flow through collateral vessels in the presence of a SFA occlusion and may compromise the patency of an aortic/extra anatomic inflow operation. In the presence of SFA occlusion it is recommended that a stenosis of the profunda femoris artery be corrected during inflow procedures. Isolated profundoplasty as an inflow procedure (sparing a femoral distal bypass) may be considered in the presence of: 1) excellent inflow; 2) > 50 % stenosis of the proximal 1 / 3 profunda; and 3) excellent collateral flow to the tibial vessels [66]. Secondary revascularization procedures Secondary patency results from the salvage of an occluded bypass and assisted patency results from pre-occlusion intervention. The non-tolerance of vein grafts to thrombosis and the success of assisted patency support the previous recommendations that all venous bypass grafts be followed by a regular regime of duplex scanning with set parameters for intervention including angioplasty (open or transluminal) or short segment interposition. This recommendation has recently been questioned by a randomized, controlled trial showing no cost benefit of such an approach [21]. In the presence of an occluded but established graft, thrombolysis may be indicated in the very early stages to remove clot and reveal the cause of the thrombosis. When limb salvage is assessed following failure of an infraingui-

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nal bypass the original indication for surgery is an important factor. The 2-year limb salvage rates for occluded grafts done for claudication is 100 %, for rest pain it is 55 % and when done for tissue loss 34 %. The early occlusion of a graft (< 30 days occlusion) led to a very poor 2-year limb salvage rate of 25 % [11]. Endovascular treatment of infrainguinal arterial occlusive disease Endovascular treatment of infrainguinal disease in patients with intermittent claudication is an established treatment option. The low morbidity and mortality of endovascular techniques such as PTA makes it the preferred choice of treatment in limited disease such as stenoses and occlusions up to 10 cm in length (TASC A and B lesions). The technical and clinical success rate of PTA of femoropopliteal artery stenoses in all series exceeds 95 % [62]. Device developments such as hydrophilic guide wires and technical developments, such as subintimal recanalization, provide high recanalization rates in total occlusions of more than 85 % [58]. The technique of subintimal angioplasty is not so much dependent on length, but rather on the presence of normal vessel above and below the occlusion to allow access [24]. The mid- and long-term patency rates were summarized in a metaanalysis by Muradin et al. [63] and in three randomized studies assessing the efficacy of stents [17, 37, 96]. Percutaneous transluminal angioplasty There is general agreement that for acute failure of PTA of an SFA lesion, stent placement is indicated. A recent randomized trial has demonstrated significantly higher primary patency rates of stenting vs. PTA of

femoropopliteal artery lesions TASC A and B at 1-year follow up [79]. Randomized trials comparing PTA versus bypass surgery in infrainguinal arterial obstructive disease are almost nonexistent. This can be explained partially by the following facts: Bypass surgery is more commonly performed for extensive disease with long lesions and CLI. PTA is more commonly performed in limited disease with IC and short obstructions. However, Wolf et al. published a multicenter, prospective randomized trial comparing PTA with bypass surgery in 263 men who had iliac, femoral or popliteal artery obstruction [101]. This study showed no significant difference in outcomes during a median followup of 4 years (survival, patency and limb salvage). In 56 patients, cumulative 1-year primary patency after PTA was 43 %, after bypass surgery it was 82 %, demonstrating that for long superficial femoral artery (SFA) stenoses or occlusions, surgery is better than PTA. This contrasts with a recent randomized study of 452 patients which demonstrated no difference in amputation-free survival at 6 months; however, surgery was somewhat more expensive [3]. Medical treatment after PTA and stent placement is recommended to prevent early failure because of thrombosis at the site of intervention. Standard therapy is heparinization during the intervention. After PTA and stenting of femoropopliteal arteries, life-long antiplatelet medication is recommended to promote patency (acetylsalicylic acid or clopidogrel). Life-long antiplatelet therapy is also recommended to prevent cardiovascular events [8, 16]. Much of the supporting evidence for periprocedural antiplatelet and adjuvant therapy is extrapolated from that related to the coronary circulation.

