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Covered stents show lower restenosis and reintervention rates than bare metal stents for chronic mesenteric ischaemia
Thursday, 07 Jun 2012 21:10
Gustavo S Oderich
Vascular surgeons and researchers from the Mayo Clinic in Rochester, USA, and University of Tennessee at Chattanooga joined hands to compare outcomes of mesenteric angioplasty using percutaneous transluminal angioplasty and stenting with iCAST/V12 covered stents (Atrium) or bare metal stents in patients with chronic mesenteric ischaemia. Their findings were released at the 66th Vascular Annual Meetingpresented by the Society for Vascular Surgery on 7 June 2012.
“Mesenteric stenting shows high restenosis and reintervention rates. Covered stents have been shown to lower restenosis rates when used for renal alignment in fenestrated endografts and treatment of failing arteriovenous grafts,” said Gustavo S Oderich, from the Mayo Clinic. “The purpose of this study was to compare outcomes of mesenteric stenting using bare metal or covered balloon expandable stents for treatment of chronic mesenteric ischaemia.”“We reviewed the clinical data of non-randomised 225 patients (65 male and 160 female; mean age 72±12 years) treated for chronic mesenteric ischaemia (2000–2010). Outcomes were analysed in patients who had primary intervention or reintervention using bare metal stents (164 patients) or covered stents (63 patients). Endpoints were freedom from restenosis, recurrence and reintervention, and primary and secondary patency rates.”Patients in both groups had similar demographics, cardiovascular risk factors and extent of disease. In terms of early outcomes, there was statistically significant difference between patients treated with bare metal and covered stents for technical success, complications, mortality, morbidity, length of stay and symptom improvement.Mean follow-up was 29 months. Patients treated by covered stents had less restenosis, recurrences and reinterventions compared to those treated by bare metal stents, both in the primary intervention and in the reintervention groups (p<0.05). Primary patency at two years was significantly higher for covered stents compared to bare metal stents in the primary intervention group (91±6 vs. 60±5; p<0.003).
Oderich concluded that covered stents were associated with less recurrences and reinterventions in patients undergoing primary interventions or reinterventions for chronic mesenteric ischaemia. “Primary patency was significantly higher for covered stents as compared to bare metal stents in the primary intervention group.”
Are inferior vena cava filters as good as we think in the prevention of pulmonary embolism?
Monday, 30 Jan 2012 15:57
By Jörn Oliver Balzer
Pulmonary embolism continues to be a major cause of morbidity and mortality in the United States. In most clinical situations, anticoagulation is the preferred form of therapy. The efficacy of inferior vena cava filters is still discussed controversially since several factors for effective pulmonary embolism prevention have to be considered.Inferior vena cava filters are indicated in only a small proportion of patients who have venous thromboembolism. Anticoagulation should be initiated after filter placement as soon as it is safe to do so and the filter should then be removed shortly thereafter. In these situations, retrievable filters are recommended. Inferior vena cava filters are known to be thrombogenic and are associated with an increased risk of recurrent deep venous thrombosis and inferior vena cava thrombosis.According to a study published by Cherry et al (J Trauma. 2008; 65:544 –548), a statistically significant increase in inferior vena cava filter placement over three years without an impact on the overall pulmonary embolism rate among trauma patients was noted in the USA.According to this study the results are similar to other studies published in this field placing the effectiveness of inferior vena cava filters in doubt. The current criteria used for determining which patients will benefit are not sufficient enough to have an effect at reducing the overall rate of pulmonary embolism.In another publication by Ingber et al (Current Opinion in Hematology 2009, 16:402–406) the authors come to the conclusion that despite increasing placement of inferior vena cava filters, particularly in the United States, they believe that the only indication for filter use is in patients with a proximal deep venous thrombosis in whom anticoagulation is contraindicated.According to the recently published guidelines Diagnosis and Management of Acute Pulmonary Embolism (European Heart Journal. 