2017 EDIZIONI MINERVA MEDICA S.p.A. Corso Bramante 83/ Torino /

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2 ISBN: EDIZIONI MINERVA MEDICA S.p.A. Corso Bramante 83/ Torino / minervamedica@minervamedica.it All rights reserved. No part of this publication may be reproduced, stored in a retrieval system, or transmitted in any form or by any means.

3 Authors Ferdinando Auricchio R. Department R. Kolvenbach of Civil Engineering and Architecture, University of Pavia, Pavia, Italy Adrian Boicean Polisano European Hospital, Sibiu, Romania Robson Chicrala de Abreu Centervasc Rio, Rio de Janeiro, Brazil Michele Conti Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy Andrea Costache Polisano European Hospital, Sibiu, Romania Victor S. Costache Lucian Blaga University, Sibiu, Romania Sara Di Gregorio Dan-Mihai Dorobantu Lucian Blaga University, Sibiu, Romania Elena Faggiano Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy Marco Fedele Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy Alice Finotello Department of Experimental Medicine, Cristina Goia Polisano European Hospital, Sibiu, Romania Ralf R. Kolvenbach Department of Vascular Surgery and Endovascular Therapy, Catholic Hospital Group Duesseldorf, Augusta Hospital, Duesseldorf, Germany Kiichiro Kumagai Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan Horatiu Moldovan Sanador Hospital, Bucharest, Romania Domenico Palombo Bianca Pane Maria C. Perfumo Ivo Petrov City Clinic Heart and Vascular Institute, Sofia, Bulgaria Yoshikatsu Saiki Division of Cardiovascular Surgery, Tohoku University Graduate School of Medicine, Sendai, Japan Adrian Santa Lucian Blaga University, Sibiu, Romania III

4 Authors Giovanni Spinella Zoran Stankov City Clinic Heart and Vascular Institute, Sofia, Bulgaria Sherif Sultan National University of Ireland, Galway, Ireland Iveta Tasheva City Clinic Heart and Vascular Institute, Sofia, Bulgaria Claude D. Vaislic Department of Cardiac, Vascular and Thoracic Surgery, Centre Hospitalier Privé Parly 2, Le Chesnay, France Alberto Vescovi Catholic University of Rio de Janeiro, Rio de Janeiro, Brazil; Centervasc Rio, Rio de Janeiro, Brazil Arno von Ristow Catholic University of Rio de Janeiro, Rio de Janeiro, Brazil; Centervasc Rio, Rio de Janeiro, Brazil IV

5 Contents Introduction... R. R. Domenico Kolvenbach Palombo VI 1 The theoretical and experimental basis of the Multilayer Flow Modulator... 1 Elena Faggiano, Giovanni Spinella, Marco Fedele, Alice Finotello, Michele Conti, Bianca Pane, Maria C. Perfumo, Ferdinando Auricchio, Domenico Palombo 2 Contemporary strategies for repair of complex thoracoabdominal aortic aneurysms: real-world experiences Ralf R. Kolvenbach 3 The STRATO trial: a multicenter, prospective study of the Multilayer Flow Modulator in high-surgical-risk patients presenting with Crawford type II and III thoracoabdominal aortic aneurysms Claude D. Vaislic 4 Italian experience with the Multilayer Flow Modulator for treatment of complex aortic disease Bianca Pane, Giovanni Spinella, Maria C. Perfumo, Sara Di Gregorio, Domenico Palombo 5 Treatment of complex aortic aneurysms and dissections with the Multilayer Flow Modulator: Romanian registry experience Victor S. Costache, Adrian Boicean, Andrea Costache, Cristina Goia, Sherif Sultan, Horatiu Moldovan, Adrian Santa, Dan-Mihai Dorobantu 6 Treatment of paravisceral and thoracoabdominal aneurysms in high-risk patients over 80 years of age Arno von Ristow, Alberto Vescovi, Robson Chicrala de Abreu 7 Bulgarian experience with the Multilayer Flow Modulator for complex aortic pathology Ivo Petrov, Zoran Stankov, Iveta Tasheva 8 A new horizon for treatment of thoracoabdominal aortic aneurysm in Japan: the Multilayer Flow Modulator Yoshikatsu Saiki, Kiichiro Kumagai V

