Effect of late prophylaxis in hemophilia on joint status: a randomized trial.

Essentials High-quality data are lacking on use of prophylaxis in adults with hemophilia and arthropathy. SPINART was a 3-year randomized clinical trial of late/tertiary prophylaxis vs on-demand therapy. Prophylaxis improved function, quality of life, activity and pain but not joint structure by MRI. Prophylaxis improves function but must start before joint bleeding onset to prevent arthropathy. SUMMARY: Background Limited data exist on the impact of prophylaxis on adults with severe hemophilia A and pre-existing joint disease. Objectives To describe 3-year bleeding, joint health and structure, health-related quality-of-life (HRQoL) and other outcomes from the open-label, randomized, multinational SPINART study. Patients/Methods Males aged 12-50 years with severe hemophilia A, ≥ 150 factor VIII exposure days, no inhibitors and no prophylaxis for > 12 consecutive months in the past 5 years were randomized to sucrose-formulated recombinant FVIII prophylaxis or on-demand therapy (OD). Data collected included total and joint bleeding events (BEs), joint structure (magnetic resonance imaging [MRI]), joint health (Colorado Adult Joint Assessment Scale [CAJAS]), HRQoL, pain, healthcare resource utilization (HRU), activity, and treatment satisfaction. Results Following 3 years of prophylaxis, adults maintained excellent adherence, with a 94% reduction in BEs despite severe pre-existing arthropathy; 35.7% and 76.2% of prophylaxis participants were bleed-free or had fewer than two BEs per year, respectively. As compared with OD, prophylaxis was associated with improved CAJAS scores (least squares [LS] mean, - 0.31 [n = 42] versus + 0.63 [n = 42]) and HAEMO-QoL-A scores (LS mean, + 3.98 [n = 41] versus - 6.00 [n = 42]), less chronic pain (50% decrease), and approximately two-fold less HRU; activity, Euro QoL-5D-3L (EQ-5D-3L) scores and satisfaction scores also favored prophylaxis. However, MRI score changes were not different for prophylaxis versus OD (LS mean, + 0.79 [n = 41] versus + 0.96 [n = 38]). Conclusions Over a period of 3 years, prophylaxis versus OD in adults with severe hemophilia A and arthropathy led to decreased bleeding, pain, and HRU, better joint health, activity, satisfaction, and HRQoL, but no reduction in structural arthropathy progression, suggesting that pre-existing joint arthropathy may be irreversible.

The effectiveness of the paclitaxel-coated Luminor® balloon catheter versus an uncoated balloon catheter in superficial femoral and popliteal arteries in preventing vessel restenosis or reocclusion: study protocol for a randomized controlled trial.

BACKGROUND: The aim of this investigator-initiated trial is to evaluate the safety and efficacy of the novel Luminor® paclitaxel-coated drug-eluting balloon (DEB) catheter (iVascular, S.L.U., Barcelona, Spain) in inhibiting restenosis and in ensuring long-term vascular patency. METHODS/DESIGN: This is a multicenter randomized controlled trial to evaluate the Luminor® paclitaxel-coated DEB catheter for stenotic or occlusive lesions (length ≤15 cm) in the superficial femoral artery (SFA) and the popliteal artery (PA) up to the P1 segment compared to the noncoated, plain old balloon angioplasty (POBA) catheter. In total 172 subjects will be treated with either the DEB catheter or the POBA catheter in 11 German study centers in a 1:1 randomization study design. The primary endpoint is late lumen loss (LLL) at 6 months. Secondary endpoints are patency rate, target lesion/vessel revascularization, quality of life (assessed with the Walking Impairment Questionnaire (WIQ) and the EQ-5D), change of Rutherford stage and ankle-brachial index, major and minor amputation rate at the index limb, number of dropouts and all-cause mortality. DISCUSSION: EffPac represents a randomized controlled trial that will provide evidence on the effectiveness of the Luminor® paclitaxel-coated DEB catheter for the reduction of restenosis compared to the POBA catheter for the SFA and the PA. The results of EffPac will allow direct comparison to other already-completed RCTs applying paclitaxel-coated DEBs from different manufacturers with different coating technologies in the same target vessel. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02540018 , registered on 17 August 2015. Protocol version: CIP Version Final04, 11 February 2016. EUDAMED No: CIV-15-03-013204.

