Multicenter Randomized Controlled Trial of APERTO-Paclitaxel Drug-Eluting Balloon Angioplasty Versus Standard Percutaneous Transluminal Angioplasty in Dysfunctional Hemodialysis Grafts and Native Fistulae.

PURPOSE: to assess the safety and efficacy of APERTO-Paclitaxel-coated balloon angioplasty versus standard angioplasty for the treatment of dysfunctional hemodialysis shunts and native arteriovenous fistulae. METHODS: consecutive patients with dysfunctional dialysis related to underlying efferent vein stenosis were included and randomized 1:1 to either APERTO-paclitaxel drug-coated balloon (study arm) or standard percutaneous transluminal angioplasty (control arm). Primary endpoint is time from treatment until dialysis access dysfunction according to standardized Kidney Disease Outcomes Quality Initiative (KDOQI)-guidelines and assessed by Kaplan-Meier survival curves and tested for significance with log-rank analysis. Secondary endpoints include device, technical, and clinical success of the index angioplasty procedure. RESULTS: The study included 103 patients (n=51 study-group) with a de novo (n=33) dysfunctional native arteriovenous fistula (n=79) in the forearm (n=60). The majority of included patients were male with a mean age of 69.8 years, presenting with a dysfunctioning autologous arteriovenous fistula in the forearm. Device-related complications did not occur in any of the included patients. Functional hemodialysis access without need for re-intervention at 1 year after index procedure was found in n=10 (19.6%) and n=5 (9.6%) of patients treated with, respectively, paclitaxel drug-coated balloon and percutaneous transluminal angioplasty (p=0.612). A nonsignificant benefit of paclitaxel drug-coated balloon (n=5; 25%) over percutaneous transluminal angioplasty (n=1; 11%) was found (p=0.953) in de novo lesions in autologous fistulas. CONCLUSION: APERTO-paclitaxel drug-coated balloon is a safe balloon catheter to manage dysfunctional hemodialysis access; however, longer period of adequate hemodialysis circuit functioning after endovascular index stenosis treatment, using APERTO-paclitaxel drug-coated balloon versus percutaneous transluminal angioplasty could not be demonstrated. CLINICAL IMPACT: APERTO-paclitaxel drug-coated balloon catheter is a safe device to manage dysfunctional hemodialysis access. Compared to conventional angioplasty balloon, the APERTO drug-coated balloon will not result in longer period of adequate hemodialysis circuit functioning. A non-significant benefit of APERTO drug-coated balloon was found in de novo lesions in autologous fistulas.

Endovascular salvage of non-maturing autogenous arteriovenous fistulas by using angioplasty and competitive vein embolization.

INTRODUCTION: The aim of this study is to evaluate the maturation and patency rates after endovascular treatment of non-maturing arteriovenous fistulas with percutaneous transluminal angioplasty, embolization of competitive veins, or a combination of both in a series of consecutive patients. MATERIAL AND METHODS: Retrospective evaluation of patients with non-matured arteriovenous fistulas treated in our hospital was performed. Fistulography and ultrasonography was performed in all patients to evaluate the presence of stenosis and competitive veins. Significant stenoses (> 50%) were treated with balloon angioplasty and competitive veins (accessory and collateral veins) with coil embolization. RESULTS: A total of 78 fistulas were treated. Angioplasty and coil embolization were performed in 73 and 51 patients, respectively. No major complications occurred. In 65 out of 78 arteriovenous fistulas (83%), successful cannulation with two needles was possible after endovascular treatment. Sixty-three arteriovenous fistulas (81%) were used successfully for at least 3 months. Accessory veins were the only lesion present in 14% of the arteriovenous fistulas; coil embolization of these accessory veins resulted in 100% successful maturation. The estimated 3, 6, and 12 months postintervention assisted primary patency rates were, respectively, 73%, 55%, and 45%. The estimated 3, 6, and 12 months postintervention secondary patency rates were, respectively, 81%, 78%, and 73%. CONCLUSION AND DISCUSSION: Angioplasty and coil embolization are successful and safe procedures that can convert a non-mature fistula into a mature one in more than 80% of patients. Accessory vein embolization may be more important than collateral vein embolization in the presence of stenosis.

Aortic Aneurysm Rupture After Urokinase Treatment for Acute Limb Ischemia in Two Patients After EVAR.