6 introduction R. R. Kolvenbach Domenico PALOMBO* Since its first reported deployment in 2008,1 the Multilayer Flow Modulator (MFM) (Cardiatis, Isnes, Belgium) has been implanted in more than 3500 patients worldwide and can represent, in selected cases, an effective alternative to standard stent-graft technology for treatment of aneurysmal disease. The MFM was granted Conformité Européene (CE) marking for peripheral artery aneurysms in 2009 and for aortic aneurysms in 2011, and has since received regulatory approval in various Asian, Middle Eastern, African, and South American countries. Whereas the leading aim of conventional endovascular treatment is to decrease the risk of rupture by excluding the aneurysm from the blood flow, with complex and demanding procedures involving customized devices required for preserving collateral arteries, the flow-diverting technology of the off-the-shelf uncovered self-expanding MFM was conceived to thrombose and stabilize the aneurysm sac while creating an organized laminar flow into covered branch vessels without the need for the extra steps involved in cannulation.2 The aim in the compilation of this book on the role of the MFM in complex aortic pathology was to advance awareness of this interventional alternative and understanding of its potential applicability, as well as to characterize and clarify the appropriate conditions for its use. To that end, the book presents the informed experience with the MFM on the part of a widespread collection of physicians who are well versed in the use of almost all devices that have been available for endovascular procedures. The book opens with an extensive review of the theoretical and experimental basis for the MFM by Elena Faggiano et al. at the University of Pavia and the University of Genoa in Italy. The physics and classification of aneurysm pathology are summarized as well as the treatment challenges presented by aortic aneurysms, including the issue of covered branch arteries. The design concept of the MFM is explicated and key performance categories such as changes in fluid dynamics, intraluminal thrombus formation, and endothelialization are introduced, along with the device technical features. Then, after an overview of clinical research to date with the MFM, the chapter concludes with an examination of innovative benchtop numerical simulation research into the hemodynamic and biomechanical effects of the device. In Chapter 2, Ralf Kolvenbach, of Augusta Hospital in Düsseldorf, Germany, presents the context for the MFM in a thorough overview of contemporary strategies for repair of complex thoracoabdominal aortic aneurysms (TAAA) covering the historical development from open surgical repair to the adaptations of endograft technology including VI Palombo_00_ok.indd 6 12/06/17 11:54

7 The current role of multilayer flow modulator stents in complex aortic pathology fenestrated and/or branched endovascular repair and then to the MFM alternative as used in many cases that are otherwise inoperable. The serious complications associated with TAAA repair including renal failure, spinal cord ischemia (SCI), chronic obstructive pulmonary disease (COPD), coronary artery disease, and peripheral arterial disease are well characterized. Then, with a look at reports from experienced high-volume centers, key parameters of perioperative and long-term outcomes are summarized for open repair, for fenestrated and/or branched repair, and for MFM treatment of TAAA. In Chapter 3, Claude Vaislic, of Centre Hospitalier Privé Parly 2 in Le Chesnay, France, reports on 4-year outcomes of the prospective multicenter STRATO trial of the MFM in high-surgical-risk patients presenting with Crawford type II and III TAAA. 3, 4 To support confirmation of the ability of the MFM to preserve collateral patency, the TAAA cases treated in the STRATO trial had to involve at least one visceral branch vessel, and for the 55 branches covered by the 53 MFM devices implanted in the trial s 23 patients, the primary and secondary patency rates at 1 year were 96.4% and 100%, respectively. There was no in-hospital or 30-day mortality, and none of the 11 deaths that occurred through 4 years of follow-up were confirmed as being aneurysm related. Through 4 years, there were no reported cases of SCI, confirmed aneurysm rupture, or respiratory, renal, or peripheral complications. Also of relevance, given the rationale for the MFM, the trial s scrupulously executed imaging follow-up demonstrated aneurysm sac thrombosis and successful reduction of residual aneurysm flow at annual time points through the 4 years. In Chapter 4, Bianca Pane et al. from the University of Genoa present a retrospective database review of 25 TAAA and suprarenal abdominal aortic aneurysm (AAA) cases from seven Italian centers using the MFM to treat complex aortic disease. Through mean follow-up of 669 days, no mortality was reported related to aneurysm rupture, and the Kaplan-Meier survival estimate was 94% at 1 year and 92.8% at 2 years. The chapter provides extensive commentary on the importance of adherence to the MFM instructions for use (IFU) and on matters including avoidance of SCI and device-related complications, and the relevance of endoleak categories in evaluating MFM performance. In Chapter 5, Victor Costache et al. review successful registry experience at Polisano European Hospital in Sibiu, Romania, in using the MFM to treat aortic dissections as well as aneurysms. They present compelling imaging from several complex cases including pan-aortic dissection and requiring carefully considered deployment of multiple MFM devices, often in staged hybrid procedures. Their commentary contextualizes the cases in light of the detailed recent reports from the STRATO trial, 3, 4 a global MFM registry, 5 and a systematic review of 15 studies with the MFM. 6 In Chapter 6, Arno von Ristow et al. of Catholic University of Rio de Janeiro, Brazil, review outcomes from their prospective registry of high-risk patients over 80 years of age with TAAA and paravisceral aortic aneurysms treated with the MFM. Whereas other studies of the MFM that have been conducted to date involved patients with mean age well below 80 years, it is understood that many octogenarian and nonagenarian patients with paravisceral aneurysms and TAAA are still quite active but not fit for conventional open or endovascular repair even though they are at serious risk of death from rupture if not treated. In follow-up ranging from 1 to 3.5 years, 6 (42.9%) of the initial 14 registry patients remained alive, and no evidence of aneurysm rupture was found; it is noted that, if left untreated, most of the patients could have been dead due to that cause within 1 year. VII