2008; 29:2276–2315) by the European Society of Cardiology, the systematic use of venous filters is not recommended in the general population with venous thromboembolism at present. According to these guidelines, venous filters may be used when there are absolute contraindications to anticoagulation and a high risk of venous thromboembolism recurrence, including, for example, the period immediately after neurosurgery or other major surgery. They may also be considered in pregnant women who develop extensive thrombosis in the weeks before delivery. As soon as it is safe to use anticoagulants, retrievable filters should be removed.So far there is only one randomised publication with a long-term follow-up of up to eight years analysing the risk/benefit of inferior vena cava filters in the prevention of pulmonary embolism (Circulation 2005; 112:416–422). In this study, 400 patients with deep venous thrombosis (with or without pulmonary embolism) were treated either with an anticoagulant (unfractionated vs. low molecular weight heparin plus an oral anticoagulant) alone, or with an anticoagulant combined with the insertion of a vena cava filter.This study shows that a reduced risk of recurrent pulmonary embolism was observed at the cost of an increased risk of recurrent deep venous thrombosis with no overall effect on survival in patients undergoing permanent inferior vena cava filter insertion.In the recent analysis by Young et al (Cochrane Database Syst Rev. 2010 Feb 17;(2)) on inferior vena cava filters for the prevention of pulmonary embolism the authors came to the conclusion that no recommendations can be drawn from the only two randomised studies published so far. One study showed a reduction in pulmonary embolism rates but not in mortality, but was subject to significant biases. The PREPIC study lacked statistical power to detect a reduction in pulmonary embolism over shorter and more clinically significant time periods. However, the PREPIC trial demonstrated that permanent vena cava filters were associated with an increased risk of long-term lower limb deep venous thrombosis.
Overall there is a lack of outcome evidence in the use of inferior vena cava filters when used within currently approved indications and a lack of trials on retrievable filters. Further trials are needed to assess vena cava filter safety and effectiveness.
Jörn Oliver Balzer is director, associate professor, Clinic for Radiology and Nuclearmedicine, St Vincenz und Elisabeth Hospital, Mainz, Germany
Large US multicentre study confirms safety and efficacy of SIR-Spheres
Monday, 25 Jun 2012 17:27
Yttrium-90 SIR-Spheres microspheres are designed to treat liver tumours with beta radiation
SIR-Spheres microspheres are well-tolerated and effective internal radiotherapy for unresectable, heavily pre-treated colorectal cancer liver metastases, according to results from a new study of more than 600 patients presented at the 2012 American Society of Clinical Oncology (ASCO) Annual Meeting.
The data were presented by lead investigator Andrew Kennedy, from Cancer Centers of North Carolina and North Carolina State University.1 SIR-Spheres microspheres (Sirtex) are the only fully FDA-approved microsphere radiation therapy for the treatment of colorectal liver metastases.“This is the largest, most comprehensive study to date evaluating the use of Selective Internal Radiation Therapy (SIRT) in liver metastases from colorectal cancer,” said Kennedy. “The data presented at ASCO confirm the safety and efficacy of this treatment option for patients and provide truly useful, validated information for clinicians. It is our hope that these results will help encourage appropriate patient selection discussion during tumor boards and with individual patients and their families.”The investigator-initiated retrospective study presented at ASCO analysed the outcomes of using SIR-Spheres microspheres in US patients treated since 2002. The study’s endpoints included safety and tolerability, tumor response and survival.The study focused on 606 patients (233 women; 373 men) at 10 institutions, who received a total of 966 SIRT treatments. Their mean age was 61.5 years (range, 20.8 to 91.9 years). Active extra-hepatic disease was present prior to the first SIRT procedure in 35.1% of patients. The vast majority (at least 92.6%) of patients had received prior chemotherapy, with over 30% having also received prior liver surgery or ablation.The median overall survival for these heavily pre-treated patients was 9.6 months (95% CI 9.0–11.1) from their first SIRT treatment, with a median follow-up of 8.6 months (0.1–77.7 months). Reported adverse events were typically transient in duration and mild or moderate in severity. In total, 45% of patients had fatigue, 28% experienced nausea and 1% had liver failure. Only 2.1% of all treatments required an overnight stay following the procedure.The modern US experience of SIRT using SIR-Spheres microspheres for unresectable, heavily pre-treated colorectal liver metastases confirms recently published data from international studies by Hendlisz, Seidensticker and Bester, who independently reported median overall survivals of 10.0, 8.3 and 11.9 months, respectively, in similar cohorts of patients with chemotherapy refractory disease.2–4“The results of this study, collected from experienced treatment sites across the US, are further evidence of the safety and efficacy of SIR-Spheres microspheres in heavily pre-treated patients,” said Mike Mangano, president, Sirtex Medical. “This also highlights that SIR-Spheres microspheres provide clear survival benefits with limited toxicity in a patient population with few treatment options.”SIR-Spheres microspheres are a novel outpatient treatment for colorectal liver metastases, both alone and in combination with chemotherapy. SIR-Spheres microspheres were FDA approved for use in colorectal liver metastases in 2002 and are now available at more than 400 cancer centres worldwide.
