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3. The Sac Evolution Imaging Follow-Up after EVAR: an international expert opinion-based Delphi consensus study

Author

Tinelli, G, D'Oria, M, Sica, S, Mani, K, Rancic, Z, Resch, T, Beccia, F, Azizzadeh, A, Da Volta Ferreira, M, Gargiulo, M, Lepidi, S, Tshomba, Y, Oderich, G, Haulon, S, Beck, A, Hertault, A, Savlania, A, Froio, A, Giaquinta, A, Zimmermann, A, Psyllas, A, Wanhainen, A, Marchetti, A, Queiroz, A, Kahlberg, A, Reyes-Valdivia, A, Schanzer, A, Tambyraja, A, Freyrie, A, Lorido, A, Millon, A, Ippoliti, A, Abai, B, Mees, B, Reutersberg, B, Maurel, B, Michel, B, Wahlgren, C, Cavazzini, C, Setacci, C, Lee, C, Ferrer, C, Bicknell, C, Raphael, C, Clair, D, Dawson, D, Arnaoutakis, D, Bockler, D, Kotelis, D, Mujagic, E, Chisci, E, Cieri, E, Gallitto, E, Marone, E, Ducasse, E, Verzini, F, Pecoraro, F, Serracino-Inglott, F, Benedetto, F, Speziale, F, Stilo, F, Alvarez-Marcos, F, Pagliariccio, G, Piffaretti, G, Lanza, G, Philipp, G, Geenberg, G, Jung, G, Melissano, G, Veraldi, G, Parlani, G, Faggioli, G, de Donato, G, Simonte, G, Colacchio, G, De Caridi, G, Pratesi, G, Spinella, G, Torsello, G, Leong Tan, G, Magee, G, Verhagen, H, Andrew, H, Koleilat, I, Ohman, J, de Vries, J, Budtz-Lilly, J, Black, J, Eldrup-Jorgensen, J, Hockley, J, Bath, J, Sobocinski, J, van Herwaarden, J, Reinhard, K, Orion, K, Amankwah, K, Bertoglio, L, di Marzo, L, Garriboli, L, Rizzo, L, Hakimi, M, Sheahan, M, Khashram, M, Schermerhorn, M, Lescan, M, Conrad, M, Davies, M, Czerny, M, Orrico, M, Eagleton, M, Smeds, M, Taurino, M, Wohlauer, M, Sharafuddin, M, Anna-Leonie, M, Reijnen, M, Antonello, M, Piazza, M, Settembre, N, Mouawad, N, Tsilimparis, N, Dias, N, Martinelli, O, Frigatti, P, Sirignano, P, Chong, P, Bevis, P, Dimuzio, P, Henke, P, Duppers, P, Holt, P, Helmio, P, Vriens, P, Pulli, R, Bellosta, R, Micheli, R, Veeraswamy, R, Cuff, R, Chiappa, R, Gattuso, R, Pini, R, Dalman, R, Milner, R, Scali, S, Bahia, S, Laukontaus, S, Trimarchi, S, Fernandez-Alonso, S, Deglise, S, Bellmunt-Montoya, S, Hofer, S, Yusuf, S, Ronchey, S, Bartoli, S, Bonvini, S, Camparini, S, Fazzini, S, Pirrelli, S, Horer, T, Bisdas, T, Vasudevan, T, Lattmann, T, Wyss, T, Maldonado, T, Pfammatter, T, Kolbel, T, Jakimowicz, T, Donati, T, Tracci, M, Bracale, U, Tolva, V, Riambau, V, Palazzo, V, Makaloski, V, Von Allmen, R, Dorigo, W, Mansour, W, Van den Eynde, W, Tinelli G., D'Oria M., Sica S., Mani K., Rancic Z., Resch T. A., Beccia F., Azizzadeh A., Da Volta Ferreira M. M., Gargiulo M., Lepidi S., Tshomba Y., Oderich G. S., Haulon S., Beck A. W., Hertault A., Savlania A., Froio A., Giaquinta A., Zimmermann A., Psyllas A., Wanhainen A., Marchetti A. A., Queiroz A. B., Kahlberg A., Reyes-Valdivia A., Schanzer A., Tambyraja A., Freyrie A., Lorido A., Millon A., Ippoliti A., Abai B., Mees B., Reutersberg B., Maurel B., Michel B., Wahlgren C. M., Cavazzini C., Setacci C., Lee C. J., Ferrer C., Bicknell C., Raphael C., Clair D., Dawson D. L., Arnaoutakis D. J., Bockler D., Kotelis D., Mujagic E., Chisci E., Cieri E., Gallitto E., Marone E. M., Ducasse