German multicenter real-world registry of stenting for superficial femoral artery disease: clinical results and predictive factors for revascularization.

PURPOSE: To investigate nitinol stent treatment of superficial femoral artery (SFA) lesions and the impact of different risk factors on the need for clinically driven target lesion revascularization (TLR) in a large, real-world population of claudicants. METHODS: Patients presenting with symptomatic SFA stenosis >70% were consecutively enrolled in the 13-center MARIS prospective registry (ClinicalTrials.gov identifier NCT01067885). There was no restriction on lesion length, thus leading to the inclusion of a real-world as well as high-risk patient cohort. The 998 participating patients (657 men; mean age 67.4±9.2 years) had 1050 lesions treated with the same nitinol stent type. The mean lesion length was 9.5±9.6 cm (range 0.5-44; median 8.0); more than a third of the lesions (450, 42.9%) were total occlusions. The primary endpoint was the need for clinically driven target lesion revascularization (TLR) at 12 months. RESULTS: Acute technical success was achieved in 1042 (99.2%) lesions. Restenosis occurred in 187 (23.7%) and reocclusion in 79 (10.0%) lesions at 12 months. The primary endpoint of TLR at 12 months was reached by 136 (17.2%) patients. The periprocedural complication rate was 5.4%. Independent predictors of TLR were female gender [odds ratio (OR) 0.5, 95% confidence interval (CI) 0.3 to 0.7, p<0.001] and lesion length >20 cm vs. 10 cm (OR 2.7, 95% CI 1.1 to 6.6, p=0.029) and 10-20 cm vs. 10 cm (OR 1.9, 95% CI 1.0 to 4.1, p=0.047). CONCLUSION: Stent implantation in the SFA is safe and associated with favorable acute and midterm results in a real-world setting. Lesion length and female gender were identified as independent risk factors for TLR.

Percutaneous transluminal angioplasty versus turbostatic carbon-coated stents in infrapopliteal arteries: InPeria II trial.

PURPOSE: To determine the clinical outcome and the success of stent application for high-grade lesions of the infrapopliteal arteries compared with treatment with percutaneous transluminal angioplasty (PTA) in critical limb ischemia (CLI). MATERIALS AND METHODS: In this ethics board-approved randomized prospective study, PTA or stent application was performed on 131 lesions in 88 patients with CLI. The primary end points were clinical improvement after endovascular treatment and limb salvage rate. Secondary end points were defined by the minimal lumen diameter (MLD) before and after the revascularization procedure, percentage of residual diameter stenosis (DS), binary restenosis rate (>50% DS and >70% DS), and incidence of target lesion revascularization at 9-month follow-up. RESULTS: At 3 months, the clinical status in the PTA group was less improved than that in the stent group (P = .008). At 9 months, there had been five minor and two major amputations in the PTA group and five major and five minor amputations in the stent group. MLD was significantly larger and the percentage of DS was significantly less in the stent group at completion angiography. At 9 months, the angiographic control showed better trends for the stent group in comparison to the PTA group despite that no significant differences were detected (MLD, 1.19 mm ± 0.92 vs 1.02 mm ± 1.02; DS, 38.68% ± 25.47 vs 43.31% ± 28.37). CONCLUSION: Infrapopliteal stent application is an effective treatment modality in CLI. The PTA and stent groups were essentially equal at 3 and 9 months except for the difference in clinical improvement in the stent group at 3 months.

Comparison of second-generation stents for application in the superficial femoral artery: an in vitro evaluation focusing on stent design.

