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心脏再同步治疗除颤器的电池寿命:制造商之间的差异以及与已发表的产品性能报告的不符之处。

Battery longevity from cardiac resynchronization therapy defibrillators: differences between manufacturers and discrepancies with published product performance reports.

作者信息

Alam Mian Bilal, Munir Muhammad Bilal, Rattan Rohit, Adelstein Evan, Jain Sandeep, Saba Samir

出版信息

Europace. 2017 Mar 1;19(3):421-424. doi: 10.1093/europace/euw044.

DOI:10.1093/europace/euw044
PMID:27009183
Abstract

AIMS

Cardiac resynchronization therapy (CRT) is an important treatment for heart failure that requires constant ventricular pacing, placing a high energy burden on CRT defibrillators (CRT-D). Longer battery life reduces the need for device changes and associated complications, thereby affecting patient outcomes and cost of care. We therefore investigated the time to battery depletion of CRT-D from different manufacturers and compared these results with manufacturers' published product performance reports (PPRs).

METHODS AND RESULTS

All CRT-D recipients at our institution between January 2008 and December 2010 were included in this study cohort. The patients were followed up to the endpoint of battery depletion and were otherwise censored at the time of death, last follow-up, or device removal for any reason other than battery depletion. A total of 621 patients [173 Boston Scientific (BSC), 391 Medtronic (MDT), and 57 St. Jude Medical (SJM)] were followed up for a median of 3.7 (IQR 1.6-5.0) years, during which time 253 (41%) devices were replaced for battery depletion. Compared with MDT devices, battery depletion was 85 and 54% less likely to happen with BSC and SJM devices, respectively (P < 0.001 for pairwise comparisons). Product performance reports from all manufacturers significantly overestimated battery longevity by more than 20% 6 years after device implantation.

CONCLUSIONS

Large differences in CRT-D battery longevity exist between manufacturers. Industry-published PPRs significantly overestimate device longevity. These data have important implications to patients, healthcare professionals, hospitals, and third-party payers.

摘要

目的

心脏再同步治疗(CRT)是心力衰竭的一种重要治疗方法,需要持续的心室起搏,这给CRT除颤器(CRT-D)带来了很高的能量负担。更长的电池寿命可减少设备更换的需求及相关并发症,从而影响患者的治疗结果和护理成本。因此,我们研究了不同制造商生产的CRT-D的电池耗尽时间,并将这些结果与制造商公布的产品性能报告(PPR)进行比较。

方法和结果

本研究队列纳入了2008年1月至2010年12月期间在我们机构接受CRT-D治疗的所有患者。对患者进行随访直至电池耗尽终点,在死亡、最后一次随访或因电池耗尽以外的任何原因取出设备时进行截尾。总共621例患者[173例波士顿科学公司(BSC)、391例美敦力公司(MDT)和57例圣犹达医疗公司(SJM)]接受了中位时间为3.7(四分位间距1.6 - 5.0)年的随访,在此期间,253台(41%)设备因电池耗尽而被更换。与MDT设备相比,BSC和SJM设备电池耗尽的可能性分别降低了85%和54%(两两比较P < 0.001)。所有制造商的产品性能报告均显著高估了设备植入6年后的电池寿命,高估幅度超过20%。

结论

不同制造商生产的CRT-D电池寿命存在很大差异。行业公布的PPR显著高估了设备寿命。这些数据对患者、医疗保健专业人员、医院和第三方支付者具有重要意义。

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