E., Verzini F., Pecoraro F., Serracino-Inglott F., Benedetto F., Speziale F., Stilo F., Alvarez-Marcos F., Pagliariccio G., Piffaretti G., Lanza G., Philipp G., Geenberg G., Jung G., Melissano G., Veraldi G. F., Parlani G., Faggioli G., de Donato G., Simonte G., Colacchio G., De Caridi G., Pratesi G., Spinella G., Torsello G., Leong Tan G. W., Magee G. A., Verhagen H., Andrew H., Koleilat I., Ohman J. W., de Vries J. P. P. M., Budtz-Lilly J., Black J., Eldrup-Jorgensen J., Hockley J., Bath J., Sobocinski J., van Herwaarden J. A., Reinhard K., Orion K. C., Amankwah K., Bertoglio L., di Marzo L., Garriboli L., Rizzo L., Hakimi M., Sheahan M., Khashram M., Schermerhorn M., Lescan M., Conrad M., Davies M. G., Czerny M., Orrico M., Eagleton M. J., Smeds M. R., Taurino M., Wohlauer M., Sharafuddin M. J., Anna-Leonie M., Reijnen M., Antonello M., Piazza M., Settembre N., Mouawad N. J., Tsilimparis N., Dias N., Martinelli O., Frigatti P., Sirignano P., Chong P., Bevis P., DiMuzio P., Henke P., Duppers P., Holt P., Helmio P., Vriens P., Pulli R., Bellosta R., Micheli R., Veeraswamy R., Cuff R., Chiappa R., Gattuso R., Pini R., Dalman R. L., Milner R., Scali S. T., Bahia S., Laukontaus S., Trimarchi S., Fernandez-Alonso S., Deglise S., Bellmunt-Montoya S., Hofer S., Yusuf S. W., Ronchey S., Bartoli S., Bonvini S., Camparini S., Fazzini S., Pirrelli S., Horer T., Bisdas T., Vasudevan T., Lattmann T., Wyss T. R., Maldonado T., Pfammatter T., Kolbel T., Jakimowicz T., Donati T., Tracci M., Bracale U. M., Tolva V. S., Riambau V., Palazzo V., Makaloski V., Von Allmen R. S., Dorigo W., Mansour W., Van den Eynde W., Tinelli, G, D'Oria, M, Sica, S, Mani, K, Rancic, Z, Resch, T, Beccia, F, Azizzadeh, A, Da Volta Ferreira, M, Gargiulo, M, Lepidi, S, Tshomba, Y, Oderich, G, Haulon, S, Beck, A, Hertault, A, Savlania, A, Froio, A, Giaquinta, A, Zimmermann, A, Psyllas, A, Wanhainen, A, Marchetti, A, Queiroz, A, Kahlberg, A, Reyes-Valdivia, A, Schanzer, A, Tambyraja, A, Freyrie, A, Lorido, A, Millon, A, Ippoliti, A, Abai, B, Mees, B, Reutersberg, B, Maurel, B, Michel, B, Wahlgren, C, Cavazzini, C, Setacci, C, Lee, C, Ferrer, C, Bicknell, C, Raphael, C, Clair, D, Dawson, D, Arnaoutakis, D, Bockler, D, Kotelis, D, Mujagic, E, Chisci, E, Cieri, E, Gallitto, E, Marone, E, Ducasse, E, Verzini, F, Pecoraro, F, Serracino-Inglott, F, Benedetto, F, Speziale, F, Stilo, F, Alvarez-Marcos, F, Pagliariccio, G, Piffaretti, G, Lanza, G, Philipp, G, Geenberg, G, Jung, G, Melissano, G, Veraldi, G, Parlani, G, Faggioli, G, de Donato, G, Simonte, G, Colacchio, G, De Caridi, G, Pratesi, G, Spinella, G, Torsello, G, Leong Tan, G, Magee, G, Verhagen, H, Andrew, H, Koleilat, I, Ohman, J, de Vries, J, Budtz-Lilly, J, Black, J, Eldrup-Jorgensen, J, Hockley, J, Bath, J, Sobocinski, J, van Herwaarden, J, Reinhard, K, Orion, K, Amankwah, K, Bertoglio, L, di