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 ContentsSection 1: Introduction1.1- Early development of bioresorbable scaffoldPatrick W. SerruysSection 2: Principles of bioresorption, vascular application2.1- Degradable, biodegradable and bioresorbable polymers for time-limited therapyMichel Vert2.2- Lactic acid-based polymers in depthMichel Vert and Antoine Lafont2.3- Scaffold processingJack Scanlon2.4- Basics of biodegradation of magnesiumMichael Haude, Daniel Lootz, Hubertus Degen and Matthias Epple2.5- Basics of biodegradation of iron scaffoldDeyuan Zhang and Runlin GaoSection 3: From bench test to preclinical assessment3.1- Unlocking scaffold mechanical propertiesJack Scanlon, Yoshinobu Onuma, Patrick W. Serruys and Joseph Deitzel3.2- Bench testing for polymeric bioresorbable scaffoldsJohn A. Ormiston, Bruce Webber, Janarthanan Sathananthan, Pau Medran-Gracia, Susann Beier and Mark WI Webster3.3- Bench test for magnesium scaffoldDaniel Lootz, Wolfram Schmidt, Peter Behrens, Klaus-Peter Schmitz, Michael Haude and Ron Waksman3.4- Simulation of flow and shear stressNicolas Foin, Ryo Torii, Renick Darren Lee, Alessio Mattesini, Carlo Di Mario, Philip Wong, Erhan Tenekecioglu, Tom Crake, Christos Bourantas and Patrick W. Serruys3.5- Preclinical assessment of bioresorbable scaffolds and regulatory implicationTobias Koppara, Eric Wittchow, Renu Virmani and Michael JonerSection 4: Lesson learned from preclinical assessment4.1- PLA scaffoldKazuyuki Yahagi, Sho Torii, Erica Pacheco, Frank D. Kolodgie, Aloke V. Finn and Renu Virmani4.2- IronRunlin Gao, Deyuan Zhang, Hong Qiu, Chao Wu, Ying Xia and Gui ZhangSection 5: Imaging to evaluate the bioresorbable scaffold: A corelab perspective, methodology of measurement and assessment5.1- Quantative coronary angiography of bioresorbable vascular scaffold: a corelab perspectiveYohei Sotomi, Patrick W. Serruys and Yoshinobu Onuma5.2- Assessment of bioresorbable scaffolds by IVUS: echogenicity, virtual histology and palpographyCarlos M. Campos, Patrick W. Serruys and Hector M. Garcia-Garcia5.3- Optical coherence tomography analysis vascular scaffold in comparison with metallic stents: a corelab perspectiveYohei Sotomi, Pannipa Suwannasom, Jouke Dijkstra, Carlos Collet, Shimpei Nakatani, Patrick W. Serruys, Yoshinobu Onuma5.4- Non-invasive coronary tomography analysis after bioresorbable scaffold implantationCarlos Collet, Koen Nieman, Patrick W. Serruys and Yoshinobu Onuma5.5- Angiography is sufficientJ Ribamar Costa, Jr. and Alexandre Abizaid5.6- Intravascular ultrasound is a must in bioresorbable scaffold implantationHiroyoshi Kawamoto, Neil Ruparelia and Antonio Colombo5.7- OCT is the way to goJiang Ming Fam, Nienke Simone van Ditzhuijzen, Jors van Sjide, Bu Chan Zhang, Antonios Karanasos, Robert-Jan van Geuns and Evelyn Regar5.8- Imaging to evaluate the bioresorbable scaffold. Clinician’s perspective: I need both (IVUS and OCT)Josep Gomez-Lara and Antoni Serra5.9- Multislice computed tomography as a modality of follow-upAntonio L. Bartorelli, Daniele Andreini, Simona Espejo and Manuel PanSection 6: Clinical evidence of randomised and non-randomised trials: personal perspective6.1- What are appropriate clinical endpoints? From device failure assessment to angina evaluationMaik J. Grundeken, Yoshinobu Onuma and Patrick W. Serruys6.2- Angina reduction after BRS implantation: correlation with changes in coronary haemodynamicsNick E.J. West, Adam J. Brown and Stephen P. Hoole6.3- 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 trialCarlos Collet et al.6.4- The ABSORB China trialRunlin Gao6.5- ABSORB JapanTakeshi Kimura6.6- What have we learned from meta-analysis of 1 year outcomes with the Absorb bioresorbable scaffold in patients with coronary heart diseaseYohei Sotomi, Carlos Collet, Takeshi Kimura, Runlin Gao, Dean J. Kereiakes, Gregg W. Stone, Stephen G. Ellis, Yoshinobu Onuma and Patrick W. Serruys6.7- Summary of investigator-driven registries on absorb