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Critical limb ischemia (CLI) is an endstage manifestation of peripheral artery disease (PAD) and typically describes patients with ischemic rest pain (Rutherford Category 4), or patients with ischemic skin lesions, either ulcers or gangrene (Rutherford Category 5-6). CLI due to infrapopliteal lesions is often not a good indication for infrageniculate bypass surgery placement, due to the presence of prohibitive comorbidities, inadequate conduit, and lack of suitable distal targets for revascularization. Therefore, CLI patients due to blockage of below-the-knee arteries are in benefit of the endovascular approach. Infrapopliteal PTA became feasible with the introduction of low-profile peripheral balloon systems and the use of coronary balloons. Stent implantation, however, is generally reserved for cases with a suboptimal outcome after PTA (i.e. >50% residual stenosis, flow-limiting dissection). Because of the fear that early thrombosis and late luminal loss due to intimal hyperplasia formation will potentially lead to insufficient long-term patency rates, efforts to extend the range of endovascular approaches to CLI are presently focused on. Cryoplasty, scoring balloon angioplasty, excimer laser therapy and atherectomy using different types of atherectomy devices have been introduced. The current article provides an overview of the endovascular treatment strategies for infrapopliteal lesions in patients with CLI.

Endoluminal treatment of infrapopliteal artery lesions is a matter of controversy. Bioabsorbable stents are discussed as a means to combine mechanical prevention of vessel recoil with the advantages of long-term perspectives. The possibility of not having a permanent metallic implant could permit the occurrence of positive remodeling with lumen enlargement to compensate for the development of new lesions. The present study was designed to investigate the safety of absorbable metal stents (AMSs) in the infrapopliteal arteries based on 1- and 6-month clinical follow-up and efficacy based on 6-month angiographic patency. One hundred seventeen patients with 149 lesions with chronic limb ischemia (CLI) were randomized to implantation of an AMS (60 patients, 74 lesions) or stand-alone percutaneous transluminal angioplasty (PTA; 57 patients, 75 lesions). Seven PTA-group patients "crossed over" to AMS stenting. The study population consisted of patients with symptomatic CLI (Rutherford categories 4 and 5) and de novo stenotic (>50%) or occlusive atherosclerotic disease of the infrapopliteal arteries who presented with a reference diameter of between 3.0 and 3.5 mm and a lesion length of <15 mm. The primary safety endpoint was defined as absence of major amputation and/or death within 30 days after index intervention and the primary efficacy endpoint was the 6-month angiographic patency rate as confirmed by core-lab quantitative vessel analysis. The 30-day complication rate was 5.3% (3/57) and 5.0% (3/60) in patients randomized for PTA alone and PTA followed by AMS implantation, respectively. On an intention-to-treat basis, the 6-month angiographic patency rate for lesions treated with AMS (31.8%) was significantly lower (p = 0.013) than the rate for those treated with PTA (58.0%). Although the present study indicates that the AMS technology can be safely applied, it did not demonstrate efficacy in long-term patency over standard PTA in the infrapopliteal vessels.

The application of percutaneous techniques for the treatment of peripheral arterial occlusive disease (PAOD) has gained widespread interest over the last decade. Together with the development of new endovascular tools and with an increasing operator experience, the minimal invasive percutaneous therapy became first line therapy at many institutions. Patients with critical limb ischemia (CLI) due to infrapopliteal lesions are often no good candidates infra-geniculate bypass surgery (IBS), as they often present with prohibitive comorbidities, inadequate conduit, and lack of suitable distal targets for revascularization. Therefore, CLI patients due to blockage of below-the-knee (BTK) arteries are in benefit of the endovascular approach: it offers the advantages of local anesthesia, potentially reduced costs (even anticipating the need for reintervention in many patients), shorter hospital stays The current article provides an overview of the diagnosis and endovascular treatment strategies for infrapopliteal lesions in patients with CLI and gives recommendations for future infrapopliteal device technology advancements.

The AngioSculpt Scoring Balloon Catheter (AngioScore, Inc., Fremont, CA) is composed of a semicompliant balloon encircled by three nitinol spiral struts providing targeted lesion scoring on balloon inflation. Between April 2005 and April 2006, procedural and follow-up data on 31 patients (mean age 76 years; 54.8% males) endovascularly treated for severe infrapopliteal disease were collected. The AngioSculpt catheter was used to treat 36 complex, tibioperoneal, atherosclerotic lesions. All patients had symptomatic critical limb ischemia (Rutherford 4-5) and single-vessel runoff to the ankle. Complication-free survival at 1 month was the safety end point, whereas primary patency and limb salvage were the efficacy end points evaluated at 1 year. The AngioSculpt balloon was successfully inflated in all 36 target lesions. Eleven patients (35.5%) required additional stenting for minor dissections or suboptimal stenosis reduction. The 1-month complication-free survival was 96.8%. One-year survival, primary patency, and limb salvage rates were 83.9 +/- 6.6%, 61.0 +/- 9.3%, and 86.3 +/- 6.4%, respectively. The 1-year data show the AngioSculpt Scoring Balloon Catheter to be an effective and safe treatment for infrapopliteal, atherosclerotic lesions in patients with critical limb ischemia. However, more patients, a longer follow-up, and randomized studies comparing it with conventional balloon angioplasty and stenting in the infrapopliteal region are required.

