Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America.
Section of Interventional Cardiology, MedStar Washington Hospital Center, Washington, DC, United States of America; Cardiovascular Branch, Division of Intramural Research, National Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD, United States of America.
Cardiovasc Revasc Med. 2021 Jun;27:57-62. doi: 10.1016/j.carrev.2020.08.038. Epub 2020 Aug 27.
BACKGROUND/PURPOSE: Coronary artery calcification is a marker of advanced atherosclerosis and a predictor of adverse clinical outcomes. Rotational atherectomy (RA) can effectively modify calcified lesions, optimizing procedural outcomes. We interrogated the most commonly reported adverse events involving rotational atherectomy systems (Rotablator and Rotapro) by analyzing post-marketing surveillance data from the Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) database.
METHODS/MATERIALS: We queried MAUDE from September 1, 2016, through December 31, 2019. After excluding duplicate reports, we included 363 reports for Rotablator and 63 reports for Rotapro in the final analysis.
Percentages represent the proportion of total submitted MAUDE reports. The most commonly reported complications for Rotablator and Rotapro included dissection (2.7% and 6.3%, respectively) and perforation (4.1% and 19%, respectively). The most commonly reported device-related issues included detachment or structural damage, or both, for Rotablator (39.1%) and entrapment of the device component for Rotapro (47.6%). The most commonly damaged device component was the Rotawire, whereas the most commonly entrapped device component was the Rotaburr for both device configurations. Rotablator and Rotapro device-related complications were most commonly reported for the left anterior descending artery.
An analysis of the MAUDE database demonstrates that in real-world practice, RA devices are associated with important complications. Ongoing surveillance of safety profiles, patient outcomes, and failure modes of RA devices is warranted. Our analysis provides important insights into the mechanisms of failure of RA devices and associated complications but cannot verify causality.
背景/目的：冠状动脉钙化是动脉粥样硬化进展的标志物，也是不良临床结局的预测因子。旋磨术（RA）可以有效地修饰钙化病变，优化手术结果。我们通过分析食品和药物管理局制造商和用户设施设备经验（MAUDE）数据库的上市后监测数据，研究了最常报道的涉及旋磨术系统（Rotablator 和 Rotapro）的不良事件。
方法/材料：我们从 2016 年 9 月 1 日至 2019 年 12 月 31 日查询了 MAUDE。排除重复报告后，我们将 363 份 Rotablator 报告和 63 份 Rotapro 报告纳入最终分析。
百分比表示提交的 MAUDE 报告总数的比例。Rotablator 和 Rotapro 最常报告的并发症分别为夹层（2.7%和 6.3%）和穿孔（4.1%和 19%）。Rotablator 最常报告的设备相关问题包括分离或结构损坏，或两者兼而有之（39.1%），而 Rotapro 最常报告的设备相关问题是设备部件的嵌顿（47.6%）。最常损坏的设备部件是 Rotawire，而最常嵌顿的设备部件是 Rotaburr，这两种设备配置都是如此。Rotablator 和 Rotapro 设备相关并发症最常发生在前降支。
对 MAUDE 数据库的分析表明，在实际实践中，RA 设备与重要并发症有关。需要对 RA 设备的安全概况、患者结局和故障模式进行持续监测。我们的分析提供了对 RA 设备故障机制和相关并发症的重要见解，但不能验证因果关系。
