Bioresorbable Scaffolds: From Basic Concept to Clinical Applications PDF
Preview Bioresorbable Scaffolds: From Basic Concept to Clinical Applications
Bioresorbable Scaffolds From Basic Concept to Clinical Applications http://taylorandfrancis.com Bioresorbable Scaffolds From Basic Concept to Clinical Applications Edited by Yoshinobu Onuma Patrick W.J.C. Serruys CRC Press Taylor & Francis Group 6000 Broken Sound Parkway NW, Suite 300 Boca Raton, FL 33487-2742 © 2017 by Taylor & Francis Group, LLC CRC Press is an imprint of Taylor & Francis Group, an Informa business No claim to original U.S. Government works Printed on acid-free paper International Standard Book Number-13: 978-1-4987-7974-6 (Pack - Hardback and eBook) This book contains information obtained from authentic and highly regarded sources. While all reasonable efforts have been made to publish reliable data and information, neither the author[s] nor the publisher can accept any legal responsibility or liability for any errors or omissions that may be made. The publishers wish to make clear that any views or opinions expressed in this book by individual editors, authors or contributors are personal to them and do not necessarily reflect the views/opinions of the publishers. The information or guidance contained in this book is intended for use by medical, scientific or health-care profes- sionals and is provided strictly as a supplement to the medical or other professional’s own judgement, their knowledge of the patient’s medical history, relevant manufacturer’s instructions and the appropriate best practice guidelines. Because of the rapid advances in medical science, any information or advice on dos- ages, procedures or diagnoses should be independently verified. The reader is strongly urged to consult the relevant national drug formulary and the drug com- panies’ and device or material manufacturers’ printed instructions, and their websites, before administering or utilizing any of the drugs, devices or materials mentioned in this book. This book does not indicate whether a particular treatment is appropriate or suitable for a particular individual. Ultimately it is the sole responsibility of the medical professional to make his or her own professional judgements, so as to advise and treat patients appropriately. The authors and pub- lishers have also attempted to trace the copyright holders of all material reproduced in this publication and apologize to copyright holders if permission to pub- lish in this form has not been obtained. If any copyright material has not been acknowledged please write and let us know so we may rectify in any future reprint. Except as permitted under U.S. Copyright Law, no part of this book may be reprinted, reproduced, transmitted, or utilized in any form by any electronic, mechanical, or other means, now known or hereafter invented, including photocopying, microfilming, and recording, or in any information storage or retrieval system, without written permission from the publishers. For permission to photocopy or use material electronically from this work, please access www.copyright.com (http://www.copyright.com/) or contact the Copyright Clearance Center, Inc. (CCC), 222 Rosewood Drive, Danvers, MA 01923, 978-750-8400. CCC is a not-for-profit organization that provides licenses and registration for a variety of users. For organizations that have been granted a photocopy license by the CCC, a separate system of payment has been arranged. Trademark Notice: Product or corporate names may be trademarks or registered trademarks, and are used only for identification and explanation without intent to