CIRSE 2010 - ValenciaTuesday, October 5, 2010Josef Roesch Lecture

C RSECardiovascular and Interventional Radiological Society of Europe

numerous lecture halls and rooms of every sizethat can cater for more than 12,000 people. Weare sure that the ICM will be a perfect environ-ment for vibrant exchange between physicists,researchers and scientists, students, techniciansand industrial representatives.

Munich itself preserves its distinct Bavarian his-tory, and combines it effortlessly with its mod-ern and fashionable present, demonstrated bythe presence of some of the world’s bestknown and finest art galleries (the old, new,and modern Pinakothek, Brandhorst Museum)and museums that display both past and pres-ent, in fields as diverse as history, art and sci-ence (such as the German Technical Museum,Bavaria Film studios and BMW World).Furthermore, authentic and romantic places,and side streets with Mediterranean-stylestreet cafes, homely and high-end restaurants,tiny ancient shops and luxury shopping miles,beg you to stroll about and experience them.

Over the recent years, CIRSE has developed intoone of the most innovative, comprehensive, andfastest growing medical societies, both withinEurope and beyond, emphasising the clinicaland scientific importance of interventional radi-ology. Therefore, on behalf of the GermanInterventional Radiological Society (DeGIR),which is part of the Local Host Committee, andthe German Radiological Society (DRG), we arevery proud to host the next CIRSE meeting inGermany, which will definitely help boost theawareness of this specialty in our country. Tocontinue the unbroken success of the recentmeetings, the preliminary preparations for CIRSE2011 are already in full swing. Thanks to theunfailing commitment of many members of oursociety and of our office in Vienna, a thrillingprogramme is going to be planned, makingCIRSE 2011 another great success.

We are looking forward to welcoming you tocharming Munich in 2011, and sharing a fasci-nating programme with you!

“Grüß Gott” in Munich!

It is a great honour and special pleasure for myco-chairman, Josef Tacke, and me, that we wereappointed as chairs of the Local HostCommittee for the upcoming CIRSE 2011 inMunich. Together with the extremely dedicatedscientific committee of CIRSE and the fantasticCIRSE organisation in Vienna, we will provideyou with another great CIRSE event which willhopefully build upon the huge success of theprevious meetings.

CIRSE 1988 was the last time Germany had theopportunity to host this prestigious meeting,and we are looking forward to welcoming dele-gates of CIRSE 2011 to Munich, the “cosmopoli-tan city with a heart”, which offers much morethan the infamous Oktoberfest. Munich is per-fectly situated at the heart of Europe - easilyaccessible for all by car, train and plane via theInternational Airport “Franz-Josef-Strauss”.Although a large and widespread city, gettingaround is quick and easy, thanks to an extensivetransport network of buses, trams, city-trains,and subways, as well as several thousand taxis.

Our congress venue is the InternationalCongress Centre München (ICM), a part of theInternationale Messe München, an architectural-ly fascinating renovation of the “old airport” ofMunich. The ICM is one of the most modern andfrequently used congress centres worldwide andoffers us a space of 350,000 m2, made up of

Dear Colleagues,

Thomas HelmbergerJosef TackeCo-Chairmen of the CIRSE 2011 Local Host Committee

Rnewscongress

The CIRSE Roesch Lecture was founded in2003 in honour of Professor Josef Rösch,whose award-winning research work spansmore than 50 years, covering a wide rangeof Vascular and Interventional Radiology.

This year’s Josef Roesch Lecture will begiven by José Ignacio “Nacho” Bilbao,Professor of Radiology and PhysicalMedicine at the University of Navarra, Spain.Prof. Bilbao started using Lipiodol andchemoembolisation for the treatment ofhepatocellular carcinomas as early as 1986.Since then, specialists from various disci-plines have cooperated in the treatment ofhundreds of patients with hepatic tumourpathologies at his department.

Prof. Bilbao is one of the co-founders of theSpanish Society of Interventional Radiology(SERVEI) and has been strongly involved innumerous CIRSE educational projects.

Josef Roesch LectureNew Frontiers inInterventional RadiologyToday, 13:00 (after the CIRSE meets the ESA Session)Auditorio Principal

Don't miss it !

The idea of percutaneously establishing an intra-hepatic connection between the hepatic veinsand the portal vein dates back to 1969, whenRösch and Hanafee described the technique inlaboratory animals [1]. The intrahepatic tractbetween the portal vein and the hepatic veinwas created using Teflon dilators and the con-nection was kept patent with a plastic tube. Theintroduction of the angioplasty balloon catheterallowed the dilatation to be performed in a lesstraumatic fashion. In 1983, Colapinto presented agroup of patients in whom the procedure hadbeen carried out with balloons, without insertingany devices for stabilising the venous connec-tion. As expected, the patency rate was poor [2].The experimental studies carried out by Palmaz,using his own prosthesis design [3], finallyallowed a transjugular intrahepatic portosys-temic shunt (TIPS) to be performed in a safe andefficient manner. The first human cases were pre-sented by Richter in 1989 [4] and since then,many articles with variable numbers of patients,randomised clinical trials and clinical notes havebeen published. This body of work allows for theestablishment of clinical recommendations onwhen and in which patients to use TIPS in thetreatment of complications of portal hyperten-sion [5-8].

According to the previous series of patients treat-ed with TIPS, a major problem of the procedure isshunt tract stenoses, which are the result of inti-mal thickening secondary to pseudointimal

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TIPS - Where are we now?

José Ignacio Bilbao

hyperplasia (proliferation of dense collagen andmyofibroblasts) [9, 10]. Biliary-TIPS fistulae havebeen indicated as the cause [11, 12]. Others,however, have demonstrated marked shuntstenoses (dense collagen and smooth muscle cellproliferation) without bile staining or bile ductproliferation [13]. In draining hepatic veinstenoses, intimal vein hyperplasia can also beobserved, which is probably due to traumaticstress during the shunt procedure, high flowafter TIPS or activation of smooth muscle cells bygrowth factors [11-13].

As demonstrated in a randomised study, the useof stents coated with polytetrafluoroethylene (e-PTFE) improves the patency of TIPS and decreas-es the number of clinical relapses and reinterven-tions, without increasing the risk ofencephalopathy [14] compared to bare stents.Currently, all available RCTs are based on the useof bare stents, and their conclusions might begreatly modified by the use of e-PTFE-coveredstents [15]. With the use of these new devices,the role of TIPS in the management and treat-ment of the complications of portal hyperten-sion continues to evolve [14, 15] and has beenre-evaluated, updating the clinical recommenda-tions for TIPS [8].

TIPS and variceal bleedingCurrently, TIPS is accepted as a second-line thera-py and should be used when medical and endo-scopic treatment have failed [8]. In such circum-stances, TIPS is able to control bleeding in 89-100% of cases, with a re-bleeding rate of 15%and a mortality (first month) of 30% [16-22].

It is well known that there are patients with ahigh degree of re-bleeding (30-60% at one year)after medical and endoscopic treatments [23].Therefore, patients at a higher risk of re-bleedingneed to be detected at an earlier stage. Twostudies have identified which parameters, meas-ured in acutely bleeding patients, are predictorsof early re-bleeding: portosystemic gradient > 20mmHg, advanced Child-Pugh class and systemicblood pressure < 100 mmHg [24, 25].

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C RSECardiovascular and Interventional Radiological Society of Europe

3Chemoembolisation using irinotecan-eluting micropheresIRnewscongress

C RSECardiovascular and Interventional Radiological Society of Europe

Patients with liver metastases from colorectalcancer (CRC) have a poor prognosis, with 1-and 3-year survival rates of 31% and 26% [1].The only curative treatment is resection; how-ever, this is feasible in less than 20% of patientsand is associated with relapse of disease in 70%of patients [2, 3].

Systemic 5-FU-based chemotherapy in combi-nation with oxaliplatin (FOLFOX) or irinotecan(FOLFIRI) in previously untreated patients offershigh response rates (35-50%) and median sur-vival of 15-20 months [4-6]. Overall survivalimproves to 20.3 months after systemic therapywith 5-FU and irinotecan, if combined with bio-logicals like bevacizumab, again in previouslyuntreated patients [7]. However, patients suf-fering from progression of liver metastasesafter previous systemic treatments rarely showdurable clinical relevant response rates andsurvival after second and third line chemother-apy [8].

Transarterial Chemoembolisation (TACE) of col-orectal cancer liver metastases has a long histo-ry starting in 1980. Several studies in the pastusing various drugs (5-FU, FUDR, Mitomycin,Gemcitabin, Cisplatin and irinotecan) andembolic materials (PVA, DSM, iodised oil)showed response rates between 14% and 82%and median survival of patients ranging from 8

to 16 months. However, survival benefit incomparison to systemic treatments was neverdemonstrated.

Substantial efforts have been made to providea more accurate delivery of chemotherapeuticagents over a prolonged period to livertumours by using drug-loaded and elutingmicrospheres. This technology, in combinationwith doxorubicin, has been proven to enhancelocal response rates in TACE of hepatocellularcarcinomas [9]. Irinotecan is another drugwhich can be precisely delivered via thesemicrospheres. This drug is active against CRCwith response rates of 13-27% in phase II stud-ies of systemic treatment of both untreatedand pretreated patients. Molecular mecha-nisms and pharmacodynamic characteristics ofdrug loading and delivery have been studiedfor both doxorubicin and irinotecan [10, 11].

These facts suggest that irinotecan-elutingmicrospheres may potentially improve the clin-ical outcome after TACE in patients with domi-nant liver metastases of CRC. Two types ofmicrospheres capable of loading irinotecan areavailable: DC-Beads® (Biocompatibles) andHepaSphere® (BioSphere), which are charac-terised by similar loading and eluting process-es, but also by different biomechanical andpharmacokinetic features. Irinotecan-elutingDC-Beads® (DEBIRI) have been used for treat-

ment of CRC liver metastases in three series of20-55 patients [12-14] excluding smaller pre-cursor studies of these two centres. Objectiveresponse 6 months after first DEBIRI was 36-80% based on EASL criteria (lack of contrastenhancement) and 7.6% based on RECIST crite-ria. Limited data concerning survival followingDEBIRI are available so far, with median survivalof 247 days [13].

TACE using irinotecan-eluting HepaSphere®microspheres was studied in one prospectivephase II trial for treatment of 15 patients withunresectable liver metastases, which had beenpretreated by several first- and second-line sys-temic chemotherapy protocols. During 37 TACE(2.5 per patient), cumulative doses rangedbetween 80-1.100 mg (mean: 418 mg) irinote-can and 40-275 mg (mean: 124 mg)HepaSphere, respectively. No major complica-tions were seen, however grade 2-3 postem-bolisation syndrome was present in 33% ofTACE, necessitating additional medicationswidening routine pain management protocol.Three-month follow-up showed objectiveresponse in 74% (CR in 27%, PR in 47%) basedon EASL criteria and SD in 87% based on RECISTcriteria. At 6-month follow-up, 54% of patientsshowed PD and 46% SD based on RECIST. Meantime to progression was 6.3 months (range 2-14months) and extrahepatic de novo metastaseswere present in 33% of patients.

Peter HuppertProfessor of RadiologyDepartment of Diagnostic and InterventionalRadiology Klinikum Darmstadt GmbHDarmstadt, Germany

Chemoembolisation of colorectal cancer liver metastases using irinotecan-elutingmicrospheres

Management of colorectal liver metastasesSpecial SessionTuesday, October 5, 10:00-11:00Sala 3F

Don't miss it !

References:1. Stangl R et al. (1994) Lancet; 343:1405-102. Cohen AD, Kemeny NE (2003) Oncologist; 8:553-663. Zorzi D et a l. (2006) J Gastrointest Surg; 10:86-944. Saltz LB et al. (2000) NEJM; 343:905-145. Rothenberg ML et a. (2003) J Clin Oncol; 21:2059-696. Goldberg RM et al. (2004) J Clin Oncol; 22:23-307. Hurwitz H et al. (2004) NEJM; 350:2335-428. Chen HX et al. (2006) J Clin Oncol; 24:3354-609. Malagari K et al. (2008) CVIR; 31:269-8010. Lewis AL et al. (2007) J Matr Sci Mater Med; 18:1691-9911. Kaiser J et al. (2009) J Oncol Pharm Practice; 0:1-912. Fiorentini G et al. (2007) in vivo: 21:1085-9213. Martin RCG et al. (2009) World J Surg Oncol; 7:80-9214. Bower M et al. (2010) HPB; 12:31-6

Irinotecan-eluting microspheres offer a poten-tial benefit for patients with liver dominantmetastases of CRC. Impressive local responseaccording to EASL criteria has been shown forboth DC-Beads® and HepaSphere® micros-pheres. However, clinical benefit in terms ofsurvival has not been shown so far, making fur-ther studies necessary. The primary endpointsof these studies should be survival and qualityof life, giving a second relevance to localresponse rates. Substantial intra- and extrahep-atic progression has been often observed andsuggests that accompanying systemic treat-ments, including chemotherapeutic and anti-angioneogenetic drugs, seems to be of poten-tial benefit.

According to some authors, limiting the use ofTIPS as a rescue therapy in cases of failure ofvasoactive drugs and endoscopic therapy needsto be revised and TIPS should be considered asfirst-line treatment in high-risk selected patients[15].

Two studies comparing TIPS to surgery (distalsplenorenal shunt-DSRS) have recently beenpublished [26, 27]. They have demonstrated thatTIPS (with covered prostheses) is as effective asDSRS in preventing variceal re-bleeding and maybe more cost-effective. It has therefore been saidin a recent editorial that “the era of surgicalshunting for treatment of portal hypertension isover” [28].

TIPS and refractory ascitesRefractory ascites represent another indicationfor TIPS [29]. A review of several RCTs has shownthat TIPS was able to significantly reduce notonly the risk of recurrence of ascites, but also themortality rate of patients with refractory asciteswhen compared with repeated large-volumeparacentesis [30]. The predictive factors for sur-vival are: age, serum bilirubin and sodium levels.Younger patients with a less compromised liverfunction and systemic haemodynamics may ben-efit from TIPS as a first-line treatment for refracto-ry ascites [15].

TIPS and Budd-Chiari syndromeA large study with data obtained from 6European institutions has collected the long-term follow-up data of 124 patients with Budd-Chiari Syndrome treated with TIPS. Patients weretreated with both non-covered and coveredstents. The OLT-free survival was 88% at one year

and 78% at 5 years, respectively. For them, TIPSshould no longer be considered as a bridge toliver transplantation, but the treatment of choicewhen anticoagulation has failed. Independentrisk factors of mortality that have been identifiedare: age, serum bilirubin levels and INR/PT values[31].

TIPS and Portal Thrombosis (PVT)Some previous reports have shown short seriesof patients with PVT in whom TIPS may be effec-tive for the palliation of symptoms [32]. Thelargest series of patients with PVT with and with-out cavernomatous transformation has recentlybeen published by Senzolo [33]. PVT is not a con-traindication for TIPS anymore and should beconsidered in patients with severe and life-threatening complications, or in whom thethrombus may jeopardise liver transplantation.Even in specialised centres, the success rate inaccomplishing the procedure is 73%, whichdemonstrates the need to refer those patients toselected units with a large experience in per-forming TIPS.

In summary, the vision of Josef Rösch, who fortyyears ago envisioned the possibility of perform-ing percutaneous connections between the por-tal vein and the inferior vena cava, is today anaccepted reality. TIPS is continuously evolving asan established method of treatment in a widevariety of portal vein complications, in both cir-rhotic and non-cirrhotic patients. Although suc-cessfully implemented in many institutionsthroughout the world, patients with expecteddifficulties (i.e. PVT or Budd-Chiari syndrome)should be referred to specialised, dedicated cen-tres.