8 Introduction In Chapter 7, Ivo Petrov et al. of the City Clinic Heart and Vascular Institute in Sofia, Bulgaria, review 12 cases of MFM implantation in different aortic segments with complex pathology including one case of type A aortic dissection. Notably, 11 of the 12 cases involved device coverage of all visceral and renal branch arteries, and through mean follow-up of 20 months, all of the covered arteries remained patent with improvement of flow. There were no deaths related to aortic pathology, no reported ruptures, and no ischemic visceral or renal complications. The chapter highlights 5 distinct cases with instructive description and detailed imaging. Finally, in Chapter 8, Yoshikatsu Saiki and Kiichiro Kumagai of Tohoku University Graduate School of Medicine in Sendai, Japan, report on the initiation in Japan (beginning in 2013) of MFM treatment of aortic and peripheral artery aneurysms. As context for this development, they relate the approximate doubling of the incidence in Japan of thoracic aortic repair during the first decade of this century, along with the gradually expanded use of thoracic endovascular aortic repair (TEVAR), and then summarize their retrospective analysis of 153 cases of reparative TAAA surgery performed from 2003 through In this chapter, with detailed, well-illustrated case reports, they present preliminary results for the first three TAAA patients enrolled in their prospective clinical study of the MFM in which, as they say, deployment was technically successful and the patients exhibited rapid recovery. In the practice of surgical treatment of complex pathologies, there are no one-sizefits-all solutions. For treating complex aortic pathologies, gratitude is in order respecting the many possible approaches currently available or under development. Having weathered some early questions regarding its design concept, and having already surpassed initial performance expectations for example, in terms of preserving branch vessel patency and reducing the risk of rupture and other complications the MFM qualifies for inclusion in the standard endovascular toolbox and should be considered for management of aortic pathology in high-risk patients that might otherwise be untreatable. Such cases in which the MFM has ensured survival and preserved quality of life underscore the importance of learning the appropriate conditions and technical principles for its successful use. References 1. Henry M, Polydorou A, Frid N, Gruffaz P, Cavet A, Henry I, et al. Treatment of renal artery aneurysm with the multilayer stent. J Endovasc Ther 2008;15: Sultan S, Hynes N, Kavanagh EP, Diethrich EB. How does the Multilayer Flow Modulator work? The science behind the technical innovation. J Endovasc Ther 2014;21: Vaislic CD, Fabiani JN, Chocron S, Robin J, Costache VS, Villemot JP, et al. One-year outcomes following repair of thoracoabdominal aneurysms with the Multilayer Flow Modulator: report from the STRATO trial. J Endovasc Ther 2014;21: Vaislic CD, Fabiani JN, Chocron S, Robin J, Costache VS, Villemot JP, et al. Three-year outcomes with the Multilayer Flow Modulator for repair of thoracoabdominal aneurysms: a follow-up report from the STRATO trial. J Endovasc Ther 2016;23: Sultan S, Kavanagh E, Stefanov F, Sultan M, Costache V, Elhelali A, et al. Streamliner Multilayer Flow Modulator stents as a therapeutic option in the management of complex thoraco-abdominal aortic pathology report from Global MFM Registry. Journal of Indian College of Cardiology 2016;6(Suppl): VIII

9 The current role of multilayer flow modulator stents in complex aortic pathology 6. Hynes N, Sultan S, Elhelali A, Diethrich EB, Kavanagh EP, Sultan M, et al. Systematic review and patient-level meta-analysis of the Streamliner Multilayer Flow Modulator in the management of complex thoracoabdominal aortic pathology. J Endovasc Ther 2016;23: *Corresponding author: Prof. Domenico Palombo, MD, PhD, Chief of Vascular and Endovascular Surgery Unit, Genoa, Italy. domenico.palombo@hsanmartino.it IX