BIOTRONIK ICD和CRT-D电池寿命的全球数据分析。

IF 2.6
David Hayes, Christian Ramharter, Stefan Paule, Daniele Giacopelli, Bobak Salehi, Volker Lang
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引用次数: 0

摘要

背景:电池寿命是选择植入式心律转复除颤器(ICDs)和心脏再同步治疗除颤器(CRT-Ds)的关键考虑因素,对临床结果和医疗成本都有影响。最近的一项研究表明,BIOTRONIK设备的电池寿命比预期的要短,这引发了一场全面的内部分析。该分析旨在利用全球远程监测数据,评估BIOTRONIK高压设备(icd和crt - d)三代的实际电池寿命。方法:利用BIOTRONIK家庭监测服务中心的数据,对2006年至2024年间植入的215,471台BIOTRONIK器械进行分析。设备分为三代(BIO 2000, 2010, 2020),并按类型分层:单室ICD (VR),双室ICD (DR), CRT-D和单导联心房浮动双极子ICD (DX)。Kaplan-Meier生存分析用于估计中位服务时间,外推法应用于审查数据。结果:中位服务时间在各代之间显著增加(p < 0.001): VR设备从92(四分位数范围72-106)改善到175(169-182)个月(+89%),DR从73(63-93)改善到155(132-168)个月(+108%),CRT-D从72(62-79)到111(95-126)个月(+52%),DX从97(92-101)到170(163-175)个月(+74%)。与DR设备相比,DX设备的寿命更长。结论:bitroonik icd和crt - d的电池寿命每一代都有显著提高。较新的设备显示服务时间达到或高于行业标准,支持其临床和经济价值。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Worldwide data analysis of BIOTRONIK ICD and CRT-D battery longevity.

Background: Battery longevity is a key consideration in the selection of implantable cardioverter-defibrillators (ICDs) and cardiac resynchronization therapy defibrillators (CRT-Ds), with implications for both clinical outcomes and healthcare costs. A recent study suggested shorter-than-expected battery life for BIOTRONIK devices, prompting a comprehensive internal analysis. This analysis aimed to evaluate the real-world battery longevity of BIOTRONIK high-voltage devices (ICDs and CRT-Ds) across three generations, using global remote monitoring data.

Methods: A total of 215,471 BIOTRONIK devices implanted between 2006 and 2024 were analyzed using data from the BIOTRONIK Home Monitoring Service Center. Devices were grouped into three generations (BIO 2000, 2010, 2020) and stratified by type: single-chamber ICD (VR), dual-chamber ICD (DR), CRT-D, and single-lead ICD with an atrial floating dipole (DX). Kaplan-Meier survival analysis was used to estimate median service times, with extrapolation applied to censored data.

Results: Median service times increased substantially across generations (p < 0.001): VR devices improved from 92 (interquartile range 72-106) to 175 (169-182) months (+89%), DR from 73 (63-93) to 155 (132-168) months (+108%), CRT-D from 72 (62-79) to 111 (95-126) months (+52%), and DX from 97 (92-101) to 170 (163-175) months (+74%). DX devices demonstrated superior longevity compared to DR devices.

Conclusion: Battery longevity of BIOTRONIK ICDs and CRT-Ds has improved markedly with each generation. Newer devices demonstrate service times at or above industry standards, supporting their clinical and economic value.

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