References1. Rösch J, Hanafee WN, Snow H (1969). Transjugular portal

venography and radiologic portocaval shunt: an experimentalstudy. Radiology 92:1112–1114

2. Colapinto RF, Stronell RD, Gildiner M, Ritchie AC; Langer B;Taylor BR; Blendis LM (1983). Formation of intrahepatic porto-systemic shunts using a balloon dilatation catheter: preliminaryclinical experience. AJR 140:709-714.

3. Palmaz JD, García F, Sibbitt RR (1986). Expandable intrahepaticportocaval shunt stents in dogs with portal hypertension. AJR147:1251-1254.

4. Richter GM, Palmaz JC, Nöldge G, Rössle M, Siegerstetter V,Franke M, Wenz W (1989). Der Transjuguläre intrahepatischeportosystemische Stent-Shunt (TIPSS). Eine neue nichtopera-tive, perkutane methode. Radiologe 29:406-411.

5. Bilbao JI, Quiroga J, Herrero JI, Benito A. TransjugularIntrahepatic portosystemic shunt (TIPS): Current status andfuture possibilities. CardioVasc Intervent Radiol 2002; 25:251-269

6. Boyer TD, Haskal ZJ. The role of transjugular intrahepatic por-tosystemic shunt (TIPS) in the management of portal hyperten-sion. Hepatology 2005;41: 386-400.

7. Boyer TD, Haskal ZJ. The role of transjugular intrahepatic por-tosystemic shunt (TIPS) in the management of portal hyperten-sion: Update 2009. Hepatology 2009;50

8. Boyer TD, Haskal ZJ. AASLD practice guidelines: The role of tran-sjugular intrahepatic portosystemic shunt (TIPS) in the man-agement of portal hypertension. Hepatology 2010; 51: 1-15.

9. Rousseau H, Vinel JP, Bilbao JI, Longo JM; Maquin P; Zozaya JM;Garcia-Villareal L; Coustet B; Railhac N; Railhac JJ, Alvarez-Cienfuegos J, Prieto J, Joffre F, Pascal JP (1994). Transjugularintrahepatic portosystemic shunts using the Wallstent prosthe-sis: a follow-up study. Cardiovasc. Intervent Radiol 17: 7-11.

10. Rössle M, Siegerstetter V, Huber M, Ochs A (1998). The firstdecade of the transjugular intrahepatic portosystemic shunt(TIPS): state of the art. Liver 18:73-89.

11. Saxon RR, Mendel-Hartvig J, Corless CL, Rabkin J, Uchida BT,Nishimine K, Keller FS (1996). Bile duct injury as a major causeof stenosis and occlusion in transjugular intrahepatic portosys-temic shunts: comparative histopathologic analysis in humansand swine. JVIR 7:487-497.

12. Jalan R, Harrison DJ, Redhead DN, Hayes PC (1996). Transjugularintrahepatic portosystemic stent-shunt and the role of biliaryvenous fistula. J Hepatol 24:169-176.

13. Sanyal A, Contos M, Yager D, Zhu Y, Willey A, Graham M (1998).Development of pseudointima and stenosis after TransjugularIntrahepatic Portosystemic Shunts: Characterization of cell phe-notype and function. Hepatology 28:22-32.

14. Bureau C, García-Pagán JC, Otal P, et al. Improved clinical out-comes using polytetrafluorethylene-coated stents for TIPS:Results of a randomized study. Gastroenterology 2004; 126:469-475.

15. Rigio O, Redola L, Lucidi C, Angeloni S. Emerging issues in theuse of transjugular intrahepatic portosystemic shunt (TIPS) formanagement of portal hipertensión: Time to update the guide-lines? Dig Liver Dis 2009

16. Bañares R, Casado M, Rodríguez-Laiz JM, Camúñez F, Matilla A,Echenagusía A, Simó G, Piqueras B, Clemente G, Cos E (1998).Urgent transjugular intrahepatic portosystemic shunt for con-trol of acute variceal bleeding. Am J Gastroenterol 93:75-79.

17. Jalan R, John TR Redhead DN, Garden OJ, Simpson KJ, FinlaysonNDC, Hayes PC (1995). A comparative study of emergency tran-sjugular intrahepatic portosystemic stent-shunt andesophageal transection in the management of uncontrolledvariceal hemorrhage. Am J Gastroenterol 90: 1932-1937.

18. Laberge JM, Somberg KA, Lake JR, et al. Two-year outcome fol-lowing transjugular intrahepatic portosystemic shunt forvariceal bleeding:results in 90 patients. Gastroenterology 1995;108: 1143-1151

19. McCormick PA, Dick R, Panagou EB, Chin JK, Greenslade L,McIntyre N, Burroughs AK (1994). Emergency TIPS as salvagetreatment for uncontrlolled variceal belleding. Br J Surg 81:1324-1327.

20. Le Moine O, Devier J, Ghysels M, et al. Transjugular intrahepaticportosystemic stent shunt as a rescue treatment after scle-rotherapy failure in variceal bleeding. Scand J Gastroenterol1994; 207: 23-28.

21. Gerbes AL, Gulberg V, Waggerhauser T, et al. Transjugular intra-hepatic portosystemic shunt (TIPS) for variceal bleeding in por-tal hypertension: comparison of emergency and elective inter-ventions. Dig Dis Sci 1998; 43: 2463-2469.

22. Sanyal AJ, Freedman AM, Luketic VA, Purdum PP, Shiffman ML,Cole PE, Tisnado J, Simmons S (1997). Transjugular intrahepaticportosystemic shunts compared with endoscopic sclerotherapyfor the prevention of recurrent variceal hemorrhage: a random-ized, controlled trial. Ann Intern Med 126:849-857.

23. Bosch J, García-Pagán JC. Prevention of variceal rebleeding.Lancet 2003; 361: 952-954.

24. Monescillo A, Martínez-Lagares F, Ruizínez-Lagares F, Ruiz delArbol L, et al. Influence of portal hipertensión and its earlydecompression by TIPS placement on the outcome of varicelableeding. Hepatology 2004; 40: 793-801.

25. García-Pagán JC. An early decision for PTFE-TIPS improves sur-vival in high risk cirrhotic patients admitted with acute varicealbleeding. Hepatology 2008; 48:373

26. Henderson JM, Boyer TD, Kutner MH, et al. Distal splenorenalshunt versus transjugular intrahepatic portal systemic shunt forvariceal bleeding: A randomized trial Gastroenterology 2006;130: 1643-1651.

27. Boyer TD, Henderson JM, Heerey M, et al. Cost of preventingvariceal rebleeding with transjugular intrahepatic portal sys-temic shunt and distal splenorenal shunt. J Hepatol 2008; 48:407-414

28. D´Amico G, Luca A. TIPS is a cost effective alternative to surgicalshunt as a rescue therapy for prevention of recurrent bleedingfrom esophageal varices. J Hepatol 2008; 48: 387-390.

29. Quiroga J, Sangro B, Núñez M, Bilbao I, Longo J, García-VillarealL, Zozaya JM; Betés M, Herrero JI, Prieto J (1995). Transjugularintrahepatic portal-systemic shunt in the treatment of refracto-ry ascites: effect on clinical, renal, humoral and hemodynamicparameters. Hepatology 21:986-994.

30. Salerno F, Cammá C, Enea M, et al. Transjugular intrahepaticportosystemic shunt for variceal refractory ascites: a meta-analysis of individual patient data. Gastroenterology 2007; 133:825-834

31. García-Pagán JC, Heydtmann M, Raffa S, et al. TIPS for Budd-Chiari syndrome: Long-term results and prognostics factors in124 patients. Gastroenterology 2008; 135: 808-815.

32. Bilbao JI, Elorz M, Vivas I, Martínez-Cuesta A, Bastarrika G,Benito A. Transjugular intrahepatic portosystemic shunt (TIPS)in the treatment of venous symptomatic chronic portal trom-bosis in non-cirrhotic patients. Cardiovasc Intervent Radiol2004; 27:474-480.

33. Senzolo M, Tibbals J, Cholongitas E, Triantos CK, Burroughs AK,Match D. Transjugular intrahepatic portosystemic shunt for por-tal vein trombosis with and without cavernous transformation.Aliment Pharmacol Ther 2006; 23:767-775

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4 Advertisement Tuesday, October 5, 2010

Special Edition / CIRSE 2010 - Valencia

Advertorial Committed to Interventional Radiology,Committed to InnovationBoston Scientific and Interventional RadiologyBoston Scientific continues to be committed tothe field of Interventional Radiology. From theearly days of Medi-Tech through to the presentday, we have been proud to provideInterventional Radiologists with the tools thatthey require to improve care for their patients.However this commitment to InterventionRadiology goes beyond products, BostonScientific has recently demonstrated it’s commit-ment to the IR community by expanding its salesteam that partner and support the Radiologistson a daily basis. Joe Fitzgerald (Executive VicePresident – Peripheral Interventions) explains “By adding an additional 20+ members to our lead-ing International Sales and Marketing team, we willbe able to not only give physicians and patientsquicker access to our innovative life improving tech-nologies, but also a greater level of service, clinicalsupport and partnership to the InterventionalRadiology community as a whole. Our commit-ment to Interventional Radiology goes beyond thedelivery of new products and lies firmly with thebelief that only through partnership with the com-munity of physicians and patients will we be able todeliver the vision of improving patient care byreducing risk, trauma, cost, procedure time and theneed for aftercare, that lies at the heart of BostonScientific”

Boston Scientific is also committed to supportingthe education of Interventional Radiologists andthe development of the field of InterventionalRadiology, through their support of the CIRSEcongress, dedicated symposia and other educa-tional congress, both International and Local andalso through Boston Scientific driven educationalevents. The opening of our state-of-the-artInstitute for Therapy Advancement in Paris, hasallowed these events to be taken to a new level,

For more than 30 years, Boston Scientific hasadvanced the practice of InterventionalRadiology by providing a broad and deep port-folio of innovative products, technologies andservices. From our first PTA balloon Catheter in1979, through the Greenfield™ Vena Cava Filterand the Peripheral Cutting Balloon™, to our lat-est Adapt™ Carotid stent, the field ofInterventional Radiology has been at the heartof innovation at Boston Scientific.

A History of InnovationWhat does it mean to be an innovator? It startswith a mission. Since its founding, BostonScientific has been motivated by the belief thatless-invasive medicine could help cliniciansimprove patient care by reducing risk, trauma,cost, procedure time and the need for aftercare.That mission began in the late 1960s, whencofounder John Abele acquired an equity inter-est in Medi-Tech, Inc., a research and develop-ment company focused on developing alterna-tives to traditional surgery. Medi-Tech’s firstproducts, a family of steerable catheters, wereintroduced in 1969 and were used in some ofthe first less-invasive procedures. In 1979, Abeleand Pete Nicholas partnered to buy Medi-Techand together formed Boston ScientificCorporation. Today, with more than 25,000employees and 26 manufacturing, distributionand technology centers, Boston Scientificremains true to its original mission. As one of theworld’s largest medical device companies dedi-cated to less-invasive medicine, Boston Scientificbelieves that each innovative product is the out-come of strong research and development,intelligent acquisitions, close collaboration withclinicians, outstanding operational and qualityprocesses and a powerful global distributionchannel.

by bringing cutting edge technology to our edu-cational programs by integrating multiple VirtualReality simulators, a fully functional cath lab andenabling live cases to be broadcast from aroundthe world. We currently offer InterventionalRadiologists the opportunity to expand theirlearning by attending a variety of courses underthe umbrella of the Institute of TherapyAdvancement including those on Carotid ArteryStenting, Peripheral Embolisation and theIschemic Foot.

Innovation never StopsAs you would expect from a company with sucha history of innovation, the future is only justaround the corner. At CIRSE 2010 the companywill be launching the Journey™ Guidewire, bring-

ing precision to the periphery, this guidewire willprovide revolutionary precision and control farbeyond the leading conventional spring coilguidewires*. But it doesn’t stop there, as JoeFitzgerald goes on to explain“Our future product pipeline reflects BostonScientific's commitment to providing physicians themost complete set of high-performance peripheralintervention devices, from Guidewires through tothe future Drug Eluting Technologies, we are striv-ing to bring innovations to InterventionalRadiology that will change the lives of patients byreducing risk and improving outcomes. This com-mitment is further demonstrated by our clinicalprogram designed to support out key technologiesand to further our understanding of the best way totreat the patients that you see everyday. ”

* Data on file at Boston Scientific

C RSECardiovascular and Interventional Radiological Society of Europe

IRnewscongress 5EVAR follow-up - the role of CEUSIRnewscongress

EVAR follow-up – the role of CEUS

Background Endovascular repair (EVAR) is playing anincreasing role in the treatment of abdominalaortic aneurysm [1]. A successful proceduredepends on the complete sealing of theaneurysm sac from blood flow to achieve gen-eral pressure relief and avoid aneurysm rup-ture, with a shrinkage of the aneurysm sac. Themost common complication of EVAR isendoleak, that is, the persistence of perigraftflow within the aneurysm sac, which has to beconsidered the major cause of enlargementand rupture of the aneurysm and the mainindication for surgical late conversion [2]. Forthis reason, a strict surveillance of thesepatients is mandatory to detect endoleaks earlyon.

The preferred method of follow-up is repre-sented by CT angiography. However, CTA haslimitations. The investigation is repeated sever-al times, making radiation exposure a neces-sary concern [3]. Therefore, it would be usefulto have another reliable diagnostic examina-tion during follow-up.

Colour Duplex ultrasound is non-invasive, doesnot use radiation or contrast medium, is lessexpensive, easy to perform and widely avail-able. However, this technique obtained poorresults in terms of sensitivity in the detection ofendoleaks [4]. In recent years, the introductionof ultrasound contrast agents and contrast-spe-cific imaging has, however, rekindled interest inthis modality and its potential for replacingCTA in routine surveillance.

CEUS Endoleak Detection On CEUS images, the endoleak appears as ahigh attenuation area beyond the graft, butwithin the aneurysm sac, absent on the base-line unenhanced phase images, due to thepresence of contrast enhancement. The evalua-tion is based on visual assessment, withoutattenuation measurements, with particularattention to the endoleak’s wash-in (defined asthe time between beginning of contrast mate-rial injection and contrast visualisation withinthe aneurysm sac), endoleak wash-out (definedas the time between beginning of contrastmaterial injection and disappearance of all con-trast from the sac), the origin of the endoleaks,as well as the identification of inflow and out-flow collateral vessels. The enhancement mor-phology of endoleaks should either be by “cavi-ty filling” (defined as contrast concentrationinto a pseudocavity within the sac) or a simplediffuse spreading of contrast agent into thethrombus.

Recent literature [5-10] demonstrates that theuse of microbubble contrast agents significant-ly improves the capability of US to detectendoleaks, overcoming its limitations, princi-pally due to echo reflection by the metallic por-tion of stent-graft, presence of calcifications,and slow endoleak flow, which does not allowdistinction of colour signals coming from vesselwalls and surrounding tissue from thosederived from corpuscular haematic compo-nents. In detail, in our recent experience per-formed on 84 consecutive patients treated with

EVAR, CEUS significantly improved the visuali-sation of all parts of the endoprosthesis as wellas the diagnostic performance in endoleakdetection, with an obtained sensitivity andnegative predictive value similar to MSCTangiography (97.5% and 97.3%, respectively)[8].

