Unexpected high failure rate of a specific MicroPort/LivaNova/Sorin pacing lead.
Aged
Aged, 80 and over
Electrodes, Implanted
/ adverse effects
Equipment Design
Equipment Failure
/ statistics & numerical data
Female
Follow-Up Studies
Foreign-Body Migration
/ complications
Heart Injuries
/ epidemiology
Humans
Incidence
Male
Pacemaker, Artificial
/ adverse effects
Registries
Retrospective Studies
Switzerland
/ epidemiology
Beflex
CapSureFix
Complication
Lead failure
Lead survival
Medtronic
MicroPort
Oversensing
Pacemaker
Vega
Journal
Heart rhythm
ISSN: 1556-3871
Titre abrégé: Heart Rhythm
Pays: United States
ID NLM: 101200317
Informations de publication
Date de publication:
01 2021
01 2021
Historique:
received:
17
05
2020
revised:
01
08
2020
accepted:
09
08
2020
pubmed:
18
8
2020
medline:
18
11
2021
entrez:
18
8
2020
Statut:
ppublish
Résumé
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). The purpose of this study was to investigate failure rates of Beflex/Vega leads. 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. 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). 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.
Sections du résumé
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.
Identifiants
pubmed: 32798776
pii: S1547-5271(20)30765-7
doi: 10.1016/j.hrthm.2020.08.010
pii:
doi:
Types de publication
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
41-49Commentaires et corrections
Type : CommentIn
Type : CommentIn
Informations de copyright
Copyright © 2020 Heart Rhythm Society. Published by Elsevier Inc. All rights reserved.