infringe. Visit the Taylor & Francis Web site at http://www.taylorandfrancis.com and the CRC Press Web site at http://www.crcpress.com Contents Contributors ix Part 1 INtrODUCtION 1 1.1 Early development of bioresorbable scaffold 2 Patrick W.J.C. Serruys as interviewed by Carlos Collet and Yoshinobu Onuma Part 2 PrINCIPLES OF BIOrESOrPtION, VaSCULar aPPLICatION 5 2.1 Degradable, biodegradable, and bioresorbable polymers for time-limited therapy 6 Michel Vert 2.2 Lactic acid-based polymers in depth 15 Michel Vert and Antoine Lafont 2.3 Scaffold processing 22 John J. Scanlon, Joseph M. Deitzel, Dieter Mairhörmann, and Roland Wölzein 2.4 Basics of magnesium biodegradation 29 Michael Haude, Daniel Lootz, Hubertus Degen, and Matthias Epple 2.5 Basics of biodegradation of iron scaffold 38 Deyuan Zhang and Runlin Gao Part 3 FrOM BENCH tESt tO PrECLINICaL aSSESSMENt 43 3.1 Unlocking scaffold mechanical properties 44 John J. Scanlon, Yoshinobu Onuma, Patrick W.J.C. Serruys, and Joseph M. Deitzel 3.2 Bench testing for polymeric bioresorbable scaffolds 53 John A. Ormiston, Bruce Webber, Janarthanan Sathananthan, Pau Medrano-Gracia, Susann Beier, and Mark W.I. Webster 3.3 Bench test for magnesium scaffold 60 Daniel Lootz, Wolfram Schmidt, Peter Behrens, Klaus-Peter Schmitz, Michael Haude, and Ron Waksman 3.4 Simulation of flow and shear stress 68 Nicolas Foin, Ryo Torii, Jaryl Ng, Alessio Mattesini, Carlo Di Mario, Philip Wong, Erhan Tenekecioglu, Tom Crake, Christos V. Bourantas, and Patrick W.J.C. Serruys 3.5 Preclinical assessment of bioresorbable scaffolds and regulatory implication 81 Tobias Koppara, Eric Wittchow, Renu Virmani, and Michael Joner Part 4 LESSONS LEarNED FrOM PrECLINICaL aSSESSMENt 95 4.1 PLA scaffold 96 Kazuyuki Yahagi, Sho Torii, Erica Pacheco, Frank D. Kolodgie, Aloke V. Finn, and Renu Virmani 4.2 Iron 117 Runlin Gao, Deyuan Zhang, Hong Qiu, Chao Wu, Ying Xia, and Gui Zhang v vi Contents Part 5 IMaGING tO EVaLUatE tHE BIOrESOrBaBLE SCaFFOLD: a core lab perspective: Methodology of measurement and assessment 123 5.1 Quantitative coronary angiography of bioresorbable vascular scaffold: A core lab perspective 124 Yohei Sotomi, Patrick W.J.C. Serruys, and Yoshinobu Onuma 5.2 Assessment of bioresorbable scaffolds by IVUS: Echogenicity, virtual histology, and palpography 134 Carlos M. Campos and Hector M. Garcia-Garcia 5.3 Optical coherence tomography analysis of bioresorbable vascular scaffold in comparison with metallic stents: A core lab perspective 142 Yohei Sotomi, Pannipa Suwannasom, Jouke Dijkstra, Carlos Collet, Shimpei Nakatani, Patrick W.J.C. Serruys, and Yoshinobu Onuma 5.4 Noninvasive coronary computed tomography analysis after bioresorbable scaffold implantation 160 Carlos Collet, Koen Nieman, Patrick W.J.C. Serruys, and Yoshinobu Onuma 5.5 Angiography is sufficient 165 J. Ribamar Costa Jr. and Alexandre Abizaid 5.6 Intravascular ultrasound is a must in bioresorbable scaffold implantation 169 Hiroyoshi Kawamoto, Neil Ruparelia, and Antonio Colombo 5.7 OCT is the way to go 177 Jiang Ming Fam, Nienke Simone van Ditzhuijzen, Jors van der Sijde, Bu-Chun Zhang, Antonios Karanasos, Robert-Jan M. van Geuns, and Evelyn Regar 5.8 Imaging to evaluate the bioresorbable scaffold—Clinicians’ perspective: I need both (IVUS and OCT) 188 Josep Gomez-Lara and Antonio Serra 5.9 Multislice computed tomography as a modality of follow-up 194 Antonio L. Bartorelli, Daniele Andreini, Simona Espejo, and Manuel Pan Part 6 CLINICaL EVIDENCE OF raNDOMIZED aND NONraNDOMIZED trIaLS: Personal perspective 205 6.1 What are appropriate clinical endpoints? From device failure assessment to angina evaluation 207 