Cruropedal lesions There is no objective evidence to preferentially select either tibial or peroneal artery. The results of femoral crural bypass have not been subject to meta-analysis. Five-year assisted patency rates in grafts constructed with vein approach 60 % and those constructed with prosthetic material are usually less than 35 %. Reports have documented the suitability of constructing bypass grafts to plantar arteries with reasonable success rates. Patients with cruropedal lesions usually have few possibilities of developing collateral vessels to compensate for reduced blood flow. Hence, these patients display faster progression to stage III and IV in the Fontaine classification, where intervention is advised. The earlier stages I–II should be treated by conservative means. Patients with CLI should be treated as an emergency since any time delay in treatment has to be avoided. However, the majority of patients are still not treated in specialized centers. Patients displaying chronic resting pain seem to be less in danger of amputation compared to those who display signs of tissue loss [33]. Patients with signs of CLI should be referred to a specialized center where ideally all disciplines necessary for the holistic therapy of vascular patients are available [47, 74]. Cruropedal vascular reconstruction Revascularization of peripheral vascular vessels is still discussed critically on one hand due to the demanding technical effort and high occlusion rates at an early stage on the other. Which surgical technique is applicable depends on the location and extent of the lesions as described in the TASC II classification [26] (Table III). In the last few years,

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are technically demanding and traumatizing for the patient, leading to an increased amount of wound healing complications and edema, limiting patients postoperatively in their mobility. The newly described dorsolateral access allows for preparation of the PA without fibula bone resection and hence with far less tissue trauma [23]. The greater saphenous vein compares favorably with other materials for bypass grafting to infrapopliteal arteries[4, 70], but this vein and other autologous veins also suitable for bypass grafting may be lacking even when pursuing a policy of maximal use of autologous tissue [68, 89]. The polytetrafluoroethylene (PTFE) or knitted polyester (Dacron) graft has been used alternatively, but earlier reports on plain synthetic grafts showed poor results [44, 94]. Improving patency was attempted by adjunctive procedures at distal anastomosis and conduits incorporating a thin wall, an external support, or a tapered end. These changes, along with other factors, are associated with better results [71, 75, 86]. Before implanting a synthetic graft some authors prefer using the arm veins, spliced veins, human umbilical veins, or cold stored venous allografts [40, 44, 64]. Comparative studies have shown similar results for limb salvage and patency [54], although the operation of a complex autologous conduit is more difficult and longer and associated with a significantly increased rate of reintervention [33, 39, 67]. The use of a synthetic graft is definitely justified in the last resort to avoid limb amputation [30, 69], but below knee alloplastic reconstructions are still mostly abandoned, despite recently reported improved results. Despite aggressive therapeutic measures, patients with distal ischemia experience significantly reduced life expectancy. Three years after success-

ful intervention, less than 60% are still alive [74, 83, 90]. Therapeutic measures should not exclusively focus on limb salvage but also take into account the overall health condition of the patient (Table I). Therefore, quality of life is another relevant endpoint [39, 100]. Impaired wound healing, readmission, and reoperations significantly reduce the quality of life in patients following infrainguinal bypass [33]. The time to heal exceeded three months in 54% of the patients. This is of particular importance as life expectancy of these patients is low and the operative trauma for a vein graft is greater than that of a synthetic graft [30, 40, 49, 75]. This aspect is of greater importance if arm veins, spliced veins, or human umbilical veins are used because the number of reoperations is much higher [64]. Therefore, the use of alloplastic materials even for below knee reconstruction might be considered in a well defined population characterized by severely impaired life expectancy. The ideal therapy therefore consists of restoration of extremity function, optimization of life expectancy by treatment of the underlying disease and its risk factors, and the best possible social reintegration of the patient. The extent and radicality of reperfusion measurements is dependent on the overall clinical constitution of the patient as well as the expected revascularization prognosis. The fact that patients displaying symptoms of CLI are in need of surgery or interventional treatment to reduce the risk of amputation is not a subject of discussion. However, the process of deciding on intervention, technique, and extent is a complex process that cannot be solved by solely applying textbook knowledge. Even though it is of utmost importance to form individually based therapeutic decisions, certain basic principles need to be taken

