Bioresorbable Scaffolds

Prof. Patrick W. Serruys is a professor of Interventional Cardiology at the Interuniversity Cardiological Institute of the Netherlands (1988-1998), and Erasmus MC. Since 1980 he was a Director of the Clinical Research Program of the Catheterization Laboratory, Thorax Center at Erasmus University, and till April 1st 2014 (retirement date) the Head of the Interventional Department, Thorax Center, Erasmus MC (University Medical Center Rotterdam), Rotterdam, The Netherlands. He is a Fellow of the American College of Cardiology and a Fellow of the European Society of Cardiology and scientific council of the International College of Angiology. In 1996 he received the TCT Career Achievement Award and in 1997 he was awarded the Wenkebach Prize of the Dutch Heart Foundation. In 2000 he was awarded the Gruentzig Award of the European Society of Cardiology. In 2001 he held the Paul Dudley White Lecture at the American Heart Association in the USA. In 2004 he received the Andreas Gruentzig Award of the Swiss Society of Cardiology. In 2005 he held the 4th International Lecture at the AHA and Mikamo Lecture at the Japanese heart Association. In 2006 he received the highest award of the Clinical Council of the American Heart Association: the James Herrick Award. In 2007 he received the Arrigo Recordati International Prize (Italy) and the ICI Achievement Award (bestowed by the President of Israel – Shimon Perez). In 2008 he received the Einthoven Penning (Leiden). In 2009 he became Doctor Honoris Causa from the University of Athens. In 2011 he received the Lifetime Achievement Award, bestowed by the American College of Cardiology, in recognition of many years of service and invaluable contributions to the ACC. At the end of 2011 Prof. Serruys received the Ray C. Fish Award, bestowed by the Texas Heart Institute, for outstanding achievement and contribution to cardiovascular medicine. In 2012 he received a Golden Medal of the European Society of Cardiology. In 2013 he became Doctor Honoris Causa from the Complutense University of Madrid.

Table of Contents

Section 1: Introduction

1.1- Early development of bioresorbable scaffold

Patrick W. Serruys

Section 2: Principles of bioresorption, vascular application

2.1- Degradable, biodegradable and bioresorbable polymers for time-limited therapy

Michel Vert

2.2- Lactic acid-based polymers in depth

Michel Vert and Antoine Lafont

2.3- Scaffold processing

Jack Scanlon

2.4- Basics of biodegradation of magnesium

Michael Haude, Daniel Lootz, Hubertus Degen and Matthias Epple

2.5- Basics of biodegradation of iron scaffold

Deyuan Zhang and Runlin Gao

Section 3: From bench test to preclinical assessment

3.1- Unlocking scaffold mechanical properties

Jack Scanlon, Yoshinobu Onuma, Patrick W. Serruys and Joseph Deitzel

3.2- Bench testing for polymeric bioresorbable scaffolds

John A. Ormiston, Bruce Webber, Janarthanan Sathananthan, Pau Medran-Gracia, Susann Beier and Mark WI Webster

3.3- Bench test for magnesium scaffold

Daniel Lootz, Wolfram Schmidt, Peter Behrens, Klaus-Peter Schmitz, Michael Haude and Ron Waksman

3.4- Simulation of flow and shear stress

Nicolas Foin, Ryo Torii, Renick Darren Lee, Alessio Mattesini, Carlo Di Mario, Philip Wong, Erhan Tenekecioglu, Tom Crake, Christos Bourantas and Patrick W. Serruys

3.5- Preclinical assessment of bioresorbable scaffolds and regulatory implication

Tobias Koppara, Eric Wittchow, Renu Virmani and Michael Joner

Section 4: Lesson learned from preclinical assessment

4.1- PLA scaffold

Kazuyuki Yahagi, Sho Torii, Erica Pacheco, Frank D. Kolodgie, Aloke V. Finn and Renu Virmani

4.2- Iron

Runlin Gao, Deyuan Zhang, Hong Qiu, Chao Wu, Ying Xia and Gui Zhang

Section 5: Imaging to evaluate the bioresorbable scaffold: A corelab perspective, methodology of measurement and assessment

