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Objectives The authors sought to report the wound healing outcomes, health-related quality-of-life changes and quality-adjusted life-years (QALYs) gain in the 2 treatment arms of the ACHILLES (Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease) multicenter randomized trial. Background The ACHILLES randomized trial has previously shown that sirolimus-eluting stents (SES) may achieve lower vessel restenosis and higher event-free survival rates compared with plain balloon angioplasty (PTA) for infrapopliteal lesions. Methods A total of 200 patients were randomly assigned between SES and PTA for the treatment of infrapopliteal arterial occlusive lesions. Progression of wound healing was serially assessed by digital photography. Health-related quality-of-life scores were assessed with the self-administered EQ-5D questionnaire up to 1 year from randomization. QALYs gained were calculated with a standard multiplicative model using distribution-free Bayesian modeling. Results In total, 109 open wounds (n = 54 in SES; n = 55 in PTA) were documented at baseline. At 6 months, wound volume reduction (%) was significantly higher in the SES group (95% healing [95% confidence interval (CI): 80% to 99%] compared with 60% healing [95% CI: 13% to 90%] in the PTA group; p = 0.048). At 1 year, rates of complete wound closure were higher in the case of SES (72.9% vs. 55.6% closed wounds in PTA; p = 0.088). The recorded weighted EQ-5D score improved significantly up to 1 year in case of SES (p Conclusions Infrapopliteal SES accelerates wound healing and may improve quality of life compared with PTA. (Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease [ACHILLES]; NCT00640770 )

Objectives This study sought to report the results of a prospective randomized controlled trial comparing paclitaxel-coated balloons (PCB) versus drug-eluting stents (DES) in long infrapopliteal lesions. Background DES have an established role in the treatment of short infrapopliteal lesions, whereas there is increasing evidence for the use of PCB in longer below-the-knee lesions. Methods Inclusion criteria were patients with Rutherford classes 3 to 6 and angiographically documented infrapopliteal disease with a minimum lesion length of 70 mm. The primary endpoint was target lesion restenosis >50% assessed by digital angiography at 6 months. Secondary endpoints included immediate post-procedure stenosis and target lesion revascularization. Results Fifty patients were randomized to undergo infrapopliteal PCB angioplasty (25 arteries in 25 limbs; PCB group) or primary DES placement (30 arteries in 27 limbs; DES group). Immediate residual post-procedure stenosis was significantly lower in DES (9.6 ± 2.2% vs. 24.8 ± 3.5% in PCB; p 50%) angiographic restenosis rate was significantly lower in DES (7 of 25 [28%] vs. 11 of 19 [57.9%] in PCB; p = 0.0457). There were no significant differences with regard to target lesion revascularization (2 of 26 [7.7%] in DES vs. 3 of 22 [13.6%] in PCB; p = 0.65). Positive vessel wall remodeling was observed in 3 cases in the PCB arm (3 of 19 [(15.8%)] vs. 0 of 19 [0%] in DES; p = 0.07). Conclusions Compared with PCB in long infrapopliteal lesions, DES are related with significantly lower residual immediate post-procedure stenosis and have shown significantly reduced vessel restenosis at 6 months. PCB may produce positive vessel remodeling. (Infrapopliteal Drug-Eluting Angioplasty Versus Stenting [IDEAS-I]; NCT01517997 )

To investigate the safety and efficacy of ticagrelor in patients with critical limb ischemia (CLI) and high on-clopidogrel platelet reactivity (HCPR) undergoing complex, limb-salvage, peripheral endovascular procedures (PEP). The study included consecutive patients with HCPR undergoing PEP for CLI. HCPR was defined as platelet reaction units (PRU) >234 as assessed by the VerifyNow P2Y12 assay. Patients with HCPR were prescribed ticagrelor, 180/90 mg twice daily, and aspirin, 100 mg daily, for 6 months and ticagrelor, 180/90 mg twice daily, thereafter. Primary safety outcome was total major bleeding, and primary efficacy outcome was the composite of cardiovascular death and major amputation. Secondary outcomes included the level of platelet inhibition achieved and target limb revascularization (TLR)-free survival rate. In total, 37 CLI patients with 40 limbs were investigated. Mean follow-up period was 11.3 ± 5.0 months (range 6–21). The mean treated lesion length was 229.2 ± 71.4 mm in the femoropopliteal axis and 179.3 ± 83.9 mm in the infrapopliteal arteries. No major or minor bleeding was detected. There were four periprocedural minor adverse events (10.8 %), and in two cases (5.6 %) ticagrelor was discontinued. In all patients, ticagrelor achieved platelet inhibition lower than the cut-off value. Mean PRU during clopidogrel therapy was 308.4 ± 41.8 (range 257–422) versus 67.0 ± 52.8 (range 2–189) when switched to ticagrelor; p

Drug-eluting stents (DES) have been proposed for the treatment of infrapopliteal arterial disease. We performed a systematic review to provide a qualitative analysis and quantitative data synthesis of randomized controlled trials (RCTs) assessing infrapopliteal DES.PubMed (Medline), EMBASE (Excerpta Medical Database), AMED (Allied and Complementary medicine Database), Scopus, CENTRAL (Cochrane Central Register of Controlled Trials), online content, and abstract meetings were searched in September 2012 for eligible RCTs according to the preferred reporting items for systematic reviews and meta-analyses selection process. Risk of bias was assessed using the Cochrane Collaboration's tool. Primary endpoint was primary patency defined as absence of ≥50 % vessel restenosis at 1 year. Secondary outcome measures included patient survival, limb amputations, change of Rutherford-Becker class, target lesion revascularization (TLR) events, complete wound healing, and event-free survival at 1 year. Risk ratio (RRs) were calculated using the Mantel-Haenszel fixed effects model, and number-needed-to-treat values are reported.Three RCTs involving 501 patients with focal infrapopliteal lesions were analyzed (YUKON-BTX, DESTINY, and ACHILLES trials). All three RCTs included relatively short and focal infrapopliteal lesions. At 1 year, there was clear superiority of infrapopliteal DES compared with control treatments in terms of significantly higher primary patency (80.0 vs. 58.5 %; pooled RR = 1.37, 95 % confidence interval [CI] = 1.18-1.58, p0.0001; number-needed-to-treat (NNT) value = 4.8), improvement of Rutherford-Becker class (79.0 vs. 69.6 %; pooled RR = 1.13, 95 % CI = 1.002-1.275, p = 0.045; NNT = 11.1), decreased TLR events (9.9 vs. 22.0 %; pooled RR = 0.45, 95 % CI = 0.28-0.73, p = 0.001; NNT = 8.3), improved wound healing (76.8 vs. 59.7 %; pooled RR = 1.29, 95 % CI = 1.02-1.62, p = 0.04; NNT = 5.9), and better overall event-free survival (72.2 vs. 57.3 %; pooled RR = 1.26, 95 % CI = 1.10-1.44, p = 0.0006; NNT = 6.7).DES for focal infrapopliteal lesions significantly inhibit vascular restenosis and thereby improve primary patency, decrease repeat procedures, improve wound healing, and prolong overall event-free survival.

