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Abstract
PurposeWe hypothesized that data in manufacturers’ product performance reports (PPRs) can provide clinically valuable ICD and cardiac resynchronization defibrillator (CRT-D) reliability and longevity information.MethodsData 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.ResultsStudy 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).ConclusionPPRs 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.
Highlights
Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization defibrillators (CRT-Ds) are lifesaving and life-sustaining devices that must perform reliably for years [1,2,3,4,5]
We hypothesized that the data in the manufacturers’ regular product performance reports (PPRs) can be aggregated and analyzed to provide comparative ICD and CRT-D reliability and longevity information that is of value to clinicians who implant and follow these devices
The study population consisted of all Abbott, Biotronik, Boston Scientific and Medtronic, ICD, and CRT-D models that were market released in the USA from 2010 to 2019 and were powered by lithium manganese dioxide (LiMnO2) or hybrid lithium silver vanadium/ carbon monofluoride (LiSVO/CFx) batteries
Summary
Implantable cardioverter defibrillators (ICDs) and cardiac resynchronization defibrillators (CRT-Ds) are lifesaving and life-sustaining devices that must perform reliably for years [1,2,3,4,5]. Selecting the most reliable and long-lived models for implantation is an ongoing challenge for physicians [6,7,8,9]. We hypothesized that the data in the manufacturers’ regular product performance reports (PPRs) can be aggregated and analyzed to provide comparative ICD and CRT-D reliability and longevity information that is of value to clinicians who implant and follow these devices. We sought to determine if PPR data could help physicians evaluate new technologies and assess potential device performance issues
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