Mullane Steven, Hicks Jacob B, Sharmin Kazi, Harrell Camden, Rock Angie, Miller Crystal
BIOTRONIK Inc., Lake Oswego, OR, 97035, USA.
BIOTRONIK NRO INC., Lake Oswego, OR, 97035, USA.
Pragmat Obs Res. 2024 Dec 19;15:233-241. doi: 10.2147/POR.S499248. eCollection 2024.
As part of Electrophysiology Predictable and Sustainable Implementation of National Registries (EP PASSION), a multi-stakeholder collaboration between the US Food and Drug Administration (FDA), academic and society partners, and cardiovascular implantable electronic device manufacturers, a 5-year bradycardia lead study transitioned from a traditional post-approval study (PAS) to a real-world data (RWD) approach using a novel method to evaluate chronic cardiac lead complications.
Lead complications were identified using a combination of diagnosis and procedure codes from 2013 to 2020 fee-for-service Medicare claims data along with BIOTRONIK device registration and Medical Device Reporting data from patients implanted between 2013 and 2015 with a Solia S lead. A proof-of-concept analysis was performed using McNemar's test to compare lead complications reported in the traditional PAS with lead complications identified in the RWD. Kaplan-Meier survival and incidence rates were evaluated to determine real-world long-term safety.
The proof-of-concept analysis of 896 patients found in both traditional PAS and RWD sources demonstrated a 99.7% proportion of overall agreement in identifying lead complications (p = 0.0833). Following this validation, 1841 study leads from 1015 Medicare patients were analyzed. A total of 33 lead complications (attributable or possibly attributable to the study lead) were identified for a rate of 0.005 complications per lead-year. The complication-free rate at 5-years post-implant was 97.2% (95% CI: 96.07%, 98.06%).
These results led to the first FDA approval for transition of a cardiac lead PAS to long-term safety reporting using RWD, paving the way for future real-world cardiac lead and device surveillance studies.
NCT01791127.
作为国家注册电生理学可预测和可持续实施项目（EP PASSION）的一部分，该项目是美国食品药品监督管理局（FDA）、学术和社会合作伙伴以及心血管植入式电子设备制造商之间的多利益相关方合作项目，一项为期5年的心动过缓导线研究从传统的批准后研究（PAS）转变为使用一种新方法评估慢性心脏导线并发症的真实世界数据（RWD）方法。
利用2013年至2020年按服务收费的医疗保险索赔数据中的诊断和程序代码，结合BIOTRONIK设备注册信息以及2013年至2015年植入Solia S导线的患者的医疗器械报告数据，确定导线并发症。使用McNemar检验进行概念验证分析，以比较传统PAS中报告的导线并发症与RWD中确定的导线并发症。评估Kaplan-Meier生存率和发病率以确定真实世界的长期安全性。
在传统PAS和RWD来源中均发现的896例患者的概念验证分析表明，在识别导线并发症方面总体一致性比例为99.7%（p = 0.0833）。在此验证之后，对来自1015名医疗保险患者的1841根研究导线进行了分析。共确定了33例导线并发症（可归因或可能归因于研究导线），每根导线年的并发症发生率为0.005。植入后5年的无并发症率为97.2%（95%CI：96.07%，98.06%）。
这些结果导致FDA首次批准将心脏导线PAS转变为使用RWD进行长期安全性报告，为未来的真实世界心脏导线和设备监测研究铺平了道路。
NCT01791127。
