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1. Meta‐analysis of individual‐patient data from EVAR‐1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years

Author

Powell, J. T., Sweeting, M. J., Ulug, P., Blankensteijn, J. D., Lederle, F. A., Becquemin, J.‐P., Greenhalgh, R. M., Greenhalgh, R. M., Beard, J. D., Buxton, M. J., Brown, L. C., Harris, P. L., Powell, J. T., Rose, J. D. G., Russell, I. T., Sculpher, M. J., Thompson, S. G., Lilford, R.J., Bell, P. R. F., Greenhalgh, R. M., Whitaker, S.C., Poole‐Wilson, the late P.A., Ruckley, C. V., Campbell, W. B., Dean, M. R. E., Ruttley, M. S. T., Coles, E. C., Powell, J. T., Halliday, A., Gibbs, S. J., Brown, L. C., Epstein, D., Sculpher, M. J., Thompson, S. G., Hannon, R. J., Johnston, L., Bradbury, A. W., Henderson, M. J., Parvin, S. D., Shepherd, D. F. C., Greenhalgh, R. M., Mitchell, A. W., Edwards, P. R., Abbott, G. T., Higman, D. J., Vohra, A., Ashley, S., Robottom, C., Wyatt, M. G., Rose, J. D. G., Byrne, D., Edwards, R., Leiberman, D. P., McCarter, D. H., Taylor, P. R., Reidy, J. F., Wilkinson, A. R., Ettles, D. F., Clason, A. E., Leen, G. L. S., Wilson, N. V., Downes, M., Walker, S. R., Lavelle, J. M., Gough, M. J., McPherson, S., Scott, D. J. A., Kessell, D. O., Naylor, R., Sayers, R., Fishwick, N. G., Harris, P. L., Gould, D. A., Walker, M. G., Chalmers, N. C., Garnham, A., Collins, M. A., Beard, J. D., Gaines, P. A., Ashour, M. Y., Uberoi, R., Braithwaite, B., Whitaker, S. C., Davies, J. N., Travis, S., Hamilton, G., Platts, A., Shandall, A., Sullivan, B. A., Sobeh, M., Matson, M., Fox, A. D., Orme, R., Yusef, W., Doyle, T., Horrocks, M., Hardman, J., Blair, P. H. B., Ellis, P. K., Morris, G., Odurny, A., Vohra, R., Duddy, M., Thompson, M., Loosemore, T. M. L., Belli, A. M., Morgan, R., Adiseshiah, M., Brookes, J. A. S., McCollum, C. N., Ashleigh, R., Aukett, M., Baker, S., Barbe, E., Batson, N., Bell, J., Blundell, J., Boardley, D., Boyes, S., Brown, O., Bryce, J., Carmichael, M., Chance, T., Coleman, J., Cosgrove, C., Curran, G., Dennison, T., Devine, C., Dewhirst, N., Errington, B., Farrell, H., Fisher, C., Fulford, P., Gough, M., Graham, C., Hooper, R., Horne, G., Horrocks, L., Hughes, B., Hutchings, T., Ireland, M., Judge, C., Kelly, L., Kemp, J., Kite, A., Kivela, M., Lapworth, M., Lee, C., Linekar, L., Mahmood, A., March, L., Martin, J., Matharu, N., McGuigen, K., Morris‐Vincent, P., Murray, S., Murtagh, A., Owen, G., Ramoutar, V., Rippin, C., Rowley, J., Sinclair, J., Spencer, S., Taylor, V., Tomlinson, C., Ward, S., Wealleans, V., West, J., White, K., Williams, J., Wilson, L., Grobbee, D. E., Blankensteijn, J. D., Bak, A. A. A., Buth, J., Pattynama, P. M., Verhoeven, E. L. G., van Voorthuisen, A. E., Blankensteijn, J. D., Balm, R., Buth, J., Cuypers, P. W. M., Grobbee, D. E., Prinssen, M., van Sambeek, M. R. H. M., Verhoeven, E. L. G., Baas, A. F., Hunink, M. G., van Engelshoven, J. M., Jacobs, M. J. H. M., de Mol, B. A. J. M., van Bockel, J. H., Balm, R., Reekers, J., Tielbeek, X., Verhoeven, E. L. G., Wisselink, W., Boekema, N., Heuveling, L. M., Sikking, I., Prinssen, M., Balm, R., Blankensteijn, J. D., Buth, J., Cuypers, P. W. M., van Sambeek, M. R. H. M., Verhoeven, E. L. G., de Bruin, J. L., Baas, A. F., Blankensteijn, J. D., Prinssen, M., Buth, J., Tielbeek, A.V., Blankensteijn, J. D., Balm, R., Reekers, J. A., van Sambeek, M. R. H. M., Pattynama, P., Verhoeven, E. L. G., Prins, T., van der Ham, A. C., van der Velden, J. J. I. M., van Sterkenburg, S. M. M., ten Haken, G. B., Bruijninckx, C. M. A., van Overhagen, H., Tutein Nolthenius, R. P., Hendriksz, T. R., Teijink, J. A. W., Odink, H. F., de Smet, A. A. E. A., Vroegindeweij, D., van Loenhout, R. M. M., Rutten, M. J., Hamming, J. F., Lampmann, L. E. H., Bender, M. H. M., Pasmans, H., Vahl, A. C., de Vries, C., Mackaay, A. J. C., van Dortmont, L. M. C., van der Vliet, A. J., Schultze Kool, L. J., Boomsma, J. H. B., van Dop, H. R., de Mol van Otterloo, J. C. A., de Rooij, T. P. W., Smits, T. M., Yilmaz, E. N., Wisselink, W., van den Berg, F. G., Visser, M. J. T., van der Linden, E., Schurink, G. W. H., de Haan, M., Smeets, H. J., Stabel, P., van Elst, F., Poniewierski, J., Vermassen, F. E. G., Lederle, F. A., Freischlag, J. A., Kohler, T. R., Latts, E., Matsumura, J., Padberg, F. T., Jr, Kyriakides, T. C., Swanson, K. M., Guarino, P., Peduzzi, P., Antonelli, M., Cushing, C., Davis, E., Durant, L., Joyner, S., Kossack, the late A., Kyriakides, T. C., LeGwin, Mary, McBride, V., OʼConnor, T., Poulton, J., Stratton, the late S., Zellner, S., Snodgrass, A. J., Thornton, J., Swanson, K. M., Haakenson, C. M., Stroupe, K.T., Jonk, Y., Hallett, J. W., Hertzer, N., Towne, J., Katz, D. A., Karrison, T., Matts, J. P., Marottoli, R., Kasl, S., Mehta, R., Feldman, R., Farrell, W., Allore, H., Perry, E., Niederman, J., Randall, F., Zeman, M., Beckwith, the late D., OʼLeary, T. J., Huang, G. D., Latts, E., Bader, M., Ketteler, E. R., Kingsley, D. D., Marek, J. M., Massen, R. J., Matteson, B. D., Pitcher, J. D., Langsfeld, M., Corson, J. D., Goff, J. M., Jr, Kasirajan, K., Paap, C., Robertson, D. C., Salam, A., Veeraswamy, R., Milner, R., Kasirajan, K., Guidot, J., Lal, B. K., Busuttil, S. J., Lilly, M. P., Braganza, M., Ellis, K., Patterson, M. A., Jordan, W. D., Whitley, D., Taylor, S., Passman, M., Kerns, D., Inman, C., Poirier, J., Ebaugh, J., Raffetto, J., Chew, D., Lathi, S., Owens, C., Hickson, K., Dosluoglu, H. H., Eschberger, K., Kibbe, M. R., Baraniewski, H. M., Matsumura, J., Endo, M., Busman, A., Meadows, W., Evans, M., Giglia, J. S., El