Objectives The study investigated the efficacy and safety of a balloon expandable, sirolimus-eluting stent (SES) in patients with symptomatic infrapopliteal arterial disease. Background Results of infrapopliteal interventions using balloon angioplasty and/or bare stents are limited by a relatively high restenosis rate, which could be potentially improved by stabilizing the lesion with a SES. Methods Two hundred patients (total lesion length 27 ± 21 mm) were randomized to infrapopliteal SES stenting or percutaneous transluminal balloon angioplasty (PTA). The primary endpoint was 1-year in-segment binary restenosis by quantitative angiography. Results Ninety-nine and 101 patients (mean age 73.4 years; 64% diabetics) were randomized to SES and PTA, respectively (8 crossover bailout cases to SES). At 1 year, there were lower angiographic restenosis rates (22.4% vs. 41.9%, p = 0.019), greater vessel patency (75.0% vs. 57.1%, p =0.025), and similar death, repeat revascularization, index-limb amputation rates, and proportions of patients with improved Rutherford class for SES versus PTA. Conclusions SES implantation may offer a promising therapeutic alternative to PTA for treatment of infrapopliteal peripheral arterial disease.

To report the long-term angiographic and clinical results in a series of below-the-ankle (BTA) angioplasty procedures and to present some biomechanical issues related to the unique anatomical geometry of the ankle.We performed a retrospective analysis of BTA angioplasty procedures. Clinical end points included technical success, patient mortality, salvage of the treated foot, and repeat target lesion revascularization. Imaging end points included primary patency, binary restenosis of the target lesion at the 50% threshold, and stent integrity (stent fracture, deformation, or collapse). Univariate subgroup analysis was performed.In total, 40 limbs in 37 patients (age 73.5 ± 8.2 years) with critical limb ischemia were included and 42 inframalleolar lesions (4.2 ± 1.4 cm) were analyzed. Technical success was achieved in 95.2% (40 of 42). Provisional stent placement was performed in 45.2% (19 of 42). Two patients died, and two major amputations occurred up to 3 years. At 1 year, overall primary vessel patency was 50.4 ± 9.1%, lesion binary restenosis rate was 64.1 ± 8.3%, and repeat intervention-free survival was 93.6 ± 4.3% according to life table analysis of all treated lesions. Pairwise subgroup analysis showed that BTA self-expanding stents were associated with significantly higher restenosis and poorer primary patency compared to plain balloon angioplasty or sirolimus-eluting balloon-expandable stents. Significant deformation and/or fracture of balloon-expandable stents placed BTA were identified in five of 11. Dynamic imaging showed that the dorsalis pedis artery is kinked during foot dorsiflexion, whereas the distal posterior tibial artery is kinked during plantar flexion of the foot.BTA angioplasty for critical limb ischemia treatment is safe and feasible with satisfactory long-term results. BTA stent placement must be reserved for bailout indications.

To report the 6-month results of a prospective randomized trial investigating angioplasty with paclitaxel-coated balloons (PCB) vs. plain balloon angioplasty (BA) for the treatment of failing native arteriovenous fistulae (AVF) or prosthetic arteriovenous grafts (AVG).The enrollment criteria for this non-inferiority hypothesis trial included clinical signs of failing dialysis access with angiographic documentation of a significant venous stenotic lesion in patients with AVF or AVG circuits. From March to December 2010, 40 patients (29 men; mean age 64.1 ± 14.3 years) were randomized to undergo either PCB dilation (n = 20) or standard BA (n = 20) of a stenosed venous outflow lesion. Regular angiographic follow-up was scheduled bimonthly. Study outcome measures included device success (30% residual stenosis without postdilation), procedural success (30% residual stenosis), and primary patency of the treated lesion (50% angiographic restenosis and no need for any interim repeat procedures).Baseline and procedural variables were comparably distributed between both groups. Device success was 9/20 (45%) for the PCB device vs. 20/20 (100%) for standard control BA (p0.001). Procedural success was 100% in both groups after further high-pressure post-dilation as necessary. There were no major or minor complications in either group. At 6 months, cumulative target lesion primary patency was significantly higher after PCB application (70% in PCB group vs. 25% in BA group, p0.001; HR 0.30, 95% CI 0.12 to 0.71, p0.006).PCB angioplasty improves patency after angioplasty of venous stenoses of failing vascular access used for dialysis.

There are no cost-utility data about below-the-knee placement of drug-eluting stents. The authors determined the cost-effectiveness of infrapopliteal drug-eluting stents for critical limb ischemia (CLI) treatment.The event-free individual survival outcomes defined by the absence of any major events, including death, major amputation, and target limb repeat procedures, were reconstructed on the basis of two published infrapopliteal series. The first included spot Bail-out use of Sirolimus-eluting stents versus bare metal stents after suboptimal balloon angioplasty (Bail-out SES).The second was full-lesion Primary Everolimus-eluting stenting versus plain balloon angioplasty and bail-out bare metal stenting as necessary (primary EES). The number-needed-to-treat (NNT) to avoid one major event and incremental cost-effectiveness ratios (ICERs) were calculated for a 3-year postprocedural period for both strategies.Overall event-free survival was significantly improved in both strategies (hazard ratio (HR) [confidence interval (CI)]: 0.68 [0.41-1.12] in Bail-out SES and HR [CI]: 0.53 [0.29-0.99] in Primary EES). Event-free survival gain per patient was 0.89 (range, 0.11-3.0) years in Bail-out SES with an NNT of 4.6 (CI: 2.5-25.6) and a corresponding ICER of 6,518euro(range 1,685-10,112euro). Survival gain was 0.91 (range 0.25-3.0) years in Primary EES with an NNT of 2.7 (CI: 1.7-5.8) and an ICER of 11,581euro(range, 4,945-21,428euro) per event-free life-year gained. Two-way sensitivity analysis showed that stented lesion length10 cm and/or DES list price1000eurowere associated with the least economically favorable scenario in both strategies.Both strategies of bail-out SES and primary EES placement in the infrapopliteal arteries for CLI treatment exhibit single-digit NNT and relatively low corresponding ICERs.

The purpose of this article is to report the results of a prospective single-center study analyzing the long-term clinical and angiographic outcomes of subintimal angioplasty (SIA) for the treatment of chronic total occlusions (CTOs) of the femoropopliteal artery.Patients with severe intermittent claudication or critical limb ischemia (CLI) were enrolled in the study. All lesions were treated with SIA and provisional stenting. Primary end points were technical success, patient survival, limb salvage, lesion primary patency, angiographic binary restenosis (50%), and target lesion revascularization (TLR). Regular clinical and angiographic follow-up was set at 6 and 12 months and yearly thereafter. Study end points were calculated with life-table survival analysis. Proportional-hazards regression analysis with a Cox-model was applied to adjust for confounding factors of heterogeneity.Between May 2004 and July 2009, 98 patients (105 limbs, patient age 69.3±9.9 years) were included in the study. Technical success rate was 91.4% with a lesion length of 121±77 mm. Limb-salvage and survival rates were 88.7% and 84.1% at 3 years, respectively. After 12, 24, and 36 months, primary patency was 80.1%, 42.3%, and 29.0%, angiographic binary restenosis was 37.2%, 68.6%, and 80.0%, and TLR was 84.8%, 73.0%, and 64.5%, respectively. CLI was the only adverse predictor for decreased primary patency (hazard ratio [HR] 0.36; 95% confidence interval [CI] 0.16-0.80, p=0.012), whereas significantly less restenosis was detected after spot stenting of the entry and/or re-entry site (HR 0.31; 95% CI 0.10-0.89, p=0.01 and HR 0.20; 95% CI 0.07-0.56, p=0.002, respectively).Subintimal angioplasty is a safe and effective revascularization technique for the treatment of CTOs of the femoropopliteal artery. Provisional stenting may have a role at the subintimal entry or true lumen re-entry site.

