Minneapolis Heart Institute Foundation, 920 East 28th Street, Minneapolis, MN, 55407, USA.
Minneapolis Heart Institute Foundation, 800 E 28th St, Minneapolis, MN, 55407, USA.
J Interv Card Electrophysiol. 2021 Dec;62(3):507-518. doi: 10.1007/s10840-020-00920-w. Epub 2021 Jan 2.
We hypothesized that data in manufacturers' product performance reports (PPRs) can provide clinically valuable ICD and cardiac resynchronization defibrillator (CRT-D) reliability and longevity information.
Data were obtained from 2019 PPRs. Kaplan-Meier (K-M) probabilities of freedom from malfunction, normal battery depletion (NBD), and NBD + malfunction were calculated for ICD and CRT-D pulse generators (PGs) with LiMnO2 or LiSVO/CFx batteries marketed in the USA from 2010 to 2019 and compared using the log-rank test. Malfunctions (MAL) included PGs that were found outside specifications.
Study population included 1,149,803 ICD and CRT-D PGs: Abbott (ABT; 35.1%), Biotronik (BIO; 4.6%), Boston Scientific (BSC; 23.5%), and Medtronic (MDT; 36.9%). Significant differences in reliability (p < 0.001), defined by freedom from MAL, were found between manufacturers; the majority of 6808 MAL occurred in ABT devices (n = 4045; 59.4%), followed by BSC (n = 2384; 35.0%), MDT (n = 338;5.0%), and BIO (n = 41; 0.6%). Battery failure (n = 890; 57.9%) was the most common cause of MAL compromising therapy; analysis of unique ABT battery MAL-indicated problem appeared a year prior to advisory. Significant differences (p < 0.001) in battery longevity, as defined by freedom from NBD, were found between manufacturers. Overall performance (freedom from NBD + MAL) favored BSC for CRT-D PGs and MDT and BIO for ICDs. BSC subcutaneous ICD reliability was inferior to its transvenous ICD (p < 0.001).
PPRs contain valuable data that can be aggregated and analyzed to inform physicians. Differences in product reliability exist between manufacturers. Battery longevity has improved, but MAL have significantly impacted performance. PPR data may be useful for assessing product problems and new technology.
我们假设制造商的产品性能报告（PPR）中的数据可以提供有价值的 ICD 和心脏再同步除颤器（CRT-D）的可靠性和寿命信息。
数据来自 2019 年的 PPR。对 2010 年至 2019 年在美国上市的使用 LiMnO2 或 LiSVO/CFx 电池的 ICD 和 CRT-D 脉冲发生器（PG），计算无故障、正常电池耗尽（NBD）和 NBD+故障的 Kaplan-Meier（K-M）概率，并使用对数秩检验进行比较。故障（MAL）包括超出规格的 PG。
研究人群包括 1149803 例 ICD 和 CRT-D PG：雅培（ABT；35.1%）、百多力（BIO；4.6%）、波士顿科学（BSC；23.5%）和美敦力（MDT；36.9%）。制造商之间的可靠性（通过 MAL 定义）存在显著差异（p<0.001）；大多数 6808 例 MAL 发生在 ABT 设备（n=4045；59.4%），其次是 BSC（n=2384；35.0%）、MDT（n=338；5.0%）和 BIO（n=41；0.6%）。电池故障（n=890；57.9%）是导致 MAL 中断治疗的最常见原因；对 ABT 独特电池 MAL 指示问题的分析表明，该问题出现在咨询前一年。制造商之间的电池寿命（通过 NBD 定义）存在显著差异（p<0.001）。整体性能（NBD+MAL 无故障）BSC 有利于 CRT-D PG，MDT 和 BIO 有利于 ICD。BSC 皮下 ICD 的可靠性低于其经静脉 ICD（p<0.001）。
PPR 包含有价值的数据，可以进行汇总和分析，为医生提供信息。制造商之间的产品可靠性存在差异。电池寿命有所提高，但 MAL 显著影响了性能。PPR 数据可能有助于评估产品问题和新技术。
