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Background: Due to the heterogeneity of literature findings, stent type selection for the endovascular treatment of complex aorto-iliac occlusive disease remains challenging. The BELSTREAM study, a physician-initiated, prospective, multicenter, single-arm study, aims to report the safety and efficacy of the balloon expandable LifeStream Peripheral Stent Graft System (BD, Tempe, Arizona, USA) for the treatment of complex TASC C and D aorto-iliac artery lesions., Methods: Seventy patients and 133 lesions were included at six Belgian institutions. The primary efficacy endpoint of the study is primary patency at 12 months' follow-up. The primary safety endpoint is freedom from periprocedural serious adverse events (SAEs)., Results: Primary patency rate at 12-month follow-up was 94.5%. Target Lesion Revascularization (TLR) was reported in three patients at 12-month follow-up, resulting in a freedom from TLR rate of 95.3%. In a subgroup of patients with aorto-iliac stenting in kissing configuration, primary patency at 12-month follow-up was 97.4% with freedom from TLR 97.9%. Freedom from a negative primary safety outcome (NPSO) was 100% at 30 days in the overall study patient population., Conclusions: The patency and freedom from TLR rates, low adverse event rates, and up to one year sustained improvement in clinical outcomes demonstrate that the LifeStream™ Balloon Expandable Vascular Covered Stent is a well-suited device for the treatment of complex TASC C and D lesions, the challenging kissing configuration included.

Background: To investigate the long-term efficacy of the paclitaxel-eluting Legflow balloon catheter in the treatment of "real-world" long and complex femoropopliteal lesions., Methods: The REFLOW study was a prospective, multi-national, non-randomized, single arm study evaluating the long-term safety and efficacy of the Legflow paclitaxel-eluting balloon dilatation catheter in the treatment of stenotic or occlusive lesions >150 mm long in the femoropopliteal arteries of symptomatic patients (Rutherford 2-5). A total of 120 study subjects were enrolled in a period of 30 months, between October 2015 and May 2018. The mean age was 71.1 years and 79 patients were men (65.8%). Mean lesion length was 216.1 mm. 45.0% of the lesions were occluded, whereas 55.0% were stenotic. For this extended study follow-up, 100 out of 120 patients agreed to participate. The primary endpoint was primary patency at 24 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 24 months., Results: Primary patency was 70.50% at 2 year. Freedom from TLR was 76.10% at 2 year., Conclusions: Longer term follow-up confirms there is no safety-concern on this paclitaxel device. The excellent results of the newer drug-eluting devices, and the Legflow paclitaxel-eluting balloon in particular, is a valid and effective alternative to treat long and complex "real-world" femoropopliteal lesions.

Background: In contemporary clinical practice, carotid artery stenting (CAS) is increasingly becoming a multispecialty field, joining operators of various training backgrounds, which bring forth their unique expertise, patient management philosophies, and procedural preferences. The best practices and approaches, however, are still debated. Therefore, real-world insights on different operator preferences and related outcomes are of utmost value, yet still rather scarce in the available literature., Methods: Using the data collected in the ROADSAVER observational, European multicenter CAS study, a prespecified comparative analysis evaluating the impact of the operator's specialization was performed. We used major adverse event (MAE) rate at 30-day follow-up, defined as the cumulative incidence of any death or stroke, and its components as outcome measures., Results: A total of 1965 procedures were analyzed; almost half 878 (44.7%) were performed by radiologists (interventional/neuro), 717 (36.5%) by cardiologists or angiologists, and 370 (18.8%) by surgeons (vascular/neuro). Patients treated by surgeons were the oldest (72.9±8.5), while radiologists treated most symptomatic patients (58.1%) and more often used radial access (37.2%). The 30-day MAE incidence achieved by cardiologists/angiologists was 2.0%, radiologists 2.5%, and surgeons 1.9%; the observed differences in rates were statistically not-significant (P=0.7027), even when adjusted for baseline patient/lesion and procedural disparities across groups. The corresponding incidence rates for death from any cause were 1.0%, 0.8%, and 0.3%, P=0.4880, and for any stroke: 1.4%, 2.3%, and 1.9%, P=0.4477, respectively., Conclusions: Despite the disparities in patient selection and procedural preferences, the outcomes achieved by different specialties in real-world, contemporary CAS practice remain similar when using modern devices and techniques.