We investigated the efficacy of Xpert (Abbott Vascular, Abbott Park, IL) nitinol stents for the treatment of infrapopliteal lesions in patients with Critical Limb Ischemia (CLI). Between May 2005 and November 2007, 94 CLI patients (70 male, mean age 73.5 years) received 134 Xpert stents in 102 limbs. Seventy-nine patients (71.2%) were scored as Rutherford Category 4, 31 patients (27.9%) as Category 5 and 1 patient (0.9%) as Category 6. Primary endpoint of this study was defined as 2-year duplex derived primary patency. Secondary endpoints were 2-year limb salvage rate and the absence of reintervention after the index procedure. Kaplan Meier analysis reported 2-year primary patency and limb salvage rates of 54.4% and 90.8%, respectively. Stratification by lesion location did not reveal any significant differences in 2-year primary patency rates in proximal and distal below the knee lesions. Our results suggest that treatment with nitinol Xpert stents can be considered effective for treating CLI patients, with satisfying patency outcome.

Objective: Data regarding the long-term efficacy of carotid artery stenting (CAS) are still scarce. As demonstrated by several major randomized controlled trials (RCT) comparing the efficacy of carotid endarterectomy (CEA) vs medical therapy, even after successful carotid revascularization late ipsilateral stroke occurs in 5-13% at 5 years. Therefore, major concerns also remain about the durability of the CAS procedure in terms of stroke prevention. The purpose of this study was to review long-term results after carotid stent implantation in a large cohort of patients., Methods: This retrospective investigation involved 3179 CAS procedures performed at four European carotid high-volume centers. Echo-duplex scan using modified velocity criteria to recognize in-stent restenosis (ISR) and neurological examinations of all patients were carried out every 6 months after the procedure. Life-table analysis was used to determine freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any ipsilateral stroke. Freedom from ISR and from reintervention were also reported. The secondary aim was to identify predictive risk factors for neurological complications and ISR., Results: At 5 years freedom from mortality, stroke-related death, ipsilateral fatal/major stroke, and any stroke rate were 82%, 93.5%, 93.3%, and 91.9%, respectively. The only predictor for neurological complications was the presence of neurological symptoms before CAS (hazard ratio 1.38 [CI 1.05, 1.82] P = .02). Freedom from restenosis at 1, 3, and 5 years was, respectively, 98.4%, 96.1%, and 94%. Uni- and multi-variate analyses showed that stent characteristics (material/design/free-cell area) were not significantly associated with time to in-stent restenosis or time to reintervention., Conclusion: Our long-term results in a large cohort of patients validated CAS as a durable procedure for stroke prevention. The annual rate of neurological complications after CAS was comparable to that of conventional surgery as demonstrated by large RCTs involving both symptomatic patients (North American Symptomatic Carotid Endarterectomy Trial [NASCET] and European Carotid Surgery Trial [ECST]) and asymptomatic patients (Asymptomatic Carotid Atherosclerosis Study [ACAS] and Asymptomatic Carotid Surgery Trial [ACST]).

The current evolution towards treating more complex femoropopliteal lesions as seen in the renewed TASC II recommendations clearly reflects the continuous evolutions in femoropopliteal stent design. Recent stent design improvements focus on decreasing stent fractures rates which can negatively impact patency rates. By rearranging strut alignment towards helical connecting bridges or full helical stent designs, stent designers have successfully improved the fracture resistance of their stents. The superior fracture resistance of the latest stent generation in combination with the production of long nitinol stents of up to 20 cm in length allow that more difficult and complex lesions can be treated endovascularly. The continuous perfection of nitinol stent platforms followed by the transfer of coronary technologies (e.g. active coatings) towards peripheral devices might broaden the indications for the minimal invasive strategy towards TransAtlantic Inter-Society Consensus (TASC) II C&D lesions.