To present a large single-center retrospective study investigating the safety and efficacy of the StarClose extravascular closure device in achieving hemostasis after antegrade or retrograde femoral artery catheterization during peripheral angioplasty procedures.Between January 2004 and October 2009, 1213 StarClose devices were implanted in 850 consecutive patients (598 men; mean age 65.8 ± 12.2 years) who underwent peripheral endovascular procedures. Femoral artery punctures included 625 (51.5%) retrograde and 588 (48.5%) antegrade accesses. The primary endpoints were hemostasis success, device failure, and major and minor complication rates up to 30 days.A 6-F vascular sheath was used in the majority of cases [39 (3.2%) 7-F and 9 (0.7%) 8-F]. The device was applied more than once in the same femoral artery of 124 (10.2%) limbs during different angioplasty sessions. Overall hemostasis success was achieved in 1139 (93.9%) cases. In 237 (20.8%) of those, additional manual compression for5 minutes was necessary due to immediate vessel oozing. The remaining 74 (6.1%) cases required prolonged standard manual compression because of hemostasis failure, including 13 (1.1%) failures to deliver the clip. Overall major and minor complication rates were 0.3% (4/1213) and 5.3% (64/1213), respectively.The StarClose vascular closure device is safe and effective in achieving hemostasis during antegrade and retrograde peripheral angioplasty procedures.

To present the results of a prospective, randomized, single-centre study investigating local anaesthesia before percutaneous common femoral artery (CFA) puncture and catheterization with the use of ultrasound-guided injection of lidocaine versus standard infiltration by manual palpation.Patients scheduled to undergo diagnostic or therapeutic transfemoral catheter-based procedures gave informed consent and were randomized in two groups. In the first arm local anaesthesia with lidocaine hydrochloride 1% was performed under ultrasound guidance (group U/S), while in the second arm the standard method of manual artery palpation was applied (group M). In both groups, subsequent CFA catheterization was achieved under ultrasound guidance. The primary study endpoint was peri-procedural pain level evaluated with a visual-analogue scale (VAS score 0-10).Between January 2009 and 2010, 200 patients (161 men, mean age 63±12 years) were equally assigned to each group without any significant differences in baseline demographics. Patients in group U/S experienced significantly less pain during CFA catheterization in comparison with group M with a difference of three points in mean VAS score reported (1.6±1.6 versus 4.6±1.9, p0.0001). In addition, significantly less volume of lidocaine was used in group U/S compared to group M (16±2.7 versus 19±0.8ml, p0.001).Total vascular access time was similar in both groups (4.4±1.3 versus 4.5±1.3min). Overall complications included two small groin haematomas in each group.Ultrasound-guided local anaesthesia of the CFA prior to percutaneous transcatheter procedures is safe and achieves superior levels of analgesia with minimal patient pain and discomfort compared to the standard method of manual palpation.

Optical coherence tomography (OCT) is a catheter-based imaging method that employs near-infrared light to produce high-resolution intravascular images. The authors report the safety and feasibility and illustrate common imaging findings of frequency-domain OCT (FD-OCT) imaging of the femoropopliteal artery in a series of 20 patients who underwent infrainguinal angioplasty.After crossing the lesion of interest, OCT was performed with a dextrose saline flush technique with simultaneous obstructive manual groin compression. An automatic pullback FD-OCT device was employed (each scan acquiring 54 mm of vessel lumen in 271 consecutive frames). OCT images were acquired before and after balloon dilatation and following provisional stenting if necessary and were evaluated for baseline characteristics of plaque or in-stent restenosis (ISR), vessel wall trauma after angioplasty, presence of thrombus, stent apposition, and tissue prolapse. Imaging follow-up was not included in this study's protocol.Twenty-seven obstructive lesions (18 cases of de novo atherosclerosis and 9 of ISR) of the femoropopliteal artery were imaged and 148 acquisitions were analyzed in total. High-resolution intravascular OCT imaging with effective blood clearance was achieved in 93.9%. Failure was mainly attributed to preocclusive proximal lesions and/or collateral flow. Mixed features of lipid pool areas, calcium deposits, necrotic core, and fibrosis were identified in all of the imaged atherosclerotic lesions, whereas ISR was purely fibrotic. After balloon angioplasty, OCT identified extensive intimal tears in all cases and one case of severe dissection that biplane subtraction angiography failed to identify.Infrainguinal frequency-domain optical coherence tomography is safe and feasible and may provide intravascular high-resolution imaging of the femoropopliteal artery during infrainguinal angioplasty procedures.

To present the 3-year angiographic and clinical results of a prospective registry investigating the performance of sirolimus-eluting stents (SESs) versus bare metal stents (BMSs) for critical limb ischemia (CLI) treatment.A single-center double-arm prospective registry included patients with CLI who underwent infrapopliteal revascularization with angioplasty and "bailout" use of an SES or BMS. Clinical and angiographic follow-up was scheduled at regular time intervals. Primary clinical and angiographic endpoints included mortality, limb salvage, primary patency, binary angiographic restenosis (ie,50%), and clinically driven repeat intervention-free survival. Results were stratified according to stent type, and cumulative proportion outcomes were determined by Kaplan-Meier plots. Multivariable Cox proportional-hazards regression analysis was applied to adjust for confounding factors of heterogeneity.In total, 103 patients were included in the analysis; 41 (75.6% with diabetes) were treated with a BMS (47 limbs; 77 lesions) and 62 (87.1% with diabetes) with an SES (75 limbs; 153 lesions). At 3 years, SES-treated lesions were associated with significantly better primary patency (hazard ratio [HR], 4.81; 95% CI, 2.91-7.94; P.001), reduced binary restenosis (HR, 0.38; 95% CI, 0.25-0.58; P.001), and better repeat intervention-free survival (HR, 2.56; 95% CI, 1.30-5.00; P = .006) versus BMS-treated ones. No significant differences were identified between SESs and BMSs with regard to overall 3-year patient mortality (29.3% vs 32.0%; P = .205) and limb salvage (80.3% vs 82.0%; P = .507).Infrapopliteal application of SESs for CLI significantly improves angiographic long-term patency and reduces infrapopliteal vascular restenosis versus BMSs, thereby lessening the rate of clinically driven repeat interventions.

