p64 flow diverter: Results in 108 patients from a single center.

BACKGROUND AND PURPOSE: Flow diverters are increasingly used to treat intracranial aneurysms. We report the safety and efficacy of the p64 flow diverter, a resheathable and detachable device for intracranial aneurysms. MATERIALS AND METHODS: We retrospectively reviewed 108 patients with 109 aneurysms treated with the p64 between March 2014 and July 2019. There were 87 women and 21 men, mean age 57 years. Of 109 aneurysms, 74 were discovered incidentally, 12 were symptomatic, 18 were previously treated, and five were ruptured dissection aneurysms. A total of 10 aneurysms were located in the posterior circulation. The mean aneurysm or remnant size was 8.1 mm. RESULTS: Hemorrhage by perforation with the distal guidewire occurred in two patients with permanent neurological deficits in one. In one patient, acute in-stent occlusion caused infarction with a permanent deficit. Permanent morbidity was 1.9% (2 of 108, 95%CI 0.1-6.9%); there was no mortality. During follow-up, three in-stent occlusions occurred, all asymptomatic. There were no delayed hemorrhagic complications. At six months, 77 of 96 aneurysms (80.2%) were completely occluded, and at last follow-up, this increased to 93 of 96 aneurysms (96.9%). In-stent stenosis at any degree occurred in 11 patients, progressing to asymptomatic complete occlusion in one. In the other patients, stenosis resolved or improved at further follow-up. CONCLUSION: The p64 offers an effective and safe treatment option. Aneurysm occlusion rate was 97% at last follow-up, mostly achieved with a single device. There were no delayed hemorrhagic complications. Delayed in-stent stenosis infrequently progresses to occlusion but remains a matter of concern.

The p48 flow diverter: First clinical results in 25 aneurysms in three centers.

BACKGROUND: The novel low-profile p48 flow diverter has been designed to treat aneurysms on small vessels of 1.75-3mm. We report our first clinical experiences. METHODS: Between March 2018-January 2020, 22 patients with 25 aneurysms were treated with the p48 in 3 centers. One patient had 3 aneurysms covered by one p48 and one patient had 2 aneurysms. There were 5 men, 17 women, with a mean age of 55 years (median 59, range 29-73 years). RESULTS: In 25 aneurysms, 24 p48 flow diverters were placed. In 1 patient additional coils were placed in the aneurysm. Procedural vessel rupture by the micro guidewire occurred in 2 patients and vessel rupture during p48 balloon dilatation occurred in 1 patient. Overall, the permanent morbidity rate was 13.6% (3 of 22, 95%CI 3.9-34.2%) and mortality was 4.5% (1 of 22, 95%CI <0.01-23.5%). Most complications were procedure-related and not device-specific. Of 22 patients with 25 aneurysms treated with p48, 18 patients with 20 aneurysms had angiographic follow-up after 5-18 months. Of 19 aneurysms, 10 were occluded and 7 showed a remnant. Two aneurysms were open after 6 months. Three aneurysms were still not occluded after 12, 14, and 18 months and these 3 were retreated. Retreatment rate was 16% (3 of 19) and the adequate occlusion rate was 90% (17 of 19). CONCLUSIONS: Treatment of aneurysms in small-caliber vessels with the p48 is feasible and effective but is not without complications. More data is needed to establish indications, safety, and efficacy more accurately.

Safety and Efficacy of Aneurysm Treatment with the WEB: Results of the WEBCAST 2 Study.

BACKGROUND AND PURPOSE: Flow disruption with the Woven EndoBridge (WEB) device is an innovative technique for the endovascular treatment of wide-neck bifurcation aneurysms. The initial version of the device (WEB Double-Layer) was evaluated in the WEB Clinical Assessment of IntraSaccular Aneurysm Therapy (WEBCAST) study, whereas the French Observatory study evaluated both WEB Double-Layer and Single-Layer versions of the device. WEBCAST 2 was designed to evaluate the WEB Single-Layer with Enhanced Visualization. MATERIALS AND METHODS: Patients with wide-neck bifurcation aneurysms for which WEB treatment was possible were included. Clinical data including adverse events and clinical status at 1 month and 1 year were collected and analyzed. A core laboratory evaluated anatomic results at 1 year following the procedure. RESULTS: Ten European neurointerventional centers included 55 patients (38 women; 27-77 years of age; mean, 54.4 ± 10.0 years) with 55 aneurysms. Aneurysm locations were the middle cerebral artery in 25 aneurysms (45.5%), the anterior communicating artery in 16 (29.1%), the basilar artery in 9 (16.4%), and the internal carotid artery terminus in 5 (9.1%). Procedural morbidity and mortality at 1 month were, respectively, 1.8% (1/55 patients) and 0.0% (0/55 patients). Morbidity and mortality at 1 year were, respectively, 3.9% (2/51 patients) and 2.0% (1/51 patients). At 1 year, complete occlusion was observed in 27/50 aneurysms (54.0%); neck remnant, in 13/50 (26.0%); and aneurysm remnant, in 10/50 (20.0%) (adequate occlusion in 40/50, 80.0%). CONCLUSIONS: WEBCAST 2 confirms the high safety and efficacy of WEB aneurysm treatment demonstrated in the WEBCAST and French Observatory studies.