PURPOSE: To examine and compare in an ex vivo study different nitinol stent designs intended for the superficial femoral artery (SFA) with regard to the appearance of fracture. METHODS: Seven different 8-×40-mm nitinol stents were evaluated (Misago, Absolute, Smart, Luminexx, Sentinol, Lifestent NT, and Sinus-Superflex). Finite element analysis (FEA) was used for digitalized stent design comparison; the strain during stent movement was calculated for bending, compression, and torsion. Additional mechanical fatigue tests for bending (70°), compression (40%), and torsion (twisted counterclockwise by 180°) were performed up to 650,000 cycles or until a fracture was observed. RESULTS: The FEA bending test showed that only the Misago, LifeStent, and Absolute stents presented no zones of high strain; in the torsion test, the Smart stent also had no zones of high strain. Macroscopic evaluation after mechanical bending indicated that the LifeStent performed the best (no stent fracture after 650,000 cycles). Misago and Absolute stents showed fractures at 536,000 cycles and 456,667 cycles, respectively (range 320,000-650,000 cycles). After compression and torsion testing, Misago showed no stent fracture after 650,000 cycles. The worst performing stent was Luminexx during all test cycles. CONCLUSION: The 7 SFA stents showed differences in the incidence of high strain zones, which indicates a potential for stent fracture, as demonstrated by the mechanical fatigue tests. Differences in stent design might play a major role in the appearance of stent strut fracture related to restenosis and reocclusion.

Prospective, randomized single-center trial to compare cryoplasty versus conventional angioplasty in the popliteal artery: midterm results of the COLD study.

PURPOSE: To evaluate safety and efficacy of cryoplasty versus conventional angioplasty for focal popliteal arterial occlusive disease. MATERIALS AND METHODS: Patients with focal atherosclerotic stenoses and occlusions of the popliteal artery were randomized to cryoplasty or conventional angioplasty as the initial treatment strategy. The primary objective was target lesion patency. The secondary endpoint was treatment success without the need for stents. Duplex ultrasonography was performed at 3, 6, 9, and 15 months. RESULTS: Eighty-six patients (mean age, 72 years; age range, 50-94 years) were enrolled in this study. Forty patients were randomized to cryoplasty and 46 to conventional angioplasty. Demographics, risk factors, clinical stage of disease, and lesion details were comparable. On intention-to-treat basis, initial success was 35% for cryoplasty versus 54% for conventional angioplasty (P = .02). The rate of grade C dissection was 35% after cryoplasty and 26% after conventional angioplasty (P = .4). Optional long-term percutaneous transluminal angioplasty (PTA) was performed in 58% of cryoplasty patients. The rate of stent placement for dissection and/or residual stenosis was 30% after cryoplasty (including long-term dilation) and 39% after conventional angioplasty (P = .34). The mean (+/-standard deviation) target lesion patency at 9 months was 79.3% +/- 7.5 for cryoplasty and 66.7% +/-8.1 for conventional angioplasty; however, the results are not significant (P = .14). CONCLUSIONS: Cryoplasty of the popliteal artery alone showed a lower anatomic success when compared with conventional angioplasty. Combined with optional long-term PTA, however, stent placement was not needed more often. There was a trend toward higher patency after cryoplasty, but differences were not statistically significant and results of long-term follow-up have to be awaited.

Embolic protection devices for peripheral application: wasteful or useful?

Distal embolization following percutaneous intervention is a universal phenomenon that has been reported in various vascular beds. Distal emboli are also very common during lower extremity percutaneous peripheral interventions. Some data from case reports and registries are currently available. Clinical data have shown that the application of an embolic protection device in the lower limb arteries is safe. Prospective and, ideally, randomized trial data are warranted to justify the increased use of filters in lower extremity interventions, despite the obvious benefits that these devices provide. However, the clinical relevance of distal embolization in the lower extremity remains unquantified.

Nitinol stent implantation in long superficial femoral artery lesions: 12-month results of the DURABILITY I study.