bioresorbable vascular scaffoldsAnna Franzone, Raffaele Piccolo and Stephen Windecker6.8- Investigator-driven randomised trialsDaniele Giacoppo, Roisin Colleran and Adnan Kastrati6.9- The DESolve scaffoldStefan Verheye, Nagarajan Ramesh, Lynn Morrison and Sara Toyloy6.10- Results of clinical trials with BIOTRONIK magnesium scaffoldsMichael Haude, Daniel Lootz, Raimund Erbel, Jacques Koolen and Ron Waksman6.11- The REVA medical program: from ReZolve® to Fantom®Alexandre Abizaid and J. Ribamar Costa Jr.6.12- The Amaranth’s bioresorbable vascular scaffold technologyAlaide Chieffo, Juan F. Granada and Antonio Colombo6.13- The mirage microfiber sirolimus eluting coronary scaffoldTeguh Santoso, Liew Houng Bang, Ricardo Costa, Daniel Chamié, Solomon Su, Alexandre Abizaid, Yoshinobu Onuma and Patrick W. Serruys6.14- The Igaki-Tamai stent: the legacy of the work of Hideo TamaiSoji Nishio, Kunihiko Kosuga, Eisho Kyo, Takafumi Tsuji, Masaharu Okada, Shinsaku Takeda, Yasutaka Inuzuka, Tatsuhiko Hata, Yuzo Takeuchi, Junya Seki and Shigeru IkeguchiSection 7: Clinical evidence in specific patient subsets: personal perspective7.1- Left main interventions with BRSBert Everaert, Piera Capranzano, Corrado Tamburino, Ashok Seth and Robert-Jan van Geuns7.2- Bioresorbable scaffolds in bifurcationsFilippo Fingini, Hiroyoshi Kawamoto and Azeem Latib7.3- BVS in chronic total occlusions: clinical evidence, tips and tricksAntonio Serra7.4- Bioresorbable scaffolds in diffuse diseaseNeil Ruparelia, Hiroyoshi Kawamoto and Antonio Colombo7.5- Bioresorbable scaffolds in mulitvessel coronary diseaseR.P. Kraak, Maik J. Grundeken and J.J Wykrzykowska7.6- Bioresorbable coronary scaffolds in non-St elevation acute coronary syndromesCharis Mamilou and Tommaso Gori7.7- Bioresorbable vascular scaffold in ST-segment elevation myocardial infarction: clinical evidence, tips and tricksGiuseppe Giacchi and Manel Sabaté7.8- Bioresorbable scaffolds for treating coronary artery disease in patients with diabetes mellitusAyyaz Sultan, Takeshi Muramatsu and Javaid Iqbal7.9- BRS in calcified lesionsAshok Seth7.10- BRS textbook: invasive sealing of vulnerable, high-risk lesionsChristos Bourantas, Ryo Torri, Nicolas Foin, Ajay Suri, Erhan Tenekecioglu, Vikas Thondapu, Tom Crake, Peter Barlis and Patrick W. SerruysSection 8: Complications (incidence, diagnosis, potential mechanisms and treatment)8.1- Acute and subacute scaffold thrombosisDavide Capodanno8.2- Late and very late scaffold thrombosisAntonios Karanasos, Bu-Chun Zhang, Jors van der Sijde, Jiang-Ming Fam, Robert-Jan van Geuns and Evelyn Regar8.3- Treatment of bioresorbable scaffold failureCordula M. Felix, Bert Everaert, Nigel Jepson, Corrado Tamburino and Robert-Jan van Geuns8.4- Recoil and bioresorbable scaffoldsJohn A. Ormiston, Bruce Webber, Janarthanan Sathananthan and Mark WI Webster8.5- Scaffold disruption and late discontinuitiesYoshinobu Onuma, Patrick W. Serruys8.6- The incidence, potential mechanism of side-branch occlusion after implantation of bioresorbable scaffold(s): insights from ABSORB IIYuki Ishibashi, Takeshi Muramatsu, Yohei Sotomi, Yoshinobu Onuma and Patrick W. SerruysSection 9: Tips and tricks to implant BRS9.1- Tips and tricks for implanting BRS: sizing, pre- and post-dilatationAkihito Tanaka, Richard J. Jabbour and Antonio Colombo9.2- Approach to bifurcation lesionsAshok SethSection 10: Emerging technologies (pre-CE mark, pre-FA, pre-PMDA and pre-CFDA)10.1- Overview of the fieldYoshinobu Onuma10.2- MeRes100™- a sirolimus eluting bioresorbable vascular scaffold systemAshok Seth, Babu Ezhumalai, Sanjeev Bhatt and Pratik Vasani10.3- XINSORB bioresorbable vascular scaffoldJunbo Ge and Li Shen10.4- NeoVas™ bioresorbable coronary scaffold systemHan Yangling10.5- ArterioSorb™ bioresorbable scaffold by Arterius LtdRasha Al-Lamee10.6- LifetechDeyuan Zhang, Wenjiao Lin, Haiping Oi10.7- Abbott: new generation absorb scaffoldLaura E. Leigh Perkins, Byron J. Lambert and Richard J. Rapoza