Educational governance for the regulation of industry sponsored continuing medical education in interventional and device based therapies.

The relationship between industry and clinicians in educational programmes needs to be regulated. Industry may be best placed to deliver educational programmes in "craft" related specialties and particularly in areas where device implantation/technology based therapy has a major clinical role. The authors supervise industry sponsored clinical teaching at a purpose built independent teaching facility, and have developed the concept of educational governance to regulate their relationship with their industry sponsor and that concept is presented.

Transcatheter embolization of biopsy-related vascular injuries in renal allografts. Long-term technical, clinical and biochemical results.

PURPOSE: Biopsy-related vascular injuries in renal transplants are rare, but they can lead to dramatic clinical symptoms prompting immediate treatment. Transcatheter embolization is a known minimally invasive technique to treat some form of arterial bleeding. This study evaluated the efficacy of this technique in iatrogenic biopsy-related vascular lesions in renal allografts. MATERIAL AND METHODS: Between 1993 and 2001, 13 patients were treated by percutaneous transcatheter intervention. Indications for embolization were hypovolemic shock due to perinephric hematoma (n = 5), persistent macroscopic hematuria (n = 7) and an asymptomatic large intrarenal pseudoaneurysm in 1 patient. Selective angiography revealed an arteriovenous fistula (n = 7), a pseudoaneurysm (n = 6), and perinephric contrast extravasation (n = 4). RESULTS: In all patients, successful embolization of the feeding artery could be performed; in 11 patients it was performed in one session, in 2 patients an additional session was needed. In 1 patient thrombosis of a segmental artery occurred immediately after embolization, but was successfully treated by short-term in situ thrombolysis. Clinical symptoms disappeared in all patients. Serum creatinine levels (determined 30 and 60 days after embolization, compared to the level before embolization) decreased significantly in 10 patients; a progressive deterioration of the renal function was observed in 3 patients. CONCLUSIONS: Transcatheter embolization is a safe and effective endovascular technique to treat biopsy-related vascular injuries in renal transplants. In the vast majority of cases an immediate clinical success and significant benefit in renal function can be obtained and the longevity of the allograft after successful embolization mainly depends on the natural (medical) outcome.

Results of a European multicentre iliac stent trial with a flexible balloon expandable stent.

PURPOSE: to determine the 12 months success rate with a balloon expandable, flexible stainless steel stent in iliac artery obstructions. MATERIALS AND METHODS: one-hundred and twenty-six consecutive patients with iliac obstructive disease and who demonstrated an unsatisfactory angioplasty result with a post-dilatation gradient of at least 10 mmHg, or a primary occluded lesion were included in the study. Follow-up was by Doppler sonography, ankle pressures with and without exercise and clinical parameters. RESULTS: after stent placement, the mean percentage diameter stenosis decreased from 79 to 4%, with a mean intra-arterial pressure gradient of 3 mmHg. Primary stent patency was 94% at 6 months and 89% at 12 months. Primary clinical result at 6 months was 88% and at 12 months 81%. Primary assisted clinical result (after re-pta) at 6 and 12 months was 89 and 86%, respectively. The Ankle Brachial Index (ABI) after exercise at 1 month follow-up was reduced from 0.88 to 0.75, with minor deterioration at 6 months to 0.72, and at 12 months to 0.68. The 1, 6, and 12 months follow-up Piek Systolic Velocity (PSV) ratios across the stented lesions remained stable at a mean of 1.4, 1.6, and 1.6, respectively. However, respectively 44, 39 and 34% of the patients still experienced symptoms of claudication. CONCLUSIONS: the results presented here support the suggestion stenting to be an effective device in the treatment of iliac artery obstructive disease. This study also, confirms other study results concerning haemodynamic patency after iliac stenting on the indication of a 10 mmHg pressure gradient after pta and the discrepancy between good haemodynamic patency and clinical result.

