Evidence map›Paper›PMID 39344010›Full record

ArticleJournal of cardiovascular electrophysiology2024

Comparing complication rates between Abbott Tendril 2088 and competitive manufacturer leads: Novel real-world data approach.

Aamir Ahmed, Bruce L Wilkoff, Jeeyun A Kim, Yelena Nabutovsky, Grant Kim, Matthew Desmond, Leonard Ganz, Anne B Curtis

Abstract readComparative Study
In one paragraph

Article in Journal of cardiovascular electrophysiology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Aamir AhmedDepartment of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.ORCID 0009-0000-0025-7429
Bruce L WilkoffCleveland Clinic Heart, Thoracic, and Vascular Institute, Cleveland, Ohio, USA.
Jeeyun A KimAbbott Laboratories, Sylmar, California, USA.
Yelena NabutovskyAbbott Laboratories, Sylmar, California, USA.
Grant KimAbbott Laboratories, Sylmar, California, USA.
Matthew DesmondAbbott Laboratories, Sylmar, California, USA.
Leonard GanzAbbott Laboratories, Sylmar, California, USA.
Anne B CurtisDepartment of Medicine, Jacobs School of Medicine and Biomedical Sciences, University at Buffalo, Buffalo, New York, USA.ORCID 0000-0002-9115-8051

Funding

Abbott Laboratories
6 · The paper itself

Abstract

introductionWhile several studies have reported on the reliability of cardiac pacing leads, there are limited comparative data on lead performance. We compared long-term performance of Abbott Tendril™ STS 2088TC (Tendril 2088) leads with competitive manufacturer (CM) pacing leads using novel real-world data analytic methods.

methodsMedicare fee-for-service (FFS) claims and Abbott device registration databases were linked to identify patients implanted with single-chamber or dual-chamber pacemakers with the Abbott Tendril 2088 lead from January 1, 2014 to December 31, 2019 and were followed through December 31, 2021. Medicare pacemaker patients who did not link to Abbott devices were assumed to have CM leads. Patients in both groups had to be enrolled in Medicare FFS at least 1 year before implant date and have an initial pacemaker and associated lead(s) implanted on the same date. Lead complications were identified based on a diagnosis code for a mechanical lead complication and a procedure code for a lead-related surgery on the same claim. Kaplan-Meier curves for lead intervention-free survival rates for up to 7 years of follow-up were compared between groups at the device level using a log-rank test.

resultsThe study cohort had 89 629 Tendril 2088 and 433 481 CM lead patients. Groups were comparable in age (79.7 ± 8.6 years), sex (52.2% male), race/ethnicity, and baseline comorbidities. At 7 years, there was no significant difference in intervention-free survival rates between groups (97.48% Tendril 2088 vs. 97.52% CM, p = .3435).

conclusionIn this large Medicare population, there was no significant difference in lead complication rates between Tendril 2088 and CM pacing leads over 7 years of follow-up.

Indexed as

Databases, FactualMedicarePacemaker, ArtificialAdministrative Claims, HealthcareAgedAged, 80 and overCardiac Pacing, ArtificialEquipment DesignEquipment FailureFee-for-Service PlansFemaleHumansMaleRetrospective StudiesRisk AssessmentRisk Factorslead complicationslead safetypacingreal‐world evidenceTendril STS 2088TC

Identifiers

PMID39344010
PMCPMC11650435

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.