PURPOSE: To evaluate the long-term efficacy and integrity of the PROTEGE EverFlex stent in superficial femoral artery (SFA) lesions in symptomatic patients with peripheral artery disease (PAD). METHODS: A prospective, multicenter, nonrandomized study enrolled 151 subjects (111 men; mean age 67.8 years, range 42-93) undergoing percutaneous treatment of de novo, restenotic, or reoccluded SFA lesions between August 11, 2006, and June 26, 2007. Subjects were scheduled to receive a single stent and be evaluated through 12 months following the implant procedure. Occlusions were present in 40% of the patients. Mean lesion length was 96.4 mm (range 10-150). RESULTS: A total of 161 stents (158 EverFlex) were implanted in the 151 patients: single stents in 93.4% (141/151) and a second stent in 6.6% (10/151). One-year follow-up information was available for 88.7% (134/151) of the study participants; of the remaining 17 subjects, 6 subjects withdrew from the study, 2 were lost to follow-up, and 9 died. Freedom from restenosis data were available for 99.3% (133/134) of the subjects who completed a 12-month follow-up visit. The mean Rutherford classification fell from 2.8+/-0.8 (range 1-5) at baseline to 0.6+/-1.1 (range 0-5) at 12 months. The mean ankle-brachial index rose from 0.6+/-0.2 (range 0-1.4) at baseline to 0.9+/-0.2 (range 0-1.2) at 12 months. The rates for freedom from >50% restenosis at 6 and 12 months were 91.3% (95% CI 84.9% to 95.2%) and 72.2% (95% CI 63.8% to 79.6%), respectively. The freedom from target lesion revascularization rate at 12 months was 79.1% (95% CI 71.2% to 85.6%). The 1-year stent fracture rate was 8.1% (95% CI 4.0% to 14.4%). CONCLUSION: The high freedom from >50% restenosis and low fracture rate at 12 months suggests that the PROTEGE EverFlex stent offers a safe and acceptably efficacious means of treating SFA lesions in symptomatic subjects with PAD.

Total percutaneous endovascular aneurysm repair with the dual 6-F Perclose-AT preclosing technique: a case-control study.

PURPOSE: To determine the safety and efficacy of total percutaneous access closure for endovascular aortic aneurysm repair with a suture-mediated preclosing technique. MATERIALS AND METHODS: One hundred thirty-two femoral access sites in 70 patients who underwent endovascular aortic aneurysm repair were closed percutaneously with off-label use of two F-6 Perclose AT devices preapplied at a 90 degrees angle. Femoral access sizes ranged from 12 to 24 F. Technical success, complications, and procedure and access closure times were evaluated. Follow-up with computed tomography and/or magnetic resonance imaging was scheduled at 1-4 days and 3, 6, and 12 months and used to obtain groin hematoma and scar severity scores (grades 1-3). Data were compared with those from a cohort of 67 patients who underwent endovascular aortic aneurysm repair with surgical femoral cutdown. RESULTS: Technical success was achieved with the preclosing technique in 127 of the 132 arteries (96.2%). Two to four closure devices were used per groin. Five technical failures were managed intraoperatively with surgical suture. There was no access-related mortality and no late groin complications. The mean procedure duration was 91 minutes +/- 32, and the mean access closure time was 12 minutes +/- 9. For surgical management, the mean procedure time was 153 minutes +/- 112 (P < .05), and the mean closure time was 12 minutes +/- 13 (not statistically significant). Hematoma severity score at 1-4 days was 1.8 for total percutaneous endovascular aneurysm repair and 2.1 for surgical closure. Scar severity scores at 3, 6, and 12 months were 1.1, 1.0, and 1.0 for total percutaneous endovascular aneurysm repair and 2.4, 2.4, and 2.3 for surgical management, respectively. CONCLUSIONS: Total percutaneous endovascular aneurysm repair with a dual 6-F-Perclose preclosing technique is safe and effective. Compared with femoral cutdown, there are fewer late groin complications and scar tissue formation is less severe.

[Anaesthetic considerations in endovascular repair of aortic aneurysms]. / Anästhesiologisches Management bei endovaskulärer Rekonstruktion.

With advancing developments of endovascular techniques, the demands on anaesthesiological management are increasing. The transfemoral implantation of coated endografts in the aorta of cardiopulmonal impaired patients is a particular challenge for the interdisciplinary team. Guided by invasive monitoring, changing blood-pressure targets have to be achieved and in case of serious complications conversion to open surgery must be available immediately.

Does a history of peritoneal dialysis result in an impaired gastrointestinal life quality?

Peritoneal dialysis (PD) invariably induces sclerotic changes in the peritoneal membrane. The impact of these changes on the well-being of PD patients has not been studied sufficiently. In a matched-pair analysis, the gastrointestinal life quality of patients with a history of PD was compared with end-stage renal disease patients who never performed PD, using a standardized questionnaire (gastrointestinal life-quality index [GLQI]). We identified all patients in our dialysis unit who underwent PD between 1989 and 2001 and who were alive in October 2001 (PD patients; n=53). Patients who were treated by hemodialysis (HD patients) were recruited as pairs. Hemodialysis and PD patients did not differ in gastrointestinal life quality (GLQI: HD 106.0+/-16.4 points; PD 104.0+/-16.7 points; p=0.70). Gastrointestinal life quality was neither correlated with the number of peritonitis episodes, nor with the duration of PD treatment. Peritoneal dialysis treatment is not associated with a long-term impairment of gastrointestinal life quality.