The objective of this study was to evaluate a percutaneous extravascular closure device (StarClose, Abbott Vascular, Redwood City, CA) after brachial endovascular approach. From 2004 to 2006, 29 patients received StarClose for brachial closure. Primary endpoints were successful deployment and absence of procedure-related morbidity, secondary endpoints were brachial artery patency on duplex and absence of late (> 30 days) complications. The device was successfully deployed in all patients. In two patients (6.8%) local complications occurred: one patient developed a large hematoma successfully treated with prolonged compression and a second patient presented with brachial artery occlusion requiring operative intervention. After a mean follow-up of 7.5+/-7.2 months, all patients had a palpable brachial/radial pulse; none had signs of infection, distal embolization or neurological deficits. On ultrasound b-mode imaging, the clip was visible as a 4 mm echolucent area at the outer anterior wall of the artery. Based on the peak systolic velocity ratios between the site of StarClose and proximal brachial artery (mean 1.08+/-0.2), none of the studied patients had a significant stenosis at the site of closure. StarClose is safe and effective in providing hemostasis following interventional procedures through the brachial artery; further advantages include patients comfort and early discharge.

Background: Use of stents following angioplasty for infragenicular lesions appears to be superior to angioplasty alone. We investigated the safety and efficacy of MULTI-LINK VISION stent (Abbott Vascular, Brussels, Belgium) for the treatment of infragenicular lesions in patients with critical limb ischaemia (CLI)., Methods and Results: During the period between February 2005 and October 2005, fifty patients with CLI (Rutherford 4 and 5) due to infragenicular disease were included in the study. The studied patient population included 28 males (56.0%) and 22 females (44.0%) with a mean age of 76 years (range 59-90 years). The medical history was significant for hypertension in 43 patients (86.0%), diabetes in 23 (46%) and hypercholesterolaemia in 37 (74%) patients. Fourteen patients (28%) admitted to the use of nicotine. Thirty-four (68%) belonged to Rutherford class 4 and 16 were class 5 (32%). All patients underwent clinical evaluation before and after the intervention. A pre-procedure Duplex ultrasound examination followed by angiography and intervention were performed on all patients included in the study. Sixty-two lesions were treated with angioplasty followed by insertion of 68 MULTI-LINK VISION stents. After intervention, patients were followed at one, six and 12 month intervals with clinical examination and arterial duplex study. The survival of the studied population was 83.3%, the limb salvage was 89.3% and primary patency of treated vessel was 62.8% at 12 months., Conclusions: Treatment of infragenicular lesions in CLI with MULTI-LINK VISION stent is safe and effective with satisfactory limb salvage. The primary patency was acceptable, but less compared to dedicated below the knee devices.

Aim: We investigated the efficacy of Xpert (Abbott Vascular Devices) nitinol stents for the treatment of infrapopliteal lesions in patients with critical limb ischemia (CLI)., Methods: Between May and October 2005, 47 CLI patients (35 men, mean age 73 years) received 67 Xpert stents for the treatment of 58 infrapopliteal lesions in 51 limbs; 43 patients (84.3%) were classified in Rutherford Category 4 and 8 (15.7%) in Category 5. Clinical examination and quantitative vascular analysis (QVA) were performed before and after the intervention and at 12-months follow-up. The primary endpoint was defined as 1-year angiographic binary restenosis rate (>50% stenosis on QVA); the secondary endpoints were 1-year primary patency and limb salvage rate., Results: QVA after 1 year showed a binary restenosis rate of 20.45%. Kaplan-Meier analysis revealed 1-year primary patency and limb salvage rates of 76.3% and 95.9%, respectively. The limb salvage rate was significantly better in patients with proximal below-the-knee (BTK) than in those with mid-section or distal lesions (100% vs 81.8%; P=0.0071)., Conclusion: Our results suggest that treatment with nitinol Xpert stents in CLI patients is effective and yields satisfactory angiographic and clinical outcome.

Objectives: The goal of this study was to review our experience with embolic protection devices (EPDs) during carotid artery stenting (CAS). Specifically, we aimed to verify their clinical effectiveness and to compare clinical outcomes between specific devices and types of EPDs., Methods: The CAS databases at four participating centers were reviewed. Adverse events were defined as death, stroke (>24 hours), or transient ischemic attack (TIA) (<24 hours). We compared the risk of procedural and 30-day events between patients treated with and without an EPD. We also compared these risks between different EPDs and between the different types of EPDs., Results: A total of 3160 CAS procedures using nine EPDs were analyzed. The risk of a procedural adverse event was 0.9% in protected and 2.3% in unprotected procedures (P = .12). Compared with the most frequently used device (FilterWire, Boston Scientific, Natick, Mass), there was no significant difference in the risk of procedural adverse events for any of the other EPDs. There was, however, an increased risk of 30-day adverse events with the Accunet (Abbott Vascular, Redwood, Calif) filter compared with the FilterWire (relative risk [RR] 2.67, confidence interval [CI] 1.41 to 5.04, P = .005). Pairwise comparison of proximal occlusion balloons to filters, distal occlusion balloons to filters, and proximal to distal occlusion balloons revealed no significant difference in the risk of procedural or 30-day adverse events. There was no significant difference in risk of procedural events between eccentric and concentric filters, however, the relative risk of eccentric compared with concentric filters at 30 days was 0.59 (unadjusted, CI 0.38 to 0.92, P = .04). This difference was still apparent after adjustment for risk factors (RR 0.61, CI 0.39 to 0.95, P = .06), but not after adjustment for risk factors and stent-type [(open-cell vs closed-cell) RR 0.76, CI 0.47 to 1.22, P = .51]., Conclusion: The use of EPDs is associated with a low risk of procedural adverse events. We were unable to detect significant differences in risks of procedural adverse events between different devices or types of devices. We speculate that the observed differences seen at 30 days are largely attributable to differences in stent-type used.