SIR-Spheres microspheres are approved for use in Australia, the United States of America (FDA approval), and the European Union (CE mark) and additionally supplied in countries such as Hong Kong, Malaysia, Singapore, Thailand, Taiwan, India, Israel and Turkey
Kennedy AS, Ball D, Cohen SJet al. USA patients receiving resin 90Y microspheres for unresectable colorectal liver metastases: A multi-center study of 506 patients. ASCO Annual Meeting 2012, Journal of Clinical Oncology 2012; 30 (suppl): Abs. 3590. (updated results, as presented)
Hendlisz A, Van den Eynde M, Peeters M et al. Phase III trial comparing protracted intravenous fluorouracil infusion alone or with yttrium-90 resin microspheres radioembolization for liver-limited metastatic colorectal cancer refractory to standard chemotherapy. Journal of Clinical Oncology 2010; 28: 3687–3694.
Seidensticker R, Denecke T, Kraus P et al. Matched-pair comparison of radioembolization plus best supportive care versus best supportive care alone for chemotherapy refractory liver-dominant colorectal metastases. Cardiovascular and Interventional Radiology 2011 Jul 29; ePub doi: 10.1007/s00270-011-0234-7.
Bester L, Meteling B, Pocock N et al. Radioembolization versus standard care of hepatic metastases: Comparative retrospective cohort study of survival outcomes and adverse events in salvage patients.Journal of Vascular and Interventional Radiology 2012; 23: 96–105.
For women, varicocoele embolization represents the most effective and least invasive treatment
Thursday, 31 May 2012 12:11
Pelvic congestion syndrome is a well described, but frequently overlooked cause of chronic pelvic pain often associated with pelvic and/or limb varicosities. The main cause of this condition is female varicocoele. While embolization in the similar condition in males is still debated by interventional radiology literature results versus subinguinal surgery, for women varicocoele embolization represents the most effective and less invasive treatment, writes Antonio Basile, Catania, Italy.
However, this statement is not sustained by widely-related literature if we consider that neither randomised controlled trials nor comparative studies have been published. If we evaluate the results coming from surgical data (laparoscopic ligation) versus that from radiological studies, we may say that surgery is curative in up to 73% of patients while interventional radiology is curative in up to 83% of cases.Reviewing the radiological literature, however, we note that we are not speaking about one standard technique, but about different embolic techniques. Until about 1997/98, unilateral left ovarian vein (LOV) embolization was the reported embolization technique with pain relief reaching 66%, a disappointing result, even if comparable with surgical outcomes.
