Adrian Wlodarczak1, Luis Antonio Iñigo Garcia2, Pasi P Karjalainen3, András Komócsi4, Francesco Pisano5, Stephan Richter6, Magdalena Lanocha7, Jose Ramón Rumoroso8, Kwok Fai Leung9. 1. Department of Cardiology, MCZ Hospital, Lubin, Poland. Electronic address: awlodarczak@mcz.pl. 2. Department of Interventional Cardiology, Hospital Costa del Sol, Marbella, Malaga, Spain. 3. Department of Cardiology, Helsinki University Hospital, Helsinki, Finland. 4. Heart Institute, Medical School, University of Pécs, Pécs, Hungary. 5. Department of Cardiology, Regional Hospital U. Parini, Aosta, Italy. 6. I. Medizinische Klinik, Hegau-Bodensee-Klinikum, Singen, Germany. 7. Department of Cardiology, MCZ Hospital, Lubin, Poland; Department of Cardiology, Poznan University of Medical Sciences, Poznan, Poland. 8. Department of Interventional Cardiology, Hospital de Galdakao (Bizkaia), Galdakao, Bizkaia, Spain. 9. Unique Medical Centre, Kowloon, Hong Kong.
Abstract
BACKGROUND: The Magmaris bioresorbable magnesium scaffold was successfully tested in in-vitro and in clinical premarket studies. Subsequently the Magmaris postmarket program aimed to review intraprocedural data of at least 2000 patients to assess user preferences, guideline adherence and intraprocedural performance in clinical routine. METHODS: This international multicentre survey encompasses data from 356 hospitals across 45 countries. As part of the certification for Magmaris implantation, each hospital had to complete consecutive post-market evaluation forms of their first 10 commercial Magmaris patients. RESULTS: From June 2016 to May 2018, data on 2018 implantations were collected. Main reasons for selecting Magmaris was patients' life expectancy (67%, n = 1359) and low or not calcified lesions, (67%, n = 1357). Magmaris was successfully deployed in 99% of cases (n = 1995), predilatation was performed in 95% (n = 1922) and post-dilatation in 87% (n = 1756). Physicians rated the overall performance and the pushability as good or very good in 96% of cases (n = 1799). Guide wire friction, trackability, and conformability were rated as good or very good in 94% of cases, and crossability in 93%. The majority of patients were scheduled to receive dual antiplatelet therapy for up to 12 months. CONCLUSION: Generally, implantation guidelines were adhered to and theoretical advantages of the metal scaffold observed in in-vitro tests have translated into practice with good intraprocedural performance outcomes, confirming the controlled roll-out of this novel technology into clinical practice. SUMMARY FOR ANNOTATED TABLE OF CONTENT: The Magmaris 2000 program includes the first commercial cases at each hospital. Overall, data on 2018 implantations were collected. The high rate of pre- and post-dilatation as well as other parameters confirm that generally the implantation guidelines are adhered to and the good intraprocedural performance (rated as good or very good in 96%) confirm the theoretical advantages of a metallic scaffold in practice.
BACKGROUND: The Magmaris bioresorbable magnesium scaffold was successfully tested in in-vitro and in clinical premarket studies. Subsequently the Magmaris postmarket program aimed to review intraprocedural data of at least 2000 patients to assess user preferences, guideline adherence and intraprocedural performance in clinical routine. METHODS: This international multicentre survey encompasses data from 356 hospitals across 45 countries. As part of the certification for Magmaris implantation, each hospital had to complete consecutive post-market evaluation forms of their first 10 commercial Magmaris patients. RESULTS: From June 2016 to May 2018, data on 2018 implantations were collected. Main reasons for selecting Magmaris was patients' life expectancy (67%, n = 1359) and low or not calcified lesions, (67%, n = 1357). Magmaris was successfully deployed in 99% of cases (n = 1995), predilatation was performed in 95% (n = 1922) and post-dilatation in 87% (n = 1756). Physicians rated the overall performance and the pushability as good or very good in 96% of cases (n = 1799). Guide wire friction, trackability, and conformability were rated as good or very good in 94% of cases, and crossability in 93%. The majority of patients were scheduled to receive dual antiplatelet therapy for up to 12 months. CONCLUSION: Generally, implantation guidelines were adhered to and theoretical advantages of the metal scaffold observed in in-vitro tests have translated into practice with good intraprocedural performance outcomes, confirming the controlled roll-out of this novel technology into clinical practice. SUMMARY FOR ANNOTATED TABLE OF CONTENT: The Magmaris 2000 program includes the first commercial cases at each hospital. Overall, data on 2018 implantations were collected. The high rate of pre- and post-dilatation as well as other parameters confirm that generally the implantation guidelines are adhered to and the good intraprocedural performance (rated as good or very good in 96%) confirm the theoretical advantages of a metallic scaffold in practice.
Authors: Stefan Verheye; Adrian Wlodarczak; Piero Montorsi; Jan Torzewski; Johan Bennett; Michael Haude; Gregory Starmer; Thomas Buck; Marcus Wiemer; Amin A B Nuruddin; Bryan P-Y Yan; Michael K-Y Lee Journal: Catheter Cardiovasc Interv Date: 2020-09-03 Impact factor: 2.692