What are the potential limitations of drug coated balloons (DCBs) and possible ways to overcome.

In several independent randomized clinical studies, it has been shown that DCBs cause persistent clinically meaningful and statistically significant inhibition of restenosis in femoropopliteal arteries in comparison to percutaneous transluminal angioplasty with uncoated balloon catheters (1-6). The potential benefits of delivering an antiproliferative drug into the vessel wall using a balloon as transporter are manifold: • Widespread applicability: Balloon angioplasty is suitable for use in a wide range of lesions. The use of DCBs is technically less demanding and offers greater flexibility compared with stenting techniques. • Maintaining options: Minimizing the use of durable implants is providing more options for following and complementary revascularization procedures. • Proven Efficacy: Consistent, positive outcomes across studies and key subgroups have been demonstrated from the first preclinical studies to ongoing clinical trials Beside the enthusiasm carried along with this novel technique and questioning if DCBs will become standard-of-care-therapy for the superficial femoral artery (SFA), the potential limitations have to be discussed.

Plasma levels following application of paclitaxel-coated balloon catheters in patients with stenotic or occluded femoropopliteal arteries.

PURPOSE: Paclitaxel-coated balloon catheters inhibit restenosis after coronary and peripheral angioplasty (PCI,PTA). The aim of this study was to investigate paclitaxel plasma levels and laboratory parameters following PTA with paclitaxel-coated balloons (PCB) in peripheral arteries. MATERIALS AND METHODS: This single treatment arm, multicenter study included 14 patients with Rutherford stage 1 - 5 with occlusions of up to 5 cm or ≥ 70 % diameter stenosis of the superficial femoral or popliteal arteries (SFA, PA). PTA was performed using up to three PCB catheters. The paclitaxel plasma levels and safety laboratory parameters were determined by collecting blood samples pre-intervention, immediately post-intervention, at 0.5, 1, 2, 4, 8, 24 hours and 1 and 4 weeks post-intervention (p. i.). Vital signs were monitored to assess clinical safety. RESULTS: PTA was performed successfully in all patients. Paclitaxel plasma levels were always below a level and duration known to cause systemic side effects. A mean peak paclitaxel plasma level (40 ng/ml) was reached immediately p. i. and decreased rapidly below detectable levels in more than half of the patients already 2 hours p. i. The paclitaxel plasma concentrations returned to values below detectable levels at 24 hours p. i. in all patients. Laboratory parameters and vital signs did not give any reason for safety concerns. No adverse events associated with balloon coating were observed. CONCLUSION: The results of 14 patients with peripheral arterial occlusive disease show no systemic bioavailability of paclitaxel > 24 hours after PTA with one or more PCB catheters, indicating that the PCB catheter is safe with regard to possible systemic effects.

[Periinterventional prophylactic antibiotics in radiological port catheter implantation]. / Periinterventionelle prophylsktische Antobiotikagabe bei der radiologischen Portkatheterimplantation.

PURPOSE: To evaluate whether catheter-related infections after radiologically placed port catheters can be reduced by single-shot periinterventional antibiosis. MATERIALS AND METHOD: Between January and September 2002, 164 consecutive patients with indication for central venous port catheter implantation were included in the present study. During implantation the interventional radiologist was responsible for deciding whether to administer a prophylactic single-shot antibiosis. The prophylactic antibiosis entailed intravenous administration of ampicillin and sulbactam (3 g Unacid, Pfizer) or 100 mg ciprofloxacine (Ciprobay, Bayer) in the case of an allergy history to penicillins. Catheter-related infection was defined as a local or systemic infection necessitating port catheter extraction. RESULTS: Indication for port catheter implantation was a malignant disease requiring chemotherapy in 158 cases. The port catheter (Chemosite [Tyco Healthcare] [n = 123], low-profile [Arrow International] [n = 35], other port system [n = 6]) was implanted via sonographically guided puncture of the right jugular vein in 139 patients, via the left jugular vein in 24 cases and via the right subclavian vein in one patient. 75 patients received periinterventional prophylactic antibiosis (Unacid [n = 63] Ciprobay [n = 12]) and 89 patients did not receive antibiosis. The prophylactic antibiosis caused a minor allergic reaction in one patient that improved with antihistamic and corticoid medication. A total of 7 ports, 6 without prophylactic antibiosis versus one with periinterventional prophylaxis, were extracted due to infectious complications. CONCLUSION: Single-shot periinterventional prophylactic antibiosis can reduce early and late infectious complications after radiological-interventional placement of central venous port catheters.