Endovascular aneurysm repair (EVAR) is first-choice treatment for many patients with abdominal aortic aneurysms. Complications unique to endovascular treatment include endoleak and endotension, which can eventually lead to rupture. We present two cases of late aortic rupture after EVAR, where both patients had recent preceding catheter-directed thrombolysis with urokinase for acute limb ischemia. These cases suggest a relation between thrombolytic therapy and aortic rupture after EVAR, and we should therefore be aware of this possible complication.

Elastoplasty: first experience in 12 patients.

PURPOSE: Percutaneous vertebroplasty with polymethylmethacrylate (PMMA) is used increasingly for pain relief in symptomatic neoplastic or osteoporotic compression fractures. However, restoration of the stiffness of the treated vertebrae might propagate secondary fracture of adjacent vertebrae. Elastoplasty might prevent these secondary fractures. We assessed retrospectively our experience with elastoplasty in 12 patients, focusing on silicone migration. METHODS: During the period from July 2011 to January 2012, all patients with an indication for vertebroplasty were treated with elastoplasty. The exclusion criterion was the presence of posterior wall defects. Chest computed tomography (CT) scans were performed to evaluate the presence of perivertebral leakage and pulmonary embolism. The prevalence of leakage was compared with the results obtained for vertebroplasty with PMMA reported in the literature. Other complications during the postprocedural period were recorded. RESULTS: Twenty-one vertebral bodies in 12 patients were treated with elastoplasty. Silicone pulmonary emboli were detected on the postprocedural chest CT in 60 % (6/10) of the patients. Leakage to the perivertebral venous plexus was seen in 67 % (14/21) of the treated vertebrae. One major complication occurred: severe, medication-resistant dyspnea developed in one patient with multiple peripheral silicone emboli. CONCLUSIONS: This preliminary evidence suggests that VK100 silicone cement should not be used in elastoplasty because of the increased risk of silicone pulmonary embolism, when compared with the use of PMMA, which occurs worldwide. The major technical disadvantage is that the time taken for the VK100 silicone material to achieve its final strength is too long for practical application.

Retrograde transvenous ethanol embolization of high-flow peripheral arteriovenous malformations.

PURPOSE: To report the clinical efficiency and complications in patients treated with retrograde transvenous ethanol embolization of high-flow peripheral arteriovenous malformations (AVMs). Retrograde transvenous ethanol embolization of high-flow AVMs is a technique that can be used to treat AVMs with a dominant outflow vein whenever conventional interventional procedures have proved insufficient. METHODS: This is a retrospective study of the clinical effectiveness and complications of retrograde embolization in five patients who had previously undergone multiple arterial embolization procedures without clinical success. RESULTS: Clinical outcomes were good in all patients but were achieved at the cost of serious, although transient, complications in three patients. CONCLUSION: Retrograde transvenous ethanol embolization is a highly effective therapy for high-flow AVMs. However, because of the high complication rate, it should be reserved as a last resort, to be used after conventional treatment options have failed.

Percutaneous treatment of peripheral vascular malformations in children: long-term clinical outcome.

PURPOSE: This study was designed to assess the rate of complications and clinical failure at 3 and 12 months after percutaneous treatment of vascular malformations in children. Furthermore, we describe patient satisfaction of treatment results during 5 years of follow-up. METHODS: In a retrospective cohort study, we evaluated 26 patients younger than aged 19 years who were treated for symptomatic vascular malformations. Data on treatment outcomes and patient satisfactions were obtained with a precoded structured questionnaire. Patient files and imaging data were retrieved to obtain information regarding the vascular malformations and treatment. Clinical success was defined as disappearance or partial improvement of the complaints. Patient satisfaction was declared whenever patients answered in the questionnaire that they were satisfied with the treatment results. RESULTS: Of 26 eligible patients, we included 23 (88%). The mean follow-up was 36 (range, 15-127) months. Posttreatment, 87% (20/23; 95% confidence interval (CI), 66-97%) of patients reported clinical success at 3 months. At 1, 2, 3, 4, and 5 years of follow-up this percentage was 74%, 59%, 59%, 59%, and 59%, respectively. Eleven (48%, 95% CI 27-69%) patients had experienced complications and 22% (95% CI 7-44%) had major complications, of which 5 had required additional treatment. In all, 83% (19/23) of the patients reported satisfaction with the treatment. CONCLUSIONS: Percutaneous treatment of vascular malformations improved clinical symptoms in 87% of the patients at 3 months and were sustainable for half of all patients during a 5-year follow-up period. However, major complications were seen in 22%.

[A woman with acute upper abdominal pain]. / Een vrouw met acute pijn in epigastrio.

