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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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2. Efficacy of Sirolimus in Patients Requiring Tracheostomy for Life-Threatening Lymphatic Malformation of the Head and Neck: A Report From the European Reference Network

Author

Holm A, Te Loo M, Schultze Kool L, Salminen P, Celis V, Eulalia Baselga Torres, Duignan S, Dvorakova V, Irvine AD, Boon LM, Vikkula M, Ghaffarpour N, Niemeyer CM, Rössler J, and Kapp FG

Subjects
tracheostoma, sirolimus, lymphatic malformation, rapamycin, tracheostomy, vascular anomaly
Abstract

Extensive lymphatic malformations (LMs) of the head and neck region may require tracheostomy to secure the airway. Treatment of these life-threatening LMs is usually multimodal and includes sclerotherapy and surgery, among others. Recently, systemic therapy with sirolimus has been introduced as an effective treatment for venous and lymphatic malformations; its efficacy and safety profile in patients with extensive LM requiring tracheostomy are, however, as yet not fully known. We performed a retrospective, multicenter review and identified 13 patients with an extensive LM of the head and neck region, who previously underwent placement of tracheostomy and subsequently received sirolimus treatment with the aim to improve the local respiratory situation and remove the tracheostomy. Under sirolimus therapy, tracheostomy could be reversed in 8/13 (62%) patients, a further 2/13 (15%) patients improved markedly, and removal of the tracheostomy was planned at the time of writing, while 3/13 (23%) patients showed insufficient or absent response to sirolimus, rendering tracheostomy reversal not feasible. The median duration of sirolimus treatment until removal of tracheostomy was 18 months (range, 8 months to 5.6 years). Adverse events of sirolimus therapy were common [10/13 (77%) patients], yet the majority of these were mild [9/10 (90%) patients] and only one severe adverse event was recorded, with ulceration and necrosis at a catheter insertion site. In conclusion, sirolimus can be considered an effective and safe salvage treatment in patients with extensive LM even after placement of a tracheostomy, as closure of the latter was possible in the majority of patients (62%) of our retrospective cohort. A better understanding of when to start sirolimus therapy, of the duration of treatment, and of factors allowing the prediction of treatment response will require further investigation.

Published
2021

3. Identification of Surgically Curable Primary Aldosteronism by Imaging in a Large Multiethnic International Study.

Author

Rossi G.P., Crimi F., Rossitto G., Amar L., Azizi M., Riester A., Reincke M., Degenhart C., Widimsky J., Naruse M., Deinum J., Schultze Kool L., Kocjan T., Negro A., Rossi E., Kline G., Tanabe A., Satoh F., Rump L.C., Vonend O., Willenberg H.S., Fuller P.J., Yang J., Chee N.Y.N., Magill S.B., Shafigullina Z., Quinkler M., Oliveras A., Wu V.C., Kratka Z., Barbiero G., Seccia T.M., Battistel M., Rossi G.P., Crimi F., Rossitto G., Amar L., Azizi M., Riester A., Reincke M., Degenhart C., Widimsky J., Naruse M., Deinum J., Schultze Kool L., Kocjan T., Negro A., Rossi E., Kline G., Tanabe A., Satoh F., Rump L.C., Vonend O., Willenberg H.S., Fuller P.J., Yang J., Chee N.Y.N., Magill S.B., Shafigullina Z., Quinkler M., Oliveras A., Wu V.C., Kratka Z., Barbiero G., Seccia T.M., and Battistel M.

Abstract

CONTEXT: Adrenal glands imaging is recommended by the current guidelines for the work-up of primary aldosteronism (PA). However, its diagnostic performance has not been established in large multi-ethnic cohorts of patients submitted to adrenal vein sampling (AVS) and adrenalectomy. OBJECTIVE(S): To assess the diagnostic accuracy of cross-sectional adrenal imaging. DESIGN: International multi-center study. SETTING: Tertiary referral centers. PATIENTS OR OTHER PARTICIPANTS: 1625 PA patients seeking surgical cure enrolled in an international study involving 19 centers in North America, Europe, Asia, and Australia. 1311 (81%) had imaging data available and 369 (23%), who received a final diagnosis of surgically cured unilateral PA, were examined. INTERVENTION(S): Patients underwent AVS and imaging by computed tomography (CT) and/or magnetic resonance (MR). MAIN OUTCOME MEASURE(S): The accuracy of detection of unilateral PA at imaging was estimated by the area under the receiver operator characteristics (ROC) curve using cure (biochemical and/or full clinical success) as the reference at follow-up after unilateral adrenalectomy. RESULT(S): In the cohort of 1311 patients with imaging data available, 34% and 7% of cases showed no detectable or bilateral nodules, respectively. Imaging did not detect the culprit adrenal in 28% of the surgically cured unilateral PA patients. Moreover, the clinical outcome did not differ significantly between the imaging-positive and imaging-negative patients. CONCLUSION(S): Cross-sectional imaging did not identify a lateralized cause of disease in around 40% of PA patients and failed in identifying the culprit adrenal in more than one fourth of patients with unilateral PA.Copyright © The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Published
2021

6. Subtyping of Primary Aldosteronism in the AVIS-2 Study: Assessment of Selectivity and Lateralization

Author

Rossitto, G., Amar, L., Azizi, M., Riester, A., Reincke, M., Degenhart, C., Widimsky, J., Naruse, M., Deinum, J., Schultze Kool, L., Kocjan, T., Negro, A., Rossi, E., Kline, G., Tanabe, A., Satoh, F., Rump, L.C., Vonend, O., Willenberg, H.S., Fuller, P., Yang, J., Chee, N.Y. Nian, Magill, S.B., Shafigullina, Z., Quinkler, M., Oliveras, A., Chang, C.C., Wu, V.C., Somloova, Z., Maiolino, G., Barbiero, G., Battistel, M., Lenzini, L., Quaia, E., Pessina, A.C., Rossi, G.P., Rossitto, G., Amar, L., Azizi, M., Riester, A., Reincke, M., Degenhart, C., Widimsky, J., Naruse, M., Deinum, J., Schultze Kool, L., Kocjan, T., Negro, A., Rossi, E., Kline, G., Tanabe, A., Satoh, F., Rump, L.C., Vonend, O., Willenberg, H.S., Fuller, P., Yang, J., Chee, N.Y. Nian, Magill, S.B., Shafigullina, Z., Quinkler, M., Oliveras, A., Chang, C.C., Wu, V.C., Somloova, Z., Maiolino, G., Barbiero, G., Battistel, M., Lenzini, L., Quaia, E., Pessina, A.C., and Rossi, G.P.