Thermoablation of liver metastases: efficacy of temporary celiac plexus block.

PURPOSE: To determine the efficacy of celiac plexus block during thermoablation of liver metastases. METHODS: Fifty-five consecutive patients underwent thermoablation therapy of liver tumors by laser-induced thermotherapy. Twenty-nine patients received a temporary celiac plexus block, 26 patients acted as control group. In both groups fentanyl and midazolam were administered intravenously upon request of the patient. The duration of the intervention, consumption of opiates, and individual pain sensations were documented. RESULTS: No complications resulting from the celiac plexus block were recorded. Celiac plexus block significantly reduced the amount of pain medication used during thermoablation therapy of liver tumors (with block, 2.45 mug fentanyl per kg body weight; without block, 3.58 mug fentanyl per kg body weight, p < 0.05; midazolam consumption was not reduced) in patients with metastases < or = 5 mm from the liver capsule. For metastases farther away from the capsule no significant differences in opiate consumption were seen. Celiac plexus block reduced the time for thermoablation significantly (178 min versus 147 min, p < 0.05) no matter how far the metastases were from the liver capsule. Average time needed to set the block was 12 min (range 9-15 min); additional costs for the block were marginal. As expected (as pain medications were given according to individual patients' needs) pain indices did not differ significantly between the two groups. CONCLUSION: In patients with liver metastases < or = 5 mm from the liver capsule, celiac plexus block reduces the amount of opiates necessary, simplifying patient monitoring. In addition celiac plexus block reduces intervention time, with positive effects on overall workflow for all patients.

Treatment of long superficial femoral artery occlusions with excimer laser angioplasty: long-term results after 48 months.

PURPOSE: To evaluate clinical and hemodynamical long-term results after laser angioplasty of long occlusions of the superficial femoral artery (SFA). MATERIAL AND METHODS: In a prospective trial of 452 patients with long occlusions of the SFA, excimer percutaneous transluminal laser angioplasty (PTLA) for recanalization was applied. The average occlusion length of the SFA was 25.5 cm (range 16-38 cm). The recanalization attempt was done with the crossover technique in 398 patients, in 36 patients with the antegrade technique and in another 18 patients with the transpopliteal technique. RESULTS: The application of laser angioplasty demonstrated a successful recanalization of the SFA in 386/452 patients (85.5%). Recanalization with PTLA was not possible in 66 patients (14.5%). The main reason for the unsuccessful PTLAs was obstructing calcified material (n = 28) resistant to PTLA application. After a follow-up period of 48 months there was a primary, primary-assisted, and secondary patency rate of 22.3%, 40.9%, and 43.2%, respectively. CONCLUSION: Laser angioplasty of long occlusions of the SFA is a feasible procedure with a low failure rate. Long-term results are promising, but additional interventions are required in most patients if a patency rate of 43.2% is to be achieved after 4 years.

Comparison of indirect CsI/a:Si and direct a:Se digital radiography. An assessment of contrast and detail visualization.