Due to the longer duration of enhancement,lack of metallic artifacts and angiodynamicevaluation of the leak during the dynamicphase, CEUS seems more specific than CTA inthe detection of small low-flow endoleaks (Fig.1). On the other hand, CEUS could also allow aneasier identification of small endoleaks withsimple diffuse spreading of contrast agent intothe thrombus, in which the lack of concentra-tion in a defined and confined region of the saccould reduce CTA detection capability.

CEUS Endoleak Classification To understand which endoleak needs to bepromptly treated, it is mandatory to correctlyclassify it. Recent preliminary data [9] suggestthat CEUS is more specific than CTA inendoleak classification thanks to longer dura-tion of enhancement, lack of metallic artifactsand angiodynamic evaluation of the leak dur-ing the dynamic phase, as also demonstratedin our experience.

Type I endoleak: Usually appears as a hugehigh-flow leak, synchronous with respect tograft enhancement, spreading from the proxi-mal or distal end of the prosthesis into thethrombus with a cranial or caudal direction,respectively.

Type II endoleak: Most pronounced at theperiphery of the aneurysmal sac, with little orno delayed contact with prosthesis, commonlylocated in a posterior or lateral position andusually associated with opacification of collat-eral arteries. Furthermore, CEUS allows anangiodynamic visualisation of the agent flowinto the aneurysm sac, recognising its directionand more easily differentiating type II (directedfrom the periphery to the graft) from type III(directed from the graft to the periphery)endoleaks (Fig. 2). With respect to the time ofappearance, it is classified as a hyperdynamicor hypodinamic endoleak if wash-in is below orabove 100 seconds, respectively [6].

As a matter of fact, a type II endoleak is neversynchronous with respect to graft enhance-ment. This characteristic allows an easier differ-entiation between type I and type II endoleaks.CEUS could also represent a valid tool in deci-sion making and treatment planning of type IIendoleaks, showing different haemodynamicfeatures which might influence rate ofaneurysm enlargement, addressing the needfor treatment. Bargellini et al. [6] found that avolume increase might be associated withhypodynamic type II leaks, characterised by aslow wash-in and wash-out not being able tocreate a way out of the sac, thus causinganeurysm pressurisation and progressiveenlargement and, consequently, needing treat-ment.

Roberto IezziDepartment of Bioimaging and RadiologicalSciences, Institute of RadiologyA. Gemelli Hospital Rome, Italy

Type III endoleak: Strictly adjacent to prosthe-sis, showing delayed contact with margins ofthe aneurysmal sac, without opacification ofcollateral arteries. This endoleak is more fre-quently synchronous with respect to graftenhancement; as previously described, theopposite direction of the contrast flow allows adifferentiation from type II endoleaks (Fig. 2).

Type IV endoleak: Similar to a diffuse type IIIendoleak, involving all the stent-graft; the diag-nosis of a type IV endoleak should be one ofexclusion.

CEUS Limitations CEUS also has some limitations: patient habitus(obesity) and bowel gas can interfere withimaging and the patient must cooperate.Moreover, sonographic examination results areoperator-dependent and obtaining qualityimages requires training and specific skills.Furthermore, in the post-EVAR follow-up, CEUScannot replace CT-angiography in providinginformation related to graft anchoring andintegrity, aneurysm morphologic changes orvisceral vessels patency (renal arteries).

Conclusions In conclusion, CEUS is a fast, non-invasive, reli-able and valid alternative to MSCT angiographyfor endoleak detection in endovascular aorticstent graft patients. However, based on its limi-tations, in the post-EVAR follow-up, CEUSshould replace CTA at 6-month follow-up andannually thereafter. On the basis of this opin-ion, our suggested post-EVAR follow-up isbased on CTA at 1 and 12 months after EVAR,with CEUS performed at 6 months and annual-ly thereafter, if no complications are detected.

References:1. Bush RL, Lumsden AB, Dodson TF, Salam AA, Weiss VJ, Smith RB,

et al. Mid-term results after endovascular repair of abdominalaortic aneurysm. J Vasc Surg 2001; 33(2 Suppl):S70-76.

2. Vallabhaneni SR, Harris PL. Lessons learnt from the EUROSTARregistry on endovascular repair of abdominal aneurysm repair.Eur J Radiol 2001; 39: 34–41.

3. Brenner DJ, Hall EJ. Computer Tomography – An increasing Sourceof Radiation Exposure. N Engl J Med 2007; 357(22): 2277-84.

4. KG, Missig-Carrol N, Richardson T, Muluk SC, Makaroun MS.Color-flow duplex ultrasound versus computed tomographicscan in the surveillance of endovascular aneurysm repair. J VascSurg 2003; 38:645-51.

5. Henao EA, Hodge MD, Felkai DD, McCollum CH, Noon GP, Lin PH,et al. Contrast-enhanced duplex surveillance after endovascularabdominal aortic aneurysm repair: improved efficacy using acontinuous infusion technique. J Vasc Surg 2006; 43:259-264.

6. Bargellini I, Napoli V, Petruzzi P, Cioni R, Vignali C, Sardella SG, etal. Type II lumbar endoleaks: hemodynamic differentiation bycontrast-enhanced ultrasound scanning and influence onaneurysm enlargement after endovascular aneurysm repair. JVasc Surg 2005; 41:10-18.

7. Napoli V, Bargellini I, Sardella SG, Petruzzi P, Cioni R, Vignali C, et al.Abdominal aortic aneurysm: contrast-enhanced US for missedendoleaks after endoluminal repair. Radiology 2004; 233:217-225.

8. Iezzi R, Basilico R, Giancristofaro D, Pascali D, Cotroneo AR, StortoML. Contrast-enhanced ultrasound versus color duplex ultra-sound imaging in the follow-up of patients after endovascularabdominal aortic aneurysm repair. J Vasc Surg. 2009; 49(3):552-60.

9. Giannoni MF, Fanelli F, Citone M, Acconcia CM, Speziale F,Gossetti B. Contrast ultrasound imaging: the best method todetect type II endoleak during endovascular aneurysm repairfollow-up. Interact Cardiovasc Thorac Surg 2007; 6:359-362.

10. Carrafiello G, Laganà D, Recaldini C, Mangini M, Bertolotti E,Caronno R, et al. Comparison of contrast-enhanced ultrasoundand computed tomography in classifying endoleaks afterendovascular treatment of abdominal aorta aneurysms: prelim-inary experience. Cardiovasc Intervent Radiol 2006; 29:969-974.

Endovascular management of abdomi-nal aortic aneurysmsSpecial SessionTuesday, October 5, 08:30-09:30Auditorio Principal

Don't miss it !

Fig.1: 85-year-old woman treated with EVAR withincrease in size of the aneurysm sac in comparisonwith previous CT exam. No endoleak was detectedon both arterial (a) and 60-seconds delayed (b)phase, with a consequent diagnosis of endoten-sion. However, a small-sized endoleak was detect-ed on contrast-enhanced ultrasonography (c)(arrows). This low-flow endoleak was confirmedby a delayed phase image performed 300 secondsafter contrast medium injection (c) (arrows), justi-fying the increased aneurysmal sac and excludingthe previously diagnosis of endotension.

Fig.2: 71-year-old man treated with EVAR (1-monthfollow-up). 3D (a, c) and axial (b) CT imagesdemonstrated a large endoleak located in a pos-tero-lateral position, associated with opacificationof a lumbar artery (c), classified as a type-IIendoleak. However, the leak is also strictly adjacentto the prosthesis, with a consequent possible diag-nosis of a concomitant type III endoleak. A clearclassification of the endoleak was not performedon the basis of CT images. Dynamic CEUS images(d) evaluation demonstrated the back-filling of theexcluded aneurysmal sac via lumbar artery,excluding a concomitant type III endoleak, as con-firmed by DSA (e-g, arrows in f and asterisk in g).

6 Advertisement Tuesday, October 5, 2010

Special Edition / CIRSE 2010 - Valencia

Advertorial Momentum increasing behind Aorfix™ as the aortic stent graft of choice for challenging anatomy

Aorfix™ is being recognised as enablingpatients who would have not been consideredsuitable for endovascular treatment to be treat-ed in this way, as acknowledged by Dr JohnHardman et al in a recent device evaluation forFuture Medicine:

“The introduction of this device into the market isalready increasing the number of patients consid-ered suitable for endovascular treatment whowould otherwise have been excluded from thistype of therapy previously.”

Hardman, Balasubramaniam, Weale & Horrocks(2010). Endovascular treatment of morphologi-cally challenging abdominal aortic aneurysms.Future Medicine ISSN 1755-5302.

The Aorfix™ stent graft from Lombard Medicalrecently achieved its 1300th EVAR case. A grow-ing volume of clinical evidence supports theview that Aorfix™ is the device of choice forpatients with challenging anatomy. Indeed, inJune 2009, Aorfix™ gained the unique labelapproval to treat AAAs with angled aorticnecks of up to 90°, the highest of any stentgraft following the European Multi-CentreArbiter II study. All patients treated had highneck angles greater than 70°. Additionally, iliactortuosity was regarded as severe in 34% ofpatients, another area where Aorfix™ offersunique solutions.

Simon Hubbert VP Sales and MarketingInternational for Lombard Medical commented:“Clinicians from around the world are identifyingthe clear benefit that Aorfix™ brings in the treat-ment of AAA in patients with tortuous anatomy.Lombard Medical are committed to expandingour distribution network and clinical training pro-gram to ensure that Aorfix™ is available to asmany clinicians as possible.”

The 1000th EVAR case with the Aorfix™ AAAstent graft was performed by Dr DimitriosTsetis, MD, University Hospital of Heraklion,Crete in Q4 2009, he commented:“Aorfix™ is a user-friendly device with a shortlearning curve. The device overcomes angulatednecks and excessive tortuosity of the external iliacor common femoral artery. We have seen no type1 endoleaks, no cases with graft kinking, or devicemigration.”

In a recent retrospective review of all EVAR per-formed over a 12-year period at the RoyalUnited Hospital, Bath, Dr John Hardman evalu-ated the impact of the introduction of theAorfix™ graft for patients with tortuous iliacanatomy. The conclusion of the study was clear:

“The rate of early iliac limb occlusion followingEVAR in patients with angulated iliac anatomycan be substantially reduced by using the flexibleAorfix™ stent graft system.”

Weale, Balasubramaniam, Hardman, Horrocks(2010). Use of the Aorfix™ stent graft in patientswith tortuous iliac anatomy. The Journal OfCardovascular Surgery 2010;51:461-6.

The impressive performance of Aorfix™ in high-ly angulated anatomy can be largely attributedto its unique, patented helical design. The elec-tro-polished nitiniol wire construction givesexcellent durability and makes for a flexibleand conformable device that follows the body’smovement.

In February 2010, Lombard built on its clinicalsuccess by raising a total of £13 million to allowfor completion of the US trial in order to gainFDA approval for Aorfix™, invest in its sales andmarketing infrastructure, plus investment indevelopment programs. Having developed aninnovative product and gained a unique indica-tion, Lombard expects strong progress andmore good news in the months and years tocome.

High-Angled NeckSource: Mr A. D. McLain,Consultant Vascular Surgery,Royal Gwent Hospital, UK.

Tortuous IliacsSource: Mr D. Morrow,Consultant Vascular Surgery,Norfolk & Norwich Hospital, UK.

CIRSE 2010

Lombard Medical has an extensive presenceat CIRSE 2010. The company’s exhibitionstand (Booth 10) features samples ofAorfix™ for delegates to evaluate as well amodel of an Aorfix™ aneurysm case. Highlyexperienced personnel will be on hand toanswer questions.

In addition, Lombard will be hosting a satel-lite symposium entitled ‘Stretching AAAEVAR: Challenging Anatomy and How toCope with it?’ A panel of highly respectedspeakers are set to give a stimulating pres-entation – this is a must-attend event for allinvolved in EVAR.

Satellite Symposium details:

Title: Stretching AAA EVAR: ChallengingAnatomy and How to Cope with it?

Speakers:Dr Peter Phillips, Lombard MedicalDr John Hardman, Royal United Hospital BathDr Jörg Tessarek, St. Bonifatius Hospital LingenDr Eric Verhoeven, Klinikum Nürnberg

Moderator:Mr Jan Macierewicz, Doncaster Royal Infirmary

Room: Sala 2GDate/time: Tuesday 05th October 2010,11.30-12.30

For more information on Aorfix™ or LombardMedical please visit the company’s stand, booth10 at CIRSE. Alternatively to evaluate Aorfix™please e-mail:productenquiries@lombardmedical.com

Information in relation to this advertorial is heldon file by Lombard Medical.

The Aorfix™ endovascular stent graft is the onlydevice labelled* for the highest angulations.

C RSECardiovascular and Interventional Radiological Society of Europe

7Challenges in GI bleedingIRnewscongress

Transcatheter embolisation is effective in thetreatment of non-variceal upper gastrointesti-nal haemorrhage (NVUGIH). Despite the publi-cation of many papers on the topic, transarteri-al embolisation (TAE) has until recently failed tobe included in published management algo-rithms [1, 2]. The British Society ofGastroenterology Endoscopy Committeeguidelines published in 2002 did not include IRin the treatment of NVUGIH [3]. The ScottishIntercollegiate Guidelines Network (2008) rec-ommended arterial embolisation for NVUGIHuncontrolled by endoscopic techniques [4]. Itwas noted that the supporting evidence wasno stronger than case series (level 3), but theguidelines stated that the level of evidence didnot reflect the importance of the recommenda-tions. Recent guidelines in North Americarecognise the importance of embolisation fornon-variceal upper GI bleeding refractory toendoscopic treatment but also note the pauci-ty of the evidence base [5].

Endoscopy vs. EmbolisationA review of the literature does not identify anypublications comparing endoscopic andtransarterial interventions. This is not unex-pected, due to the clinical utility of the tech-niques. Endoscopy can identify the site ofbleeding, its pathological cause, quantify therisk of continued bleeding or re-bleeding andtreat the culprit lesion. Gastrointestinal bleed-ing is often an intermittent phenomenon.Definitive angiographic demonstration of thesite of haemorrhage requires the patient to beactively bleeding, but pseudo-aneurysms, ves-sel spasm and cut-off, early venous filling andfocal hypervascularity are useful indirect signs.Increasingly, computed tomography (CT) isused to identify the site of bleeding after anon-diagnostic endoscopy. Reported accuracyhas been as high as 89% [6].

The superiority of endoscopic over medicaltherapy in controlling bleeding from pepticulcer with adherent clot was confirmed in ameta-analysis of six randomised controlled tri-als [7]. Re-bleeding occurred in 5 of 61 (8.2%)patients in the endoscopic therapy group, com-pared with 21 of 85 (24.7%) in the medicaltherapy group (P = 0.01). Patients in the endo-scopic therapy group were less likely to under-go surgery. The reported range of re-bleedingrates after endoscopic treatment is 5%–20%[8]. It most commonly occurs within 72 hours.A meta-analysis of systematic second-lookendoscopy with retreatment found thatalthough the risk of recurrent bleeding was sig-nificantly reduced [9], it neither reduced theneed for surgical intervention or mortality.When re-bleeding occurred, repeat endoscopictreatment resulted in equivalent 30-day mor-tality and transfusion requirements with alower rate of complications compared to sur-gery [9, 10].

Current evidence supports two attempts atendoscopic control of active bleeding.Identification of the source of recurrent bleed-ing at second look endoscopy should lead tothe placement of endoscopic clips at the ulcerrim. Should the endoscopic treatment subse-quently fail to control the haemorrhage, themetal clips allow the interventional radiologistto embolise the culprit vessel, even when thereare no angiographic stigmata of bleeding [11].