Abstract

Contains fulltext : 220552.pdf (Publisher’s version ) (Closed access), CONTEXT: Adrenal venous sampling (AVS) is the key test for subtyping primary aldosteronism (PA), but its interpretation varies widely across referral centers and this can adversely affect the management of PA patients. OBJECTIVES: To investigate in a real-life study the rate of bilateral success and identification of unilateral aldosteronism and their impact on blood pressure outcomes in PA subtyped by AVS. DESIGN AND SETTINGS: In a retrospective analysis of the largest international registry of individual AVS data (AVIS-2 study), we investigated how different cut-off values of the selectivity index (SI) and lateralization index (LI) affected rate of bilateral success, identification of unilateral aldosteronism, and blood pressure outcomes. RESULTS: AVIS-2 recruited 1625 individual AVS studies performed between 2000 and 2015 in 19 tertiary referral centers. Under unstimulated conditions, the rate of biochemically confirmed bilateral AVS success progressively decreased with increasing SI cut-offs; furthermore, with currently used LI cut-offs, the rate of identified unilateral PA leading to adrenalectomy was as low as <25%. A within-patient pairwise comparison of 402 AVS performed both under unstimulated and cosyntropin-stimulated conditions showed that cosyntropin increased the confirmed rate of bilateral selectivity for SI cut-offs >/= 2.0, but reduced lateralization rates (P < 0.001). Post-adrenalectomy outcomes were not improved by use of cosyntropin or more restrictive diagnostic criteria. CONCLUSION: Commonly used SI and LI cut-offs are associated with disappointingly low rates of biochemically defined AVS success and identified unilateral PA. Evidence-based protocols entailing less restrictive interpretative cut-offs might optimize the clinical use of this costly and invasive test. (J Clin Endocrinol Metab XX: 0-0, 2020).

Published
2020

7. Clinical Outcomes of 1625 Patients with Primary Aldosteronism Subtyped with Adrenal Vein Sampling.

Author

Widimsky J., Chee N.Y.N., Magill S.B., Shafigullina Z., Quinkler M., Oliveras A., Dun Wu K., Wu V.-C., Kratka Z., Barbiero G., Battistel M., Chang C.-C., Vanderriele P.-E., Pessina A.C., Rossi G.P., Rossitto G., Amar L., Azizi M., Riester A., Reincke M., Degenhart C., Naruse M., Deinum J., Schultze Kool L., Kocjan T., Negro A., Rossi E., Kline G., Tanabe A., Satoh F., Christian Rump L., Vonend O., Willenberg H.S., Fuller P.J., Yang J., Widimsky J., Chee N.Y.N., Magill S.B., Shafigullina Z., Quinkler M., Oliveras A., Dun Wu K., Wu V.-C., Kratka Z., Barbiero G., Battistel M., Chang C.-C., Vanderriele P.-E., Pessina A.C., Rossi G.P., Rossitto G., Amar L., Azizi M., Riester A., Reincke M., Degenhart C., Naruse M., Deinum J., Schultze Kool L., Kocjan T., Negro A., Rossi E., Kline G., Tanabe A., Satoh F., Christian Rump L., Vonend O., Willenberg H.S., Fuller P.J., and Yang J.

Abstract

We sought to measure the clinical benefits of adrenal venous sampling (AVS), a test recommended by guidelines for primary aldosteronism (PA) patients seeking surgical cure, in a large registry of PA patients submitted to AVS. Data of 1625 consecutive patients submitted to AVS in 19 tertiary referral centers located in Asia, Australia, Europe, and North America were collected in a large multicenter international registry. The primary end points were the rate of bilateral success, ascertained lateralization of PA, adrenalectomy, and of cured arterial hypertension among AVS-guided and non AVS-guided adrenalectomy patients. AVS was successful in 80.1% of all cases but allowed identification of unilateral PA in only 45.5% by the criteria in use at each center. Adrenalectomy was performed in 41.8% of all patients and cured arterial hypertension in 19.6% of the patients, 2-fold more frequently in women than men (P<0.001). When AVS-guided, surgery provided a higher rate of cure of hypertension than when non-AVS-guided (40.0% versus 30.5%; P=0.027). Compared with surgical cases, patients treated medically needed more antihypertensive medications (P<0.001) and exhibited a higher rate of persistent hypokalemia requiring potassium supplementation (4.9% versus 2.3%; P<0.01). The low rate of adrenalectomy and cure of hypertension in PA patients seeking surgical cure indicates suboptimal AVS use, possibly related to issues in patient selection, technical success, and AVS data interpretation. Given the better outcomes of AVS-guided adrenalectomy, these results call for actions to improve the diagnostic use of this test that is necessary for detection of surgical PA candidates. Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifier: NCT01234220.Copyright © 2019 American Heart Association, Inc.

Published
2020

8. Volumetric evaluation of CT images of adrenal glands in primary aldosteronism.

Author

Velema, M. S., Canu, L., Dekkers, T., Hermus, A. R. M. M., Timmers, H. J. L. M., Schultze Kool, L. J., Groenewoud, H. J. M. M., Jacobs, C., Deinum, J., for the SPARTACUS Investigators, Prejbisz, A., Kool, L. J. S., Velema, M., Spiering, W., Kołodziejczyk-Kruk, S., Arntz, M., Kądziela, J., Langenhuijsen, J. F., Kerstens, M. N., and van den Meiracker, A. H.

Published
2021
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11. Long-term survival and secondary procedures after open or endovascular repair of abdominal aortic aneurysms

Author

Van Schaik, Theodorus G., Yeung, Kak K., Verhagen, Hence J., De Bruin, Jorg L., Van Sambeek, Marc R H M., Balm, Ron, Zeebregts, Clark J., Van Herwaarden, Joost A., Blankensteijn, Jan D., DREAM Trial Participants, Grobbee, D E., Blankensteijn, J D., Bak, A A A., Buth, J., Pattynama, P M., Verhoeven, E L G., Van Voorthuisen, A E., Balm, R., Cuypers, P W M., Prinssen, M., Van Sambeek, M R H M., 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., Reekers, J., Tielbeek, X., Wisselink, W., Boekema, N., Heuveling, L M., Sikking, I., De Bruin, J L., Tielbeek, A V., Reekers, J A., Pattynama, P., 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., 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., and Vermassen, F E G.