Aim: The aim of this study was to identify predictive risk factors for complications during and after carotid artery stenting (CAS)., Methods: A multivariate analysis was performed on the databases of 4 European high-volume centers regarding risk factor distribution between patients presenting with or without neurological complications 30 days after CAS. The cumulative 30-day neurological complication rate (death, major stroke, minor stroke and transient ischemic attack) was 2.8% in the total examined cohort of 3 179 consecutive CAS procedures. The following risk factors were taken into consideration for statistical analysis: age, symptomatic, male gender, nicotine abuse, hypertension, hypercholesterolemia, polyvascular disease, diabetes, restenosis after carotid endarterectomy (CEA)/CAS, calcified internal carotid artery., Results: Symptomatic (P=0.02) or hypercholesterolemic (P=0.02) patients are at significantly increased risk for neurological events 30 days after CAS. Asymptomatic women and men without hypercholesterolemia have the lowest risk on any 30-day neurological complications after CAS., Conclusions: CAS is a safe technique in experienced hands. Preprocedural neurological complaints and hypercholesterolemia can be defined as predisposing factors for 30-day neurological complications after CAS.

Aim: The aim of this study was to evaluate the technical feasibility and safety of implanting a polytetrafluoroethylene (PTFE) covered balloon expandable stent to treat iliac artery stenoses and occlusions. Additionally, the primary patency and clinical and hemodynamic efficacy at 1 year were analysed., Methods: This nonrandomized, prospective study involved patients with claudication and iliac artery occlusive disease at 2 participating centres. Patients with suitable lesions determined by clinical examination, ankle-brachial indices (ABIs), colour-flow duplex ultrasound (CFDU), magnetic resonance angiogram (MRA) and confirmed with biplanar digital subtraction angiography (DSA) were treated with PTFE-covered stainless steel stents. Procedural and 30-day periprocedural complications were recorded prospectively. According to in-hospital standards, follow-up with clinical ischemia category determination, ABI and CFDU was performed at 1, 6 and 12 months to determine treatment efficacy and primary limb patency., Results: In total, 91 limbs were treated in 65 patients (51 male; mean age 65 years). Stent-graft deployment was successful in 91 (100%) limbs. There were no limbs with residual stenosis >30%. There were no procedural or 30-day complications. The clinical ischemia category distribution improved significantly at 1, 6 and 12 months. The mean ABI rose significantly from 0.59 before treatment to 0.98, 0.98 and 0.99 at 1, 6 and 12 months after the procedure. Primary limb patency at 1-year was 91.1%, Conclusions: Implantation of Advanta V12 PTFE-covered stent for iliac occlusive disease shows to be safe and feasible with excellent clinical results at 1 year in the investigated patient cohort.

Objectives: The study was conducted to identify patient and procedural parameters that negatively impact the 30-day rates for stroke, death and transient ischemic attack (TIA) after carotid artery stenting (CAS) and that might be modified or further studied in future efforts to improve CAS., Methods: This was a retrospective investigation of a dual-center CAS database of 701 consecutive CAS patients (414 men; mean age, 72.4 +/- 8.4). A subset of patient-related, lesion-related, or procedure-related variables (age >or=80, left sided lesion, symptomatic, nicotine abuse, hypertension, diabetes mellitus, other peripheral vascular disease, hypercholesterolemia, embolic protection devices usage, predilation, ulcerated lesion, echolucent plaque, restenosis after surgery) were analyzed for association with occurrence of stroke, death, or TIA