Embolisation vs. Surgery There are no prospective randomised studiesthat compare the outcomes of surgical and IRtreatment in peptic ulcer haemorrhage. Thereare five studies that retrospectively compareembolisation and surgery in patients withNVUGIH refractory to endoscopic management[12-16]. All five used an intention-to-treatanalysis. The methodology used does not allowthem to compare the two salvage methods,but they do shed some light on patient selec-tion, adverse clinical features and give someestimation of mortality rates, albeit in patientpopulations where decision bias exists.

In 1990, Lang and colleagues [12] were the firstto correlate patient outcome with treatmentmodality and clinical status at the time of treat-ment. Their cohort of 36 patients referred forangiography resulted in 24 patients undergo-ing an embolisation procedure. The remaining12 had alternative treatments. There was nosignificant difference in the mortality rates inthose treated by embolisation and those treat-ed by alternative therapies. Surgery was under-represented in this study relative to embolisa-tion.

In 2004, Ripoll et al. [13] were the first toanalyse decision making in salvage of NVUGIH,albeit using a univariate analysis which mayidentify correlated variables as independentrisk factors. They reviewed 15 years experienceof uncontrollable or recurrent peptic ulcerbleeding. Seventy patients were studied with31 undergoing TAE and 39 surgery. It was stat-ed that embolotherapy was generally consid-ered when the patient was at high surgical risk.This is corroborated by the significantly greaterage, incidence of heart disease and previousanticoagulation treatment in the embolisationgroup. No significant difference was seenbetween TAE and surgery in terms of the inci-dence of recurrent bleeding (29% vs. 23.1%; p= 0.751), need for additional surgery (16.1 vs.30.8; p=0.108), or mortality (25.8% vs. 20.5%;p=0. 0.79).

In 2008, Eriksson and colleagues published aretrospective non-case-controlled studyreviewing the outcome of TAE (n=51) and sur-gery (n=40) as salvage therapy of NVUGIH afterfailed endoscopic treatment [14]. Peptic lesionsaccounted for all the aetiologies in the emboli-sation group and all except for 4 Dieulafoylesions in the surgical group. There was a cleartrend towards a lower 30-day mortality rate inpatients treated with embolisation (1/40; 3%)compared to patients treated with surgery(7/51; 14%), although this did achieve statisticalsignificance (P<0.07). This was despite patientstreated by embolisation being older (mean age76 years vs. 71 years for surgery) and havingmore co-morbidities.

Kaplan-Meier estimates showed that the initialexcess mortality in the surgical group was notmaintained at one year. It might be postulatedthat this is because the embolisation groupincluded higher risk patients with consequentlower longer-term survival. It was concludedthat following a failed therapeutic endoscopyfor upper gastrointestinal bleeding, embolisa-tion should be the treatment of choice. Anadditional finding was that most re-bleedingafter secondary interventions (surgery and IR)was effectively treated with embolisation.Embolisation was recommended as the treat-ment of choice for failed secondary interven-tions.

A. Nicholson (pictured), S.J. McPherson (pictured),S. Mirsadraee, P. TirukondaLeeds Teaching HospitalsLeeds, UK

Also in 2008, Defreyne [15] examined the clini-cal and endoscopic parameters used to assignsalvage therapy in 96 patients with endoscopi-cally confirmed NVUGIH in the previous 24hours; 46 patients were treated by embolisa-tion and 51 treated by surgery. Univariate andmultivariate analysis was employed. This studydiffers from the others comparing surgery andembolisation in employing endoscopy-baseddecision making. The Forrest ulcer classification(re-bleeding risk assessment) was documented.The hypothesis that haemodynamic instabilityinfluenced the therapy decision was tested.Objective criteria (serum haemoglobin, haema-tocrit, use of packed red blood cells and shocktherapy) were no different in the two groups.Testing of subjective assessment (the clinicalopinion on the haemodynamic status) faileddue to limited documentation. Univariateanalysis of demographics, risk factors andbleeding characteristics found that only coagu-lation disorder was significantly different(20.4% in the surgery group and 41.4% in theangiography group; p=0.044).

The endoscopist was more likely to choose sur-gery when a peptic ulcer (84%) was identified,with the majority of these (82%) duodenalulcers. Peptic ulcers were the cause of bleedingin <50% of angiography cases with duodenalulcers just the majority (p <0.001 for duodenalulcer). Irrespective of their clinical status,patients with peptic ulcer were 5.2 times morelikely to be referred for surgery (p=0.021). Inthis study, decision making was based onendoscopy and therefore differed from themultidisciplinary decision making in the otherstudies where increased surgical risk steeredpatients to embolisation. DeFreyne’s patientswith inconclusive endoscopy were more likelyto undergo angiography; 56% arteriographyand 15% surgery. Only 37% of the angiographygroup had a diagnosis.

The authors acknowledged that surgery with-out a diagnosis carries 6 times greater mortali-ty, but ignored the corollary that the samepatients likely have excess mortality when sub-jected to angiography without endoscopicdiagnosis. All patients (N=6 in each group) inwhom bleeding persisted despite interventiondied. In-hospital mortality was not statisticallydifferent in the groups (laporotomy 27.5%,angiography 39.1%; p=0.28) with no differencein the odds of dying. Clinical success was 87%for both groups. A primary failure (re-bleeding)rate of 43.5% was observed for the angiogra-phy group, but this must be weighed againstthe embolisation rate of 74%. An excess oftreatment failures in this study relative to oth-ers might be anticipated from the use of arteri-ography as the modality of choice in undiag-nosed NVUGIH, from the endoscopist’s preju-dice in directing duodenal ulcers away fromarteriography and in the failure to consistentlyemploy blind embolisation or, when an endo-scopic diagnosis was available, to use emboli-sation targeted by endoscopic clips.

A third paper published in 2008 by Larssen etal. [16] focussed on the management of 278patients with duodenal ulcers over a 5.5 yearperiod. Patients with uncontrolled or recurrentbleeding were referred for salvage therapy. Thedecision-making process was clearly not docu-mented. The initial intention was to restrict TAEto the high surgical risk group, but it quicklybecame the second-line therapy of choice,resulting in the majority of patients with

Challenges in GI bleeding: improving the evidence base

Management of gastrointestinal haemorrhageSpecial SessionTuesday, October 5, 08:30-09:30Auditorio 1A

Don't miss it !

References: 1. Barkun A, Bardou M, Marshall JK. Consensus recommendations

for managing patients with nonvariceal upper gastrointestinalbleeding. Annals of Internal Medicine 2003; 139 (10), 843-57.

2. Non-variceal upper gastrointestinal haemorrhage: guidelines.British Society of Gastroenterology Endoscopy Committee. Gut.2002; 51 Suppl 4:iv1-6.

3. Palmer K, Nairn M; Guideline Development Group.Management of acute gastrointestinal blood loss: summary ofSIGN guidelines. BMJ. 2008 Oct 10; 337:a1832. doi:10.1136/bmj.a1832.

4. Yoon W, Jeong YY, Shin SS, et al. Active massive gastrointestinalbleeding: detection and localization with arterial phase multi-detector row helical CT. Radiology 2006; 239: 160-7.

5. Barkum A, Bardou M, Kuipers E, et al. International ConsensusRecommendations on the Management of Patients WithNonvariceal Upper Gastrointestinal Bleeding Ann Int Med 2010;152:110-113

6. Kahi CJ, Jensen DM, Sung JJ, Bleau BL, Jung HK, Eckert G,Imperiale TF. Endoscopic therapy versus medical therapy forbleeding peptic ulcer with adherent clot: a meta-analysis.Gastroenterology. 2005; 129(3):855-62.

7. Lim J, Ahmed A. Endoscopic approach to the treatment of gas-trointestinal bleeding. Tech Vasc Interv Radiol 2005;7(3):123–29.

8. Marmo R, Rotondano G, Bianco MA, Piscopo R, Prisco A,Cipolletta L. Outcome of endoscopic treatment for peptic ulcerbleeding: Is a second look necessary? A meta-analysis.Gastrointest Endosc. 2003; 57(1):62-7.

9. Lau JY, Sung JJ, Lam YH, Chan AC, Ng EK, Lee DW, Chan FK,Suen RC, Chung SC. Endoscopic retreatment compared withsurgery in patients with recurrent bleeding after initial endo-scopic control of bleeding ulcers. N Engl J Med. 1999 11;340(10):751-6.

10. Nicholson T, Travis S, Ettles D, Dyet J, Sedman P, Wedgewood K,Royston C. Hepatic artery angiography and embolization forhemobilia following laparoscopic cholecystectomy. CardiovascIntervent Radiol 1999; 22: 20–24.

11. Eriksson LG, Sundbom M, Gustavsson S, Nyman R. Endoscopicmarking with a metallic clip facilitates transcatheter arterialembolization in upper peptic ulcer bleeding. J Vasc IntervRadiol. 2006; 17(6):959-64.

12. Forrest JA, Finlayson ND, Shearman DJ. Endoscopy in gastroin-testinal bleeding. Lancet 1974 17; 2(7877):394-7

13. Ripoli C, Banares R, Beceiro I et al. Comparison of transcatheterarterial embolizationand surgery for treatment of bleedingpeptic ulcer after endoscopic failure. JVIR 2004; 15:447-50

14. Eriksson LG, Ljungdahl M, Sundbom M, Nyman R. Transcatheterarterial embolization versus surgery in the treatment of uppergastrointestinal bleeding after therapeutic endoscopy failure. JVasc Interv Radiol. 2008 Oct; 19(10):1413-8.

15. Defreyne L, De Schrijver I, Decruyenaere J, Van Maele G, CeelenW, De Looze D, Vanlangenhove P. Therapeutic decision-makingin endoscopically unmanageable nonvariceal upper gastroin-testinal hemorrhage. Cardiovasc Intervent Radiol. 2008;31(5):897-905.

16. Larssen L, Moger T, Bjørnbeth BA, Lygren I, Kløw NE.Transcatheter arterial embolization in the management ofbleeding duodenal ulcers: a 5.5-year retrospective study oftreatment and outcome. Scand J Gastroenterol. 2008; 43(2):217-22.

uncontrolled or recurrent bleeding beingreferred for TAE (TAE 36, surgery 10). The TAEpatients were significantly older. Second-lookendoscopy was not routinely employed; 11 of278 patients were controlled with second-lookendoscopy, but 2 died before haemostasiscould be achieved. Empirical embolisation ofthe gastroduodenal artery was used whenthere was no angiographic abnormality. Themortality in the two groups was nearly identi-cal (surgery 20%, embolisation 19%). Technicalsuccess was 84% for endoscopy, 92% forembolisation (3 failures due to access vessels)and 100% for surgery. Clinical success was 51%,72% and 80% respectively. The authors esti-mated that two thirds of their patients weresaved from undergoing acute surgery, mainlyBillroth II resections, by successful embolisa-tion.

ConclusionEmbolisation is as effective as surgery in PUGIThaemorrhage refractory to endoscopic therapyand should be the treatment of choice foralmost all patients with TPH. The reportedequivalent outcomes, despite the use ofembolisation in a sicker group of patients, sug-gest it may be superior to surgery, but thisrequires stronger level 1 evidence. Althoughthere are ethical concerns, it is possible todesign prospective randomised trials for clini-cal situations where patient’s lives are immedi-ately threatened by active bleeding. In theinterim, the available evidence justifies theinclusion of embolisation in guidelines andalgorithms for the management of NVUGH.

C RSECardiovascular and Interventional Radiological Society of Europe

IRnewscongress

C RSECardiovascular and Interventional Radiological Society of Europe

IRnewscongress 9EVAR vs. open repair: what works best for fit and unfit patients?IRnewscongress

EVAR vs. open repair: what works best for fit and unfit patients?

IntroductionThe treatment options for asymptomatic AAAsare continuing surveillance or surgical repairaccording to size. Two modes of repair are cur-rently available for an AAA; open aneurysmrepair (OR) and endovascular aneurysm repair(EVAR). The conventional thinking is that openrepair is appropriate for young, healthypatients and EVAR for older, sicker patients ifthey are anatomically suitable. The hypothesisis that the impact of risk factors upon perioper-ative mortality might differ between patientsundergoing open repair and endovascularrepair.

Endovascular repair versus open repair inpatients with AAAEvolution in the endovascular area has influ-enced the management of AAA. The efficacy ofendovascular repair compared with open surgi-cal repair has been tested in two randomisedtrials, the EVAR I and the DREAM trial whichwere published in 2005 [1, 2]. These trials hadrelatively similar results and showed an initialsurvival advantage with the endovascular tech-nique. The 8- and 6-year follow-up results ofthe EVAR I and DREAM trials were recently pub-lished. Both trials demonstrated similar survivalrates between patients treated with OR andEVAR, but patients with EVAR in long-term fol-low-up were associated with increased rates ofgraft-related complications and reinterventions[3, 4].

Stratification scales developed for vascularsurgical proceduresIn the era of decision making, the patient’s fit-ness is an important variable predicting theoutcome of AAA surgical reconstruction. Thenecessity of accurately defining and differenti-ating the “high risk” patient from the “low risk”leads to stratification scales. Various scoringsystems, such as the Leiden Score and theGlasgow Aneurysm Score, have been consid-ered and applied to determine the fitness sta-tus. Described in 1994, the Glasgow AneurysmScore was a cardiac risk score intended solelyfor vascular surgical procedures, while one yearlater the Leiden Risk Model was developed toassess perioperative mortality in patients withAAA [5, 6]. Two more risk indices giving empha-sis to cardiac risk assessment have been devel-oped for vascular surgical procedures, theCustomized Probability Index and the L’ItalienIndex [7, 8] (Table 1).

Does EVAR or open repair work best for fitand unfit patients?Analysis of data from the EVAR 1 trial based onthe Customized Probability Index showed thatthe fittest group of patients experienced thegreatest benefit of EVAR over open repair interms of 30-day operative mortality [9]. TheGlasgow Aneurysm Score was used to predict30-day and 2-year mortality in the patientsfrom the DREAM trial. The authors concludedthat the Glasgow Aneurysm Score was mostvaluable for identifying low-risk patients andnot very useful for the identification of high-risk patients [10].

Additional data from recent literature havegiven space to relatively contradictory conclu-sions. In a recent report, Egorova et al. applieda new scoring system in 44,630 patients,assessing baseline risk factors such as renal fail-ure with dialysis, renal failure without dialysis,clinically significant lower extremity ischaemia,patient age, heart failure, chronic liver disease,female gender, neurological disorders, chronicpulmonary disease, surgeon’s experience inEVAR and hospital annual volume in EVAR [11].The authors identified a group of high-riskpatients that should not be treated with EVARbecause of prohibitively high mortality [11].

Similar results are described in a different data-base study of 862 patients. The GlasgowAneurysm Score, the Modified Leiden Scoreand the Modified Comorbidity Severity Scorewere correlated for perioperative mortality inboth open repair and endovascular reconstruc-tion [12]. This study revealed that patients atlow medical risk for open repair did not derivestatistically significant mortality benefit withEVAR, while patients at high medical risk foropen repair derived significant benefit fromEVAR [12]. On the contrary, Giles et al. evaluat-ed the risk prediction score for perioperativemortality based on 22,830 patients and using amultiple logistic regression model and con-cluded that mortality after AAA repair is pre-dicted by comorbidities, gender and age, andthese predictors have similar effects for bothmethods of AAA repair [13].