[Endovascular treatment of atherosclerotic arterial stenoses and occlusions of the supraaortic arteries: mid-term results from a single center analysis]. / Endovaskuläre Behandlung arteriosklerotisch bedingter arterieller Stenosen und Okklusionen der Aortenbogengefässe: Mittelfristige Ergebnisse einer Ein-center-Analyse.

OBJECTIVE: To determine mid-term patency rates after endovascular treatment of supraaortic atherosclerotic arterial stenoses and occlusions using percutaneous transluminal angioplasty (PTA) and stent placement. PATIENTS AND METHODS: During a period of 83 months, 48 patients (18 female, 30 male; mean age 61 years, range 31-82 years) were included into this prospective single-center study. Fifty-five lesions of the brachial and cephalic arteries (subclavian/axillary artery n = 42, innominate artery n = 7, origin common carotid artery n = 6) were treated using PTA (n = 38), PTA plus stent (n = 11) or primary stent placement (n = 6). For anticoagulation, patients received a bolus of heparin (5000 IU) intraarterially during the intervention followed by intravenous application for 24h. At discharge, life-time application of ASA (100mg/day) was initiated. Follow-up protocol included clinical examination, colour-coded duplex ultrasound and intraarterial angiography in case of re-stenosis. RESULTS: PTA and stent placement were technically successful in all patients (100%). No major complications occurred. Of seven patients presenting with total occlusions, six were treated with stent placement. Stent implantation was also performed in all lesions located at the origin of the supraaortic arteries (n = 6). In 38 lesions, the result of PTA was satisfactory. Mean follow-up time is 22 months (range 1-83 months). During follow-up examinations, re-stenoses occurred in 10 cases (at 1 month n = 2, at 6 months n = 2, at 12 months n = 3, at 24 months n = 3). In 9 lesions, re-interventions were performed (PTA n = 7; PTA plus stent n = 2). According to Kaplan-Meier life-table analysis, cumulative primary and primary assisted patency rates are 69.5% (patients at risk n = 15; standard error 9%) and 90.6% (patients at risk n = 16; standard error 6.3%) at 20 months, respectively. CONCLUSIONS: Endovascular treatment of atherosclerotic obstructive disease in brachial and cephalic arteries is a safe procedure showing promising mid-term patency rates.

Reproducibility of computer-aided volumetry of artificial small pulmonary nodules in ex vivo porcine lungs.

OBJECTIVE: The main purpose of this study was to investigate the reproducibility of computed tomography (CT)-based volumetric measurements of small pulmonary nodules. METHODS: We implanted 70 artificial pulmonary nodules in 5 ex vivo porcine lungs in a dedicated chest phantom. The lungs were scanned 5 times consecutively with multislice-CT (collimation 16 x 0.75 mm, slice thickness 1 mm, reconstruction increment 0.7 mm). A commercial software package was used for lesion volumetry. The authors differentiated between intrascan reproducibility, interscan reproducibility, and results from semiautomatic and postprocessed volumetry. RESULTS: Analysis of intrascan reproducibility revealed a mean variation coefficient of 6.2% for semiautomatic volumetry and of 0.7% for human adapted volumetry. For interscan reproducibility a mean variation coefficient of 9.2% and for human adapted volumetry a mean of 3.7% was detected. CONCLUSION: The presented volumetry software showed a high reproducibility that can be expected to detect nodule growth with a high degree of certainty.

Influence of various cell-detachment solutions on endothelial cells after catheter abrasion for prosthesis colonization prior to implantation.

