Wlodarczak Adrian, Garcia Luis Antonio Iñigo, Karjalainen Pasi P, Komócsi András, Pisano Francesco, Richter Stephan, Lanocha Magdalena, Rumoroso Jose Ramón, Leung Kwok Fai
Department of Cardiology, MCZ Hospital, Lubin, Poland.
Department of Interventional Cardiology, Hospital Costa del Sol, Marbella, Malaga, Spain.
Cardiovasc Revasc Med. 2019 Dec;20(12):1140-1145. doi: 10.1016/j.carrev.2019.02.003. Epub 2019 Feb 10.
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.
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.
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.
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.
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.
Magmaris生物可吸收镁合金支架已在体外和临床上市前研究中成功进行了测试。随后，Magmaris上市后项目旨在审查至少2000例患者的术中数据，以评估临床常规操作中的用户偏好、指南遵循情况和术中性能。
这项国际多中心调查涵盖了来自45个国家356家医院的数据。作为Magmaris植入认证的一部分，每家医院都必须填写其首批10例接受Magmaris治疗的商业患者的连续上市后评估表。
2016年6月至2018年5月，收集了2018例植入手术的数据。选择Magmaris的主要原因是患者的预期寿命（67%，n = 1359）以及病变低钙化或无钙化（67%，n = 1357）。Magmaris在99%的病例（n = 1995）中成功植入，95%（n = 1922）的病例进行了预扩张，87%（n = 1756）的病例进行了后扩张。96%的病例（n = 1799）中医生对总体性能和推送性的评价为良好或非常好。94%的病例中导丝摩擦力、可跟踪性和顺应性的评价为良好或非常好，93%的病例中通过性的评价为良好或非常好。大多数患者计划接受长达12个月的双联抗血小板治疗。
总体而言，遵循了植入指南，体外测试中观察到的金属支架的理论优势已转化为良好的术中性能结果，证实了这项新技术在临床实践中的可控推广。
Magmaris 2000项目包括每家医院的首批商业病例。总体而言，收集了2018例植入手术的数据。预扩张和后扩张的高比例以及其他参数证实，总体上遵循了植入指南，良好的术中性能（96%评价为良好或非常好）证实了金属支架在实践中的理论优势。