Christos D. LiapisChairman of the Department of Vascular SurgeryAthens University Medical School, AttikonUniversity HospitalAthens, Greece

EVAR vs. no-intervention for unfit patientsOnly one study, the EVAR 2 trial, randomisedpatients unfit for OR between EVAR and con-servative non-operative management. This trialdemonstrated a high operative mortality rateassociated with EVAR in the highest riskpatients [14]. The EVAR 2 trial concluded thatEVAR does not even improve survival over no-intervention for patients unfit for open repair.The message emphasised by the investigatorswas that "if the patient is high risk, the impor-tance should be to get the patient fit enoughfirst rather than perform early EVAR". The 8-yearfollow-up results of the EVAR 2 trial wererecently published. The investigators foundthat EVAR was associated with a significantlylower rate of aneurysm-related mortality thanno repair [15]. However, EVAR was not associat-ed with a reduction in the rate of death fromany cause.

References:1. Blankensteijn JD, de Jong SE, Prinssen M, van der Ham AC, Buth

J, van Sterkenburg SM, et al. Two-year outcomes after conven-tional or endovascular repair of abdominal aortic aneurysms. NEngl J Med 2005; 352:2398-405.

2. Endovascular aneurysm repair versus open repair in patientswith abdominal aortic aneurysm (EVAR trial 1): randomisedcontrolled trial. Lancet 2005; 365:2179-86.

3. Steinbauer MG, Stehr A, Pfister K, Herold T, Zorger N, Topel I, etal. Endovascular repair of proximal endograft collapse after treat-ment for thoracic aortic disease. J Vasc Surg 2006; 43:609-12.

4. Idu MM, Reekers JA, Balm R, Ponsen KJ, de Mol BA, LegemateDA. Collapse of a stent-graft following treatment of a traumaticthoracic aortic rupture. J Endovasc Ther 2005; 12:503-7.

5. Steyerberg EW, Kievit J, de Mol Van Otterloo JC, van Bockel JH,Eijkemans MJ, Habbema JD. Perioperative mortality of electiveabdominal aortic aneurysm surgery. A clinical prediction rulebased on literature and individual patient data. Arch InternMed 1995; 155:1998-2004.

6. Biancari F, Leo E, Ylonen K, Vaarala MH, Rainio P, Juvonen T. Valueof the Glasgow Aneurysm Score in predicting the immediateand long-term outcome after elective open repair of infrarenalabdominal aortic aneurysm. Br J Surg 2003; 90:838-44.

7. Kertai MD, Boersma E, Klein J, van Sambeek M, Schouten O, vanUrk H, et al. Optimizing the prediction of perioperative mortali-ty in vascular surgery by using a customized probability model.Arch Intern Med 2005; 165:898-904.

8. L’Italien GJ, Paul SD, Hendel RC, et al. Development and valida-tion of a Bayesian model for perioperative cardiac risk assess-ment in a cohort of 1,801 vascular surgical candidates. J AmColl Cardiol. 1996; 27:779-786.

9. Brown LC, Greenhalgh RM, Howell S, Powell JT, Thompson SG.Patient fitness and survival after abdominal aortic aneurysm repairin patients from the UK EVAR trials. Br J Surg 2007; 94:709-16.

10. Baas AF, Janssen KJ, Prinssen M, Buskens E, Blankensteijn JD.The Glasgow Aneurysm Score as a tool to predict 30-day and 2-year mortality in the patients from the Dutch RandomizedEndovascular Aneurysm Management trial. J Vasc Surg. 2008;47:277-81.

11. Egorova N, Giacovelli JK, Gelijns A, Greco G, Moskowitz A,McKinsey J, et al. Defining high-risk patients for endovascularaneurysm repair. J Vasc Surg. 2009; 50:1271-9

12. Faizer R, DeRose G, Lawlor DK, Harris KA, Forbes TL. Objectivescoring systems of medical risk: a clinical tool for selectingpatients for open or endovascular abdominal aortic aneurysmrepair. J Vasc Surg. 2007; 45:1102-1108.

Endovascular management of abdominal aortic aneurysmsSpecial SessionTuesday, October 5, 08:30-09:30Auditorio Principal

Don't miss it !

Leiden Risk Model [5]1995

ENDPOINT: All-cause perioperativemortality

• Myocardial infarction• Congestive heart

failure• ECG evidence of

ischemia• Chronic Pulmonary

Disease• Renal Dysfunction

• Age (<60, 60-70, >70)• Female Gender

Glasgow Aneurysm Score [6]1994

ENDPOINT: All-cause perioperativemortality

• Myocardial disease• Cerebrovascular

Disease• Renal Dysfunction

• Age

L’Italien Index [8]1996

ENDPOINT: Cardiac death andnonfatal MI

• Myocardial infarction• Congestive heart

failure• Angina pectoris

• Prior coronary revascularisation

• Diabetes mellitus

• Age >70

CustomizedProbability Index [7]2005

ENDPOINT: All-cause perioperativemortality

• Ischemic heart disease• Congestive heart

failure• Cerebrovascular

Events• Hypertension

• Chronic PulmonaryDisease

• Renal Dysfunction• Type of vascular

surgery

Ruptured aneurysms and patient’s fitnessConcerning the management of rupturedaneurysms, no sufficient available data existdescribing the influence of fitness on perioper-ative mortality after EVAR and open repair.Population review studies provide evidencethat mortality from EVAR appears to be lowerthan that of open surgery [16-18]. However,this conclusion should be balanced throughthe understanding that in these studies therewere publication bias and significant patientselectivity according to haemodynamic insta-bility, suitability for EVAR and surgeon’s prefer-ence. In addition, a randomised study – theNottingham trial – failed to demonstrate anybenefit of EVAR over OR [19]. Three randomisedstudies are currently running and in the nearfuture will attempt to elucidate whether EVARhas the potential to improve outcome afterruptured abdominal aortic aneurysm and toclarify the impact of risk factors upon perioper-ative mortality [20-22].

ConclusionAccording to the available data, there is emerg-ing evidence that patients at high medical riskfor open repair may benefit from EVAR, while inlow risk patients with suitable anatomy forEVAR, both techniques have similar effects. Thedecision-making depends on the balance ofrisks and benefits and medical advice for thetreatment of an abdominal aortic aneurysmshould be individualised. The treating physicianmust take into account the patient’s lifeexpectancy, the patient’s fitness, the anatomicsuitability that make endovascular repair possi-ble and finally the patient’s preference.

13. Giles KA, Schermerhorn ML, O'Malley AJ, Cotterill P, Jhaveri A,Pomposelli FB, Landon BE. Risk prediction for perioperativemortality of endovascular vs open repair of abdominal aorticaneurysms using the Medicare population. J Vasc Surg. 2009;50:256-62.

14. EVAR trial participants. Endovascular aneurysm repair and out-come in patients unfit for open repair of abdominal aorticaneurysm (EVAR trial 2): randomized controlled trial. Lancet.2005 1; 365:2187-92.

15. United Kingdom EVAR Trial Investigators, Greenhalgh RM,Brown LC, Powell JT, Thompson SG, Epstein D. Endovascularrepair of aortic aneurysm in patients physically ineligible foropen repair. N Engl J Med. 2010; 362:1872-80.

16. McPhee J, Eslami MH, Arous EJ, Messina LM, Schanzer A.Endovascular treatment of ruptured abdominal aorticaneurysms in the United States (2001-2006): a significant sur-vival benefit over open repair is independently associated withincreased institutional volume. J Vasc Surg. 2009; 49:817-26.

17. Giles KA, Hamdan AD, Pomposelli FB, Wyers MC, Dahlberg SE,Schermerhorn ML. Population-based outcomes followingendovascular and open repair of ruptured abdominal aorticaneurysms. J Endovasc Ther. 2009; 16:554-64.

18. Veith FJ, Lachat M, Mayer D, Malina M, Holst J, Mehta M,et al;RAAA Investigators. Collected world and single center experi-ence with endovascular treatment of ruptured abdominal aor-tic aneurysms. Ann Surg. 2009; 250:818-24.

19. Hinchliffe RJ, Bruijstens L, MacSweeney ST, Braithwaite BD. Arandomised trial of endovascular and open surgery for rup-tured abdominal aortic aneurysm – results of a pilot study andlessons learned for future studies. Eur J Vasc Endovasc Surg.2006; 32:506-13;

20. IMPROVE Trial, Powell JT, Thompson SG, Thompson MM, GrieveR, Nicholson AA, Ashleigh R, et al. The Immediate Managementof the Patient with Rupture: Open Versus Endovascular repair(IMPROVE) aneurysm trial--ISRCTN 48334791 IMPROVE trialists.Acta Chir Belg. 2009; 109:678-80.

21. Desgranges P, Kobeiter H, Castier Y, Sénéchal M, Majewski M,Krimi A. The Endovasculaire vs Chirurgie dans les AnévrysmesRompus PROTOCOL trial update. J Vasc Surg. 2010; 51:267-70.

22. Amsterdam Acute Aneurysm Trial Collaborators. AmsterdamAcute Aneurysm trial: background, design, and methods.Vascular. 2006; 14:130-5.

Table 1: Risk indices based on clinical cardiac risk factors were developed to stratify vascular surgical patients.

Special Edition / CIRSE 2010 - Valencia

10 Update on fenestrated and branched stent-grafts Tuesday, October 5, 2010

Update on fenestrated and branched stent-grafts

IntroductionEndovascular aortic aneurysm repair (EVAR) hasbeen established as an alternative to open surgi-cal repair. One of the main limitations of EVAR,however, is the need for a sufficient sealing zonebelow or above vital aortic branches. The pro-posed solution to this problem came with thecustomisation of fenestrated stent-grafts toincorporate vital aortic branches. First, short-necked infrarenal abdominal aortic aneurysmswere addressed, later juxtarenal aneurysms andeven selected suprarenal and thoracoabdominalaneurysms. The further development of stent-grafts with incorporated branches opened theway to the treatment of more complex thora-coabdominal aneurysms (TAAA).

This article discusses endovascular repair ofcomplex aortic aneurysms. In open surgery, acomplex aortic aneurysm involves the visceralbranches of the aorta and requires, at the veryleast, clamping above the renal arteries to allowa secure proximal anastomosis. This surgical def-inition therefore includes juxtarenal, suprarenaland thoracoabdominal aneurysms. Short-necked infrarenal aneurysms (i.e., neck lengthbetween 4-10 mm) are generally not regardedas suitable for standard EVAR, but they do not fitthe surgical definition of complex aorticaneurysms, as most surgeons would still consid-er infrarenal aortic clamping.

Publications on fenestrated EVAR invariablyinclude both juxtarenal and short-neckedinfrarenal aneurysms, because the endovasculartechnique is the same for both types ofaneurysms. Similarly, the surgical classificationfor thoracoabdominal aneurysms is not tailoredto endovascular techniques with fenestratedand branched grafts. The main determinant ofthe complexity of endovascular treatment is thenumber of visceral branches incorporated in therepair. Unlike open surgery, the length of aortato be treated does not add much to the techni-cal difficulty of the procedure, although it doeshave a bearing on the risk of spinal cordischaemia.

This review will discuss endovascular repair ofcomplex abdominal aortic aneurysms (short-necked infrarenal, juxtarenal and suprarenal)with fenestrated grafts, and endovascular repairof thoracoabdominal aneurysms with fenestrat-ed and branched stent-grafts. Complex abdomi-nal aneurysms and thoracoabdominalaneurysms differ not only in the extent of theaneurysm requiring treatment, but also in thecomplexity of the endovascular repair and therisks to the patient from intervention. In addi-tion, the fenestrated technique for complexabdominal aneurysms is mature, has been dis-seminated widely and there are several largeseries reporting mid-term results. By contrast,thoracoabdominal branched techniques are stillevolving, performed only in a small number ofspecialist centres and with few literature reportsof usually small series offering only short-termresults.

Endovascular repair of complex abdominalaneurysms with fenestrated grafts - current statusIn the early years of this century, several smallcase series were published, demonstrating thefeasibility of the technique [1-4]. A report fromthe Cleveland Clinic, undoubtedly the mostexperienced centre, discussed the risks of renal

impairment associated with the technique andprovided important guidance on patient selec-tion and follow-up [5]. In recent years, largerseries have been published, reporting convinc-ing and consistent early and medium-term out-comes with peri-operative mortality ratesaround 1%, and mid-term target vessel patencyrates around 95% [6-8]. Several authors havealso demonstrated the fenestrated technique tobe a promising alternative to open surgery inpatients with aneurysmal disease after previousopen or endovascular surgery [9-13].

A recently published review comparing fenes-trated EVAR and open surgery for juxtarenalAAA confirmed the lower peri-operative mortali-ty with endovascular approach, but acknowl-edged the lack of longer term data [14]. In theUnited States, a small multicentre trial was con-ducted in order to obtain graft approval fromthe US Food and Drug Administration, the out-comes of which confirmed the results of previ-ous reports [15]. The largest European experi-ences, from the Netherlands and France, haveconfirmed that fenestrated EVAR is associatedwith low peri-operative mortality, excellent tar-get vessel patency, low re-intervention rate andexcellent protection from aneurysm rupture atlonger term [16, 17].

TechniqueFenestrated stent-grafting requires access viatwo femoral arteries. The procedure can be per-formed under general or regional anaesthesiausing cut-down femoral artery exposure or apercutaneous approach. The stent-graft nowa-days is a composite prosthesis based on theZenith system (William A. Cook Australia Pty.Ltd., Brisbane, Australia), which has a self-expanding modular design with an uncoveredGianturco Z-stent (William Cook Europe,Bjaeverskov, Denmark) for proximal fixation inthe standard configuration. The proximal part ofthe graft is fitted with single or double diameterreducing ties to allow only partial deploymentprior to catheterisation of the branches and finalorientation of the stent-graft.

Customisation of the stent-grafts is based oneach individual anatomical configuration. Threetypes of fenestrations are possible: scallops,large and small fenestrations. Each fenestrationis marked by three (scallop) or four (small orlarge fenestration) radiopaque markers toenable accurate alignment. Each tube graft is fit-ted with anterior and posterior markers to facili-tate orientation during insertion and deploy-ment. Complete deployment of the stent-grafthas to be carried out after catheterisation of thebranches and secure positioning of a guidingsheath inside them. Stenting of small fenestra-tions has been applied in most cases. The pur-pose of stenting the fenestrations is to matchand secure the fenestration with the ostium ofeach branch, and (when a covered stent is used)reduce the possibility of primary endoleak.Moore et al. have published a comprehensivestep-by-step technical approach [18].

Future perspectiveAt this moment, two important developmentsare addressing open issues with fenestratedgrafting. The first one is the development of apreloaded fenestrated device that will incorpo-rate catheterisation wires and guiding sheathsinside the main introduction device (Fig. 1).Advantages should include easier and quickercatheterisation of target vessels, but also therequirement for only one iliac access vessel. Thefirst prototypes of this device have already beenused and development is ongoing (compart-mentalisation of the introduction system to

Eric L.G. Verhoeven, David E. HartleyDepartment of Vascular and Endovascular SurgeryKlinikum Nürnberg SüdNürnberg, Germany

avoid entangling of components, and a newer,easier-to-use and safer top-cap retrieval).

The second innovation, still in pre-clinical devel-opment, is an off-the-shelf fenestrated stent-graft for more acute indications. Indeed, time forplanning and manufacturing of the current cus-tomised graft easily requires 4-6 weeks. This“standard” off-the-shelf device would includethree fenestrations and a scallop and allow forflexibility in the position of the fenestrations inorder to address more than 50% of complexabdominal aortic aneurysms.