Abstract

Journal of vascular surgery 66(5), 1379-1389 (2017). doi:10.1016/j.jvs.2017.05.122, Published by Elsevier, Amsterdam [u.a.]

Published
2017

12. Predicting reinterventions after open and endovascular aneurysm repair using the St George's Vascular Institute score

Author

De Bruin, Jorg Lucas, Karthikesalingam, Alan, Holt, Peter J., Prinssen, Monique, Thompson, Matt M., Blankensteijn, Jan D., Grobbee, D. E., Blankensteijn, J. D., Bak, A. A A, Buth, J., Pattynama, P. M., Verhoeven, E. L G, Van Voorthuisen, A. E., Balm, R., Cuypers, P. W M, Prinssen, M., Van Sambeek, M. R H M, 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., Reekers, J., Tielbeek, X., Wisselink, W., Boekema, N., Heuveling, L. M., Sikking, I., De Bruin, J. L., Tielbeek, A. V., Reekers, J. A., Pattynama, P., 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, H. R., De Mol Van Otterloo, J. C A, De Rooij, T. P W, Smits, T. M., Yilmaz, E. N., 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, De Bruin, Jorg Lucas, Karthikesalingam, Alan, Holt, Peter J., Prinssen, Monique, Thompson, Matt M., Blankensteijn, Jan D., Grobbee, D. E., Blankensteijn, J. D., Bak, A. A A, Buth, J., Pattynama, P. M., Verhoeven, E. L G, Van Voorthuisen, A. E., Balm, R., Cuypers, P. W M, Prinssen, M., Van Sambeek, M. R H M, 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., Reekers, J., Tielbeek, X., Wisselink, W., Boekema, N., Heuveling, L. M., Sikking, I., De Bruin, J. L., Tielbeek, A. V., Reekers, J. A., Pattynama, P., 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, H. R., De Mol Van Otterloo, J. C A, De Rooij, T. P W, Smits, T. M., Yilmaz, E. N., 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., and Vermassen, F. E G

Published
2016

13. Predicting reinterventions after open and endovascular aneurysm repair using the St George's Vascular Institute score

Author

Cardiovasculaire Epi Team 9, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Genetica Klinische Genetica, Arts Assistenten CTC, Psychiatrie_Medisch, Pathologie Pathologen staf, Arts-assistenten Radiologie, PCR MN, Other research (not in main researchprogram), JC Overig onderzoek, De Bruin, Jorg Lucas, Karthikesalingam, Alan, Holt, Peter J., Prinssen, Monique, Thompson, Matt M., Blankensteijn, Jan D., Grobbee, D. E., Blankensteijn, J. D., Bak, A. A A, Buth, J., Pattynama, P. M., Verhoeven, E. L G, Van Voorthuisen, A. E., Balm, R., Cuypers, P. W M, Prinssen, M., Van Sambeek, M. R H M, 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., Reekers, J., Tielbeek, X., Wisselink, W., Boekema, N., Heuveling, L. M., Sikking, I., De Bruin, J. L., Tielbeek, A. V., Reekers, J. A., Pattynama, P., 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, H. R., De Mol Van Otterloo, J. C A, De Rooij, T. P W, Smits, T. M., Yilmaz, E. N., 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, Cardiovasculaire Epi Team 9, Circulatory Health, JC onderzoeksprogramma Cardiovasculaire Epidemiologie, Genetica Klinische Genetica, Arts Assistenten CTC, Psychiatrie_Medisch, Pathologie Pathologen staf, Arts-assistenten Radiologie, PCR MN, Other research (not in main researchprogram), JC Overig onderzoek, De Bruin, Jorg Lucas, Karthikesalingam, Alan, Holt, Peter J., Prinssen, Monique, Thompson, Matt M., Blankensteijn, Jan D., Grobbee, D. E., Blankensteijn, J. D., Bak, A. A A, Buth, J., Pattynama, P. M., Verhoeven, E. L G, Van Voorthuisen, A. E., Balm, R., Cuypers, P. W M, Prinssen, M., Van Sambeek, M. R H M, 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., Reekers, J., Tielbeek, X., Wisselink, W., Boekema, N., Heuveling, L. M., Sikking, I., De Bruin, J. L., Tielbeek, A. V., Reekers, J. A., Pattynama, P., 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, H. R., De Mol Van Otterloo, J. C A, De Rooij, T. P W, Smits, T. M., Yilmaz, E. N., 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., and Vermassen, F. E G

Published
2016

15. Validation of the Simulator for Testing and Rating Endovascular SkillS (STRESS)-machine in a setting of competence testing

Author

Berger, P., Willems, M. C., Van Der Vliet, J. A., Schultze Kool, L. J., Bergqvist, David, Blankensteijn, J. D., Berger, P., Willems, M. C., Van Der Vliet, J. A., Schultze Kool, L. J., Bergqvist, David, and Blankensteijn, J. D.

Abstract

AIM: Endovascular skills are an integral part of modern-day vascular surgery. The STRESS machine has been developed to test these skills in vascular surgeons. This study aims to define an optimal pass/fail cutoff value for the STRESS test score. METHODS: The STRESS machine consists of a dry glass model of the abdominal aorta and its tributaries with various stenotic lesions, elongations, and tortuosities. A camera and computer software are used to simulate plain fluoroscopy-mode. The test subjects are given two assignments after which two reviewers use a combination of the ICEPS and MRS to produce the final total score; 43 subjects were tested. According to previous endovascular experience, subjects were classified into four groups: novice-low (no experience, less than 11 performed procedures, less than 50 assisted procedures), novice-high (11-25 performed procedures, more than 50 assisted procedures), intermediate (1-10 performed and >11-25 assisted procedures, 11-25 performed and >1-10 assisted procedures or 25-50 performed procedures) and advanced (more than 50 performed procedures). RESULTS: Test-score and noted experience showed a correlation of 0.794. All intermediate and advanced test subjects scored more than 50 points compared to 4 out of 15 novices. CONCLUSION: We demonstrated that it is possible to determine an optimal cut-off value for competence testing with the STRESS machine.