Marzo, L, Garriboli, L, Rizzo, L, Hakimi, M, Sheahan, M, Khashram, M, Schermerhorn, M, Lescan, M, Conrad, M, Davies, M, Czerny, M, Orrico, M, Eagleton, M, Smeds, M, Taurino, M, Wohlauer, M, Sharafuddin, M, Anna-Leonie, M, Reijnen, M, Antonello, M, Piazza, M, Settembre, N, Mouawad, N, Tsilimparis, N, Dias, N, Martinelli, O, Frigatti, P, Sirignano, P, Chong, P, Bevis, P, Dimuzio, P, Henke, P, Duppers, P, Holt, P, Helmio, P, Vriens, P, Pulli, R, Bellosta, R, Micheli, R, Veeraswamy, R, Cuff, R, Chiappa, R, Gattuso, R, Pini, R, Dalman, R, Milner, R, Scali, S, Bahia, S, Laukontaus, S, Trimarchi, S, Fernandez-Alonso, S, Deglise, S, Bellmunt-Montoya, S, Hofer, S, Yusuf, S, Ronchey, S, Bartoli, S, Bonvini, S, Camparini, S, Fazzini, S, Pirrelli, S, Horer, T, Bisdas, T, Vasudevan, T, Lattmann, T, Wyss, T, Maldonado, T, Pfammatter, T, Kolbel, T, Jakimowicz, T, Donati, T, Tracci, M, Bracale, U, Tolva, V, Riambau, V, Palazzo, V, Makaloski, V, Von Allmen, R, Dorigo, W, Mansour, W, Van den Eynde, W, Tinelli G., D'Oria M., Sica S., Mani K., Rancic Z., Resch T. A., Beccia F., Azizzadeh A., Da Volta Ferreira M. M., Gargiulo M., Lepidi S., Tshomba Y., Oderich G. S., Haulon S., Beck A. W., Hertault A., Savlania A., Froio A., Giaquinta A., Zimmermann A., Psyllas A., Wanhainen A., Marchetti A. A., Queiroz A. B., Kahlberg A., Reyes-Valdivia A., Schanzer A., Tambyraja A., Freyrie A., Lorido A., Millon A., Ippoliti A., Abai B., Mees B., Reutersberg B., Maurel B., Michel B., Wahlgren C. M., Cavazzini C., Setacci C., Lee C. J., Ferrer C., Bicknell C., Raphael C., Clair D., Dawson D. L., Arnaoutakis D. J., Bockler D., Kotelis D., Mujagic E., Chisci E., Cieri E., Gallitto E., Marone E. M., Ducasse E., Verzini F., Pecoraro F., Serracino-Inglott F., Benedetto F., Speziale F., Stilo F., Alvarez-Marcos F., Pagliariccio G., Piffaretti G., Lanza G., Philipp G., Geenberg G., Jung G., Melissano G., Veraldi G. F., Parlani G., Faggioli G., de Donato G., Simonte G., Colacchio G., De Caridi G., Pratesi G., Spinella G., Torsello G., Leong Tan G. W., Magee G. A., Verhagen H., Andrew H., Koleilat I., Ohman J. W., de Vries J. P. P. M., Budtz-Lilly J., Black J., Eldrup-Jorgensen J., Hockley J., Bath J., Sobocinski J., van Herwaarden J. A., Reinhard K., Orion K. C., Amankwah K., Bertoglio L., di Marzo L., Garriboli L., Rizzo L., Hakimi M., Sheahan M., Khashram M., Schermerhorn M., Lescan M., Conrad M., Davies M. G., Czerny M., Orrico M., Eagleton M. J., Smeds M. R., Taurino M., Wohlauer M., Sharafuddin M. J., Anna-Leonie M., Reijnen M., Antonello M., Piazza M., Settembre N., Mouawad N. J., Tsilimparis N., Dias N., Martinelli O., Frigatti P., Sirignano P., Chong P., Bevis P., DiMuzio P., Henke P., Duppers P., Holt P., Helmio P., Vriens P., Pulli R., Bellosta R., Micheli R., Veeraswamy R., Cuff R., Chiappa R., Gattuso R., Pini R., Dalman R. L., Milner R., Scali S. T., Bahia S., Laukontaus S., Trimarchi S., Fernandez-Alonso S., Deglise S., Bellmunt-Montoya S., Hofer S., Yusuf S. W., Ronchey S., Bartoli S., Bonvini S., Camparini S., Fazzini S., Pirrelli S., Horer T., Bisdas T., Vasudevan T., Lattmann T., Wyss T. R., Maldonado T., Pfammatter T., Kolbel T., Jakimowicz T., Donati T., Tracci M., Bracale U. M., Tolva V. S., Riambau V., Palazzo V., Makaloski V., Von Allmen R. S., Dorigo W., Mansour W., and Van den Eynde W.