A 42-year-old woman came to the emergency department with acute abdominal pain. CT-scan showed an isolated dissection of the A. mesenterica superior and signs of ischaemic colitis. The patient was treated with endovascular stent placement in the artery and partial small bowel resection.

Management of liver adenomatosis by radiofrequency ablation.

Traditionally, surgical resection has been the treatment of choice in many patients with hepatocellular adenoma because of the risk of rupture, hemorrhage and malignant transformation. However, some patients are not amenable for surgery due to the extensive involvement of the liver, as in patients with liver adenomatosis. We report 2 cases with liver adenomatosis in which we combined surgery with open and percutaneous radiofrequency ablation for lesions located in both lobes of the liver. Minimal invasive treatment including radiofrequency ablation may offer new perspectives in the treatment of patients with liver adenomatosis.

Protein kinase B (PKB/c-akt) regulates homing of hematopoietic progenitors through modulation of their adhesive and migratory properties.

Limited number of hematopoietic stem cells in umbilical cord blood (UCB) presents a problem when using UCB for stem cell transplantation. Improving their homing capacity could reduce the need for high initial cell numbers during transplantation procedures. Although it is evident that protein kinase B (PKB/c-Akt) plays an important role in regulation of migration of various cell types, a role for PKB in regulation of migration and homing of human hematopoietic stem and progenitor cells remains to be determined. PKB activity was found to be required for induction of adhesion to bone marrow-derived stromal cells and detrimental for migration of UCB-derived CD34(+) hematopoietic progenitors. In addition, PKB activity was found to positively regulate integrin expression. CD34(+) hematopoietic progenitors, and their capacity to form colonies in vitro, were not affected by transient inhibition of PKB. Finally, transplantation of ß2-microglobulin(-/-) nonobese diabetic/severe combined immunodeficient mice with CD34(+) cells ectopically expressing constitutively active PKB resulted in reduced migration to the bone marrow, whereas inhibition of PKB activity resulted in an induction in bone marrow homing and engraftment. These results indicate that transient inhibition of PKB activity may provide a means for ex vivo stem cell manipulation to improve bone marrow transplantation regimes.

[The radiologist as the treating physician for cancer: interventional oncology]. / De radioloog als behandelaar bij kanker: oncologische interventieradiologie.

Interventional oncology is a new specialism which focuses on image-guided minimal-invasive treatment of cancer patients. Interventional oncology has joined the traditional treatments of surgery, chemotherapy and radiotherapy as the fourth pillar of cancer care. Oncological interventions can be divided into three categories: intra-arterial techniques, tumour ablation techniques, and palliative procedures. Two examples of such interventions in Dutch hospitals are the intra-arterial Yttrium-90 microsphere radioembolisation of colorectal liver metastases and the CT-guided radiofrequency ablation of tumours such as renal cell carcinoma. In interventional oncology all procedures are performed under image guidance. Imaging is used to guide the instruments and for real-time monitoring of the procedure.

Transjugular intrahepatic portosystemic shunt in patients with chronic portal vein occlusion and cavernous transformation.

GOALS: To determine the feasibility of transjugular intrahepatic portosystemic shunt (TIPS) creation as a possible salvage intervention in patients with variceal bleeding and chronic portal vein thrombosis with cavernous transformation, refractory to endoscopic therapy. BACKGROUND: TIPS is technically feasible in partial portal vein occlusion or complete occlusion due to fresh thrombosis. However, when the portal vein occlusion is complete and chronic, placement of TIPS is technically difficult. STUDY: In a tertiary referral center setting 4 patients with portal hypertension associated complications, received TIPS, as salvage therapy. In all patients a covered stent was placed to the cavernous transformation. RESULTS: Creation of TIPS to the dilated veins of a cavernous transformation was feasible in patients for whom recanalization of the portal vein was not possible. However, the collaterals need to be suitably wide for placement of TIPS and the high-pressure collaterals should communicate with the varices. CONCLUSIONS: TIPS should be considered as salvage therapy when endoscopic treatment is unsuccessful in patients with chronic portal vein thrombosis and cavernous transformation.

Long-term patient satisfaction after percutaneous treatment of peripheral vascular malformations.