Endovascular repair of thoracoabdominalaneurysms with fenestrated and branchedgrafts - current statusA technique using a graft with four downward-pointing side branches was first described byChuter in 2001 [19]. This concept, as well as arange of fenestrated, and fenestrated/branchedcombinations was further developed by Cookand a group of interested physicians. TheCleveland Clinic group published the largestexperience to date with a series of 73 patients[20]. Technical success was achieved in 93% ofpatients (68/73) and the 30-day mortality was5.5% (4/73). Major peri-operative complicationsoccurred in 11 (14%) patients and included para-plegia (2.7%, 2/73), new onset of dialysis (1.4%,1/73), prolonged ventilator support (6.8%, 5/73),myocardial infarction (5.5%, 4/73), and minorhaemorrhagic stroke (1.4%; 1/72). Mean lengthof stay was 8.6 days. At follow-up, six deaths hadoccurred and there were no instances of stentmigration or aneurysm growth.

Recently, Haulon and colleagues published thefirst literature review of TAAA branched stent-grafting, which demonstrated encouraging out-comes, especially as most patients were high-risk for open surgery [21]. Results of publishedcase series of endovascular TAAA repair are sum-marised in Table 1 [19, 20, 22-31]. Longer termreports are awaited, but both graft and targetvessel stability appear to be good, and type Iendoleak is very uncommon. A comparison withopen repair, however, is unrealistic; firstly, mostof the patients treated by endovascular meanswere deemed unsuitable for open repair, andsecondly, one must acknowledge that anatomi-cal suitability for endovascular repair representsa selection bias.

TechniquesEndovascular branched techniques for TAAAusually require access via one or sometimes twofemoral arteries and one brachial access. Theindividual anatomy of a visceral artery and theaorta (including the diameter and quality of theaorta in the proximity of the visceral artery andthe take-off angle of the visceral artery) dictatesthe choice between a fenestration or a branch.Grafts for complex TAAA may have only fenestra-tions or only branches, or a combination ofboth. There is usually at least one pre-loadedcatheter, usually placed in the branch for thesuperior mesenteric artery. A 300cm wire can bepassed through this catheter, and snared fromthe brachial artery to allow an 80cm long 10-12Fr flexor sheath to pass into the body of themain graft. Where a graft has only downward-facing branches, each target vessel is cannulatedand the bridging stent-graft deployed beforemoving to the next target vessel. For graftswhich also have fenestrations, catheterisation ofthese fenestrations is mandatory before com-plete deployment of the stent-graft (as in fenes-trated technique described above).

Future perspectiveThe technique of endovascular TAAA repair hasevolved at an all together slower pace com-

pared with the fenestrated technique for com-plex abdominal aortic aneurysms, probably dueto the smaller proportion of thoracoabdominalaneurysms. Two important improvements to thegraft with downward-pointing side brancheshave been made. Tapering the main graft at thelevel of the branches creates room for thebranches to open fully within the lumen of theaneurysm and greatly facilitates the catheterisa-tion process and the introduction of the bridg-ing covered stents (Fig. 2). The second improve-ment is the deliberate off-set positioning ofbranches in terms of their orientation, whichagain creates room for catheterisation andavoids obstruction of lower target vessels by abranch. This is often important for the celiactrunk and superior mesenteric artery (Fig. 2).

Chuter et al. recently focused on device optionswith regard to fenestrations and different typesof branches (type of orientation, internal/exter-nal, caudally directed, axial, helical) as well as thepotential standardisation of branched grafts, inan attempt to make them available off-the-shelf[32-34]. A certain degree of misalignment anddistance between graft branch and target vesselhas been shown to have no detrimental effecton the feasibility of multi-branched stent-graftinsertion. Interestingly, it may be possible totreat almost 90% of TAAA cases with a standardoff-the-shelf multi-branched stent-graft, therebyeliminating long manufacturing delays andexpanding the scope of endovascular repair tothe treatment of symptomatic or even rupturedTAAA.

References:1. Anderson JL, Berce M, Hartley DE. Endoluminal aortic grafting

with renal and superior mesenteric artery incorporation bygraft fenestration. J Endovasc Ther 2001; 8(1):3-15.

2. Greenberg RK, Haulon S, Lyden SP, Srivastava SD, Turc A,Eagleton MJ, et al. Endovascular management of juxtarenalaneurysms with fenestrated endovascular grafting. J Vasc Surg2004; 39(2):279-287.

3. Greenberg RK, Haulon S, O'Neill S, Lyden S, Ouriel K. Primaryendovascular repair of juxtarenal aneurysms with fenestratedendovascular grafting. Eur J Vasc Endovasc Surg 2004;27(5):484-491.

4. Verhoeven EL, Prins TR, Tielliu IF, van den Dungen JJ, ZeebregtsCJ, Hulsebos RG, et al. Treatment of short-necked infrarenal aor-tic aneurysms with fenestrated stent-grafts: short-term results.Eur J Vasc Endovasc Surg 2004; 27(5):477-483.

5. Haddad F, Greenberg RK, Walker E, Nally J, O’Neill S, Kolin G, etal. Fenestrated endovascular grafting: The renal side of thestory. J Vasc Surg 2005; 41(2):181-90.

6. O’Neill S, Greenberg RK, Haddad F, Resch T, Sereica J, Katz E. Aprospective analysis of fenestrated endovascular grafting:Intermediate-term outcomes. Eur J Vasc Endovasc Surg 2006;32(2):115-23.

7. Muhs BE, Verhoeven EL, Zeebregts CJ, Tielliu IF, Prins TR,Verhagen HJ, et al. Mid-term results of endovascular aneurysmrepair with branched and fenestrated endografts.J Vasc Surg2006; 44(1):9-15.

8. Ziegler P, Avgerinos ED, Umscheid T, Perdikides T, Stelter WJ.Fenestrated endografting for aortic aneurysm repair: a 7-yearexperience.J Endovasc Ther 2007; 14(5):609-18.

9. Adam DJ, Berce M, Hartley DE, Anderson LJ. Repair of juxtarenalpara-anastomotic aortic aneurysms after previous openaneurysm repair with fenestrated and branched endovascularstent-grafts. J Vasc Surg 2005; 42:997-1001.

10. Adam DJ, Fitridge RA, Berce M, Hartley DE, Anderson JL.Salvage of failed prior endovascular abdominal aorticaneurysm repair with fenestrated endovascular stent-grafts. JVasc Surg 2006; 44:1341-44.

11. Verhoeven EL, Muhs BE, Zeebregts CJ, Tielliu IF, Prins TR, BosWT, et al. Fenestrated and branched stent-grafting after previ-ous surgery provides a good alternative to open redo surgery.Eur J Vasc Endovasc Surg 2007; 33(1):84-90.

12. Beck AW, Bos WT, Vourliotakis G, Zeebregts CJ, Tielliu IF,Verhoeven EL. Fenestrated and branched endograft repair ofjuxtarenal aneurysms after previous open aortic reconstruction.J Vasc Surg 2009; 49(6):1387-94.

13. Vourliotakis G, Bos WT, Beck AW, Van Den Dungen JJ, Prins TR,Verhoeven EL. Fenestrated Stentgrafting after PreviousEndovascular Abdominal Aortic Aneurysm Repair. J CardiovascSurg 2009 May 19 [Epub ahead of print]

14. Nordon IM, Hinchliffe RJ, Holt PJ, Loftus IM, Thompson MM.Modern treatment of juxtarenal abdominal aortic aneurysmswith fenestrated endografting and open repair-a systematicreview. Eur J Vasc Endovasc Surg 2009; 38(1):35-41.

15. Greenberg RK, Sternbergh WC 3rd, Makaroun M, Ohki T, ChuterT, Bharadwaj P, et al. Intermediate results of a United Statesmulticenter trial of fenestrated endograft repair for juxtarenalabdominal aortic aneurysms. J Vasc Surg. 2009; 50(4):730-737.

16. Verhoeven EL, Vourliotakis G, Bos WT, Tielliu IF, Zeebregts CJ,Prins TR, et al. Fenestrated Stent Grafting for Short-necked andJuxtarenal Abdominal Aortic Aneurysm: An 8-year Single-cen-tre Experience, Eur J Vasc Endovasc Surg 2010; 39(5):529-536.

17. Amiot S, Haulon S, Becquemin JP, Magnan PE, Lermusiaux P,Goueffic Y, et al. Fenestrated Endovascular Grafting: The FrenchMulticenter Experience, Eur J Vasc Endovasc Surg 2010;39(5):537-44.

18. Moore R, Hinojosa CA, O'Neill S, Mastracci TM, Cinà CS.Fenestrated endovascular grafts for juxtarenal aorticaneurysms: a step by step technical approach. CatheterCardiovasc Interv 2007; 69(4):554-71.

Authors Year No Technical 30d mort 1-yr survivalsuccess

Chuter19,22 2001 1 100% - -

Anderson23 2005 4 75% 25% 75%

Greenberg24(*) 2006 9 89% 0% 78%

Simi25 2007 1 100% - -

Roselli20 (*) 2007 73 93% 5.5% 81%

Chuter 26 2008 22 100% 9.1% 77%

Gilling-Smith 27 2008 6 100% 0% 100%

Ferreira 28 2008 11 - 23.7% 76.3%

Bicknell29 2009 8 100% 0% -

Verhoeven30 2009 30 93% 6.7% 76%

Haulon31 2010 33 94% 9% 82%

C RSECardiovascular and Interventional Radiological Society of Europe

11Update on fenestrated and branched stent-grafts / The Early Days of IRIRnewscongress

Endovascular management of abdomi-nal aortic aneurysmsSpecial SessionTuesday, October 5, 08:30-09:30Auditorio Principal

Don't miss it !

* same series

19. Chuter TA, Gordon RL, Reilly LM, Goodman JD, Messina LM. Anendovascular system for thoracoabdominal aortic aneurysmrepair. J Endovasc Ther 2001; 8: 25-33.

20. Roselli EE, Greenberg RK, Pfaff K, Francis C, Svensson LG, LytleBW. Endovascular treatment of thoracoabdominal aorticaneurysms. J Thorac Cardiovasc Surg 2007; 133: 1474-1482.

21. D’Elia P, Tyrrell M, Sobocinski J, Azzaoui R, Koussa M, Haulon S.Endovascular thoracoabdominal aortic aneurysm repair: a liter-ature review of early and mid-term results. J Cardiovasc Surg2009; 50:439-445.

22. Chuter TAM, Gordon RL, Reilly LM, Pak LK, Messina LM. Multi-branched stent-graft for type III thoracoabdominal aorticaneurysm. J Vasc Interv Radiol 2001; 12: 391-392.

23. Anderson JL, Adam DJ, Berce M, Hartley DE. Repair of thora-coabdominal aortic aneurysms with fenestrated and branchedendovascular stent grafts. J Vasc Surg 2005; 42: 600-607.

24. Greenberg RK, Lytle B. Endovascular repair of thoracoabdomi-nal aneurysms. Circulation. 2008; 117:2288-2296.

25. Simi A, Ishii R, Ferreira M, Santos A, Simi AC. Branched endovas-cular stent graft for thoracoabdominal aortic aneurysm repair. JVasc Bras 2007; 6: 86-91.

26. Chuter TA, Rapp JH, Hiramoto JS, Schneider DB, Howell B, ReillyLM. Endovascular treatment of thoracoabdominal aorticaneurysms. J Vasc Surg. 2008; 47:6-16.

27. Gilling-Smith GL, McWilliams RG, Scurr JRH, Brennan JA, FisherRK, Harris PL, Vallabhaneni SR. Wholly endovascular repair ofthoracoabdominal aneurysm. Br J Surg 2008; 95:703-708.

28. Ferreira M, Lanziotti L, Monteiro M. Branched devices for thora-coabdominal aneurysm repair: Early experience. J Vasc Surg2008; 48:30S-36S.

29. Bicknell CD, Cheshire NJW, Riga CV, Bourke P, Wolfe JH, GibbsRG, et al. Treatment of Complex Aneurysmal Disease withFenestrated and Branched Stent Grafts. Eur J Vasc EndovascSurg 2009; 37:175-181.

30. Verhoeven EL, Tielliu IF, Bos WT, Zeebregts CJ. Present andfuture of branched stent grafts in thoracoabdominal aorticaneurysm repair: a single-centre experience. Eur J VascEndovasc Surg. 2009; 38:155-161.

31. Haulon S, D’Elia P, O’Brien N, Sobocinski J, Perrot C, Lerussi G, etal. Endovascular repair of thoracoabdominal aortic aneurysms.Eur J Vasc Endovasc Surg 2010; 39:171-8.

32. Reilly LM, Chuter TAM. Endovascular repair of thoracoabdomi-nal aneurysms: design options, device construct, patient selec-tion and complications. J Cardiovasc Surg 2009; 50:447-60.

33. Park KH, Hiramoto JS, Reilly LM, Sweet M, Chuter TA. Variation inthe shape and length of the branches of a thoracoabdominalaortic stent graft: Implications for the role of standard off-the-shelf components. J Vasc Surg 2010; 51(3):572-6.

34. Sweet MP, Hiramoto JS, Park KH, Reilly LM, Chuter TAM. AStandardized Multi-Branched Thoracoabdominal Stent-Graft forEndovascular Aneurysm Repair. J Endovasc Ther 2009; 16:359-364.

Fig.1: Introduction system of the preloaded fenestrated graft including the wires and guiding sheaths forthe catheterisation of the target vessels.

Fig.2: Branched graft with tapering of the bodygraft diameter to allow for room for the branchesand deliberate off-set positioning of branches forthe celiac artery and the superior mesenteric artery.

Table 1

The Early Days of IRThe Seldinger Technique

Interventional radiology was born in 1963,but it would not have been possible withoutthe early innovations of pioneer radiolo-gists.

Largely credited as being the single mostimportant innovation to enable interventionalradiology, the Seldinger Technique has beenused for almost 60 years. The straight-forward-ness of the technique belies the difficultiesfaced by innovators to find a safe and practicalway to insert a catheter into a blood vessel. Butfinally, in 1952, a young Swedish radiologistnamed Sven-Ivar Seldinger came up with theanswer.

The quest to find the solution began in 1940. ACuban radiologist, Fariñas, managed to intro-duce a catheter into the aorta by means of asurgical incision in the femoral artery. While ahighly commended breakthrough, most doc-tors, including Fariñas himself, had their reser-vations. It was a start, but there were still toomany hazards associated with it - and besides,accessing the aorta was not enough. A way toallow access to more vessels was needed.

So the odyssey continued, with doctors such asLund and Jönsson in Sweden, Cournand,Richards, Miller, Freeman and Pierce in the USA,Euler in Germany and Ponsdomenech andBeato-Nuñez in Cuba putting all their effortsinto finding the answer.

Problems were manifold. Surgical openingsincreased the risk of infection and haemor-rhage, so a hollow needle was devised throughwhich the catheters could be fed. But thecatheters were too flexible - once inside theartery, it was impossible to advance or steerthem properly. So the idea of a guidewire wasborn - but how to advance it without injuringthe delicate walls of the blood vessels? It was atricky one.

However, in 1952, our hero (at the time ayoung resident at the soon-to-be-famousKarolinska Institute in Sweden) stood in a lab,unsuccessfully attempting to practice insertinga catheter through a hollow needle, and thenintroducing a guidewire to support it. To noavail. It just would not work. But the darkesthour comes right before the dawn, and in light-ning-bolt eureka moment, he suddenly realisedhow to crack the puzzle.

The materials (hollow needle, catheter andguidewire) were the right instruments, but he,and everyone before him, had been usingthem in the wrong order. Instead of needle-catheter-wire, the logical and workable order ofdoing things was:needle in, wire in· needle out, catheter placed over wire· insert catheter, remove wire

Portrait taken from the article by Greitz,T, Sven-Ivar Seldinger, American Journal of Neuroradiology 20:1180-1181, 6, 1999, © by American Society of Neuroradiology.