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excellent long-term results were published for femorocrural bypass surgery with a reported patency rate of 83 % over a 5-year period [4, 30, 51, 69–71], resulting in a “boom” of crural vascular surgery [5, 78]. In particular, bypass anastomosis to the peroneal artery (PA) is rarely performed because this vessel often has a slender lumen and operative dissection is technically demanding. Several authors have postulated that the PA, in contrast to the other two arteries, only takes part in the perfusion of the pedal area via collateral vessels and therefore is confronted with too high of a peripheral efflux resistance, accounting in turn for early bypass stenosis [29]. Furthermore, the poor results of revascularization compared to those of anterior or posterior tibial bypass revascularization have often led to considerations of primary amputation instead of PA reconstruction [48]. On the other hand, studies have shown that the PA often seems to be protected from arteriosclerosis [29, 72]. This phenomenon accounts for the term “peroneal leg” [48]. This shows that in many cases of PAD with distal affection, the PA poses the only vessel available for anastomosis, leaving the revascularization technique of the PA as the last resort to prevent amputation. Compared to bypasses onto the tibial arteries, the PA bypass nowadays shows equal results for patency, limb salvage, and mortality [22, 72]. The operative access to the PA is technically more demanding and presents a far greater trauma to the patient owing to extensive tissue damage. The preparation of the PA, similar to the preparation of the tibial vessels, is mainly performed via medial access. Alternatively, the lateral access may be of use where a resection of the fibula bone of several centimeters is required to reveal the PA. Both of these access points

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into account. Mortality, morbidity, and comorbidity, as well as risk factors and life expectancy, need to be evaluated regarding prognosis and long-term results of each intervention technique applied. Ideally the patient should be treated with the method posing the least risk of intervention while at the same time offering the best initial success rate and long-term prognostic patency. In many cases, multiple lesions are found, rendering a combination of interventional and surgical techniques the better option that may significantly enhance the outcome. In the crural region, studies have shown that the autologous vein displays a better outcome compared to alloplastic bypass material. This has led to the consensus of favoring venous bypass even if the GSV is not available. Only in cases where there is no side branch vein (small saphenous vein or veins of the arm) is the use of a synthetic bypass recommended [9, 25]. Randomized studies of venous bypass material in this region have shown a patency rate of 72 %–83 % over a 5-year period [27, 84]. The patency rate of PTFE material, on the other hand, only averages a 17 % rate after a 4-year period [94]. However, heparin-bonded PTFE may be associated with favorable long-term results [20, 57]. Composite bypass grafts (partly alloplastic, partly autologous) in the infrainguinal region display a patency rate of 61 % over a 4-year interval but require up to 20 % secondary intervention to maintain sufficient function [18]. The superficial femoral vein may also serve as an adequate bypass option. The resection of this vein may lead to initial edema. The success rate of this bypass alternative is comparable to that of GSV [19]. It is commonly accepted that the integrity of plantar perfusion is a major predictor of the patency success rate of cruropedal reconstructions [82].