The authors sought to report the wound healing outcomes, health-related quality-of-life changes and quality-adjusted life-years (QALYs) gain in the 2 treatment arms of the ACHILLES (Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease) multicenter randomized trial.The ACHILLES randomized trial has previously shown that sirolimus-eluting stents (SES) may achieve lower vessel restenosis and higher event-free survival rates compared with plain balloon angioplasty (PTA) for infrapopliteal lesions.A total of 200 patients were randomly assigned between SES and PTA for the treatment of infrapopliteal arterial occlusive lesions. Progression of wound healing was serially assessed by digital photography. Health-related quality-of-life scores were assessed with the self-administered EQ-5D questionnaire up to 1 year from randomization. QALYs gained were calculated with a standard multiplicative model using distribution-free Bayesian modeling.In total, 109 open wounds (n = 54 in SES; n = 55 in PTA) were documented at baseline. At 6 months, wound volume reduction (%) was significantly higher in the SES group (95% healing [95% confidence interval (CI): 80% to 99%] compared with 60% healing [95% CI: 13% to 90%] in the PTA group; p = 0.048). At 1 year, rates of complete wound closure were higher in the case of SES (72.9% vs. 55.6% closed wounds in PTA; p = 0.088). The recorded weighted EQ-5D score improved significantly up to 1 year in case of SES (p0.0001), but not in case of PTA. There was a trend of more QALYs gained with SES compared with PTA up to 1 year after randomization. Relative QALY gain was 0.10 (95% CI: -0.01 to 0.21; p = 0.08) in the whole study and 0.17 (95% CI: -0.03 to 0.35; p = 0.09) in the wound subgroups comparison.Infrapopliteal SES accelerates wound healing and may improve quality of life compared with PTA. (Comparing Angioplasty and DES in the Treatment of Subjects With Ischemic Infrapopliteal Arterial Disease [ACHILLES]; NCT00640770).

To investigate the phenomenon of distal embolization during subintimal angioplasty with or without stenting of femoropopliteal chronic total occlusions (CTOs).This prospective study included 40 consecutive patients (35 men; mean age 65.4±9.3 years) who underwent subintimal angioplasty alone (n=14) or with stenting (n=26) of CTOs in the femoropopliteal segment. A Spider protection filter was used to capture any possible macro- or microemboli generated during balloon inflation/stenting. Arterial outflow was angiographically checked during each consecutive procedural step. All filters were examined on site for macroscopic material, while the first 20 filters underwent further histopathological qualitative and semiquantitative analysis using a 0+ to 3+ score.There was no angiographically or clinically evident distal embolization. Macroscopic particulate debris was not detected in any filter. Histopathology confirmed the absence of macroemboli but revealed microembolic material (diameter100 μm) in all filters (20/20). The mean number of particles detected was 9.4±4.5 (range 5-17). Histopathological findings included fibrin conglomerates (20/20), trapped erythrocytes (19/20), inflammatory cells (16/20), calcification minerals (6/20), extracellular matrix (6/20), cholesterol clefts (6/20), and endothelial cells (6/20). Captured material was classified as fresh and old thrombus in 7/20 and 4/20 cases, respectively. Semiquantitative analysis demonstrated that the collected microparticles consisted primarily of fibrin conglomerates (median score 2+), trapped erythrocytes (median score 1+), and inflammatory cells (median score 1+).Macroscopically evident emboli were not detected following subintimal angioplasty or stenting of femoropopliteal CTOs. Microscopic debris was present in all filters. The clinical significance of the phenomenon remains to be determined.

To report 1-year results of a single-center randomized controlled trial comparing paclitaxel-coated balloon (PCB) versus high-pressure plain balloon angioplasty for the treatment of failing arteriovenous fistulae (AVFs).Forty patients (26 men; mean age, 61 y ± 14.63) were randomized at 1:1 to undergo PCB (n = 20) or high-pressure balloon (HPB; n = 20) angioplasty of dysfunctional AVFs. There were no significant differences in baseline demographics between groups. Enrollment required a clinical diagnosis of a dysfunctional AVF attributed to a single stenotic lesion verified with digital subtraction angiography. Primary endpoints included device success, anatomic success, clinical success, and target lesion revascularization (TLR)-free survival. Secondary endpoints included dialysis circuit primary patency and procedure-related complication rates.Device success rates were 100% in the HPB group and 35% in the PCB group (P0001): further dilation with an HPB was needed to achieve anatomic success in 13 of 20 cases in the PCB group (65%). Anatomic and clinical success rates were 100% in both groups. TLR-free survival (PCB, 308 d; HPB, 161 d; hazard ratio [HR], 0.478; 95% confidence interval [CI], 0.236-0.966; P = .03) and access circuit primary patency (PCB, 270 d; HPB, 161 d; HR, 0.479; 95% CI, 0.237-0.968; P = .04) were significantly in favor of PCB angioplasty. No minor or major procedure-related complications occurred.In this single-center study, the use of PCBs resulted in superior TLR-free survival and dialysis access circuit primary patency of dysfunctional AVFs. However, additional HPB postdilation was required in the majority of cases.

To report the final results and cost-effectiveness analysis of a prospective randomized controlled trial investigating drug-eluting balloon (DEB) versus plain balloon angioplasty (BA) for the treatment of failing dialysis access (NCT01174472).40 patients were randomized to angioplasty with either DEB (n=20) or BA (n=20) for treatment of significant venous stenosis causing a failing dialysis access. Both arteriovenous fistulas (AVF) and synthetic arteriovenous grafts (AVG) were included. Angiographic follow up was scheduled every two months. Primary endpoints were technical success and target lesion primary patency at 1 year. Cumulative and survival analysis was performed. Incremental net benefit (INB) and incremental cost effectiveness ratio (ICER) were calculated and the cost-effectiveness acceptability curve (CEAC) was drawn.Baseline variables were equally distributed between the two groups. At 1 year, cumulative target lesion primary patency was significantly higher after DEB application (35% vs. 5% after BA, p0.001). Overall, median primary patency was 0.64 years in case of DEB vs. 0.36 years in case of BA (p=0.0007; unadjusted HR=0.27 [95%CI: 0.13-0.58]; Cox adjusted HR=0.23 [95%CI: 0.10-0.50]). ICER was 2198 Euros (€) per primary patency year of dialysis access gained. INB was 1068€ (95%CI: 31-2105€) for a willingness-to-pay (WTP) threshold of 5000€ (corresponding acceptability probability97%).DEB angioplasty may be a cost-effective option that significantly improves patency after angioplasty of venous stenoses of failing vascular dialysis access. Further large-scale randomized trials are warranted.