Abstract

Objective: Management of follow-up protocols after endovascular aortic repair (EVAR) varies significantly between centers and is not standardized according to sac regression. By designing an international expert-based Delphi consensus, the study aimed to create recommendations on follow-up after EVAR according to sac evolution. Methods: Eight facilitators created appropriate statements regarding the study topic that were voted, using a 4-point Likert scale, by a selected panel of international experts using a three-round modified Delphi consensus process. Based on the experts' responses, only those statements reaching a grade A (full agreement ≥75%) or B (overall agreement ≥80% and full disagreement <5%) were included in the final document. Results: One-hundred and seventy-four participants were included in the final analysis, and each voted the initial 29 statements related to the definition of sac regression (Q1-Q9), EVAR follow-up (Q10-Q14), and the assessment and role of sac regression during follow-up (Q15-Q29). At the end of the process, 2 statements (6.9%) were rejected, 9 statements (31%) received a grade B consensus strength, and 18 (62.1%) reached a grade A consensus strength. Of 27 final statements, 15 (55.6%) were classified as grade I, whereas 12 (44.4%) were classified as grade II. Experts agreed that sac regression should be considered an important indicator of EVAR success and always be assessed during follow-up after EVAR. Conclusions: Based on the elevated strength and high consistency of this international expert-based Delphi consensus, most of the statements might guide the current clinical management of follow-up after EVAR according to the sac regression. Future studies are needed to clarify debated issues.

Published
2024

5. Contralateral Stenosis and Echolucent Plaque Morphology are Associated with Elevated Stroke Risk in Patients Treated with Asymptomatic Carotid Artery Stenosis within a Controlled Clinical Trial (SPACE-2)