Published
2010

21. Diagnostiek en behandeling van atherosclerotisch vaatlijden in de perifere vaten.

Author

Schultze Kool, L. J.

Abstract

Copyright of Leerboek Atherotrombose is the property of Springer Nature / Books and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Published
2008
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29. Hepatic Vein Stenting for Budd-Chiari Syndrome.

Author

Witte, A. M. C., Schultze Kool, L. J., Veenendaal, R., Tamers, C. B. H. W., and Van Hoek, B.

Subjects
ASCITES, HEPATIC artery, LIVER diseases, SURGERY, THERAPEUTICS
Abstract

This report describes two patients with Budd-Chiari syndrome with intractable ascites due to a tight hepatic vein stenosis while the other hepatic veins were occluded. Percutaneous transluminal angioplasty of the hepatic vein stenosis followed by insertion of expandable metallic stents reduced the pressure gradient across the stenosis to almost zero. In both patients, ascites disappeared and diuretic therapy could be reduced significantly. This treatment has remained effective for more than 1 yr in one case and 2 yr in the other. These cases demonstrate the feasibility of hepatic vein stenting as a therapy for hepatic venous outflow obstruction. This therapy may be used in selected patients to defer and perhaps avoid shunt-surgery or liver transplantation. [ABSTRACT FROM AUTHOR]

Published
1997

37. The VASCERN-VASCA Working Group Diagnostic and Management Pathways for Venous Malformations.

Author

Dompmartin A, Baselga E, Boon LM, Diociaiuti A, Dvorakova V, El Hachem M, Gasparella P, Haxhija E, Ghaffarpour N, Kyrklund K, Irvine AD, Kapp FG, Rößler J, Salminen P, van den Bosch C, van der Vleuten C, Schultze Kool L, and Vikkula M

Abstract

To elaborate expert consensus patient pathways to guide patients and physicians toward efficient diagnostics and management of patients with venous malformations., Methods: VASCERN-VASCA (https://vascern.eu/) is a European network of multidisciplinary centers for Vascular Anomalies. The Nominal Group Technique was used to establish the pathways. Two facilitators were identified: one to propose initial discussion points and draw the pathways, and another to chair the discussion. A dermatologist (AD) was chosen as first facilitator due to her specific clinical and research experience. The draft was subsequently discussed within VASCERN-VASCA monthly virtual meetings and annual face-to-face meetings., Results: The Pathway starts from the clinical suspicion of a venous type malformation (VM) and lists the clinical characteristics to look for to support this suspicion. Strategies for subsequent imaging and histopathology are suggested. These aim to inform on the diagnosis and to separate the patients into 4 subtypes: (1) sporadic single VMs or (2) multifocal, (3) familial, multifocal, and (4) combined and/or syndromic VMs. The management of each type is detailed in subsequent pages of the pathway, which are color coded to identify sections on (1) clinical evaluations, (2) investigations, (3) treatments, and (4) associated genes. Actions relevant to all types are marked in separate boxes, including when imaging is recommended. When definite diagnoses have been reached, the pathway also points toward disease-specific additional investigations and recommendations for follow up. Options for management are discussed for each subtype, including conservative and invasive treatments, as well as novel molecular therapies., Conclusion: The collaborative efforts of VASCERN-VASCA, a network of the 9 Expert Centers, has led to a consensus Diagnostic and Management Pathways for VMs to assist clinicians and patients. It also emphasizes the role of multidisciplinary expert centers in the management of VM patients. This pathway will become available on the VASCERN website (http://vascern.eu/)., Competing Interests: The authors declare that they have no conflicts of interest with regard to the content of this report., (Copyright © 2023 The Authors. Published by Wolters Kluwer Health, Inc. on behalf of The International Society for the Study of Vascular Anomalies.)

Published
2023
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38. GNA11-mutated Sturge-Weber syndrome has distinct neurological and dermatological features.

Author

Dompmartin A, van der Vleuten CJM, Dekeuleneer V, Duprez T, Revencu N, Désir J, Te Loo DMWM, Flucke U, Eijkelenboom A, Schultze Kool L, Vikkula M, and Boon L

Subjects
Anticonvulsants, Brain diagnostic imaging, Brain pathology, Humans, Magnetic Resonance Imaging, Retrospective Studies, GTP-Binding Protein alpha Subunits genetics, Sturge-Weber Syndrome complications, Sturge-Weber Syndrome genetics, Sturge-Weber Syndrome pathology
Abstract

Background and Purpose: Sturge-Weber syndrome (SWS) is a neurocutaneous disorder characterized by clinical manifestations involving the brain, eye and skin. SWS is commonly caused by somatic mutations in G protein subunit Alpha Q (GNAQ). Five cases of subunit Alpha 11 (GNA11) mutations have been reported. We studied phenotypic features of GNA11-SWS and compared them with those of classic SWS., Methods: Within two European multidisciplinary centers we looked for patients with clinical characteristics of SWS and a GNA11 mutation. Clinical and radiological data were collected retrospectively and prospectively., Results: We identified three patients with SWS associated with a somatic GNA11 mutation. All had disseminated capillary malformation (CM) and hyper- or hypotrophy of an extremity. At birth, the CMs of the face, trunk and limbs were pink and patchy, and slowly darkened with age, evolving to a purple color. Two of the patients had glaucoma. All had neurological symptoms and moderate brain atrophy with a lower degree of severity than that classically associated with SWS. Susceptibility-weighted imaging (SWI) and contrast-enhanced fluid-attenuated inversion recovery (FLAIR) magnetic resonance imaging demonstrated the best sensitivity to reveal the pial angiomas., Conclusions: We have differentiated two distinct clinical/radiological phenotypes of SWS; GNAQ- and GNA11-SWS. The classic GNAQ-SWS is characterized by a homogeneous dark-red CM, commonly associated with underlying soft tissue hypertrophy. The CM in GNA11-SWS is more reticulate and darkens with time, and the neurological picture is milder. SWI and post-contrast FLAIR sequences appear to be necessary to demonstrate leptomeningeal angiomatosis. Anti-epileptic medication or future targeted therapies may be useful, as in classic SWS., (© 2022 European Academy of Neurology.)

Published
2022
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39. Drug-resistant hypertension in primary aldosteronism patients undergoing adrenal vein sampling: the AVIS-2-RH study.