We (1) evaluated the effectiveness of different media on the detachment of endothelial cells (ECs) from a catheter brush (Cragg thrombolytic catheter system) that was previously used for endothelial cell abrasion in 10 cm human umbilical vein (HUV) segments; (2) tested the practicability of endovascular catheter brush abrasion followed by EC detachment from the catheter brush, in vitro culture of harvested ECs, and finally endothelialization of a prosthesis; and (3) analyzed the defect created by the catheter brush in HUV segments after endovascular catheter abrasion. Best results in detachment of ECs from the catheter brush were obtained with a mixture of phosphate-buffered saline + 1% human albumin. EC vitality was time-dependent in the collected HUV segments postdelivery. Harvested EC viability decreased from (26.28 +/- 5.76)% (0-3 h postdelivery) to (17.29 +/- 4.56)% (after 4-8 h). ECs were easily cultured ex vivo within 2-3 weeks; seeded on nitinol stents, they grew to confluency and formed a monolayer on the stent surface (determined by scanning electron microscopy - SEM). Histological and SEM analysis of HUV segments that had undergone previous catheter brush abrasion revealed slight disruption of the intima but intact subintimal layers. Our findings indicate an advantageous method of capturing and culturing primary ECs for gene therapy or for the analysis and diagnosis of certain blood vessel diseases, especially in cases in which endovascular intervention is performed anyway. Moreover, and of high relevance to the biomaterial field, theoretically the procedure could be used to endothelialze a prosthesis ex vivo for implantation into the patient from whom the ECs were harvested, to reduce the inherent thrombogenicity of the prosthesis.

Value of fat-suppressed PD-weighted TSE-sequences for detection of anterior and posterior cruciate ligament lesions--comparison to arthroscopy.

OBJECTIVE: To evaluate fat-suppressed (FS) proton-density-weighted (PDw) turbo spin-echo (TSE) magnetic resonance imaging for the detection of anterior and posterior cruciate ligament lesions in comparison to arthroscopy. MATERIALS AND METHODS: In a prospective study 31 knee joints were imaged on a 1.5T MR scanner (Vision, Siemens, Erlangen) prior to arthroscopy using following sequences: (a) sagittal FS-PDw/T2w TSE (TR/TE: 4009/15/105 ms); (b) sagittal PDw/T2w TSE (TR/TE:3800/15/105 ms). Further imaging parameters: slice thickness 3mm, FOV 160 mm, matrix 256 x 256. A total of 62 anterior and posterior cruciate ligaments (ACL/PCL) were evaluated, standard of reference was arthroscopy. Sensitivity, specificity, positive (ppv) and negative predictive value (npv) and accuracy were calculated. RESULTS: Twenty-one cruciate ligament ruptures were detected in arthroscopy, 19 ACL- and 2 PCL-ruptures (on MRI 34/124, 25/62 ACL, 9/62 PCL lesions). For all four sequences in the 31 patients with arthroscopic correlation sensitivity, specificity, ppv, npv and accuracy were 86%, 98%, 95%, 93% and 94% for detection of tears, and 84%, 100%, 100%, 80% and 90% for ACL-ruptures respectively. The two PCL-ruptures were true positive in all sequences, one intact PCL was diagnosed as torn (false positive). CONCLUSIONS: Fat-suppressed PDw/T2w TSE-MR sequences are comparable to PDw TSE sequences for the detection of ACL/PCL-lesions.

Peripheral arterial applications of percutaneous mechanical thrombectomy.

Various devices have been introduced for the purpose of percutaneous mechanical thrombectomy (PMT). These devices show promise as a valuable treatment option in acute arterial thrombotic occlusions, in addition to the gold-standard surgical method, the Fogarty balloon embolectomy, and local fibrinolysis therapy. Local fibrinolytic therapy cannot be used in the presence of contraindications, and can be time-consuming in limb threatening situations. Surgical intervention can also result in intimal vessel wall injury and is of limited value in infrageniculate occlusions. In this review, currently available PMT devices for peripheral arterial applications will be introduced, and their advantages, drawbacks and finally the reported clinical experience with these devices will be presented.

CT fluoroscopy-guided lung biopsy with novel steerable biopsy canula: ex-vivo evaluation in ventilated porcine lung explants.