Background: To report the 3-year safety and effectiveness results of a multicenter, prospective, randomized controlled trial comparing the ZILVER PTX paclitaxel-eluting stent to surgical bypass and to conduct a health economic analysis up to 3-year follow-up of the two treatment modalities., Methods: This is a study in symptomatic TransAtlantic Inter-Society Consensus (TASC) C and D femoropopliteal lesions comparing endovascular ZILVER PTX stenting vs. surgical bypass surgery using a prosthetic graft (ClinicalTrials.gov identifier NCT01952457). Between October 2013 and July 2017, 220 patients (mean age 68.6±10.5 years; 159 men) were enrolled and randomized to the ZILVER PTX treatment group (113, 51.40%) or the bypass treatment group (107, 48.60%). One of the secondary outcomes was primary patency at 3-year, defined as no evidence of binary restenosis or occlusion within the target lesion or bypass graft based on a duplex ultrasound peak systolic velocity ratio <2.4 and no clinically-driven target lesion revascularization (TLR) in endovascular cases or reintervention to restore flow in the bypass. An economic analysis was conducted to analyze the cost differences between ZILVER PTX and bypass, which shows the perspective of the public authority/organization that pays for healthcare in the two countries (payor), Germany and USA., Results: The 3-year primary patency rate was 53.30% (95% CI 61.40% to 45.20%) for the ZILVER PTX group vs. 58.20% (95% CI 67.10% to 49.30%) for the bypass arm (P=0.9721). Freedom from TLR at 3-year was 62.80% (95% CI 72.60% to 53%) for the ZILVER PTX group vs. 65.30% (95% CI 75.40% to 55.20%) for the bypass group (P=0.635). There was also no significant difference (P=0.358) in survival rate at 3-year between the ZILVER PTX group 78.50%, (95% CI to 87.70% to 69.30%) and the bypass group 87.40% (95% CI 97.6% to 77.2%). None of the deaths was categorized as related to the procedure or device. The economic analysis, taking into account procedural-, hospitalization- and reintervention costs, showed a clear cost-benefit for Zilver PTX in both investigated countries up to 3-year follow-up: Germany (Bypass €9446 per patient versus ZILVER PTX €5755) and USA (Bypass $26,373 per patient versus ZILVER PTX $19,186)., Conclusions: The non-inferior safety and effectiveness results of the ZILVER PTX stent were associated with lower costs for the payer and confirmed that ZILVER PTX stent treatment can be considered as a valid alternative for bypass surgery in long and complex femoropopliteal lesions.

Background: This clinical trial aims to evaluate the outcome (up to 24-months) of the treatment of in-stent restenotic or reoccluded lesions in the femoropopliteal arteries, by comparing the treatment of the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface (W. L. Gore & Associates, Flagstaff, AZ, USA) with a standard PTA treatment. The primary effectiveness endpoint of the study is the primary patency at 12 months, defined as no evidence of restenosis or occlusion within the originally treated lesion based on color-flow duplex ultrasound (PSVR≤2.5) and without target lesion revascularization (TLR) within 12 months. The primary safety endpoint is the proportion of subjects who experience serious device-related adverse events within 30 days postprocedure., Methods: A total of 83 patients meeting inclusion and exclusion criteria have been enrolled in this prospective, randomized, multicenter, controlled study in 7 sites between June 2010 and February 2012. Patients with an in-stent restenosis lesion in the femoropopliteal region and a Rutherford classification from 2 to 5 could be enrolled. After screening, the patient was randomized to either treatment with the GORE ® VIABAHN ® Endoprosthesis with PROPATEN Bioactive Surface or treatment with a standard PTA balloon. After the index procedure, follow-up visits at 1 month, 6 months, 12 months and 24 months were required. A color flow Doppler ultrasound was performed on all follow-up visits and a quantitative vascular angiography at the 12-month follow-up visit., Results: In the VIABAHN ® group, 39 patients (74.4% male; mean age 67.69±9.77 years) were enrolled and in the PTA group, 44 patients (72.7% male; mean age 68.98±9.71 years) were enrolled, which is comparable for both treatment groups. In the VIABAHN ® group, 34 (87.2%) patients presented with claudication (Rutherford 2 and 3) and 5 (12.8%) patients had critical limb ischemia (Rutherford 4 and 5). In the PTA group, 36 (81.8%) patients were claudicants (Rutherford 2 and 3) and 8 (18.2%) presented with critical limb ischemia (Rutherford 4 and 5). The 12-month primary patency rates were 74.8% for the VIABAHN ® group and 28.0% for the PTA group (P<0.001). No patients were reported to have device-related serious adverse events within 30 days postprocedure. The primary patency rate for the 24-month follow-up was 58.40% in the Viabahn group and 11.60% in the PTA group (P<0.001)., Conclusions: The treatment of femoropopliteal in-stent restenosis with a VIABAHN ® Endoprosthesis shows significantly better results than the treatment with a standard PTA balloon. This demonstrates that the use of the VIABAHN ® Endoprosthesis is a very promising tool for the treatment of complex in-stent restenosis.

Background: The aim of this study is to investigate the efficacy of the paclitaxel-eluting Legflow balloon catheter in the treatment of "real-world" long and complex femoropopliteal lesions., Methods: The REFLOW study was a prospective, multi-national, non-randomized, single arm study evaluating the safety and efficacy of the Legflow paclitaxel-eluting balloon dilatation catheter in the treatment of stenotic or occlusive lesions >150 mm long in the femoropopliteal arteries of symptomatic patients (Rutherford 2-5). A total of 120 study subjects were enrolled in a period of 30 months, between October 2015 and May 2018. The mean age was 71.1 years and 79 patients were men (65.8%). Mean lesion length was 216.1 mm. 45.0% of the lesions were occluded, whereas 55.0% were stenotic. Primary endpoint was primary patency at 12 months, defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.4) at the target lesion and without TLR within 12 months., Results: Technical and procedural success (<30.0% residual angiographic stenosis without major complications) was achieved in all 120 cases (100.0%). Primary patency was 84.6% at 6 months and 71.1% at 1 year. Freedom from TLR was 79.9% at 1 year., Conclusions: If longer term follow-up confirms there is no safety-concern on these paclitaxel device, the excellent results of the newer drug-eluting devices, and the Legflow paclitaxel-eluting balloon in particular, is a valid and effective alternative to treat long and complex "real-world" femoropopliteal lesions.