The patency rate of pedal bypass reconstruction is not significantly different from that of proximal crural bypasses and averages after a 3-year period 79 % versus 82 % [80]. Specific issues in below knee vascular surgery Venous bypass: in-situ versus reversed The long-term patency of in-situ bypass reconstruction has been compared to the reversed venous bypass technique. Studies have shown a clear advantage in favor of the reversed technique after a 5-year study interval (46.2 % vs. 68.8 %) [13, 98]. This is mainly attributed to the technically more demanding effort of the in-situ technique. These bypasses require frequent secondary intervention, most notably due to “forgotten” side branches. The secondary patency rate, on the other hand, shows no relevant difference compared to the reversed bypass technique (71.6 % vs. 79.4 %). Differences in outcome will depend upon indications for surgery, the quality of the vessels, and co-morbidities. Isolated popliteal segment In some cases, the bypass reconstruction onto an isolated segment of the popliteal region may be reasonable under the circumstances of good distal collateralization [12]. The long-term patency rates for such bypasses has proven to be of lower quality compared to that of free distal perfusion in the popliteal segment and crural bypass; however, the overall patency is 55 %–74% [53]. Techniques for enhancement of long-term patency Arteriovenous fistula (AV fistula): When a prosthetic bypass graft is placed into the below-knee popliteal or distal artery region, adjunctive procedures, such as arteriovenous

fistula at or distal to the bypass and the use of a vein interposition/cuff, have been suggested [66]. The AV fistula is a means to enhance the patency in patients with poor efflux by reducing the peripheral outflow by partially diverting blood into the venous low pressure system. There is little reliable data concerning this technique, but so far it appears that AV fistulae cannot significantly improve the results in comparison to direct anastomosis techniques. Randomized studies have shown a patency rate for AV fistulas of 55.2 % over a 1-year period, whereas the control group achieved an patency rate of 53.4 % [41]. Venous cuff: Distal interposition venous cuffs have been described to optimize outcome of synthetic grafts [73]. Based on their results with vein cuffs in 42 patients, Pappas et al. concluded that this reconstruction is an acceptable alternate conduit in patients with critical limb ischemia when autologous saphenous vein is absent [68]. Various venous cuff techniques have been introduced in order to face the compliance mismatch between rigid synthetic bypass material and elastic vessels at the distal anastomosis region. Randomized studies of venous cuff techniques applied to regions above the knee joint have shown no relevant improvement compared to direct suture techniques. However, applying this technique in regions below the knee joint has shown a significant advantage for the venous cuff technique with a 2-year patency rate of 57 % versus 29 % [36, 87]. Combination of venous cuff and arteriovenous fistula may have additive effects [65]. Further studies are required to support the current study results.

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tive according to this study [21]. In practice, many surgeons continue a program of vein graft surveillance awaiting further confirmation of the findings of this trial. According to the TASC II document [66], patients undergoing bypass graft placement in the lower extremity for the treatment of claudication or limb-threatening ischemia should be entered into a clinical surveillance program. This program should consist of Interval history (new symptoms), vascular examination of the leg with palpation of proximal, graft and outflow vessel pulses, periodic measurement of resting and, if possible, post-exercise ankle brachial indices. Clinical surveillance programs should be performed in the immediate postoperative period and at regular intervals (usually every 6 months) for at least 2 years.

tive therapies do not terminate the need for lifelong medical care. Due to the progressive tendencies of the underlying disease, further followup examinations on a regular basis appear to be crucial to ensure longterm success rates. Only by means of stringent diagnosis, therapy, and follow-up examinations in the environment of an interdisciplinary vascular center is it possible to provide optimal therapeutic results with long-term preservation of limb.

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Surveillance programs following revascularization Patients are considered successfully treated when peripheral perfusion is restored to a point where claudication symptoms or resting pain has vanished or ischemic tissue necrosis shows a relevant healing tendency with the formation of granulating tissue. However, these patients cannot be considered completely cured with respect to the underlying disease since a progression of disease is very likely and relapse conditions (CLI) are common. Those patients receiving reconstructive surgery therefore need regular post-operative checkups in order to reveal bypass occlusion at an early point [97]. Followup examinations should generally take place in the same clinic where the intervention was performed. The importance of the healing process in ischemic tissue often seems underestimated. Any sign of stagnation of the healing process and of course any type of tissue damage progression should lead to the presumption of bypass occlusion or overall progression of the underlying disease and requires immediate further diagnostic work up [15]. Following construction of an infrainguinal autogenous bypass graft, it has been recommended in the past that a program of regular graft review with duplex scanning be undertaken [65]. The purpose of this is to identify lesions that predispose to graft thrombosis and allow their repair prior to graft occlusion. A recent multicentered, randomized, controlled trial has shown that duplex surveillance after venous femoral distal bypass grafts leads to no significant clinical benefit or quality of life improvement at 18 months. The previous recommendation of routine duplex scanning following autogenous lower extremity bypass has proven to be not cost-effec-