Sayed, H., Reed, A. B., Ruf, M., Ross, S., Jean‐Claude, J. M., Pinault, G., Kang, P., White, N., Eiseman, M., Jones, the late R., Timaran, C. H., Modrall, J. G., Welborn, M. B., III, Lopez, J., Nguyen, T., Chacko, J. K. Y., Granke, K., Vouyouka, A. G., Olgren, E., Chand, P., Allende, B., Ranella, M., Yales, C., Whitehill, T. A., Krupski, the late W. C., Nehler, M. R., Johnson, S. P., Jones, D. N., Strecker, P., Bhola, M. A., Shortell, C. K., Gray, J. L., Lawson, J. H., McCann, R., Sebastian, M.W., Kistler Tetterton, J., Blackwell, C., Prinzo, P. A., Lee, N., Padberg, F. T., Jr, Cerveira, J. J., Lal, B. K., Zickler, R. W., Hauck, K. A., Berceli, S. A., Lee, W. A., Ozaki, C. K., Nelson, P. R., Irwin, A. S., Baum, R., Aulivola, B., Rodriguez, H., Littooy, F. N., Greisler, H., OʼSullivan, M. T., Kougias, P., Lin, P. H., Bush, R. L., Guinn, G., Bechara, C., Cagiannos, C., Pisimisis, G., Barshes, N., Pillack, S., Guillory, B., Cikrit, D., Lalka, S. G., Lemmon, G., Nachreiner, R., Rusomaroff, M., OʼBrien, E., Cullen, J. J., Hoballah, J., Sharp, W. J., McCandless, J. L., Beach, V., Minion, D., Schwarcz, T. H., Kimbrough, J., Ashe, L., Rockich, A., Warner‐Carpenter, J., Moursi, M., Eidt, J. F., Brock, S., Bianchi, C., Bishop, V., Gordon, I. L., Fujitani, R., Kubaska, S. M., III, Behdad, M., Azadegan, R., Ma Agas, C., Zalecki, K., Hoch, J. R., Carr, S. C., Acher, C., Schwarze, M., Tefera, G., Mell, M., Dunlap, B., Rieder, J., Stuart, J. M., Weiman, D. S., Abul‐Khoudoud, O., Garrett, H. E., Walsh, S. M., Wilson, K. L., Seabrook, G. R., Cambria, R. A., Brown, K. R., Lewis, B. D., Framberg, S., Kallio, C., Barke, R. A., Santilli, S. M., dʼAudiffret, A. C., Oberle, N., Proebstle, C., Johnson, L. L., Jacobowitz, G. R., Cayne, N., Rockman, C., Adelman, M., Gagne, P., Nalbandian, M., Caropolo, L. J., Pipinos, I. I., Johanning, J., Lynch, T., DeSpiegelaere, H., Purviance, G., Zhou, W., Dalman, R., Lee, J. T., Safadi, B., Coogan, S. M., Wren, S. M., Bahmani, D. D., Maples, D., Thunen, S., Golden, M. A., Mitchell, M. E., Fairman, R., Reinhardt, S., Wilson, M. A., Tzeng, E., Muluk, S., Peterson, N. M., Foster, M., Edwards, J., Moneta, G. L., Landry, G., Taylor, L., Yeager, R., Cannady, E., Treiman, G., Hatton‐Ward, S., Salabsky, the late B., Kansal, N., Owens, E., Estes, M., Forbes, B. A., Sobotta, C., Rapp, J. H., Reilly, L. M., Perez, S. L., Yan, K., Sarkar, R., Dwyer, S. S., Perez, S., Chong, K., Kohler, T. R., Hatsukami, T. S., Glickerman, D. G., Sobel, M., Burdick, T. S., Pedersen, K., Cleary, P., Back, M., Bandyk, D., Johnson, B., Shames, M., Reinhard, R. L., Thomas, S. C., Hunter, G. C., Leon, L. R., Jr, Westerband, A., Guerra, R. J., Riveros, M., Mills, J. L., Sr, Hughes, J. D., Escalante, A. M., Psalms, S. B., Day, N. N., Macsata, R., Sidawy, A., Weiswasser, J., Arora, S., Jasper, B. J., Dardik, A., Gahtan, V., Muhs, B. E., Sumpio, B. E., Gusberg, R. J., Spector, M., Pollak, J., Aruny, J., Kelly, E. L., Wong, J., Vasilas, P., Joncas, C., Gelabert, H. A., DeVirgillio, C., Rigberg, D. A., Cole, L., Becquemin, J.‐P., Marzelle, J., Becquemin, J.‐P., Sapoval, M., Becquemin, J.‐P., Favre, J.‐P., Watelet, J., Lermusiaux, P., Sapoval, M., Lepage, E., Hemery, F., Dolbeau, G., Hawajry, N., Cunin, P., Harris, P., Stockx, L., Chatellier, G., Mialhe, C., Fiessinger, J.‐N., Pagny, L., Kobeiter, H., Boissier, C., Lacroix, P., Ledru, F., Pinot, J.‐J., Deux, J.‐F., Tzvetkov, B., Duvaldestin, P., Watelet, J., Jourdain, C., David, V., Enouf, D., Ady, N., Krimi, A., Boudjema, N., Jousset, Y., Enon, B., Blin, V., Picquet, J., LʼHoste, P., Thouveny, F., Borie, H., Kowarski, S., Pernes, J.‐M., Auguste, M., Becquemin, J.‐P., Desgranges, P., Allaire, E., Marzelle, J., Kobeiter, H., Meaulle, P.‐Y., Chaix, D., Juliae, P., Fabiani, J. N., Chevalier, P., Combes, M., Seguin, A., Belhomme, D., Sapoval, M., Baque, J., Pellerin, O., Favre, J. P., Barral, X., Veyret, C., Watelet, J., Peillon, C., Plissonier, D., Thomas, P., Clavier, E., Lermusiaux, P., Martinez, R., Bleuet, F., C, Dupreix, Verhoye, J. P., Langanay, T., Heautot, J. F., Koussa, M., Haulon, S., Halna, P., Destrieux, L., Lions, C., Wiloteaux, S., Beregi, J. P., Bergeron, P., Pinot, J.‐J., Patra, P., Costargent, A., Chaillou, P., DʼAlicourt, A., Goueffic, Y., Cheysson, E., Parrot, A., Garance, P., Demon, A., Tyazi, A., Pillet, J.‐C., Lescalie, F., Tilly, G., Steinmetz, E., Favier, C., Brenot, R., Krause, D., Cercueil, J. P., Vahdat, O., Sauer, M., Soula, P., Querian, A., Garcia, O., Levade, M., Colombier, D., Cardon, J.‐M., Joyeux, A., Borrelly, P., Dogas, G., Magnan, P.‐É., Branchereau, A., Bartoli, J.‐M., Hassen‐Khodja, R., Batt, M., Planchard, P.‐F., Bouillanne, P.‐J., Haudebourg, P., Bayne, J., Gouny, P., Badra, A., Braesco, J., Nonent, M., Lucas, A., Cardon, A., Kerdiles, Y., Rolland, Y., Kassab, M., Brillu, C., Goubault, F., Tailboux, L., Darrieux, H., Briand, O., Maillard, J.‐C., Varty, K., and Cousins, C.