Author

Beyersdorf, F, Grügerny, M, Macharzina, R-R, Lechner, G, Menz, C, Schonhardt, S, Weinbeck, M, Greb, O, Otto, D, Winker, T, Berger, H, Poppert, H, Pütz, V, Haase, K, Bodechtel, U, Weiss, N, Bergert, H, Meyne, J, Groß, J, Botsch, A, Kruse, M, Gerdes, B, Reinbold, WD, Wuttig, H, Maier-Hasselmann, A, Segerer, M, Fuchs, H-H, Gass, S, Schultz, H, Groden, C, Niedergethman, M, Griebe, M, Rosenkranz, M, Beck, C, Thomalla, G, Zeumer, H, Jauß, M, Kneist, W, Kneist, M, Staudacher, T, Bernhard, A, Jost, D, Prey, N, Knippschild, J, Kastrup, O, Köhrmann, M, Frank, B, Bongers, V, Hoffmann, J, Kniemeyer, H-W, Knauth, M, Wasser, K, Stojanovic, T, Emmert, H, Tacke, J, Schwalbe, B, Nam, E-M, van Lengerich, U, Lowens, S, Gröschel, K, Uphaus, T, Gröschel, S, Boor, S, Dorweiler, B, Schmid, E, Henkes, H, Hupp, T, Singer, O, Hamann, G, Wagner-Heck, M, Kerth-Krick, S, Kilic, M, Huppert, P, Niederkorn, K, Fruhwirth, J, Klein, G, Pulkowski, U, Jöster, K, Wacks, J-H, Kloppmann, E, Vatankhah, B, Hopf-Jensen, S, Stolze, H, Müller-Hülsbeck, S, Walluscheck, KP, Schmitt, H-M, Grüger, A, Seemann, J, Tilahun, B, Dichgans, M, Wollenweber, F, Dörr, A, Zollver, A, Gäbel, G, Hedtmann, G, Kollmar, R, Claus, D, Petermann, C, Kirsch, S, Bosnjak, B, Heiß, J, Mühling, H, Wunderlich, S, Sabisch, PN, Gahn, G, Storck, M, Arnold, S, Fischer, U, Gralla, J, von Mering, M, Dißmann, R, Kirsch, D, Schmidauer, C, Waldenberger, P, Furtner, M, Kazarians, H, Breuer, P, Arning, C, Rieper, J, Schmidt, G, Arnold, M, Schroth, G, Weise, J, Zanow, J, Mayer, T, Töpper, R, Gross-Fengels, W, Daum, H, Dittrich, R, Ritter, M, Kasprzak, B, Torsello, G, Pohlmann, C, Brüning, R, Amiri, H, Ludwig, I, Blessing, E, Möhlenbruch, M, Crispin, A, Hofman, M, Müller, T, Reiff, Tilman, Eckstein, Hans-Henning, Mansmann, Ulrich, Jansen, Olav, Fraedrich, Gustav, Mudra, Harald, Böckler, Dittmar, Böhm, Michael, Brückmann, Hartmut, Debus, E. Sebastian, Fiehler, Jens, Mathias, Klaus, Ringelstein, E. Bernd, Schmidli, Jürg, Stingele, Robert, Zahn, Ralf, Zeller, Thomas, Niesen, Wolf-Dirk, Barlinn, Kristian, Binder, Andreas, Glahn, Jörg, and Ringleb, Peter Arthur

Published
2021
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6. RANDOMisation Screening for Drug coated or Drug Eluting Device Randomised Trials Among Patients Undergoing Endovascular FemorOPopliteal Procedures (RANDOM-STOP study)

Author

Stavroulakis, K., primary, Katsogridakis, E., additional, Torsello, G., additional, Zayed, H., additional, van Herzeele, I., additional, Coscas, R., additional, Nasr, B., additional, Gonzalez, T.M., additional, Troisi, N., additional, Saratzis, A., additional, Bohnert, A., additional, Martin-Gonzalez, T., additional, Torsello, G.B., additional, Wichmann, K., additional, Cardona, Y.G., additional, Stavroulakis, C., additional, Stavroulakis, K., additional, Tsilimparis, N., additional, Konstantinou, N., additional, Croo, A., additional, Jacobs, K., additional, Pecceu, S., additional, Van Langenhove, K., additional, Mercier, L., additional, Simonte, G., additional, Terpin, A.M., additional, Isernia, G., additional, Furlan, F., additional, Frigatti, P., additional, Canovaro, F., additional, Torri, L., additional, D'Oria, M., additional, Lepidi, S., additional, Magalhães, T., additional, Pedro, L.M., additional, Marone, E.M., additional, Marazzi, G., additional, Rinaldi, L.F., additional, Thulasidasan, N., additional, Benton, L., additional, Gregory, M., additional, Asciutto, G., additional, Korosoglou, G., additional, and Torsello, G.F., additional

Published
2023
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21. Moderne endovaskuläre Therapieoptionen bei diabetischem Fußsyndrom

Author

Argyriou, A., Rantner, B., Stana, J., Tsilimparis, N., Sensebat, Ö., Torsello, G., and Stavroulakis, K.