Summary The reconstruction of arterial occlusion processes of the lower extremities has proven to be highly effective in every region of perfusion with respect to symptom management and limb salvage. As a result of high comorbidity rates, especially in advanced stages of PAD, effective management principles without great time delay are of utmost importance. Whenever surgical techniques are applied, the least traumatizing technique should be preferred in order to anticipate avoidable disturbances in wound healing in an already ischemic environment. According to the TASC II document, A and B lesions should be treated preferably by endovascular means, whereas more extensive disease (TASC C and D lesions) are primarily prone to surgical techniques. The autologous venous bypass is the technique of choice for the supra- and infrainguinal regions. Admittedly, reconstruc-

Conflicts of interest There are no conflicts of interest existing.

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85 Sharn DM, Dirven M, Barendregt WB, Boll APM, Roelofs D, van der Vliet JA Human umbilical vein versus heparin-bonded polyesdter for femoropopliteal bypass: 5-year results of a prospective randominzed multicentre trial. EJVEVS 2008; 35: 61–7. 86 Smeets L, Ho GH, Tangelder MJ, et al. Outcome after occlusion of infrainguinal bypasses in the Dutch BOA Study: comparison of amputation rate in venous and prosthetic grafts. Eur J Vasc Endovasc Surg 2005; 30: 604–9. 87 Stonebridge PA, Prescott RJ, Ruckley CV Randomized trial comparing infrainguinal polytetrafluorethylene bypass grafting with and without vein interposition cuff at the distal anastomosis. J Vasc Surg 1997; 26: 543–50. 88 Suggested standards for reports dealing with lower extremity ischemia Prepared by the Ad Hoc Committee on Reporting Standards, Society for Vascular Surgery / North American Chapter, International Society for Cardiovascular Surgery. J Vasc Surg 1986; 4: 80–94. 89 Taylor LM, Jr., Porter JM. Clinical and anatomic considerations for surgery in femoropopliteal disease and the results of surgery. Circulation 1991; 83: I63–I69. 90 The ICAI group (Gruppo di dtudio dell ischemia cronica degli arti inferiori) Long-term mortality and its predictors in patients with critical leg ischemia. Eur J Vasc Surg 1997; 14: 91–5. 91 Upchurch GR, Dimick JB, Wainess RM, Eliason JL, Henke PK, Cowan JA, et al. Diffusion of new technology in health care: the case of aorto-iliac occlusive disease. Surgery 2004; 136: 812–8. 92 van Det RJ, Vriens BH, van der Palen J, Geelkerken RH Dacron

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101 Wolf G, Wilson S, Cross A, Deupree R, Stason W. Surgery or balloon angioplasty for peripheral vascular disease: a randomized clinical trial. Principal investigators and their Associates of Veterans Administration Cooperative Study Number 199. J Vasc Interv Radiol. 1993; 4 (5): 639–48. 102 Wolfe JH, Wyatt MG Critical and subcritical ischemia. Eur J Vasc Endovasc Surg 1997; 13: 578–82.

Correspondence address Prof. Dr. med. E. Sebastian Debus Klinik und Poliklinik für Gefäßmedizin Gefäßchirurgie – endovaskuläre Therapie – Angiologie Universitäres Herzzentrum (UHZ) Universitätsklinikum Hamburg – Eppendorf Martinistr. 52 D-20246 Hamburg Germany Submitted: 3.4.2009 Accepted after revision: 11.7.2009