There are two main causes of iatrogenic arteriovenous fistula (AVF) formation related to peripheral endovascular procedures. AVF may be puncture-site related and may occur during arterial revascularization procedures. The reported incidence of post-femoral catheterization AVF is very low and ranges from 0.006 to 0.5 %, whereas reported data about AVF occurring during balloon angioplasty are scarce. The diagnosis of femoral AVF can be made by palpation and auscultation. Clinical symptoms include pain, femoral thrill and haematoma, while Doppler ultrasonography can confirm the diagnosis. In the majority of the cases, the prognosis of an uncomplicated AVF is good, as most of the lesions present with moderate clinical symptoms and may resolve spontaneously. However, in rare cases of large AVF that is associated with aneurysmal expansion, more serious complications such as ischaemia from steal syndrome, high output cardiac failure and limb oedema may develop.

One of the most fearful major complications related with common femoral artery access is retroperitoneal haemorrhage, occurring in less than

Nerve growth factor (NGF) has been reported to play an important role in physiological and pathological angiogenesis. Based on these observations, we hypothesized that NGF may induce the formation of functional blood vessels in a hindlimb ischemic rabbit model. Hindlimb ischemia was induced in 34 rabbits bilaterally by endovascular embolization of femoral arteries. On the 7th, 14th, and 20th postembolization days, NGF was injected intramuscularly, in 1 ischemic limb, and vehicle was injected in the contralateral control limb. On the 40th day, newly developed collateral vessels (diameter >500 μm) were quantified by transauricular intraarterial subtraction angiography. Perfusion analysis of an in vivo dynamic computed tomography study was performed to the limbs to investigate the hemodynamic recovery of the distal ischemic tissues. Functional estimation of limb perfusion showed a statistically significant increase of blood flow and blood volume for NGF. However, the increase of the collateral vessels was not detectable angiographically, providing evidence for the existence of a NGF-stimulated capillary angiogenic network but not increase of arteriogenesis. The combination of NGF with either tropomyosin-related kinase type A or vascular endothelial growth factor receptor 2 antagonists abolished the NGF-induced hemodynamic recovery. These findings provide new insights into understanding the involvement of NGF in vascular formation and its applications in therapeutic angiogenesis.

This study was designed to investigate the incidence of arterial embolization using a peripheral protection filter device in a series of patients undergoing percutaneous mechanical thrombectomy for the management of thrombosed hemodialysis arteriovenous grafts (AVGs).This prospective, single-center study included all eligible patients presenting during an 18-month period to undergo AVG percutaneous thrombectomy. Inclusion criteria was a recently thrombosed AVG with 2 cm of artery before the next arterial branching. Primary endpoint was the incidence of distal arterial macro- and micro-embolization determined by both digital subtraction angiography and histopathological analysis of the material collected. Secondary endpoints included quantitative measurements of the specimens using a 0+ (no material) to 3+ (maximum load) score.In total, 42 patients met the study's inclusion criteria. No procedure-related complications or angiographically evident arterial embolization were noted. Macroscopically evident material was present in 47.6% (20/42 filters). Histopathology demonstrated that the embolic material was primary consisted of fibrin conglomerates and platelets (median score: 1.5, confidence interval: 1.0-3.0), whereas inflammatory cells, trapped erythrocytes, extracellular matrix, cholesterol clefts, foam cells, necrotic core, and smooth muscle cells also were detected. Mean total area of embolic material was 5.04 mm(2) (range 0.05-5.21). The mean major axis of the largest particle was 1.83 mm (range 0.29-6.64), whereas 19% (8/42) contained particles with major axis1 mm and 12% (5/42) with major axis3 mm.In this study, the percentage of arterial micro-embolization was significantly higher than previously reported. However, the detrimental, long-term, clinical relevance remains to be determined.

Application of metal stents is complicated by neointimal hyperplasia leading to vessel restenosis and reocclusion. Treatment options in cases presenting with complete occlusion of the stented segment and recurrent critical limb ischemia (CLI) are limited. We present the option of the subintimal/substent technique in dealing with occluded stents. The study included patients presenting with recurrent CLI due to impaired blood flow as a result of complete occlusion of previously inserted metal stents and unsuccessful intraluminal crossing of the lesion via either the antegrade or retrograde approach. In these cases, crossing the occlusion through the subintimal/substent plane was attempted. Primary end points included technical success, safety of the procedure, clinical improvement, and limb salvage, while secondary end points were patient survival, primary patency, and vessel restenosis rates at 1-year follow-up. Study end points were calculated by Kaplan–Meier survival analysis. Between July 2006 and October 2011, a total of 14 patients (mean age 69.14 ± 12.59 years, 12 men) were treated with the substent technique and included in the analysis. Technical success rate was 85.71 % (12 of 14), with a total lesion length of 193.57 ± 90.78 mm. The mean occluded stented segment length was 90.21 ± 44.34 mm. In 10 (83.33 %) of 12 cases, a new stent had to be placed by the side of the old occluded one, while the remaining two cases (16.67 %) were treated only with balloon angioplasty. No serious adverse events were noted during the immediate postprocedural period. All successfully treated patients improved clinically. Estimated limb salvage was 90.9 %, and patient survival rate was 90.0 % at 1 year’s follow-up. Primary patency was 45.50 % and vessel restenosis 77.30 %. Subintimal recanalization of occluded metal stents through the substent plane is a valuable alternative treatment option, especially in patients with recurrent CLI with few alternatives.

The study investigated the efficacy and safety of a balloon expandable, sirolimus-eluting stent (SES) in patients with symptomatic infrapopliteal arterial disease.Results of infrapopliteal interventions using balloon angioplasty and/or bare stents are limited by a relatively high restenosis rate, which could be potentially improved by stabilizing the lesion with a SES.Two hundred patients (total lesion length 27 ± 21 mm) were randomized to infrapopliteal SES stenting or percutaneous transluminal balloon angioplasty (PTA). The primary endpoint was 1-year in-segment binary restenosis by quantitative angiography.Ninety-nine and 101 patients (mean age 73.4 years; 64% diabetics) were randomized to SES and PTA, respectively (8 crossover bailout cases to SES). At 1 year, there were lower angiographic restenosis rates (22.4% vs. 41.9%, p = 0.019), greater vessel patency (75.0% vs. 57.1%, p =0.025), and similar death, repeat revascularization, index-limb amputation rates, and proportions of patients with improved Rutherford class for SES versus PTA.SES implantation may offer a promising therapeutic alternative to PTA for treatment of infrapopliteal peripheral arterial disease.