Author

Rossi GP, Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J, Naruse M, Deinum J, Schultze Kool L, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Rump LC, Vonend O, Willenberg HS, Fuller PJ, Yang J, Chee NYN, Margill SB, Shafigullina Z, Quinkler M, Oliveras A, Lee BC, Wu VC, Kratka Z, Seccia TM, and Lenzini L

Subjects
Adolescent, Adrenal Glands blood supply, Adrenal Glands surgery, Adrenalectomy adverse effects, Adrenalectomy methods, Female, Humans, Male, Retrospective Studies, Hyperaldosteronism diagnosis, Hyperaldosteronism surgery, Hypertension diagnosis, Hypertension drug therapy, Hypertension epidemiology
Abstract

Aims: We aimed at determining the rate of drug-resistant arterial hypertension in patients with an unambiguous diagnosis of primary aldosteronism (PA). Moreover, we sought for investigating the diagnostic performance of adrenal vein sampling (AVS), and the effect of adrenalectomy on blood pressure (BP) and prior treatment resistance in PA patients subtyped by AVS in major referral centres., Methods and Results: The Adrenal Vein Sampling International Study-2 (AVIS-2) was a multicentre international study that recruited consecutive PA patients submitted to AVS, according to current guidelines, during 15 years. The patients were over 18 years old with arterial hypertension and had an unambiguous diagnosis of PA. The rate of resistant hypertension was assessed at baseline and after adrenalectomy using the American Heart Association (AHA) 2018 definition. Information on presence or absence of resistant hypertension was available in 89% of the 1625 enrolled PA patients. Based on the AHA 2018 criteria, resistant hypertension was found in 20% of patients, of which about two-thirds (14%) were men and one-third (6%) women (χ2 = 17.1, P < 1*10-4) with a higher rate of RH in men than in women (23% vs. 15% P < 1*10-4). Of the 292 patients with resistant hypertension, 98 (34%) underwent unilateral AVS-guided adrenalectomy, which resolved BP resistance to antihypertensive treatment in all., Conclusions: (i) Resistant hypertension is a common presentation in patients seeking surgical cure of PA; (ii) AVS is key for the optimal management of patients with PA due to resistant hypertension; and (iii) AVS-guided adrenalectomy allowed resolution of treatment-resistant hypertension., (Published on behalf of the European Society of Cardiology. All rights reserved. © The Author(s) 2021. For permissions, please email: journals.permissions@oup.com.)

Published
2022
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40. Identification of Surgically Curable Primary Aldosteronism by Imaging in a Large, Multiethnic International Study.

Author

Rossi GP, Crimì F, Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J, Naruse M, Deinum J, Schultze Kool L, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Christian Rump L, Vonend O, Willenberg HS, Fuller PJ, Yang J, Chee NYN, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Cent Wu V, Kratka Z, Barbiero G, Seccia TM, and Battistel M

Subjects
Adult, Asia, Australia, Cohort Studies, Europe, Female, Humans, Hyperaldosteronism pathology, Magnetic Resonance Imaging, Male, Middle Aged, North America, Retrospective Studies, Sensitivity and Specificity, Tomography, X-Ray Computed, Treatment Outcome, Veins, Adrenal Glands blood supply, Adrenal Glands diagnostic imaging, Adrenalectomy methods, Aldosterone blood, Hyperaldosteronism diagnostic imaging, Hyperaldosteronism surgery
Abstract

Context: Adrenal gland imaging is recommended by the current guidelines for the workup of primary aldosteronism (PA). However, its diagnostic performance has not been established in large, multiethnic cohorts of patients who undergo adrenal vein sampling (AVS) and adrenalectomy., Objective: This work aims to assess the diagnostic accuracy of cross-sectional adrenal imaging., Methods: This international multicenter study took place in tertiary referral centers. A total of 1625 PA patients seeking surgical cure were enrolled in an international study involving 19 centers in North America, Europe, Asia, and Australia. Of these, 1311 (81%) had imaging data available and 369 (23%), who received a final diagnosis of surgically cured unilateral PA, were examined. Patients underwent AVS and imaging by computed tomography and/or magnetic resonance imaging. The accuracy of detection of unilateral PA at imaging was estimated by the area under the receiver operator characteristics curve using cure (biochemical and/or full clinical success) as the reference at follow-up after unilateral adrenalectomy., Results: In the cohort of 1311 patients with imaging data available, 34% and 7% of cases showed no detectable or bilateral nodules, respectively. Imaging did not detect the culprit adrenal in 28% of the surgically cured unilateral PA patients. Moreover, the clinical outcome did not differ significantly between the imaging-positive and imaging-negative patients., Conclusion: Cross-sectional imaging did not identify a lateralized cause of disease in around 40% of PA patients and failed to identify the culprit adrenal in more than one-fourth of patients with unilateral PA., (© The Author(s) 2021. Published by Oxford University Press on behalf of the Endocrine Society. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Published
2021
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41. De-novo FAIRification via an Electronic Data Capture system by automated transformation of filled electronic Case Report Forms into machine-readable data.

Author

Kersloot MG, Jacobsen A, Groenen KHJ, Dos Santos Vieira B, Kaliyaperumal R, Abu-Hanna A, Cornet R, 't Hoen PAC, Roos M, Schultze Kool L, and Arts DL

Subjects
Data Management, Electronics, Registries, Biomedical Research, Metadata
Abstract