Published
2017
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12. The p48 flow diverter: First clinical results in 25 aneurysms in three centers.

Author

den Bergh, FRA Van, De Beule, T, van Rooij, WJ, Voormolen, MH, Van der Zijden, T, Stockx, L, van Zwam, WH, and Fransen, H

Subjects
ANEURYSMS, CEREBRAL revascularization, INTRACRANIAL aneurysms, ENDOVASCULAR surgery
Abstract

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

Published
2021
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18. p64 flow diverter: Results in 108 patients from a single center.

Author

De Beule, Tom, Boulanger, T, Heye, S, van Rooij, WJ, van Zwam, WH, and Stockx, L

Subjects
INTRACRANIAL aneurysms, INTRACRANIAL arterial diseases, DRUG efficacy, DISSECTING aneurysms, ANEURYSMS, INFARCTION, CAROTID endarterectomy
Abstract

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

Published
2021
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25. Does carotid stent cell design matter?

Author

Schillinger M, Gschwendtner M, Reimers B, Trenkler J, Stockx L, Mair J, Macdonald S, Karnel F, Huber K, Minar E, Schillinger, Martin, Gschwendtner, Manfred, Reimers, Bernhard, Trenkler, Johannes, Stockx, Luc, Mair, Johann, Macdonald, Sumaira, Karnel, Franz, Huber, Kurt, and Minar, Erich

Published
2008
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29. Percutaneous hydrodynamic thrombectomy of acute thrombosis in transjugular intrahepatic portosystemic shunt (TIPS): a feasibility study in five patients.

Author

Raat, Henricus, Stockx, Luc, Ranschaert, Eric, Nevens, Frederik, Wilms, Guy, Baert, Albert, Raat, H, Stockx, L, Ranschaert, E, Nevens, F, Wilms, G, and Baert, A L

Subjects
INTRAVENOUS catheterization, CARDIOVASCULAR disease treatment, TREATMENT of surgical complications, SURGICAL arteriovenous shunts, VASCULAR resistance, RADIOGRAPHY, SURGICAL stents, SURGICAL complications, THROMBOSIS, DISEASE relapse, VEIN surgery, PILOT projects, EQUIPMENT & supplies, MEDICAL suction
Abstract

Purpose: To evaluate the feasibility of percutaneous hydrodynamic thrombectomy in restoring patency of acutely thrombosed stent-shunts after transjugular intrahepatic portosystemic shunt (TIPS).Methods: Percutaneous hydrodynamic thrombectomy was performed in five consecutive patients with angiographically documented complete thrombosis of the stent-shunt which developed within 2 weeks after the TIPS procedure. Thrombectomy was performed with a hydrolytic suction thrombectomy catheter, introduced via a transjugular approach.Results: In all patients, immediate restoration of patency of the stent-shunt was achieved after deploying additional stent(s) to cover residual adherent mural thrombus. In two patients early reocclusion occurred.Conclusion: Percutaneous hydrolytic suction thrombectomy in acutely thrombosed intrahepatic portosystemic shunts is technically feasible. [ABSTRACT FROM AUTHOR]

Published
1997
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30. Assessment of accuracy of renal artery stenosis grading in helical CT angiography using maximum intensity projections.

Author

Hoe, L., Vandermeulen, D., Gryspeerdt, S., Mertens, L., Baert, A., Suetens, P., Marchal, G., and Stockx, L.

Abstract

The purpose of the study was to investigate whether visual inspection of maximum intensity projection (MIP) images is a reliable method for assessment of the severity of renal artery stenoses (RAS). Therefore, 20 RAS were investigated with helical CT. Native axial images and MIP images were analysed separately or in combination ('two-step method'). A phanton study was performed to investigate the influence of window setting on apparent stenosis severity. Accuracy for diagnosis of 50-69% and 70-99% RAS and the mean inter-observer agreement were 82.5%, 77.5% and 82.5% respectively, using study of MIP images alone, and 100%, 97.5% and 95% using the 'two-step method'. The phantom study showed that the apparent severity of vascular stenoses on MIP images depends on the selected window centre values. It is concluded that combined evaluation of both MIP images and native axial images is more reliable than study of MIP images alone for assessing the severity of RAS. [ABSTRACT FROM AUTHOR]

Published
1996
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31. Iatrogenic pseudoaneurysm in the upper arm: treatment by transcatheter embolization.

Author

Maleux, Geert, Stockx, Luc, Brys, Peter, Lammens, Johan, Lacroix, Hendrik, Wilms, Guy, Marchal, Guy, Maleux, G, Stockx, L, Brys, P, Lammens, J, Lacroix, H, Wilms, G, and Marchal, G

Abstract

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

Published
2000
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32. Repositioning and leaving in situ the central venous catheter during percutaneous treatment of associated superior vena cava syndrome: a report of eight cases.

Author

Stockx, Luc, Raat, Henricus, Donck, Jan, Wilms, Guy, Marchal, Guy, Stockx, L, Raat, H, Donck, J, Wilms, G, and Marchal, G

Abstract

Purpose: To describe a combined procedure of repositioning and leaving in situ a central venous catheter followed by immediate percutaneous treatment of associated superior vena cava syndrome (SVCS).Methods: Eight patients are presented who have central venous catheter-associated SVCS (n = 6 Hickman catheters, n = 2 Port-a-cath) caused by central vein stenosis (n = 4) or concomitant thrombosis (n = 4). With the use of a vascular snare introduced via the transcubital or transjugular approach, the tip of the central venous catheter could be engaged, and repositioned after deployment of a stent in the innominate or superior vena cava.Results: In all patients it was technically feasible to reposition the central venous catheter and treat the SVCS at the same time. In one patient flipping of the Hickman catheter in its original position provoked dislocation of the released Palmaz stent, which could be positioned in the right common iliac vein.Conclusion: Repositioning of a central venous catheter just before and after stent deployment in SVCS is technically feasible and a better alternative than preprocedural removal of the vascular access. [ABSTRACT FROM AUTHOR]

Published
1999
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39. Aneurysm treatment with the Woven EndoBridge (WEB) device in the combined population of two prospective, multicenter series: 5-year follow-up.