BACKGROUND A well-established method to preserve failing synthetic arteriovenous grafts (AVGs) dialysis accesses is percutaneous transluminal angioplasty (PTA). Nevertheless, the one-year primary patency rate following PTA is approximately 25%. This study was designed to compare the angiographic and clinical outcomes following stent-graft insertion versus angioplasty and/or bare metal stenting (BMS) of recurrently failing AVGs, because of anastomotic and/or venous outflow stenoses. METHODS Self-expanding stent-grafts were deployed for the treatment of failing AVGs in case of recurrent stenosis after treatment with conventional angioplasty or bail-out BMS. Regular angiographic follow-up was scheduled every two months the first six months and every three months thereafter. Data from previous procedures on the same treatment site were retrieved from our database. Primary patency was defined as a functioning graft with a patent treatment site without angiographic restenosis >50% and without any subsequent repeat procedures. Outcome data were analyzed by Kaplan-Meier analysis. RESULTS In total, 35 patients previously treated with angioplasty and/or BMS for the treatment of recurrent significant AVG stenosis (group PTA), underwent stent-graft placement of the same treatment site (group SG). Of those, 20 patients had undergone angioplasty and 15 bail-out BMS. Mean lesion length was 4.8±1.7cm. Primary patency was significantly improved in the SG group (Hazard Ratio [HR] = 0.2 [95% CI= 0.11-0.36], P=.0001) by log-rank test. The estimated six and 12-month patency rates were 76.9% vs. 25.7%, and 61.4% vs. 8.6% for groups SG and PTA respectively, (P

Endovascular procedures have evolved to the mainstream treatment of choice for revascularization of infrapopliteal obstructive disease, especially in patients suffering from critical limb ischemia and multiple comorbidities. However, standard balloon angioplasty is limited by the potential of a suboptimal acute outcome due to elastic recoil and/or flow-limiting dissection, followed by neointimal hyperplasia and progressive vascular restenosis even in the case of bare-metal stent use. Drug-eluting stents and drug-coated balloons are emerging endovascular technologies with the promise of significant inhibition of vessel restenosis and improved clinical outcomes. The current review outlines the drug-eluting properties of those instruments and summarizes the currently available clinical data. The authors critically appraise the current status and also provide a glimpse of the near future of endovascular below-the-knee treatments.

To report the long-term outcomes of a single-center prospective study investigating primary placement of everolimus-eluting metal stents for recanalization of long infrapopliteal lesions compared to a matched historical control group treated with plain balloon angioplasty and provisional placement of bare metal stents in a bailout manner.The study included 81 patients (63 men; mean age 71 years, range 45-85) suffering from critical limb ischemia (CLI) and angiographically proven long-segment (at least 1 lesion4.5 cm) de novo infrapopliteal artery disease who underwent below-the-knee revascularization with either primary placement of everolimus-eluting stents (n = 47, 51 limbs, 102 lesions) or angioplasty and bailout bare metal stenting (n = 34, 36 limbs, 72 lesions). Clinical and angiographic follow-up was collected at regular time intervals. Primary clinical and angiographic endpoints included patient survival, major amputation-free survival, angiographic primary patency, angiographic binary restenosis (50%), and overall event-free survival. Results were stratified according to endovascular treatment received. Multivariable Cox proportional hazards regression analysis was applied to adjust for confounding factors of heterogeneity.Baseline demographics were well matched. No significant differences were identified between the 2 groups with regard to overall 3-year patient survival (82.2% versus 65.7%; p = 0.90) and amputation-free survival (77.1% versus 86.9%; p = 0.20). Up to 3 years, lesions fully covered with everolimus-eluting stents were associated with significantly higher primary patency [hazard ratio (HR) 7.98, 95% CI 3.69 to 17.25, p0.0001], reduced binary restenosis (HR 2.94, 95% CI 1.74 to 4.99, p0.0001), and improved overall event-free survival (HR 2.19, 95% CI 1.16 to 4.13, p = 0.015) versus the matched historical control group.Primary infrapopliteal everolimus-eluting stenting for CLI treatment significantly inhibits restenosis and improves long-term angiographic patency and overall patient event-free survival compared to balloon angioplasty and bailout bare metal stenting.

We report a combination of unusual features demonstrating a permanent pacemaker implantation of a single-pass VDD lead by way of an anomalous persistent left superior vena cava in the middle cardiac vein. The ventricular stimulation resembled a right bundle branch block QRS morphology and was successfully synchronized by spontaneous atrial activity. This case illustrates an alternative approach of effective VDD pacing and sensing in patients with such a venous anomaly when other standard implantation sites fail.

Percutaneous catheter-directed intra-arterial thrombolysis is a safe and effective method of treating acute and subacute lower limb ischemia, as long as accurate patient selection and procedural monitoring are ensured. Although larger, controlled trials are needed to establish the role of PTDs in ALI, mechanical thrombectomy could currently be applied combined with lytic infusion in selected cases where rapid recanalization is required or as a stand-alone therapy when the administration of thrombolytic agents is contraindicated.

The purpose of this study was to investigate the immediate and long-term results of cryoplasty versus conventional balloon angioplasty in the femoropopliteal artery of diabetic patients. Fifty diabetic patients (41 men, mean age 68 years) were randomized to cryoplasty (group CRYO; 24 patients with 31 lesions) or conventional balloon angioplasty (group COBA; 26 patients with 34 lesions) of the femoropopliteal artery. Technical success was defined as30% residual stenosis without any adjunctive stenting. Primary end points included technical success, primary patency, binary in-lesion restenosis (50%), and freedom from target lesion recanalization. Cox proportional hazards regression analysis was performed to adjust for confounding factors of heterogeneity. In total, 61.3% (19 of 31) in group CRYO and 52.9% (18 of 34) in group COBA were de novo lesions. More than 70% of the lesions were Transatlantic Inter-Society Consensus (TASC) B and C in both groups, and 41.4% of the patients in group CRYO and 38.7% in group COBA suffered from critical limb ischemia. Immediate technical success rate was 58.0% in group CRYO versus 64.0% in group COBA (p = 0.29). According to 3-year Kaplan-Meier estimates, there were no significant differences with regard to patient survival (86.8% in group CRYO vs. 87.0% in group COBA, p = 0.54) and limb salvage (95.8 vs. 92.1% in groups CRYO and COBA, respectively, p = 0.60). There was a nonsignificant trend of increased binary restenosis in group CRYO (hazard ratio [HR] 1.3; 95% CI 0.6-2.6, p = 0.45). Primary patency was significantly lower in group CRYO compared with group COBA (HR 2.2; 95% CI 1.1-4.3, p = 0.02). Significantly more repeat intervention events because of recurrent symptoms were required in group CRYO (HR 2.5; 95% CI 1.2-5.3, p = 0.01). Cryoplasty was associated with lower primary patency and more clinically driven repeat procedures after long-term follow-up compared with conventional balloon angioplasty.

To investigate the incidence, anatomical location, and clinical impact of fractures and/or compression of infrapopliteal balloon-expandable metal stents implanted for critical limb ischemia (CLI) treatment.This prospective study included 63 CLI patients (45 men; mean age 71.3+/-9.5 years) who had been treated with infrapopliteal angioplasty and stent placement for 191 lesions in 84 limbs. In all, 369 stents (296 stainless steel and 73 cobalt-chromium alloy) were implanted; 239 were placed overlapping in tandem lesions. Mean length of the overall stented segment was 4.4+/-6.3 cm (range 1.6-14.0). Stents were located in the tibioperoneal (n = 34), anterior tibial (n = 195), posterior tibial (n = 63), and peroneal (n = 77) arteries. Follow-up consisted of digital subtraction angiography and infrapopliteal radiography imaging at 2 different angles. Evaluation of stents for the presence of fracture and/or compression was done after digital processing at the highest possible magnification. Stent fractures were defined according to published standards, whereas compression was classified as severe shape alteration and/or collapse of the stent mesh. Angiographic restenosis was based on a 50% threshold.Mean follow-up was 15+/-11 months (range 6-60). Image analysis detected 1 (0.3%) severe stent fracture (complete separation and misalignment of stent struts) and 11 (3.0%) stent compressions. Infrapopliteal stent fracture and compressions were associated with increased artery restenosis [100% (12/12) versus 47.3% (169/357), p0.001] and an increased rate of clinical deterioration and clinically-driven reinterventions [41.7% (5/12 limbs) versus 19.4% (14/72 limbs), p = 0.04]. The single fracture and most of the compressions were located in the distal third of the anterior tibial artery.Stent fractures and compressions of infrapopliteal balloon-expandable metal stents are infrequent. However, they may be related to increased restenosis.