Aim: Expanded polytetrafluoroethylene (ePTFE) grafts are commonly used for femoropopliteal (FP) and femorocrural (FC) bypass grafting. Especially in below-knee (BK) reconstructions, patency is often inferior to the outcome in patients eligible for venous bypass grafting. This study assesses whether the Carmeda BioActive Surface (CBAS), which employs covalent end-point linkage to retain heparin on the device surface, as it is used on the Propaten vascular graft successfully, can prolong patency., Methods: From June 2002 to December 2005, 138 patients (97 men and 41 women; mean age: 73 years) received the CBAS-ePTFE graft for 153 infrainguinal bypass procedures. Seventy-five above-knee (AK) and 78 BK (including 37 FC) procedures were performed. Follow-up evaluations consisted of clinical examinations, ultrasonographic studies, and distal pulse assessments. Patency and limb salvage rates were assessed by using life-table analyses., Results: The overall primary and secondary 2-year patency rates were 73.6% and 86%, respectively. Two-year primary patency rates according to bypass type were 76.2%, 72.6%, and 68.9% for AK FP, BK FP, and FC bypasses, respectively; the corresponding secondary patency rates were 87.5%, 87.8%, and 79.4%. The 2-year limb salvage rate in patients with critical limb ischemia (n=68) was 89.9%., Conclusion: Our findings show that CBAS-ePTFE bypass grafts appear to give prolonged patency rates and indicate that the use of this graft may represent a viable alternative for BK bypasses, which have traditionally yielded less than desirable outcomes. A prospective randomized trial is required to provide more definitive information about the graft's patency and limb salvage performance.

Peripheral stents aim to support revascularization procedures of intravascular stenoses by mechanically preventing vessel recoil and counteracting pathophysiologic processes of luminal re-narrowing triggered by procedural injury of the vessel wall. Despite improvements in stenting techniques and concomitant medication, repeated intervention due to target lesion re-stenosis is necessary on a significant percentage of patients. The permanent presence of an artificial implant plays a prominent role in the discussion of mechanisms causing in-stent restenosis. Permanent metallic implants pose the risk of a continuous interaction between non-absorbable stent and surrounding tissue, leading to physical irritation, long-term endothelial dysfunction, or chronic inflammatory reactions. In addition, there is a risk of stent fracture due to external mechanical forces. To overcome these shortcomings, technology of stenting has moved towards the development of temporary implants composed of biocompatible materials which mechanically support the vessel during the period of high risk for recoil and then completely degrade in the long-term perspective. This removes a potential trigger for late restenosis.

Aim: The aim of this paper was to evaluate the mid-term results of remote endarterectomy and balloon-expandable, radially reinforced ePTFE endograft uplining of the superficial femoral artery (SFA) for long occlusions., Methods: One hundred and two limbs in 92 patients were included in this prospective, multicenter study. Indications were disabling claudication (n=74), restpain (n=10) and tissue loss (n=16) due to an SFA occlusion of at least 10 cm in length. Remote endarterectomy of the SFA using a modified ringcutter in an over-the-wire technique, was followed by implantation of a balloon-expandable Enduring endovascular graft. Control visits were performed at 1, 3 and 6 months postprocedure and every half year from then on. Follow-up protocol included physical examination, Doppler ankle-brachial index measurement and, in case of doubt, duplex examination., Results: A technical success rate of 98% was achieved. Mean follow-up was 36 months. Four patients were lost to follow-up and 17 patients died of nondevice-related causes. The primary, primary assisted and secondary patency rates were 68%, 73% and 97.5% at 1 year and 50%, 60%, and 89% at 3 years, respectively., Conclusion: Although technical success rate is high and early patency rates are good, mid-term results are inferior to those of conventional femoro-popliteal synthetic bypass grafts. In order to become competitive to conventional bypass surgery, further technical refinements will be necessary, especially to overcome the problem of stenoses at the distal transition zone.

Aim: We investigated the safety and efficacy of sirolimus-eluting stents in the treatment of patients with severe below-the-knee' critical limb ischemia., Methods: Between October 2004 and January 2005 we performed 20 percutaneous transluminal angioplasty procedures on 18 patients (7 female, 11 male, mean age 72.8 years), implanting 24 sirolimus-eluting stents. At pre-procedure, 12 patients (66.7%) presented with a Rutherford Category 4, 4 (22.2%) with Category 5 and 2 (11.1%) with Category 6. The majority of patients (72.2%, n=13) were non-smokers and 77.8% (n=14) presented with hypercholesterolemia. Calcification was present in 52.2% (n=12) of lesions. Pre-dilation was performed in half the patients. The majority of lesions (95.7%, n=22) were treated with a single sirolimus-eluting stent. Two patients underwent 2 procedures, each one receiving 2 sirolimus-eluting stents. Clinical examination and quantitative vascular analysis were performed in all patients at discharge and at 6-month follow-up., Results: Percutaneous transluminal angioplasty was successfully performed on all 18 patients. The mean stent length and stent diameter were 30.29 mm and 3.23 mm, respectively. Mean follow-up was 256 days (170-368 days). At the 6-month follow-up, the minimum lumen diameter as measured by Quantitative Vessel Analysis was 2.39 mm with an attendant LLS of 0.38 mm. The overall 6-month survival and limb salvage rate were 94.4% and 94%, respectively., Conclusions: Our results suggest that treatment with sirolimus-eluting stents can be considered as an effective and safe treatment of patients with critical ischemia.