Author

Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Klisch J, Herbreteau D, Costalat V, Fiehler J, Januel AC, Liebig T, Stockx L, Weber W, Berkefeld J, Moret J, Molyneux A, and Byrne J

Subjects
Humans, Treatment Outcome, Follow-Up Studies, Prospective Studies, Retrospective Studies, Endovascular Procedures methods, Intracranial Aneurysm diagnostic imaging, Intracranial Aneurysm surgery, Embolization, Therapeutic methods
Abstract

Background: Evaluating a new endovascular treatment for intracranial aneurysms must not only demonstrate short-term safety and efficacy, but also evaluate longer-term outcomes (eg, delayed complications, anatomical results, retreatment). The current analysis reports the 5-year clinical and anatomical results of Woven EndoBridge (WEB) treatment in two European combined trial populations (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2)., Methods: All adverse events occurring between the procedure and 5-year follow-up were independently evaluated by an expert. Aneurysm occlusion was evaluated by an independent core laboratory using a three-grade scale: complete occlusion, neck remnant, and aneurysm remnant. In cases where data were not available at 5-year follow-up, the last observation carry forward (LOCF) method was used., Results: The safety and efficacy populations comprised 100 patients and 95 aneurysms, respectively. No adverse event related to the device occurred after the procedure during the 5-year follow-up period. Mortality at 5 years was 7.0% (7/100 patients) including mortality related to the WEB (0/100, 0.0%), the procedure (1/100, 1.0%), and another condition (6/100, 6.0%). At 5 years, complete aneurysm occlusion was observed in 49/95 (51.6%) aneurysms, neck remnant in 25/95 (26.3%), and aneurysm remnant in 21/95 (22.1%). Retreatment rate at 5 years was 11.6% (11/95 aneurysms)., Conclusions: This analysis conducted in a population of patients with wide-neck bifurcation aneurysms confirms WEB's safety profile. Additional evidence demonstrates good stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) at 5 years in 77.9% of aneurysms with a low retreatment rate (11.6%)., Clinical Trial Registration: WEBCAST and WEBCAST-2: Unique identifier: NCT01778322., Competing Interests: Competing interests: LP reports support for the present manuscript from Microvention; consulting fees from Balt, Microvention, Perflow, Phenox, Vesalio; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Balt, Microvention, Perflow, Phenox, Vesalio; support for attending meetings and/or travel from Balt, Microvention, Phenox. IS reports grants or contracts from National Brain Research Fund (Hungary); consulting fees from Stryker, Microvention, Medtronic, Cerenovus; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Medtronic, Stryker, Cerenovus; support for attending meetings and/or travel from Gabriel Vegh Neurointerventional Fondation (Hungary); leadership in European Board of NeuroIntervention (EBNI), Hungarian Sociaty of Neuroradiology, Hungarian Society of Neurosurgery, Hungarian Stroke Society. XB reports consulting fees from Sequent; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Sequent. MH reports consulting fees from Balt, Stryker, Medtronic, Microvention, Phenox; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Cerenovus, Phenox, Stryker, Microvention, Cerus Medical. LSp reports grants or contracts from Philips (institutional); consulting fees from Balt, Medtronic, Phenox, Microvention, Stryker; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Balt, Medtronic, Microvention, Stryker; support for attending meetings and/or travel from Balt, Medtronic, Microvention, Stryker. JK reports consulting fees from Microvention, Phenox. DH reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Microvention; support for attending meetings and/or travel from Microvention. VC reports grants or contracts from Medtronic, Cerenovus, Stryker, Balt, Microvention; consulting fees from Medtronic, Stryker, Microvention; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Medtronic, Stryker, Microvention; leadership in Sim & Cure. JF reports grants or contracts from Microvention (institutional); consulting fees from Microvention, Sequent; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Microvention; leadership role in JNIS (Associate Editor). A-CJ reports payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Microvention; leadership in European Society for Minimally Invasive Neurological Therapy (ESMINT). TL reports consulting fees from Microvention, Cerus Endovascular; payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Stryker, Cerus Endovascular; support for attending meetings and/or travel from Stryker, Cerus Endovascular. LSt reports no disclosures. WW reports consulting fees from Microvention. JBe reports consulting fees from Siemens (institutional). JM reports consulting fees from Microvention: other financial interests from Balt. AM reports CEC services to Sequent Medical and Microvention (institutional); payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing, or educational events from Microvention; support for attending meetings and/or travel from Microvention. JBy reports core laboratory services to Sequent Medical and Microvention (institutional); consulting fees from Oxford Endovascular Ltd and Microvention; core laboratory activities for Sequent and Microvention; leadership (Board Member) of Oxford Endovascular Ltd; stock in Oxford Endovascular Ltd., (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2023
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40. Diversion-p64: results from an international, prospective, multicenter, single-arm post-market study to assess the safety and effectiveness of the p64 flow modulation device.

Author

Bonafe A, Perez MA, Henkes H, Lylyk P, Bleise C, Gascou G, Sirakov S, Sirakov A, Stockx L, Turjman F, Petrov A, Roth C, Narata AP, Barreau X, Loehr C, Berlis A, Pierot L, Miś M, Goddard T, Clifton A, Klisch J, Wałęsa C, Dall'Olio M, Spelle L, Clarencon F, Yakovlev S, Keston P, Nuzzi NP, Dima S, Wendl C, Willems T, and Schramm P

Subjects
Adult, Aged, Cerebral Angiography, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Retrospective Studies, Stents, Treatment Outcome, Embolization, Therapeutic methods, Endovascular Procedures methods, Intracranial Aneurysm diagnostic imaging, Intracranial Aneurysm surgery
Abstract

