Angioplasty of the pelvic and femoral arteries in PAOD: Results and review of the literature

Material and methods The data of 195 consecutive patients with 285 obstructions of the common and or external iliac artery as well as the data of 452 consecutive patients with 602 long occlusions (length > 5 cm) of the SFA were retrospectively analyzed. The lesions were either treated with percutaneous transluminal angioplasty (PTA) or Excimer laser assisted percutaneous transluminal angioplasty (LPTA). Overall 316 stents were implanted (Nitinol stents: 136; stainless steel stents: 180) in the iliac artery and 669 stents were implanted (Nitinol stents: 311; Easy Wallstents: 358) in the SFA. The follow-up period was 36–65 months (mean 46.98 ± 7.11 months) postinterventionally using clinical examination, ABI calculation, and color-coded duplex sonography. Patency rates were calculated on the basis of the Kaplan–Meier analysis. Results The overall primary technical success rate was 97.89% for the iliac arteries and 92.35% for the SFA. Minor complications (hematoma, distal emboli and vessel dissection) were documented in 11.79% for the iliac arteries and 7.97% for the SFA. The primary patency rate was 90.3% for the iliac and 52.8% for the SFA after 4 years. The secondary patency rate was 96.84% for the iliac and 77.8% for the SFA after 4 years. Conclusion Percutaneous recanalization of iliac and superficial femoral artery obstructions is a safe and effective technique for the treatment of patients with PAOD. By consequent clinical monitoring high secondary patency rates can be achieved. The use of a stents seems to result in higher patency rate especially in the SFA when compared to the literature in long-term follow-up. Keywords PAOD Iliac arteries Superficial femoral artery Stent Angioplasty 1 Introduction The annual incidence of symptomatic peripheral arterial obstructive disease (PAOD) is 26/10,000 in men and 12/10,000 in women according to the results of the Framingham study; this means that PAOD is at least as frequent as angina in the U.S. population [1] . The most common clinical manifestation of PAOD is intermittent claudication involving the pelvis, upper thigh and lower limb. Patients presenting with critical limb ischemia usually have multisegmental disease with involvement of the infra-inguinal arteries. Anatomically, approximately 30% of the arterial lesions are located in the iliac arteries, 70% in the femoro-popliteal and tibial tract. Isolated lesions below the knee are present in only 15% of the cases. Approximately 30% of the symptomatic PAD patients have diffuse arterial disease, and the majority of CLI patients, most of whom are diabetic, have distal arterial disease with occlusions in the tibial arteries [2] . Considerable advances have been made over the last decade in percutaneous technology for the treatment of atherosclerotic diseases in the iliac, femoro-popliteal, and distal tibioperoneal arteries [3,4] . The techniques that have been developed include percutaneous balloon angioplasty and stenting, atherectomy and laser therapy [3,5,6] . The primary goal of any treatment of patients with PAOD will be either relief of significant lifestyle-limiting symptoms or limb salvage. Surgery has long been considered the gold standard treatment when symptoms could not be controlled by risk factor modification, exercise therapy or medication. With the introduction of new interventional techniques and devices acute treatment success and durability of endovascular technology has improved during the last decade. As a result, endovascular intervention has become a first line therapy to treat PAOD in many cases and even complex arterial diseases [2] . According to the recently updated TransAtlantic Consensus Document on treatment of PAOD (TASC II), the choice between endovascular therapy and surgery depends on the lesion type in terms of complexity and length [7] . This paper presents the follow-up data of patients with PAOD treated with percutaneous transluminal recanalization either in the iliac or femoral artery and reviews the literature to date. 2 Materials and methods 2.1 Iliac artery recanalizations The data of 195 consecutive patients with 285 obstructions of the common and or external iliac artery were retrospectively analyzed. These patients were identified by routine registry and routine scheduled follow-up regimens. The lesions were either treated with percutaneous transluminal angioplasty (PTA) or Excimer laser assisted percutaneous transluminal angioplasty (LPTA). Overall 316 stents were implanted (Nitinol stents: 136; stainless steel stents: 180). A total of 134 men (mean age 60.9 ± 12.5 years) and 61 women (mean age 58.8 ± 10.8 years) were treated. Patients with the disease extending into the common femoral artery (CFA), requiring also treatment of the CFA, were excluded from percutaneous revascularization. In these cases vascular surgery was preferred. Patients with Fontaine classification stages I and IIa were treated medically. 