After 2000, bilateral ovarian vein embolization was becoming the norm, and in cases in which the right ovarian vein cannot be found or is extremely small, its embolization began not to be considered necessary. Nowadays as assessed by the largest retrospective study on 131 patients published by Kim et al in the Journal of Vascular and Interventional Radiology in 2006, bilateral ovarian vein embolization is considered if the right ovarian vein is refluxing; if the symptoms persist for a period of 3/6 months, it should be followed by the embolization of internal iliac veins which is suggested to be performed without coils but only with sclerosant agents. However, there are still controversies regarding which embolic material is best, up to which part of ovarian vein should be embolized and how to deal with high flow varicocoele through other ipsilateral or controlateral internal iliac veins or ovarian vein.Reviewing the literature we find good results achieved with sclerosant alone (Gandini R, Cardiovascular and Interventional Radiology 2008), coils alone (Asciutto G, European Journal of Vascular Endovascular Surgery 2009) or with sclerosant plus coils (Kim HS, Journal of Vascular and Interventional Radiology 2006).The latter technique seems to be more complete and less prone to recurrence because it refers to the sclerosis of distal portion of ovarian vein including periuterine varicosities, with coil embolization of the proximal portion of the left ovarian vein almost up to the left renal vein; the latter step of this technique, releasing coil close to the LRV, could increase the risk of coil migration, for this reason in 2006 we underlined the usefulness of the amplatzer plug at this stage. Not all papers report the embolization of the proximal portion of the left ovarian vein, some authors (Asciutto G, European Journal of Vascular Endovascular Surgery 2009) have achieved good results by only embolizing the distal portion of the left ovarian vein with coils, the same technique used by Gandini only with sclerosant. It can be argued that, compared to what we see in male varicocoele, the ovarian vein has a high flow and only total embolization can obviate collateral development. However, this hypothesis is not always supported.The last controversy in the literature is focused on the means that can be used to obviate dislocation of embolic material, in particular sclerosants, in cases of high retrograde flow from the left ovarian vein, through the ispilateral internal iliac veins or contralateral ovarian vein or internal iliac veins. Some authors suggest closing the “back doors”— this means that we should use an occlusion balloon with a different venous approach in each involved vessel. This manoeuvre was suggested by some authors (Gandini R, CIRSE 2011) and used up to three balloon in cases of reflux through ipsilateral and contralateral ovarian vein or internal iliac veins; this sound a little bit complicated and invasive, for this reason I suggest avoiding non-target embolization just by using an occluding balloon in the distal portion of the left ovarian vein, with slow injection of sclerosants.
In conclusion interventional treatment could be considered the gold standard for pelvic congestion syndrome, however the lack of large literature data on this should push the efforts of the interventional radiology community to build a standard, accepted technique and clear scientific evidence by means of randomised trials.
Antonio Basile is with the Department of Diagnostic and Interventional Radiology, Garibaldi Centro Hospital, Catania, Italy.
Ultrasound-accelerated catheter-directed thrombolysis of acute iliofemoral vein thrombosis remains safe
Thursday, 19 Jul 2012 11:10
The use of ultrasound-accelerated catheter-directed thrombolysis to treat acute iliofemoral deep vein thrombosis continues to be feasible and safe, according to a study presented by Rob H W Strijkers (Department of Vascular Surgery and Cardiovascular Research Institute Masstricht, Maastricht University, Limburg, The Netherlands) at the 13th Meeting of the European Venous Forum(Florence, Italy, 28-30 June 2012).
Previous positive results on the Maastricht and Aachen clinical experience were presented by Strijkers at the European Venous Forum in Ljubljna, Slovenia, last year. According to Kahn et al, Strijkers said, “Iliofemoral vein thrombosis is associated with a twofold increased risk of developing post-thrombotic syndrome.” However, “early thrombolysis may decrease the incidence of this syndrome,” Strijkers noted. “Results presented from the CaVent study, in December last year, showed an absolute risk reduction of 14.4% in the incidence of post-thrombotic syndrome in patients with iliofemoral deep vein thrombosis treated with catheter-directed thrombolysis.”Strijkers highlighted that new catheters with mechanical components such as the Ekos endowave system (used in this study), Trellis-8 or the Angiojet system may enhance clot lysis and lower treatment time and bleeding complications. At this year’s meeting, Strijkers presented data of patients with acute iliofemoral deep vein thrombosis treated with ultrasound-accelerated catheter-directed thrombolysis, from October 2008 to March 2012. Cases with in-stent thrombosis and chronic clots, which are also part of the Maastricht and Aachen clinical experience, were excluded. The main outcome of the study was patency at one year. Secondary outcomes included: treatment time, bleeding complications, and pulmonary embolism. Diagnosis of deep vein thrombosis was assessed using duplex sonography and/or magnetic resonance venography and CT venography.
In the study, 37 patients, average age 42 years (5–76), were included. The deep venous thrombosis location was unilateral in 33 patients (20 left side, 13 right) and bilateral in four patients. The average treatment duration was 43 hours, success rate of recanalisation was 95% (n=35) and re-thrombosis occurred after 11 (30%) procedures. Additional procedures of underlying stenotic disease were required in 18 patients. Strijkers highlighted that there were no cases of major bleeding and only three patients had minor bleeding at the insertion point of the catheter. One case of pulmonary embolism was reported and one additional complication due to prolonged catheter placement was observed. There were no intracranial haemorrhages cases and no deaths related to treatment.