Background: The use of flow diversion to treat intracranial aneurysms has increased in recent years., Objective: To assess the safety and angiographic efficacy of the p64 flow modulation device., Methods: Diversion-p64 is an international, prospective, multicenter, single-arm, study conducted at 26 centers. The p64 flow modulation device was used to treat anterior circulation aneurysms between December 2015 and January 2019. The primary safety endpoint was the incidence of major stroke or neurologic death at 3-6 months, with the primary efficacy endpoint being complete aneurysm occlusion (Raymond-Roy Occlusion Classification 1) on follow-up angiography., Results: A total of 420 patients met the eligibility criteria and underwent treatment with the p64 flow modulation device (mean age 55±12.0 years, 86.2% female). Mean aneurysm dome width was 6.99±5.28 mm and neck width 4.47±2.28 mm. Mean number of devices implanted per patient was 1.06±0.47, with adjunctive coiling performed in 14.0% of the cases. At the second angiographic follow-up (mean 375±73 days), available for 343 patients (81.7%), complete aneurysm occlusion was seen in 287 (83.7%) patients. Safety data were available for 413 patients (98.3%) at the first follow-up (mean 145±43 days) with a composite morbidity/mortality rate of 2.42% (n=10)., Conclusions: Diversion-p64 is the largest prospective study using the p64 flow modulation device. The results of this study demonstrate that the device has a high efficacy and carries a low rate of mortality and permanent morbidity., Competing Interests: Competing interests: ABo serves as a consultant for Balt, phenox, and Stryker. MAP serves as proctor and consultant for phenox. HH is a co-founder and shareholder of phenox, femtos, and CONTARA; serves as proctor and consultant for phenox; and declares personal financial interest in Johnson & Johnson and Penumbra. PL, CB, GG, SS, AS, AP, CR, A-PN, XB, AC, CWa, MDO, SY, NPN, CWe have no personal, financial, or institutional interest to report. LSt declares personal financial interest for Medtronic and Terumo. FT serves as a consultant for Balt and Medtronic. CL declares proctoring and consultant services for phenox and also serves as consultant for Penumbra and receives travel and meeting expanses from Acandis and Penumbra. ABe serves as consultant for Microvention and as CEC chairman for phenox for the ARTESp trial. LP declares consulting services for Balt, Cerus Endovascular, Microvention, Perflow, phenox, and Vesalio. MM serves as a proctor for Penumbra and declares support for Procardia and Polimed. TG serves as a proctor for phenox. JK serves as a proctor and consultant for Microvention and phenox with payment to his institution. LSp is a consultant for Balt, Medtronic, Microvention, phenox, and Stryker and also declares support for Balt, Medtronic, Microvention, and Stryker outside of this work. FC serves as a consultant for Balt, Medtronic, and Stryker; receives payment for support of Penumbra; and participates as DSMB/advisory board of Microvention. PK serves as proctor and consultant for phenox and received travel and meeting expenses from phenox. SD declares no other competing interests besides that he was the President of the Central and Eastern European Committee of ESMINT until September 2020. TW serves as consultant for phenox. PS serves as consultant for Penumbra, phenox, and Stryker., (© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2022
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41. Hybrid Repair of an Aneurysm of the Innominate Artery.

Author

Vancoillie PJ, Peeters K, Nauwelaers S, Stockx L, and Lauwers G

Abstract

Introduction: Innominate artery aneurysms (IAAs) are rare. They are notorious for causing thromboembolic events. Modern imaging modalities make early detection in an asymptomatic phase possible. In Kieffer group B aneurysms the origin of the innominate artery is affected. Thanks to the combination of open and endovascular techniques, off pump repair is feasible in patients with a fragile aortic arch. During this hybrid procedure the aortic arch is debranched and reinforced with a stent graft., Report: A 73 year old white man with a history of extensive thoraco-abdominal aortic reconstructions for aneurysmal disease presented with a progressive Kieffer B IAA of 35 mm. He underwent an off pump hybrid repair. A bifurcated Dacron prosthesis was used for the debranching. The main body originated from the ascending aorta. The right limb was anastomosed to the common ostium of the right carotid and subclavian arteries. The left limb was anastomosed to the left subclavian and carotid artery. The aortic arch was reinforced with a 40 × 162 mm Zenith TX2 endoprosthesis. The endoprosthesis was inserted through a temporary conduit on the main body and deployed during rapid ventricular pacing. The endoprosthesis lined the ascending aorta distal to the debranching up to Ishimaru zone 3. The antegrade insertion prevented excessive manipulation of the aortic arch and the tortuous aorta, which was lined with mural thrombus. Post-operative computed tomography showed a patent debranching with excellent alignment of the endoprosthesis without endoleak., Discussion: Hybrid repair of the aortic arch is well described in literature. This technique was adapted in the treatment of a Kieffer group B IAA. The tortuous aorta and mural thrombus led to the antegrade placement of the endoprosthesis through the main body of the debranched aorta. This approach seems safe and feasible., Competing Interests: None., (© 2021 Published by Elsevier Ltd on behalf of European Society for Vascular Surgery.)

Published
2021
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42. The Woven EndoBridge for unruptured intracranial aneurysms: Results in 95 aneurysms from a single center.

Author

De Beule T, Boulanger T, Heye S, van Rooij WJ, van Zwam W, and Stockx L

Subjects
Female, Humans, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Aneurysm, Ruptured diagnostic imaging, Endovascular Procedures, Intracranial Aneurysm diagnostic imaging, Intracranial Aneurysm therapy
Abstract

Background and Purpose: The Woven EndoBridge (WEB) is an intrasaccular flowdisruptor that is increasingly used for the treatment of (wide-necked) aneurysms. We present our experience with the WEB for unruptured aneurysms., Materials and Methods: Between April 2014 and August 2019, 93 patients with 95 unruptured aneurysms were primarily treated with the WEB. There were 69 women and 24 men, mean age 61 years (median 58, range 37-80)., Results: Of 95 aneurysms, 86 had been discovered incidentally, 3 were symptomatic and 6 were additional to another ruptured aneurysm. Location was anterior communicating artery 33, middle cerebral artery 29, basilar tip 19, carotid tip 8, posterior communicating artery 4, posterior inferior cerebellar artery 1, superior cerebellar artery 1. Mean aneurysm size was 6 mm (median 6, range 3-13 mm).In one aneurysm additional coils were used and in another, a stent was placed. There was one procedural rupture without clinical sequelae. There were two thrombo-embolic complications leading to permanent deficit in one patient (mRS 2). Morbidity rate was 1.0% (1 of 93, 95%CI 0.01-6.5%) and mortality was 0% (0 of 93, 95%CI 0.0-4.8%). Angiographic follow-up at six months was available in 85 patients with 87 aneurysms (91%). Of 87 aneurysms, 68 (78%) were completely occluded, 14 (16%) had a neck remnant and 5 were incompletely occluded. Four aneurysms were retreated. Retreatment rate was 4.5% (4 of 87, 95%CI 1.7-13.6%)., Conclusion: WEB treatment of unruptured aneurysms is safe and effective. Additional devices are needed only rarely and retreatment at follow-up is infrequent.

Published
2021
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43. The external carotid artery as a rare feeder of a spinal dural arteriovenous fistula causing cervical myelopathy: A review of the literature.

Author

Broekx S, Houben R, Stockx L, Boulanger T, Gelin G, Weyns F, and De Beule T

Abstract

Introduction: A causal relationship between SDAVF's and cervical myelopathy is exceedingly rare. 1-2% of these lesions are located at the craniocervical junction of which 12% are caused by arterial feeders from the external carotid artery. A correct diagnosis can be challenging with a high rate of initial misdiagnosis., Research Question: Which aspects constitute the most important potential pitfalls in the diagnostic workup and treatment of SDAVF's with feeders from the external carotid artery causing cervical myelopathy?, Material and Methods: We performed a PRISMA-guided review of the literature in which fourteen articles were included. We illustrate the diagnostic hazards through one of our own cases., Results: SDAVF's at the cervical segment contain unique clinical and radiographic characteristics which differ from those elsewhere. Cervical myelopathy is caused by a SDAVF in 2.3% of cases. Pitfalls are numerous and diagnosis can be challenging, due to a broad differential diagnosis, potential isolated lower extremity involvement and absence of spinal cord edema on MRI. MR-alterations not always correlate with fistula localization., Discussion and Conclusion: A SDAVF should be part of the differential diagnosis in patients with subacute tetraparesis. When MRI shows signal alterations in combination with enlarged perimedullary vessels, a SDAVF should be suspected. Spinal angiography should include the vertebrobasilar system, as well as the internal and external carotid arteries. Early and adequate occlusion by means of an endovascular or neurosurgical approach of the draining radicular veins should be pursued. A multidisciplinary approach is key in the diagnostic workup and treatment of these patients., (© 2021 The Authors.)

