Balloon sacroplasty as a palliative pain treatment in patients with metastasis-induced bone destruction and pathological fractures.

PURPOSE: In the case of metastatic involvement of the sacrum with destruction and consecutive pathological fracture, intense disabling pain is one of the defining factors. The feasibility, safety and pain development with cement augmentation were to be investigated. MATERIALS AND METHODS: CT-guided balloon sacroplasty was conducted in 10 patients with metastasis-induced bone destruction of the sacrum. After establishment of the entry point, a K-wire was first introduced as far as the central tumor lesion via the short, or transiliac axis. A cannula was then positioned over the wire. Under CT guidance, a balloon catheter was introduced through the cannula and inflated and deflated several times. The PMMA cement was then injected into the preformed cavity. The procedure was completed by a spiral CT control using the thin-slice technique. Pain intensity was determined using a visual analog scale (VAS) before the procedure, on the 2nd postoperative day and 6 months after the intervention. Finally, the patients were asked to state how satisfied they were. RESULTS: Balloon sacroplasty was technically feasible in all patients. The control CT scan showed central distribution of the cement in the tumor lesion. On average 6 +/- 1.78 (4 - 10) ml of PMMA cement were introduced per treated lesion. A significant (p < 0.001) reduction in pain according to the VAS occurred in all patients from 9.3 +/- 0.67 (8 - 10) pre-operatively to 2.7 +/- 1.28 (1 - 5) on the 2nd postoperative day and 2.9 +/- 0.81 (2 - 5) 6 months after the intervention. All of the patients were re-mobilized after the procedure and underwent the further therapeutic measures as planned. CONCLUSION: Balloon sacroplasty is a helpful therapeutic option in the overall palliative treatment of patients with tumor-induced destruction. It is a safe and practicable procedure that markedly reduces disabling pain.

Single-phase percutaneous recanalization of malignant bile duct obstructions with a covered stent graft.

PURPOSE: The aim of this study was to evaluate the benefit of a percutaneous transhepatic biliary drainage (PTCD) endoprothesis in the case of patients with malignant occlusion of the common bile duct (CBD). MATERIALS AND METHODS: 32 patients (mean age 72 ±â€Š13 years) were treated with an endoprosthesis (VIABIL; M. L. GORE & ASSOCIATES, INC., USA) due to failed attempts of endoscopic retrograde cholangiopancreatography (ERCP) in the case of malignant occlusion of the CBD. RESULTS: The technical success rate was 96.9 %. In one patient the probing of an intrahepatic bile duct was impossible. Two major complications (bleeding, liver abscess) were successfully treated with appropriate measures. The bilirubin level did not significantly decrease immediately after intervention (13.2 ±â€Š6.5 mg/dl; p > 0.05). However, the follow-up displayed a highly significant decrease of bilirubin to 6.0 ±â€Š7.4 mg/dl; p < 0.05). The endoprosthesis was extended with bare metal NITINOL stents in 9 patients. The mean survival time of the patient group was 64 ±â€Š28 days (range 2 - 250  days). CONCLUSION: The implantation of an endoprosthesis proved to be an option with high technical success, a low complication rate and good benefit in our patients with malignant bile duct obstruction in palliative therapy situations. KEY POINTS: • The primary objective in the case of malignant bile duct obstruction is the treatment of jaundice.• After failed endoscopic recanalization of the bile ducts, transhepatic biliary drainage is desirable.• An ePTFE-FEP covered endoprothesis is a good treatment option in palliative situations.• A single-stage procedure shortens hospitalization time.

Percutaneous Vascular Closure System Based on an Extravascular, Bioabsorbable Polyglycolic Plug (ExoSeal): Results from 1000 Patients.