2.2 Femoral artery recanalizations The data of 452 consecutive patients with 602 long occlusions (length > 5 cm) of the SFA were retrospectively analyzed. These patients were identified by routine registry and routine scheduled follow-up regimens. The occlusions were either treated with percutaneous transluminal angioplasty (PTA) or Excimer laser assisted percutaneous transluminal angioplasty (LPTA). Overall 669 stents were implanted (Nitinol stents: 311; Easy Wallstents: 358). 310 men (mean age 64.85 ± 8.49 years) and 142 women (mean age 69.70 ± 9.49 years) with intermittent claudication or chronic limb ischemia classified as Fontaine stage IIb, III or IV were treated. Patients with the disease extending into the common femoral artery (CFA), who requiring additional treatment of the CFA also and those patients with occlusions also in the popliteal artery were excluded from percutaneous interventional procedures. In these cases bypass surgery was preferred. Patients with Fontaine classification stages I and IIa were excluded and treated medically. 2.3 Interventions All procedures were performed in the interventional radiology suite equipped with a C-arm angiographic unit (AXIOM Multistar, Siemens, Erlangen, Germany). Measurements of vessel diameter and percentage of stenosis were performed with the integrated measurement system. 2.4 Iliac artery recanalizations The appropriate choice of vessel access is depending on lesion localization. The technique of recanalizations has been described already elsewhere [8,9] . In case of a stenosis in the distal common iliac artery (CIA) or the proximal external iliac artery (EIA) the ipsilateral femoral artery was punctured under local anesthesia at the groin. After successfully crossing of the lesion with a soft angled hydrophilic guide-wire (Terumo Inc.) an i.a. DSA in p.a. and oblique projection (left anterior oblique (LAO) or right anterior oblique (RAO)) was performed via a 5 French (F) Pigtail catheter (Cordis endovascular Inc.) which was placed in the infrarenal aorta. The 5F sheath was then exchanged for a 6–8F sheath. In case of an occlusion of the CIA or EIA the contralateral approach was preferred. A hydrophilic guide-wire (Terumo Inc.) was then used to pass the occlusion in an antegrade direction. The guide-wire was captured in the contralateral groin and all further interventional procedures (debulking, PTA, stent placement) were performed via the retrograde approach with or without protection of the contralateral CIA by balloon (kissing balloon technique), if appropriate. For debulking in case of occlusion or severe stenosis a F7 or F8 multifiber Excimer laser catheter (Spetranetics Inc.) was used. After successful recanalization implantation of stents with a mean diameter of 7.34 ± 0.81 mm and a mean length of 47.8 ± 18.6 mm without predilatation was performed. The more flexible self-expanding Nitinol stents (SMART (Cordis endovascular; n = 89), Luminexx (C.R. Bard; n = 47)) were used for cross-over techniques and tortuous vessels and especially EIA occlusions while balloon-expandable stents (AVE iliac Bridge (Medtronic AVE, n = 77), Corinthian IQ (Cordis endovascular; n = 96)) with the stronger radial expansion were used in extremely calcified stenosis and especially CIA occlusions. Covered stents (Jostent, Jomed Inc.; n = 7) were used in seven patients. Final angiography including evaluation of the lower limb run-off was performed before the sheath was removed and the access site was closed using percutaneous suture devices (Closer or Prostar 8 system (Perclose Inc.)). During the intervention 5000–10,000 International Units (IU) of heparin were administered i.a. based on patient's weight, level of preinterventional anticoagulation and duration of intervention. 2.5 Superficial femoral artery recanalization The contralateral approach can be considered the standard method for femoro-popliteal angioplasty. The main advantage of this technique is the fact that no postinterventional flow reduction during manual compression and following pressure bandage is applied to the treated leg. Thus, the flow in the treated vessel segment is not reduced, which subsequently may reduce early thrombotic reocclusion. After obtaining the pre-interventional angiography, a suitable shaped diagnostic catheter (e.g. Pigtail, Cobra or Hook) was used for cross-over navigation of a soft angled guide-wire (Terumo). After successful cross-over placement of the diagnostic catheter the soft angled guide-wire was