PURPOSE: To assess and quantify the image quality at two dose levels for an amorphous Silicon (a:Si) Cesium Iodide (CsI) flat panel system compared with a direct amorphous Selenium (a:Se) digital radiography system. MATERIAL AND METHODS: A contrast detectability test was performed employing the CDRAD-phantom at mAs-values leading to approximately equal phantom entrance doses of 41.4, 57.9, 75.1 and 120.8 micro Gy for the a:Se and 39.9, 58.4, 75.6 and 117.9 micro Gy for the CsI system. Images were presented to 4 independent observers. For quantitative comparison, the image quality figure (IQF) was calculated. Statistical analysis was performed using Pearson's correlation and the Wilcoxon test. A ROC-analysis was performed employing the TRG-phantom in a high- and a low-dose setting leading to entrance doses of 126.2 and 35 micro Gy for the direct, and 125.9 and 34.4 micro Gy for the indirect system. Statistical significance was evaluated using the Wilcoxon test. RESULTS: The flat panel a:Si digital system provided superior results compared with the a:Se drum digital system with respect to low-dose settings for CDRAD-phantom and ROC-analysis, ensuring a better image quality with respect to contrast and detail detectability. Higher-dose settings provided similar results for both systems. CONCLUSION: Image quality of a:Si flat panel digital radiography proved to be superior to a:Se drum digital radiography using low-dose settings. If the primary target is dose reduction indirect flat panel technology should be used.

[Extracapsular spread of cervical lymph node metastases: diagnostic relevance of ultrasound examinations]. / Kapseldurchbrüche zervikaler Lymphknotenmetastasen: Diagnostischer Stellenwert der Sonographie.

OBJECTIVE: Assessment of the value of ultrasound examination in the determination of extracapsular neoplastic infiltration and soft tissue infiltration of cervical lymph nodes. MATERIAL AND METHODS: In a prospective study the results of ultrasound studies in 110 patients with squamous cell carcinoma in the head-neck region were compared with the findings of the histologic examination after neck dissection. RESULTS: Ultrasound examination showed a specificity of 81.8 % in the determination of extracapsular neoplastic infiltration. The sensitivity was only 78.6 % - this was mainly caused by microscopic extracapsular growth, which gave false-negative results. Infiltration of blood vessels were identified in all patients. There was only one false negative diagnosis of muscle infiltration. CONCLUSION: The specificity (81.8 %) and sensitivity (78.6 %) of ultrasound examinations in the diagnosis of extracapsular infiltration in patients with lymph nodes metastasis is promising. But the examiner has to keep in mind that especially microscopic extracapsular neoplastic infiltration cannot be seen in ultrasound.

Short (1-10 cm) superficial femoral artery occlusions: results of treatment with excimer laser angioplasty.

PURPOSE: To evaluate the safety and long-term results after laser angioplasty of short occlusions of the superficial femoral artery (SFA). METHODS: In a prospective trial in 312 patients with short occlusions of the SFA excimer laser angioplasty for recanalization was applied. The average occlusion length of the SFA was 7.5 cm (range 1-10 cm). The recanalization attempt was done using either a cross-over technique from the contralateral femoral artery (278 patients), antegrade technique (16 patients) or transpopliteal technique (18 patients). RESULTS: Percutaneous transluminal laser angioplasty (PTLA) produced successful recanalization of the SFA in 286 of 312 patients (91.7%). In 26 patients (8.3%) recanalization was not possible. The reason for the unsuccessful PTLAs was obstructing calcified materialn = 8) which was resistant to laser application. In nine cases obstructing calcifications resulted in positioning of the laser catheter in subintimal tissue or perforation of the SFA. In another four patients there was an aberrant anatomy of the SFA which resulted in a direct vessel injury after advancing the laser catheter. In five patients subintimal recanalization failed. After a follow-up period of 36 months there was a primary, primary assisted and secondary patency rate of 49.2%, 76.5% and 86.3%. CONCLUSION: Excimer laser angioplasty of short occlusions of the SFA is a feasible procedure with a low failure rate. Long-term results are promising but additional interventions are required in most patients to achieve a patency rate of 86.3% after 3 years. Further studies are needed to compare the clinical outcome of PTLA and PTA in short occlusions of the SFA.

[System continuity and energy distribution in laser-induced thermo therapy (LITT)]. / Systemkonstanz und Energieverteilung bei Laser-induzierter interstitieller Thermotherapie (LITT).