Maik J. Grundeken, Yoshinobu Onuma, and Patrick W.J.C. Serruys 6.2 Angina reduction after BRSs implantation: Correlation with changes in coronary hemodynamics 215 Nick E.J. West, Adam J. Brown, and Stephen P. Hoole 6.3 Comparison of everolimus-eluting bioresorbable scaffolds with everolimus-eluting metallic stents for treatment of coronary artery stenosis: Three-year follow-up of the ABSORB II randomized trial 224 Carlos Collet, Yohei Sotomi, Bernard Chevalier, Angel Ramón Cequier Fillat, Didier Carrié, Jan Piek, A.J. Van Boven, Marcello Dominici, Dariusz Dudek, Dougal McClean, Steffen Helqvist, Michael Haude, Sebastian Reith, Manuel de Sousa Almeida, Gianluca Campo, Andrés Iñiguez, Robert-Jan M. van Geuns, Pieter Smits, Manel Sabaté, Stephan Windecker, Yoshinobu Onuma, and Patrick W.J.C. Serruys 6.4 The ABSORB China trial 238 Runlin Gao on behalf of the ABSORB China Investigators 6.5 ABSORB Japan 243 Takeshi Kimura 6.6 What have we learned from meta-analysis of 1-year outcomes with the ABSORB bioresorbable scaffold in patients with coronary artery disease? 254 Yohei Sotomi, Carlos Collet, Takeshi Kimura, Runlin Gao, Dean J. Kereiakes, Gregg W. Stone, Stephen G. Ellis, Yoshinobu Onuma, and Patrick W.J.C. Serruys 6.7 Summary of investigator-driven registries on ABSORB bioresorbable vascular scaffolds 263 Anna Franzone, Raffaele Piccolo, and Stephan Windecker 6.8 Investigator-driven randomized trials 272 Daniele Giacoppo, Roisin Colleran, and Adnan Kastrati 6.9 The DESolve scaffold 283 Stefan Verheye, Nagarajan Ramesh, Lynn Morrison, and Sara Toyloy 6.10 Results of clinical trials with BIOTRONIK magnesium scaffolds 294 Michael Haude, Daniel Lootz, Raimund Erbel, Jacques Koolen, and Ron Waksman 6.11 The REVA Medical Program: From ReZolve® to Fantom® 305 Alexandre Abizaid and J. Ribamar Costa Jr. Contents vii 6.12 The Amaranth bioresorbable vascular scaffold technology 309 Alaide Chieffo, Juan F. Granada, and Antonio Colombo 6.13 The Mirage microfiber sirolimus eluting coronary scaffold 316 Teguh Santoso, Liew Houng Bang, Ricardo Costa, Daniel Chamié, Solomon Su, Alexander Abizaid, Yoshinobu Onuma, and Patrick W.J.C. Serruys 6.14 The Igaki–Tamai stent: The legacy of the work of Hideo Tamai 319 Soji Nishio, Kunihiko Kosuga, Eisho Kyo, Takafumi Tsuji, Masaharu Okada, Shinsaku Takeda, Yasutaka Inuzuka, Tatsuhiko Hata, Yuzo Takeuchi, Junya Seki, and Shigeru Ikeguchi Part 7 CLINICaL EVIDENCE IN SPECIFIC PatIENt SUBSEtS: Personal perspective 325 7.1 Left main interventions with BRSs 326 Bert Everaert, Piera Capranzano, Corrado Tamburino, Ashok Seth, and Robert-Jan M. van Geuns 7.2 Bioresorbable scaffolds in bifurcations 332 Filippo Figini, Hiroyoshi Kawamoto, and Azeem Latib 7.3 BVSs in chronic total occlusions: Clinical evidence, tips, and tricks 340 Antonio Serra 7.4 Bioresorbable scaffolds in diffuse disease 347 Neil Ruparelia, Hiroyoshi Kawamoto, and Antonio Colombo 7.5 Bioresorbable scaffolds in multivessel coronary disease 354 R.P. Kraak, Maik J. Grundeken, and Joanna J. Wykrzykowska 7.6 Bioresorbable coronary scaffolds in non-ST elevation acute coronary syndromes 362 Charis Mamilou and Tommaso Gori 7.7 Bioresorbable vascular scaffold in ST-segment elevation myocardial infarction: Clinical evidence, tips, and tricks 369 Giuseppe Giacchi and Manel Sabaté 7.8 Bioresorbable scaffolds for treating coronary artery disease in patients with diabetes mellitus 379 Ayyaz Sultan, Takashi Muramatsu, and Javaid Iqbal 7.9 BRSs in calcified lesions 389 Ashok Seth and Babu Ezhumalai 7.10 Invasive sealing of vulnerable, high-risk lesions 398 Christos V. Bourantas, Ryo Torri, Nicolas Foin, Ajay Suri, Erhan