Bioresorbable Scaffolds: From Basic Concept to Clinical Applications

552 Pages·2017·140.055 MB·English

by  Yoshinobu Onuma, Patrick W.J.C. Serruys

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
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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