Background: The aim of this study was to investigate the efficacy of the balloon expandable Promus Element and Promus Element Plus stents (both Boston Scientific, Marlborough, MA, USA), coated with everolimus, in the treatment of short, focal infrapopliteal lesions., Methods: The PREVENT study was a prospective, multicenter, non-randomized, single arm study evaluating the safety and efficacy of the Promus Element and Promus Element Plus stent in the treatment of stenotic or occlusive lesions ≤40 mm long in the tibioperoneal arteries of patients with critical limb ischemia (CLI). A total of 70 study subjects were enrolled in a period of 26 months, between November 2012 and December 2014. The mean age was 77.84±6.62 years (62-90 years) and 47 patients were men (67.1%). Mean lesion length was 22.83±8.78 mm (5-40 mm). Twenty percent of the lesions were occluded, whereas 80.00% were stenotic. Primary endpoint was primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion within the originally treated lesion based on angiography. Secondary outcomes included hemodynamic primary patency on duplex ultrasound (PSV ratio ≤2.4), limb salvage and freedom from target lesion revascularization (TLR)., Results: Technical and procedural success (<30% residual angiographic stenosis without major complications) was achieved in all 70 cases (100%). Primary patency was 93.8% at 6 months and 86.2% at 1 year. Freedom from TLR was 93% at 1 year. Limb salvage rate at 12-month follow-up, defined as absence of major amputation, was 100%., Conclusions: This study shows the safety and efficacy of the everolimus-eluting, balloon expandable Promus Element and Promus Element Plus stent in the treatment of below-the-knee lesions in patients with critical limb ischemia.

Background: According to the guidelines, bypass surgery is still the golden standard treatment in patients with femoropopliteal TASC C and D lesions and life-style limiting claudication or critical limb ischemia. Over the past few decades, endovascular therapy has made great advancements. However, the success rates of surgical and endovascular procedures cannot be directly compared. According to the surgical term "patency," vessel patency can be maintained even in case of a high grade stenosis, whereas according to the endovascular primary patency definition, being binary restenosis, patency is lost from the moment there is a re-narrowing at any location within the treated segment., Methods: One hundred consecutive patients with a previously implanted femoropopliteal bypass which was primary patent according to the surgical definition were included in this study. Once enrolled, duplex ultrasonography was performed, measuring the Peak Systolic Velocity Ratio for proximal and distal anastomosis., Results: Out of the 100 bypasses that were considered patent according to the surgical definition, Peak Velocity Ratio of ≥2.4 were detected in 11 patients., Conclusions: Based on these findings a 78% primary patency according to the open vascular criteria turned into ~70% primary patency using the stricter endovascular criteria. In the light of these findings, one might conclude that modern endovascular treatment of long TASC C and D femoropopliteal lesions yielded similar results in terms of primary patency as above-the-knee bypasses.

Background: The EVOLUTION Study is a prospective, non-randomized study, investigating the iVolution stent (iVascular, Barcelona, Spain). The study was conducted at the vascular departments of four hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without Target Lesion Revascularization (TLR) within 12 months., Methods: Between April 2015 and November 2016, 120 patients with TASC A&B femoropopliteal lesions were included. The mean lesion length was 89.63 mm. Most of the lesions were stenotic lesions (60.00%)., Results: Primary patency rate for the total patient population was 86.30% at 12-month follow-up. Freedom from TLR at 12-month was 88.00%., Conclusions: These results confirm the already existing enthusiasm of the use of bare metal self-expandable nitinol stents in the treatment of TASC A&B femoropopliteal lesions. Longer follow-up and a comparison or addition with drug-eluting technology has to be studied in the future.

Background: The BeGraft Peripheral PMCF study is a prospective, non-randomized study, conducted at the vascular departments of 4 hospitals in Belgium. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study is primary patency at 12 months. Primary patency is defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.4) and without target lesion revascularization (TLR) within 12 months., Methods: Between June 2014 and March 2015, 70 patients with TASC II Class A (77.1%), B (14.3%), C (5.7%) or D (2.9%) aortoiliac lesions were included. The mean lesion length was 34.3 mm with a mean degree of stenosis of 83.16%., Results: Primary patency rate for the total patient population was 94.4% at 12-month follow-up. Freedom from TLR at 12-month was 96.7%., Conclusions: These results confirm the already existing enthusiasm of the use of covered stents in the aorto-iliac field. Longer follow-up and more complex lesions have to be studied in the upcoming future.

Common femoral artery (CFA) atherosclerotic lesions currently remain one of the last limitations for adoption of endovascular repair as the first-line treatment. The bulky, eccentric, heavily calcified character of the CFA plaques, frequent involvement of the femoral bifurcation, easy surgical accessibility and last but not least, favorable long-term outcomes still make CFA disease treatment part of the surgical domain. In the last 5 years, improvement of the endovascular equipment and technical skills of the operators have led to an increase in percutaneous CFA procedures. Especially the vascular mimetic implant Supera Peripheral Stent system (Abbott Vascular), with its extreme crush resistance (if correctly implanted), seems to be an ideal tool to deal with eccentric calcified plaques, crush risk and maintaining access possibilities. The multicentric, prospective, single arm VMI-CFA Trial evaluates the outcome of treatment of symptomatic (Rutherford 2-4) CFA stenotic or occlusive lesions with the Supera Peripheral Stent System. A 6-month cumulative primary patency rate of 100% is noticed, up to 210 days. The cumulative freedom from TLR rate is 100%. Four patients died, not procedure or device related. From a clinical point of view, a tremendous switch from Rutherford 2-4 towards Rutherford 0-1 happened. No procedure nor device related adverse events are noticed. These short-term data confirm the safety and feasibility of an endovascular approach with the Supera stent to the "no-stent zone" CFA. Of course 12- and 24-month data are essential to bring more clarification in this interesting field.

