Yuichi Ozaki1,2, Hector M Garcia-Garcia1,2, Alexandre Hideo-Kajita1,2, Kayode O Kuku2, Michael Haude3, Hüseyin Ince4, Alexandre Abizaid5, Ralph Tölg6, Pedro Alves Lemos7, Clemens von Birgelen8, Evald Høj Christiansen9, William Wijns10, Javier Escaned11, Jouke Dijkstra12, Ron Waksman1. 1. Section of Interventional Cardiology, MedStar Washington Hospital Center, 110 Irving Street NW, Suite 4B-1, Washington, DC, USA. 2. Section of Interventional Cardiology, MedStar Cardiovascular Research Network, MedStar Washington Hospital Center, Washington, DC, USA. 3. Medical Clinic I, Städtische Kliniken Neuss, Lukaskrankenhaus GmbH, Neuss, Germany. 4. Department of Cardiology, Vivantes Klinikum im Friedrichschain and Am Urban, Berlin, Germany. 5. Instituto de Cardiologia Dante Pazzanese, Sao Paulo, Brazil. 6. Herzzentrum Segeberger Kliniken GmbH, Bad Segeberg, Germany. 7. Instituto do Coração - HCFMUSP, University of Sao Paulo, São Paulo, Brazil. 8. Department of Cardiology, Medisch Spectrum Twente, Thoraxcentrum Twente, Enschede, the Netherlands. 9. Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark. 10. Cardiology Department, Cardiovascular Research Center Aalst, OLV Hospital, Aalst, Belgium. 11. Department of Cardiology, Hospital Clinico San Carlos, Madrid, Spain. 12. LKEB, Leiden University, Leiden, the Netherlands.
Abstract
AIMS: Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) is an alternative novel device for treating coronary lesions. However, the relationship between in-scaffold dimensions after implantation of DREAMS 2G and vessel healing and luminal results at follow-up is unknown. The aim of this study is, therefore, to investigate whether the expansion index after implantation of DREAMS 2G as assessed by optical coherence tomography (OCT) impacts late luminal status and healing of the vessel wall. METHODS AND RESULTS: This study comprises of a total 65 out of 123 patients who were enrolled in the BIOSOLVE-II trial. We assessed both qualitative and quantitative OCT findings and the expansion index of DREAMS 2G after implantation frame by frame using OCT. Expansion index was defined as minimum scaffold area/mean reference lumen area. The over-expansion group was also defined with expansion index >1.0. The total number of analysed frames at post-procedure and 6-month follow-up was 8243 and 8263 frames, respectively. At 6-month follow-up, in-scaffold healing was documented by the reduction of 82% in dissections, 93% in attached intra-luminal mass (ILM), 65% in non-attached ILM, and 76% in jailed side branch. The over-expansion group had significantly greater in-scaffold luminal volume loss (LVL) compared with the non-over-expansion group [over-expansion: 35.0 (18.5-52.1) mm3 vs. non-over-expansion: 21.0 (11.6-37.9) mm3, P = 0.039]. CONCLUSION: Excellent in vivo healing process after implantation of DREAMS 2G was observed at 6 months. We found that higher expansion indices were associated with higher in-scaffold LVL at 6 months assessed by OCT. Published on behalf of the European Society of Cardiology. All rights reserved.
AIMS: Second-generation drug-eluting absorbable metal scaffold (DREAMS 2G) is an alternative novel device for treating coronary lesions. However, the relationship between in-scaffold dimensions after implantation of DREAMS 2G and vessel healing and luminal results at follow-up is unknown. The aim of this study is, therefore, to investigate whether the expansion index after implantation of DREAMS 2G as assessed by optical coherence tomography (OCT) impacts late luminal status and healing of the vessel wall. METHODS AND RESULTS: This study comprises of a total 65 out of 123 patients who were enrolled in the BIOSOLVE-II trial. We assessed both qualitative and quantitative OCT findings and the expansion index of DREAMS 2G after implantation frame by frame using OCT. Expansion index was defined as minimum scaffold area/mean reference lumen area. The over-expansion group was also defined with expansion index >1.0. The total number of analysed frames at post-procedure and 6-month follow-up was 8243 and 8263 frames, respectively. At 6-month follow-up, in-scaffold healing was documented by the reduction of 82% in dissections, 93% in attached intra-luminal mass (ILM), 65% in non-attached ILM, and 76% in jailed side branch. The over-expansion group had significantly greater in-scaffold luminal volume loss (LVL) compared with the non-over-expansion group [over-expansion: 35.0 (18.5-52.1) mm3 vs. non-over-expansion: 21.0 (11.6-37.9) mm3, P = 0.039]. CONCLUSION: Excellent in vivo healing process after implantation of DREAMS 2G was observed at 6 months. We found that higher expansion indices were associated with higher in-scaffold LVL at 6 months assessed by OCT. Published on behalf of the European Society of Cardiology. All rights reserved.
Authors: Maria Natalia Tovar Forero; Laurens van Zandvoort; Kaneshka Masdjedi; Roberto Diletti; Jeroen Wilschut; Peter P de Jaegere; Felix Zijlstra; Nicolas M Van Mieghem; Joost Daemen Journal: Catheter Cardiovasc Interv Date: 2019-04-29 Impact factor: 2.692