PURPOSE: Evaluation of the continuity and energy distribution of a laser system for laser-induced thermo therapy. MATERIAL AND METHODS: For evaluation of the continuity of laser optical devices, laser generating units and optical fibers of three different manufactures (Dornier, Hüttinger, Somatex), we used the equipment to generate a laser beam of 25 Watt for 60 minutes. Measurements of the applied energy were done sequentially with two MY Test (Fa. Hüttinger) units. We also performed two in vitro ablations of animal liver tissue with different fiber optics [Mikrodom A 13-0540, Microflexx REF A 13-0561 (Hüttinger), Diffusor-Tip H-6111-T 3, Diffusor H-6111-T 4 (Dornier), Somaflex-Diffusor (Somatex)] over 20 minutes at- an energy flow of 25 J per second. We then evaluated the geometry of coagulation. RESULTS: The different equipment used for our tests showed differences of a maximum of 10 %. Some components did not work properly in certain configurations even though the manufacturer assured it would. We saw significant differences in the ablation characteristics of the different fiber optics, especially in axial and frontal directions. CONCLUSION: Knowledge of the different characteristics in energy distribution and ablation characteristics are an important factor in performing a successful laser-induced thermo therapy.

[Extracapsular spread of cervical lymph node metastases: Diagnostic value of magnetic resonance imaging]. / Kapseldurchbrüche zervikaler Lymphknotenmetastasen: Diagnostischer Stellenwert der Magnetresonanztomographie.

OBJECTIVE: Assessment of the value of magnetic resonance tomography in the determination of extracapsular neoplastic spread and soft tissue infiltration of cervical lymph nodes. MATERIALS AND METHODS: The results of magnetic resonance tomographies of 110 patients with squamous cell carcinoma in the head-neck region were prospectively compared with the findings of the histologic examination after neck dissection. RESULTS: Magnetic resonance tomography reaches a specificity of 72.2 % in the detection of extracapsular neoplastic spread. The sensitivity of the method is 74.4 %. Mainly small (less than 1 cm; n = 11) extracapsular growth was not detected and was diagnosed false-negative in the MRI examinations. CONCLUSION: The specificity (72.2 %) and sensitivity (74.4 %) of MRI examinations to detect extracapsular spread of lymph nodes is only partially satisfying.

Stent placement in short unilateral iliac occlusion. Technique and 24-month results.

PURPOSE: To determine the success rate and 24-month follow-up results of primary stent implantation for reconstruction of unilateral short iliac occlusion involving the aortic bifurcation. MATERIAL AND METHODS: In 90 patients attempts of percutaneous transluminal recanalization of a short unilateral occlusion of the iliac arteries were performed. In 72/90 patients, the treatment was successful. Stent implantation was performed after recanalization in all 72 patients. Pre-interventional angiography of successfully treated patients showed unilateral occlusions and contralateral stenosis in 34/72 patients. In 38/72 patients unilateral occlusion without contralateral stenosis was diagnosed. The recanalization of the common iliac artery obstructions were performed with a guidewire and excimer laser angioplasty. Totally 152 stents were used for the treatment of iliac occlusion. Standardized treadmill testing and color-coded Doppler ultrasound were performed before treatment and during the follow-up. RESULTS: In all patients, stents were placed successfully; 5 major and 7 minor complications were observed. A clinical improvement of +2 to +3 according to the American Heart Association criteria was observed in 62 and 10 patients, respectively. Angiographic control was performed after 1-30 months. The primary angiographic patency rate was 83.1%. Angiography revealed significant restenoses in 4 patients successfully treated with transluminal angioplasty, and re-occlusion in 6 patients which were referred to surgery. The patency rate after 24 months was 90.0%. CONCLUSION: Primary stent implantation is an effective treatment for short iliac obstructions and represents a true endovascular alternative to surgery.

Excimer laser-assisted recanalisation of femoral arterial stenosis or occlusion caused by the use of Angio-Seal.