Introduction: Existing methods to make data Findable, Accessible, Interoperable, and Reusable (FAIR) are usually carried out in a post hoc manner: after the research project is conducted and data are collected. De-novo FAIRification, on the other hand, incorporates the FAIRification steps in the process of a research project. In medical research, data is often collected and stored via electronic Case Report Forms (eCRFs) in Electronic Data Capture (EDC) systems. By implementing a de novo FAIRification process in such a system, the reusability and, thus, scalability of FAIRification across research projects can be greatly improved. In this study, we developed and implemented a novel method for de novo FAIRification via an EDC system. We evaluated our method by applying it to the Registry of Vascular Anomalies (VASCA)., Methods: Our EDC and research project independent method ensures that eCRF data entered into an EDC system can be transformed into machine-readable, FAIR data using a semantic data model (a canonical representation of the data, based on ontology concepts and semantic web standards) and mappings from the model to questions on the eCRF. The FAIRified data are stored in a triple store and can, together with associated metadata, be accessed and queried through a FAIR Data Point. The method was implemented in Castor EDC, an EDC system, through a data transformation application. The FAIRness of the output of the method, the FAIRified data and metadata, was evaluated using the FAIR Evaluation Services., Results: We successfully applied our FAIRification method to the VASCA registry. Data entered on eCRFs is automatically transformed into machine-readable data and can be accessed and queried using SPARQL queries in the FAIR Data Point. Twenty-one FAIR Evaluator tests pass and one test regarding the metadata persistence policy fails, since this policy is not in place yet., Conclusion: In this study, we developed a novel method for de novo FAIRification via an EDC system. Its application in the VASCA registry and the automated FAIR evaluation show that the method can be used to make clinical research data FAIR when they are entered in an eCRF without any intervention from data management and data entry personnel. Due to the generic approach and developed tooling, we believe that our method can be used in other registries and clinical trials as well., (Copyright © 2021 The Author(s). Published by Elsevier Inc. All rights reserved.)

Published
2021
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42. Applying the FAIR Data Principles to the Registry of Vascular Anomalies (VASCA).

Author

Dos Santos Vieira B, Groenen K, 't Hoen PAC, Jacobsen A, Roos M, Kaliyaperumal R, Kersloot M, Cornet R, and Schultze Kool L

Subjects
Humans, Rare Diseases, Semantics, Common Data Elements, Registries, Software
Abstract

Background: Connecting currently existing, heterogeneous rare disease (RD) registries would greatly facilitate epidemiological and clinical research. To increase their interoperability, the European Union developed a set of Common Data Elements (CDEs) for RD registries., Objectives: To implement the CDEs and the FAIR data principles in the Registry of Vascular Anomalies (VASCA)., Methods: We created a semantic model for the CDE and transformed this into a Resource Description Framework (RDF) template. The electronic case report forms (eCRF) were mapped to the RDF template and published in a FAIR Data Point (FDP)., Results: The FAIR VASCA registry was successfully implemented using Castor EDC (Electronic Data Capture) software., Conclusion: FAIR technology allows researchers to query and combine data from different registries in real-time.

Published
2020
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43. Clinical Outcomes of 1625 Patients With Primary Aldosteronism Subtyped With Adrenal Vein Sampling.

Author

Rossi GP, Rossitto G, Amar L, Azizi M, Riester A, Reincke M, Degenhart C, Widimsky J Jr, Naruse M, Deinum J, Schultze Kool L, Kocjan T, Negro A, Rossi E, Kline G, Tanabe A, Satoh F, Christian Rump L, Vonend O, Willenberg HS, Fuller PJ, Yang J, Chee NYN, Magill SB, Shafigullina Z, Quinkler M, Oliveras A, Dun Wu K, Wu VC, Kratka Z, Barbiero G, Battistel M, Chang CC, Vanderriele PE, and Pessina AC

Subjects
Adult, Blood Specimen Collection, Female, Humans, Hyperaldosteronism surgery, Male, Middle Aged, Retrospective Studies, Treatment Outcome, Adrenal Glands blood supply, Adrenalectomy, Aldosterone blood, Hyperaldosteronism blood
Abstract

We sought to measure the clinical benefits of adrenal venous sampling (AVS), a test recommended by guidelines for primary aldosteronism (PA) patients seeking surgical cure, in a large registry of PA patients submitted to AVS. Data of 1625 consecutive patients submitted to AVS in 19 tertiary referral centers located in Asia, Australia, Europe, and North America were collected in a large multicenter international registry. The primary end points were the rate of bilateral success, ascertained lateralization of PA, adrenalectomy, and of cured arterial hypertension among AVS-guided and non AVS-guided adrenalectomy patients. AVS was successful in 80.1% of all cases but allowed identification of unilateral PA in only 45.5% by the criteria in use at each center. Adrenalectomy was performed in 41.8% of all patients and cured arterial hypertension in 19.6% of the patients, 2-fold more frequently in women than men ( P <0.001). When AVS-guided, surgery provided a higher rate of cure of hypertension than when non-AVS-guided (40.0% versus 30.5%; P =0.027). Compared with surgical cases, patients treated medically needed more antihypertensive medications ( P <0.001) and exhibited a higher rate of persistent hypokalemia requiring potassium supplementation (4.9% versus 2.3%; P <0.01). The low rate of adrenalectomy and cure of hypertension in PA patients seeking surgical cure indicates suboptimal AVS use, possibly related to issues in patient selection, technical success, and AVS data interpretation. Given the better outcomes of AVS-guided adrenalectomy, these results call for actions to improve the diagnostic use of this test that is necessary for detection of surgical PA candidates. Clinical Trial Registration- URL: http://www.clinicaltrials.gov. Unique identifier: NCT01234220.

Published
2019
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44. Quality of Life in Primary Aldosteronism: A Comparative Effectiveness Study of Adrenalectomy and Medical Treatment.

Author

Velema M, Dekkers T, Hermus A, Timmers H, Lenders J, Groenewoud H, Schultze Kool L, Langenhuijsen J, Prejbisz A, van der Wilt GJ, and Deinum J

Subjects
Combined Modality Therapy, Female, Humans, Male, Middle Aged, Prognosis, Prospective Studies, Surveys and Questionnaires, Adrenalectomy, Hyperaldosteronism therapy, Mineralocorticoid Receptor Antagonists therapeutic use, Quality of Life
Abstract

