Elsevier

Heart Rhythm

Volume 18, Issue 1, January 2021, Pages 41-49
Heart Rhythm

Clinical
Devices
Unexpected high failure rate of a specific MicroPort/LivaNova/Sorin pacing lead

https://doi.org/10.1016/j.hrthm.2020.08.010Get rights and content

Background

Pacing leads are the Achilles heel of pacemakers. Most manufacturers report a 3-year survival rate of >99% of their leads. We observed several failures of the Beflex/Vega leads (MicroPort, Shanghai, China; formerly Sorin/LivaNova).

Objective

The purpose of this study was to investigate failure rates of Beflex/Vega leads.

Methods

We analyzed the performance of Beflex/Vega leads implanted at our tertiary referral center. All-cause lead failures (any issues requiring reinterventions such as lead dislocations, cardiac perforations, and electrical abnormalities) were identified during follow-up. The Beflex/Vega lead was compared with a reference lead (CapSureFix Novus 5076, Medtronic, Minneapolis, MN) implanted within the same period and by the same operators.

Results

A total of 585 leads were analyzed (382 Beflex/Vega and 203 CapSureFix Novus 5076 leads). Cumulative failure rate estimates were 5.2%, 6.3%, and 12.4% after 1, 2, and 3 years for the Beflex/Vega lead. This was worse compared to the reference lead (1.5%, 1.5%, 3.7% after 1, 2, and 3 years; P = .001). Early failure manifestations up to 3 months occurred at a similar rate (Beflex/Vega vs CapSureFix Novus 5076 lead: 1.3% vs 0.5% for dislocations; 1.3% vs 1.0% for perforations). During follow-up, electrical abnormalities such as noise oversensing (P = .013) and increased pacing thresholds (P = .003) became more frequent in the Beflex/Vega group. Electrical abnormalities were the most common failure manifestation 3 years after implantation in this group (9.4% vs 2.2% for the CapSureFix Novus 5076).

Conclusion

The failure rate of the Beflex/Vega lead of >10% after 3 years was higher than that of a competitor lead. This gives rise to concern since >135,000 such leads are active worldwide.

Introduction

Leads are the most vulnerable parts of permanent pacemaker (PM) and implantable cardioverter-defibrillator (ICD) systems. Lead-related failures are relatively common1 and exhibit various mechanisms, ranging from dislocations and cardiac perforations to structural failures (eg, conductor fractures and insulation defects).

The impact of lead failures is significant. In recent years, different ICD leads such as Sprint Fidelis 69492 (Medtronic, Minneapolis, MN) or Riata/Riata ST3,4 (Abbott/St. Jude Medical, North Chicago, IL) were recalled because of unexpected high failure rates. The clinical presentation varies depending on the failure manifestation but may result in dramatic adverse events such as inadequate ICD shocks.5 Despite the lower design complexity of PM leads compared with ICD leads, various PM leads have exhibited unusually high failure rates as well,6, 7, 8 presenting as incidental finding but also resulting in syncope or major secondary complications related to lead revision.9

On the basis of our clinical observation of several index patients who experienced lead failures, we investigated systematically the performance of the Beflex/Vega lead (MicroPort, Shanghai, China; formerly Sorin/LivaNova). According to MicroPort, this lead has a 3-year survival rate of >99.8%, which seemed not to reflect our initial experience.10

Section snippets

Study design

In this single-center retrospective study, we assessed the performance of all MicroPort Beflex/Vega PM leads implanted de novo between January 2014 and January 2018 at our high-volume tertiary care center (>700 device implantations in 2019). As a reference benchmark, we chose all Medtronic CapSureFix Novus 5076 leads (Medtronic) implanted during the same period by the same operators.

All patients had a guideline-conformant PM indication. Patients were identified retrospectively via the Web-based

Patient characteristics

Table 1 summarizes the key patient baseline characteristics at the time of implantation. There were no differences between the Beflex/Vega group and the CapSureFix Novus 5076 group, except for a higher prevalence of arterial hypertension in patients of the Beflex/Vega group.

PM lead survival

In total, 382 Beflex/Vega and 203 CapSureFix Novus 5076 leads were included in the performance analysis. The median follow-up for all leads was 20.4 months (IQR 13.8–33.3 months); for the Beflex/Vega lead, 15.4 months (IQR

Discussion

In this investigator-initiated observational study, we found an unexpectedly high rate of lead failures with the Beflex/Vega lead, which was significantly higher than that of a reference lead from a competitor. The observed number of lead failures gives rise to concerns given that >135,000 such leads are currently active worldwide.

Conclusion

The failure rate of the Beflex/Vega lead of >10% after 3 years was significantly higher than that of a competitor lead and raises concern since >135,000 such leads are currently active worldwide.

Acknowledgments

We thank Florian Schüffelgen (MicroPort) and Martin Wynistorf (Medtronic) for providing us additional technical information and illustrations on the lead design.

References (20)

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  • Electrical abnormalities with St. Jude/Abbott pacing leads: A systematic review and meta-analysis

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    When leads were compared in a pairwise fashion to all other leads, Abbott leads (RR 7.81; 95% CI 3.21–19.04) (Figure 1) and MicroPort leads (RR 5.58; 95% CI 1.32–23.56) demonstrated an increased risk of abnormalities whereas Medtronic leads (RR 0.18; 95% CI 0.09–0.36) and Boston Scientific leads (RR 0.26; 95% CI 0.15–0.45) were associated with a decreased risk of lead abnormalities. It should be noted that the MicroPort data are based on a single study of the Beflex/Vega lead.27 The weighted mean time to abnormality for Abbott leads was 3.7 years in studies in which it was reported, and there was no difference between Abbott leads and non-Abbott leads (mean difference −1.28; 95% CI −3.58 to 1.01).

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Funding sources: The authors have no funding sources to disclose.

Disclosures: Dr Haeberlin has received a travel grant from Medtronic for work outside this study. He is a consultant for Cairdac and a co-founder and head of Act-Inno and has received research funding from Novartis. Dr Baldinger has received travel grants from MicroPort, Biosense Webster, and Boston Scientific as well as research support from Biosense Webster. Dr Tanner has received a travel grant from Abbott. Dr Roten is a consultant for Medtronic and Abbott. Dr Reichlin is a consultant for Medtronic. He has received speaker’s honoraria, travel, or institutional support from Abbott, Bayer, Biotronik, Biosense Webster, Bristol Myers Squibb, Boston Scientific, Daiichi, Medtronic, MicroPort, and Pfizer. Dr Noti is a consultant for Medtronic and has received a travel grant from Boston Scientific and speaker honoraria from Medtronic and Abbott. The rest of the authors report no conflicts of interest.

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Drs Haeberlin and Anwander contributed equally.

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