The aim of this study was to demonstrate the effect of excimer laser and balloon angioplasty of femoral artery stenosis and occlusion after use of a haemostatic puncture closure device. A haemostatic puncture closure device (Angio-Seal) was used in 6000 patients after diagnostic or therapeutic artery catheterisation. In 34 of those patients symptoms of peripheral artery disease occurred. Sixteen of those 34 cases were transferred to our clinic for excimer laser angioplasty. All 16 patients presented with symptoms of acute peripheral artery disease within 1-14 days: superficial femoral artery (SFA) occlusions (4 cases); superficial femoral artery stenosis (3 cases); high-grade stenosis of the common femoral artery (CFA; 3 cases); high-grade stenosis of CFA; SFA and profund femoral artery (PFA; 3 cases); and occlusions of CFA, SFA and PFA (3 cases). Before any procedure was performed, informed consent was given by the patient, which included the use of the Angio-Seal closure device. Every patient who had to undergo recanalisation procedures gave additional informed consent which especially included the usage of the excimer laser for recanalisation. A measurement of the walking distance, ankle-brachial systolic pressure index (ABI) and diagnostic angiography was performed in 13 cases before and immediate after as well as 3 and 6 months after therapeutic percutaneous transluminal laser angioplasty followed by balloon angioplasty (PTLA/PTA). In 3 patients the risks of PTLA/PTA was considered too high; those patients underwent surgical repair. Angiographic and clinical improvement was achieved in 13 of 13 patients. The mean walking distance increased from 81 to > 400 m. The average ankle-brachial systolic pressure index (ABI) increased from 0.47 to 0.84. One patient developed a dissection of the SFA, and in 1 case a peripheral embolisation was seen. The PTLA/PTA technique is a successful therapeutic option for patients with femoral artery occlusion or high-grade stenosis after Angio-Seal application.

[Treatment of arterial traumas by the Wallgraft endoprosthesis]. / Behandlung von iliakalen Gefässverletzungen mittels der Wallgraft-Endoprothese.

PURPOSE: Percutaneous peripheral interventional procedures as well as coronary interventions can be complicated by dissections and traumatic lesions of peripheral arteries. The aim of this study was to evaluate the efficacy of treatment for traumatic peripheral arterial lesions. MATERIAL AND METHODS: In this study we used the Wallgraft-Endoprothesis (Boston Scientific, USA), which is a self-expanding covered stent. In 17 patients a total number of 24 endoprostheses (mean length 6.4 cm) were implanted in iliac arteries. Indications for stenting were large dissections (n = 9), arterial perforations (n = 4), aneurysms (n = 3), and stent in stent implantation (n = 2). RESULTS: An immediate exclusion of the lesion could be achieved in all cases. There were no major procedural complications. The primary patency after a mean follow-up of 18 months was 82.4% (14/17). Early reocclusion was seen in two cases, one stent in stent reocclusion and one reocclusion after acute stent thrombosis. In one other case the angiography revealed relevant restenosis (> 75%). The patency could be restored in one of these three cases leading to a secondary patency rate of 94.1%. CONCLUSIONS: The Wallgraft-Endoprotheses seems to be safe and effective to seal large dissections and traumatic lesions of peripheral arteries, showing a high long-term patency rate.

[Multi-slice spiral CT: 3D CT angiography for evaluating therapeutically relevant stenosis in peripheral arterial occlusive disease]. / Mehrschicht-Spiral-CT: 3D CT-Angiographie zur Evaluation therapeutisch relevanter Stenosen bei peripherer arterieller Verschlusskrankheit.