5.1- Quantative coronary angiography of bioresorbable vascular scaffold: a corelab perspective

Yohei Sotomi, Patrick W. Serruys and Yoshinobu Onuma

5.2- Assessment of bioresorbable scaffolds by IVUS: echogenicity, virtual histology and palpography

Carlos M. Campos, Patrick W. Serruys and Hector M. Garcia-Garcia

5.3- Optical coherence tomography analysis vascular scaffold in comparison with metallic stents: a corelab perspective

Yohei Sotomi, Pannipa Suwannasom, Jouke Dijkstra, Carlos Collet, Shimpei Nakatani, Patrick W. Serruys, Yoshinobu Onuma

5.4- Non-invasive coronary tomography analysis after bioresorbable scaffold implantation

Carlos Collet, Koen Nieman, Patrick W. Serruys and Yoshinobu Onuma

5.5- Angiography is sufficient

J Ribamar Costa, Jr. and Alexandre Abizaid

5.6- Intravascular ultrasound is a must in bioresorbable scaffold implantation

Hiroyoshi Kawamoto, Neil Ruparelia and Antonio Colombo

5.7- OCT is the way to go

Jiang Ming Fam, Nienke Simone van Ditzhuijzen, Jors van Sjide, Bu Chan Zhang, Antonios Karanasos, Robert-Jan van Geuns and Evelyn Regar

5.8- Imaging to evaluate the bioresorbable scaffold. Clinician’s perspective: I need both (IVUS and OCT)

Josep Gomez-Lara and Antoni Serra

5.9- Multislice computed tomography as a modality of follow-up

Antonio L. Bartorelli, Daniele Andreini, Simona Espejo and Manuel Pan

Section 6: Clinical evidence of randomised and non-randomised trials: personal perspective

6.1- What are appropriate clinical endpoints? From device failure assessment to angina evaluation

Maik J. Grundeken, Yoshinobu Onuma and Patrick W. Serruys

6.2- Angina reduction after BRS implantation: correlation with changes in coronary haemodynamics

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

Carlos Collet et al.

6.4- The ABSORB China trial

Runlin Gao

6.5- ABSORB Japan

Takeshi Kimura

6.6- What have we learned from meta-analysis of 1 year outcomes with the Absorb bioresorbable scaffold in patients with coronary heart disease

Yohei Sotomi, Carlos Collet, Takeshi Kimura, Runlin Gao, Dean J. Kereiakes, Gregg W. Stone, Stephen G. Ellis, Yoshinobu Onuma and Patrick W. Serruys

6.7- Summary of investigator-driven registries on absorb bioresorbable vascular scaffolds

Anna Franzone, Raffaele Piccolo and Stephen Windecker

6.8- Investigator-driven randomised trials

Daniele Giacoppo, Roisin Colleran and Adnan Kastrati

6.9- The DESolve scaffold

Stefan Verheye, Nagarajan Ramesh, Lynn Morrison and Sara Toyloy

6.10- Results of clinical trials with BIOTRONIK magnesium scaffolds

Michael Haude, Daniel Lootz, Raimund Erbel, Jacques Koolen and Ron Waksman

6.11- The REVA medical program: from ReZolve® to Fantom®

Alexandre Abizaid and J. Ribamar Costa Jr.

6.12- The Amaranth’s bioresorbable vascular scaffold technology

Alaide Chieffo, Juan F. Granada and Antonio Colombo

6.13- The mirage microfiber sirolimus eluting coronary scaffold

Teguh Santoso, Liew Houng Bang, Ricardo Costa, Daniel Chamié, Solomon Su, Alexandre Abizaid, Yoshinobu Onuma and Patrick W. Serruys

6.14- The Igaki-Tamai stent: the legacy of the work of Hideo Tamai

Soji Nishio, Kunihiko Kosuga, Eisho Kyo, Takafumi Tsuji, Masaharu Okada, Shinsaku Takeda, Yasutaka Inuzuka, Tatsuhiko Hata, Yuzo Takeuchi, Junya Seki and Shigeru Ikeguchi