exchange for a stiff guide-wire (e.g. Amplatz guide-wire). The 5F introducer sheath was the exchanged for a 6–7F cross-over sheath. The initial passage of femoral lesion was performed using a standard 0.035 guide-wire. For crossing of an occlusion, a stiff angled hydrophilic guide-wire (Terumo, 0.035″) was used. A diagnostic Multipurpose-catheter (F4, Cordis) was used as support catheter to increase the steerability of the guide-wire. In some cases a 0.018″ Nitinol-tipped flexible guide-wire (V18 Control wire, Boston Scientific) supported by a hydrophilic guiding-catheter (4F Glide-Cath, Terumo) was used to cross the occlusion. For balloon angioplasty the size of the balloon was chosen according to the length of the lesion and the diameter of an adjacent healthy vessel segment (balloon length: 20–80 mm, diameter: 4–6 mm). Balloon inflation was performed with up to 12–14 atm for 1–2 min. Prolonged balloon inflations up to 5 min were performed in case of relevant dissections. Stent implantation was only performed in case of major flow-limiting dissections. The antegrade femoral approach was used as an alternative technique in those cases, where a cross-over recanalization failed or could not be performed due to specific anatomical conditions (e.g. stents in the region of the aortic bifurcation). During the intervention 5000–10,000 International Units (IU) of heparin were administered i.a. based on patient's weight, level of preinterventional anticoagulation and duration of intervention. Final angiography including evaluation of the lower limb run-off was performed before the sheath was removed and the access site was closed using a percutaneous suture device (Closer system (Perclose Inc.)). 2.6 Postinterventional therapy Postinterventional medication consisted of 100 mg acetylsalicylate (ASA) on a lifetime basis plus 75 mg Clopidogrel for 6 months for lesions with poor distal run-off or after stent implantation following a definition made by our vascular center. Additionally all drugs used for risk factor reduction such as oral antidiabetics, insulin, statins and all antihypertensive drugs were administered to provide optimal secondary anti-atherosclerotic care for the patient. Technical success was defined as a successful recanalization with less than 30% residual narrowing and restoration of rapid antegrade perfusion. For these purposes pressure gradients were determined by measuring arterial blood pressure after stent placement. Clinical success was determined by using the Rutherford classification [10] . Primary patency was defined as uninterrupted patency with no procedures performed on or at the margins of the treated segment. Secondary patency implies patency following the initial procedure or following a reintervention to restore patency of a restenosed or occluded vessel [10] . 2.7 Follow-up The period of follow-up was 36–65 months (mean 46.98 ± 7.11 months). All patients were scheduled for follow-up examination performing clinical examination, ankle-brachial index (ABI) measurement and duplex sonography at the first day postinterventionally, at 1, 3, 6 and 12 months and then yearly. Duplex examination included imaging in the transverse and sagittal planes using both greyscale and color Doppler. Pulsed-wave spectral Doppler data of the common and superficial femoral as well as popliteal artery were acquired bilaterally. Velocity criteria used for determining the degree of stenosis included the peak systolic and end diastolic velocity. Although not every scheduled follow-up was attended by every patient the 36 and 48 months follow-up was obtained since we actively invited patients for the 24 and 36 months follow-up. If there were signs of clinical worsening an i.a. DSA was performed. 2.8 Statistical analysis Continuous variables are presented as mean ± SD values, if appropriate. Patency rates were calculated with the use of the Kaplan–Meier life-table method using XLSTAT for Windows ® (Addinsoft, Germany). All results and patency rates were calculated on an intention-to-treat-basis. 3 Results 3.1 Iliac arteries 195 patients, 134 men (mean age 60.9 ± 12.5 years) and 61 women (mean age 58.8 ± 10.8 years) with intermittent claudication or chronic limb ischemia classified as Fontaine stages IIb, III or IV, were treated with PTA and stent implantation. The clinical characteristics of the patients are summarized in Table 1 . Overall 285 lesions in the pelvic arteries were detected which could be subdivided into 234 stenosis (50–74%: n = 46; 75–99%: n = 188 ( Fig. 1 ); based on biplane angiographies and measurements in the DSA unit; CIA: n = 138, EIA: n = 96) and 51 occlusions (17.89%; CIA: n = 32; Fig. 2 , and EIA: n = 19). Altogether 316 stents were placed in 285 lesions. 