The individual characteristics of a stent may make it an attractive choice in some circumstances, but render it a less desirable option in others. The applicability depends primarily on the arterial anatomy and the specific details of the lesion being treated. A careful assessment by the interventionalist is required to select the proper type of stent that is of appropriate size. Certainly, personal preferences and familiarity with a specific device may legitimately influence the decision to choose one stent over another. Finally, stent design can play a role in the selection procedure. Although carotid stents are often functionally equivalent in the clinical setting and have been used successfully to treat a wide variety of lesions, a basic knowledge of stent geometry can contribute to make up your mind in certain carotid cases.

Endovascular strategies for the treatment of critical infrageniculate peripheral arterial occlusive disease exist and are becoming the primary methodology for such lesions at many centers. Although technically feasible for experienced operators, the evidence to support this strategy for below the knee (BTK) interventions is still evolving. We studied the 6-month and 1-year outcomes of percutaneous transluminal angioplasty (PTA) alone, PTA with stenting, and excimer laser recanalization for BTK lesions in patients with critical limb ischemia. Between September 2002 and June 2005, 443 patients (355 Rutherford category 4, 82 category 5, 6 category 6) underwent intervention for 681 BTK lesions. Follow-up was performed at 6-month intervals after index intervention: limb salvage data were recorded and duplex ultrasonography was performed to measure the patency of treated areas. The primary patency and limb salvage rates of the entire population were 85.2% and 97.0% and 74.2% and 96.6% at 6 months and 1 year, respectively. Stratified for the treatment strategy (PTA alone in 79, PTA with stenting in 300 patients, and excimer laser in 64), 1-year primary patency rates were 68.6%, 75.5%, and 75.4%, whereas the limb salvage rates were 96.7%, 98.6%, and 87.9% for each modality, respectively. Endovascular intervention will become the primary treatment for BTK lesions in patients with critical limb ischemia, with 1-year primary patency and limb salvage rates that compare favorably with published surgical data. Prospective, randomized, multicenter trials will be needed to further establish the role of endovascular intervention in this challenging patient group.

Objective: Several prosthetic materials have been used for femoropopliteal bypass grafting in patients with peripheral vascular disease in whom a venous bypass is not possible. Expanded polytetrafluoroethylene (ePTFE) is the most commonly used, but patency results have not always equaled those achieved with vein, especially in below-knee reconstructions. This study assessed the performance of a new heparin-bonded ePTFE vascular graft that was designed to provide resistance to thrombosis and thereby decrease early graft failures and possibly prolong patency., Method: From June 2002 to June 2003, 86 patients (62 men and 24 women; mean age, 70 years; 99 diseased limbs) were enrolled prospectively in a nonrandomized, multicenter study of the heparin-bonded ePTFE graft. Fifty-five above-knee and 44 below-knee (including 21 femorocrural) procedures were performed. Follow-up evaluations consisted of clinical examinations, ultrasonographic studies, and distal pulse assessments. Patency and limb salvage rates were assessed by using life-table analyses., Results: All grafts were patent immediately after implantation. There were no graft infections or episodes of prolonged anastomotic bleeding. During the 1-year follow-up, 10 patients died, 15 grafts occluded, and 5 major amputations were performed. The overall primary and secondary 1-year patency rates were 82% and 97%, respectively. The limb salvage rate in patients with critical limb ischemia (n = 41) was 87%. Primary patency rates according to bypass type were 84%, 81%, and 74% for above-knee femoropopliteal, below-knee femoropopliteal, and femorocrural bypasses, respectively; the corresponding secondary patency rates were 96%, 100%, and 100%., Conclusions: In this study, the heparin-bonded ePTFE graft provided promising early patency and limb salvage results, with no device-related complications, in patients with occlusive vascular disease. Longer-term and randomized studies are warranted to determine whether this graft provides results superior to those achieved with other prostheses, especially in patients at increased risk of early graft failure, such as those undergoing below-knee bypass and those with poor run-off or advanced vascular disease.

The different geometries and working principles of carotid stents (nitinol or cobalt chromium, open- or closed-cell configuration) provide each product with unique functional properties. The individual characteristics of each device may make it an attractive choice in one circumstance but render it less desirable in other situations. In approximately 75% of all procedures, all types of stents will achieve similar outcomes, making adequate device selection unnecessary. For the remaining quarter, careful preoperative screening is mandatory. In addition to eventual access issues, the choice of the optimal carotid stent depends mainly on arterial anatomy and lesion morphology. When treating a tortuous anatomy, stents with a flexible and comformable open-cell configuration are preferred. In arteries with a significant mismatch between common carotid artery and internal carotid artery diameter, cobalt chromium (Elgiloy) or tapered nitinol stents are selected. Lesions with suspected high emboligenicity are best covered with stents with a closed-cell configuration, whereas highly calcified lesions need treatment with nitinol stents. Thorough knowledge of the characteristics, advantages and disadvantages, and working principles of the different available stents is mandatory to optimally select the materials to be used for patients eligible for carotid revascularization.