Seldinger had, in a split second’s inspiration,devised a safe and easy way to gain catheteraccess to virtually every vessel and organ in thebody. His first published paper appeared inActa Radiologica in 1953, bringing his newmethod to the radiologists of the world. Intime, this discovery was to win him both fameand acclaim in medical circles, but bizarrely, hischief at the Department of Radiology at theKarolinska Institute did not think that this dis-covery was enough to form the basis for a doc-toral thesis. So Seldinger began to researchanother proj ect, investigating percutaneoustranshepatic cholangiography and defendedhis thesis in 1966.

Despite his ingenious discovery, Seldingernever looked for acclaim, never became a pro-fessor, and worked quietly and diligently asChief of Radiology in the hospital of his home-town of Mora, a small town in northernSweden, from 1967 until his retirement.

Seldinger’s breakthrough, effectively the ignit-ing spark to a collaborative project that hadtaken over a decade, allowed for diagnosticangiography to come into its own, and 11 yearslater, was to lead to yet another eurekamoment of medical discovery - the first percu-taneous angioplasty.

With thanks to Professors Lars Lönn and UlfNymen for their insights

The Seldinger Techniquea) The artery punctured. The needle pushedupwards. b) The leader inserted. c) The needlewithdrawn and the artery compressed. d) Thecatheter threaded on to the leader. e) Thecatheter inserted into the artery. f ) The leaderwithdrawn.

Taken from the original manuscript by Seldinger,Sven Ivar (1953) 'Catheter Replacement of theNeedle in Percutaneous Arteriography: A newtechnique', Acta Radiologica [Old Series], 39:5,368-376(http://informahealthcare.com/loi/ard)

Sven-Ivar Seldinger 1921-1998“Founder of Seldinger Technique”• Qualified as Docent of Radiology, 1967• Presented with the Valentine Award by

the New York Academy of Medicine, 1975• Awarded honorary membership to both the

Swedish Association of Medical Radiologyand the German Roentgen Association

Reproduced by kind permission of Interventional Quarter magazine.

C RSECardiovascular and Interventional Radiological Society of Europe

13Tissue examinations from ablated liver tumoursIRnewscongress

Tissue examinations from ablated liver tumours

Ablation of tumours has become an acceptedalternative treatment for selected non-surgicalpatients with liver malignancies. Several publi-cations reported promising outcomes andoverall survival comparable to surgery. Despitethe safety and efficiency of the modality, abla-tion has several limitations.

One of the most important limitations is that atthe end of ablation there is no method to con-firm that the tumour has been completelytreated. The lack of tissue examinations andevaluation of the ablation margin remain animportant limitation of the technique whencompared to resection. This limitation mayexplain the relatively high rate of local tumourprogression (LTP) reported after percutaneousradiofrequency ablation (RFA).

Prior series have performed histologic exami-nations in ablated tumours that were resectedin animals as well as in humans. Some of theseexaminations demonstrated that thermal injury(tumour necrosis) may not be evident in histo-logical examinations until 24 or even 72 hoursafter treatment. Other studies demonstratedcoagulation necrosis on a significant number ofablated tumours evaluated immediately afterablation. Immunohistochemistry with the useof cytosolic (LDH ase) or mitochondrial (NADPHase) viability stains have been applied anddemonstrated lack of viability in ablated cellsthat may maintain their morphology.

Areas of tumour have been seen on other studieswhen examining tissue extracted on multitinedRF electrodes after treatment of liver tumours. Inrecent studies collected tissue from multitinedelectrodes was evaluated by histopathology withthe use of routine Hematoxylin and Eosin (H & E)stains that showed necrosis in up to 40% of spec-imens immediate after ablation, whereas in 60%of the specimens cellular characteristics ortumour could be identified. The limitation of thisstudy was addressed with the application of pro-liferation and apoptotic immunohistochemicalevaluation.

Specifically, we used the proliferation marker Ki67 in order to evaluate whether cells morpho-logically identified as tumour maintain theirability to proliferate. Ki 67 is a nuclear compo-nent during late G1, S, G2 and M phases.Polyclonal antibodies detecting Ki-67 will bepositive in the proliferation phase of cell cycleconsistent with cell viability. This marker wasused in combination with the apoptotic markercaspase 3. Caspase 3 is involved in the latestages of cell death. Polyclonal antibodies tocaspase 3 were utilised for immunohistochemi-cal evaluation of necrosis. Using the combina-tion of H&E morphologic stains, we examined allfragments of tissue adherent on multitined elec-trodes (RITA XL, Angiodynamics and LeVeen,Boston Scientific) that were used for the abla-tion of 68 tumours. In this cohort we showedthat the presence of proliferation marker Ki67 intumour cells was associated with high rates ofLTP. Specifically for tumours measuring under 5cm in larger diameter, the presence of Ki-67 pos-itive cells extracted on the electrode after RFA ofliver tumours was associated with a hazard ratioof 6 (P < 0.001) and for tumours under 3 cmwith a hazard ratio of 10 (P<0.001) for LTP.

Constantinos SofocleousDivision of Interventional Radiology and Image-Guided TherapiesMemorial Sloan Kettering Cancer CenterNew York, USA

Since that study, published in 2008, we havecontinued follow-up of the patients treated. Asof our latest follow-up in 2010, median pro-gression free survival was 50 vs. 5 months forcompleted coagulated and Ki67 negative speci-mens when compared to those that had Ki 67positive tumour cells (p<0.001). The overall sur-vival for the patients with coagulated/Ki67 neg-ative specimens was 41 compared with 21months for those patients with Ki67 positivetumours cells (p =0.032).

The current methodology is limited and onlyoffers evaluation of tissue extracted on theelectrode. The areas of the tumour betweenthe tines are not interrogated and this canexplain the occurrence of LTP even in speci-mens that were found to be completely coagu-lated by histopathology. Furthermore, theapplied methodology does not allow theimmediate assessment of the ablated area dur-ing or immediately after treatment as it is donewith the frozen section methodology duringsurgery. Despite these limitations, these earlyresults are important because they show howthe use of tissue extracted on multitined elec-trodes can be examined by histopathology andbe used as prognostic biomarker of outcomes.Specifically, such examinations can identifypatients at risk for LTP and even shorter sur-vival after treatment.

In an ongoing effort to improve the methodol-ogy of ablated tumour examinations we arecurrently enrolling in an NIH supported trial ofpatients with colon cancer liver metastasesundergoing ablation. At the end of ablation, wecollect all tissue fragments extracted on theelectrode. Additionally, we perform biopsies ofthe epicentre and margin of the ablation defect

References:1. Chinn SB, Lee FT, Kennedy GD et al: Effect of vascular occlusion

on RFA of the liver: results in a porcine model. AJR 2001;176:789-795

2. Raman SS, Lu DK, Vodopich DJ et al: Creation of Radiofrequencylesions in a porcine model: correlation with sonography, CT andhistopathology. AJR 2000; 175:1253-1258.

3. Sugimori K, Morimoto M, Shirato K et al RadiofrequencyAblation in a pig liver model: effect of transcatheter arterialembolization on coagulation diameter and histological charac-teristics. Hepatol Res 2002; 24:164-173

4. Goldberg SN, Gazelle GS, Compton CC et al: Treatment of intra-hepatic malignancy with radiofrequency ablation: radiologic-pathologic correlation Cancer 2000; 11: 2452-2463

5. Morimoto M, Sugimori K, Shirato K et al: Treatment of hepato-cellular carcinoma with radiofrequency ablation: radiologic-his-tologic correlation during follow-up periods. Hepatology 2002;35:1467-1475

6. Sofocleous CT, Klein K, Hubbi B, Baker SR et al. AJR 2004 Jul;183(1):209-13.

7. Scholzen T GJ. The Ki-67 Protein: from the known and theUnknown J. Cell. Physiol. 2000; 182:311-322.

8. Sofocleous CT, Nascimento R, Petrovic L, Brown KT, et al:Histopathologic and Immunohistochemical Features of TissueAdherent to Multitined electrodes after RF Ablation of LiverMalignancies can Help Predict LTP. Radiology 249:1, October2008

9. Snoeren N, Jansen MC, Rijken AM et al: Assessment of ViableTumour Tissue Attached to Needle Applicators after LocalAblation of Liver Tumours Dig Surg 2009; 26:56-62

Endovascular management of abdominal aortic aneurysmsSpecial SessionTuesday, October 5, 08:30-09:30Auditorio Principal

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as depicted by contrast enhanced CT. The col-lected tissue is then processed and evaluatedwith different immunohistochemical and fluo-rescent essays in order to better define theoptimal examination for immediate assessmentof ablated tumours. Such an examinationshould provide key information about the sta-tus of the tumour cells at the end of ablation.This information will identify patients at riskwho will benefit from additional treatmentprior to the radiographic evidence of recurrentdisease. As targeted therapies evolve, the iden-tification of specific tumour biomarkers thatmay hold prognostic value has been recog-nised. The application of such biomarkers inthe evaluation of ablated tumours is of greatimportance for the improvement of ablation asa therapeutic option in cancer.

Today’s Featured Papers

FP 2607Oncologic interventions 3: tumour ablationTumour response to transarterial chemoem-bolization in hepatocellular carcinoma: rela-tionship between amended RECIST criteriaand histopathologic tumour necrosisI. Bargellini, V. Battaglia, D. Campani, P. Carrai, R. Cioni, F. Filipponi, C. Bartolozzi; Pisa/IT

Location: Sala 4F

FP 2608PVD 3Arterial closure devices versus manual com-pression for femoral haemostasis in inter-ventional radiological procedures: a system-atic review and meta-analysisR. Das, K. Ahmed, T. Athanasiou, R.A. Morgan, A.-M. Belli; London/UK

Location: Sala 3A

FP 2609 Embolotherapy: UFEDeformation influences arterial distribution:embozene vs embosphere in sheep kidneyand uterusV. Verret1, J.-P. Pelage2, M. Wassef1, S.H. Ghegediban1, J. Golzarian3, A. Laurent1;1Paris/FR, 2Boulogne/FR, 3Minneapolis, MN/US

Location: Sala 3F

will be presented in Free Paper sessions takingplace 17:00 – 18:00

Stay up to date on thelatest CIRSE and CIRSEFoundation activitiesby becoming a fan ofthe CIRSE facebooksite!

Join CIRSE on Facebook!

Be it photos of thelast CIRSE event orinformation on upco-ming registries andtrials, it’s all just a click away.

Special Edition / CIRSE 2010 - Valencia

Cordis has launched a new vascular closuredevice in 2010 and completed its portfoliofrom “Stick to Seal” with this exciting product.EXOSEALTM is combining an easy-to-use func-tionality with a trusted bioabsorbable plug anda precise extravascular positioning.

The ExoSealTM Vascular Closure Device incor-porates key advancements including the use ofthe Polyglycolic Acid Plug, two visual indicatorsto moderate control of the device and lockoutfeatures to reduce the risk of complications.The device is designed for ease of use, reduc-ing the number of components and deploy-ment steps.

The EXOSEALTM clinical study ‘ECLIPSE’ record-ed no adverse clinical events and achieved alevel of safety comparable to manual compres-sion while significantly reducing time to ambu-lation.

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HT Winn is the first peripheral solution forchronic occlusions. It features three tip diame-ters with increasing stiffness to cross any chal-lenging lesion. HT Winn has been designedwith innovative features that improve tactilefeedback, increase steering and control andmaximize pushability – all to allow physiciansto cross the most challenging of infrapoplitealocclusions.

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C RSECardiovascular and Interventional Radiological Society of Europe

15Irreversible electroporationIRnewscongress

Electroporation is a technique that increasescell membrane permeability by changing thetransmembrane potential and subsequentlydisrupting the lipid bilayer integrity to allowtransportation of molecules across the cellmembrane via nano-size pores. This process –when used in a reversible fashion – has beenused in research for drug or macromoleculedelivery into cells.

Irreversible electroporation (IRE) is a method toinduce irreversible disruption of cell membraneintegrity, resulting in cell death without theneed for additional pharmacological injury [1-3].

IRE creates a sharp boundary between thetreated and untreated area in vivo. This wouldsuggest that IRE has the ability to sharply delin-eate the treated area from the non-treated, andthat treatment planning can be precisely per-formed according to mathematical predictions[2, 4, 5]. In addition, IRE can effectively createtissue death in micro- to millisecond ranges oftreatment time compared to conventionalradiofrequency ablation techniques, whichrequire at least 20 minutes to hours. Moreover,because IRE is a non-thermal technique, thereappears to be complete ablation to the marginof blood vessels without compromising thefunctionality of the blood vessels. Therefore,issues associated with perfusion-mediated tis-sue cooling or heating (a significant challengewith thermal ablation methods) are not rele-vant [1-4].

The IRE System (NanoKnife, AngioDynamicsInc.) consists of two major components: a gen-erator and needle-like electrical probes. Thegenerator can deliver up to 3,000 V of energy ina maximum of 100 pulses, which have a maxi-mum pulse length of 100 µsec. The generatorhas user-controlled settings of voltage, pulselength and number of pulses applied, and isdesigned to be used in conjunction with specif-ic electrode probes. The electrode probe is 19gauge in diameter and either 15cm or 25cm inlength, with an active tip that can be exposedup to 4cm. Two or more monopolar probes or asingle bipolar probe must be used at a time.The number of monopolar probes that areused during an IRE procedure is dependent onthe size and shape of the desired zone of tissueablation. The system can be used with up to sixsingle electrode probes at one time. The treat-ment parameter for voltage is dependent onthe distance between probes within the target-ed tissue.

The basic principles of operation of the IRE sys-tem consist of powering the unit on, enteringpatient and treatment parameters into the sys-tem interface, placement of electrode probesinto the tissue that is targeted for ablation, acti-vation of the system to deliver the desiredtreatment, and removal of the probes from thetissue. IRE is administered under general anaes-thesia with administration of atracurium, cis-atracurium, pancuronium or an equivalent neu-romuscular blocking agent to prevent undesir-able muscle contraction [6].

IRE affects tissue in a way that can be imagedin real-time with ultrasound, which shouldfacilitate real-time control of electroporationduring clinical applications. After treatment inexperimental models, an extremely rapid reso-lution of lesions has been reported – withintwo weeks – which is consistent with retentionof vasculature. Tentative evidence for animmunological response to the ablated tissuewas also demonstrated. With non-thermal celldeath and a markedly decreased treatmenttime, IRE provides a potential new ablationmethod that can be operated in a well-con-trolled and focused manner under image-mon-itoring. Additionally, it may be possible to treata considerably larger lesion with shorter treat-ment times than available with current tech-niques [3, 4].

Preclinical investigation focused on hepatocel-lular carcinoma (HCC) has shown promisingresults. In a recent study, HCC tumours weregrown in 30 Sprague-Dawley rats that weredivided into treatment and control groups [7].In the treatment groups, IRE electrodes wereinserted and eight 100 µsec, 2,500-V pulseswere applied to ablate the targeted tumour tis-sues. Pathology correlation studies document-ed progression from poorly differentiatedviable HCC tissues before treatment to exten-sive tumour necrosis and full regression in 9 of10 treated rats 7 to 15 days after treatment [7].

These findings suggest that IRE can be an effec-tive strategy for targeted ablation of HCC andhave prompted its clinical evaluation. The pilotclinical study, “A Prospective, Multi-Center,Clinical Trial Using Irreversible Electroporationfor the Treatment of Early-Stage HepatocellularCarcinoma”, aimed at investigating safety andefficacy - as measured by modified ResponseEvaluation Criteria In Solid Tumours (mRECIST)criteria by computed tomography (CT) or mag-netic resonance (MR) imaging [8] – has alreadybeen started [9].