Published
2021
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44. Aneurysm treatment with WEB in the cumulative population of two prospective, multicenter series: 3-year follow-up.

Author

Pierot L, Szikora I, Barreau X, Holtmannspoetter M, Spelle L, Herbreteau D, Fiehler J, Costalat V, Klisch J, Januel AC, Weber W, Liebig T, Stockx L, Berkefeld J, Moret J, Molyneux A, and Byrne J

Subjects
Adult, Aged, Endovascular Procedures instrumentation, Female, Follow-Up Studies, Humans, Magnetic Resonance Angiography methods, Male, Middle Aged, Prospective Studies, Treatment Outcome, Endovascular Procedures methods, Intracranial Aneurysm diagnostic imaging, Intracranial Aneurysm therapy
Abstract

Background: WEB treatment is an endovascular approach for wide-neck bifurcation aneurysms that has demonstrated high safety and good efficacy in mid-term follow-up. While evaluating safety in the long term is important to determine if delayed adverse events occur affecting late morbidity and mortality, the most important point to evaluate is the long-term stability of aneurysm occlusion. The current analysis reports the 3-year clinical and anatomical results of WEB treatment in the combined population of two European trials (WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy) and WEBCAST-2)., Methods: Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant., Results: The safety population comprised 79 patients. The efficacy population comprised 61 aneurysms. Aneurysm locations were middle cerebral artery in 32/61 aneurysms (52.5%), anterior communicating artery in 13/61 (21.3%), basilar artery in 9/61 (14.8%), and internal carotid artery terminus in 7/61 (11.5%). No adverse events related to the device or procedure occurred between 2 and 3 years. At 3 years, complete occlusion was observed in 31/61 (50.8%) aneurysms, neck remnant in 20/61 (32.8%), and aneurysm remnant in 10/61 (16.4%). Between 1 year and 3 years, aneurysm occlusion was improved or stable in 53/61 (86.9%) aneurysms and worsened in 8/61 (13.1%). Worsening was mostly from complete occlusion to neck remnant in 6/61 (9.8%) aneurysms. The retreatment rate at 3 years was 11.4%., Conclusions: This analysis confirms the high safety profile of WEB. Moreover, evidence demonstrates the great stability of aneurysm occlusion with adequate occlusion (complete occlusion or neck remnant) in 83.6% of aneurysms., Clinical Trial Registration: URL: http://www.clinicaltrials.gov. WEBCAST and WEBCAST-2: Unique identifier: NCT01778322., Competing Interests: Competing interests: LP consults for Balt, MicroVention, Neuravi, and Penumbra. ISI consults for Codman, Medtronic, Sequent, and Stryker. XB consults for MicroVention and Stryker. LS consults for Stryker, MicroVention, Medtronic, and Balt. JF has received fees as consultant or lecturer from Acandis, Bayer, Boehringer-Ingelheim, Codman, Covidien, MicroVention, Penumbra, Philips, Sequent, Siemens, and Stryker; his institution received funding from MicroVention, Medtronic, BMBF, BMWi, DFG, and the EU. VC consults for MicroVention and Balt, and receives educational grants from Medtronic and Stryker. JK consults for MicroVention/Sequent. WW consults for MicroVention, Phenox, and Medtronic. TL consults for Medtronic, Mentice, Microvention, and Route 92. JM consults for Medtronic, MicroVention, Stryker, and Balt. AM consults for MicroVention/Sequent and Cerus Endovascular. JB consults for, and is shareholder of, Oxford Endovascular Ltd; his institution received funding from MicroVention., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2021
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45. Aneurysm Treatment With Woven EndoBridge in the Cumulative Population of 3 Prospective, Multicenter Series: 2-Year Follow-Up.

Author

Pierot L, Moret J, Barreau X, Szikora I, Herbreteau D, Turjman F, Holtmannspötter M, Januel AC, Costalat V, Fiehler J, Klisch J, Gauvrit JY, Weber W, Desal H, Velasco S, Liebig T, Stockx L, Berkefeld J, Molyneux A, Byrne JV, and Spelle L

Subjects
Adult, Aged, Embolization, Therapeutic methods, Endovascular Procedures methods, Europe, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Embolization, Therapeutic instrumentation, Endovascular Procedures instrumentation, Intracranial Aneurysm therapy, Treatment Outcome
Abstract

Background: Woven EndoBridge (WEB; Sequent Medical) treatment is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown high safety with good efficacy at short term confirmed by trials conducted in United States (WEB-Intrasaccular Therapy) and in Europe (WEB Clinical Assessment of Intrasaccular Aneurysm Therapy [WEBCAST], French Observatory, and WEBCAST-2)., Objective: To report the 2-yr clinical and anatomical results of WEB treatment in the combined population of 3 European trials., Methods: In a French Observatory, 2-yr clinical and anatomical data were collected. In WEBCAST and WEBCAST-2, 2-yr follow-up was optional, and data were collected when follow-up was performed. Aneurysm occlusion was evaluated using a 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant., Results: The population for safety was 138/168 patients (82.1%), including 89 females (64.5%), with mean age of 55.5 ± 10.2 yr. The population for efficacy was 121/169 aneurysms (71.6%). Aneurysm locations were middle cerebral artery in 65/121 aneurysms (53.7%), anterior-communicating artery in 25/121 (20.7%), basilar artery in 17/121 (14.0%), and internal carotid artery terminus in 14/121 (11.6%). No clinically relevant adverse events occurred between years 1 and 2. At 2 yr, complete occlusion was observed in 62/121 (51.2%) aneurysms, neck remnant in 36/121 (29.8%) aneurysms, and aneurysm remnant in 23/121 (19.0%) aneurysms. The global retreatment rate at 2 yr was 9.3%., Conclusion: This analysis confirms the high safety profile of WEB treatment at 2 yr. Aneurysm occlusion is generally stable at 2 yr, and the retreatment rate between 1 yr and 2 yr is low (2.0%)., (© Congress of Neurological Surgeons 2020.)

Published
2020
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46. Prediction of Functional Outcome After Acute Ischemic Stroke: Comparison of the CT-DRAGON Score and a Reduced Features Set.