Section 7: Clinical evidence in specific patient subsets: personal perspective

7.1- Left main interventions with BRS

Bert Everaert, Piera Capranzano, Corrado Tamburino, Ashok Seth and Robert-Jan van Geuns

7.2- Bioresorbable scaffolds in bifurcations

Filippo Fingini, Hiroyoshi Kawamoto and Azeem Latib

7.3- BVS in chronic total occlusions: clinical evidence, tips and tricks

Antonio Serra

7.4- Bioresorbable scaffolds in diffuse disease

Neil Ruparelia, Hiroyoshi Kawamoto and Antonio Colombo

7.5- Bioresorbable scaffolds in mulitvessel coronary disease

R.P. Kraak, Maik J. Grundeken and J.J Wykrzykowska

7.6- Bioresorbable coronary scaffolds in non-St elevation acute coronary syndromes

Charis Mamilou and Tommaso Gori

7.7- Bioresorbable vascular scaffold in ST-segment elevation myocardial infarction: clinical evidence, tips and tricks

Giuseppe Giacchi and Manel Sabaté

7.8- Bioresorbable scaffolds for treating coronary artery disease in patients with diabetes mellitus

Ayyaz Sultan, Takeshi Muramatsu and Javaid Iqbal

7.9- BRS in calcified lesions

Ashok Seth

7.10- BRS textbook: invasive sealing of vulnerable, high-risk lesions

Christos Bourantas, Ryo Torri, Nicolas Foin, Ajay Suri, Erhan Tenekecioglu, Vikas Thondapu, Tom Crake, Peter Barlis and Patrick W. Serruys

Section 8: Complications (incidence, diagnosis, potential mechanisms and treatment)

8.1- Acute and subacute scaffold thrombosis

Davide Capodanno

8.2- Late and very late scaffold thrombosis

Antonios Karanasos, Bu-Chun Zhang, Jors van der Sijde, Jiang-Ming Fam, Robert-Jan van Geuns and Evelyn Regar

8.3- Treatment of bioresorbable scaffold failure

Cordula M. Felix, Bert Everaert, Nigel Jepson, Corrado Tamburino and Robert-Jan van Geuns

8.4- Recoil and bioresorbable scaffolds

John A. Ormiston, Bruce Webber, Janarthanan Sathananthan and Mark WI Webster

8.5- Scaffold disruption and late discontinuities

Yoshinobu Onuma, Patrick W. Serruys

8.6- The incidence, potential mechanism of side-branch occlusion after implantation of bioresorbable scaffold(s): insights from ABSORB II

Yuki Ishibashi, Takeshi Muramatsu, Yohei Sotomi, Yoshinobu Onuma and Patrick W. Serruys

Section 9: Tips and tricks to implant BRS

9.1- Tips and tricks for implanting BRS: sizing, pre- and post-dilatation

Akihito Tanaka, Richard J. Jabbour and Antonio Colombo

9.2- Approach to bifurcation lesions

Ashok Seth

Section 10: Emerging technologies (pre-CE mark, pre-FA, pre-PMDA and pre-CFDA)

10.1- Overview of the field

Yoshinobu Onuma

10.2- MeRes100™- a sirolimus eluting bioresorbable vascular scaffold system

Ashok Seth, Babu Ezhumalai, Sanjeev Bhatt and Pratik Vasani

10.3- XINSORB bioresorbable vascular scaffold

Junbo Ge and Li Shen

10.4- NeoVas™ bioresorbable coronary scaffold system

Han Yangling

10.5- ArterioSorb™ bioresorbable scaffold by Arterius Ltd

Rasha Al-Lamee

10.6- Lifetech

Deyuan Zhang, Wenjiao Lin, Haiping Oi

10.7- Abbott: new generation absorb scaffold

Laura E. Leigh Perkins, Byron J. Lambert and Richard J. Rapoza