The purpose was to evaluate ex-vivo a prototype of a novel biopsy canula under CT fluoroscopy-guidance in ventilated porcine lung explants in respiratory motion simulations. Using an established chest phantom for porcine lung explants, n = 24 artificial lesions consisting of a fat-wax-Lipiodol mixture (approx. 70HU) were placed adjacent to sensible structures such as aorta, pericardium, diaphragm, bronchus and pulmonary artery. A piston pump connected to a reservoir beneath a flexible silicone reconstruction of a diaphragm simulated respiratory motion by rhythmic inflation and deflation of 1.5 L water. As biopsy device an 18-gauge prototype biopsy canula with a lancet-like, helically bended cutting edge was used. The artificial lesions were punctured under CT fluoroscopy-guidance (SOMATOM Sensation 64, Siemens, Erlangen, Germany; 30mAs/120 kV/5 mm slice thickness) implementing a dedicated protocol for CT fluoroscopy-guided lung biopsy. The mean-diameter of the artificial lesions was 8.3 +/- 2.6 mm, and the mean-distance of the phantom wall to the lesions was 54.1 +/- 13.5 mm. The mean-displacement of the lesions by respiratory motion was 14.1 +/- 4.0 mm. The mean-duration of CT fluoroscopy was 9.6 +/- 5.1 s. On a 4-point scale (1 = central; 2 = peripheral; 3 = marginal; 4 = off target), the mean-targeted precision was 1.9 +/- 0.9. No misplacement of the biopsy canula affecting adjacent structures could be detected. The novel steerable biopsy canula proved to be efficient in the ex-vivo set-up. The chest phantom enabling respiratory motion and the steerable biopsy canula offer a feasible ex-vivo system for evaluating and training CT fluoroscopy-guided lung biopsy adapted to respiratory motion.

Percutaneous tissue-engineered pulmonary valved stent implantation.

PURPOSE: The purpose of this study was to evaluate the feasibility of percutaneously implanted tissue-engineered valved stents in the ovine pulmonary valve position. DESCRIPTION: Porcine pulmonary heart valves and small intestinal submucosa were obtained from a slaughterhouse, and the intestinal submucosa used to cover the inside of the porcine pulmonary valved stents. Endothelial cells and autologous myofibroblasts were obtained from carotid artery segments of juvenile sheep. After myofibroblast seeding, constructs were placed in a dynamic bioreactor system and were cultured for 16 days. After Endothelial cell seeding, the tissue-engineered valved stents were deployed into the pulmonary valve annular site. Angiography was performed at implantation and explantation (4 weeks). Constructs were analyzed macroscopically and microscopically. EVALUATION: Orthotopic positioning of the stents (n = 3) at the time of implantation and explantation, as well as normal valve function, was observed through angiography. Gross morphology confirmed excellent opening and closing of all leaflets. Strong expression of alpha-smooth muscle actin in neointerstitial cells and of von-Willebrand-Factor in endothelial cells was revealed by immunocytochemistry. CONCLUSIONS: This study demonstrates successful merging of two novel technologies: (1) percutaneous valved stent implantation and (2) tissue engineering of autologous heart valves.

Final results of the protected superficial femoral artery trial using the FilterWire EZ system.

The purpose of this study was to evaluate the safety and efficacy of debris-capture for distal protection using the FilterWire EZ Embolic Protection System (Boston Scientific, Mountain View, CA) with the additional aim to further define the incidence of distal embolization during superficial femoral artery (SFA) interventions. A prospective, single-centre registry was designed to evaluate the performance of the FilterWire EZ in capturing debris during standard SFA percutaneous intervention. The PRO-RATA study included 30 patients suitable for PTA (Fontaine IIb to III or Rutherford I to II classification). The primary end points were occurrence of distal embolization or decreased runoff, improvement in ankle-brachial index ankle-brachial index (ABI) after the procedure, and number of filters containing emboli. Secondary end points included major adverse events (i.e., procedure- or device-related death and/or clinical target lesion revascularisation), device delivery, deployment success, and incidence of embolic recovery (patients with device success exhibiting embolic protection in the filter). Procedural success was determined as ≤30% residual stenosis with no worsening of distal runoff as determined on angiography. A total of 29 patients (age 66.2 ± 12 years; total no. of limbs = 30; total no. of lesions = 30) suitable for PTA were enrolled in the study between February 2007 and March 2008. There were 26 patients with claudication (Fontaine IIB) and 3 patients with stage IV peripheral vascular disease. In one patient, lesions in both legs were treated. No procedural or device-related complications occurred. The average degree of stenosis was 86 ± 7%. Stenosis length ranged from 8 to 88 mm. The average degree of residual stenosis was 10 ± 10%. ABI improved from 0.56 ± 0.16 to 0.92 ± 0.19 (P < 0.05). No restenosis or dissection was seen at 1-month ultrasound follow-up. Macroscopic debris was found in 27 of 30 filters of all distal protection devices used in all 29 patients. Debris particle size ranged from 90 to 2000 µm (1200 ± 640). Histological debris analysis showed platelets, erythrocytes, inflammatory cells, extracellular matrix, and cholesterol as being the major components of emboli. Additional immunochemistry showed no correlation between lesion morphology and debris components. The FilterWire EZ is easy and safe to handle. The system caused no complications. In all cases, macroscopic debris was captured. Using a distal protection device during femoropopliteal interventions has the potential to prevent migration of debris, which may be important for high-risk patients with limited distal runoff.