136 self-expending stents with a mean length of 61.5 ± 16.8 mm (10–80 mm), 173 balloon-expendable stents, 41.18 ± 18.23 mm (10–79 mm) in length and 7 covered stents with a mean length of 40 ± 4.9 mm (38–50 mm). The covered stents were used to seal perforation ( n = 2), to exclude additionally found aneurysms ( n = 3), or to treat dissections caused by guide-wire passage ( n = 2). A 10% oversizing of the diameter of the implanted stent was routinely used, based on measurements of the adjacent healthy vessel segment or the contralateral vessel segment. 279/285 lesion were successfully treated according to the criteria mentioned above, as the occlusions or stenosis could be reduced to less than 30%. The overall primary technical success rate was 97.89%. Clinical improvement, defined by the reporting standards of Rutherford et al. [10] as an increase in the ABI of at least 0.1 and an increase of at least one stage could be observed in 97.43% of the patients. No patient showed signs of clinical worsening. Clinical improvement could be observed in 97.43% of the patients with improvement of the mean ABI from a 0.51 ± 0.15 preinterventionally to 0.92 ± 0.14 on the day following intervention and to 0.88 ± 0.19 within the third year postinterventionally. No patient showed signs of clinical worsening after intervention. In 23/195 (11.79%) patients complication occurred, but only 11 (5.64%) of them led to prolonged hospital stay. The overall the primary patency rate for all treated lesions calculated to 90.3% within the follow-up period of 4 years. There was no statistical difference between male and female patients ( p = 0.393, Fig. 3 ). During the follow-up period four patients died of acute cardiac event. Altogether we found a secondary patency rate of 94.87% per patient and 96.84% per lesions. 3.2 Superficial femoral artery The data of 452 consecutive patients (mean age 66.47 ± 9.45 years) who underwent recanalization of chronic superficial femoral artery occlusions (number of lesions, n = 602, mean occlusion length 19.4 ± 6.0 cm) was analyzed. The clinical characteristics of the patients are summarized in Table 2 . The primary approach to recanalize the occlusion in cross-over technique was successful in 549 of 602 lesions (91.19%; Fig. 4 ). A secondary attempt was performed in 53 cases including use of an antegrade or transpopliteal approach. The total technical success rate was 556/602 (92.35%). Postinterventionally 316 patients (69.91%) were in clinical category 0; 78 patients (17.26%) in category 1 and 37 patients (8.18%) in category 2 according to the Rutherford et al. [10] classification. No patient showed signs of clinical worsening. The average ABI improved from 0.56 ± 0.08 preinterventionally to an average of 0.97 ± 0.14 on the day following intervention and to 0.93 ± 0.13 at the end of the follow-up period. Relevant interventional complications were acute reocclusion (1.66%), perforation (2.16%), embolization/distal thrombosis (4.15%) but could be solved interventionally. Prolonged hospitalization or rehospitalization due to complications was noted in 15 patients (3.32%). Re-obstructions during the follow-up period were detected in 47.2% of the cases. However, using secondary interventions in the majority of the patients the re-obstructions were treatable on an outpatient basis. During the follow-up period 29 patients (6.41%) died, in the majority of the cases due to coronary heart disease and heart attack. As a result, the primary patency rate was 52.8% after 4 years ( Fig. 5 ) with no statistical significant difference between male and female patients. The secondary patency rate and the end of the follow-up period calculated to 77.8% after 4 years ( Fig. 6 ). 4 Discussion 4.1 Iliac arteries Today the percutaneous recanalization of iliac artery obstructions is considered as method of choice in the wide majority of iliac artery lesions. Still issue for discussion remains on employed techniques for recanalization (retrograde, antegrade, primary stenting and debulking first), the outcome in female versus male patients, as well as the stent material employed (self-expanding, balloon expanding and covered stents). Besides disease progression long-term outcome also depends on outflow limitations, concomitant medication as well as risk factor reduction. The technical and clinical success of PTA of iliac stenoses plus additional stent implantation have been described in various series to exceed 90% and for short stenoses even reach 100%, whereas technical success of recanalization an iliac occlusion is 80–85%. Once successfully opened the patency rates of both types of lesion at 5 years are approximately 80–90% and are similar to surgical results. [8,11,12] . Timaran et al. [13] reported that poor runoff is the