Purpose To report the midterm (≤1 year) angiographic and clinical outcomes of a prospective study investigating the infrapopliteal application of paclitaxel-eluting stents (PES) in patients with critical limb ischemia (CLI). Materials and Methods Infrapopliteal angioplasty was chosen as first-line therapy in patients with unilateral or bilateral CLI and additional femoropopliteal angioplasty was performed in case of multilevel disease. Implantation of coronary PES was performed in case of a suboptimal angioplasty result (eg, elastic recoil, residual stenosis >30%, or flow-limiting dissection). Patients were followed up with regular clinical evaluation, and digital subtraction angiography was scheduled at 6 months and 1 year. Life-table analysis and Kaplan-Meier plotting of angiographic and clinical variables were performed. Cox proportional-hazards regression analysis was employed to adjust for various covariates and search for independent adverse predictors of angiographic and clinical outcome. Results Infrapopliteal procedures were performed in 29 patients with 32 limbs with CLI; 79.3% of the patients had diabetes and 34.5% had renal disease. A total of 62 coronary PES were deployed in 50 below-knee lesions (mean stent-implanted length, 25.51 mm ± 12.16). Technical success rate was 100%. The 1-year mortality rate was 16.9%, and the limb salvage rate was 88.5%. The 1-year angiographic in-stent primary patency rate was 30.0%, whereas the incidence of in-stent binary (>50%) restenosis was 77.4%. The 1-year incidence of clinically driven repeat interventions was 30.5%. The Cox model calculated renal disease as the only independent predictor of decreased primary patency and increased repeat intervention events. Initial occlusions also adversely affected primary patency. Conclusions Infrapopliteal PES achieved acceptable clinical results in CLI, even though they failed to inhibit vascular restenosis and decrease the need for repeat interventions. Renal disease and initial occlusions are adverse prognostic factors for infrapopliteal endovascular procedures.

Editor: We read with great interest the article by Dwarka et al (1) in the October issue of JVIR regarding the occurrence of bradyarrhythmias during central venous application of the AngioJet thrombectomy catheter (Possis Medical, Minneapolis, Minn). We have also recently published our experience on the matter, describing similar phenomena during intrapulmonary activation of the device (2). However, we would like to express our skepticism with respect to the mechanistic explanation provided for the bradyarrythmias by the authors and our disagreement with the proposed rationale for pre-treatment with gadolinium or streptomycin. Indeed, the AngioJet device uses lateral saline jets, which are combined with periods of negative pressure vacuums due to the Bernoulli effect, so as to simultaneously macerate and aspirate thrombi. Nevertheless, mechanical pressure wave fronts propagate radially and in a cross-sectional level perpendicular to the distal catheter tip. Should one contemplate carefully the anatomy of the large vessels and heart, it is rather improbable that pressure waves originating from an AngioJet catheter that is activated in pulmonary branches, especially those of the right lung lobe, will have an influence on left ventricular electrophysiology. To our utmost surprise, the authors proposed that pretreatment with gadolinium or streptomycin may prevent stretch-induced activation of endothelial receptors by the hydrodynamic jets. After careful review of the cited literature (1), however, it is well understood that mechanical stimulation of stretch-activated receptors of ventricular myocytes may lead to shorter refractory intervals and decreased re-polarization periods. As a result, extrasystoles and pro-arrhythmogenic re-entry cycles may occur, which are actually tachyarrhythmias. All that notwithstanding, the AngioJet invokes bradycardia and type III heart block, which has been documented electrocardiographically (3). Moreover, activation of the AngioJet catheter in the pulmonary vessels causes not only bradyarrhythmia but also disruption of normal breathing. Both Siablis et al (2) and Zeni et al (4) have reported episodes of shortness of breath and apnea, which is even more difficult to explain. In addition, it was stated that aura symptoms with associated cutaneous erythema were also experienced (2). Hence, the generation of rapidly degrading local humoral byproducts during rheolytic maceration of thrombus is a more plausible explanation. Liberated adenosine may be incriminated for the short-lasting bradyarrythmias, whereas serotonin has been proposed as an explanation for the erythema and the aura symptoms (2). Conversely, we have proposed that mechanical irritation of the afferent vagal pulmonary c-fibers that underline the wall of pulmonary vessels and stimulate the apneustic center in the central nervous system could account for the apnea phenomena (2). In our experience, pre-treatment with aminophylline and short-lasting activation of the AngioJet device has produced satisfactory results in limiting the aforementioned complications. Nevertheless, because neither the above suggestions nor the ones proposed by Dwarka et al (1) bear any credible scientific evidence or at least experimental proof of concept, we think that the necessary cautiousness during central venous operation of the AngioJet device cannot be overstressed.

Purpose: To report the 1-year angiographic and clinical outcome from a prospective single-center study investigating the infrapopliteal application of sirolimus-eluting versus bare metal stents in patients with critical limb ischemia (CLI) who underwent below-the-knee endovascular revascularization. Methods: Stenting was performed as a bailout procedure for suboptimal angioplasty results (flow-limiting dissection, elastic recoil, or postangioplasty residual stenosis >30%). In the first 29 patients, infrapopliteal stenting was performed with bare metal stents (group B) and with sirolimus-eluting stents in the other 29 patients (group S). Results: Below-the-knee angioplasty and stenting involved 65 lesions in 40 infrapopliteal arteries of 29 limbs in group B and 66 lesions in 41 infrapopliteal arteries of 29 limbs in group S. Baseline comorbidities (hyperlipidemia and symptomatic cardiac and carotid disease) were more pronounced in group S (pConclusion: The application of sirolimus-eluting stents reduces the restenosis rate in the infrapopliteal arteries and the rate of repeat endovascular procedures the first year after treatment.