The 6-F nitinol TrapEase inferior vena cava filter: results of a prospective multicenter trial.

PURPOSE: The authors report the first results of a new 6-F symmetrically designed permanent nitinol inferior vena cava (IVC) filter, the Cordis TrapEase, evaluated in a multicenter prospective study with 6-months of follow-up. MATERIALS AND METHODS: A total of 65 patients (29 men, 36 women) who ranged in age from 37 to 96 years (mean age, 68 years) and who were at high risk of pulmonary embolism (PE) were enrolled in 12 centers in Europe and Canada. The study was approved by the institutional review boards at all centers. Study objectives were to evaluate filter effectiveness, filter stability, and caval occlusion. Indications for filter placement were deep vein thrombosis with recurrent thromboembolism and/or free-floating thrombus with contraindication to anticoagulation in 37 patients, and complications in achieving adequate anticoagulation in 28 patients. Follow-up included clinical examination, plain film, Doppler ultrasound, CT scan, and nuclear medicine. RESULTS: The analysis of the data revealed a technical success of 95.4% (three filter-system related implantations not at the intended site, no events of filter tilting) and a clinical success of 100% at 6 months (no cases of symptomatic PE), the study primary endpoint. There were no cases (0%) of filter migration, insertion site thrombosis, filter fracture, or vessel wall perforation. During the study period, there were two cases of filter thrombosis: one case of early symptomatic thrombosis that was successfully treated in the hospital, and one case of nonsymptomatic filter thrombosis detected at 1-month follow-up, with spontaneous recanalization at 3 months. In the latter patient, some residual thrombus was still detected at 6 months. Of the study population of 65 patients, there were 23 deaths. These deaths were not related to the device or the implantation procedure but to the underlying disease process. CONCLUSION: This study demonstrates the new nitinol permanent IVC filter to be a safe and an effective device, with a low overall complication rate, for use in patients with thromboembolic disease at high risk of PE.

Postoperative retroperitoneal hemorrhage due to a bleeding ureteric artery: treatment by transcatheter embolization.

We report a case of a postoperative retroperitoneal haemorrhage due to an iatrogenic perioperative injury of an ureteric artery. Transcatheter embolization using microparticles stopped the bleeding and the patient stabilized immediately. Ureteric artery injury is a very rare condition but can be managed successfully by percutaneous interventional techniques.

Sedation, analgesia and anesthesia for interventional radiological procedures in adults. Part I. Survey of interventional radiological practice in Belgium.

A questionnaire was mailed to 217 interventional radiologists to evaluate current practice in analgesia and sedation in adults. Response rate was 15% (33/217). Diagnostic angiography was performed with local anesthesia in 94% to 99%; for PTA, local thrombolysis or stent placement, light sedation was added in 0.1%. Premedication was given in 43% of diagnostic angiographies and in 68% of therapeutic procedures. Radiologists consulted an anesthesiologist before administration of intravenous sedation, always in 54% of cases, occasionally in 19% and never in 27%. General anesthesia with artificial ventilation was applied in 56% of TIPS, in 70% of aortic stent grafting and in 82% of neuroradiological interventions. Intravenous sedation was applied given in 53% of percutaneous biliary drainage, in 42% of bile duct dilatation or stenting, in 40% of percutaneous nephrostomy and in 72% of ureteral balloon dilatation. Patient monitoring during an interventional procedure was always carried out by an anesthesiologist in 52% of cases. 21% of radiologists never visited the patient before a therapeutic procedure, and 36% never did so after completion of a procedure. This survey showed that high standard practice of sedation and analgesia, with the assistance of anesthesiologists, is underused by interventional radiologists in Belgium.

Carcinoma of the kidney, testis, and rare urologic malignancies.

The purpose of this symposium was to provide a forum for discussion on current information on the etiology and diagnosis of, and therapy for, tumors of the kidney, testis, and several uncommon malignancies of the genitourinary tract. The most recent contributions in epidemiology and molecular genetics were discussed with specific reference to their importance for clinical practice. Contemporary treatment approaches with the emphasis on multidisciplinary patient management of tumors commonly seen in the clinic as well as those that are only rarely diagnosed by urooncologists were presented. Major stress was given to the management optimization as it pertains to short- and long-term quality of life issues of patients treated for these tumors. Methods to reduce treatment toxicity including carcinogenic potential of chemotherapy, radiotherapy, or their combination were found to be of nearly equal importance to patient survival. Symposium participants reached consensus on a number of important points: 1) The management of patients with several malignancies discussed requires the presence of a multidisciplinary team of specialist who are interested in diagnosis and treatment of genitourinary tumors; 2) Patients managed in such an environment are expected to have optimal survival and the best possible quality of life; 3) Real advances in the management of patients can be best obtained through well-designed prospective clinical trials; and 4) There is a need for timely introduction of relevant advances in epidemiology and molecular genetics to clinics.

