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. 2021 Dec;62(3):507-518.
doi: 10.1007/s10840-020-00920-w. Epub 2021 Jan 2.

Reliability and longevity of implantable defibrillators

Robert G Hauser  1   2 , Susan A Casey  3 , Christopher B Gitter  3 , Chuen Y Tang  3 , Raed H Abdelhadi  3 , Charles C Gornick  3 , Larissa Stanberry  3 , Jay D Sengupta  3
Affiliations

Reliability and longevity of implantable defibrillators

Robert G Hauser et al. J Interv Card Electrophysiol. 2021 Dec.

Abstract

Purpose: 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.

Methods: 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.

Results: 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).

Conclusion: 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.

Keywords: Battery; Cardiac resynchronization; Implantable defibrillator; Longevity; Malfunction; Reliability.

PubMed Disclaimer

Conflict of interest statement

Dr. Hauser: Medical Advisory Board, Cardiac Insight, Inc., Bellevue, WA, USA. The other authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Reliability of CRT-D, DR-ICD, and VR-ICD pulse generators by manufacturer. Note: Biotronik plot is under the Medtronic plot
Fig. 2
Fig. 2
a Impact of malfunctions on therapy availability. b Causes of malfunctions that compromised therapy
Fig. 3
Fig. 3
Cumulative Abbott versus Medtronic battery malfunctions. The Abbott batteries were subject to an advisory in October 2016 (arrow) that alerted physicians to the potential risk of rapid battery depletion
Fig. 4
Fig. 4
Normal battery longevity of CRT-D, DR-ICD, and VR-ICD pulse generators by the manufacturer
Fig. 5
Fig. 5
Performance of CRT-D, DR-ICD, and VR-ICD pulse generators by the manufacturer
Fig. 6
Fig. 6
Comparison of subcutaneous and transvenous implantable cardioverter defibrillators
Fig. 7
Fig. 7
Longevity of lithium manganese dioxide and hybrid lithium silver vanadium oxide/carbon monofluoride batteries (NEW) compared to lithium silver vanadium oxide batteries (OLD). Data were obtained from 2019 Abbott, Biotronik, Boston Scientific, and Medtronic product performance reports
See this image and copyright information in PMC

References

    1. Moss AJ, Zareba W, Hall WJ, Klein H, Wilber DJ, Cannom DS, Daubert JP, Higgins SL, Brown MW, Andrews ML. Pro-phylactic implantation of a defibrillator in patients with myocardial infarction and reduced ejection fraction. N Engl J Med. 2002;346:877–883. doi: 10.1056/NEJMoa013474. - DOI - PubMed
    1. The Antiarrhythmics versus Implantable Defibrillators (AVID) Investigators A comparison of antiarrhythmic-drug therapy with implantable defibrillators in patients resuscitated from near-fatal ventricular arrhythmias. N Engl J Med. 1997;337:1576–1583. doi: 10.1056/NEJM199711273372202. - DOI - PubMed
    1. Bardy GH, Lee KL, Mark DB, Poole JE, Packer DL, Boineau R, Domanski M, Troutman C, Anderson J, Johnson G, McNulty SE, Clapp-Channing N, Davidson-Ray LD, Fraulo ES, Fishbein DP, Luceri RM, Ip JH. Sudden Cardiac Death in Heart Failure Trial (SCD-HeFT) Investigators. Amiodarone or an implantable cardioverter-defibrillator for congestive heart malfunction. N Engl J Med. 2005;352:225–237. doi: 10.1056/NEJMoa043399. - DOI - PubMed
    1. Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, de Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, Feldman AM. Cardiac-resynchronization therapy with or without an implantable defibrillator in advanced chronic heart malfunction. N Engl J Med. 2004;350:2140–2150. doi: 10.1056/NEJMoa032423. - DOI - PubMed
    1. Buxton AE, Lee KL, Fisher JD, Josephson ME, Prystowsky EN, Hafley G. A randomized study of the prevention of sudden death in patients with coronary artery disease. Multicenter Unsustained Tachycardia Trial Investigators. N Engl J Med. 1999;341:1882–1890. doi: 10.1056/NEJM199912163412503. - DOI - PubMed