Author

Lesenne A, Grieten J, Ernon L, Wibail A, Stockx L, Wouters PF, Dreesen L, Vandermeulen E, Van Boxstael S, Vanelderen P, Van Poucke S, Vundelinckx J, Van Cauter S, and Mesotten D

Abstract

Background and Purpose: The CT-DRAGON score was developed to predict long-term functional outcome after acute stroke in the anterior circulation treated by thrombolysis. Its implementation in clinical practice may be hampered by its plethora of variables. The current study was designed to develop and evaluate an alternative score, as a reduced set of features, derived from the original CT-DRAGON score. Methods: This single-center retrospective study included 564 patients treated for stroke, in the anterior and the posterior circulation. At 90 days, favorable [modified Rankin Scale score (mRS) of 0-2] and miserable outcome (mRS of 5-6) were predicted by the CT-DRAGON in 427 patients. Bootstrap forests selected the most relevant parameters of the CT-DRAGON, in order to develop a reduced set of features. Discrimination, calibration and misclassification of both models were tested. Results: The area under the receiver operating characteristic curve (AUROC) for the CT-DRAGON was 0.78 (95% CI 0.74-0.81) for favorable and 0.78 (95% CI 0.72-0.83) for miserable outcome. Misclassification was 29% for favorable and 13.5% for miserable outcome, with a 100% specificity for the latter. National Institutes of Health Stroke Scale (NIHSS), pre-stroke mRS and age were identified as the strongest contributors to favorable and miserable outcome and named the reduced features set. While CT-DRAGON was only available in 323 patients (57%), the reduced features set could be calculated in 515 patients (91%) ( p < 0.001). Misclassification was 25.8% for favorable and 14.4% for miserable outcome, with a 97% specificity for miserable outcome. The reduced features set had better discriminative power than CT-DRAGON for both outcomes (both p < 0.005), with an AUROC of 0.82 (95% CI 0.79-0.86) and 0.83 (95% CI 0.77-0.87) for favorable and miserable outcome, respectively. Conclusions: The CT-DRAGON score revealed acceptable discrimination in our cohort of both anterior and posterior circulation strokes, receiving all treatment modalities. The reduced features set could be measured in a larger cohort and with better discrimination. However, the reduced features set needs further validation in a prospective, multicentre study. Clinical Trial Registration : http://www.clinicaltrials.gov. Identifiers: NCT03355690, NCT04092543., (Copyright © 2020 Lesenne, Grieten, Ernon, Wibail, Stockx, Wouters, Dreesen, Vandermeulen, Van Boxstael, Vanelderen, Van Poucke, Vundelinckx, Van Cauter and Mesotten.)

Published
2020
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47. Minimally Invasive Aneurysm Clipping: The Extent of the Supraorbital Approach.

Author

Niknejad HR, Stockx L, and Wuyts J

Subjects
Aged, Female, Humans, Male, Middle Aged, Minimally Invasive Surgical Procedures instrumentation, Neurosurgical Procedures instrumentation, Prefrontal Cortex diagnostic imaging, Prefrontal Cortex surgery, Retrospective Studies, Craniotomy methods, Intracranial Aneurysm diagnostic imaging, Intracranial Aneurysm surgery, Minimally Invasive Surgical Procedures methods, Neurosurgical Procedures methods, Surgical Instruments
Abstract

Background: The supraorbital keyhole craniotomy is a well-established minimally invasive approach for the treatment of intracranial aneurysms. However, the surgical range of exposure using this technique for treatment of intracranial aneurysms has not been studied., Methods: We retrospectively reviewed the data of all clipped aneurysm cases using the supraorbital approach (SO) between 2006 and 2016 in our center. Most importantly, we determined the location of the treated aneurysms in the axial 2-dimensional plane, with the anterior clinoid process (ACP) as the point of reference: the ACP to aneurysm distance. Finally, we extracted data on patient age, aneurysm size, size of the craniotomy, length of hospital stay, and surgery-related complications., Results: We included 142 patients for this series. A total of 170 aneurysms were clipped by means of the SO, and in 18 cases multiple aneurysms were treated during the same surgery. The mean aneurysm size was 7 mm (3.5-22 mm) and the mean craniotomy size was 28 mm (19-41 mm). The aneurysm location ranged from 14.4 mm medially to 35 mm laterally, measured with the ipsilateral ACP as the zero reference., Conclusions: Although the SO is conventionally used in the treatment of anterior circulation aneurysms, we were able to treat aneurysms over a range of 50 mm over the skull base. With its low complication risk, relatively short hospital stay, and excellent cosmetic results, SO remains a valuable treatment option for both young and aged patients., (Copyright © 2019 Elsevier Inc. All rights reserved.)

Published
2019
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48. Treatment of intracranial aneurysms using the pipeline flex embolization device with shield technology: angiographic and safety outcomes at 1-year follow-up.

Author

Martínez-Galdámez M, Lamin SM, Lagios KG, Liebig T, Ciceri EF, Chapot R, Stockx L, Chavda S, Kabbasch C, Faragò G, Nordmeyer H, Boulanger T, Piano M, and Boccardi EP

Subjects
Adult, Aged, Blood Vessel Prosthesis adverse effects, Blood Vessel Prosthesis trends, Cerebral Angiography adverse effects, Embolization, Therapeutic adverse effects, Female, Follow-Up Studies, Humans, Male, Middle Aged, Prospective Studies, Recurrence, Retreatment trends, Time Factors, Treatment Outcome, Cerebral Angiography trends, Embolization, Therapeutic instrumentation, Embolization, Therapeutic trends, Intracranial Aneurysm diagnostic imaging, Intracranial Aneurysm therapy
Abstract

Purpose: The Pipeline Embolization Device (PED) is a routine first-line treatment option for intracranial aneurysms (IAs). The Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield) is an updated version of the PED which has been modified to include a surface phosphorylcholine biocompatible polymer. Its early technical success and safety have been reported previously. Here, we assessed the long-term safety and efficacy of the Pipeline Shield for the treatment of IAs., Materials and Methods: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study was a prospective, single-arm, multicenter study for the treatment of unruptured IAs using the Pipeline Shield. The primary endpoint was a major stroke in the territory supplied by the treated artery or neurologic death at 1-year post-procedure. Angiographic outcomes were also assessed by an independent radiology laboratory at 6 months and 1 year., Results: Fifty patients (mean age, 53 years; 82% female) with 50 unruptured IAs were treated. Mean aneurysm diameter was 8.82±6.15 mm. Of the target aneurysms, 38/50 (76%) were small (<10 mm), 11/50 (22%) were large (≥10 and<25 mm), and 1/50 (2%) was giant (≥25 mm). Forty-seven (94%) were located in the internal carotid artery and three (6%) in the vertebral artery. At 1-year post-procedure, no major strokes or neurologic deaths were reported, and complete occlusion was achieved in 27/33 (81.8%). There were no instances of aneurysm recurrence or retreatment., Conclusions: Our 1-year follow-up concerning angiographic and safety outcomes corroborate previous evidence that the Pipeline Shield is a safe and effective treatment for IAs., Trial Registration Number: NCT02390037., Competing Interests: Competing interests: MM-G serves as a proctor and consultant for Medtronic. SML proctors and consults for Medtronic. TL previously consulted and proctored for Covidien, Stryker, and MicroVention, and currently serves as a proctor and consultant for Sequent Medical. EPB receives honoraria from Medtronic and serves as a consultant for Medtronic., (© Author(s) (or their employer(s)) 2019. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

Published
2019
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49. Safety and efficacy of aneurysm treatment with WEB in the cumulative population of three prospective, multicenter series.