Because of the focal nature of stenoses or occlusions in the supra-aortic vasculature, the high blood-pressures in this area and the very low morbidity rates related to percutaneous therapy have largely replaced surgical revascularization as the initial treatment of choice for patients with supra-aortic arterial occlusive disease. The initial technical success and durability of percutaneous angioplasty (PTA) and stenting in these lesions is excellent. Nevertheless several factors can make PTA and stenting a complex procedure that requires advanced endovascular skills for a successful outcome. Profound knowledge of surgical reconstruction techniques or extra-anatomic bypasses remains mandatory, as it is occasionally required for failure of endovascular techniques or if contraindications exist.

Aim: Although the first long-term results of Carotid Artery Stenting (CAS) became available only recently, CAS has become an accepted treatment for carotid artery disease. We report CAS data up to 5 years, both late stroke rate and patency rates as observed in 4 high-volume European centers., Methods: Between February 1, 1993 and December 31, 2004, 2 172 patients were selected over the 4 participating centres, with intention to treat endovascularly. Conscientious follow-up was done according to the in-hospital stipulations of each centre and was entered into a database both retrospectively and prospectively. Long-term restenosis and stroke-death rates were investigated and statistically analysed and stratified using the Kaplan-Meier method., Results: Of the 2 172 patients with intention to treat 2 165 (99.7%) were technically successful. Of these 306 (14.1%) were performed without and 1 859 (85.9%) with embolic protection device (EPD); 96 patients (4.4%) received balloon dilation only and stenting was performed in 2 069 (95.6%) cases. Kaplan-Meier analysis of major stroke/all death and of significant restenosis (>50%) for the total population showed stroke/death rates of 4.1% (nar=1 356), 10.1% (nar=476) and 15.5% (nar=138); and restenosis rates of 1% (nar=1 363), 2% (nar=480) and 3.4% (nar=139), after 1, 3 and 5 years respectively., Conclusions: The patency and stroke/death rates resulting from our database analysis are pleasing and indicate that CAS also on longer term is a valuable treatment method for carotid artery disease. Due to the fact that our dataset contains prospective as well as retrospective data, it may have its limitations. Until this moment, data indicating that certain patient subgroups are at increased risk for neurological complications and in-stent restenosis during and after CAS are sparse. Further multivariant analysis on this unique dataset is mandatory in order to identify any potential links in between plaque morphology, preprocedural neurological complications, risk factor distribution, procedural steps and clinical outcome.

Patients presenting with atherosclerosis of the extracranial carotid arteries may be offered carotid endarterectomy (CEA), carotid artery stenting (CAS), or medical therapy to reduce their risk of stroke. In many cases, the choice between treatment modalities remains controversial. An algorithm based on patients' neurologic symptoms, comorbidities, limiting factors for CAS and CEA, and personal preferences was developed to determine the optimal treatment in each case. This algorithm was then employed to determine therapy in 308 consecutive patients presenting to a single institution during one calendar year. Ninety-five (30.8%) patients presented with an asymptomatic carotid stenosis of more than 80% and 213 (69.2%) with a symptomatic stenosis of more than 50%. According to our algorithm, 59 (62.1%) of the 95 asymptomatic patients received CAS, 20 (21.1%) received CEA, and 16 (16.8%) received medical therapy. All symptomatic patients underwent intervention; 153 (71.8%) were treated with CAS and 60 (28.2%) with CEA. Combined 30-day stroke and death rates after CAS were 1.7% in asymptomatic patients and 2.6% in symptomatic patients. After CEA, these rates were 0% and 3.3%, respectively. Careful selection of treatment modality according to predetermined criteria can result in improved outcomes.

Purpose: To report the preliminary 3-month follow-up of a recently developed absorbable metal stent (AMS) for treatment of infrapopliteal lesions in patients with critical limb ischemia (CLI)., Methods: Between December 2003 and January 2004, 20 patients (10 men; mean age 76 years, range 59-96) with symptomatic critical limb ischemia (CLI) due to high-grade (80% to 100%) infrapopliteal stenoses received 1 or 2 AMS devices for suboptimal angioplasty. Clinical examination and color-flow duplex imaging were performed in all patients at discharge and at 1 and 3 months., Results: Angiographic procedural success was achieved in all 20 patients. One patient died (non-procedure-related) during the periprocedural period. Three months after the procedure, primary clinical patency was 89.5% (17/19). No major or minor amputation was necessary in any of the patients, yielding a limb salvage rate of 100%. The average improvement in Rutherford class was 2.3 at the 3-month assessment. A comparison of postprocedural and 1-month color-flow duplex ultrasound and magnetic resonance images clearly indicated the ongoing absorption process of the AMS., Conclusions: After 3 months, the primary clinical patency and limb salvage rates suggest a potentially promising performance of these AMS devices in the treatment of below-knee lesions in CLI patients.