In summary, IRE represents an innovative,promising method of ablation and maybecome an important new tool in theInterventional Radiology armamentarium.

Riccardo LencioniProfessor and Director, Division of Diagnostic Imaging and Intervention, Department of Liver Transplantation, Hepatology and Infectious DiseasesPisa University HospitalPisa, Italy

Fig.1: Irreversible electroporation of small hepato-cellular carcinoma. Monopolar mode with place-ment of 3 electrodes in a triangular fashion. Theexpected treatment zone, as shown (in grey) onthe screen of the system before the start of theprocedure, includes the target tumour (yellow cir-cle) as well as a peritumoural ablative margin (a).The hypoechoic area seen on the ultrasoundimage obtained immediately after the procedure(b) matches the expected treatment zone. Thehyperehoic spots correspond to the location ofthe electrodes. Subsequent computed tomogra-phy follow-up has confirmed complete tumourresponse.

Irreversible electroporation: Moving frombench investigation to clinical experience

Interventional oncology at the cellular levelSpecial SessionTuesday, October 5, 08:30-09:30Sala 3F

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References:1. Davalos RV, Mir IL, Rubinsky B. Tissue ablation with irreversible

electroporation. Ann Biomed Eng 2005; 332:23-2312. Lee EW, Loh CT, Kee ST. Imaging guided percutaneous irre-

versible electroporation: ultrasound and immunohistologicalcorrelation. Technol Cancer Res Treat 2007; 6:287-94

3. Rubinsky B, Onik G, Mikus P. Irreversible electroporation: a newablation modality-clinical implications. Technol Cancer ResTreat 2007; 6:37-48

4. Lencioni R. Loco-regional treatment of hepatocellular carcino-ma. Hepatology 2010 [Epub ahead of print]

5. Edd JF, Horowitz L, Davalos RV, Mir LM, Rubinsky B. In vivoresults of a new focal tissue ablation technique: irreversibleelectroporation. IEEE Trans Biomed Eng 2006; 53:1409-15

6. Ball C, Thomson KR, Kavnoudias H. Irreversible electroporation:A new challenge in "out of operating theater" Anesthesia.Anesth Analg 2010; 110:1305-1309

7. Guo Y, Zhang Y, Klein R, Nijm GM, Sahakian AV, Omary RA, et al.Irreversible electroporation therapy in the liver: longitudinalefficacy studies in a rat model of hepatocellular carcinoma.Cancer Res 2010; 70:1555-1563

8. Lencioni R, Llovet JM. Modified RECIST (mRECIST) assessment inhepatocellular carcinoma. Semin Liver Dis 2010; 30:52-60

9. www.clinicaltrials.gov: NCT01078415 (accessed July 12, 2010)

Fig.1a.

Fig.1b.

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Special Edition / CIRSE 2010 - Valencia

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NavAlign Delivery System for IVC Filters

Positioned in the main vein that collects bloodfrom the lower part of the body, IVC filters aredesigned to trap the blood clots before theyget to the lungs. Traditionally, they are placedusing fluoroscopy by threading a catheterguided through the veins.

The introduction of Cook's NavAlign systemincorporates new technology allowing physi-cians to navigate tortuous anatomy withgreater speed and safety than previous Cookdelivery systems. NavAlign, available for boththe Cook Celect® and Günter Tulip® filters inboth jugular and femoral access versions and ina universal access set, is designed to minimisevessel trauma and streamline filter placement.A hemostatsis valve minimises blood loss at thepoint of entry, while a multipurpose dilator hasradiopaque sizing bands and flushing sideportsthat help to decrease fluoroscopy time and theamount of contrast medium required.

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The risk for pulmonary embolism increaseswith age and occurs equally in men andwomen. For every 10 years after the age of 60,the risk of PE doubles.Those at high risk for PEinclude those who have deep vein thrombosis(DVT) or those who have had a PE in the past.In addition, people who are immobile due toillness or have had recent surgery or suffered abroken bone in the last few weeks are atincreased risk for PE3.

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The NavAlign system has been designed tominimise the risk of patient trauma during filterdelivery. The new system is designed to addprocedural speed, control and accuracy, simpli-fying femoral and jugular deployment of IVCfilters.

1 Statistics by country for pulmonary embolism.Wrong Diagnosis website. http://www.wrong-diagnosis.com/p/pulmonary_embolism/stats-country.htm. Accessed August 18, 2010.

2 PDR health blood clots: pulmonary embolism.Physicians Desktop Reference website. 2009.http://www.pdrhealth.com/disease/disease-mono.aspx?contentFileName=BHG01CA10.xml&contentName=Blood+Clots%3A+Pulmonary+Embolism&contentId=13. Accessed August18, 2010.

3 National Heart Lung and Blood Institute. Whois at risk for Pulmonary Embolism?http://www.nhlbi.nih.gov/health/dci/Diseases/pe/pe_risk.html. Accessed August 18, 2010

For over three decades CookMedical has been at the forefrontof developing new technologiesfor the prevention of pulmonaryembolisms (PE). Since 1989, whenCook introduced the Bird's Nest®IVC filter to the U.S. market, over200,000 patients worldwide havereceived Cook products designedto help prevent PE. The release ofthe NavAlign™ delivery system inthe U.S. in 2009 marked the 20thanniversary of Cook’s first IVC fil-ter, further advancing the preven-tion of PE, a life-threatening con-dition caused by blood clots in thelungs that affects millions of peo-ple globally1.

18 Standards of Practice Tuesday, October 5, 2010

Special Edition / CIRSE 2010 - Valencia

Setting Standards in Patient Treatment – The Activities of the SOP Committee in 2009

· Quality Improvement Guidelines forPlacement of Oesophageal Stents

· Quality Improvement Guidelines forPercutaneous Vertebroplasty

· Quality Assurance Guidelines for SuperiorVena Cava Stenting in Malignant Disease

· Quality Assurance Guidelines for theEndovascular treatment of Occlusive Lesionsof the Subclavian and Innominate Arteries

· Quality Assurance Guidelines for thePerformance of Carotid Stenting

· Quality Assurance Guidelines for Placementof Gastroduodenal Stents

· Quality Improvement Guidelines forEndovascular Treatment of Iliac ArteryOcclusive Disease

· Standards for the Endovascular Managementof Aortic Occlusive Disease

· Patient Radiation Dose Management (©2009, Society of Interventional Radiology. Allrights reserved.)

· Periprocedural Management of CoagulationStatus and Hemostasis Risk in PercutaneousImage-guided Interventions (© 2009, Societyof Interventional Radiology. All rightsreserved.)

· Treatment of Lower Extremity SuperficialVenous Insufficiency with AmbulatoryPhlebectomy (© 2009, Society ofInterventional Radiology. All rights reserved.)

· Treatment of Lowerextremity SuperficialVenous Insufficiency with EndovenousThermal Ablation (© 2009, Society ofInterventional Radiology. All rights reserved.)

· Guidelines for Peripheral and VisceralVascular Embolization Training (© 2009,Society of Interventional Radiology. All rightsreserved.)

“Quality is everyone’s responsibility.”William Edwards Deming

Quality Improvement Guidelines andStandard of Practice Documents currentlyavailable on www.cirse.org: 21

CIRSE would like to thank the Society ofInterventional Radiology (SIR) for its cooper-ation in the production of SOP documents.SIR documents can be viewed onwww.cirse.org and www.sirweb.org.

SOP Documents currently available atwww.cirse.org:

· Occupational radiation protection for inter-ventionalists

· Quality Improvement guidelines for PortalVein Embolization

· Quality Improvement Guidelines forRadiofrequency Ablation of Liver Tumours

· Quality Improvement Guidelines forPercutaneous Inferior Vena Cava FilterPlacement for the Prevention of PulmonaryEmbolism

· Quality Improvement Guidelines forPercutaneous Transhepatic Cholangiographyand Biliary Drainage

· Quality Improvement Guidelines for Stentingin Infrainguinal Arterial Disease

· Quality Improvement Guidelines for UterineArtery Embolisation for SymptomaticLeiomyomata

· Quality Improvement Guidelines forPercutaneous Nephrostomies

Documents successfully completed· Quality Improvement guidelines for Radio

frequency Ablation of Liver Tumours by L. Crocetti, T. de Baere and R. Lencioni

· Quality Improvement guidelines on BoneTumour Management by A. Gangi, G. Tsoumakidou, X. Buy and E. Quoix

· Quality Improvement guidelines for theEndovascular Treatment of Thoracic ArteryAneurysm and Type B Dissection by F. Fanelliand M. Dake

· Quality Assurance guidelines forPercutaneous Ablative Techniques ofIntervetrebral Discs by Alexis Kelekis, 'D. Filippiadis, J-B. Martin, E. Brountzos

Joint CIRSE/SIR documents initiated by CIRSE

· Occupational Radiation Protection by D. Miller, G. Bartal and E. Vano

SIR documents endorsed by CIRSE · Periprocedural Management of Coagulation

Status and Hemostasis Risk in PercutaneousImageguided Interventions

· Patient Radiation Dose Mangement· Treatment of Lower Extremity Superficial

Venous Insufficiency with AmbulatoryPhlebectomy

· Treatment of Lowerextremity SuperficialVenous Insufficiency with EndovenousThermal Ablation

· Guidelines for Peripheral and VisceralVascular Embolization Training

If you are interested in supporting the CIRSE SOPCommittee in the production of new documents,please contact the CIRSE Office at info@cirse.org.

SOP Committee 2007-2009 Thierry de Baère, ChairmanLaura CrocettiFabrizio FanelliAlexis KelekisManuel Maynar

SOP Committee 2009-2011Dimitrios TsetisChairmanDimitris KarnabatidisSalvatore MasalaThomas RandVlastimil Válek

How to party like a Valencian

Valencia is famous for its party attitude,even by Spanish standards, so if it’s funyou’re looking for, you’re in the right place!

ClubbingHaving worked and slept all day, and only hav-ing had their dinner at midnight, Valencianslike to spend the hours of darkness letting theirhair down. Clubs and pubs only start filling upat about 11 or 12 at night, which can be a bit ofa shocker if you’re from a country where thepubs are all legally obliged to throw you out atthat time.

Nightlife is exuberant, but is divided into differ-ent zones. Zona Carmen is located on thenorthern end of the central district. Officially,Carmen means the Barrio del Carmen, but inreality, anything north of the PlazaAyuntamento goes. This is considered the heartof Valencia’s nightlife, and is a virtual caleidas-cope of cultures and ambiences. It could bebest described as “alternative” or “bohemian”,with a wide range of jazz, latino, trance, reggae,goth, blues, and other establishments tochoose from, as well as being the only area inValencia with a gay nightlife.

The district itself is a bit of a maze, due to itsold buildings – Arab city planning tendedtowards winding little streets, which allowedmore privacy for family homes, but are a bit ofa nightmare for 21st century tourists. It can bequite fun getting lost and seeing what youhappen upon though – there’s plenty to beseen. The same small buildings mean that it’snot really a disco quarter, as most places aretoo small to cater for this market. Instead, thepubs are cosy, but unfortunately almost allclose by 2 a.m. – it has often been remarkedthat the heart of Valencian nightlife also hasthe lamest opening hours.

If you’re planning on staying in town after thecongress, you must be sure to attend the Diade la Comunidad Valenciana (Day of theValencian Community). Held every year on the9th of October, it commemorates the city’s “res-cue” from Islamic Rule by the Christian armiesof King Jaime I in 1238. King Jaime then estab-lished the Valencian Kingdom as anautonomous region, which is a source of greatpride for Valencians. The day was chosen as it isthe anniversary of the army entering gates ofValencia, a week after the surrender of theMoorish defenders.

This year, the following events are taking place:on the 7th of October, at 9p.m., the Moorishand Christian Embassies will be performed – astaged reconstruction of the surrender ofValencia. At the fall of darkness, the Moors taketheir place by the Torres de Serranos to awaitChristian king, who arrives in pomp and cere-mony, accompanied by gunfire. The colours,costume and atmosphere will transport you toMiddle Ages. The performance lasts 2 hours.

On the 9th of October itself, various events willbe held throughout the day - a procession, fire-works, traditional dancing, and best of all, theMoros y Cristianos parade, where costumedknights, ladies, Saracens, pirates, belly dancersand toreros will take over the streets ofValencia.

FallasOf course, the most famous event of all is theFallas festival. From the 15th-19th March,around 800 enormous and elaborate wood andpapier-mâché sculptures (some as high as 25m)are dotted around the city. There are about 350Fallas-Communities – neighbourhood collec-tives with their own traditions and customs,and each community usually makes 2 sculp-tures. During the four days, there is every

Once you’ve been kicked out of your cosy,kooky pub in Carmen, head on to the ZonaCentro. This is not a well-defined clubbing areaas such, but does have plenty of late discoswhere all of Valencia parties until 8 a.m. LaIndiana (R&B), Piccadilly (funky), Latex (under-ground) are the most famous – if you’re feelinglike you want to go native, head to Betty Popfor 80s Spanish pop fixes. There are also plentyof partying opportunities along the beachfront.

Our Local Host Committee have recommendedBlack Note on Calle Polo y Peyrolon, 15 and LasAnimas on Playa de las Arenas s/n as being wor-thy of a visit.

Bull Fighting Bull fighting is still quite popular, but is not aregular event. It is linked to religious dates andfestivals, and is held during 3 short seasons –Las Fallas (March), Feria de Julio (July), andOctober (see bull ring's website for pro-gramme). The main bull ring is located by thecentral train station. Plaza de Toros is a spectac-ular Roman amphitheatre-style building, whichis nowadays mostly used for concerts and cul-tural events. Bull-fighting itself, while the sub-ject of much moral debate in Spain andbeyond, is a highly ritualised cultural event,rich in colours, costumes and music. Much hon-our is bestowed upon both bull-fighter andbull, although the bull usually gets killed, so hedoesn’t get to bask in his adulation for long.

FestivalsValencians throw the most amazing festivals,most of which are based around the religiouscalendar. Holy week celebrations are considerthe most colourful in Spain. Valencian tradi-tional costumes are often worn at these events,which are among the most elaborate in Spain,and cost upwards of €1,000, with many costing 5 times that amount.

excess imaginable - parties, fireworks, mobilediscos and concerts; the Fallas communities setup camp on the street and cook outdoor pael-la; parades of traditional costumes are held;and at night, comes the carnival. After 4 days,all fallas-sculptures are simultaneously burned,in a blazing pyromaniacal extravaganza. Originally, the sculptures were a way of clear-ing out old winter junk in readiness for spring,but nowadays, the tradition survives as anexcuse for a huge party, and a way of celebrat-ing Valencian identity.

Valencia is also a very family-oriented city, andin case anyone thought all the partying funwas reserved for the grown-ups, you clearlyhaven’t heard of La Tomatina. This is the annualtomato fight in the nearby town of Buñol inAugust – although not strictly for the kids, it ismost children’s dream come true.

IR Congress News is published as an additional source of information for all CIRSE 2010participants. The articles and advertorials in this newspaper reflect the authors' opinion.CIRSE does not accept any responsibility regarding their content. If you have any questions about this publication, please contact us at madden@cirse.org.

Editors in Chief: Klaus Hausegger, Julio Palmero da Cruz Managing Editor: Ciara Madden, CIRSE OfficeGraphics/Artwork: LO O P. E N T E R P R I S E S media / www.loop-enterprises.com