PURPOSE: To determine long-term patient satisfaction for percutaneous treatment by using sclerosing agents (sclerotherapy) and/or arterial embolization for peripherally located vascular malformations (VMs). This treatment has been described as successful; however, there is a relative paucity of published long-term results. MATERIALS AND METHODS: This retrospective study was institutional review board approved; 107 patients treated for symptomatic VM were evaluated. After informed consent was obtained, 66 patients were sent a questionnaire regarding treatment effectiveness and patient satisfaction. Patient files and imaging data were retrieved to obtain information regarding the VMs and VM treatment. Kaplan-Meier survival curves were constructed to analyze clinical success rates over time. RESULTS: The most frequent reasons for patients to seek treatment were pain (89%, n = 59) and swelling (91%, n = 60). The majority of VMs were the low-flow venous type (83%, n = 55). Three months after treatment, clinical success was reported for 58% (n = 38) of patients and clinical failure was reported for 42% (n = 28). At 1-, 2-, 3-, 4-, and 5-year follow-up, clinical success was 49%, 49%, 42%, 42%, and 42%, respectively. Twenty-seven (40%) patients experienced complications, 12 of which required additional treatment. In all, 35 (53%) patients reported being satisfied with their treatment. Patient satisfaction was closely correlated with clinically successful long-term outcome of treatment. CONCLUSION: Initial partial or complete relief of VM complaints after percutaneous treatment is expected in 58% of patients, irrespective of VM size or classification. These results were durable over a 5-year follow-up period.

Assessment of viable tumour tissue attached to needle applicators after local ablation of liver tumours.

AIM: Local recurrence and needle track seeding are serious complications after local ablation for liver malignancies and potentially affect long-term survival. The aim of this study was to assess the incidence of viable tissue adherent to the needle applicators after ablation to gain insight into the possible mechanisms of local recurrence and needle track seeding. METHODS: A total of 40 consecutive patients underwent 59 local liver ablations. Cells and tissue attached to the needle applicators were analysed for morphology (HE, PAP and Giemsa staining) and viability (G6PD staining). RESULTS: Macroscopic tissue adherence was visible following 31 of the ablative procedures, all with radiofrequency ablation. Four applications were performed percutaneously and 27 during an open procedure. Morphologically intact tumour cells could be identified in 8 patients (20%), and viable tumour cells in 5 patients (12.5%). Morphologically intact tumour cells or viable tumour cells could only be demonstrated when track ablation was not performed. CONCLUSION: Viable tumour cells adherent to the needle applicators were found in an alarming 12.5% of patients after local ablation. We recommend track ablation not only after the procedure but also during any shifting and (re-)positioning to prevent shedding of viable tumour cells during or after ablation.

Embolization with the Amplatzer Vascular Plug in TIPS patients.

Vessel embolization can be a valuable adjunct procedure in transjugular intrahepatic portosystemic shunt (TIPS). During the creation of a TIPS, embolization of portal vein collaterals supplying esophageal varices may lower the risk of secondary rebleeding. And after creation of a TIPS, closure of the TIPS itself may be indicated if the resulting hepatic encephalopathy severely impairs mental functioning. The Amplatzer Vascular Plug (AVP; AGA Medical, Golden Valley, MN) is well suited for embolization of large-diameter vessels and has been employed in a variety of vascular lesions including congenital arteriovenous shunts. Here we describe the use of the AVP in the context of TIPS to embolize portal vein collaterals (n = 8) or to occlude the TIPS (n = 2).

Treatment of vertebral tumor with posterior wall defect using image-guided radiofrequency ablation combined with vertebroplasty: preliminary results in 12 patients.

PURPOSE: To evaluate the safety and clinical benefit of vertebral tumor treatment by combined radiofrequency ablation (RFA) and vertebroplasty, for pain reduction in patients who are unable to benefit from noninvasive treatment methods. MATERIALS AND METHODS: Twelve patients with painful vertebral tumors with posterior wall defect, in whom medical treatment together with radiation therapy and/or chemotherapy had failed, were treated with RFA combined with vertebroplasty. Procedures were performed using multislice CT-fluoroscopy and lateral C-arm fluoroscopic guidance. All patients had posterior wall defects of the vertebra being treated. Ten had lytic posterior wall destruction and two had posterior wall fracture. The visual analog scale (VAS) pain score was measured before, one week after, and three months after treatment. VAS patient satisfaction score was measured before and one week after treatment. The VAS score range was 0-20. The analgesic use was evaluated before and four weeks after treatment and complications were monitored. RESULTS: Combined RFA and vertebroplasty treatment was technically successful in all patients. Pain significantly decreased after treatment: the mean VAS pain score before treatment was 17.33 +/- 2.46 (range, 13-20) versus 9.25 +/- 4.81 (range, 2-18) one week after treatment (P < .001) and was 7.00 +/- 5.26 (range, 1-14) three months after treatment (P = .020). The mean VAS satisfaction score of all patients was 15.83 +/- 4.26 (range, 4-20). Analgesic use decreased after treatment. No serious treatment related complications occurred. CONCLUSION: RFA in combination with vertebroplasty for treating vertebral tumors with posterior wall defect appeared safe, and reduced pain substantially in patients who did not benefit from other noninvasive treatment methods.