Although evidence supports that the performance of drug coated balloons seems to be lesion complexity independent, it is quite clear that in long lesions, severe calcified lesions and chronic total occlusions, the bail out stent ratio is very high and that the "leaving nothing behind" strategy remains a dream in a lot of our daily cases. On the other side of the spectrum, "full metal jackets" of nitinol stents are creating even more problems. Stent fractures, intimal hyperplasia and reintervention difficulties complicate the recurrent vascular disease treatment. The go-between with the "As Less As Reasonably Achievable Stenting" strategy (ALARAS), earlier named with a bad name "spot" stenting, seems the most attractive one. Scaffolding where needed and allowing freedom of vessel motion will lead to reduction of target lesion revascularization (TLR) rates. New technologies like the Tack Endovascular System and the Vascuflex MultiLOC MSD are responding very well tot this idea. Animal tests and pivotal trials (like TOBA and LOCOMOTIVE trials) already showed with both devices good results in terms of patencies and freedom from target lesion revascularizations, and with less metallic implants. Primary patency at 12 months was 76.4% and 85.7% in the TOBA and LOCOMOTIVE trial respectively. Target lesion revascularization at 12 months was 10.5% and 9.3%, respectively. In an era of "leaving nothing behind," post-angioplasty dissections are more frequent than ever. With a direct link between lesion complexity, dissections and increase of TLR rates, scaffolding solutions remains essential. The ALARAS strategy tries to leave as little metal behind as possible, minimizing the risk of stent fractures, allowing freedom of vessel motion and reducing TLR rates. However, the lack of clear strategies and guidelines in where to scaffold which kind of dissections is the biggest issue at the moment. More objective classifications based on newer types of imaging like intraoperative ultrasound, intravascular ultrasound, optical coherence tomography, and/or fractional flow reserve pressure wire gradient measurements will potentially offer more solutions in this interesting field.

Background: Recent advances in endovascular techniques have made it a seductive choice in the management of TASC C and D lesions. Currently, this tendency remains controversial, despite high success rates. The aim of the study was to regroup and harmonize the results of three surgical teams in 5 centers in order to obtain the largest series ever published on TASC C and D femoro-popliteal lesions primary stenting., Methods: Two hundred and three patients and 209 lower limbs were included from March 2008 to October 2013. Each patient underwent primary stenting for TASC C or D femoro-popliteal lesions., Results: Mean age was 70±10; 71.4% were male with a 39.8% rate of coronary heart disease, 20.1% of renal insufficiency and 35.9% of diabetes; 57,4% suffered from claudication and 42.6% from critical limb ischemia (CLI); 61.8% of the 144 limbs analyzed for run-off presented with 3 patent infra-popliteal arteries. Four hundred and three stents were implanted in the 209 limbs included. Median stented length was 252 mm. Associated procedures were performed in 35 patients (17.0%) including 4.3% minor amputations. The 30-day mortality rate was 1.4% (3 patients). Major complications occurred in 19 patients (9.3%) including 7 patients (3.4%) presented with early in-stent thrombosis. Median follow-up duration was 12 months (range 9.5-17.2 months). The 12-month mortality rate was 11.8% (24 patients). The 3, 6 and 12 months primary patency rates according to Kaplan Meier estimates were 98.1±0.9, 85.2±2.5 and 67.0±3.3% respectively. Secondary patency rates were 96.1±1.9, 89.3±3.0 and 75.7±4.2% respectively. A subgroup analysis reported significantly higher patency rates for TASC C lesions compared to TASC D lesions (82.1% vs. 44% respectively, P=0.009). The 12-month in-stent thrombosis and restenosis rates were 19.6% and 13.9% respectively. A subgroup analysis showed higher rates of in-stent restenosis for TASC D lesions compared to TASC C lesions (35% vs. 10% respectively, P=0.005). The stent fracture rate was equal to 10.2% (30 stents). Occurrence of in-stent thrombosis and restenosis were associated with 3 and 5 cases of stent fracture (type II to IV) respectively. Freedom from TLR was 70.5%. Rutherford class decreased from 3.7 to 0.9 (3.52±1.06 to 0.75±1.24) (P<0.0001). At 12 months 61.3% were asymptomatic, 33.3% suffered from claudication (21.3% Rutherford 1) and 5.4% suffered from CLI. Healing rates were 63.9% with a limb salvage rate of 95.5% and a major amputation rate of 3.8%., Conclusions: This is the largest series of TASC C and D femoro-popliteal lesions primary stenting to our knowledge. The results are encouraging with acceptable primary patency and clinical improvement at 12 months. Results from mid- to long-term follow-up are awaited.

Background: The MISAGO ILIAC Study is a prospective, non-randomized, multicenter, bi-national, monitored trial, conducted in 3 hospitals in Belgium and 2 hospitals in Germany. This manuscript reports the findings up to 12-month follow-up time for the total cohort. The primary endpoint of the study was primary patency, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, peak systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR), within 12 months., Methods: Between September 2011 and April 2012, 120 patients with TASC II Class A or TASC II Class B aortoiliac lesions were included. The cumulative lesion length in the overall population was 45.49 mm with a maximum stenosis pre-treatment of 83.76%. The demographic data were compatible for the TASC II class A and TASC II class B cohort. One patient with a TASC II class C was included as a protocol deviation., Results: The primary patency rate for the total patient population was 97.4%. The primary patency rates at 12 months for the TASC II class A and TASC II class B(C) lesions were respectively 98.3% and 96.6%. No statistical significant difference was shown when comparing these 2 groups (P=0.6407)., Conclusions: Our findings confirm that nowadays primary stenting with modern generation stents replaced the more invasive surgery as the golden standard treatment for patients with TASC II class A and B aortoiliac lesions.