Author

Pierot L, Moret J, Barreau X, Szikora I, Herbreteau D, Turjman F, Holtmannspötter M, Januel AC, Costalat V, Fiehler J, Klisch J, Gauvrit JY, Weber W, Desal H, Velasco S, Liebig T, Stockx L, Berkefeld J, Molyneux A, Byrne J, and Spelle L

Subjects
Adult, Aged, Embolization, Therapeutic instrumentation, Embolization, Therapeutic methods, Endovascular Procedures instrumentation, Female, France epidemiology, Humans, Intracranial Aneurysm epidemiology, Male, Middle Aged, Prospective Studies, Treatment Outcome, Endovascular Procedures methods, Intracranial Aneurysm diagnostic imaging, Intracranial Aneurysm surgery, Self Expandable Metallic Stents statistics & numerical data
Abstract

Background: Flow disruption with the WEB is an innovative endovascular approach for treatment of wide-neck bifurcation aneurysms. Initial studies have shown a low complication rate with good efficacy., Purpose: To report clinical and anatomical results of the WEB treatment in the cumulative population of three Good Clinical Practice (GCP) studies: WEBCAST (WEB Clinical Assessment of Intrasaccular Aneurysm), French Observatory, and WEBCAST-2., Methods: WEBCAST, French Observatory, and WEBCAST-2 are single-arm, prospective, multicenter, GCP studies dedicated to the evaluation of WEB treatment. Clinical data were independently evaluated. Postoperative and 1-year aneurysm occlusion was independently evaluated using the 3-grade scale: complete occlusion, neck remnant, and aneurysm remnant., Results: The cumulative population comprised 168 patients with 169 aneurysms, including 112 female subjects (66.7%). The patients' ages ranged between 27 and 77 years (mean 55.5±10.2 years). Aneurysm locations were middle cerebral artery in 86/169 aneurysms (50.9%), anterior communicating artery in 36/169 (21.3%), basilar artery in 30/169 (17.8%), and internal carotid artery terminus in 17/169 (10.1%). The aneurysm was ruptured in 14/169 (8.3%). There was no mortality at 1 month and procedure/device-related morbidity was 1.2% (2/168). At 1 year, complete aneurysm occlusion was observed in 81/153 aneurysms (52.9%), neck remnant in 40/153 aneurysms (26.1%), and aneurysm remnant in 32/153 aneurysms (20.9%). Re-treatment was carried out in 6.9%., Conclusions: This series is at the moment the largest prospective, multicenter, GCP series of patients with aneurysms treated with WEB. It shows the high safety and good mid-term efficacy of this treatment., Clinical Trial Registration: French Observatory: Unique identifier (NCT18069); WEBCAST and WEBCAST-2: Unique identifier (NCT01778322)., Competing Interests: Competing interests: LP: consultant for Balt, Microvention, Neuravi, and Penumbra. JM: consultant for Medtronic, Microvention, Stryker, and Balt. XB: consultant for Microvention and Stryker. ISI: consultant for Codman, Medtronic, Sequent, and Stryker. VC: consultant for Microvention and Balt and receives educational grants from Medtronic and Stryker. JF: has received fees as consultant or lecturer from Acandis, Bayer, Boehringer-Ingelheim, Codman, Covidien, MicroVention, Penumbra, Philips, Sequent, Siemens, and Stryker; his institution received funding from MicroVention, Medtronic, BMBF, BMWi, DFG, EU. JK: consultant for Microvention/Sequent. WW: consultant for Microvention, Phenox, and Medtronic. TL: consultant for Medtronic, Mentice, Microvention, and Route92. AM: consultant for Microvention/Sequent and Cerus Endovascular. JB: consultant and shareholder for Oxford Endovascular Ltd; his institution received funding from MicroVention. LS: consultant for Stryker, MicroVention, Medtronic, Balt. J-YG, HD, and SV have no disclosures., (© Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.)

Published
2018
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50. Periprocedural outcomes and early safety with the use of the Pipeline Flex Embolization Device with Shield Technology for unruptured intracranial aneurysms: preliminary results from a prospective clinical study.

Author

Martínez-Galdámez M, Lamin SM, Lagios KG, Liebig T, Ciceri EF, Chapot R, Stockx L, Chavda S, Kabbasch C, Farago G, Nordmeyer H, Boulanger T, Piano M, and Boccardi EP

Subjects
Adult, Aged, Embolization, Therapeutic trends, Female, Follow-Up Studies, Humans, Male, Middle Aged, Perioperative Care trends, Prospective Studies, Treatment Outcome, Embolization, Therapeutic methods, Intracranial Aneurysm diagnosis, Intracranial Aneurysm therapy, Perioperative Care methods, Stents
Abstract

Background and Purpose: The Pipeline Embolization Device (PED) has become a routine first-line option for treatment of intracranial aneurysms (IAs). We assessed the early safety and technical success of a new version of PED, Pipeline Flex Embolization Device with Shield Technology (Pipeline Shield), which has the same design and configuration but has been modified to include a surface synthetic biocompatible polymer., Materials and Methods: The Pipeline Flex Embolization Device with Shield Technology (PFLEX) study is a prospective, single-arm, multicenter study for the treatment of unruptured IAs using Pipeline Shield. The primary study endpoints included the occurrence of major stroke in the territory supplied by the treated artery or neurologic death at 1 year post-procedure. Secondary endpoints included the rate of Pipeline Shield-related or procedure-related serious or non-serious adverse events. Analyses were conducted to evaluate early safety findings in the 30-day post-procedure period as well as technical procedural success outcomes., Results: Fifty patients with 50 unruptured target IAs were enrolled. Mean aneurysm diameter was 8.82±6.15 mm. Thirty-eight aneurysms (76%) were small (<10 mm). Device deployment was technically successful with 98% of devices. Complete wall apposition was achieved immediately post-procedure in 48 cases (96%). No major strokes or neurologic deaths were reported in the 30-day post-procedure period., Conclusions: The results of this first experience with the new Pipeline Flex corroborate the early safety of the device. Mid-term and long-term follow-up examinations will provide data on safety outcomes at the 6-month and 1-year follow-up periods., Clinical Trial Registration: NCT02390037., Competing Interests: Competing interests: MM-G serves as a proctor and consultant for Medtronic. SML receives honoraria from Medtronic in relation to proctoring, speaking, and consulting. TL previously consulted and proctored for Covidien, Stryker, and MicroVention, and currently serves as a proctor and consultant for Sequent Medical. EPB receives honoraria from Medtronic and serves as a consultant for Medtronic., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.)

Published
2017
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