Current stent technology is based on the use of permanent implants that remain life long in the vessel wall, far beyond the time required for the prosthesis to accomplish its main goals of sealing dissection and preventing wall recoil. With the possibility to implant long vessel segments using antiproliferative drugs to prevent restenosis, the practice of transforming the coronary vessels into stiff tubes with a full metal jacket covering all side branches and being unable to adjust to the long-term wall changes, including wall remodeling with lumen ectasia becomes a serious concern. In this article, we describe the first biodegradable stent based on a magnesium alloy that allows controlled corrosion with release to the vessel wall and the blood stream of a natural body component such as magnesium with beneficial antithrombotic, antiarrhythmic, and antiproliferative properties. We also discuss the animal experiments and the initial clinical applications in 20 patients with implants below the knee, with final results soon to be released, and the plans for the first coronary study. The results of these last two studies will indicate whether the absence of a permanent implant and the antiproliferative properties shown in animals are sufficient to prevent the restenotic process in humans or whether the prosthesis must be modified by adding the biodegradable coating with conventional antiproliferative drugs.

Liver disease alters the glucose metabolism and may cause diabetes, but this condition is potentially reversible with liver transplantation (LTx). Type 1 diabetes mellitus may be coincidentally present in a LTx candidate and immunosuppressive drugs will aggravate diabetes and make its management more difficult for posttransplant. In addition, diabetes negatively influences outcome after LTx. Therefore, the question arises as to why not transplanting the pancreas in addition to the liver in selected patients suffering from both liver disease and Type 1 diabetes. We report two cases of en bloc combined liver and pancreatic transplantation, a technique originally described a decade ago in the treatment of upper abdominal malignancies but rarely used for the treatment of combined liver disease and Type 1 diabetes. Both recipients are currently liver disease-free and insulin-free more than 2 and 4 years posttransplant, respectively. Surgical, medical and immunological aspects of combined liver-pancreas transplantation are discussed in the light of the existing relevant literature.

Purpose: To evaluate the performance of the FilterWire EX for the capture and removal of debris and prevention of embolic events during endovascular carotid interventions., Methods: In the period from October 2001 to May 2002, 100 patients (60 men; mean age 72 years, range 48-90), 69 symptomatic with >or=50% internal carotid artery (ICA) stenosis and 31 asymptomatic with >or=70% stenosis were scheduled for carotid stenting with cerebral protection provided by the FilterWire EX system. Satisfactory performance of the filter was defined as effectiveness in preventing intraprocedural embolic events shown by visible debris in the filter and unchanged neurological status assessed by an independent neurologist., Results: The placement and retrieval of the FilterWire EX was technically successful in 93 of 100 patients. Five delivery failures were due to severe ICA angulation; one stenosis was underestimated on preprocedural imaging, and one case was aborted following a major stroke during sheath manipulation before filter introduction. In 56.9% of the protected cases, the filter contained debris. One neurological event occurred 6 hours after the procedure: a transient ischemic attack from which the patient recovered fully after 2 hours. No other procedure-related events were recorded within 30 days of the procedure. The procedural success among the 93 patients stented under FilterWire EX protection was 98% (92% by intention to treat)., Conclusion: The FilterWire EX appears to be an effective tool in the prevention of embolic events and in preserving neurological status during endovascular treatment of carotid artery stenosis.

Background: Incisional hernias are treated laparoscopically in an increasing number of cases. The simplest technique is the peritoneal onlay technique. Composite mesh, consisting of one layer of polypropylene mesh, destined to face the abdominal wall, and one layer of less adhesion-inducing material, destined to face the bowel, has been developed in an effort to avoid intraperitoneal adhesion formation and viscus erosion. While probably superior, this type of mesh is very bulky, easily damaged, and hence extremely difficult to be safely introduced through conventional trocars., Methods: We present a simple technique to safely introduce intraperitoneally large sheets of composite mesh, without the need for larger-bore cannulas. After temporarily removing one of the 10 mm trocars, the mesh is rolled as tightly as possible and placed in a sterile bag, which is then easily introduced intraperitoneally through the trocar opening., Results: Between September 1999 and January 2000 the technique was successfully used in 12 patients., Conclusion: This simple trick protects the mesh while making its intraperitoneal introduction straightforward. It is quick, cheap, and easily reproducible.