Background: The aim of this study was to evaluate the short and mid-term safety and efficacy of the EPIC™ nitinol vascular stent system for the treatment of lesions located in the superficial femoral artery (SFA)., Methods: From October 2010 to June 2012, 83 subjects were enrolled in a prospective, multicenter, non-randomized study designed to demonstrate that the EPIC nitinol vascular stent system for SFA lesions is non-inferior to the published patency rates found in literature. Inclusion criteria were stenosis or occlusion of the SFA or SFA and proximal popliteal artery, with total length from 4 to 11 cm and amenable for treatment with a single stent, in patients with a score from 2 to 5 on Rutherford classification. The primary endpoint was primary patency rate at 12 months as determined by Duplex ultrasound. The secondary endpoints evaluated were: initial arteriographic success, primary patency rate at 6 months, major adverse event rate at one year and technical success. Follow-up with a complete clinical and physical exam, including ABI and Duplex ultrasound was performed at 6 and 12 months., Results: Most patients (56.6%) were men and the mean age was 68.59 (33.1-99.15) years. 25.3% of the total population had intermittent claudication and 73.5% presented with critical limb ischemia. Most lesions were total occlusions (75.9%) and the mean lesion length was 71.16 mm. Contralateral femoral access was performed in 26.5%cases, and ipsilateral femoral approach was used for the remaining 73.5% patients. Technical and arteriographic success was obtained in all 83 (100.00%) patients. Duplex controlled primary patency rate at 6 and 12 months was 95.8% and 76.1%, respectively. The freedom from target lesion revascularization rate was 98.7% and 92.6% at 6 and 12 months, respectively. No stent fractures were observed in this study. Major adverse event rate at 1 year (clinically driven TLR, major amputation, and all-cause mortality) was 15.7%: two target lesion revascularizations (2.4%), one major amputation (1.2%) and ten deaths not related to the procedure (12%)., Conclusions: In conclusion, this study demonstrates the safety and efficacy of the EPIC™ Nitinol Vascular Stent System for the treatment of SFA lesions.

Background: The superiority of drug eluting stents versus bare metal stents or balloon angioplasty in the treatment of patients with critical limb ischemia and infrapopliteal lesions has been established. However, only shorter lesions were evaluated. This study was designed to evaluate the immediate and long-term (up to 12 months) outcome of the Xience Prime™ Everolimus-Eluting Coronary Stent System (Abbott Vascular) in a controlled, prospective, multi-center investigation for long lesions up to 10 cm., Methods: All patients with critical limb ischemia and long infrapopliteal lesions between 30 and 100 mm, who met the inclusion criteria, were included in this study. The primary endpoint was primary patency at 12 months, defined as absence of restenosis (≥50% stenosis) or occlusion based on quantitative analysis of contrast angiography., Results: Between August 2011 and October 2013, 60 patients were enrolled in this study with a mean lesion length of 47.40±25.06 mm (range 2-100 mm). The primary patency rate at 12 months was 75.4%. Freedom from target lesion revascularization was 84.9%. The amputation rate was rare (94.4% freedom from amputation). At the 12-month follow-up time point, a total of 36 out of 42 (85.7%) patients improved in their Rutherford classification by at least 1 class., Conclusions: The use of everolimus-eluting stents in longer infrapopliteal lesions in the treatment of critical limb ischemia is safe and effective with a comparable primary patency, freedom from target lesion revascularization and amputation free survival as in short lesions.

Endovascular techniques have improved markedly over the past several decades. Plain old balloon angioplasty can only reach patencies around 40% after 1 year. Scaffolding stents have resulted in improved short-term results but encountered limitations for longer-term durability. With the introduction of drug-eluting technologies the process of intimal hyperplasia might be slowed, resulting in improved long-term patency results. At first, limus-eluting technologies were not able to transfer the enthusiasm from the coronaries to the infrainguinal vascular bed. However, the newer generation paclitaxel-eluting technologies perform significantly better in femoropopliteal arteries than their non-eluting or non-coated counterparts. The results of a prospective randomized trial comparing DES versus DCB is eagerly awaited. For the moment there seems, based on the meta-analysis, no difference between the two treatment modalities. Although, we need to keep in mind that DCB perform worse in long calcified lesions.

Surgical endarterectomy has been considered the prefered technique for treating the common femoral artery (CFA). Although favorable endovascular treatment results of the CFA have recently become available, losing the groin area as an important acess site is still the major concern for this technique to become the golden standart. Nevertheless, the endovascular approach has shown, through several studies, including our experience, the capacity to establish itself as a complementery treatment for the modern vascular surgeon.

The endovascular approach has known a great evolution in terms of vessel patency and treatment possibilities. Longer and more complex lesions with a difficult anatomy can be addressed by a range of endovascular tools. However, to maintain the patency of the treated lesion is the true challenge. In order to fulfill these long-term expectations, newer devices have been developed. The drug-coated balloon combines local drug uptake with no residual material after treatment. To maintain patency and prevent recoil of the arterial wall, the drug-eluting stent has been created to offer stent support with an antiproliferative drug. The main drawbacks of the drug-coated balloon and the drug-eluting stent are being addressed by the drug-eluting absorbable scaffold. The initial scaffolding support in combination with the drug release during a prolonged period, poses the same advantages while the scaffold is being metabolized over time. This continuing evolution in endovascular tools paves the way to an endovascular treatment for the majority of peripheral artery diseases.

