Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts 02115, USA.
JACC Cardiovasc Interv. 2012 Jan;5(1):82-9. doi: 10.1016/j.jcin.2011.09.017.
This study sought to quantify the learning curve for the safety and effectiveness of a newly introduced vascular closure device through evaluation of the NCDR (National Cardiovascular Data Registry) CathPCI clinical outcomes registry.
The impact of learning on the clinical outcomes complicates the assessment of the safety and efficacy during the early experience with newly introduced medical devices.
We performed a retrospective analysis of the relationship between cumulative institutional experience and clinical device success, defined as device deployment success and freedom from any vascular complications, for the StarClose vascular closure device (Abbott Vascular, Redwood City, California). Generalized estimating equation modeling was used to develop risk-adjusted clinical success predictions that were analyzed to quantify learning curve rates.
A total of 107,710 procedures used at least 1 StarClose deployment, between January 1, 2006, and December 31, 2007, with overall clinical success increasing from 93% to 97% during the study period. The learning curve was triphasic, with an initial rapid learning phase, followed by a period of declining rates of success, followed finally by a recovery to a steady-state rate of improved device success. The rates of learning were influenced positively by diagnostic (vs. percutaneous coronary intervention) procedure use and teaching status and were affected inversely by annual institutional volume.
An institutional-level learning curve for the initial national experience of StarClose was triphasic, likely indicating changes in patient selection and expansion of number of operators during the initial phases of device adoption. The rate of learning was influenced by several institutional factors, including overall procedural volume, utilization for percutaneous coronary intervention procedures, and teaching status.
本研究通过评估 NCDR（国家心血管数据注册） CathPCI 临床结果注册，旨在量化新引入的血管闭合装置的安全性和有效性的学习曲线。
学习对临床结果的影响使评估新引入的医疗器械早期经验中的安全性和疗效变得复杂。
我们对机构累计经验与临床器械成功（定义为器械部署成功且无任何血管并发症）之间的关系进行了回顾性分析，使用 StarClose 血管闭合装置（加利福尼亚州雷德伍德市 Abbott Vascular）。使用广义估计方程模型对风险调整后的临床成功预测进行分析，以量化学习曲线率。
2006 年 1 月 1 日至 2007 年 12 月 31 日期间，共有 107710 例手术至少使用 1 次 StarClose 部署，整体临床成功率从研究期间的 93%增加到 97%。学习曲线呈三阶段，初始快速学习阶段，随后成功率下降，最后恢复到稳定的器械成功率提高阶段。学习的速度受到诊断（与经皮冠状动脉介入治疗相比）程序使用和教学状态的积极影响，而受到机构年度容量的负面影响。
StarClose 的初始全国经验的机构水平学习曲线呈三阶段，可能表明在设备采用的初始阶段患者选择和操作人员数量的扩张发生了变化。学习速度受到几个机构因素的影响，包括整体手术量、经皮冠状动脉介入治疗程序的使用情况和教学状态。