PURPOSE: The objective of this prospective study was to evaluate the effectiveness and safety of a percutaneous closure system based on a polyglycolic acid plug for achieving hemostasis. MATERIAL AND METHODS: In this study from 2011 to 2014, a percutaneous vascular closure system (ExoSeal) was used in 1000 patients (mean age 70.6 ± 10.2 years), using antegrade and retrograde techniques within the context of an angiographic intervention. The system was used in conjunction with transfemoral approaches with a sheath size of 6F. Post the intervention (on the following day and after 6 weeks), follow-up was conducted clinically and using color-coded duplex ultrasound. RESULTS: Immediate hemostasis was achieved in 939/1000 patients (93.9%). In the remaining 61 cases, a correct positioning of the polyglycolic acid plug was not possible because of malfunctioning of the device, massive vascular wall calcifications, postoperative scar tissue, or too steep a puncture angle. In these cases, manual compression was successful. There was one retroperitoneal bleeding requiring transfusion. Minor complications were observed (7.4% in total) with 10 pseudoaneurysm (1%), 63 inguinal hematomas (up to 3 cm; 6.3%), and 1 stenosis (0.1%). CONCLUSION: Safe and effective hemostasis is possible with the percutaneous ExoSeal closure system at puncture sizes of 6F.

Combination of rotational atherothrombectomy and Paclitaxel-coated angioplasty for femoropopliteal occlusion.

OBJECTIVE: The rotational atherothrombectomy with Straub Rotarex(®) is a safe and efficient treatment of acute/subactute vascular occlusions. The purpose of this study was to evaluate the benefit of paclitaxel-coated angioplasty after rotational atherothrombectomy over an observation period of six months. MATERIALS AND METHODS: Overall, 29 patients were treated with the Rotarex catheter in combination with paclitaxel-coated angioplasty. All patients had acute/subacute and chronic occlusions of the superficial femoral artery (SFA) and/or popliteal arteries. The ankle-brachial index (ABI) was detected before the intervention, after the procedure, and after six months. Also clinical examination and ultrasound scans were done in the observation period. RESULTS: There were no technical failures. The ABI shows a significant increase from 0.52 ± 0.17 to 0.91 ± 0.25 in the follow-up. By ultrasound examination, there were found two (6.9%) restenoses during the follow-up. There was one dissection during the intervention (3.5%). CONCLUSION: The rotational atherothrombectomy in combination with paclitaxel-coated angioplasty might be an effective and safe method with a promising low rate of restenosis at six months.

Reduction of radiation exposure for the examiner in angiography using a direct dosimeter.

PURPOSE: To evaluate whether a reduction in radiation exposure can be achieved using a direct dosimeter with an acoustic warning signal (model EDD-30, Unfors Instruments, Billdal, Sweden). MATERIALS AND METHODS: A total of 183 diagnostic and interventional angiographies of the pelvis and lower limbs using a direct dosimeter were analyzed. The vascular interventions were performed either by an experienced examiner (> 5000 interventions), an intermediate examiner (> 1000 interventions) or by a beginner (< 200 interventions). The measuring sensor of the direct dosimeter was attached to the back of the left hand, below the sterile glove, and was worn throughout the examination. If the limit values set on the dosimeter were exceeded, an acoustic signal sounded. At the end of the examination, the mean dose and the mean dose rate could be read off directly. RESULTS: Exposure is clearly dependent on the experience of the examiner. The highest mean dose rate was found for the beginner, followed by the intermediate examiner. The lowest dose rate was shown by the experienced examiner, even though he mostly performed complex interventions. Over the course of 3 months, an improvement in the average dose rate can be shown in the third month for the intermediate examiner. CONCLUSION: The use of a direct dosimeter with an acoustic warning signal is a practicable tool for sensitizing interventional radiologists to unavoidable radiation exposure, with the aim of reducing the dose. "Real-time" dosimetry represents a sensible extension of indirect protection of the radiation-exposed examiner in angiography.

Excimer laser atherectomy after unsuccessful angioplasty of TASC C and D lesions in femoropopliteal arteries.

AIM: The study objective was to examine the application of excimer laser atherectomy (ELA) in patients with refractory occlusions in femoropopliteal arteries, where the initial conventional percutaneous transluminal angioplasty (PTA) recanalization attempts, were unsuccessful. METHODS: The average age of the 40 patients (32 men, 8 women) included in this study was 65.4±9.1 years. The average occlusion length was 17.5 cm (range: 12-25 cm). The initial recanalization attempts were performed with stiff Terumo guidewires (curved or straight) supported by various catheters (straight/multipurpose/Cobra). After the unsuccessful attempt, an excimer laser catheter (catheter diameters from 1.7-2.5 mm) was used for recanalization using the step-by-step method of crossing. After successful crossing, balloon dilatation was performed in all cases. Stent implant was required in 10% (4/40) of procedures. Patients were followed for 12 months with colour-coded Duplex sonography (CCDS). RESULTS: The initial technical success rate of 90% (36/40) resulted in primary, primary-assisted and secondary-assisted patency rates of 58.9%, 67.8% and 83.2%, respectively, after 12 months. No serious complications occurred that were attributable to the intervention. CONCLUSION: According to these results, ELA recanalization provides a low stent rate alternative to surgical procedures for refractory occlusions. This would offer patients, with increased operative risks, a promising and low-risk therapeutic procedure. The option of a subsequent vascular operation would not be compromised.