most predicting factor for decreased primary patency rates after iliac stenting. Moreover untreated or de novo atherosclerotic lesions at other vessel segments within the follow-up period also will result in a decrease of the ABI even if the treated segment was still patent. Associated complication rates with recanalization of iliac artery obstructions of up to 20% are reported in the early days of percutaneous recanalization [14] while newer studies report on complication rates of 1–7% [7–9,12] . Pekka and Manninen [15] reported a major complication rate of 5.6% and a minor in 4.6% of 4662 published PTA procedures, resulting in a total rate of 10.2%. The fact that most of the lesions (66%) treated were located in the femoro-popliteal region can be neglected due to the fact that they found out that not the location of the lesion but its type was the only predictor of the overall complication rate. This was also confirmed by Gardiner et al. [16] (3% for iliac PTA versus 3% for femoro-popliteal PTA). Significantly more complications were associated with occlusions than with stenoses (18% versus 7%). The most common complications are bleeding complications such as hematoma or pseudoaneurysm at the puncture site and thromboembolic complications such as distal embolization, thrombosis or occlusion and were present in this study. Several patient factors contribute to increased complication rates such as obesity, cardiac and renal comorbidities [7] . The discussion on primary versus selective stenting was evaluated by Bosch et al. [17] who assessed the quality-of-life of 254 patients with 356 lesions who underwent either primary stent placement or primary PTA followed by secondary stent placement. They reported significant improvement with no significant difference in both groups in quality-of-life outcomes but similar immediate hemodynamic results and clinical outcomes during a mean follow-up of 14.7 months (range 3–24 months). In the reported series of iliac artery occlusion by Kim et al. [18] all lesions were treated with primary stent placement using a self-expanding spiral stent leading to a good technical (100%) and clinical result (94%) with only two reocclusion in a mean follow-up period of 11.9 months (6–36 months). Önal et al. [19] treated iliac artery stenoses with complex plaque morphology, which responded poorly to PTA alone and were associated with a high risk of complication and a low patency rate. Overall the discussion on primary stenting versus stenting on indication remains open and the decision is left to the discretion of the operator and individual findings on plaque morphology and location. 4.2 Superficial femoral artery Balloon angioplasty (PTA) remains the basic technique and may be the first treatment to employ for some lesions, but its technical success and durability strongly correlates with the lesion morphology [20–23] . In general, the results obtained after treating longer stenoses and/or occlusions have demonstrated to be not encouraging. A 5-year cumulative patency rate of 75% can be expected for short focal stenoses. PTA of lesions <5 cm is generally more durable than PTA of lesions >10 cm [21] . In the STAR registry [24] the primary patency rate for PTA calculated to 87% at 1 year, 80% at 2 years, 69% at 3 years, and 55% at 4 and 5 years. Additionally, in this study it can be concluded that TASC C lesions may be treated with similar results to those of TASC B. Several factors proved to affect the long-term patency rate: diabetes and renal failure, lesion length, stenosis versus occlusion, diameter stenosis at baseline and post-PTA, calcification, eccentricity, post-PTA dissection, and serial lesions versus single lesion. The most limiting factor for reduced vessel patency, however, was poor tibial vessel run-off compared with an unaffected run-off situation to the foot [24] . The technique of subintimal angioplasty as a primary attempt to cross an occlusion still remains controversial and is found beneficial for long-term patency only by some centers. Bell [25] reported on more than 1000 procedures with a technical success rate of 86%, a 6-year patency rate of 55% and a 3-year limb salvage of approximately 90% which competes with surgery. Overall, it is so far widely excepted that stent implantation in the SFA is only performed in cases of flow-limiting dissection of significant residual stenosis after PTA. As of this writing the self-expanding Nitinol stent is the stent of choice in the infra-inguinal arteries. Several non-randomized studies have demonstrated the significant improvement of the Nitinol stents over the older Wallstent for the SFA. Hayerizadeh et al. [26] retrospectively compared SMART Nitinol stents (Cordis endovascular) with Wallstent (Boston