Context: In primary aldosteronism (PA), two subtypes are distinguished: aldosterone-producing adenoma (APA) and bilateral adrenal hyperplasia (BAH). In general, these are treated by adrenalectomy (ADX) and mineralocorticoid receptor antagonists (MRA), respectively., Objective: To compare the effects of surgical treatment and medical treatment on quality of life (QoL)., Design: Post hoc comparative effectiveness study within the Subtyping Primary Aldosteronism: A Randomized Trial Comparing Adrenal Vein Sampling and Computed Tomography Scan (SPARTACUS) trial., Setting: Twelve Dutch hospitals and one Polish hospital., Participants: Patients with PA (n = 184)., Interventions: ADX or MRAs., Main Outcome Measures: At baseline and 6-month and 1-year follow-up, we assessed QoL by two validated questionnaires: RAND 36-Item Health Survey 1.0 (RAND SF-36) and European Quality of Life-5 Dimensions (EQ-5D)., Results: At baseline, seven of eight RAND SF-36 subscales and both summary scores, as well as three of five EQ-5D dimensions and the visual analog scale, were lower in patients with PA compared with the general population, especially in women. The beneficial effects of ADX were larger than for MRAs for seven RAND SF-36 subscales, both summary scores, and health change. For the EQ-5D, we detected a difference in favor of ADX in two dimensions and the visual analog scale. Most differences in QoL between both treatments exceeded the minimally clinically important difference. After 1 year, almost all QoL measures had normalized for adrenalectomized patients. For patients on medical treatment, most QoL measures had improved but not all to the level of the general population., Conclusion: Both treatments improve QoL in PA, underscoring the importance of identifying these patients. QoL improved more after ADX for suspected APA than after initiation of medical treatment for suspected BAH., (Copyright © 2017 Endocrine Society)

Published
2018
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45. The merits of decision modelling in the earliest stages of the IDEAL framework: An innovative case in DIEP flap breast reconstructions.

Author

Hummelink S, Gerrits JGW, Schultze Kool LJ, Ulrich DJO, Rovers MM, and Grutters JPC

Subjects
Cost Savings, Diffusion of Innovation, Evidence-Based Medicine, Female, Humans, Mammaplasty economics, Mastectomy, Operative Time, Postoperative Complications economics, Postoperative Complications prevention & control, Quality-Adjusted Life Years, Decision Support Techniques, Mammaplasty methods, Perforator Flap economics
Abstract

Background: The IDEAL framework aims at improving the evidence base of available surgical innovations. However, the development of such innovations and collection of evidence is costly. Surgical innovation can provide more value for money if innovations are evaluated at an early stage, where evaluations can inform the decision whether to stop or to further develop an innovation. We illustrate how decision modelling can be readily adopted at the earliest stages (0-1) of the IDEAL framework, using an innovation in bilateral DIEP flap breast reconstruction as an example., Methods: We quantified expected costs and quality-adjusted life years (QALYs) of the current treatment and compared them with an innovation aimed at reducing complications and surgery time. The maximum effect of eliminating all complications (headroom analysis) was explored. Moreover, three scenarios with varying complications and surgery time reductions were modelled. Furthermore, the maximum price of the innovation was estimated in a threshold analysis according to its impact and societal willingness to pay., Results: The headroom analysis showed that when all complications associated with the current treatment are prevented, up to €889 per patient is saved. Scenario analysis showed cost savings between €256 and €828 per patient. When surgery time is reduced by 15 min and complications by 50%, the innovation will remain cost-effective at €671 per patient., Conclusion: In a field struggling with cost containment, decision modelling can help to separate promising innovations from costly failures at an early stage. In this example, decision modelling showed that it seems worthwhile to further develop the innovation., (Copyright © 2017 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Published
2017
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46. A single-centre experience of the implementation of adrenal vein sampling procedure: the impact on the diagnostic work-up in primary aldosteronism.

Author

Kądziela J, Prejbisz A, Michałowska I, Kołodziejczyk-Kruk S, Schultze Kool L, Kabat M, Janaszek-Sitkowska H, Toutounchi S, Gałązka Z, Ambroziak U, Bednarczuk T, Ptasińska-Wnuk D, Hoffmann M, Januszewicz M, Januszewicz A, and Witkowski A

Subjects
Aged, Female, Humans, Hydrocortisone blood, Male, Middle Aged, Patient Safety, Adrenal Glands blood supply, Blood Specimen Collection standards, Catheterization standards, Hyperaldosteronism diagnosis, Veins
Abstract

Background: Primary aldosteronism is one of the most common causes of secondary hypertension. Adrenal vein sampling (AVS) remains a "gold standard" procedure in differentiation between unilateral (adenoma) and bilateral (hyperplasia) disease., Aim: The aim of this study was to present our single-centre experience in establishing and implementating the AVS procedure., Methods: All patients had primary aldosteronism confirmed in a salt-infusion test. AVS was performed sequentially during a continuous intravenous infusion of cosyntropin and was preceded by multislice contrast-enhanced computed tomography (CT) examination of adrenal glands performed a few weeks before AVS in the majority of patients. AVS was regarded as successful if the ratio of each adrenal vein cortisol to inferior vena cava cortisol levels (selectivity index [SI]) was higher than 3.0. In the case of failure, a second attempt was considered in a few weeks. Patients were divided into four groups according to the order of the procedure by quartiles., Results: Between 31 May, 2012 and 5 May, 2016, AVS was performed in 124 patients (69% males, aged 55.3 ± 10.3 years) and was successful in 120 (96.8%) patients. All failed cases were due to the failure of cannulation of the right adrenal vein. The first-attempt success rate was 94.3% (117 of 124 patients) and increased from 83.9% in the first 31 patients to 100% in the last 31 patients. Similarly, the overall success rate increased from 93.5% to 100%. The right SI was significantly higher than the left one (26.4 vs. 11.0, p < 0.0001). Both indices did not differ across quartiles of patients. No complications occurred during the procedure., Conclusions: The AVS procedure, preceded by adrenal CT, may be implemented into daily diagnostic practice safely with an excellent success rate.

Published
2017
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47. Displaying inguinal lymph nodes before transplantation in a deep inferior epigastric perforator flap breast reconstruction using an innovative projection method.