The BRAVISSIMO study is a prospective, non-randomized, multi-center, multi-national, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports the findings up to the 12-month follow-up time point for both the TASC A&B cohort and the TASC C&D cohort. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on Duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without target lesion revascularization (TLR) within 12 months. Between July 2009 and September 2010, 190 patients with TASC A or TASC B aortoiliac lesions and 135 patients with TASC C or TASC D aortoiliac lesions were included. The demographic data were comparable for the TASC A/B cohort and the TASC C/D cohort. The number of claudicants was significantly higher in the TASC A/B cohort, The TASC C/D cohort contains more CLI patients. The primary patency rate for the total patient population was 93.1%. The primary patency rates at 12 months for the TASC A, B, C and D lesions were 94.0%, 96.5%, 91.3% and 90.2% respectively. No statistical significant difference was shown when comparing these groups. Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A, B, C and D aortoiliac lesions. We notice similar endovascular results compared to surgery, however without the invasive character of surgery.

The treatment of femoropopliteal lesions has known an important evolution in the last years. An important limitation of current endovascular therapy remains the occurrence of restenosis. In order to minimize restenosis rates, drug eluting technologies are evolving. The use of drug-eluting stents (DES) in coronary arteries shows beneficial results, leading to investigation of DES in femoropopliteal arteries. In this article, we give an overview of current available data on treatment with drug eluting technologies in the superficial femoral artery (SFA). This paper summarizes also the current available data of the use of drug-coated balloons (DCB) in the femoropopliteal tract. Currently, no data are available on the use of DCB in long lesions. A drug eluting bioresorbable scaffold seems to be very promising in coronary arteries. The transfer to the peripheral area is nowadays ongoing. Which technique and device for which lesion and patient requires further investigation to build up a real evidence based SFA treatment strategy.

Aim: The aim of the present article was to report the 12-month results of the Zilver® PTX® Single Arm StudyTASC C/D de novo lesion subgroup., Methods: The Zilver PTX Drug-Eluting Peripheral Stent is a self-expanding nitinol stent with a polymer-free paclitaxel coating. This is a prospective, single-arm, multicentre clinical study evaluating the Zilver PTX Drug-Eluting Peripheral Stent for treating patients with symptomatic lesions in the above-the-knee femoropopliteal artery. This study enrolled 787 patients (900 lesions) with Rutherford class 2 or higher treated with the Zilver PTX stent; 135 were long de novo lesions, corresponding to TASC II Class C or D., Results: The 135 long lesions had a mean length of 226.1±43.6 mm. The 12-month Kaplan-Meier estimates included a 77.6% primary patency rate, an 84.7% event-free survival rate, and an 85.4% rate of freedom from target lesion revascularization (TLR). The 12-month stent fracture rate was 2.1%., Conclusion: The primary patency rates in the analysis of the TASC C/D de novo lesion subgroup of the Zilver PTX Single Arm Study indicate that endovascular therapy outcomes with a paclitaxel eluting stent may equal those of bypass surgery. Endovascular treatment with DES may play an important role for treatment of patients who present with TASC C or D femoropopliteal lesions.

Stents were created as a mechanical scaffold to prevent vessel recoil and luminal renarrowing after percutaneous transluminal angioplasty (PTA). In femoropopliteal arteries, indication for stent implantation remains a topic much debated on, especially in long lesion configurations. Ever since the first stents were introduced on the market, in-stent restenosis (ISR) has been an important issue. The evolution in stent design has known a major progression in the last decades from the first generation of stents, plagued with high fracture rates and low primary patency rates, to the design of newer stents to tackle these outcomes. More flexible and longer stents decreased the high fracture rates and drug-eluting stents offered a solution to the restenosis rates by local drug application. The difficult recrossibility of the lesion because of the presence of a permanent vascular scaffold is an obstacle that the drug-coated balloon (DCB) overcomes. Future perspectives in the treatment of femoropopliteal lesions are found in the bioresorbable stent implantation. The bioresorbable stent combines the advantages of a drug-eluting scaffolding stent without the remainder of a foreign object in the long-term. Further investigations in this area will eventually evolve in the creation of a superior endovascular treatment modality with high long-term patency rates and minimal detriments.

With subintimal recanalization, a channel is deliberately created by dissecting the vessel wall in order to replace the native occluded lumen. This is opposed to intraluminal recanalization, where passage of an arterial obstructive lesion is performed by central luminal navigation. Both intraluminal and subintimal treatment has its proponents and adversaries. The appreciation of an investigator for a certain technique is commonly related to the training received and the personal experience. Yet, the intraluminal technique uses the clinically preferred route for adjunctive treatment, such as balloon angioplasty or stent deployment. A wide variety of devices designed to obtain intraluminal lesion passage is available and is currently being used in vascular centers worldwide. With intraluminal techniques, success rates of up to 95% have been reported.

Critical limb ischemia (CLI) is affecting an increasing number of patients, mainly due to an ageing population and the growing number of diabetics. Clinically, CLI is characterized by rest pain, non-healing foot wounds and gangrene, due to insufficient arterial blood supply. Limb preservation should be the goal in patients with diabetic foot due to tibial occlusive disease. As surgery is associated with considerable morbidity and mortality rates, endovascular therapy can offer a valuable alternative. Small-diameter below-the-knee arteries that were previously unamenable to surgical methods, can now be reached and treated. Currently, many endovascular techniques are available, from regular PTA and bare metal stents to drug-coated balloons and drug-eluting stents. In our opinion the results of endovascular therapy for below-the-knee vessels will be further improved by the continuous technical evolution and new material developments. In the light of the current evolution towards minimally invasive techniques, an increasing number of experienced centers will be able to treat the vast majority of all below-the-knee arterial pathology by endovascular means.