Multiple small pseudoaneurysms complicating pancreatitis: angiographic diagnosis and transcatheter embolization.

We report a case of retroperitoneal hemorrhage due to multiple, small pseudoaneurysms complicating a chronic alcoholic pancreatitis. Cross-sectional imaging with CT and US could not clearly depict these vascular lesions. Selective arteriography of the superior mesenteric and gastroduodenal arteries clearly showed the small pseudoaneurysms and definitive treatment was performed by transcatheter embolization using coils. Eight months after successful embolization, the patient is asymptomatic without any recurrent bleeding.

Vascular malformations in the uterus: ultrasonographic diagnosis and conservative management.

OBJECTIVE: To investigate the presence and outcome of uterine vascular malformations in women with abnormal premenopausal bleeding. STUDY DESIGN: In this observational study 265 consecutive patients with abnormal premenopausal bleeding were examined by the same ultrasonographer with transvaginal gray-scale ultrasonography and color Doppler imaging. A final diagnosis of uterine vascular malformation was based on ultrasonographic findings, hysteroscopy or histological findings. Patients suspected of uterine vascular malformations at ultrasonography were closely monitored. RESULTS: In nine patients (3.4%) we found ultrasonographic features of uterine vascular malformations. Color Doppler imaging showed hypervascularity, marked turbulence, and low-impedance, high-velocity flow. In six patients the condition resolved spontaneously. Two patients with hydatiform mole needed chemotherapy and their condition normalized. One patient underwent a selective embolization of the uterine artery. Subsequently, five patients had uncomplicated pregnancies after resolution of the vascular malformation. CONCLUSION: Uterine vascular malformations are more common than previously thought. We conclude that conservative management is a valuable option in many of the acquired pregnancy-related cases that are diagnosed with color Doppler imaging.

Vascular targeting of solid tumours: a major 'inverse' volume-response relationship following combretastatin A-4 phosphate treatment of rat rhabdomyosarcomas.

Tumour-specific vascularisation may be therapeutically approached in two different ways: by antiangiogenic treatments specifically directed to dividing and migrating endothelial cells, or by agents that target principally the inadequate and ill-structured tumour vasculature. Combretastatin A-4 phosphate (combreAp), a recently synthesised prodrug (OXiGENE, Lund, Sweden), is a vascular targeting agent of the latter kind. We evaluated the effect of a single intraperitoneal (i.p.) combreAp injection on the growth of rhabdomyosarcomas syngeneic in WAG/Rij rats. Different tumour volume groups, ranging between 0.1 and 27 cm(3), were selected to assess the relationship between the size at treatment time and the response to combreAp. A double combreAp treatment (2x25 mg/kg) was investigated within the same overall aim: the relationship between growth delay and tumour size. Our results show that the systemic administration of combreAp induces a clear-cut differential growth delay in the solid rat rhabdomyosarcomas: with very large tumours (>/= 14 cm(3)), a 17.6-fold stronger effect was measured than with very small tumours (<1 cm(3)). This is the 'inverse' of the volume-response seen with the conventional therapeutic approaches (radiotherapy, chemotherapy or surgery). These combreAp antitumour responses were observed without treatment limiting systemic toxicity in the rats. With clinical digital subtraction angiography, using microsurgical cannulation of a major tumour draining vessel, and with histopathology, we demonstrate that growth delay is related to an early (within 3-6 h) and extensive breakdown of tumour blood vessels. The experiments involving a second injection also indicate a volume-dependent effect of combreAp in reducing the regrowth rate of small or large rhabdomyosarcomas. This significant differential volume-response obtained with 'selective' vascular targeting, stronger in larger tumours than smaller ones, suggests the potential of broadening the therapeutic window.

Ovarian vein embolization for the treatment of pelvic congestion syndrome: long-term technical and clinical results.