Author

Hummelink S, Schultze Kool LJ, and Ulrich DJ

Subjects
Abdominal Wall blood supply, Abdominal Wall surgery, Adult, Arm, Breast Neoplasms surgery, Cohort Studies, Epigastric Arteries transplantation, Female, Humans, Inguinal Canal, Lymph Nodes blood supply, Lymph Nodes surgery, Mammaplasty adverse effects, Mastectomy methods, Middle Aged, Perforator Flap transplantation, Preoperative Care methods, Prognosis, Tomography, X-Ray Computed methods, Treatment Outcome, Angiography methods, Imaging, Three-Dimensional, Lymph Nodes diagnostic imaging, Lymphedema prevention & control, Mammaplasty methods, Perforator Flap blood supply
Abstract

Introduction: Lymphedema of the arm is a common postoperative complication as a result of breast cancer surgery. One of the surgical treatments comprises modification of a deep inferior epigastric perforator (DIEP) flap breast reconstruction to facilitate additional lymph node transplantation from the inguinal area. Using computed tomography angiography (CTA), the distribution of these lymph nodes can be assessed. A virtual planning based on this CTA created for the DIEP flap is presented, with the inguinal lymph nodes included, followed by preoperatively projecting this information on the patient's abdomen., Methods: A total of 10 patients underwent the standard imaging protocol: A preoperative CTA to assess the vascular anatomy of the lower abdomen. A three-dimensional (3D) model of the blood vessels was produced, and the inguinal lymph nodes in this reconstruction were included. Preoperative projection of the 3D model onto the patients' abdomen and inguinal area was performed, followed by tracing of this image. Intraoperatively found lymph nodes were identified by touch and compared with the markings on the skin., Results: In all 10 patients, all lymph nodes located preoperatively were found intraoperatively within a 1-cm radius of the marking on the skin; and these were more easily located by two operating surgeons., Conclusion: Virtual planning of lymph node transplantations in a deep inferior epigastric artery perforator flap breast reconstruction seems feasible and can be performed quickly. This additional visual support aids the surgeon in locating the lymph nodes in the inguinal area., (Copyright © 2015 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Published
2016
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48. [A pregnant patient with spontaneous haemothorax: hereditary haemorrhagic telangiectasia in pregnancy].

Author

Mourad SM, Mies R, Frenzel T, Willems S, van der Heijden E, and Schultze Kool LJ

Subjects
Adult, Female, Gestational Age, Humans, Lung blood supply, Pregnancy, Telangiectasia, Hereditary Hemorrhagic genetics, Tomography, X-Ray Computed, Arteriovenous Malformations genetics, Hemothorax genetics, Pregnancy Complications, Cardiovascular genetics, Telangiectasia, Hereditary Hemorrhagic complications
Abstract

Background: The incidence of hereditary haemorrhagic telangiectasia (HHT - Osler-Weber-Rendu disease) in the Netherlands is 1:5000 but approximately 1:1300 in people from the Antilles. The disease is characterised by the development of telangiectasia and arteriovenous malformations (AVMs) that may result in serious morbidity and mortality., Case Description: A 31-year-old primigravid patient consulted her general practitioner at 31 1/7 weeks gestational age with dyspnoea. She was referred for further diagnostics because of suspected pulmonary embolism. A CT scan showed haemothorax and a bleeding arteriovenous malformation (AVM) in the left lung. Family history suggested the possibility of HHT. After multidisciplinary consideration, a primary caesarean section was performed, followed by embolisation of the AVM during the same surgical session. The patient had a gene mutation consistent with HHT type 2., Conclusion: Pregnant patients with HHT are at risk of serious morbidity, especially if they are not screened for AVMs. A multidisciplinary approach for such patients, with consideration of various scenarios, is highly recommended.

Published
2016

49. [Hypertension due to fibromuscular dysplasia: look for additional disease sites].

Author

Maas ML, Kroese JM, Bredie SJ, Postma CT, de Leeuw FE, Schultze Kool LJ, and Riksen NP

Subjects
Humans, Fibromuscular Dysplasia complications, Hypertension etiology
Abstract

Fibromuscular dysplasia (FMD) is a non-inflammatory, non-atherosclerotic vasculopathy that can lead to arterial stenosis, occlusion, aneurysms, and dissection. FMD of the renal arteries can lead to renovascular hypertension. Percutaneous angioplasty of the renal arteries (PTRA) can lead to normalization of blood pressure in 45% of patients with renal artery stenosis caused by FMD, particularly in younger patients and patients with a short history of hypertension. A considerable number of the patients with renovascular FMD also have cervical FMD, which can lead to ischaemic or haemorrhagic stroke. In this article we discuss diagnostic and therapeutic options, illustrated by two cases of patients with renovascular and carotid FMD. Most of the recommendations are based on data from retrospective studies and expert opinion; prospective studies on the optimal diagnostic strategy and treatment are therefore, urgently required.

Published
2016

50. Preliminary results using a newly developed projection method to visualize vascular anatomy prior to DIEP flap breast reconstruction.

Author

Hummelink S, Hameeteman M, Hoogeveen Y, Slump CH, Ulrich DJ, and Schultze Kool LJ

Subjects
Abdominal Wall blood supply, Epigastric Arteries transplantation, Female, Humans, Image Interpretation, Computer-Assisted, Imaging, Three-Dimensional, Microsurgery methods, Tomography, X-Ray Computed, Mammaplasty methods, Perforator Flap blood supply, Surgery, Computer-Assisted, Ultrasonography, Doppler
Abstract

Introduction: In a deep inferior epigastric perforator (DIEP) flap breast reconstruction, computed tomography angiography (CTA) is currently considered as the gold standard in preoperative imaging for this procedure. Unidirectional Doppler ultrasound (US) is frequently used; however, this method does not distinguish the main axial vessels from perforator arteries at the height of the fascia, it has a limited penetration depth, and it cannot assess the branching patterns of the deep inferior arteries. A new method and system were developed, which consisted of a video projector preoperatively displaying the location and intramuscular course of the artery perforators and subcutaneous branching on the patient's abdomen., Method: All patients (n=9) underwent a standard protocol: a preoperative CTA was performed and the DIEPs were localized using a unidirectional Doppler probe. In addition, a three-dimensional (3D) reconstruction of the perforator locations based on CTA was projected on the abdomen of the patients. All projected perforator locations were assessed using a unidirectional Doppler probe. The intraoperative results were collected for comparison., Results: A total of 88 locations were marked with the use of unidirectional Doppler and a total of 100 perforators were projected (p=0.38). In 98 out of 100 projected perforator locations, a Doppler signal was audible. The intraoperative results demonstrate that 19 out of 34 transplanted perforators were correctly identified with unidirectional Doppler (56.9%±31.4%), where the projection method properly revealed 29 locations (84.3%±25.8%) (p=0.030)., Conclusion: The projection method is not only capable of providing more information and identifying more perforators used for transplantation than unidirectional Doppler probing but also more accurate in pointing out the corresponding perforator found intraoperatively., (Copyright © 2014 British Association of Plastic, Reconstructive and Aesthetic Surgeons. Published by Elsevier Ltd. All rights reserved.)

Published
2015
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