Scientific). The 1-year primary patency rate was 61% with the Nitinol stent versus 30% with the Wallstent ( p < 0.0001). A similar study was presented by Sabeti et al. [27] . The primary patency rate in this study was almost identical after 2 years (Nitinol: 69%, Wallstent: 34%; p < 0.008) as compared to the previously cited study. Sabeti et al. [28] reported in another study on the treatment of long SFA lesion (>20 cm in length) using Nitinol stents and found encouraging results with a 1-year patency rate of 93% in non-diabetic and 78% in diabetic patients ( p < 0.01). However, recently published trials demonstrated the difference between various stent designs concerning patency rates as well as fracture rates. One of the first studies reporting on stent fractures was the SIROCCO II trial [29,30] which not only demonstrated restenosis rates 7.7 and 25% at 6 months and 2 years, respectively, but also revealed stent fractures after 6 months in 17 and 12% for three and two overlapping stents, respectively. The FESTO trial [31] demonstrated a high amount of stent fracture in two of the older Nitinol stent generations independently of the SFA segment they were implanted in. Recently published studies on Nitinol stents in the SFA however showed lower stent fractures rates, probably due to the newer stent design and different Nitinol surface finishing [32,33] . Implantation of an endografts for the treatment of SFA obstructions seems to be an alternative to a prosthetic surgical bypass are discusses with a reduced inflammatory vessel wall response since reported primary and secondary patency rates are promising (79% primary patency rate and 93% secondary patency rate after 4 years). However, these studies are in the majority of cases non-randomized single center studies with small population sizes [34–37] . A comparative study between the endovascular placement of the Hemobahn stent-graft and bare Nitinol stenting or, even better, surgical bypass would help provide solid evidence-based support for the use of this technology. The benefit of the application of drug eluting stents (DES) could not be proven by the SIROCCO I and II trials since the difference in patency between des DES group and the bare metal Nitinol group was virtually identical [29,30] . Explanations for the failure of a beneficial outcome of DES application to femoro-popliteal arteries are numerous, including wrong (too short) release kinetics and an insufficient peak concentration of the used drug (Sirolimus), and a completely different remodeling behavior of the vessel wall following placement of self-expanding stents compared to balloon-expandable stents as used in the coronaries. Further research has to be awaited to make final conclusions on the potential benefit of DES application in the femoro-popliteal vessel area. Currently, another study is still including patients to investigate the long-term outcome of a polymer-free Nitinol stent platform using paclitaxel as a antiproliferative agent (ZILVER study). All the techniques available today for the treatment of the SFA lesions are still controversial, although the use of SFA angioplasty with or without stenting is expanding with an increasingly aggressive management strategy for all TASC lesions. It is widely accepted that TASC A and B lesions can be treated with acceptable long-term results using percutaneous minimally invasive techniques. The new techniques may allow us to extend endovascular procedures to TASC C and D lesions. However, despite primary success rates of more than 90%, even in TASC D lesions, the role of endovascular therapy for TASC D lesions remains debated, and many advocate that these patients should be considered for surgical intervention. Surgical bypass remains the gold standard for these more advanced SFA diseases [2,7] . 5 Conclusion In summary, the data on percutaneous iliac artery recanalization underline that stent-supported reconstruction of even complex lesions, classified as TASC C and D can be treated successfully with endovascular intervention ( Table 3 ). However, further investigations should be focused on the 5- and 10 year patency rates in comparison with the surgical results. Still unresolved seems to be the discussion on primary was selective stent implantation. Concerning the treatment of SFA lesions PTA remains the method of choice for the majority of cases. If stent implantation is required the Nitinol stent is the adequate choice since newer stent designs as well as stent surfaces have proven lower fracture and restenosis rates. The discussion is still open concerning drug eluting stents of the newer generation as well as the long-term results of drug eluting balloon angioplasty. 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