[Clinical importance of CT-assisted sympathicolysis in primary, focal plantar and palmar hyperhidrosis]. / Klinische Bedeutung der CT-gestützten Sympathikolyse bei der primären, fokalen Hyperhidrosis plantaris et palmaris.

PURPOSE: The objective of this study was to evaluate the benefit of thoracic and lumbar computed tomographic-assisted sympathicolysis (CTSy) in patients with primary, focal hyperhidrosis. MATERIALS AND METHODS: Thoracic and/or lumbar CTSy was conducted on 101 patients (average age 37.5 ± 15.5 years) with primary, focal hyperhidrosis of the hands and/or feet, who experienced persistent symptoms after all conservative treatment options had been exhausted. The patients were divided into groups with palmar, palmoplantar and plantar hyperhidrosis. The patients evaluated the severity of their symptoms prior to the intervention and 2 days, 6 months and 12 months after the intervention using a Dermatology Quality of Life Index (DLQI) and side effects. RESULTS: The performed interventions led to a statistically significant decrease in the preinterventional severity of symptoms after the intervention (2 days), and 6 and 12 months after CTSy in the palmar, palmoplantar and plantar (p < 0.01) group. The technical success rate of CTSy was 100 %. No major complications occurred. Patients reported compensatory perspiration over the course of treatment, neuralgia and paraesthesia as side effects. The differentiated assessment of the strength of perspiration of the hands and feet showed statistically significant differences between the foot and hand region, whereby the decrease in sweat secretion of the feet was more significant and more lasting (p < 0.02). CONCLUSION: After conservative measures have been exhausted, CT-assisted sympathicolysis represents a therapeutic option with minimal side effects for patients with primary, focal hyperhidrosis.

Treatment of femoropopliteal stenoses and occlusions with mechanical rotational catheters: comparison of results with the Rotarex and Pathway devices.

AIM: For the treatment of chronic lesions, various ablative procedures have been developed with the aim of improving the outcome of percutaneous transluminal angioplasty (PTA)/stent and/or reducing the length and number of implanted stents by removing stenotic or occlusive material. The objective of this study was to compare two mechanical rotational catheters (Rotarex and Pathway) with regard to their safety and effectiveness in the treatment of stenoses and occlusions of the femoropopliteal arteries. METHODS: A total of 156 patients with chronic stenoses or occlusions of the femoropopliteal vasculature were treated, 114 of them with the Rotarex catheter and 42 with the Pathway catheter. The pre-interventional Rutherford classification was on average 3.32 (2-5) in the Rotarex group and 2.93 (2-5) in the Pathway group. The mean lesion length was 13.9 cm (2-30 cm) and 5.1 cm (1-10 cm), respectively (P<0.05). The Ankle-Brachial Index (ABI) was determined pre- and postinterventionally and after 12 months. Colour-coded duplex ultrasound was additionally performed as a follow-up. RESULTS: The technical success rate was 98.2 % in the Rotarex group and 97.6% in the Pathway group. In the Rotarex group, additional balloon dilatation was performed in 75 patients (65.8%) and stent implantation was necessary in 12 patients (10.5%). In the Pathway group, 27 patients (64.3%) underwent additional balloon dilatation and 5 (11.9%) stent implantation. Clinically, there was an increase in the ankle-brachial index from 0.59 to 0.84 ± 0.15 postinterventionally and 0.80 ± 0.16 12 months after Rotarex treatment, compared with an increase from 0.62 ± 0.14 to 0.84 ± 0.15 postinterventionally and 0.81 ± 0.12 12 months after Pathway treatment. In addition, there was a reduction in the Rutherford stage to 1.73 (1-3) and 1.43 (1-3), respectively. During the follow-up period, 21 (21.4%) restenoses occurred in the Rotarex group and 8 (19.0%) in the Pathway group. Peri-interventional complications included 7 dissections (4 after Rotarex, 3 after Pathway). Two distal embolisations were observed (both after Pathway). Throughout the entire duration of the study there were no amputations or fatalities. CONCLUSION: The atherectomy of lesions of the femoropopliteal arteries using the Rotarex and Pathway systems is safe. The low stent rate peri-interventionally and the low restenosis rate after 12 months, with a significantly longer lesion length, indicate a better effectiveness of the Rotarex system as a whole.