Aim: The BRAVISSIMO study is a prospective, non-randomized, multicenter, multinational, monitored trial, conducted at 12 hospitals in Belgium and 11 hospitals in Italy. This manuscript reports on the BRAVISSIMO TASC A&B iliac lesion cohort, based on data collected up to the 13-month time point. The primary endpoint of the study is primary patency at 12 months, defined as a target lesion without a hemodynamically significant stenosis on duplex ultrasound (>50%, systolic velocity ratio no greater than 2.0) and without Target Lesion Revascularization (TLR) within 12 months., Methods: Between July 2009 and February 2010, a total of 190 patients who presented with TASC A or TASC B aorto-iliac lesions were included, of which 140 patients were enrolled in Belgium and 50 in Italy., Results: The demographic data were comparable for the TASC A and TASC B patients groups. The number of occlusions, the average degree of stenosis, the average lesion length was significantly higher in the group of TASC B lesions, which is congruent with the TASC lesions definitions. Similarly, there were significantly more unilateral lesions in the TASC A group, compared to the TASC B group. The 12-month primary patency rate was 94.0% for TASC A lesions and 96.5% for TASC B lesions, which is not statistically significant. The 12-month primary patency rate was 92.9% in lesions treated with the Omnilink Elite stent, 97.1% in lesions treated with the Absolute Pro stent groups, and 100% in lesions treated with both stents., Conclusion: Our findings confirm that endovascular therapy, and more specifically primary stenting, is the preferred treatment for patients with TASC A/B aortoiliac lesions. Currently, we are collecting the 12-month data for the TASC C/D subgroup in the BRAVISSIMO study. Upon release of the results from this subgroup, we will be able to compare the results from both arms of this large-scale international study.

The fear that early thrombosis and late luminal loss due to intimal hyperplasia formation potentially leads to insufficient long-term patency rates can explain the reluctance on implanting stents in small diameter below-the-knee (BTK) arteries. Drug-eluting stent (DES) technology was developed to prevent early thrombosis and late luminal loss to potentially improve long-term patency rates. Currently, the first level 1 evidence from prospective, randomized, controlled DESTINY and ACHILLES studies indicate that the implantation of DES in short lesion lenghts in the infrapopliteal vasculature leads to favorable outcomes with high primary patency rates. This makes that primary DES placement can be recommended as treatment strategy in short BTK-lesions.

Training in surgery has for a long time been based on the classical model of master-apprentice, leading to the creation of "schools" comparable to the famous painter schools of Rubens, Rembrandt and many others during the Middle Ages. Although it may offer some advantages, this model is no longer suitable today. Modern vascular surgery covers several fields, including not only open vascular and endovascular treatment, but also non-invasive diagnosis and medical treatment of vascular diseases in different parts of the human body. However, the goal of training remains the formation of a "holistic vascular surgeon", with knowledge of and experience in all these areas. As most training centers are more focused on and have more expertise in one or some of these areas, an ideal training curriculum would consist of a rotation between different centers with different points of attention and possibly even rotations in other specialties, such as interventional radiology, vascular medicine or ultrasonography. Such an exchange cannot only be beneficial for the trainee but contact with trainees with a different background can also offer an added value to the training center. Thanks to new ways of communication and transportation, exchange of trainees, even in different countries, has become much easier. Nevertheless, a problem often arises concerning the requirements for training as, despite the many efforts already undertaken, it still differs significantly between different countries. The development of a core-curriculum and mutual recognition of training centers is urgently needed and further steps in the harmonization of training programs and requirements need to be stimulated.

Over the past several years, there has been continued significant interest in refinement of patient selection, devices, procedures and protocols in an effort to optimize the outcome of percutaneous intervention for carotid bifurcation stenosis, including: ongoing National Institutes of Health and manufacturer trials and registries; the further refinement of existing devices and emergence of new platforms to attain distal embolic protection; ongoing study of what really constitutes a high-risk carotid surgery or stenting patient; and attention to device characteristics and patient-device matching. Within the latter area, considerable interest has focused on stent characteristics that have the potential to impact short and long-term outcome when compared with other stent design strategies when studied in large series. The stent in carotid artery intervention occupies a unique role in that after the embolic protection system has been removed, it is the main line of defense (in concert with aggressive dual antiplatelet therapy) from embolic and thromboembolic complications that may arise from the newly remodeled plaque after post-stent angioplasty. In this review, we aim to update the current status of efforts to relate stent design strategy to outcome in intervention for extracranial carotid artery disease with a focus primarily on the function of "free cell area" (typically lower with closed-cell stents and higher with open-cell stents) in analyses of outcome in carotid artery stenting. Also, the potential role of closed-cell vs. open-cell stent selection in other reports related to carotid artery stenting outcome or complications is reviewed. Rigorous studies have examined the issue of free cell area and arrived at disparate conclusions. Randomized data on the impact of free cell area and cell design strategy on carotid intervention are presently lacking. However, we believe sufficient data and rationale exist 1) to warrant ongoing study of the impact of stent design on outcome in carotid intervention; and 2) to make consideration of closed-cell (low free cell area) stent use a reasonable approach to device selection--when patient factors, lesion characteristics, or device availability make doing so possible.

