Ahmed Aamir, Wilkoff Bruce L, Kim Jeeyun A, Nabutovsky Yelena, Kim Grant, Desmond Matthew, Ganz Leonard, Curtis Anne B
Department of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.
Division of Cardiology, Northwestern University, Feinberg School of Medicine, Chicago, Illinois, USA.
J Cardiovasc Electrophysiol. 2024 Dec;35(12):2305-2311. doi: 10.1111/jce.16437. Epub 2024 Sep 29.
While several studies have reported on the reliability of cardiac pacing leads, there are limited comparative data on lead performance. We compared long-term performance of Abbott Tendril™ STS 2088TC (Tendril 2088) leads with competitive manufacturer (CM) pacing leads using novel real-world data analytic methods.
Medicare fee-for-service (FFS) claims and Abbott device registration databases were linked to identify patients implanted with single-chamber or dual-chamber pacemakers with the Abbott Tendril 2088 lead from January 1, 2014 to December 31, 2019 and were followed through December 31, 2021. Medicare pacemaker patients who did not link to Abbott devices were assumed to have CM leads. Patients in both groups had to be enrolled in Medicare FFS at least 1 year before implant date and have an initial pacemaker and associated lead(s) implanted on the same date. Lead complications were identified based on a diagnosis code for a mechanical lead complication and a procedure code for a lead-related surgery on the same claim. Kaplan-Meier curves for lead intervention-free survival rates for up to 7 years of follow-up were compared between groups at the device level using a log-rank test.
The study cohort had 89 629 Tendril 2088 and 433 481 CM lead patients. Groups were comparable in age (79.7 ± 8.6 years), sex (52.2% male), race/ethnicity, and baseline comorbidities. At 7 years, there was no significant difference in intervention-free survival rates between groups (97.48% Tendril 2088 vs. 97.52% CM, p = .3435).
In this large Medicare population, there was no significant difference in lead complication rates between Tendril 2088 and CM pacing leads over 7 years of follow-up.
虽然有多项研究报告了心脏起搏导线的可靠性，但关于导线性能的比较数据有限。我们使用新颖的真实世界数据分析方法，比较了雅培Tendril™ STS 2088TC（Tendril 2088）导线与竞争制造商（CM）起搏导线的长期性能。
将医疗保险按服务收费（FFS）索赔数据和雅培设备注册数据库相链接，以识别在2014年1月1日至2019年12月31日期间植入带有雅培Tendril 2088导线的单腔或双腔起搏器的患者，并随访至2021年12月31日。未与雅培设备相链接的医疗保险起搏器患者被假定植入的是CM导线。两组患者在植入日期前至少1年必须已参加医疗保险FFS，且在同一日期植入初始起搏器及相关导线。根据同一份索赔中机械性导线并发症的诊断代码和与导线相关手术的操作代码来识别导线并发症。使用对数秩检验在设备层面比较两组长达7年随访期的无导线干预生存率的Kaplan-Meier曲线。
研究队列中有89629例植入Tendril 2088导线的患者和433481例植入CM导线的患者。两组在年龄（79.7±8.6岁）、性别（男性占52.2%）、种族/民族和基线合并症方面具有可比性。在7年时，两组的无干预生存率无显著差异（Tendril 2088为97.48%，CM为97.52%，p = 0.3435）。
在这个庞大的医疗保险人群中，随访7年期间，Tendril 2088导线和CM起搏导线的导线并发症发生率无显著差异。