PURPOSE: Evaluation of 3D multislice CT angiography for the assessment of relevant stenoses of pelvic arteries and arteries of the lower extremity in patients with peripheral artery occlusive disease compared to digital subtraction angiography. METHOD/MATERIALS: For this study we examined 31 patients with peripheral artery occlusive disease. All patients received a multislice helical CT angiography and arterial digital subtraction angiography. Multislice CT angiography was performed with a Somatom Plus 4 Volume Zoom (Siemens, Erlangen, Germany). After test bolus injection of 20 ml Ultravist 370 (Schering AG, Berlin) additional 150 ml were applied with a flow rate of 3 ml/sec and a scan delay between 20-35 sec depending on individual blood circulation time. Collimation was 4 x 2.5 mm with a pitch of 6. Reconstructed slice thickness was 3 mm. 3D reconstructions of arteries of pelvic and lower extremity arteries were performed in volume rendering technique on a 3D Virtuoso workstation (Siemens, Erlangen). RESULTS: For the assessment of therapeutically relevant stenoses (over 50% reduction of luminal diameter) multislice CT achieved the following results compared to conventional angiography for the diagnosis of stenosis: sensitivity of 86%, specificity of 86% and an accuracy of 72%. CONCLUSIONS: Multislice helical CT angiography of pelvic arteries and arteries of the thigh represents a reliable means for the detection of relevant stenoses in patients with peripheral occlusive artery disease.

Treatment of postinterventional pseudoaneurysms by ultrasound-guided compression.

RATIONALE AND OBJECTIVES: This 3-year study was performed to evaluate the effectiveness and safety of ultrasound-guided compression (UGC) in the treatment of postinterventional pseudoaneurysms (PAs). METHODS: One hundred ten PAs were sonographically diagnosed after peripheral or cardiac interventions. In 98 patients (65 men and 33 women; age range, 44-79 years), UGC was performed. The PAs were related to the common femoral artery (n = 78), the superficial femoral artery (n = 26), the profound femoral artery (n = 2), and the distal external iliac artery (n = 4). The PAs showed diameters ranging from 0.8 to 9.86 cm (mean, 4.8 cm) and volumes between 0.6 and 109 mL (mean, 15.6 mL). Follow-up examinations including color Doppler-coded ultrasound and peripheral Doppler were performed after 18 hours +/-6 and 28 days +/-4. RESULTS: Complete closure of the PA and its neck was achieved by UGC in 96 of 98 cases (98%). In 86 of 98 cases (87.8%), UGC was successful during the first session; a second treatment was needed in 10 cases. The compression time varied from 12 to 85 minutes (mean, 35.6 minutes). Except for medically controllable vagal reactions in 4 of 98 cases (4.1%) and 1 easily controlled PA rupture, no treatment-related complications were observed. CONCLUSIONS: According to the effectiveness and safety results, we conclude that UCG is the method of choice in the treatment of postinterventional PAs. Diagnosis and UGC treatment should be performed as early as possible to minimize symptoms and hospitalization time.

Laser angioplasty of peripheral arteries after unsuccessful recanalization of the superficial femoral artery.

AIM: To demonstrate the range of applying laser angioplasty after unsuccessful recanalization of the superficial femoral artery (SFA) with conventional interventional techniques. MATERIALS AND METHODS: In a prospective trial in 94 cases with occlusion of the SFA and formerly unsuccessful conventional percutaneous transluminal angioplasty, laser angioplasty for recanalization was applied. The average occlusion length of the SFA was 17.5 cm (range 4-36 cm). The recanalization attempt was made using the crossover technique in 78 patients, in eight patients with the antegrade technique and in another eight patients using the transpopliteal technique. The primary recanalization attempt was performed with Terumo wires (curved and straight) as well as different catheters (Multipurpose/Vertebralis/Cobra). After the unsuccessful recanalization attempt the laser catheter was applied. RESULTS: The application of laser angioplasty demonstrated a successful recanalization of the SFA in 76/94 patients (80.9%). In 18 patients (19.1%) the recanalization was not possible even with percutaneous transluminal laser angioplasty (PTLA). The reason for the unsuccessful PTLA was in 10 cases due to obstructing calcified material, which was resistant to PTLA application. In four cases obstructing calcifications caused the laser catheter to be positioned in subintimal tissue, resulting in perforation of the SFA. In another four patients there was an aberrant anatomy of the SFA which resulted in a direct vessel injury after advancing the laser catheter. After a follow-up period of 12 months primary, primary-assisted and secondary patency rates were 50.0%, 65.8% and 73.7%, respectively. DISCUSSION: In primarily unsuccessful recanalization of the SFA, PTLA allows in 80% of cases a successful recanalization of the SFA. The technical success rate and the patency rate support the application of PTLA.