Tenekecioglu, Vikas Thondapu, Tom Crake, Peter Barlis, and Patrick W.J.C. Serruys Part 8 COMPLICatIONS (INCIDENCE, DIaGNOSIS, POtENtIaL MECHaNISMS aND trEatMENt) 411 8.1 Acute and subacute scaffold thrombosis 412 Davide Capodanno 8.2 Late and very late scaffold thrombosis 421 Antonios Karanasos, Bu-Chun Zhang, Jors van der Sijde, Jiang Ming Fam, Robert-Jan M. van Geuns, and Evelyn Regar 8.3 Treatment of bioresorbable scaffold failure 431 Cordula M. Felix, Bert Everaert, Nigel Jepson, Corrado Tamburino, and Robert-Jan M. van Geuns 8.4 Recoil and bioresorbable scaffolds 439 John A. Ormiston, Bruce Webber, Janarthanan Sathananthan, and Mark W.I. Webster 8.5 Acute scaffold disruption and late discontinuities 444 Yoshinobu Onuma, Yohei Sotomi, Takeshi Kimura, Robert-Jan M. van Geuns, and Patrick W.J.C. Serruys 8.6 The incidence and potential mechanism of side-branch occlusion after implantation of bioresorbable scaffolds: Insights from ABSORB II 462 Yuki Ishibashi, Takashi Muramatsu, Yohei Sotomi, Yoshinobu Onuma, and Patrick W.J.C. Serruys Part 9 tIPS aND trICKS tO IMPLaNt BrSs 469 9.1 Tips and tricks for implanting BRSs: Sizing, pre- and postdilatation 470 Akihito Tanaka, Richard J. Jabbour, and Antonio Colombo 9.2 Approach to bifurcation lesions 477 Ashok Seth and Babu Ezhumalai viii Contents Part 10 EMErGING tECHNOLOGIES (PrE-CE MarK, PrE-Fa, PrE-PMDa, aND PrE-CFDa) 483 10.1 Abbott: Current and next generation ABSORB scaffold 484 Laura E. Leigh Perkins, Byron J. Lambert, and Richard J. Rapoza 10.2 Emerging technologies: Overview of the field 491 Yoshinobu Onuma, Yohei Sotomi, Yuki Katagiri, and Patrick W.J.C. Serruys 10.3 MeRes100TM—A sirolimus eluting bioresorbable vascular scaffold system 494 Ashok Seth, Babu Ezhumalai, Sanjeev Bhatt, and Pratik Vasani 10.4 XINSORB bioresorbable vascular scaffold 500 Junbo Ge and Li Shen 1 0.5 NeoVasTM bioresorbable coronary scaffold system 502 Yaling Han and Yao-Jun Zhang 1 0.6 ArterioSorbTM bioresorbable scaffold by Arterius Ltd. 503 Rasha Al-Lamee 10.7 IBSTM bioresorbable scaffold by Lifetech 509 Deyuan Zhang, Wenjiao Lin, and Haiping Qi Index 513 Contributors Alexandre Abizaid Antonio L. Bartorelli Department of Interventional Cardiology Centro Cardiologico Monzino Instituto Dante Pazzanese de Cardiologia IRCCS São Paulo, Brazil University of Milan and Manuel de Sousa Almeida Department of Clinical Sciences and Community Health Department of Cardiology Cardiovascular Section Hospital Santa Cruz University of Milan Carnaxide, Portugal Milan, Italy Rasha Al-Lamee Peter Behrens International Centre for Circulatory Health Institute for Biomedical Engineering Imperial College London University Medicine Rostock United Kingdom Rostock, Germany Daniele Andreini Susann Beier Centro Cardiologico Monzino Mercy Angiography IRCCS Auckland, New Zealand University of Milan and Sanjeev Bhatt Department of Clinical Sciences and Community Health Meril Life Sciences Pvt. Ltd. Cardiovascular Section Vapi, Gujarat, India University of Milan Milan, Italy Christos V. Bourantas Barts Heart Centre Liew Houng Bang Barts Health NHS Trust Clinical Research Centre (CRC) and Department of Cardiology Institute of Cardiovascular Sciences University College Queen Elizabeth Hospital 2 London Kota Kinabalu, Malaysia London, United Kingdom Peter Barlis A.J. Van Boven Melbourne Medical School Department of Cardiology Faculty of Medicine Medical Center Leeuwarden Dentistry and Health Sciences Leeuwarden, the Netherlands The University of Melbourne Melbourne, Australia Adam J. Brown Department of Interventional Cardiology Papworth Hospital Cambridge, United Kingdom ix
The list of books you might like