[Use of a percutaneous suture-mediated closure system after 6 - 8F transfemoral approaches: results for 2200 patients]. / Einsatz eines perkutanen Nahtverschlusssystems nach 6 - 8F transfemoralen Zugängen: Ergebnisse von 2200 Patienten.

PURPOSE: The safety and effectiveness of a percutaneous suture-mediated closure system for achieving hemostasis using a transarterial femoral approach were investigated. MATERIALS AND METHODS: A percutaneous suture closure system (Perclose/Proglide, Abbott Vascular, Redwood City, California) was used in 2200 patients (average age 67.5 ± 12.5 years) who had undergone an angiographic intervention. Vascular access sites (1331 retrograde, 869 antegrade) with a sheath size of between 6F and 8F were closed. Platelet aggregation was inhibited with 100 mg/d ASA and all patients additionally received 5000 IU heparin peri-interventionally. After application of the suture-mediated closure system and achievement of sufficient hemostasis, a light compression bandage was applied in all patients and 6 hours of bed rest were recommended. The puncture site of all patients was checked using color-coded duplex sonography post-interventionally (following day and after 6 weeks). RESULTS: Immediate hemostasis was achieved in 2103/2200 patients (95.6 %). In the remaining 97/2200 cases, correct development of the suture was not possible, because of calcifications. In such cases, hemostasis was achieved by manual compression. Major complications (0.4 %) involved 3 infections that required vascular surgical debridement with the use of an interposition graft. In addition, there were 5 cases of secondary bleeding requiring transfusion. Minor complications (15.6 %) involved 3 (0.14 %) pseudoaneurysms, 256 (11.6 %) groin hematomas (up to max. 3 cm) and 85 (3.9 %) palpable suture granulomas. CONCLUSION: At a puncture size of 6 - 8F, safe and effective hemostasis is possible with the percutaneous suture-mediated closure system.

[Interventional pain relief using balloon-kyphoplasty in patients with osteoporotic-based fatigue fractures of the os sacrum]. / Interventionelle Schmerztherapie mittels Ballon-Kyphoplastie bei Patienten mit osteoporosebedingten Insuffizienzfrakturen des Os sacrum.

PURPOSE: In older patients with reduced bone quality, fatigue fractures of the os sacrum are relatively common and are typically accompanied by strong, disabling pain. The aim of our study was to verify the feasibility and safety of sacroplasty using a balloon catheter as well as the reduction of pain. MATERIALS AND METHODS: 25 patients were diagnosed with an os sacrum fracture in MRI. As a manifestation of an extant bone reconstruction process, all patients were diagnosed with distinctive edema on the basis of MRI strong T 2-weighted images. CT-controlled balloon sacroplasty was performed in all patients. To allow the cement to be dispensed at a longitudinal angle to the fracture, the balloon catheter is directed through a hollow needle in the os sacrum either from the caudal to the cranial direction or from the craniodorsal to the caudoventral direction. The thus created cavity was then filled with PMMA cement. A control CT and a conventional X-ray in two planes were then carried out. The pain intensity was defined by means of VAS before the intervention, on the second day, and 6 and 12 months after the intervention. RESULTS: The balloon sacroplasty yielded good technical performance in every patient. The control CT and the X-ray control of the os sacrum showed adequate distribution of the cement, and cement leakage was not detected. Before the operation, the average pain encountered was in accordance with VAS 8.3. On the second postoperative day, a considerable reduction with an average of 2.7 was reported, and this remained stable with an average of 2.5 after 6 and 12 months. CONCLUSION: Balloon sacroplasty is an effective treatment method for fast pain relief in patients with fatigue fractures of the os sacrum.