Accurate detection of stent-graft migration in a pulsatile aortic model using Roentgen stereophotogrammetric analysis.

PURPOSE: To evaluate the feasibility and accuracy of Roentgen stereophotogrammetric analysis (RSA) versus computed tomography (CT) for detecting stent-graft migration in an in vitro pulsatile circulation model and to study the feasibility of a nitinol endovascular clip (NEC) as an aortic wall reference marker for RSA. METHODS: An aortic model with stent-graft was constructed and connected to an artificial circulation with a physiological flow and pressure profile. Tantalum markers and NECs were used as aortic reference markers for RSA analysis. Stent-graft migrations were measured during pulsatile circulation with RSA and CT. CT images acquired with 64 x 0.5-mm beam collimation were analyzed with Vitrea postprocessing software using a standard clinical protocol and central lumen line reconstruction. RSA in the model with the circulation switched off was used as the reference standard to determine stent-graft migration. The measurement errors of RSA and CT were determined during pulsatile circulation. RESULTS: The mean measurement error +/- standard deviation (maximum) of RSA during pulsatile circulation using the tantalum markers was -0.5+/-0.16 (0.7) mm. Using the NEC, the mean (maximum) measurement error was -0.4+/-0.25 (1.1) mm. The mean (maximum) measurement error of CT was -1.1+/-1.17 (2.8) mm. CONCLUSION: RSA is an accurate and feasible tool to measure stent-graft migration in a pulsatile environment. Migration measurement with RSA was more accurate than CT in this experimental setup. The nitinol clip tested in this study is potentially feasible as an aortic reference marker in patients after endovascular repair.

Necrosis of a large hepatic tumor after hemorrhage and subsequent selective arterial embolization.

This case report describes a young female patient presenting with acute intra-abdominal hemorrhage originating from a large tumor in the liver, most likely a hepatocellular adenoma. The bleeding was stopped by selective embolization of right hepatic artery branches. Subsequently, partial hepatectomy was performed after 6 mo. Macro- and microscopic examination showed complete necrosis and absence of tumorous tissue. The patient was discharged without complications, and subsequent follow-up until 22 mo after resection did not reveal any new lesions in the liver. This case emphasizes the significance of selective arterial embolization in the management of bleeding liver tumors and questions the need for (partial) hepatectomy after this procedure in selective cases.

Roentgen stereophotogrammetric analysis: an accurate tool to assess stent-graft migration.

PURPOSE: To evaluate in an in vitro model the feasibility and accuracy of Roentgen stereophotogrammetric analysis (RSA) versus computed tomography (CT) for the ability to detect stent-graft migration. METHODS: An aortic model was constructed from a 22-mm-diameter Plexiglas tube with 6-mm polytetrafluoroethylene inlays to mimic the renal arteries. Six tantalum markers were placed in the wall of the aortic tube proximal to the renal arteries. Another 6 markers were added to a Gianturco stent, which was cast in Plexiglas and placed inside the aorta and fixed to a micromanipulator to precisely control displacement of the stent along the longitudinal axis. Sixteen migrations were analyzed with RSA software and compared to the micromanipulator. Thirty-two migrations were measured by 3 observers from CT images acquired with 16x0.5-mm beam collimation and reconstructed with a 0.5-mm slice thickness and a 0.4-mm reconstruction interval. Measurements were made with Vitrea postprocessing software using a standard clinical protocol and central lumen line reconstruction. Results of CT were also compared to the micromanipulator. RESULTS: The mean RSA measurement error compared to the micromanipulator was 0.002+/-0.044 mm, and the maximum error was 0.10 mm. There was no statistically significant interobserver variability for CT (p=0.17). The pooled mean (maximum) measurement error of CT was 0.14+/-0.29 (1.00) mm, which was significantly different from the RSA measurement error (p<0.0001). CONCLUSION: Detection of endograft migration by RSA is feasible and was significantly more accurate than CT in this nonpulsatile in vitro model.