PURPOSE: Ovarian vein embolization has been used recently to treat pelvic congestion syndrome. The purpose of this study is to evaluate the clinical efficacy and safety of ovarian vein embolization in the treatment of symptomatic pelvic varices. MATERIALS AND METHODS: We performed ovarian vein embolization in 41 patients (mean age, 37.8 years; range, 30-58 years): 32 patients underwent unilateral embolization and nine patients underwent bilateral embolization. All had lower abdominal pain and pelvic varicosities were found on retrograde ovarian vein venography. Embolization was performed with a mixture of enbucrilate and lipiodized oil in all but one patient, in whom enbucrilate and minicoils were used. Initial technical success rate and clinical follow-up (1-61 months; mean, 19.9 months), conducted with use of mailed questionnaires, are reported. RESULTS: Initial technical success rate was 98%. Immediate complications were noted in two patients (4%) in the form of migration of some fragments of glue (used as embolic agent), which was treated conservatively. Clinical follow-up reveals variable symptomatic relief in 9.7% of cases and a total relief of symptoms in 58.5% of cases. Results in patients who had insufficient ovarian veins bilaterally were no better than those in patients for whom only the left ovarian vein was found insufficient. CONCLUSIONS: Transcatheter embolization of the ovarian veins is a safe and feasible technique leading to complete relief of symptoms in more than half of cases. No statistically significant difference in clinical outcome could be noted between patients presenting with bilateral insufficient ovarian veins, who underwent bilateral embolization, and patients presenting with an insufficient left ovarian vein, who underwent left unilateral embolization.

Iatrogenic pseudoaneurysm in the upper arm: treatment by transcatheter embolization.

A 32-year-old woman presented with a pulsatile, painful mass in her left upper arm, originating several days after removal of an Ilizarov external fixation. The diagnosis of a pseudoaneurysm was made by medical history and by physical and ultrasonographic examination of the mass. Angiography confirmed the presence of the pseudoaneurysm, originating from a branch of the arteria profunda brachii, and definitive treatment was performed by transcatheter embolization. Clinical follow-up showed absence of pulsation and pain in the upper arm and a gradual volume decrease of the mass lesion.

Outcome and one year follow-up of intra-arterial staphylokinase in 191 patients with peripheral arterial occlusion.

Wild-type or equipotent variants of recombinant staphylokinase (rSak) were given intra-arterially (as a 2 mg bolus injection followed by an infusion of 1 mg/h or 0.5 mg/h overnight, with concomitant heparin [1000 IU/h]) to 191 patients of less than 80 years (62 +/- 1 years, mean +/- SEM), with a peripheral arterial occlusion (PAO) of less than 120 days (mean 14 +/- 1 days, median 11 days, 5 to 95 percentiles 3 to 30 days). Ninety nine patients presented with acute or subacute ischemia, 57 with severe claudication, 33 with chronic rest pain and 2 with gangrene. Occlusion occurred in 122 native arteries and in 69 grafts. Revascularization was complete in 83 percent (158/191), partial in 13 percent (24/191) and absent in 4 percent (7/191) after administration of 12 +/- 0.5 mg rSak over 14 +/- 0.7 h. Complete revascularization of acute occlusions of popliteal or more distal arteries was less frequent (60 percent, 15/25) than of acute occlusions of more proximal native arteries (95 percent, 37/39, p <0.001) or grafts (89 percent, 50/56, p = 0.005). Additional endovascular procedures were performed in 47 percent and subsequent elective bypass surgery in 23 percent of patients. Major bleeding occurred in 12 percent (23/191), one month mortality was 3.1 percent (6/191) and one year mortality was 6.9 percent (12/174). However, four patients (2.1 percent) had an intracranial bleeding following therapy: a 85 year old woman with severe diabetic arteriopathy, who was included in violation of the protocol, a 79 and a 74-year-old woman and a 74-year-old man, all with severe hypertension and limb threatening ischemia; these four patients died within two months after treatment. Amputations were performed within the first year in 16 of 162 surviving patients (9.8 percent): in 7 percent (7/96) with an occluded native artery and 14 percent (9/66) with an occluded graft (p = 0.19). No significant difference in lysis rate, one month mortality or one year amputation-free survival was observed in occlusions of recent onset (< or =14 days, n = 126) as compared to occlusions of longer duration (>14 days, n = 65). Treatment was interrupted prematurely in 4 patients because of a suspected allergic reaction. Fibrinogen levels remained unaffected during treatment (3.3 +/- 0.1 g/l before vs. 3.3 +/- 0.1 g/l after infusion, n = 167). In conclusion, rSak appears to be a highly effective thrombolytic agent in patients with PAO, resulting in a low one month mortality (3.1 percent) and a high one year amputation free survival (84 percent), with an acceptable incidence of major bleedings, but with occasional fatal intracranial hemorrhages.