Percutaneous intraluminal recanalization of long, chronic superficial femoral and popliteal occlusions using the Frontrunner XP CTO device: a single-center experience.

The purpose of this study was to examine the safety and efficacy of the Frontrunner XP CTO (chronic total occlusion) Catheter (Cordis) for recanalization of long femoropopliteal artery occlusions. A Frontrunner catheter was used to treat 26 CTOs in SFA after guidewire failure (68.3 +/- 8.8 years). Sixty-seven percent of patients had severe claudication. Critical lower limb ischemia with rest pain or minor tissue loss was present in three and eight patients, respectively. All the lesions were considered complex (TASC B, C, and D); 68% of the lesions were heavily calcified. The mean lesion length was 17.6 cm (range, 10-42 cm). The initial attempt to cross the occlusion with the CTO guidewire V18 was unsuccessful in 26 of 76 limbs (34.26%). A secondary attempt using the Frontrunner catheter (crossover approach, 27%; antegrade, 73%) performed in all 26 failed cases was successful in 17 limbs (65.38%), increasing the technical success rate to 88.12%. The main reasons for failure with the Frontrunner were inability to cross the lesion due to heavy calcification (six of nine) and inability to re-enter the true lumen after subintimal passage of the occluded segment (three of nine). The mean fluoroscopy time was 22.9 min. Minor complications included one distal extension of the dissection with involvement of the first popliteal segment and one perforation in the occluded segment. No major complications were seen. In conclusion, recanalization with the Frontrunner CTO catheter is a simple and safe method with a high technical success rate in the endovascular treatment of long superficial femoral artery occlusions and should be an alternative method after guidewire failure.

Leash your guiding catheter: or how to obtain a stable catheter position for crossover iliac embolization procedures.

We present a safe and quick technique for crossover embolization procedures of the internal iliac artery with high-profile guiding catheter systems, after a pull-through maneuver with establishment of a crossover catheter-snare system. The attached snare is used to stabilize and direct the guiding catheter.

Reduction of cerebral embolization in carotid angioplasty: an in-vitro experiment comparing 2 cerebral protection devices.

PURPOSE: To evaluate the efficiency of 2 distal filtration devices designed for cerebral protection during carotid angioplasty in an in-vitro bench-top model. METHODS: After positioning the respective protection devices (RX Accunet and DynaCap) 5 cm distal to the bifurcation, embolization from carotid angioplasty was simulated by injecting polyvinyl alcohol particles in groups of small (150 to 250-microm diameter, approximately 500 particles), medium (250 to 355-microm diameter, approximately 200 particles), and large (700 to 1000-microm diameter, approximately 80 particles). Five milligrams of each group were injected separately into the internal carotid artery (ICA) model proximal to the protection filters. Particles passing the protection devices were caught in 100-microm filters and weighed. RESULTS: For small particles, the amount in the effluent of the ICA was 0.34+/-0.12 mg (6.8%) for the RX Accunet and 0.51+/-0.16 mg (11.2%) for the Occam DynaCap (p<0.05). For the other particle sizes, there was no statistical difference between the filters (p>0.05). CONCLUSION: In all test runs, neither of the tested devices prevented embolization completely, with approximately 3% to 6% of particles penetrating. For small particles, the lowest amount of particles passing the protection device was achieved using the RX Accunet system.