The purpose of our study was to develop a user-independent computerized tool for the automated segmentation and quantitative assessment of in vivo-acquired digital subtraction angiography (DSA) images. Vessel enhancement was accomplished based on the concept of image structural tensor. The developed software was tested on a series of DSA images acquired from one animal and two human angiogenesis models. Its performance was evaluated against manually segmented images. A receiver's operating characteristic curve was obtained for every image with regard to the different percentages of the image histogram. The area under the mean curve was 0.89 for the experimental angiogenesis model and 0.76 and 0.86 for the two clinical angiogenesis models. The coordinates of the operating point were 8.3% false positive rate and 92.8% true positive rate for the experimental model. Correspondingly for clinical angiogenesis models, the coordinates were 8.6% false positive rate and 89.2% true positive rate and 9.8% false positive rate and 93.8% true positive rate, respectively. A new user-friendly tool for the analysis of vascular networks in DSA images was developed that can be easily used in either experimental or clinical studies. Its main characteristics are robustness and fast and automatic execution. J Digit Imaging

To describe a safe percutaneous method of transauricular endovascular access in small and large animals that uses basic catheter-based interventional skills and renders surgery and general anesthesia with intubation unnecessary.Twenty New Zealand White rabbits and five domestic juvenile swine were used in the experiments. Animals were restrained in the supine position after induction of dissociative anesthesia. Transauricular endovascular access was accomplished by percutaneous catheterization of the auricular artery or vein, roadmap imaging, introduction of a 0.018-inch hydrophilic guide wire, and over-the-wire vascular sheath insertion after serial tract dilations.Technical success rates were 90% and 100% for intraarterial and endovenous access in the rabbit, respectively, and 100% for both routes in the pig. The largest sheaths inserted were 5 F in the rabbits' aortae, 7 F in the rabbits' venae cavae, 6 F in the pigs' aortae, and 8 F in the pigs' venae cavae. Animal recovery was uneventful, and 48-hour necropsy detected only minor perivascular hematoma in cases of transauricular intraarterial access. Peripheral, intracoronary, intrapulmonary, and intracerebral selective vascular access was safe and feasible. A method of reserving the transauricular endovascular access for future interventions or follow-up by placement of indwelling hydrophilic catheters was also established.Transauricular endovascular access is a successful technique for establishing and maintaining intraarterial or endovenous vascular access. It obviates surgical cutdown and sacrifice of the femoral and cervical vessels and might considerably improve and expedite cardiovascular experimental protocols in small and large animals.

l l Purpose: To investigate distal embolism during endovascular procedures of the infra-aortic arteries by utilizing a commercial filter basket and unveil any correlation between the baseline clinical and procedural variables and the histopathological findings of the col- lected particles. Methods: In a prospective study, 48 patients (37 men; mean age 70.867.8 years, range 50- 83) underwent endoluminal therapy of infra-aortic lesions (stenosis .75% or occlusion; mean lesion length 52.2638.0 mm) with standard endovascular procedures. A nitinol filter basket (n550) was employed for distal protection. The collected particles were histopath- ologically analyzed. The harvested specimens were quantified after digital image post pro- cessing. Results: Procedural success of filter-protected revascularization was 93.8%. Three failures included 1 vasospasm, 1 distal embolus, and 1 side-branch occlusion. The total area of retrieved particles per basket was 2.7666.49 mm 2 (range 0.0-40.3). Particles with a major axis .1 and .3 mm were detected in 29 (58.0%) and 6 (12.0%), respectively, of the ex- amined filters. Collected particles consisted primarily of platelets and fibrin conglomerates, trapped erythrocytes, inflammatory cells, and extracellular matrix. Increased lesion length, increased reference vessel diameter, acute thromboses, and total occlusions were posi- tively correlated with higher amounts of captured particles (p,0.05). Multivariate analysis incriminated declotting procedures as the only independent predictor of increased embolic burden (p,0.05). Conclusion: The embolism phenomenon during infra-aortic interventions is frequent and underestimated. The liberated particles consisted primarily of atheromatous plaque ele- ments and thrombus. The reported data might support the application of a protective filter basket in selected subsets of lesions with a riskier embolic profile and whenever declotting procedures are performed. J Endovasc Ther 2006;13:269-280

To report the 6-month angiographic results from a prospective single-center study investigating the efficacy and outcome of sirolimus-eluting stents used for bailout after infrapopliteal revascularization of patients with critical limb ischemia (CLI).Twenty-nine patients (21 men; mean age 68.7 years) underwent infrapopliteal revascularization with bare metal stents (group B) implanted for bailout in 65 lesions (38 stenoses and 27 occlusions) in 40 infrapopliteal arteries. Another 29 patients (21 men; mean age 68.8 years) underwent infrapopliteal bailout stenting with sirolimus-eluting stents (group S) in 66 lesions (46 stenoses and 20 occlusions) in 41 vessels. Preliminary 6-month angiographic and clinical results were analyzed.Hyperlipidemia and symptomatic cardiac and carotid diseases were more pronounced in group S (p0.05). Technical success was 96.6% (28/29 limbs) in group B versus 100.0% in group S (p=0.16). Six-month primary patency was 68.1% in group B versus 92.0% in group S (p0.002). Binary in-stent and in-segment restenosis rates were 55.3% and 66.0%, respectively, in patients with bare stents versus 4.0% and 32.0%, respectively, in patients treated with the sirolimus-eluting stents (both p0.001). The target lesion re-intervention rate at 6 months was 17.0% in group B versus 4.0% in group S (p=0.02). Limb salvage was 100% in both groups. Six-month mortality and minor amputation rates were 6.9% and 17.2%, respectively, in group B versus 10.3% and 3.4%, respectively, in group S (p=0.32 and p=0.04, respectively).Sirolimus-eluting stents seem to restrict neointimal hyperplasia in the infrapopliteal vascular bed.

l l Purpose: To compare the efficacy of full-dose local intrapulmonary thrombolysis (LIT) ver- sus AngioJet rheolytic thrombectomy (ART) in the treatment of massive pulmonary em- bolism. Methods: A retrospective review was conducted of 8 consecutive patients (5 women; mean age 66.065.9 years, range 56-74) who underwent LIT with high-dose intrapulmonary uro- kinase (4400 IU/kg over 10 minutes followed by a 2000-IU/kg/h infusion) and a subsequent 6 consecutive patients (4 men; mean age of 59.2617.0 years, range 26-69) who underwent ART plus adjunctive low-dose urokinase infusions (100,000 IU) until hemodynamic recov- ery was achieved. Pre and postprocedural Miller scores were calculated, and relative Miller score improvement, total urokinase doses, and duration of therapy were compared. Results: Hemodynamic stability was restored in all 8 LIT patients and in 5 (83%) of the 6 ART patients; 1 (16.7%) patient died during the ART procedure due to recurrent MPE. In the LIT group, the mean Miller score prior to intervention was 17.3862.67, which was reduced to 6.1361.46 after the intervention (p,0.0001) compared to scores of 18.8362.86 and 6.8362.79, respectively, in the ART group (p,0.0001). The mean urokinase dose was 2.0760.44 million IU in the LIT group versus 0.7060.36 million IU in the ART group (p,0.0001). The mean duration of therapy was 11.4562.94 hours in the LIT group versus 3.3761.41 hours in the ART group (p,0.0001). No significant difference in relative Miller score improvement was observed. Conclusion: By accelerating the fragmentation of thrombus, ART plus adjunctive low-dose urokinase seems to be more rapidly effective compared to LIT. ART achieves both rapid cardiovascular relief and reduces the dose of thrombolytic agent necessary in patients with massive pulmonary embolism. J Endovasc Ther 2005;12:206-214