Strijkers told delegates that one year patency results are reasonable with 70% patency rate and secondary patency of 87% after one year.Looking at the future of thrombus removal, Strijkers told delegates that there are two randomised controlled trials currently recruiting patients: the ATTRACT trial in USA and the CAVA trial in The Netherlands, which incorporate clinical endpoints such as post-thrombotic syndrome and quality of life. “We think that with these studies, together with the CaVent study, we can report critical evidence in the treatment of patients with deep vein thrombosis.”
Failures and complications after uterine fibroid embolization
Monday, 20 Aug 2012 10:08
David N Siegel, chief, Division of Vascular and Interventional Radiology, Northshore Island Jewish Health System, New York, USA, told delegates atGEST 2012 US that interventional radiologists must take primary responsibility for the initial evaluation and management of post-uterine fibroid embolization patients.
“Interventional radiologists must be available, respond quickly and collaborate with gynaecology in order to address any complications or failures that arise after the procedure. However, it is important to remember that the serious complication rate associated with uterine fibroid embolization is quite low,” he said.Siegel noted that complete infarction of the fibroids after uterine fibroid embolization led to greater symptom control while incomplete infarction led to increased interventions after. Infarction depends on technical issues such as catheterisation and spasm, achieving the embolization endpoint and ovarian embolization. When infarction of fibroids is an issue, the patients can be referred for a hysterectomy, he said.Based on Scott C Goodwin et al’s Reporting Standards for Uterine Artery Embolization for the Treatment of Uterine Leiomyomata, Siegel explained that complications associated with uterine fibroid embolization included those associated with of angiography (such as dissection, renal failure), non-target embolization, radiation injury, adverse drug reaction and pulmonary embolism. They could also include pelvic infection, uterine infarction, post-embolization syndrome, passage of fibroid tissue and ovarian/sexual dysfunction.Siegel then focussed on uterine infarction, post-embolization syndrome, pelvic infection and fibroid tissue passage. “Post-embolization syndrome can be seen as a complication or expected event after uterine fibroid embolization, but can require re-admission or prolonged hospitalisation. It can occur after embolization of a solid parenchymal organ such as the liver, kidney, spleen, or uterus. It is characterised by self-limiting pain, nausea, vomiting, loss of appetite, malaise and fever and can affect roundabout 40% of patients who undergo fibroid embolization,” Siegel noted. Treatment of post-embolization syndrome includes hydration an anti-inflammatory regimen, narcotics and an anti-emetic.In order to distinguish between post-embolization syndrome vs. infection, it is important to take into account the time for symptoms to appear, Siegel clarified. “Post-embolization syndrome occurs in the days following uterine artery embolization, whereas infection usually occurs weeks later and is usually accompanied by foul-smelling discharge.
Enduring symptoms favour infection,” Siegel said. In cases of suspected infection vs. prolonged post-embolization syndrome, the factors that need to be considered are prolonged symptoms, foul-smelling discharge, a white blood count of more than 18–20,000 and non-aborting debris in the cavity. “Cultures must be taken and broad spectrum antibiotics (including those covering beta-lactamase producing anaerobes) and hydration made available to the patient. The clinical condition of the patient and white blood cell count need to be monitored. Imaging must be performed and in the case of debris, the patient can be referred for hysteroscopy, or hysterectomy,” Siegel advised.With regard to the transcervical passage of fibroids, Siegel told delegates to be prepared to deal with aborting fibroids at any time post-procedure. The passage of debris can be managed by vaginal/hysteroscopic resection, he noted.
Siegel made the point that evaluation of symptomatic patients post uterine fibroid embolization needed to focus on the timing in the history. Typically, infarction and post-embolization syndrome occur early and infection and fibroid expulsion later. “The physical should include an internal exam, the clinical exam was important in identifying signs of fever and a white blood cell count; imaging should be performed to exclude any abscess, infarction post-embolization syndrome vs endometritis and debris,” he recommended.