Abstract

Weltweit steigt die Prävalenz der peripheren arteriellen Verschlusskrankheit (pAVK) und insbesondere die der kritischen Extremitätenischämie. Letztere ist das Endstadium der arteriellen Verschlusskrankheit und mit erhöhter Mortalität, erhöhtem Amputationsrisiko und beeinträchtigter Lebensqualität assoziiert. Menschen mit Diabetes mellitus und kritischer Ischämie bilden eine besondere Subgruppe unter dieser Klientel. Diabetische Ulzerationen und Wundinfektionen erhöhen das Amputationsrisiko erheblich. Darüber hinaus stellen die diabetische Mikro- und Makroangiopathie, die isolierte Unterschenkel-pAVK und die starke Kalzifizierung der betroffenen Gefäße eine zusätzliche Herausforderung dar. Dementsprechend erfordert die Revaskularisation bei Diabetespatienten komplexe chirurgische und endovaskuläre Strategien. Aufgrund ihrer erhöhten periprozeduralen Mortalität nach chirurgischen Rekonstruktionen führte die Entwicklung neuer endovaskulärer Techniken zu einem Paradigmenwechsel in der Behandlung dieser Hochrisikopatienten. Vor diesem Hintergrund ist die endovaskuläre Technik als Therapie der Wahl für Menschen mit Diabetes und pAVK anzusehen. Der vorliegende Beitrag soll zur Klärung und Präsentation neuer Entwicklungen im Bereich der endovaskulären Therapie des diabetischen Fußsyndroms beitragen.

Published
2024
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29. Percutaneous Large-Bore Pulmonary Thrombectomy with the FlowTriever Device: Initial Experience in Intermediate-High and High-Risk Patients

Author

Luedemann, W. M., primary, Zickler, D., additional, Kruse, J., additional, Koerner, R., additional, Lenk, J., additional, Erxleben, C., additional, Torsello, G. F., additional, Fehrenbach, U., additional, Jonczyk, M., additional, Guenther, R. W., additional, De Bucourt, M., additional, and Gebauer, B., additional

Published
2022
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40. One-year results of the INSIGHT study on endovascular treatment of abdominal aortic aneurysms

Author

Torsello, G., Bertoglio, L., Kellersmann, R., Wever, J.J., Warle, M.C., Overhagen, H. van, Stavroulakis, K., Torsello, G., Bertoglio, L., Kellersmann, R., Wever, J.J., Warle, M.C., Overhagen, H. van, and Stavroulakis, K.

Abstract

Item does not contain fulltext, OBJECTIVE: Endovascular repair of abdominal aortic aneurysms (AAAs) using the INCRAFT AAA Stent Graft System was safe and effective in regulatory approval studies. We herein report on the 1-year results of a real-world clinical study. METHODS: The INSIGHT study is a multi-center, prospective, open label, post-approval study conducted to continually evaluate the safety and performance of the INCRAFT System. Between 2015 and 2016, 150 consecutive patients with AAA at 23 centers in Europe were treated with the device in routine clinical practice. The primary endpoint was freedom from major adverse events (MAEs), namely death, myocardial infarction, cerebrovascular accident, and renal failure, within 30 days of the index procedure. End point data were assessed by a core laboratory. The secondary end points included technical success at the conclusion of the procedure and clinical success. RESULTS: All 150 patients studied (mean age, 73.6 ± 8.0 years; 89.3% men) met the primary end point without MAEs at 30-day follow-up. Technical success was achieved in 99.3% of patients without stent fractures at 30 days. Among the 146 patients eligible for 1-year follow-up, the MAE rate was 8.2% (ie, 12 patients suffered 13 MAEs: cerebrovascular accident in 8, myocardial infarction in 1, and 4 died, resulting in a 2.7% all-cause mortality rate). There were no reports of new onset renal failure requiring dialysis. Only 2.7% of patients had type I endoleak, and no type III endoleaks were identified through 1 year. The rate of clinical success at 1 year was 91.8%. CONCLUSIONS: The 1-year results of this multicenter real-world study underscore the safety and effectiveness of endovascular treatment of AAA with the INCRAFT System in routine clinical practice.

Published
2022

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