In-stent restenosis has always been an important issue, since the launch of the first stents on the market. The occurrence of in-stent restenosis (ISR) is due to two main reasons. First, the presence of stent fractures significantly influences restenosis rates. Second, the continuous interaction between the permanently implanted artificial material and the vessel tissue, leads to physical irritation, long-term endothelial dysfunction, or chronic inflammatory reactions. In the Literature only very limited data on ISR treatment in the peripheral arteries are available. There are no peer-reviewed publications or studies with in-depth follow-up on this specific indication. The underlying reason for this probably being that currently available treatments do not yield satisfactory results. However, the continuing search for better solutions and the technological evolution lead to the introduction of the Viabahn with PROPATEN coating, DES and DCB, which may result in the first promising treatment options for ISR.

Acute limb ischemia (ALI) refers to a rapid worsening of limb perfusion resulting in rest pain, ischemic ulcers or gangrene. With an estimated incidence of 140 million/year, ALI is serious limb-threatening and life-threatening medical emergency demanding prompt action. Three prospective, randomized clinical trials provide data on trombolytic therapy versus surgical intervention in patients with acute lower extremity ischemia. Although they did not give us the final answer, satisfactory results are reported for percutaneous thrombolysis compared with surgery. Moreover, they suggest an important advantage of thrombolysis in acute bypass graft occlusions. Therefore, we believe thrombolytic therapy should be a part of the vascular surgeon's armamentarium to safely and successfully treat ALI patients.

Patients with cerebral ischemia as a result of acute cervical internal carotid artery occlusion are generally considered to have a poor prognosis. Despite maximal medical treatment, a better treatment for patients with acute ischemic stroke who present with serious neurologic symptoms on admission or continue to deteriorate neurologically due to a total occlusion, a dissection or a high-grade stenosis of the internal carotid artery is required. An effective intervention to improve their neurologic symptoms and clinical outcome has not yet been established and represents a challenging and complex problem. Treatment of acute symptomatic occlusion of the cervical internal carotid artery includes intravenous administration of thrombolytic agent, carotid endarterectomy and an interventional approach (intra-arterial administration of thrombolytic agent, transluminal angioplasty with or without stenting). The endovascular interventional approach is becoming a part of the stroke therapy armamentarium for intracranial occlusion. It may also now be considered in select patients with acute internal carotid artery occlusion. Stenting and angioplasty for acute internal carotid artery occlusion appears to be feasible, safe and may be associated with early neurological improvement. The encouraging preliminary results await confirmation from prospective, randomized studies.

Aim: It was the objective of the Cryoplasty CLIMB to evaluate the effectiveness of the PolarCath device in a standard clinical practice in the treatment of infrapopliteal lesions in critical limb ischemia patients., Methods: Between May 2007 and July 2008, 100 patients (72 years, 67%male) with CLI were enrolled in the trial for the treatment of 100 infrapopliteal stenoses or occlusions. The mean lesion length and diameter stenosis were 54.9+/-55.8 mm and 91.3+/-8.3%. Primary endpoint was defined as 12-month primary patency based on duplex. Secondary endopoints were immediate success and 12-month limb salvage and survival rate., Results: Multiple cryoplasty cycles were performed in 56 cases (2.1 inflations per patient) and in 4 the use of a different size balloon was required. The immediate technical success rate was 95.0% and the stent rate was 17.0%. The 12 month primary patency, limb salvage and survival rates were 55.9+/-7.4%, 93.8+/-2.5% and 81.8+/-3.9%, respectively. Stratification for lesion length did not show significant outcome differences for lesions < or =50.0 mm and those >50.0 mm neither for primary patency (P=0.94), nor for limb salvage (P=0.32)., Conclusion: The cryoplasty technique is effective for the treatment of infrapopliteal lesions in CLI patients. The results seem to be within the range of those of conventional PTA. Especially for shorter lesion (<50.0 mm), the wide-spread use of cryoplasty is not recommended. For lesions with a minimal length of 50.0 mm, the results are encouraging.

Several limitations inherent to the implantation of a metallic device, such as the occurrence of in-stent re-stenosis, in an arterial lumen intuitively explain the interest for developing bio-absorbable stents. Two main types of bio-absorbable stents currently exist: polymer stents and metallic stents. To date, no studies with bio-absorbable stents have been conducted in the superficial femoral artery (SFA). Because of their strut thickness and lack of radial force, polymer stents are no good candidates for endovascular use. Absorbable metal stents (AMS) do have the potential to perform well for artery treatment, although current evidence from in-human coronary and infrapopliteal studies yield unsatisfactory results. Drastic technological improvements are mandatory before AMS can be considered for every day practice. Yet, it is our belief that further development of other metal and non-metal bio-absorbable stents, with or without drug-coating, may lead to the creation of the ultimate SFA stent.

Drug-eluting stent (DES) technology was developed to prevent early thrombosis and late luminal loss to potentially improve long-term patency rates. Although favorable DES results have recently become available with the Zilver PTX and STRIDES studies, the high price of DES is a major drawback for this technology to become the golden standard for peripheral endovascular therapy in de novo femoro-popliteal (FP) lesions. Nevertheless, DES has the potential to make the difference and to establish itself as an important treatment option in patients presenting with TASC C&D FP lesions who are at high-risk for surgery and for the treatment of in-stent restenosis, where until now, no valuable treatment option has proven to be beneficial.

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.

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.

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.

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.

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.

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.